The Rising Challenge of Poor Health Literacy of Patients with Systemic Sclerosis: Preliminary Data Identify Important Unmet Needs in an Italian Cohort

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

The article submitted for review addresses the problem of low health literacy in patients with systemic sclerosis in an Italian cohort. Health literacy (HL) is important for effective and independent management of chronic diseases, including systemic sclerosis (SSc). Therefore, this study by the Authors aims to assess the level of HL in an Italian cohort of patients with SSc.

Summary - a good introduction to all the issues contained in the article. Explains the importance of HL in chronic diseases, including SSc, and provides the aim of the study. Then it discusses how to recruit patients for the study and provides the research tool. The results focus on 3 levels of HL. In summary, the authors draw attention to the need for periodic screening to detect poor reading and writing skills of SSc patients, which contributes to their insufficient level of health knowledge. The selection of keywords is correct and takes into account the scope of the research being conducted.

Introduction - Based on the literature, the authors explain that SSc is an immune-related rheumatic disease causing loss of immunity and significant fibrosis of the skin and internal organs. The causes and progression of the disease are still not fully understood. SSc remains a chronic, complex and devastating disease, causing significant mortality worldwide. The quality of life of SSc patients depends on their health condition. In practice, patients with SSc must follow a variety of health behaviors to be able to function independently in the disease. There is evidence that self-care is lacking in this patient population. Current research has shown that patients with rheumatic diseases have difficulty understanding their condition and treatment options, as well as difficulty seeking support. The paucity of data on HL in SSc, especially in Europe, prompted the authors to evaluate HL levels in an Italian cohort of SSc patients. The introduction is short, but it provides a good introduction to the essence of the problem of the article, mainly based on European data.

Materials and methods - This descriptive observational study was conducted on an Italian sample of patients (57 people, mainly women) with SSc with the support of ASSMAF (Associazione Sclerosi Sistemica e Malattie Fibrosanti), GILS (Gruppo Italiano Lotta alla Sclerodermia) and ANMAR (Associazione Nazionale Malati Reumatici) . The Italian version of the HLS-EU-Q16 questionnaire was used as a research tool. This scale consists of 16 items that measure the ability to obtain, understand, evaluate and use health information and health promotion, disease prevention and health care. The answers to the HLS-EU-Q16 questionnaire were developed on a 4-point Likert scale. The HLS-EU-Q16 analysis is characterized by satisfactory validity and reliability (Cronbach's scale was 0.87). The methods of statistical analysis and data on obtaining consent from the Bioethics Committee for the research are provided.

Results - The HLS-EU-Q16 total score ranged from 0 to 16, with higher scores indicating higher levels of HL. Three levels of HL were demonstrated, i.e., inadequate HL (0–8); problematic HL (9–12) and sufficient HL (13–16). The results are presented in 3 tables. Table 1 shows the clinical and sociodemographic characteristics of the 57 study participants. Table 2. Levels of health literacy according to the 16-item European Health Literacy Survey. Table 3 is Descriptive statistics of the HLS-EU-Q16 questionnaire items (16-item European Health Literacy Survey Questionnaire).

Discussion – Discussing the results, the authors emphasized that they do not have data on the SSc population with which to compare their findings, except for a study conducted in China. However, a comparison of these two groups is not fully possible due to significant differences in the analyzed areas. The authors also demonstrated the limitations of the study (sample size and descriptive nature of the design). In the discussion, the authors first of all discuss the results of their own research.

Conclusions – The authors demonstrated that SSc patients do not cope optimally and vary in their ability to use effective coping strategies. Therefore, assessing HL in SSc patients and improving their self-management is crucial to improve the care of these patients and realize their full potential to promote good quality of life.

References – the article refers to 40 current, well-selected items. All items are cited in the text.

I highly recommend this article for publication. Especially since no other studies assessing HL in the European population of SSc patients have been previously conducted. This study also has important implications for practice and further research to confirm Authors results and investigate predictors of HL in patients with SSc.

Author Response

Dear Reviewer 1,
the authors would like to thank you for the precise and detailed analysis of the manuscript, and the positive feedback. We really appreciate it.

However, we revised the manuscript also based on the reviewers’ 2 and 3, and we think it is really improved. Thanks for highlighting all the positive aspects.

Best regards

Reviewer 2 Report

Comments and Suggestions for Authors

Line 37 needs to read “health literacy skills”

 

Overall, the methodology and discussion seem well done and pertinent to seeking answers to the issue proposed.

 

However, I think several conclusions are missing in this article:

 

1)    If these people were diagnosed 10-19 years ago, their health literacy surrounding this disease has probably increased over time. So, it would be remiss to not state and speculate that perhaps someone newly diagnosed would have even lower health literacy skills.

2)    Perhaps, recommendations might include a follow-up study with newly diagnosed people to compare their scores.

3)    I’m also concerned that the conclusion is that people need to be screened for their health literacy skills rather than pointing out that materials and education should be tailored to meet the needs of these low levels of health literacy surrounding this disease to minimize the poor outcomes.

4)  Screening alone is not going to address these issues and this study could be much more impactful if given another recommendation that includes looking at the education and direction to credible and understandable materials that are offered upon diagnosis and how it might be improved.

Author Response

Dear Reviewer 2, 

many thanks for revising our manuscript, we addressed all the comments as follows:

R2: Line 37 needs to read “health literacy skills”

Authors: Thanks, it was a typo, and we added the word “health” to the sentence.

Overall, the methodology and discussion seem well done and pertinent to seeking answers to the issue proposed.

However, I think several conclusions are missing in this article:

If these people were diagnosed 10-19 years ago, their health literacy surrounding this disease has probably increased over time. So, it would be remiss to not state and speculate that perhaps someone newly diagnosed would have even lower health literacy skills.

Authors: thanks for the comment. Indeed, we initially expected to find that disease duration may not only moderate the direct relationship between health literacy and health outcomes but also mediate the effect of self-efficacy, as demonstrated in literature for other conditions.

Conversely, this does not apply for our patients, which, in our opinion, increases the importance of the findings and means that we cannot take this assumption for granted.

Clearly, this aspect requires further attention to establish the actual relation between health literacy and other health outcomes in this specific condition.

Based on the reviewer’s comment, the authors modified the main text as follows (line 221-225):

Indeed, Marciano et al. (2022), in their meta-analysis, suggest a positive and significant association between HL and self-care, yet in chronic conditions the nature and the direction of this relationship is not clear. This applies also to specific self-care behaviors, such as medication adherence, where Hyvert et al. (2023) confirm the unclear association.

Also, the reference section has been updated as follows:

-Marciano L, Camerini AL, Schulz PJ. The Role of Health Literacy in Diabetes Knowledge, Self-Care, and Glycemic Control: a Meta-analysis. J Gen Intern Med. 2019 Jun;34(6):1007-1017. doi: 10.1007/s11606-019-04832-y. Epub 2019 Mar 15. PMID: 30877457; PMCID: PMC6544696.

- Hyvert, S., Yailian, A. L., Haesebaert, J., Vignot, E., Chapurlat, R., Dussart, C., ... & Janoly-Dumenil, A. (2023). Association between health literacy and medication adherence in chronic diseases: a recent systematic review. International Journal of Clinical Pharmacy, 45(1), 38-51.

- Huang YM, Shiyanbola OO, Chan HY. A path model linking health literacy, medication self-efficacy, medication adherence, and glycemic control. Patient Educ Couns. 2018 Nov;101(11):1906-1913. doi: 10.1016/j.pec.2018.06.010. Epub 2018 Jun 18. PMID: 29935739.

Perhaps, recommendations might include a follow-up study with newly diagnosed people to compare their scores.

Authors: Thanks for the suggestions, we’ve added it to the main text (lines 254-255).

I’m also concerned that the conclusion is that people need to be screened for their health literacy skills rather than pointing out that materials and education should be tailored to meet the needs of these low levels of health literacy surrounding this disease to minimize the poor outcomes. Screening alone is not going to address these issues and this study could be much more impactful if given another recommendation that includes looking at the education and direction to credible and understandable materials that are offered upon diagnosis and how it might be improved.

Authors: the authors are very grateful for this insight as it allowed us to broaden our view on the findings, we modified the manuscript discussion and conclusion based on your comment.

Lines 253-259: Specifically, we refer to the need of screening SSc patients for their HL levels and skills in order to provide materials and education tailored to meet their needs. Indeed, in these patients, low levels of HL should be addressed promptly to minimize poor health outcomes.

Lines 276-279: Therefore, it is critical to have the appropriate skills to make adequate decisions and play an active role in the decision-making process, which might be facilitated by tailored patient education and understandable materials that are offered upon diagnosis.

Reviewer 3 Report

Comments and Suggestions for Authors

Dear Author 

"The rising challenge of poor Health Literacy of patients with Systemic Sclerosis: preliminary data identifies important unmet needs in an Italian cohort." This article holds significant importance, particularly in the context of health literacy's crucial role in the self-management of chronic diseases. However, it presents weaknesses that I point out below:

Abstract:

The Abstract should be structured as follows: introductory note, goals, methodology, results, and conclusion. It is crucial to reformulate the content for clarity and coherence.

Introduction:

The introduction must provide a justification for the choice of evaluating health literacy levels in an Italian cohort of Systemic Sclerosis (SSc) patients.

Materials and Methods:

Clearly explain how the sample of 91 patients was selected. Detail the process used to arrive at this specific number.

 Instruments:

Describe the data collection procedure and specify the Cronbach’s alpha of the original version of the scale used in the study.

Discussion:

There seems to be a discrepancy between the stated objectives in the abstract  and the discussion section. The summary emphasizes the evaluation of health literacy levels, while the discussion mentions assessing health literacy skills. Align these objectives for consistency.

Moreover, reinforce the discussion with relevant literature from the last three years to strengthen the arguments and provide a current context.

Conclusion:

The conclusion appears to be lacking in depth and development. It is recommended to enhance and expand upon the conclusion, drawing from the obtained results.

I hope these suggestions contribute to the improvement of the article. Thank you for considering these points, and I look forward to seeing the revised version.

Best regards.

Author Response

Dear Reviewer 3, 

The authors would like to deeply thank you as our manuscript is more consistent and improved, based on your suggestions, which have been all addressed. 

Abstract: The Abstract should be structured as follows: introductory note, goals, methodology, results, and conclusion. It is crucial to reformulate the content for clarity and coherence.

Authors: Thanks for the suggestion, the authors have corrected and rephrased the abstract section accordingly.

Introduction: The introduction must provide a justification for the choice of evaluating health literacy levels in an Italian cohort of Systemic Sclerosis (SSc) patients.

Authors: Health literacy is a health outcome that is still not studied in SSc patients, while the literature provides studies on its role and pivotal impact on several health outcomes. Thus, we deem relevant the study and assessment of this specific outcome in a population with a complex and systemic chronic condition.

Materials and Methods: Clearly explain how the sample of 91 patients was selected. Detail the process used to arrive at this specific number. Instruments: Describe the data collection procedure and specify the Cronbach’s alpha of the original version of the scale used in the study.

Line 94-95: A sentence about convenience sample was added in the method section.

Line 105-107: details on how data were collected have been added to the method section “A data collection tool based on sociodemographic questions and the HL questionnaire, as specified in the instrument section, has been disseminated online through the patients’ associations who participated in the study. “

Line 121-122: In this study the Cronbach’s Alpha for the total scale was also adequate at 0.87.

Discussion: There seems to be a discrepancy between the stated objectives in the abstract and the discussion section. The summary emphasizes the evaluation of health literacy levels, while the discussion mentions assessing health literacy skills. Align these objectives for consistency. Moreover, reinforce the discussion with relevant literature from the last three years to strengthen the arguments and provide a current context.

Authors: Thanks for your comment and suggestion, we acknowledge the different meaning of the two terms, i.e. skills and levels, thus we corrected the sentence of the discussion section to align the objective for consistency.

However, analysing each item of the health literacy scale also allowed an insight on the patients’ skills, offering a more comprehensive overview of the health literacy.

Moreover, we agree on the need to strengthen the discussion and we provide some changes, as follows:

Despite Marciano et al. (2022), in their meta-analysis, suggest a positive and significant association between HL and self-care, in chronic conditions the nature and the direction of this relationship is not clear yet. This applies also to specific self-care behaviours, such as medication adherence, where Hyvert et al. (2023) confirm the unclear association.

Conclusion: The conclusion appears to be lacking in depth and development. It is recommended to enhance and expand upon the conclusion, drawing from the obtained results.

Authors: Thanks for your suggestion, which allowed us to enhance the conclusion of our paper and make it more impactful. The conclusion section has been modified as follows: Based on our findings, it is relevant to remind that despite pharmacological treatment has achieved very important therapeutic goals, and experts has developed diagnostic criteria also for the very early recognition of SSc, individuals do not necessarily self-manage optimally and vary in their ability to develop effective coping strategies. Indeed, assessing HL in SSc patients brought up inadequate/problematic levels of this specific health outcome and prompts us to further analyze this aspect. Namely, we recommend that healthcare professionals involved in the care of SSc patients, start considering HL as part of periodic screenings to uncover poor health literacy skills, in order to provide tailored and understandable educational materials to SSc patients, thus   enhancing the patient care to its fullest potential, and ultimately enhance their quality of life.