PONE-D-23-32983Presenting decision-relevant numerical information concerning harms and benefits to patients with varying levels of Health Literacy: case example of adjuvant systemic therapy for breast cancerPLOS ONE

Dear Dr. van Strien,

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. Please submit your revised manuscript by Feb 16 2024 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

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Felix G. Rebitschek

Academic Editor

PLOS ONE

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Partly

Reviewer #3: Yes

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

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: No

Reviewer #3: No

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4. 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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5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: This paper reports a study which aimed to investigate the effect of survival rates and side-effects presentation formats on understanding and feeling informed and effects of health literacy using breast cancer therapy as an example. The study question is important and the study is interestingly designed. I do however have a few important comments for the authors to consider:

- Overall, the writing could be clearer. For example, some of the sentences are quite long.

- Why did the authors choose breast cancer therapy as the case example? Could findings be different in another example? This is not entirely clear to me throughout.

- There is a lot of information in the Methods – it is quite hard to follow. I appreciate all of the Tables and Figures, however is there any way this could be simplified? Consider collating all of it together as an Appendix (ie. the entire survey) and simplifying in the text to make it easier for those who are not familiar with these methods to follow.

- Following on from that, there are a lot of tables – I think some need to be reduced (suggest in the Methods as opposed to the Results).

- In the first Figure make clear Experiment 1 and 2.

- The figures are coming up blurry – please check quality.

- While the Discussion is well written, the conclusions could be much stronger. What does this mean for current policy and practice – what else could be done to help with this or future research in regard to health literacy?

Reviewer #2: This study endeavors to create and evaluate visual aids conveying both survival rates and the probabilities of side effects associated with a specific breast cancer treatment. The design of visual aids adhered to state-of-the-art recommendations and involved consultations with the oncologist and patients. The manuscript maintains a robust theoretical foundation, exhibiting transparency through preregistration, comprehensive outcome reporting, and inclusion of statistical analyses, even when non-significant.

However, to enhance the manuscript's accessibility for other researchers, I propose several improvements. Firstly, supplementing details in the supplementary materials compensating for the lack of a dataset would increase the potential utility of the research in future meta-analyses (e.g., by incorporating a matrix of correlations and reliability analyses for all measures in the supplementary materials).

Additionally, a more comprehensive dropout analysis for each experimental condition, along with updates to Figure 1, is recommended, considering potential variations in emotional responses across conditions. Figure 1 would also benefit from additional information on the assignment method for experiments.

Furthermore, I suggest conducting analyses controlling for numeracy, graph literacy, and education to ensure that health literacy indeed predicts the outcomes. As the study could evoke negative emotions, please provide more details about measures that the authors used to ensure the well-being of the subjects.

I recommend, adding more information regarding the numeracy measure, including the reference, psychometric properties, and relationships with other measures (the measure is introduced only briefly in the supplementary materials).

Finally, A revised title reflecting the exclusive focus on female subjects aged 50-70 and the absence of real breast cancer patients would enhance accuracy.

Reviewer #3: This manuscript reports an online experimental study conducted among women in the Netherlands. The study investigates important questions that are broadly relevant for determining the best formats to use in health information provision. The manuscript is generally clear and well written. Below, I have indicated a few points where I think information is missing and some suggestions to consider to improve the manuscript’s presentation and English expression.

DATA AVAILABILITY

1. Information from the manuscript submission system says the “study was exempted from review by the medical research ethics committee”. However, it also says: “Data cannot be shared publicly because the Ethics Committee approved the collection and analysis of the data for the specific study only. The Ethics Committee requires that the data collected remains securely stored and not be shared publicly.” To me, these statements seem contradictory. The authors need to clarify.

INTRODUCTION

2. Page 5 line 97-98. This sentence is too long and awkward. I suggest breaking it down into 2 sentences to convey the ideas that (a) unlike previous studies, we designed info to reflect practice; (b) specifically, in practice info is complex and includes… etc.

METHODS

3. Page 8 line 145. I would save the presentation and mention of Figure 1 until the Results section.

4. Page 8 line 149-156. I think the information about the sample size calculation belongs in the Data Analysis section.

5. Please specify when and how participant demographics and background characteristics were collected (i.e., age, education level, medical background, medical knowledge).

6. Page 9 line 163. “empathise with this situation” may be the accurate direct translation from Dutch, but reading the scenario presented in Figure 2, I suggest it would be more appropriate to say “imagine themselves in the hypothetical situation” (as per Page 15 line 259).

7. Table 4. The abbreviations PA and NA are defined in the text, but they should also be in a footnote to the table. Also, this label is missing from Overwhelmed and Worried. After reading further, I now realise this is because these 2 terms were added to the original PANAS items. However, I think it would be helpful to use an asterisk or something and put a brief explanation in a footnote to the table.

8. Secondary outcome measures. To avoid confusion with “decision uncertainty”, I suggest renaming the single item “decision confidence” instead of “decision certainty”.

RESULTS

9. Table 5. A cell in the middle of this table – “20 (37.0)” – is missing the “%” sign.

10. Did the authors check for any significant differences between groups on any of these characteristics? If there were differences, should these have been controlled for in analyses?

11. Page 18 line 297. “HL was neither associated” should be “Nor was HL associated”.

12. Page 19 line 316. Similarly, “HL neither influences” should be “Nor did HL influence”.

13. Figure 4. I think the authors should consider whether this information would be better conveyed via a bar chart, because there are distinct groups/conditions being compared (as opposed to different points in time).

DISCUSSION

14. Page 26 line 449. “this limitation does not seem to have occurred” doesn’t seem quite right; perhaps replace with something like “this limitation was not consequential” or “this limitation ultimately did not influence our findings”.

15. Page 26 line 450. The acronym IPDAS should be explained.

16. Page 26 line 456. “while ordinal logistic regression analyses were performed” – I suggest instead “whereas ultimately ordinal logistic regression analyses were performed”.

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Reviewer #1: No

Reviewer #2: No

Reviewer #3: Yes: Dr Jolyn Hersch

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PONE-D-23-32983R1Presenting decision-relevant numerical information to Dutch women aged 50-70 with varying levels of Health Literacy: case example of adjuvant systemic therapy for breast cancerPLOS ONE

Dear Dr. van Strien,

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.

Please submit your revised manuscript by May 25 2024 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

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

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

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

We look forward to receiving your revised manuscript.

Kind regards,

Felix G. Rebitschek

Academic Editor

PLOS ONE

Additional Editor Comments :

Dear Authors,

Thank you for submitting a revision that has addressed the reviewers’ concerns well!

My outstanding points are listed below:

1) The presentation formats fit for groups of differential education, numeracy, or health literacy is an important target. However, an argumentation is required. Why do you expect – according to which theory of health literacy – that people with different levels of health literacy would respond differently to a given piece of health information? For instance, HL-EU substantially refers to the perceived ability to seek, to find, and apply health information (besides evaluating and comprehending). For instance, the sentence in l.39-40, according to which skills related to information processing could be captured by HL is too speculative. The introduction needs to derive the health-literacy-expectations from the literature. Why should which concept of HL produce which type of differences given formats? This also may help explain why HL made no difference in comprehension in Experiment 2.

2) Your descriptive statistics even with a higher powered sample let nobody expect to find medium effects on comprehension depending on health literacy. Provided an argumentation for an interaction with health literacy, this leads to discuss

a. the stimuli: The icon array and the bar chart in Experiment 1 have a small but relevant error how visualisations are labelled: The legend labels Hormone therapy and Chemotherapy in option 2 and 3 although correctly would be Surgery and Hormone Therapy and Surgery and Chemotherapy, respectively. A scientist may perceive this difference trivial, but actually this misspecification can create confusion in laypeople who aim to understand the legend, particularly if they are not really aware about that they might have already undergone surgery. Items referring to Hormone and Chemotherapy (verbatim!) could bring the visualisation formats at disadvantage. On the other hand, it would be sufficient to read (in Experiment 1) the statement “Alive after 10 years: XX%” – this allows for correct responding to any item and this is constant across presentation conditions. So, why to expect any difference? One could say, the graphs did not mislead them.

b. the participants: Have they just not taken deep notice of the material and answered the questions correctly anyway? [e.g., the gist comprehension questions] Where attention checks for compliant responding included [only three for “poor data quality”, e.g. straightliners, excluded?]? I comprehend the power calculation, but the cells with low literates in the end are not all sufficiently powered, even assuming highly compliant participants.

c. the measurement. You did pretesting with 30 low-literate participants, but what has been learned? Items with more than 90% correctness in their group did not enter the main survey, anything else on discriminability? Probably the three gist comprehension tasks were too easy for guessing people – many people would expect more treatment more benefit. What are the internal consistencies of comprehension gist and comprehension verbatim and comprehension combined?

d. the analysis. Have you considered format analysis across all items (simple comprehension sum score)? Have you considered a sensitivity analysis excluding those, who respond “I don’t know”?

3) Please refer not only to shared decision making but to the goal of health communication enabling informed decisions according to evidence-based medicine, Western health system standard. Particularly, informing patients about benefits and harms is one of many rules according to established guidelines on how to design health communication (e.g., .

4) Also, how did you arrive at subscale of decisional conflict (instead of the full assessment?) Could you derive in the introduction why it is relevant to assess how someone could have felt informed?

5) Abstract

a. “When communicated adequately..”

b. Capitalisation of shared decision making and health literacy seems unusual

c. When high/low …. Perhaps better expressed “depending on their”….

d. Probability information in numbers/visualisations … Perhaps better expressed “numbers with or without…” Numbers accompanied also visualisations here.

6) Introduction; generally: the impression of specific visualisation that outperforms no visualisation should be avoided, because state of evidence is that different presentation formats are beneficial for different problems and different dialog groups. Please leave it in a format comparison, as you analysed it, bar vs. text and icon vs. text.

a. L.49… reduced by conveying the part-to-whole relationship [11].

b. L.62… please be more explicit what is meant by general recommendations. There is evidence for different formats and decision problems, but do you mean guidelines?

c. L.61-l.76: some studies could be considered that compared communication formats for medical evidence (with and without text control) with regard to knowledge/comprehension, also with regard to education and health literacy – references below; you may find further literature, if you review literature on the health communication of benefits and harms

d. What is meant by decision (l.95) for women without BC from the general population (hypothetical decision, intention?).

e. Experiment 1 and 2 should be capitalised throughout the manuscript

7) Method

a. Please mention that it is a convenience sample, not representative for Dutch women from 50-70.

b. Move the SBSQ to the Measures section

c. Why SBSQ, please explain, given so many others?

d. Though mentioned in the text, I cannot recognise quotas from Fig. 3.

e. How have you excluded that participants of Experiment1 participate in the subsequent Experiment2?

f. Which questions about medical knowledge and medical education have been included (reference), where reported, and why at all?

g. 1 decimal might be sufficient for age M and SD

h. What was the order of the comprehension items?

8) Results

a. Figures that illustrate the main effects and (non-)interactions with regard to gist and verbatim comprehensions would be very helpful.

b. Figure 4

i. Commas on the y-axis!?

ii. The figure showing sample-based data requires uncertainty intervals.

c. What is low, middle, high education?

d. Table 5 does not need a total column

e. Two decimals for test values and confidence intervals might be sufficient (APA)

f. L.463 (you pointed above on Bonferroni adjustments with regard to the large number of secondary outcome analyses), but here risk perception is considered to reveal an effect – please check across the results whether you corrected as planned.

9) Discussion

a. Why women with low HL did comprehend less about survival rates but not less about side effects?

10) References

a. See 13 and 45, there are variations across the references in capitalisation and abbreviations of journals, please ensure references consistency!

References to the Editor’s comment

Brick, C., McDowell, M., & Freeman, A. L. (2020). Risk communication in tables versus text: a registered report randomized trial on ‘fact boxes'. Royal Society Open Science, 7(3), 190876.

Hinneburg, J., Lühnen, J., Steckelberg, A., & Berger-Höger, B. (2020). A blended learning training programme for health information providers to enhance implementation of the Guideline Evidence-based Health Information: development and qualitative pilot study. BMC Medical Education, 20, 1-11.

McDowell, M., Gigerenzer, G., Wegwarth, O., & Rebitschek, F. G. (2019). Effect of tabular and icon fact box formats on comprehension of benefits and harms of prostate cancer screening: a randomized trial. Medical Decision Making, 39(1), 41-56.

Scalia, P., Schubbe, D. C., Lu, E. S., Durand, M. A., Frascara, J., Noel, G., ... & Elwyn, G. (2021). Comparing the impact of an icon array versus a bar graph on preference and understanding of risk information: Results from an online, randomized study. Plos one, 16(7), e0253644.

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

Reviewer #3: All comments have been addressed

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2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #3: Yes

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

Reviewer #1: I Don't Know

Reviewer #3: Yes

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4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #3: (No Response)

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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 #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. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: The authors have done a good job at addressing all of the previous comments and concerns and have made some extensive changes. The manuscript is much clearer. I have no further comments.

Reviewer #3: (No Response)

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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: No

Reviewer #3: Yes: Dr Jolyn Hersch

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While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

PONE-D-23-32983R2Presenting decision-relevant numerical information to Dutch women aged 50-70 with varying levels of health literacy: case example of adjuvant systemic therapy for breast cancerPLOS ONE

Dear Dr. van Strien,

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.

Please submit your revised manuscript by Aug 10 2024 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

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

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

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

We look forward to receiving your revised manuscript.

Kind regards,

Felix G. Rebitschek

Academic Editor

PLOS ONE

Journal Requirements:

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

Additional Editor Comments:

Dear Authors,

You have extensively addressed concerns and corrected where necessary. Thank you! Finally, one thing remains, which centers around low-literacy findings/non-findings of Experiment 2.

In your preregistration you hypothesised:

H2a. People provided with information in a visualization [..] will report more adequate comprehension of the trade-off between survival rates and likelihood of side-effects (gist comprehension trade-off) compared to people provided with the information in numbers only (condition 2a and 3a). Health literacy will moderate this relation, in the sense that those with lower/inadequate health literacy will be better supported in comprehension of the trade-off with the visualization (condition 2b – condition 3b) compared to numbers only (condition 2a and 3a) compared to those with higher/adequate health literacy. Similarly, H2b.

Then you tested that according to the manuscript:

"in both experiments the analyses with comprehension as outcome were performed with cumulative odds ordinal logistic regression with proportional odds (instead of ANOVAs)."

The power calcuation, however, was made for an ANOVA. And you in the discussion: "However, it should be noted that the expected interaction-effects were ordinal-interactions rather than full crossover interactions, therefore the statistical power to detect the expected interactions is lower than the a priori calculated 90% and 91%."

Now, Experiment 2 that varies the presentation of probability came with cell samples between 17 and 26 participants. You referred to both the power calculation (which was made under different assumptions) and limitation section in your discussion as cited.

Now we can say that Experiment2-Comprehension was less likely to detect any difference among the factor stages (than planned), but even less likely to enable planned comparisons as you hypothesised them in the preregistration.

Btw: With which tool have you done the power calculation?

On the other side you wrote about applying Bonferroni correction but your results seem to be interpreted still consistently under alpha<.05. How do I recognise your adjustment? For the example: “Regarding ‘feeling informed’ (H3), we found an interaction between HL and format, F(4, 274) = 2.67, p = .032, partial η2 = .04.“ If alpha is adjusted, this may typically would not count as being significant. Note that according to the preregistration the interaction on „feeling informed“ is exploratory.

Taken together, please check how both low power and multiple testing correspond with your results and discussion on the interaction with HL; according to my understanding the manuscript would benefit if you make more concrete that the question whether low HL people comprehended your interventions differently than high HL people could not be reliably addressed by your studies.

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Presenting decision-relevant numerical information to Dutch women aged 50-70 with varying levels of health literacy: case example of adjuvant systemic therapy for breast cancer

PONE-D-23-32983R3

Dear Dr. van Strien,

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Kind regards,

Felix G. Rebitschek

Academic Editor

PLOS ONE

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