Caregiving and Shared Decision Making in Breast and Prostate Cancer Patients: A Systematic Review

Round 1

Reviewer 1 Report (Previous Reviewer 1)

Thanks to authors for an improved manuscript.

The following points still need to be addressed. Old numbering is kept for convenience.


2. “Old Lines 11-31: Please provide full names of the databases and write out acronyms (such as, QOL) here and in the main body of the manuscript.”
Thanks for revisions but see, for example, “RCT” in new line 199.
5. “Old Lines 84-94: Did authors register this SR? If yes, where and what is the registration number?”
Thanks for responding internally that this SR was not registered. Please provide a discussion in the Limitations section about this.
6. “Old Lines 84-94: Did authors develop a protocol for this SR? If yes, which guidelines were followed in developing the protocol?”
Thanks for responding internally that no protocol was developed for this SR. Please provide a discussion in the Limitations section about this.
7. “Old Lines 84-94: Where was this protocol published?”
Please see #6 above.
8. “Old Lines 84-94: Did authors use a guideline in reporting this SR? If yes, which one?”
Thanks for providing a reference to Page et al. in this revised version of the manuscript and in new Figure 2. However, the PRISMA diagram given in the new Figure 2 does not reflect the revised flow diagram given in Page et al. Please reconcile.
9. “Old Lines 84-94: Were experts in the field consulted?”
Thanks for internal response. This review point was in reference to contacting experts after the electronic searches were conducted to ensure that the results of this SR are exhaustive and that new studies were not missed.
12. “Old Lines 84-87: Please explain why both PubMed and Medline were searched?”
Thanks for internal response. This reviewer is finding it hard to follow the internal explanation. Regardless, since one is a subset of the other, please consider revising “…four major databases…” (new line 120) to “three major databases…”
15. “Old Lines 98-100 & Figure 2: Thanks for the information but please be clear about included study types. Which quantitative study types? Please be specific. What does “qualitative (primary and secondary analysis of data sets)” mean? Is “interview/focus group” or “consultation audit-studies” a study type?”
Thanks for revisions and the new Table 1. Please discuss why both “survey” and “questionnaire” are given as examples of different “quantitative” research designs. Further, are they different “quantitative” research designs types? It is also not clear to this reviewer why the “qualitative” research design needed the “in-depth interview, semi-structured interview, focus group” attached to it. Are “in-depth interview, semi-structured interview, focus group” different “qualitative” research design types?
21. “Old Lines 111-116: Please provide the initials of those who screened the title and abstracts.”
Thanks for including information. It is concerning to this reviewer that “1160 articles that were screened for irrelevant … articles by the first author…” (new lines 156-157). The concern over here is that 1 author conducted this “screening” rather than 2 authors.
22. “Old Lines 111-116: Please provide the details of the screening process.”
It seems like there was further screening (see new lines 158-159). Could authors explain why there were these 2 levels of screening? Also, could authors explain what it means that the “the first author … and two co-authors … independently” performed this second level of screening?
25. “Old Lines 111-116: Please provide the details of the full-text review process.”
Thanks for information. Again, could authors explain what it means that the “the first author … and two co-authors … independently” performed the full text review?
27. “Old Lines 111-116: What happened if there were more than one report from the same study?”
Thanks for internal response. There needs to be a clarity about this in the manuscript and the flow diagram. Please also see the above point about flow diagram. Further, it is confusing that the new flow diagram (new Figure 2) now says “17 studies”, manuscript says “17 articles” (new line 166) and internal response indicates that “2 reports referring to the same study” were found. Please reconcile.
28. “Old Lines 111-116 & Figure 3: From which source(s) were those “2 additional records” identified?”
Thanks for internal response. Please see above for this reviewer’s related concerns.
29. “Old Lines 111-116 & Figure 3: Please provide a citation for Figure 3.”
Please see above, the citation and the new PRISMA diagram do not match.
30. “Old Lines 111-116 & Figure 3: Figure 3 implies that authors included “studies” not paying attention to the distinction between “reports” and “studies” that is very concerning to this reviewer. Please be clear.”
Thanks for explanations. Again, this reviewer’s concern remains. Again, please see above, the citation and the new PRISMA diagram do not match. Again, as above, there are discrepancies in this revised version in that the new flow diagram (new Figure 2) now says “17 studies”, manuscript says “17 articles” (new line 166) and internal response indicates that “2 reports referring to the same study” were found.
31. “Old Lines 120-127: Please be specific what is “a standard format”. Did they use a form for this phase? “
Thanks for revisions. Why “time-point” is capitalized?
34. “Old Lines 120-127: It is concerning to this reviewer that data were extracted by one author.”
Thanks for explanations. This reviewer is still concerned that data were not extracted independently by 2 authors.
37. “Old Lines 120-127: Were there an assessment of risk of bias of included studies?”
Thanks for including a risk of bias assessment. Should there be the same type of assessment in terms of “…the statistical power evaluations…” in quantitative and qualitative study designs? Please discuss.
38. “Old: The rest of the sections: This reviewer is unsure on how to continue with the following sections given the review points above.”
Please see above points.


Additional: (a) “PRISM”? (new line 124).

Author Response

Dear Reviewer #1,

 thank you for your revision. Below you can find our point-to-point answers to your comments. 

2. “Old Lines 11-31: Please provide full names of the databases and write out acronyms (such as, QOL) here and in the main body of the manuscript.” 
   Thanks for revisions but see, for example, “RCT” in new line 199.

Thank the reviewer for this suggestion. We wrote out all the acronyms in the manuscript.

5. “Old Lines 84-94: Did authors register this SR? If yes, where and what is the registration number?” 
   Thanks for responding internally that this SR was not registered. Please provide a discussion in the Limitations section about this.

Thank the reviewer for this suggestion. Finally, we registered the SR in the Research Registry (here it is the link to the website: https://www.researchregistry.com/browse-the-registry#registryofsystematicreviewsmeta-analyses/). We added in the manuscript this information (see lines 134-135).

6. “Old Lines 84-94: Did authors develop a protocol for this SR? If yes, which guidelines were followed in developing the protocol?” 
   Thanks for responding internally that no protocol was developed for this SR. Please provide a discussion in the Limitations section about this.

Thank the reviewer for this comment. We did not register the protocol before starting the systematic review, but we followed the guidelines for systematic review according to the PRISMA guidelines. We now registered the protocol a posteriori on the Research Strategy website (see above) and added the number of protocol registration.

7. “Old Lines 84-94: Where was this protocol published?” 
   Please see #6 above.

Thank the reviewer for this suggestion. Finally, we registered the SR in the Research Registry (here it is the link to website: https://www.researchregistry.com/browse-the-registry#registryofsystematicreviewsmeta-analyses/).

8. “Old Lines 84-94: Did authors use a guideline in reporting this SR? If yes, which one?”
   Thanks for providing a reference to Page et al. in this revised version of the manuscript and in new Figure 2. However, the PRISMA diagram given in the new Figure 2 does not reflect the revised flow diagram given in Page et al. Please reconcile.

Thank the reviewer for this comment. We used the PRISMA 2020 flow diagram available on the PRISMA statement website (here it is the link to the website: https://prisma-statement.org/PRISMAStatement/FlowDiagram).

9. “Old Lines 84-94: Were experts in the field consulted?” 
   Thanks for internal response. This review point was in reference to contacting experts after the electronic searches were conducted to ensure that the results of this SR are exhaustive and that new studies were not missed.

Thank the reviewer for this suggestion. We apologize for not understanding the request previously. We did not contact experts in the field, but we updated the literature research. Furthermore, most of the authors are experienced in conducting SR, so we did not find it necessary to seek the advice of a librarian.

12. “Old Lines 84-87: Please explain why both PubMed and Medline were searched?” 
    Thanks for internal response. This reviewer is finding it hard to follow the internal explanation. Regardless, since one is a subset of the other, please consider revising “…four major databases…” (new line 120) to “three major databases…” 

Thank the reviewer for this comment. Finally, after extensive discussion, we decided to follow the reviewer’s indication (see line 121) and the new Appendix 1.

15. “Old Lines 98-100 & Figure 2: Thanks for the information but please be clear about included study types. Which quantitative study types? Please be specific. What does “qualitative (primary and secondary analysis of data sets)” mean? Is “interview/focus group” or “consultation audit-studies” a study type?” 
    Thanks for revisions and the new Table 1. Please discuss why both “survey” and “questionnaire” are given as examples of different “quantitative” research designs. Further, are they different “quantitative” research designs types? It is also not clear to this reviewer why the “qualitative” research design needed the “in-depth interview, semi-structured interview, focus group” attached to it. Are “in-depth interview, semi-structured interview, focus group” different “qualitative” research design types?

Thank the reviewer for this comment. We did not use surveys and questionnaires as examples of different quantitative research designs, since they are referred to as different tools that can be used by researchers who want to conduct quantitative research. In particular, the term survey has a broad meaning, that describes contents, method, and analysis. Here we referred to the content meaning. Similarly, in-depth interviews, semi-structured interviews and focus groups are different tools that can be used by researchers who want to conduct qualitative research.

21. “Old Lines 111-116: Please provide the initials of those who screened the title and abstracts.” 
    Thanks for including information. It is concerning to this reviewer that “1160 articles that were screened for irrelevant … articles by the first author…” (new lines 156-157). The concern over here is that 1 author conducted this “screening” rather than 2 authors. 

Thank the reviewer for this concern. However, we cannot do anything about it. We followed the procedures described in the Prisma statement and reported what was done (https://www.bmj.com/content/372/bmj.n160).

22. “Old Lines 111-116: Please provide the details of the screening process.” 
    It seems like there was further screening (see new lines 158-159). Could authors explain why there were these 2 levels of screening? Also, could authors explain what it means that the “the first author … and two co-authors … independently” performed this second level of screening?

Thank the reviewer for this comment. However, two levels of screening were not carried out. Initially, the first author eliminated duplicates and all those records that appeared from the title to be not at all consistent with our area of investigation, namely psycho-oncology (in the manuscript we named these records ad irrelevant). Examples were those strictly medical records. Then, the three authors screened the titles left over from the general screening done initially, then they screened the abstracts and finally the full texts. The screening procedure was carried out independently by the three authors, who compared themselves at the end of the process to verify that they had kept the same articles. If there was any discordant data, they discussed it until an agreement was reached. Where needed, the fourth author was involved until a consensus was reached. We follow the procedure described in the Prisma statement (https://www.bmj.com/content/372/bmj.n160).

25. “Old Lines 111-116: Please provide the details of the full-text review process.” 
    Thanks for information. Again, could authors explain what it means that the “the first author … and two co-authors … independently” performed the full text review?

Thank the reviewer for this comment. As reported above, the 925 records obtained from the removal of duplicate and irrelevant records were screened by the three authors independently. This means that the three authors independently carried out the screening procedure of these 925 records. When they selected the full texts that they thought should be included in the SR, they met and discussed the results together. If some full texts were not included by all three, the three authors discussed them until an agreement was reached.

27. “Old Lines 111-116: What happened if there were more than one report from the same study?” 
    Thanks for internal response. There needs to be a clarity about this in the manuscript and the flow diagram. Please also see the above point about flow diagram. Further, it is confusing that the new flow diagram (new Figure 2) now says “17 studies”, manuscript says “17 articles” (new line 166) and internal response indicates that “2 reports referring to the same study” were found. Please reconcile.

Thank the reviewer for this suggestion. We reconciled all this information both in the manuscript and in the flow diagram (See the methods section).

28. “Old Lines 111-116 & Figure 3: From which source(s) were those “2 additional records” identified?” 

Thanks for internal response. Please see above for this reviewer’s related concerns.

Thank the reviewer for this suggestion. We resolved this issue.

29. “Old Lines 111-116 & Figure 3: Please provide a citation for Figure 3.” 
    Please see above, the citation and the new PRISMA diagram do not match.

Thank the reviewer for this comment. We used the PRISMA 2020 flow diagram available on the PRISMA statement website (here it is the link of the website: https://prisma-statement.org/PRISMAStatement/FlowDiagram).

30. “Old Lines 111-116 & Figure 3: Figure 3 implies that authors included “studies” not paying attention to the distinction between “reports” and “studies” that is very concerning to this reviewer. Please be clear.” 
    Thanks for explanations. Again, this reviewer’s concern remains. Again, please see above, the citation and the new PRISMA diagram do not match. Again, as above, there are discrepancies in this revised version in that the new flow diagram (new Figure 2) now says “17 studies”, manuscript says “17 articles” (new line 166) and internal response indicates that “2 reports referring to the same study” were found.

Thank the reviewer for this suggestion. We resolved this issue.

31. “Old Lines 120-127: Please be specific what is “a standard format”. Did they use a form for this phase? “ 
    Thanks for revisions. Why “time-point” is capitalized?

Thank the reviewer for this suggestion. We corrected it.

34. “Old Lines 120-127: It is concerning to this reviewer that data were extracted by one author.” 
    Thanks for explanations. This reviewer is still concerned that data were not extracted independently by 2 authors.

Thank the reviewer for this concern. However, we cannot do anything about it. We followed the procedures described in the Prisma statement and reported what was done.

37. “Old Lines 120-127: Were there an assessment of risk of bias of included studies?” 
    Thanks for including a risk of bias assessment. Should there be the same type of assessment in terms of “…the statistical power evaluations…” in quantitative and qualitative study designs? Please discuss.

Thank the reviewer for the comment. We used the same instrument for all the retrieved studies, which, as the reviewer noted, were qualitative and quantitative. In the case of qualitative studies, we considered if the paper had explicit considerations about the data to be analyzed and the analysis plan to reach for instance data saturation. We commented on the issue of statistical power evaluation in qualitative studies in the previous version of the manuscript and we now added a further explanation. Please see the “Risk of bias assessment” paragraph.

38. “Old: The rest of the sections: This reviewer is unsure on how to continue with the following sections given the review points above.” 
    Please see above points.

Thank the reviewer for the comment. However, we are concerned about the reviewer’s decision not to go on with the manuscript revision. We felt that we now addressed all the comments highlighted by the Reviewer.

Author Response File: Author Response.docx

Round 2

Reviewer 1 Report (Previous Reviewer 1)

Thanks to authors for a new version of the manuscript.

This manuscript is a resubmission of an earlier submission. The following is a list of the peer review reports and author responses from that submission.

Round 1

Reviewer 1 Report

This systematic review (SR) aims at reviewing the literature on the involvement of (breast and prostate cancer) patients and their caregivers in the treatment decision making (TDM) process. The following points will help strengthen the manuscript.

1. Lines 1-3: Could authors revise the title with appropriate capitalization?
2. Lines 11-31: Please provide full names of the databases and write out acronyms (such as, QOL) here and in the main body of the manuscript.
3. Lines 76-78: Please be clear by what is meant by “an exhaustive overview…” here. Are there no other SRs on this topic? Please state explicitly. Are there only traditional or other types of reviews, other than SRs? If yes, which ones? What does this one add…
4. Lines 78-82: Please ensure that the aim of the SR is fully explained here. Before it was suggested that the focus is on breast and prostate cancer patients, now it sound like the focus is on all cancer patients. Which one? Further, is the focus on the “role of caregivers in cancer care” in general or is it specifically regarding the TDM process, and especially, is it the dyadic aspect of TDM? Please be specific.
5.Lines 84-94: Did authors register this SR? If yes, where and what is the registration number?
6. Lines 84-94: Did authors develop a protocol for this SR? If yes, which guidelines were followed in developing the protocol?
7. Lines 84-94: Where was this protocol published?
8. Lines 84-94: Did authors use a guideline in reporting this SR? If yes, which one?
9. Lines 84-94: Were experts in the field consulted?
10. Lines 84-94:Please define all of the concepts that are important for this SR, especially the TDM and caregiver.
11. Lines 84-87: As before, please provide full names of the databases searched.
12. Lines 84-87: Please explain why both PubMed and Medline were searched?
13. Lines 84-87: We are now in August 2022 and it is a concern to this reviewer that the search is almost 2 years old. Are authors concerned?
14. Lines 90-92: Which SRs are those? Please be consistent and see above point about other reviews, SR or otherwise, and what this one adds.
15. Lines 98-100 & Figure 2: Thanks for the information but please be clear about included study types. Which quantitative study types? Please be specific. What does “qualitative (primary and secondary analysis of data sets)” mean? Is “interview/focus group” or “consultation audit-studies” a study type?
16. Lines 98-100 & Figure 2: Thanks for the information but please be clear about the participants included.Who are those “both of the participants” in Figure 2?
17. Lines 98-103 & Figure 2: Again, thanks for the information but more information is needed for all participants. Do the study participants include cancer patients (breast and prostate only?) and their caregivers in general (such as, for example, as indicated here “their close friends” too…) or is it cancer patients and their partners as their caregivers only (given the motivation for this SR in the Introduction section and, therefore, the choice of breast and prostate cancer)?
18. Lines 98-105 & Figure 2: Thanks for the information but please be clear about the interventions included. Any “dyadic decision making” as is portrayed in Figure 2? Or is it “dyads’ decision-making related” specifically “to cancer treatments”? Please be specific.
19. Lines 98-105 & Figure 2: Thanks for the information but please explain what those studies that “did not include any intervention” were investigating?
20. Lines 98-105 & Figure 2: Any outcomes?
21. Lines 111-116: Please provide the initials of those who screened the title and abstracts.
22. Lines 111-116: Please provide the details of the screening process.
23. Lines 111-116: What happened if there were disagreements at this stage?
24. Lines 111-116: Please provide the initials of those who conducted the full-text reviews of the reports.
25. Lines 111-116: Please provide the details of the full-text review process.
26. Lines 111-116: What happened if there were disagreements at this second stage?
27. Lines 111-116: What happened if there were more than one report from the same study?
28. Lines 111-116 & Figure 3: From which source(s) were those “2 additional records” identified?
29. Lines 111-116 & Figure 3: Please provide a citation for Figure 3.
30. Lines 111-116 & Figure 3: Figure 3 implies that authors included “studies” not paying attention to the distinction between “reports” and “studies” that is very concerning to this reviewer. Please be clear.
31. Lines 120-127: Please be specific what is “a standard format”. Did they use a form for this phase?
32. Lines 120-127: Was this form pre-tested?
33. Lines 120-127: Please see above. It is still not clear what authors mean by “qualitative”, “quantitative” study designs… It gets even more confusing if one looks at Table 1, the results table. What is the definition of a “perspectival design” (p.14), for example? How is it different or similar to “longitudinal study”? “What type of a study design is “pilot study”…
34. Lines 120-127: It is concerning to this reviewer that data were extracted by one author.
35. Lines 120-127: Again, please be specific, were all data extraction “cross-checked”, or some? If some, what percentage? Also, what does “cross-checking” involve? Please be specific.
36. Lines 120-127: What happened if there were disagreements during this “cross-checking” process?
37. Lines 120-127: Were there an assessment of risk of bias of included studies?
38. The rest of the sections: This reviewer is unsure on how to continue with the following sections given the review points above.
39. One suggestion for the results table: This table should be split into at least 2 tables and presented in a format that is easy for the readership to follow. Currently, it is full of disparate information, making it hard to follow; it seems to be 8 and a half pages long; and some pages do not even have titles for the columns continuing from the previous pages…

Author Response

1. Lines 1-3: Could authors revise the title with appropriate capitalization?

Thank you for your suggestion. We noticed that the title was not appropriately capitalized, we corrected it (see lines 2-3).

 

2. Lines 11-31: Please provide full names of the databases and write out acronyms (such as, QOL) here and in the main body of the manuscript.

Following your suggestion, we provide the full name of the databases and the acronyms used in the manuscript (see lines 19-20; 31).

 

3. Lines 76-78: Please be clear by what is meant by “an exhaustive overview…” here. Are there no other SRs on this topic? Please state explicitly. Are there only traditional or other types of reviews, other than SRs? If yes, which ones? What does this one add…

We thank the reviewer for this suggestion. By the term "exhaustive overview" we refer to the fact that in literature there are no literature reviews on the caregivers’ involvement in the treatment decision-making process of patients with breast or prostate cancer. There are some literature reviews, but they are focused on elderly patients, end of life or dyadic psychological intervention aimed at improving the communication between patients, caregivers, and physicians. Whereas our focus is on the role of caregivers in the newly diagnosed prostate and breast cancer patients’ decision-making. In this case, cancer treatments, by affecting the sphere of intimacy, could engage more caregivers in the treatment decision-making process. We agree in clarifying this in the text. Therefore, we substantially intervened in it, to improve the overall flow, adding the aforementioned literature reviews (see lines 100-117).

 

4. Lines 78-82: Please ensure that the aim of the SR is fully explained here. Before it was suggested that the focus is on breast and prostate cancer patients, now it sound like the focus is on all cancer patients. Which one? Further, is the focus on the “role of caregivers in cancer care” in general or is it specifically regarding the TDM process, and especially, is it the dyadic aspect of TDM? Please be specific.

We followed reviewer’s suggestion and better clarified the aim of our systematic review (see lines 100-117).

 

5. Lines 84-94: Did authors register this SR? If yes, where and what is the registration number?

Lines 84-94: Did authors develop a protocol for this SR? If yes, which guidelines were followed in developing the protocol?

Lines 84-94: Where was this protocol published?

Thank the reviewer for your questions, we did not register this SR thus no registration nr is associated nor a protocol is published. We followed PRISMA guidelines in order to conduct our SR. 

 

6. Lines 84-94: Did authors use a guideline in reporting this SR? If yes, which one?

Thank the reviewer for this remark. We followed the PRISMA 2020 statement to report this SR (Page, M.J., McKenzie, J.E., Bossuyt, P.M. et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. Syst Rev 10, 89 (2021). https://doi.org/10.1186/s13643-021-01626-4).

 

7. Lines 84-94: Were experts in the field consulted?

Yes, one of the authors in particular, prof Gabriella Pravettoni, has an extensive experience in the field of psycho-decisional support for cancer patients, shared decision-making among patients-caregivers and clinicians and dyadic intervention for patients-caregivers. Other clinicians in our team with similar expertise has been consulted before conducting the SR.  Prof. Pravettoni and her team has conducted several systematic reviews in the psycho-oncology field.

 

8. Lines 84-94: Please define all of the concepts that are important for this SR, especially the TDM and caregiver.

Thank you for this suggestion, we described in detail the core concepts of our SR in the introduction (see lines 62-99).

 

9. Lines 84-87: As before, please provide full names of the databases searched.
   Following your suggestion, we provide the full name of the databases and the acronyms used in the manuscript.

 

10. Lines 84-87: Please explain why both PubMed and Medline were searched?

Thank the reviewer for your comments, we searched both on PubMed and Medline because in Medline there are also papers that are not indexed yet, and thus do not appear on PubMed.

11. Lines 84-87: We are now in August 2022 and it is a concern to this reviewer that the search is almost 2 years old. Are authors concerned?

Thank the reviewer for your comments. Before submitting this SR (at the end of July 2022), we performed again the database research, limiting the research in the last two years and we did not find any other paper to include in our SR. For this reason, we are not particularly concerned.

12. Lines 90-92: Which SRs are those? Please be consistent and see the above point about other reviews, SR or otherwise, and what this one adds.
    Thank the reviewer again for this comment. We added these systematic reviews in the introduction section to clarify our main goal and the impact that this SR may have in the research field (see lines 102-107).

 

13. Lines 98-100 & Figure 2: Thanks for the information but please be clear about included study types. Which quantitative study types? Please be specific. What does “qualitative (primary and secondary analysis of data sets)” mean? Is “interview/focus group” or “consultation audit-studies” a study type?

Thank the reviewer for this suggestion. We substantially intervened in Figure 2, to improve the overall understanding of the information about the types of studies included. Moreover, we substantially intervened in the manuscript, clarifying the inclusion and exclusion criteria in the text (see Table 1 and lines 138-154).

14. Lines 98-100 & Figure 2: Thanks for the information but please be clear about the participants included. Who are those “both of the participants” in Figure 2?

Thank the reviewer for this remark, the participants included in the SR were breast and prostate cancer patients and their caregivers. We clarified it in Table 1.

 

15. Lines 98-103 & Figure 2: Again, thanks for the information but more information is needed for all participants. Do the study participants include cancer patients (breast and prostate only?) and their caregivers in general (such as, for example, as indicated here “their close friends” too…) or is it cancer patients and their partners as their caregivers only (given the motivation for this SR in the Introduction section and, therefore, the choice of breast and prostate cancer)?

Thank the reviewer for your suggestion. We explicitly declared the reason why we focused only on breast and prostate cancer patients and included all the relationships that patients have with their caregivers in the introduction (see lines 100-117). We also added specifications in Table 1 that we hope can disambiguate the topic of our contribution.

 

16. Lines 98-105 & Figure 2: Thanks for the information but please be clear about the interventions included. Any “dyadic decision making” as is portrayed in Figure 2? Or is it “dyads’ decision-making related” specifically “to cancer treatments”? Please be specific.

Thank the reviewer for this suggestion. We realized that the inclusion and exclusion criteria were not very clear. Therefore, we intervened in it improving it both in the text and in Table 1.

 

17. Lines 98-105 & Figure 2: Thanks for the information but please explain what those studies that “did not include any intervention” were investigating?

Thank the reviewer for this remark. The studies considered for this literature review could have been either exploratory studies of caregivers’ involvement in breast or prostate cancer patients’ decision-making related to cancer treatment or experimental studies of the effectiveness of psychological interventions aimed at improving caregivers’ involvement (see lines 138-154). However, no studies with psychological interventions aimed at improving TDM were found; the interventions were concerned with communication, for example. Therefore, we have no outcomes.

 

18. Lines 98-105 & Figure 2: Any outcomes?

Thank the reviewer for this remark. This SR is explorative and for that reason, we did not prearrange it. As for the comment above, unfortunately, we did not find intervention studies that addressed TDM and therefore otucome could not be included. Furthermore, the present SR is an exploratory review with specific focus on these decision-making issues. We suggest further reading of the results to find further answers to this question.

19. Lines 111-116: Please provide the initials of those who screened the title and abstracts.
    Lines 111-116: Please provide the details of the screening process.
    Lines 111-116: What happened if there were disagreements at this stage?
    Lines 111-116: Please provide the initials of those who conducted the full-text reviews of the reports.
    Lines 111-116: Please provide the details of the full-text review process.
    Lines 111-116: What happened if there were disagreements at this second stage?
    Lines 111-116: What happened if there were more than one report from the same study?
    The reviewer is right. We clarified the screening procedure in the text, adding the initials of those who screened the title, abstract and full text. We inserted what happened if there were disagreements. Finally, we found 2 reports referring to the same study. In that case, we inserted both the reports because they had different aims and consequently different outcomes.

 

20. Lines 111-116 & Figure 3: From which source(s) were those “2 additional records” identified?

Thank the reviewer for this suggestion. We also used the snowball technique and citation tracking to identify additional potentially relevant publications. Indeed, we found these two additional records. To clarify this, we added a sentence in the screening procedure (see lines 156-169). However, we modified the PRISMA flowchart following the last model and Figure 3 began Figure 2.

 

21. Lines 111-116 & Figure 3: Please provide a citation for Figure 3.
    Thank the reviewer for this suggestion. We added the citation for the ex Figure 3, now Figure 2.

 

Lines 111-116 & Figure 3: Figure 3 implies that authors included “studies” not paying attention to the distinction between “reports” and “studies” that is very concerning to this reviewer. Please be clear.
Thank the reviewer for this remark. Following the definition provided by Page and colleagues (2021), a Report is a document (paper or electronic, e.g., a journal article, preprint, conference abstract, etc.) supplying information about a particular study. Instead, a study is an investigation, such as a clinical trial, that includes a defined group of participants and one or more interventions and outcomes. Between these two terms, there is a relationship: a “study” might have multiple reports. Finally, the authors defined the record as the title or abstract (or both) of a report indexed in a database or website. Based on these definitions and the new PRISMA flowchart, we intervened in Figure 3 by converting it in Figure 2. In conclusion, we identified 1160 records through the databases (PubMed, Embase, Medline, and PsycINFO); then, we removed 239 duplicated records; we screened 925 records based on the title and then only 154 based on the abstract. At that point, we had 47 reports included in our SR.

 

22. Lines 120-127: Please be specific what is “a standard format”. Did they use a form for this phase?

Lines 120-127: Was this form pre-tested?

Thank the reviewer for this remark. By the term standard format, we meant to refer to a format constructed by us based on some formats used in other studies. However, we realize that the more exact term would be the following "custom template", so we made this change in the text to make it clearer (see line 173). 

 

23. Lines 120-127: Please see above. It is still not clear what authors mean by “qualitative”, “quantitative” study designs… It gets even more confusing if one looks at Table 1, the results table. What is the definition of a “perspectival design” (p.14), for example? How is it different or similar to “longitudinal study”? “What type of a study design is “pilot study”…

Thank the reviewer for this suggestion. We intervened in the manuscript to clarify this aspect. Specifically, we divided the studies included in the SR according to the research methodology used. There are three research methodologies: quantitative, qualitative, and mixed methods. The quantitative method relies on statistical procedures to analyze data and uses questionnaires or survey to collect them. In contrast, qualitative methods rely on descriptive narrative for data analysis, usually obtained through interviews or focus groups. Finally, the mixed methods approach combines quantitative and qualitative methods. To divide the studies included in our SR, we decided to follow this classification, and to avoid misunderstanding, we have included an explanation of what we mean in the text (see lines 137-154) and modified the tables of results.

 

24. Lines 120-127: It is concerning to this reviewer that data were extracted by one author.

Lines 120-127: Again, please be specific, were all data extraction “cross-checked”, or some? If some, what percentage? Also, what does “cross-checking” involve? Please be specific.

Lines 120-127: What happened if there were disagreements during this “cross-checking” process?

Thank the reviewer for these concerns. We noticed that this section was not clear, so we substantially intervened in it clarifying the data extraction process (see lines 173-186). Specifically, the first and the second authors, after independently reading the studies included and underlining the relevant part, together discussed what to extract from the studies included in the review. One author actually extracted the data and then the second author cross-checked the work to assess their accuracy. This process consisted in reading the data extracted by the first author and controlling the accuracy of the extraction. In case of disagreement, other authors were involved and consulted.

 

25. Lines 120-127: Were there an assessment of risk of bias of included studies?

Thank the reviewer for this suggestion. Initially, we did not feel necessary to include an assessment of risk of bias. However, your suggestion was helpful for us to reflect on the importance of conducting this assessment as well. We thus included in the text a paragraph designated to the assessment of risk of bias (See lines 188-202) and we added as Appendix 2 the table. We used the model created by Downs and Black (1998).

REF: Downs, S. H., & Black, N. (1998). The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions. Journal of Epidemiology & Community Health, 52(6), 377-384.

26. The rest of the sections: This reviewer is unsure on how to continue with the following sections given the review points above.
    Thank the reviewer for all these comments. We hope that these revisions are sufficient for the reviewer to continue with the following sections.

 

27. One suggestion for the results table: This table should be split into at least 2 tables and presented in a format that is easy for the readership to follow. Currently, it is full of disparate information, making it hard to follow; it seems to be 8 and a half pages long; and some pages do not even have titles for the columns continuing from the previous pages…

Thank the reviewer for this suggestion. We divided the Table in 3 subsequent tables in order to clarify our subdivision.

Reviewer 2 Report

I appreciated the opportunity to review this manuscript.  I felt that the methods and findings were sound and well and clearly presented.  I especially appreciated the figures/graphs, which were clear and enlightening.   I look forward to similar research regarding the role of caregivers in decision making in other cancers and life-threatening illnesses.

Author Response

Thank you very much.

Reviewer 3 Report

The review study was constructed with basis in international protocols and have outcomes so good delineates. I recommend for publication.

Author Response

Thank you very much.