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Readability in printed education materials for Chinese patients with systemic lupus erythematosus: a mixed-method design

Objectives To assess the readability of printed education materials (PEMs) for patients with systemic lupus erythematosus (SLE) and to explore the perceptions of patients with SLE with different health literacy regarding the readability of PEMs. Design A mixed-methods study, including a cross-sectional survey and semistructured interviews. Setting The SLE PEMs were collected from 13 hospitals in China. The interviews were conducted in the Department of Rheumatology of a hospital in Hefei, China. Participants In the cross-sectional survey, convenience sampling was used to select the Chinese SLE PEMs, with 20 PEMs included. In the qualitative study, the patients with SLE were divided into two groups based on their health literacy. Then, purposive sampling was used to select participants in each group, with 18 patients recruited. Outcome measures The readability of PEMs was assessed by the language analysis technology and the Chinese version of the Suitability Assessment of Materials (SAM-C) instrument. Results For text factors of readability, the mean Chinese language difficulty coefficient was 67.09±8.03, which indicates that the text of PEMs was difficult to read. For non-text factors, the mean SAM-C score was 45.62±9.51. Eight PEMs were rated not suitable, 12 were adequate and none were superior. In the interviews, eight categories were identified: information source, content, actionability, plain language, pictures, tables, numbers and layout. Patients with different health literacy had discrepant views on the detail of basic information, the necessity of question list, the location of functional pictures and the application of mathematical symbols. Conclusions The readability of Chinese SLE PEMs does not perform well, and it is necessary to reduce the difficulty of words, shorten the length of sentences and improve the picture design and actionability. To develop PEMs tailored to patients’ level of health literacy, patients’ unique view of readability should be integrated into the design of PEMs.

3: When and how was the participants health literacy assessed? Did you assess all participants in the cross-sectional study and purposeful select based on that? 4: The MMSE is described as one of the exclusion criteria. Was the MMSE conducted on all eligible patients? Is this because the participants are selected based on another study. Why was patients with reading difficulties excluded? How was this assessed? It seems strange as health literacy is part of the qualitative study. This may be important information as the population can be very selected. Please also describe what you mean by purposive sampling in this study. 5: The qualitative part of the study need some more explanation and description. Please explain more clearly the reason for choosing individual interviews rather than focus group interviews which would seem like a relevant choice for the aim of the last study. Please also argue why two interviews was chosen rather than one interview where both types of SEMs are discussed? What type of field-notes were taken during and after the interview? (p 9). What was the purpose and the focus for the field-notes? How did you use the notes in the analysis of the material? 6: It is an interesting choice to present patients with SEM of different quality. Which type did you present in the first interview? Did you alternate the sequence in the different interviews? This seems to be of importance for the patients' assessment of the SEMs? Please also clarify whether it was the same two SEMs you used for all interview participants. 7: You chose to send a summary of each interview for the participants. What was the reason for this? Did this process lead to any changes? Why do you find this appropriate? Could the patient have changed their opinion after the interviewand what is then the "right" version? 8: The participants gave their informed consent to participate. Did they give a written consent? How about permission to store and manage data? Other ethical considerations. It seems as if rather specific information about each participant is provided in the supplementary file. There may be a risk that some of them can be identified by themselves or others. Please consider if you need i.e. exact age or whether some age-groups could be used instead. Please provide some additional information about ethical considerations. 9: The interviewguide does not quite seem to match the described purpose of the qualitative interview studyto gain insight into how SLE patients with varying health literacy levels perceive the readability of PEMs. The interview guide reflects the content in the instruments used in the first part of the study and is less open towards other elements in the participants' understanding. Please discuss the impact of this.
10: The description of the analysis of the qualitative interviews is not quite aligned with the method the authors refer to. The analysis seem to be mainly deductive and descriptive and as such an interpretation of the findings are lacking. This may be a choice by the authors, but it should be explicated that the analysis stayed at the manifest level describing categoriesand thus not involves more in depth interpretation to derive a latent content. As it is for now, the description of the analysis is not convincing. The reader is not convinced that the process was stringent and the results can be trusted. 11: Only women were interviewed and the mean age is low for the participants. What do you think these issues have on your findings? Please address this as limitations for the study in the Discussion section.
12: Parts of the results does not seem relevant for the described purpose of the study.
13: The description of the scoring of the non-textual elements using the SAM-C is not easy so follow. It could help the reader if the authors provide a comprehensive description of the SAM-C as part of the Methods section, as the details in the results will then make sense.
14: Only one material was rated "superior" in presenting content in a tangible, behavior-related Context 8p. 11). Was this relevant for all the PEMs evaluated? According to the description of the selected SEMs they were not all related to behavior. 15: The whole paper needs English language edition. There are several paragraphs which does not make sense as they stand unless you try to guess what is meant, small words are missing throughout the text -to make the language fluent and understandable (such as missing "a", "the") and words are with "s" at the end where this is not appropriate and there are some typing errors too. All this disturbs when reading.
Minor topics 1: Please reformulate first dot under "strengths and limitations" 2: In the Background section the use of past tense and present tense is confusing 3: There is a flaw in reference 32 4: On p. 6, when referring to "The general information form" it sounds as if It is already described or well known. What was the use of this form? Please reformulate. 5: P. 6, NLPIR needs to be defined. 6: Please describe what is meant by "dimension scores" p. 7. 7: The authors refer to Flesch-Kincaid formula (p. 7), but no reference for this is provided. Is this the same you refer to in the Discussion section? 8: Why was both SPSS and STATA used as statistical software? No reason is provided. Maybe because the study was conducted as small parts by different persons in their master-theses. 9: What is meant by "behavioral record" p. 9? What is "superclass words" (p. 12)?. There are concepts throughout the paper, which are not defined.
10: The first sentence in the Discussion section does not quite make sense. Please reformulate. 11: The quotes in Table 5 some are marked by high or low health literacy, but not all. What about age and gender of the participantthen you can show that different participants are cited.

GENERAL COMMENTS
Thank you for the opportunity to review this article. It was very interesting and I can see that you have all made a huge effort to comprise two large studies into one article. I have attached my comments directly in the pdf file. Please revert back to me if you can´t see my comments.
Regarding the Abstract: Please consider not using abbreviations in the abstract or write these in full after the abbreviation. I will be happy to take a second review if necessary. All the best.
The reviewer provided a marked copy with additional comments. Please contact the publisher for full details.

Responses to Dr Rebecca Jessup's Comments:
General Remarks: This is interesting and important research. However, I believe there are some specific methodological issues and therefore I do not recommend publication in BMJ at this time.

Response:
We thank you for your appreciation of our contributions. We have addressed your concerns in the revised version of this paper. We are grateful to you for your comments, which make our paper more precise. For example, in item 3b (type of graphics), we referred to previous studies to illustrate the graphics with which patients might be unfamiliar, such as X-ray films and pathological pictures. As shown in the figure below, we also include the evaluation examples of previous studies under each scoring criterion.
In summary, this study did not adjust the core content of the SAM-C. The work was done only to avoid repeated measurements and to improve item comprehension. Therefore, the researchers thought that it would not affect the validity of the instrument.
Comment 2: Your interview process not assess comprehension or readability. The table on Page 10 (Table 2) which outlines the interview guide suggests you were actually measuring likeability and/or preferences. Using a 'think aloud' format for these interviews would have allowed for assessment of inferences made by participants while reading the material, thus providing an indication of comprehension and readability.

Response:
We designed the interview according to the purpose of the study. The purpose was to explore the perceptions of patients regarding the readability of PEMs. When designing the interview topic guide, we wanted to summarize the influencing factors of readability and asked patients about their reading experience regarding these factors. Therefore, we collected instruments for measuring readability and studies of readability assessment, from which we summarized what should be included in the text factors and non-text factors, and formed the interview guide on this basis. Using a 'think aloud' format for these interviews is a good suggestion. However, because there are some drawbacks to this approach, including a long period of participant training, heavier burden on the participants, and understanding bias in the analysis of data, we do not adopt this approach.

Response:
We have invited an English editor to check the vocabulary and grammar of the whole article and corrected the errors in the revised version.
Comment 4: Line 12 page 2 in the abstract, spell out PEMS and SLE once before using the acronym e.g. patient education materials (PEMS).

Response:
On page 2 of the revised version, we have added the full English name before the corresponding abbreviation in the abstract. Comment 6: Page 7 line 9: It is sufficient to say it has been validated previously and the context (which population) within which it was validated. You do not need to report statistical outcomes of the validation process following translation.
Response: On page 6, line 20 of the revised version, we have removed the statistical outcomes of the validation process. We explained in the article that the content validity, internal consistency, and interrater reliability of the SAM-C were measured in the Chinese version of printed educational materials on asthma. Response: In the original article, we did not express this clearly. We have made a small change in the exclusion criteria. On page 8, line 27 of the revised version, we excluded patients who were unable to read because of serious organ damage, such as heart, brain, and kidney damage. stresses the interaction between the text and a class of readers of known characteristics such as reading skill, prior knowledge, and motivation." Therefore, a 'given class of people' is understood in this study as a predetermined target group, SLE patients, which have known characteristics.

Responses to Dr Jette Primdahl's Comments:
General Remarks: This paper addresses a very important topic, the readability of written patient education materials, and it addresses materials specifically for people with SLE. The study is a mixed methods study encompassing a language analysis of the text, an analysis of the non-text factors using an SAM-C instrument and two individual interviews with patients with high and low health literacy who were presented with different material deemed to have high and low quality. Finally, the two groups of patients' views and suggestions on the readability of these materials were collected and compared. As such, the study is comprehensive and contributes different types of data to illuminate the topic, and the combination with health literacy is highly relevant. Before publication in BMJ Open can be considered, some major and minor points need to be addressed.

Response:
We thank you for your appreciation of our contributions. We address your concerns in the revised version of this paper. Detailed modification information is listed below.

Major topics
Comment 1: The aim of the study seems to differ between the abstract: "to assess the readability of PEMs given to SLE patients and to provide suggestions for improving the readability of the SLE PEMs" and the formulation in the paper: (1) evaluate the readability of PEMs for SLE patients based on the text and non-text factors of readability, (2) explore the perceptions of the SLE patients with high and low health literacy on the readability of PEMs. Later (p 8) the authors describe the purpose of the qualitative interviews as "We want to gain insight into how SLE patients with varying health literacy levels perceive the readability of PEMs". Please align.
Response: On page 2, line 5 of the revised version, we have modified the description of the purpose in the abstract. The aim of the study consists of two parts: (1) to assess the readability of SLE PEMs using standardized instruments and (2) to explore the perceptions of SLE patients with different levels of health literacy regarding the readability of PEMs using individual interviews. We have improved the logic of the background section: (1) the special problem of SLE patients is that their disease activity is generally high (paragraph 1); (2) improving the health literacy of SLE patients is an effective measure to reduce disease activity (paragraph 2); and (3)  is part of the qualitative study. This may be important information as the population can be very selected.
Please also describe what you mean by purposive sampling in this study.

Response:
We conducted the MMSE on all eligible patients. To exclude patients with cognitive impairment, we asked them to complete the MMSE. The participants are not selected based on another study.
In the original article, we did not express this clearly. We have made a small change to the exclusion criteria. On page 8, line 27 of the revised version, we excluded patients who were unable to read because of serious organ damage, such as heart, brain, and kidney damage.
The sampling method of this study was stratified purposive sampling, which has been clarified on page 8, lines 23 to page 9 line 2 of the revised version. The specific sampling steps are introduced in the response to comment 3.

Comment 5:
The qualitative part of the study needs some more explanation and description. Please explain more clearly the reason for choosing individual interviews rather than focus group interviews which would seem like a relevant choice for the aim of the last study. Please also argue why two interviews was chosen rather than one interview where both types of PEMs are discussed? What type of field-notes were taken during and after the interview? (p 9). What was the purpose and the focus for the fieldnotes? How did you use the notes in the analysis of the material?
Response: There are two reasons for using individual interviews. First, the disadvantage of the focus group interview format is that the direction of the discussion may be dominated by some positive participants, which leads to some participants' views not being fully reflected. Previous studies indicate that some patients with poor reading and writing skills often do not want to show their lack of these abilities in front of a group. Therefore, this kind of psychology may lead patients to conceal. If we conducted focus group interviews, patients with poor reading and writing skills may have concealed what they did not understand about the material to remain consistent with the other participants. In individual interviews, because the participants are not influenced by others, they are more likely to express their true views. Second, if we conducted focus group interviews, we would have needed to distribute the same material to each participant the day before the interview and ask them to read it. However, the materials were collected from other hospitals, and there was only one copy of each material, so the above steps could not be implemented. For these reasons, as explained on page 9, line 6 of the revised version, 'Considering the feasibility of the research implementation and the authenticity of the participants' expression, we chose individual interviews rather than focus groups to collect data.' In this study, two PEMs were used as stimulus materials. During the design phase of the study, we intended to distribute the material to patients and invite them to read it the day before the interview, and we asked several nurses for suggestions about this design. They suggested two interviews. They told us if we conducted one interview, patients would need to read two materials the day before, and they might be bored and skimmed through the materials due to the large amount of reading, which might lead to inaccurate interview results. Based on this. We chose two interviews rather than one interview in which both types of PEMs were discussed because we wanted to obtain accurate interview results. We explain this on page 9, line 10 of the revised version: 'If the participants were asked to read two PEMs in a short time, they might be bored and skimmed through the materials because of the large amount of reading, which might lead to inaccurate interview results.
With that in mind, every participant received two individual interviews with a break of 2-3 days between the interviews.' During the interviews, field notes were used to record the participants' facial expressions and body movements and the researcher's understanding of the patient's perceptions. After the interview, field notes were used to record a summary of representative views, shortcomings in the interview, and new perceptions that did not emerge in the previous interviews. In the next interview, we corrected the shortcomings and verified the new perceptions. During the transcription process, we added the participants' facial expressions and body movements to the corresponding text. In the data analysis, the researcher's understanding of the patients' perceptions can help in interpreting the data. On the page 9, line 19 of the revised version, we have added a description of the content of the field notes.

Comment 6:
It is an interesting choice to present patients with SEM of different quality. Which type did you present in the first interview? Did you alternate the sequence in the different interviews? This seems to be of importance for the patients' assessment of the PEMs? Please also clarify whether it was the same two PEMs you used for all interview participants.

Response:
In the first interview, the material with low readability was used, and in the second interview, the material with high readability was used. We have made this clear on page 9, line 13 of the revised version.
We did not change the reading order of the materials in the course of the research. During the design stage of the study, we invited some colleagues to read the material with low readability first and then to read the high-readability material. In another group of colleagues, we alternated the reading sequence. We found that the first group was able to express more views on the readability.
Therefore, we chose the first reading sequence in this study.
We used the same two PEMS for all interview participants. On page 9, line 8 of the revised version, we have clarified these two PEMs chosen from the quantitative study with the lowest and highest readability scores were used as stimulation materials in the interview.
Comment 7: You chose to send a summary of each interview for the participants. What was the reason for this? Did this process lead to any changes? Why do you find this appropriate? Could the patient have changed their opinion after the interview -and what is then the "right" version?

Response:
We sent a summary of each interview to the participants because we wanted to improve the explanatory validity of the qualitative research, which meant ensuring that the researchers understood the true views of the participants.
In this process, the participants corrected our misunderstandings of the content of interviews. For example, in the summary of an interview with a patient with high health literacy, we wrote that this patient wanted to add many pictures to the material to help with reading. However, the patient pointed out that this was somewhat inaccurate, and she only wanted to add pictures next to words that were difficult to understand. We used the corrected version in the analysis. On page 9, line 28 of the revised version, we have added this content. Participants could withdraw from the study at any time without reason and would not receive unfair treatment as a result. In the data collation stage, the identifiable information of the participants was hidden and replaced by a number. Only the involved researchers had access to the interview data, which were kept by QW and sealed after the analysis was completed.
We have revised the table in the supplementary file. We divided the participants into two groups according to their health literacy level and showed the characteristics of patients in each group. The data were collapsed across participants.

Comment 9:
The interview guide does not quite seem to match the described purpose of the qualitative interview studyto gain insight into how SLE patients with varying health literacy levels perceive the readability of PEMs. The interview guide reflects the content in the instruments used in the first part of the study and is less open towards other elements in the participants' understanding.
Please discuss the impact of this.
Response: According to the existing instruments for measuring readability and previous research findings on the readability of PEMs, we summarized the influencing factors of readability including text factors and non-text factors. When designing the interview topic guide, we aimed to know the patients' view on these factors. So, the interview guide not only contained the contents in the SAM-C, but also contained other elements, such as numerical information. We also asked the patients to give some suggestions regarding further improvements to the materials. In addition, the participants proposed some opinions that could not exist in the quantitative evaluation results, such as contradictory information in the materials and mathematical symbols. During the interviews, the patients also talked about what information they wanted to add to the material, such as perinatal recommendations and new progress in treatment. However, the above information is related more to the information needs of patients than the readability of PEMs, so it is not shown in the results.

Comment 10:
The description of the analysis of the qualitative interviews is not quite aligned with the method the authors refer to. The analysis seems to be mainly deductive and descriptive and as such an interpretation of the findings are lacking. This may be a choice by the authors, but it should be explicated that the analysis stayed at the manifest level describing categoriesand thus not involves more in-depth interpretation to derive a latent content. As it is for now, the description of the analysis is not convincing. The reader is not convinced that the process was stringent and the results can be trusted.
Response: On page 10, line 9 of the revised version, we have clarified that the analysis stayed at the manifest level of describing categories and thus did not involves more in-depth interpretation to derive latent content. The choice of this analysis strategy stems from the research purpose, which was to collect the patients' opinions on the readability of the materials.
Comment 11: Only women were interviewed and the mean age is low for the participants. What do you think these issues have on your findings? Please address this as limitations for the study in the Discussion section.

Response:
The participants in this study were all female, and the mean age was low, which was mainly due to the epidemiological characteristics of SLE patients. On page 3, line 18 of the revised version, we have added that 'SLE typically presents between the ages of 15 and 45 years, and the female-tomale sex ratio is 9:1'. Because SLE is much more common in women than men, we did not encounter male inpatients during the study period (2019.2-2019.7). The average diagnostic age is low, resulting in a low average age of the participants. For the above reasons, we do not think that these two points are limitations of this study. If you believe that these reasons are inappropriate, please let us know.
Comment 12: Parts of the results does not seem relevant for the described purpose of the study.

Response:
We are unclear about whether you mean the question in Comment 14. If there are other results that are not relevant for the described purpose, please let us know.

Comment 13:
The description of the scoring of the non-textual elements using the SAM-C is not easy so follow. It could help the reader if the authors provide a comprehensive description of the SAM-C as part of the Methods section, as the details in the results will then make sense.
Response: On page 7, line 1 to line 13 of the revised version, the six dimensions of the SAM-C are described in detail in the Methods section.
Comment 14: Only one material was rated "superior" in presenting content in a tangible, behaviorrelated Context 8p. 11). Was this relevant for all the PEMs evaluated? According to the description of the selected SEMs they were not all related to behavior.

Response:
Here is a description of the evaluation results for the 'content topics' item. In this item, the developer of the SAM indicate that since adult patients usually want to solve their immediate health problem rather than learn a series of medical facts (that may only imply a solution), the content of greatest interest and use to clients is likely to be behavioral information to help solve their problem.
Based on this, the scoring criteria for 'superior' on this item was that the 'thrust of the material is the application of knowledge/skills aimed at desirable reader behavior rather than nonbehavioral facts'. In this study, there was only one material in which most of the content was related to behavioral suggestions, therefore, it was rated 'superior' in this item.

Comment 15:
The whole paper needs English language edition. There are several paragraphs which does not make sense as they stand unless you try to guess what is meant, small words are missing throughout the text -to make the language fluent and understandable (such as missing "a", "the") and words are with "s" at the end where this is not appropriate and there are some typing errors too. All

Comment 6:
Please describe what is meant by "dimension scores" p. 7.
Response: On page 7, line 16 of the revised version, we have added the formula for calculating the dimension score. We divided the sum of the ratings in this dimension by the maximum possible score of this dimension to obtain the dimension score.

Comment 7:
The authors refer to Flesch-Kincaid formula (p. 7), but no reference for this is provided.
Is this the same you refer to in the Discussion section? Comment 9: What is meant by "behavioral record" p. 9? What is "superclass words" (p. 12)? There are concepts throughout the paper, which are not defined. Response: In this study, we chose another participant to verify whether the data were saturated after we found that was no new information emerging from the data. On page 9, line 3 of the revised version, we have added this content.
Comment 7: Page 8 line 56, please explain the rationale for conducting two interviews per patient.
What was the gain with two consecutive conversations?
Page 9 line 39, Same as above-I´m a little confused as to why two interviews were needed?
Response: In this study, two PEMs were used as stimulus materials. During the design phase of the study, we intended to distribute the material to patients and invite them to read it the day before the interview, and we asked several nurses for suggestions about this design. They suggested two interviews. They told us if we conducted one interview, patients would need to read two materials the day before, and they might be bored and skimmed through the materials due to the large amount of reading, which might lead to inaccurate interview results. Based on this. We chose two interviews rather than one interview in which both types of PEMs were discussed because we wanted to obtain accurate interview results. We explain this on page 9, line 10 of the revised version: 'If the participants were asked to read two PEMs in a short time, they might be bored and skimmed through the materials because of the large amount of reading, which might lead to inaccurate interview results.
With that in mind, every participant received two individual interviews with a break of 2-3 days between the interviews.' Comment 8: Page 9 line 14, please make clear if the pilot testing was done with another group or if it was the first patients in the study?
Response: Pilot testing (pilot interviews) was performed on the first and second patient in this study.
The first patient had low health literacy, while the second had high health literacy. On page 9, line 23 of the revised version, we have added this content.
Comment 9: Page 9 line 16, please explain what kind of data you obtained from the pilot testing, that could be used in the analysis?

Response:
We obtained patients' perceptions of the readability of materials in the pilot interviews. On page 9, line 25 of the revised version, we explain why the data from the pilot interviews could be used in the analysis and what kind of data: 'Because there was no difference between the questions in the initial interview guide and the formal guide, the audio files and the field notes obtained in the pilot interviews were also used in the data analysis.' Comment 10: Page 9 line 18, did the participants have any comments?
Response: After each interview, we summarized the views of these participants preliminarily and asked the corresponding participant to verify the summary to ensure that their views were consistent with the interpretation of researchers. In this process, the participants corrected our misunderstandings of the content of interviews. For example, when we discussed a patient with high health literacy, we wrote in the summary that this patient wanted to add many pictures to the material to help with reading. However, this patient pointed out that this was somewhat inaccurate, and she only wanted to add pictures next to words that were difficult to understand. We used the corrected version in the analysis. On page 9, line 29 of the revised version, we have added this content. The argumentation in the Background section has improved remarkably, but I do not understand your argument in the response -that there is a need to investigate materials for SLE patients specifically because they have high disease activity. It is low health literacy which can lead to higher disease activity -not high disease activity leading to reading problems. The argument for the need of this study is rather that the one study you identified which used reading formulas to assess readability is old and an assessment of written materials used today is needed. 6: I can understand that brain damage is a relevant exclusion criteria as this group of people may have reading problems, but it is not clear why you deemed heart and kidney damage relevant as exclusion criteria? 7: In the Methods setion p. 6 line 12, please add 'analysed'. 8: p. 9 line 13, you mention 'after a training session'. Please clarify what this encompassed. 9: In the section Statistical analyses, continuous data were described by mean and SD. What if data were not normally distributed? Did you test for this and how? 10: It is fine that you have added a short explanation about data saturation, but please support this approach by a relevant reference. 11: p. 11 line 1-2 it is not quite clear whether you mean two pilot interviews with participants with high literacy level and two pilot interviews with participants with low literacy level or two pilot interviews in total. Please clarify. 12: p. 11 line 5 you mention 'All interviews were conducted by QW, who received training'. What kind of training do you refer to? 13: Although the majority of SLE patients are women, I still think you need to discuss the limitations for the transferability or generalisability of your of your results to older women and men. 14: The section 'Information source' in the results section does not seem to link to the description of the methods for the qualitative study. I see now that it probably refers to the first question in the interview guide. The same applies for the first three lines p. 20 in the Discussion section. This link could be clarified for the readers. 15: I am not sure I fully understand the last sentence in the conclusion. How is i.e. information source an inductively derived subject area? 16: The interview topic guide seem to ask for whether the participants 'liked' the amunt of information, the order of presentation and the expression of words and sentences. As another reviewer suggested, a 'think aloud' strategy while the participants read the materials would have been helpful and these issues would be very relevant to add in the Discussion section. Comment 2: The first two dots in the 'strengths and limitations of this study' are methods rather than strengths and limitations. Please reformulate.
information, the order of presentation and the expression of words and sentences. As another reviewer suggested, a 'think aloud' strategy while the participants read the materials would have been helpful and these issues would be very relevant to add in the Discussion section. Response: On page 20, line 27 of the revised version, we have added the statement that using a 'think aloud' format for these interviews may be a more intuitive strategy, which allows for assessment of inferences made by participants while reading the material, thus reflecting the reading experience of participants and theirs understanding of the material.
Comment 18: About the use of tense: In the Introduction section, the new text line 30-31 is in past tense, but present tense seems more appropriate ('.... of the patients with SLE have (instead of had) episodes with flares....'). Also, the tense p. 7 lines 15-17 is confusing. It reads as if you translated the original SAM and measured validity, internal consistency and interrater reliability of the translated version. (Please add if this was on the translated version). On p 11 (Data collection) line 19, 'skimmed' should be 'skim' Response: We have corrected the tenses according to the above suggestions in the revised version.
Responses to Dr Janni Lisander Larsen's Comments: General Remarks: Thank you for the opportunity to review the second version of your interesting study entitled: "Readability in printed education materials for Chinese patients with systemic lupus erythematosus: A mixed method design". I can see that the authors have made a huge effort to accommodate all the reviewers. Based on the below mentioned comments, I will suggest a second minor revision before recommending publication. Response: We thank you for your appreciation of our last revision. We address your concerns in the revised version of this paper.
Comment 1: I acknowledge that the authors had a narrow inclusion period, and that including males with SLE could have extended the study. However, I think that excluding male participation just by referring to the gender ratio in SLE is appropriate, since reading abilities should not have anything to do with gender? In this regard, I still think it is a limitation. I recommend the authors to mention this and maybe point out that future health literacy studies should include an even gender distribution whenever possible. Response: On page 20, line 23 of the revised version, we have added the limitation you suggest. That is 'All the participants in this study were hospitalized women and most of them were younger, and this might lead to selection bias, as the results cannot be generalized to outpatients with milder disease states, male patients, and elderly patients. In the future, we will include these kinds of patients in our study as possible as we can to reduce the bias.'.

GENERAL COMMENTS
I can see that the authors have made substantial revisions to the manuscript and I believe the article is almost complete. I only had one minor comment to the "Introduction" (see comment in the attached file". I think the article is ready for publication when the author has reviewed this.