Impact of Decision Aids for Shared Decision-Making for Patients with Early Stage Breast Cancer: A Systematic Review

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

The purpose of this review is to evaluate the effectiveness of patient decision aids for women with early-stage breast cancer with respect to decision-making outcomes, psychological variables, and quality of life.

The authors cite a previous review on this topic, published in 2016. The aim is to update the literature from the last 10 years. Since this time, other similar reviews have been published that the authors should acknowledge.

Williams, T., Fine, K., Duckworth, E., Adam, T., Bozigar, C., McFarland, A., Nguyen, A., Coles, B. M., & Galiano, R. D. (2025). Patient decision aids in breast surgery and breast reconstruction reduce decisional conflict: a systematic review and meta-analysis. Breast cancer research and treatment, 213(1), 1–14. https://doi.org/10.1007/s10549-025-07752-0

Lopez-Fernandez, O.; Aguilar Castillo, C.P.; Horrillo, B.; Sánchez de Molina Ramperez, M.L.; Guadalajara, H. The Implementation of Shared Decision-Making Using Patient Decision Aid Tools to Select Breast Cancer Treatment Options: A Systematic Review in the Time of Minimum Quality Standards. Healthcare 2025, 13, 748. https://doi.org/10.3390/healthcare13070748

Su, Y., Sun, C. Y., Chiu, W. K., Kang, Y. N., & Chen, C. (2024). Patient Decision Aids for Breast Cancer Reconstruction: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials. Plastic and reconstructive surgery, 154(5), 929–940. https://doi.org/10.1097/PRS.0000000000011292

Si, J., Guo, R., Lu, X. et al. Decision aids on breast conserving surgery for early stage breast cancer patients: a systematic review. BMC Med Inform Decis Mak 20, 275 (2020). https://doi.org/10.1186/s12911-020-01295-8

 

I have several concerns with the methodological conduct/reporting of the review: 

• The eligibility criteria should be clarified. The authors state that all study designs were included, but then criterion 2) says it must be a cohort study. However, to answer a question of effectiveness, some type of intervention should be included (as stated in the PICO).
• Were the full texts reviewed independently (e.g., using blind mode in Rayyan)?
• The results of the search should be in the results section, not the methods
• How is “early stage” defined in the context of this review?
• Table 1 belongs in the results section, not the methods
• It seems it would be important to also report on study design in Table 1, and incorporate the strength of design into the interpretation of findings (e.g., RCT vs. single-arm study)
• Is it possible for study details in Tables 1 and 2 to be presented together? It is very hard for the reader to follow; I think there are lots of spaces where the text could be condensed
• Table 3 should be presented in the results, not the methods
  • Suggest making the full results of the quality assessment available in an appendix, and integrate a summary of the study quality into other tables, or as a figure to show the quality of the body of evidence as a whole.
• The methods are missing a discussion about how data were synthesized and analyzed

Results

• It is surprising to me that only 26 studies were included, when in the previous review that the authors cited, 33 articles were included.
  • I do have concerns about the search strategy, given the very small numbers the search returned. I think the string related to ‘early stage’ may have been overly restrictive. In comparison, the search in the older review the authors are aiming to update identified 2185 references, and this was 10 years ago.
• Given the similarities in the outcomes reported, why was a meta-analysis not conducted?
• I think it would be important to structure the results based on the types of decisions or type of decision aid, rather than collapsing everything together, given the diversity of intervention approaches. A PDA is not a single thing, and thus should not be treated as such.
• I appreciate the explicit focus on low SES and low literacy populations; however, these results should be presented within the larger body of evidence, and then any findings specific to this group highlighted.

Comments on the Quality of English Language

There were several grammatical mistakes throughout that should be thoroughly reviewed prior to resubmission. 

Author Response

REVIEWER 1

• The purpose of this review is to evaluate the effectiveness of patient decision aids for women with early-stage breast cancer with respect to decision-making outcomes, psychological variables, and quality of life.

The authors cite a previous review on this topic, published in 2016. The aim is to update the literature from the last 10 years. Since this time, other similar reviews have been published that the authors should acknowledge.

Williams, T., Fine, K., Duckworth, E., Adam, T., Bozigar, C., McFarland, A., Nguyen, A., Coles, B. M., & Galiano, R. D. (2025). Patient decision aids in breast surgery and breast reconstruction reduce decisional conflict: a systematic review and meta-analysis. Breast cancer research and treatment, 213(1), 1–14. https://doi.org/10.1007/s10549-025-07752-0

Lopez-Fernandez, O.; Aguilar Castillo, C.P.; Horrillo, B.; Sánchez de Molina Ramperez, M.L.; Guadalajara, H. The Implementation of Shared Decision-Making Using Patient Decision Aid Tools to Select Breast Cancer Treatment Options: A Systematic Review in the Time of Minimum Quality Standards. Healthcare 2025, 13, 748. https://doi.org/10.3390/healthcare13070748

Su, Y., Sun, C. Y., Chiu, W. K., Kang, Y. N., & Chen, C. (2024). Patient Decision Aids for Breast Cancer Reconstruction: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials. Plastic and reconstructive surgery, 154(5), 929–940. https://doi.org/10.1097/PRS.0000000000011292

Si, J., Guo, R., Lu, X. et al. Decision aids on breast conserving surgery for early stage breast cancer patients: a systematic review. BMC Med Inform Decis Mak 20, 275 (2020). https://doi.org/10.1186/s12911-020-01295-8

Thank you for this valuable comment. We agree that several systematic reviews on Patient Decision Aids (PDAs) in breast cancer have been published since the review by Zdenkowski et al. (2016). However, our review was designed with a different and more specific objective. Rather than focusing on a single treatment decision (e.g., breast surgery or breast reconstruction), we aimed to provide a comprehensive synthesis of PDAs developed for women with early-stage breast cancer across the entire treatment pathway, while specifically restricting our review to interventions explicitly developed within the Shared-Decision Making (SDM) framework to ensure conceptual consistency. For this reason, the reviews by Si et al. (2020), Su et al. (2024), and Williams et al. (2025), which focus on specific treatment decisions or narrower clinical contexts, were not considered directly comparable to the scope of the present review. Regarding the review by López-Fernández et al. (2025), this work became available while our review was already underway. Our protocol had been prospectively registered in PROSPERO (CRD42024597666) in October 2024, and the initial literature search was conducted shortly thereafter. Following the review process, we updated our search to include studies published up to December 2025. Although the review by López-Fernández et al. was not identified during our original search, we have now carefully examined it and revised the Introduction and Discussion to better clarify the distinctive aims and scope of the present review and to acknowledge this recently published contribution.

I have several concerns with the methodological conduct/reporting of the review: 

• The eligibility criteria should be clarified. The authors state that all study designs were included, but then criterion 2) says it must be a cohort study. However, to answer a question of effectiveness, some type of intervention should be included (as stated in the PICO).

 

Thank you for this helpful comment. We agree that the eligibility criteria required further clarification. In the revised manuscript, we have revised the Methods section to clearly specify the eligible study designs and to ensure consistency between the PICOS framework and the inclusion criteria. We also clarified that the intervention of interest was the implementation of one or more Patient Decision Aids (PDAs) and that studies of any design (quantitative, qualitative, or mixed-methods) evaluating PDAs in women with early-stage breast cancer were considered eligible.

 

• Were the full texts reviewed independently (e.g., using blind mode in Rayyan)?

Thank you for this important comment. We have clarified this aspect in the revised Methods section.

 

• The results of the search should be in the results section, not the methods

Thank you for this comment. We agree with this suggestion. In the revised manuscript, we have moved all results related to the literature search, including the PRISMA flow diagram and the description of the study selection process, from the Methods section to the Results section to improve the organization of the manuscript and ensure consistency with reporting guidelines.

 

• How is “early stage” defined in the context of this review?

Thank you for this important comment. Throughout this review, early-stage breast cancer was defined according to the American Joint Committee on Cancer (AJCC) staging system, including non-metastatic stages 0–III. This definition was reported in the Introduction; however, we agree that it should also be explicitly stated in the eligibility criteria. To improve clarity and transparency, we have revised the Methods section to clearly specify that studies were eligible only if they included women with early-stage breast cancer, defined according to the AJCC classification (stages 0–III, non-metastatic).

 

• Table 1 belongs in the results section, not the methods

Thank you for your comment. We made sure to attach all tables and figures related to results under the Results section.

 

• It seems it would be important to also report on study design in Table 1, and incorporate the strength of design into the interpretation of findings (e.g., RCT vs. single-arm study)

 

Thank you for this helpful suggestion. We carefully considered merging Tables 1 and 2. However, we felt that combining all study characteristics and outcome data into a single table would reduce readability and make the presentation overly dense. Instead, we substantially revised Table 2 by reorganizing the results into a more concise evidence summary, reducing the amount of text and improving consistency across studies. We made also sure to add a column referring to the quality assessment (MMAT total score) of each study, in order to guarantee an easier interpretation of the results. We also shortened several descriptions in both tables to improve clarity while maintaining the information necessary to interpret the findings.

 

• Is it possible for study details in Tables 1 and 2 to be presented together? It is very hard for the reader to follow; I think there are lots of spaces where the text could be condensed

 

Thank you for this helpful suggestion. We carefully considered merging Tables 1 and 2. However, we felt that combining all study characteristics and outcome data into a single table would reduce readability and make the presentation overly dense. Instead, we substantially revised Table 2 by reorganizing the results into a more concise evidence summary, reducing the amount of text and improving consistency across studies. We made also sure to add a column referring to the quality assessment (MMAT total score) of each study, in order to guarantee an easier interpretation of the results. We also shortened several descriptions in both tables to improve clarity while maintaining the information necessary to interpret the findings.

 

• Table 3 should be presented in the results, not the methods

Thank you for this helpful comment. In the revised manuscript, we have moved Table 1 from the Methods to the Results section to improve the organization of the manuscript and ensure consistency with reporting guidelines.

 

• Suggest making the full results of the quality assessment available in an appendix, and integrate a summary of the study quality into other tables, or as a figure to show the quality of the body of evidence as a whole.

 

Thank you for this suggestion. We substantially revised Table 2 by reorganizing the results into a more concise evidence summary, and we made sure to add a column referring to the quality assessment (MMAT total score) of each study, in order to guarantee an easier interpretation of the results. As per your suggestion, the full results of the quality assessment will be made available in an appendix.

 

• The methods are missing a discussion about how data were synthesized and analyzed

Thank you for this helpful comment. We agree that the Methods section lacked a description of the data synthesis process. In the revised manuscript, we have added a dedicated subsection describing how the evidence was synthesized and analyzed. Specifically, we explain the rationale for conducting a narrative synthesis, the criteria used to organize the results, and the approach adopted to compare findings across studies.

Results

• It is surprising to me that only 26 studies were included, when in the previous review that the authors cited, 33 articles were included.
• I do have concerns about the search strategy, given the very small numbers the search returned. I think the string related to ‘early stage’ may have been overly restrictive. In comparison, the search in the older review the authors are aiming to update identified 2185 references, and this was 10 years ago.

Thank you for this important observation. Our intention was to provide a more focused synthesis of the evidence by addressing a specific patient population and a clearly defined theoretical framework. Specifically, we restricted our review to women with early-stage breast cancer and included only interventions that were explicitly described by the authors as patient decision aids developed to support Shared Decision-Making (SDM). These eligibility criteria were chosen to ensure conceptual consistency and to provide a more detailed and clinically relevant overview of the evidence within this specific context, rather than a broader review of all decision-support interventions. We acknowledge that these more stringent inclusion criteria likely resulted in a smaller number of included studies compared with the previous review. To clarify this rationale, we have revised the manuscript to better explain the scope of the review and the reasons for adopting a more focused search strategy.

 

• Given the similarities in the outcomes reported, why was a meta-analysis not conducted?

Thank you for your comment. Due to the heterogeneity of the included studies in terms of study design, characteristics of the patient decision aids, outcome measures, and assessment instruments, a quantitative meta-analysis was not considered appropriate and a narrative approach was preferred. We made sure to clarify this aspect in the paragraph regarding data aysthnesis and análisis.

 

• I think it would be important to structure the results based on the types of decisions or type of decision aid, rather than collapsing everything together, given the diversity of intervention approaches. A PDA is not a single thing, and thus should not be treated as such.

 

Thank you for this valuable suggestion. We agree that the included PDAs are heterogeneous with respect to their content, format, and the treatment decisions they support. However, rather than organizing the Results according to the type of PDA or treatment decision, we chose to synthesize the evidence based on the main outcomes of interest (i.e., decision-related processes, knowledge, psychological well-being, acceptability, and implementation). We believe this approach facilitates comparison across studies despite the heterogeneity of the interventions and is more closely aligned with the objectives of our review.

 

• I appreciate the explicit focus on low SES and low literacy populations; however, these results should be presented within the larger body of evidence, and then any findings specific to this group highlighted.

Thank you for your suggestion. We agree that these findings should be interpreted within the broader evidence base. Nevertheless, we intentionally presented them in a separate subsection to improve the readability of the Results and to emphasize the evidence available for this underserved population, which represents one of the aims of our work. To clarify this rationale, we have revised the manuscript accordingly.

 

 

Comments on the Quality of English Language

There were several grammatical mistakes throughout that should be thoroughly reviewed prior to resubmission. 

Thank you for this helpful comment. We carefully revised the manuscript to address grammatical and stylistic issues throughout the text. In addition, the revised version was thoroughly proofread to improve the overall clarity and quality of the language.

 

References:

Rubio, I. T., & Sobrido, C. (2022). Neoadjuvant approach in patients with early breast cancer: patient assessment, staging, and planning. Breast (Edinburgh, Scotland), 62 Suppl 1(Suppl 1), S17–S24. https://doi.org/10.1016/j.breast.2021.12.019

 

 

Reviewer 2 Report

Comments and Suggestions for Authors

Introduction: The authors explain that choices usually depend on biomedical characteristics, but in the case of breast cancer, there is almost always a choice to be made. This is because there are various options available, and values and preferences play a significant role in the decision-making process. They then state that SDM has recently been developed, but SDM in breast cancer has actually been applied for more than 20 years.

A little further on, it mentions that PDAs are ‘even’ interactive websites. I believe that most PDAs are currently offered in this form?

Methods:

• Why was no meta-analysis with pooling conducted?
• Were studies with a combined group (early-stage and later-stage) excluded?
• If other choices might be made through the use of PDAs (stated in the introduction), why was this outcome not included?
• Why were studies with male participants excluded? These often involve a very small number of participants, which could still contribute valuable insights from otherwise high-quality studies.
• Were multilevel studies considered, such as a combination of PDAs with, for example, training? We know that combined interventions are often more effective.

Results:

• The introduction to the results could be more concise and the phrasing in what the authors envisioned seems to me like a stylistic inconsistency.
• In the table, I miss whether the PDA was part of a combined intervention, as this could influence the effects found.
• In section 3.2.1, it is not clear to me what is meant by the “decision-making process.”
• Sections 3.3 and 3.5 contain a lot of repetition and could be better combined.

Discussion:

• It is discussed that psychological stress increased, but this is based on only one study, while, for example, two studies showed reduced depression scores.
• Many results are reflected upon, but I miss important reflections, such as:
  • Whether a time effect can be observed (given that there has been 25 years of development in PDAs for breast cancer).
  • whether study’s that showed a higher level of SDM (eg. Higher OPTION) had better results (as the decision is made in the patiënt-clinician interaction)
  • Whether there is a difference between well-developed and moderately developed PDAs (criteria for this have been established).
  • Whether the PDAs were used as a tool within a broader intervention or not (since the final decision is made in the consultation room).

       

Author Response

REVIEWER 2

Introduction: The authors explain that choices usually depend on biomedical characteristics, but in the case of breast cancer, there is almost always a choice to be made. This is because there are various options available, and values and preferences play a significant role in the decision-making process. They then state that SDM has recently been developed, but SDM in breast cancer has actually been applied for more than 20 years.

Thank you for these valuable suggestions. We have revised the Introduction to better reflect the preference-sensitive nature of treatment decision-making in early-stage breast cancer. Specifically, we expanded the description of the available surgical treatment options to highlight the multiple decision points throughout the treatment pathway at which patients and healthcare professionals jointly weigh clinical evidence alongside patients' values and preferences. In addition, we revised the paragraph introducing the Shared Decision-Making (SDM) framework to avoid implying that SDM is a recent concept and to more accurately reflect its long-established role in breast cancer care.

 

A little further on, it mentions that PDAs are ‘even’ interactive websites. I believe that most PDAs are currently offered in this form?

We thank the reviewer for pointing this out. We agree that the use of the term “even” could be misleading, as interactive websites are a common format for PDAs and should not be presented as an exceptional form of delivery. We have therefore revised the wording in the manuscript to avoid implying otherwise and to more accurately reflect the range of formats in which PDAs are currently provided.

 

Methods:

• Why was no meta-analysis with pooling conducted?

 

Thank you for your comment. Due to the heterogeneity of the included studies in terms of study design, characteristics of the patient decision aids, outcome measures, and assessment instruments, a quantitative meta-analysis was not considered appropriate.

 

• Were studies with a combined group (early-stage and later-stage) excluded?

 

Thank you for this important comment. Studies including both early- and later-stage breast cancer populations were generally excluded if the results for patients with early-stage disease were not reported separately. However, only a small number of studies identified through our search included mixed-stage populations. Among these, we included studies only when the study population consisted predominantly of patients with early-stage breast cancer (stages 0–III), to ensure that the evidence synthesized was primarily representative of the target population of this review. Based on this criterion, only one study (Belkora et al., 2012) was included despite enrolling a small proportion (<15%) of patients with more advanced disease. To improve transparency, we have clarified this eligibility criterion in the revised Methods section.

 

• If other choices might be made through the use of PDAs (stated in the introduction), why was this outcome not included?

 

Thank you for this important observation. Although PDAs may influence additional outcomes, including the final treatment choice, the primary aim of this review was to evaluate their impact on decision-making processes and the contextual factors influencing their implementation (e.g., acceptability, usability, feasibility, and equity considerations). These objectives were prespecified in the review protocol and guided the selection of outcomes to be synthesized. We have clarified the scope of the review in the Introduction and Methods to better explain why treatment choice itself was not included as a primary outcome.

 

• Why were studies with male participants excluded? These often involve a very small number of participants, which could still contribute valuable insights from otherwise high-quality studies.

 

Thank you for this valuable comment. We acknowledge that studies including male patients with breast cancer may provide useful insights. However, this review was intentionally restricted to women with early-stage breast cancer to ensure a clinically homogeneous study population. Given the rarity of male breast cancer and its distinct epidemiological, biological, and clinical characteristics, we considered that including both sexes could have introduced additional heterogeneity and reduced the comparability of the findings. To improve transparency, we have clarified this rationale in the eligibility criteria of the revised manuscript.

 

• Were multilevel studies considered, such as a combination of PDAs with, for example, training? We know that combined interventions are often more effective.

 

Thank you for this important comment. We agree that multicomponent interventions combining PDAs with strategies such as clinician training or communication support may be more effective in promoting Shared Decision-Making. However, the objective of this review was specifically to evaluate the evidence relating to Patient Decision Aids as the intervention of interest. Therefore, studies in which the effects of the PDA could not be distinguished from those of other intervention components were not eligible for inclusion. We have clarified this criterion in the revised Methods section.

 

Results:

• The introduction to the results could be more concise and the phrasing in what the authors envisioned seems to me like a stylistic inconsistency.

Thank you for this helpful comment. We agree that the introductory section of the Results could be streamlined. We have therefore revised this section to make it more concise, improve its readability, and ensure greater consistency in style and terminology throughout the manuscript.

 

• In the table, I miss whether the PDA was part of a combined intervention, as this could influence the effects found.

Thank you for this valuable suggestion. We agree that multicomponent interventions may influence the observed effects. To improve clarity, we have revised the Methods section to explicitly state that studies evaluating multicomponent interventions were excluded from this review. We have also clarified this criterion in the eligibility criteria. Consequently, all included studies evaluated PDAs as the primary intervention of interest, and an additional column in the table was considered unnecessary.

 

• In section 3.2.1, it is not clear to me what is meant by the “decision-making process.”

 

We thank the reviewer for pointing this out. We agree that the term “decision-making process” was insufficiently clear. We have therefore clarified its meaning in Section 3.2.1 in the revised manuscript.

 

• Sections 3.3 and 3.5 contain a lot of repetition and could be better combined.

We thank the reviewer for this valuable observation. We agree that some overlap existed between the two sections, particularly because some of the included studies reported both qualitative evaluations of the PDA itself and findings related to its implementation. However, after carefully reviewing the content of the two sections, we considered that merging them would reduce the conceptual distinction between two different aspects of the findings.Specifically, Section 3.3 focuses on **qualitative outcomes related to the PDA itself**, including participants’ perceptions of its usefulness, acceptability, feasibility, and its role in facilitating shared decision-making, as well as their experiences with the information provided by the PDA. In contrast, Section 3.5 focuses specifically on **implementation-related outcomes**, namely factors concerning how, when, and under which circumstances the PDA is introduced and used in clinical practice. These include the training required by healthcare professionals, the timing and mode of PDA delivery, the availability of additional support, differences between clinical settings and surgeons, and patients’ preferences regarding their involvement in the decision-making process. We therefore decided to retain the two sections as separate subsections, as we believe that this distinction more clearly reflects the different dimensions of the findings. Nevertheless, in response to the reviewer’s comment, we have revised both sections to make their respective scopes more explicit and have removed/rephrased overlapping information where appropriate, thereby reducing repetition and improving the overall clarity of the Results section.

Discussion:

• It is discussed that psychological stress increased, but this is based on only one study, while, for example, two studies showed reduced depression scores.

We thank the reviewer for this important observation. We agree that the original discussion placed undue emphasis on the findings of a single study reporting increased psychological distress. We have revised the Discussion to provide a more balanced interpretation of the available evidence.

• Many results are reflected upon, but I miss important reflections, such as:
• Whether a time effect can be observed (given that there has been 25 years of development in PDAs for breast cancer).
• whether study’s that showed a higher level of SDM (eg. Higher OPTION) had better results (as the decision is made in the patiënt-clinician interaction)
• Whether there is a difference between well-developed and moderately developed PDAs (criteria for this have been established).
• Whether the PDAs were used as a tool within a broader intervention or not (since the final decision is made in the consultation room).

 

We sincerely thank the reviewer for these thoughtful and constructive suggestions. In response, we have substantially revised the Discussion to incorporate these additional reflections. Specifically, we have expanded the discussion to consider potential temporal trends in PDA development over the past 25 years, explored the relationship between findings and MMAT score, discussed differences related to the developmental maturity of the included PDAs, and reflected on the role of PDAs as stand-alone tools versus components of broader clinical interventions. We believe that these additions provide a more comprehensive interpretation of the findings and strengthen the overall discussion of the review.

 

Reviewer 3 Report

Comments and Suggestions for Authors

This systematic review addresses a clinically relevant and timely topic. Patient decision aids may play an important role in supporting shared decision-making in early-stage breast cancer, particularly among patients with lower health literacy or socioeconomic disadvantage. The review was prospectively registered, follows the PRISMA framework, includes three major databases, and incorporates quantitative, qualitative, and mixed-methods evidence. These are important strengths.

However, substantial methodological, reporting, and language revisions are required before the manuscript can be considered for publication.

Comments for author File: Comments.pdf

Author Response

Major comments

1.

PRISMA flow diagram: The numbers reported in the PRISMA diagram are inconsistent. Forty-two reports were assessed for eligibility and 26 studies were included; therefore, 16 reports should have been excluded, not 12. Moreover, the listed reasons for exclusion sum to 16 (1 wrong language, 4 posters, 2 protocols, 3 conference abstracts, and 6 wrong interventions). Please correct the diagram and ensure that all categories are mutually exclusive and consistent with the manuscript.

 

Thank you for carefully identifying these inconsistencies. We have revised the PRISMA flow diagram to correct the numerical discrepancies and ensure that the number of excluded reports is consistent throughout the manuscript. We also verified that the reasons for exclusion are mutually exclusive and that the reported totals accurately correspond to the number of excluded studies.

 

 

2.

Definition of early-stage breast cancer: The eligibility criteria require further clarification. The manuscript defines early-stage breast cancer as stages I–III, although stage III may include locally advanced or inoperable disease. In addition, some included studies appear to contain patients with stage IV or metastatic breast cancer. Please provide a clear operational definition of early-stage breast cancer, justify the inclusion of stage III disease, and explain how studies with mixed-stage populations were handled. Where possible, only data that can be attributed to the eligible early-stage population should be included.

 

Thank you for this important comment. We agree that the eligibility criteria required further clarification. In the revised manuscript, we have explicitly defined early-stage breast cancer according to the American Joint Committee on Cancer (AJCC) staging system as non-metastatic stages 0–III. We have also clarified the rationale for including stage III disease and specified how studies including mixed-stage populations were handled. Specifically, studies with mixed-stage populations were included only when the study population consisted predominantly of patients with early-stage breast cancer (stages 0–III), or when results for the eligible population could be clearly identified. To improve transparency, these criteria have been explicitly described in the Methods section.

 

 

3.

Inconsistency between the Abstract and Methods: The Abstract states that the search identified “quantitative studies,” whereas qualitative and mixed-methods studies were also eligible and included. Please revise the Abstract to accurately reflect the included study designs.

Thank you for identifying this inconsistency. We have revised the Methods section of the Abstract to accurately reflect the eligibility criteria of the review. The Abstract now states that quantitative, qualitative, and mixed-methods studies were eligible for inclusion, ensuring consistency with the Methods section of the manuscript.

 

4.

Eligibility criteria: The wording “had cohort study with patients with early-stage breast cancer” is unclear and appears inconsistent with the inclusion of randomized, non-randomized, qualitative, and mixed-methods studies. Please rewrite the eligibility criteria using a clear PICOS framework and provide explicit exclusion criteria.

 

Thank you for this helpful comment. We agree that the eligibility criteria required clarification. In the revised manuscript, we have rewritten this section to ensure consistency with the PICOS framework and the objectives of the review. Specifically, we now clearly describe the eligible population, intervention, comparison, outcomes, and study designs, explicitly stating that quantitative, qualitative, and mixed-methods studies were eligible for inclusion. We have also revised and expanded the exclusion criteria to clearly specify the study designs and intervention characteristics that were not eligible (e.g., conference abstracts, study protocols, and multicomponent interventions in which the independent effect of the Patient Decision Aid could not be distinguished).

 

 

5.

Heterogeneity and evidence synthesis: The review combines highly heterogeneous study designs, patient populations, clinical decisions, PDA formats, and outcome measures. The narrative synthesis should be more clearly structured according to study design, clinical decision, type of PDA, outcome, follow-up duration, and methodological quality. The current presentation makes it difficult to determine which interventions are effective, for which patients, and for which outcomes.

 

Thank you for this thoughtful comment. We agree that the included studies were highly heterogeneous with respect to study design, Patient Decision Aid (PDA) characteristics, clinical decisions addressed, outcome measures, and follow-up periods. For this reason, a quantitative synthesis was not considered appropriate, and we have added a dedicated subsection to the Methods describing the rationale for the narrative synthesis and the approach used to analyze the evidence. In the revised manuscript, we have substantially reorganized the Results to improve their clarity. Specifically, we first describe the characteristics of the included PDAs, followed by a narrative synthesis structured according to the principal outcome domains (decision-related processes, patient knowledge, psychological well-being, qualitative findings on acceptability, evidence relating to women with lower socioeconomic status or limited health literacy, and implementation issues). We also redesigned the evidence summary table to provide, for each study, the study design, outcomes assessed, and principal findings, allowing readers to readily compare the available evidence across studies. Although we considered organizing the Results according to the type of clinical decision or PDA, individual studies frequently evaluated multiple outcomes simultaneously and several PDAs addressed more than one treatment decision. We therefore judged that organizing the synthesis by outcome domain provided the clearest and least repetitive presentation of the evidence while preserving the clinical heterogeneity of the included studies.

 

 

 

 

6.

Quality appraisal: The use of the MMAT is appropriate for a review including diverse study designs. However, the results of the quality assessment should be more explicitly incorporated into the synthesis and interpretation. Please report how many studies were rated as low, moderate, or high quality and indicate whether the principal conclusions are supported by higher-quality studies. The rationale and method used to calculate the overall MMAT score should also be explained.

We thank the reviewer for this helpful suggestion. We have now more explicitly incorporated the quality assessment into both the Results and the Discussion.

 

7.

Conclusions: Several conclusions are stronger than the evidence presented. Improvements in knowledge, psychological outcomes, quality of life, and decision-related outcomes were not consistent across all studies. Please use more cautious language, distinguish statistically significant findings from non-significant trends, and avoid implying a uniform beneficial effect across all outcomes.

We appreciate this important observation and have revised the Conclusions and Clinical Implications section accordingly.

 

8.

Economic implications: The conclusion that PDAs may contribute to cost-effective care requires direct supporting evidence. Please identify the included studies that assessed costs or cost-effectiveness, or remove/qualify this statement.

Thank you for your suggestion. We have qualified the statement on cost‑effectiveness in the Discussion, clarifying that none of the included studies directly assessed costs or cost‑effectiveness and that this claim is based on broader literature rather than on the evidence synthesized in this review.

 

 

 

9.

Tables: Tables 1–3 contain valuable information but are excessively dense and difficult to interpret. Please standardize terminology, correct typographical errors, clarify missing data, and consider moving detailed study-level descriptions to the

Supplementary Materials. A concise summary table showing direction of effect, statistical significance, study design, and methodological quality would improve readability.

 

Thank you for this valuable suggestion. We agree that the original tables were overly detailed and could be difficult to interpret. In the revised manuscript, we substantially reorganized the tables to improve their clarity and readability. Specifically, we standardized the terminology throughout, corrected typographical inconsistencies, and redesigned the main evidence table into a concise evidence map summarizing, for each study, the study design, methodological quality, outcomes assessed, and the direction of the observed effects. We also reduced redundancy by presenting the findings according to the main outcome domains in the text, while retaining the study-level information in the tables to allow readers to easily identify the characteristics and results of each included study. We believe these revisions substantially improve the readability of both the tables and the overall manuscript.

 

10.

Language: The manuscript requires comprehensive English-language editing. Numerous grammatical, syntactic, and typographical errors are present throughout the Abstract, Methods, Results, tables, and Discussion. Professional language revision is strongly recommended.

Thank you for this helpful comment. We carefully revised the manuscript to address grammatical and stylistic issues throughout the text. In addition, the revised version was thoroughly proofread to improve the overall clarity and quality of the language.

 

 

 

Minor comments

 

Use “Patient Decision Aids” rather than “Patients Decision Aids.”

Thank you for this helpful comment. We carefully revised the manuscript to address these issues throughout the text.

 

Replace “preemptively registered” with “prospectively registered.”

Thank you for this helpful comment. We changed the wording as suggested.

 

 

 

Check the consistency of the number of studies assessing knowledge; the Abstract reports eight studies, whereas the Discussion refers to nine.

Thank you for identifying this inconsistency. In the revised manuscript we have standardized the reporting: both the Abstract and the Results/Discussion now state that eight studies assessed knowledge-related outcomes. All references to this outcome have been checked and corrected accordingly.

 

Standardize the use of PDA, DA, SDM, SES, and ESBC.

Thank you for identifying this inconsistency. We have standardized the use of abbreviations throughout the manuscript. The abbreviation “DA” has been replaced with “PDA” to ensure uniformity.

 

 

Correct typographical errors throughout the tables and text.

Thank you for this helpful comment. We have carefully proofread the entire manuscript and corrected typographical and formatting errors in the text and tables.

 

 

 

Replace placeholder text in the Supplementary Materials section.

Thank you for your

Thank you for identifying this consistency. In the revised manuscript Supplementary Materials will be available.

 

Clarify the funder’s role in study design, analysis, interpretation, manuscript preparation, and the decision to submit the work.

We have clarified the funder’s role in the revised manuscript. The Program was developed with the unconditional support of Eli Lilly and Company. The funder had no role in study design, data collection, analysis, interpretation of results, manuscript preparation, or the decision to submit the work for publication.

 

Overall, the manuscript has the potential to provide a useful synthesis of the literature, but major revisions are necessary to improve methodological transparency, consistency, readability, and the strength of the conclusions

Round 2

Reviewer 2 Report

Comments and Suggestions for Authors

Most points have been carefully addressed in the revised manuscript. However, I noticed a few remaining issues:

1. The authors state in their response that paragraphs 3.3 and 3.5 will not be merged. While this choice is justified, I still observe overlapping content. For example:

• (in 3.3) “For instance, Schubbe and collaborators (2021) found that doctors often needed a training period before flawlessly implementing the PDA within their standard consultation, without it having an impact on the duration of the consultations.”

• (in 3.5) “For instance, Schubbe and collaborators (2021), while implementing a PDA within their standard oncological consultations, noted that physicians needed a brief training period before the PDA could be flawlessly implemented within their consultations without interfering with their schedules.”

2. I believe the discussion still has room for improvement:

• Many results are discussed, but by making a stricter selection of the key highlights (and delete some of the lesser), these will stand out more clearly.
• The comments on potential effects mentioned in my first review are listed as possible influencing factors in the discussion. However, it would be stronger if the authors examined their own data to see whether there are indications that these factors influenced the data they reported.
• As a limitation, it might be good to mention that PDAs were examined as a standalone intervention, while we know that combined interventions are often implemented more successfully.

   

Author Response

Most points have been carefully addressed in the revised manuscript. However, I noticed a few remaining issues:

1. The authors state in their response that paragraphs 3.3 and 3.5 will not be merged. While this choice is justified, I still observe overlapping content. For example:

• (in 3.3) “For instance, Schubbe and collaborators (2021) found that doctors often needed a training period before flawlessly implementing the PDA within their standard consultation, without it having an impact on the duration of the consultations.”
• (in 3.5) “For instance, Schubbe and collaborators (2021), while implementing a PDA within their standard oncological consultations, noted that physicians needed a brief training period before the PDA could be flawlessly implemented within their consultations without interfering with their schedules.”

We thank the Reviewer for the positive evaluation and for the additional constructive suggestions. We have carefully addressed all remaining points in the revised manuscript. All most recent changes are highlighted in green.

 

We appreciate the reviewer’s comment regarding the overlap between sections 3.3 and 3.5. We have now revised section 3.5 to avoid repetition of the example concerning Schubbe et al. (2021), and we have streamlined the description of implementation issues so that each study is cited only once for a given point. We believe this change improves the clarity and readability of the results.

 

 

2. I believe the discussion still has room for improvement:

• Many results are discussed, but by making a stricter selection of the key highlights (and delete some of the lesser), these will stand out more clearly.
• The comments on potential effects mentioned in my first review are listed as possible influencing factors in the discussion. However, it would be stronger if the authors examined their own data to see whether there are indications that these factors influenced the data they reported.
• As a limitation, it might be good to mention that PDAs were examined as a standalone intervention, while we know that combined interventions are often implemented more successfully.

 

We thank the reviewer for these helpful suggestions. In the revised manuscript we shortened the paragraphs related to the main findings; we also reformulated part of the discussion as to interpret our findings along with your previous suggestions.

 

We appreciate this suggestion and have added a new paragraph in the Limitations section noting that this review examined PDAs primarily as stand-alone interventions. We acknowledge that such combined approaches may be more effective than stand-alone tools, and that our findings may therefore underestimate the potential impact of PDAs when embedded within comprehensive shared decision-making interventions.

 

Reviewer 3 Report

Comments and Suggestions for Authors

I would like to thank the Authors for their careful and comprehensive response to all comments raised during the first round of peer review. The revised manuscript has been substantially improved in terms of methodological clarity, consistency, and overall presentation. I particularly appreciate the clarification of the eligibility criteria, the correction of the inconsistencies in the PRISMA flow diagram, the more balanced interpretation of the findings, and the improvements in the language and readability of the manuscript.

In my opinion, the Authors have satisfactorily addressed all of my previous comments, and the manuscript now meets the scientific and editorial standards expected for publication in Current Oncology. I have no further substantive comments and congratulate the Authors on their thorough revision of the manuscript.

Comments on the Quality of English Language

n.

Author Response

We are grateful for the Reviewer’s recognition of our efforts and for confirming that the manuscript now meets the scientific and editorial standards for publication in Current Oncology. We thank the Reviewer again for the time and expertise devoted to improving our work.