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. 2020 Aug 6;15(8):e0236963. doi: 10.1371/journal.pone.0236963

Measuring Health Literacy in Southern Italy: A cross-sectional study

Sara Schiavone 1, Francesco Attena 1,*
Editor: Stefano Federici2
PMCID: PMC7410250  PMID: 32760150

Abstract

Introduction

Health Literacy (HL) is an important determinant of individual health. Limited HL is an increasing problem affecting the general population. This study aims to assess the level of HL in patients attending outpatient medical facilities in general medicine located in Naples and Caserta and investigate the association of HL with health behaviours and health status.

Materials and methods

The study involved patients attending outpatient medical facilities in general medicine. The questionnaire had four sections–the sociodemographic information, the 16-items version of the European Health Literacy Survey questionnaire, the general self-efficacy scale (GSE) and the health status scale (EQ-VAS). Univariate and multivariate analyses were performed to investigate the sociodemographic determinants of HL. The Pearson correlation coefficients were determined to compare HL with health behaviours (GSE) and health status (EQ-VAS).

Results

The study showed that 61.6% of 503 patients had a low level of HL. After the multivariate analysis, HL was found to be higher among patients with higher education level and general self-efficacy score ≥30. There were no differences in HL between the age groups and people with or without chronic diseases. HL was stronger correlated with GSE than with EQ-VAS (0.53 vs 0.27).

Conclusion

This is the first study on HL for Southern Italy. It showed a low level of HL. As the sample was not representative of the reference population, we cannot derive a corresponding conclusion for the general population of Southern Italy. Therefore, more data in Italy are needed to plan actions for improving HL.

Introduction

Health Literacy (HL) is an important determinant of individual health [13]. HL refers to ‘the knowledge, motivation and competence to access, understand, appraise and apply health information in order to make judgement and take decisions in everyday life concerning health care, disease prevention and health promotion, to maintain or improve quality of life throughout the course of life’ [1, 2, 4]. HL can be briefly defined as the capability to make informed health decisions in daily life [5]. A high level of HL means being able to make reasonable judgement and explain the health problem and personal concerns that make a medical consultation necessary [6]. In addition, HL provides the capability to change one’s beliefs if necessary [6]. Conversely, limited HL is an increasing problem affecting the general population [715]. A low level of HL leads to the misuse of available health resources and inappropriate access to care, which is defined as the degree of adaptation between patient skills and health-care system requirements [12, 16, 17].

HL covers three different areas–health care, disease prevention and health promotion. According to the European Health Literacy Survey, almost every second, EU citizen has limited HL and therefore perceived difficulties in accessing, understanding and using health information [4, 8, 18, 19].

HL has gained increasing attention in public health research, as well as health services reform processes, as an essential determinant of individual health and health service use [15, 1924]. The evaluation of HL in Italy is important to ensure the sustainability of the health-care service system [12, 21, 25].

General practitioners, also called family doctors, are the first contact for health concerns in the Italian health system. They have different responsibilities for their patients: solving health problems, controlling adherence to treatment, ensuring continuity of care, identifying the correct path within the complexity of the health service and carrying out health education for promoting health and well-being. Therefore, the general practitioner should be the first contact person in the health literacy process.

In Italy, as in other European countries, the population of old people and therefore the prevalence of chronic diseases is rapidly increasing [26]. This indicates the need for a more complex health service, as several studies have suggested that HL decreases with age [2729]. The decline in HL in older age groups is associated with decreasing cognitive function and potential health impairments [8, 17]. Globally, HL has been an important topic in public health research over the past decades [30]. However, in Italy, data on HL among the general population are still scarce [11, 12, 31].

This study aims to assess the level of HL in patients attending outpatient medical facilities in general medicine located in Naples and Caserta using the 16-items version of the European Health Literacy Survey questionnaire (HLS-EU-Q16) and investigate the association of HL with health behaviours and health status. The HLS-EU-Q16 questionnaire was recently developed and validated in the Italian language with a Cronbach’s alpha of 0.799 [31]. This short version made measuring HL in the general population easier [11, 31].

Materials and methods

Study design and setting

This study used a cross-sectional design in which data collection was carried out between April 2019 and May 2019. Fifteen general practitioners working in outpatient medical facilities in general medicine located in Naples and Caserta were randomly selected from the register of the Local Health Authority of Naples and Caserta. Five of the selected general practitioners did not consent to participate. The participating patients were citizens enrolled in these outpatient medical facilities. The study was, therefore, conducted in the waiting room of the remaining 10 medical facilities (5 in Naples and 5 in Caserta). The outpatient medical facilities in general medicine normally open five times a week, between mornings and afternoons, at the discretion of the general practitioner based on the total number of patients, up to a maximum of 1,500 patients for each general practitioner. According to the regulations of the National Healthcare Service and the Constitution of the Italian Republic, every Italian and foreign resident over the age of 18 years has to be registered in an outpatient medical facility in general medicine [5]. Ethical approval was obtained from the Ethics Committee of the University of Campania ‘Luigi Vanvitelli’ (Prot. N 302/2019).

Sample size

The sample size was estimated to be at least 400 subjects, assuming a 50% of expected prevalence of the main outcome (high/low level of HL), with precision of 5% and level of significance of 95%.

Study participants and data collection

The study population comprised patients attending outpatient medical facilities in general medicine. The inclusion criteria were patients who could speak Italian and were at least 18 years old. The patients waiting for a medical consultation were advised of the research project by the secretary of the general practitioner. They were informed that participation was voluntary and that they could withdraw from the study at any time with no subsequent consequences. The medical researcher was available to the participants to answer questions relating to the protocol. The questionnaire was self-administered and the participants were asked to sign the informed consent form. The exclusion criteria were patients with cognitive impairment, severe psychiatric diseases and end-stage diseases. All the data were collected anonymously.

Questionnaire

The questionnaire had sections such as sociodemographic information (age, sex, education level and chronic diseases), the HLS-EU-Q16, the general self-efficacy scale (GSE), the EuroQol visual analogue scale (EQ-VAS) [3133] and an Italian version of the PEN-13 (not evaluated because still under the Italian validation) [34]. The total number of questions was 44. The average duration to fill the questionnaire was 20 minutes.

The HLS-EU-Q16 contained 16 items, which was used to measure HL in the study populations. Each of the respondents was asked to give their opinion on a 4-point Likert scale–‘very difficult’, ‘difficult’, ‘easy’ and ‘very easy’. The questionnaire covered the conceptual model proposed by Sorensen et al. [4] by investigating the ability of individuals to access or obtain, understand, process and use health information.

Beside HLS-EU-Q16, two other questionnaires have been used to investigate the association of HL with health behaviours and health status.

The GSE is a standardised measurement tool consisting of 10 items that capture the overall self-efficacy in a one-dimensional way. Each of the respondents was asked to give their opinion on a 4-point Likert scale–‘Not at all true’, ‘Hardly true’, ‘Moderately true’, ‘Exactly true’ [32].

EQ-VAS is a visual analogue scale for assessing a subject’s view on global health status from 0 to 100 [33].

Statistical analysis

Descriptive analysis was performed to evaluate the level of HL in the study population. To calculate the score of the HLS-EU-Q16, the answers were dichotomised into two categories with two scores–easy (easy or very easy) and difficult (difficult or very difficult). The HL score is a sum score and three levels have been defined–inadequate HL (0–8), problematic HL (9–12) and adequate HL (13–16). The categories were dichotomised into adequate and not adequate (inadequate and problematic). This approach has been utilised previously [7, 11, 20, 31]. The category with adequate HL is assumed to have high level of HL, the category with not adequate is assumed to have low level of HL.

Age was recorded in years and categorised into three groups (18–45 years, 46–65 years and ≥65 years). Education level was assessed using the International Standard Classification of Education (ISCED 2011), which allows for cross-national comparisons of education levels and is dichotomised into two groups (ISCED 0–2 and ISCED 3–8) [35].

To investigate the sociodemographic determinants of HL, univariate analysis was performed and the results were expressed in terms of odds ratio, confidence interval and p-value. P-value ≤ 0.05 was considered statistically significant. Variables that showed a p-value ≤ 0.25 in the univariate analysis were included in the multivariate logistic regression.

The Pearson correlation coefficients for continuous variables were determined to compare HL level with health behaviours (from GSE) and health status (from EQ-VAS). Correlations with a coefficient from 0.1 to below 0.3 were considered as low, from 0.3 to below 0.5 as medium and from 0.5 and above as strong [36]. We assumed a high positive correlation between the HL level and the GSE score. This assumption is based on the fact that believing in the achievement of desired health outcomes leads a more active and self-determined life [12, 3739]. We assumed a moderate positive correlation between HL score and the assessment of personal health status using EQ-VAS. Poor HL skills were associated with lower self-perceived health status [12]. Patients with low HL reported higher hospitalisation rates and greater use of health services [12, 23, 40]. In contrast, people with high HL skills are less likely to smoke or consume alcohol, and, generally, have a better health status [12].

The statistical analysis was carried out using the IBM Statistical Package for Social Science (version 21).

Results

Sociodemographic characteristics

In total, 503 patients completed the questionnaire and 42 (7.7%) declined to participate. The sociodemographic characteristics of the participants are reported in Table 1. There were more females (60.2%) than males (39.0%); most of the patients were more than 45 years (67.8%) and 62.8% had a high level of education. Among the patients, 50.7% had one or more chronic diseases.

Table 1. Socio-demographic characteristics of the participants.

Socio-demographic characteristics n %
Gender
Male 196 39.0
Female 303 60.2
Missing 4 0.8
Age
Mean (Standard deviation) 52,5 (16,7)
Range 18–88
18–45 150 29.8
46–65 208 41.4
≥ 65 133 26.4
Missing 12 2.4
Education Level
ISCED§ 0–2 184 36.6
ISCED 3–8 316 62.8
Missing 3 0.6
Chronic Diseases
Yes 255 50.7
No 229 45.5
Don’t know 16 3.2
Missing 3 0.6
Total 503 100

§International Standard Classification of Education.

Health Literacy

The analysis of the 503 questionnaires and the dichotomisation of the responses into two categories showed that 61.6% of the patients had a low level of HL (Table 2). In Table 2, the sociodemographic characteristics were reported in comparison to the level of HL. There was no difference in HL between the males and the females. We found a higher level of HL among younger patients and those with a higher level of education. Moreover, patients who had no chronic diseases showed a higher level of HL (48.0%) compared to patients with one or more chronic diseases (30.6%). In the multivariate analysis, two variables remained associated with high HL: high education level and general self-efficacy score ≥30. Using a stratified analysis, we found that level of education was the main confounder of the association between age and HL because a lower level of education was more frequent in older patients (Table 3).

Table 2. Sociodemographic characteristics and health behaviours disaggregated for Health Literacy.

Low Health Literacy High Health Literacy crude p-value Adjusted p-value* Adjusted Odds Ratio*
Age
≥ 65 102 (76.7%) 31 (23.3%) 1
46–65 126 (60.6%) 82 (39.4%) <0.001 0.508 1.3 (C.I. 0.7–2.4)
18–45 77 (51.3%) 73 (48.7%) 1.5 (C.I. 0.7–2.9)
Total 305 (62.1%) 186 (37.9%)
Sex
Female 188 (62.0%) 115 (38.0%)
Male 120 (61.2%) 76 (38.8%) 0.854 - -
Total 308 (61.7%) 191 (38.3%)
Education Level
ISCED§ 0–2 148 (80.4%) 36 (19.6%) 1
ISCED 3–8 160 (50.6%) 156 (49.4%) <0.001 <0.001 1.2 (C.I. 1,1–1,3)
Total 308 (61.6%) 192 (38.4%)
Chronic Diseases
Yes 177 (69.4%) 78 (30.6%) 1
No 119 (52.0%) 110 (48.0%) <0.001 0.714 0.9 (C.I. 0.7–1,2)
Total 296 (61.2%) 188 (38.8%)
GSE score
≤ 29 244 (74.6%) 83 (25.4%) 1
≥ 30 64 (36.8%) 110 (63.2%) <0.001 <0.001 3.8 (C.I. 2.5–5,8)
Total 308 (61.5%) 193 (38.5%)
Total 310 (61.6%) 193 (38.4%)

* Multivariate logistic regression (in the model, the following variables with a p≤0.25 have been included: age, education level, chronic diseases and self-efficacy score).

§ International Standard Classification of Education.

Table 3. Stratified analysis between Health Literacy and age by education level.

Age
18–45 >45 Total
Education Level N % N % N % RR* p-value
ISCED§ 0–2 Low HL 22 73.3 125 82.8 147 81.2 1.11 (C.I. 0.91–1.36) 0.30
High HL 8 26.7 26 17.2 34 18.8
ISCED 3–8 Low HL 55 45.8 103 54.5 158 51.1 1.14 (C.I. 0.96–1.37) 0.16
High HL 65 54.2 86 45.5 151 48.9
Total Low HL 77 51.3 228 67.1 305 62.2 1.23 (C.I. 1.08–1.41) <0.00
High HL 73 48.7 112 32.9 185 37.8

§ International Standard Classification of Education.

* Relative risk.

Pearson correlation

We correlated the HLS-EU-Q16 score with GSE and EQ-VAS scores. The coefficient of correlation between the scores is shown in Table 4. HL was stronger correlated to general self-efficacy than the assessment of personal health status. In particular, a strong positive correlation between the HL score and the GSE score was found (0.53), while a weak positive correlation between the HL score and the assessment of personal health status using EQ-VAS was found (0.27). A weak positive correlation was also found between the assessment of personal health status and general self-efficacy (0.28).

Table 4. Pearson's correlation among HL score, GSE score and EQ-VAS scale.

EQ-VAS Scale GSE score HL score p-value
EQ-VAS 1 0.28 0.27 <0.001
GSE 0.28 1 0.53 <0.001
HL score 0.27 0.53 1 <0.001

Discussion

The study investigated HL level among 503 patients attending medical facilities in general medicine located in Naples and Caserta, in Southern Italy. We achieved a high response rate (92.3%) and a high level of completion of the questionnaire because the medical researcher was available to provide information to patients. Although not representative of the reference population, our analysis revealed that 38.4% of the participants had a high level of HL.

Findings from two other studies conducted in Italy using a representative sample, reported a higher level of HL using the HLS-EQ-Q47 in one [12], whereas the other study [11] showed a lower level using the HLS-EQ-Q16.

The scarcity of national studies on this topic did not allow us to make a valid comparison between North and South Italy. We considered comparing these two areas important because the imbalances between the north and the south are very high. Northern Italy is more industrialised, healthier and wealthier than Southern Italy and the National Health Service in Northern Italy is faster, richer and has better quality [4143]. Consequently, patients in Northern Italy may have a higher HL than those in the South. If this was true, interventions to improve HL should be differentiated between these two geographical areas.

In Europe, Sorensen et al. [4] analysed HL level in eight countries (Austria, Bulgaria, Germany, Greece, Ireland, Netherlands, Poland and Spain). The highest level of HL was found in the Netherlands and the lowest level of HL in Bulgaria (respectively 71.4% and 37.9% of sufficient/excellent HL).

Many studies have shown that low level of HL is associated with poorer health outcomes, older people, lower education level, poorer self-rated health, limited use of preventive health services, increased hospital visits and higher mortality rates as well as inferior physical and mental health [19, 23, 24, 4448].

Three sociodemographic characteristics (education level, age and chronic diseases) and two scales (GSE and EQ-VAS) were included in our analysis. Multivariate analysis showed that only the education level was associated with HL among the three sociodemographic characteristics. This is consistent with other studies [2, 4, 5, 10, 20, 4953] and the World Health Organisation’s statement that consider people with low level of education as a vulnerable group with a scarce HL [2].

Health behaviour measured by GSE and health status measured by EQ-VAS were positively correlated with HL as expected [2, 53, 54].

Health Literacy and self-efficacy are important factors contributing to health promotion behaviour. Therefore, it would be desirable for each person to have both high HL and high GSE. In our sample, these two factors were correlated, but this correlation was stronger when both factors were consistent (48.5% both low vs 21.9% both high). Therefore, only 21.9% of the respondents in our sample seem to have had means for health promotion behaviour.

In our healthcare system, general practitioners might actively promote HL of their target group by providing information, advice, education and guidance. Their role should be important for the creation of an appropriate database to develop health literacy promotion strategies and to plan evidence-based interventions. However, the general practitioners included in our study would appear to have had little influence in promoting the HL of their patients.

Limitation. The main limitation of the study is related to its external and internal validity. Firstly, the respondents were a selected group of patients waiting in outpatient medical facilities in general medicine, and not a sample of the general population. Therefore, their HL level may be different from the general population. Secondly, they completed the questionnaire after the secretary of the general practitioner gave them the opportunity to participate in the study. They voluntarily took part in the study but the presence of the medical researcher during the completion of the questionnaire might have caused them not to answer the items truthfully, rather in a certain desired direction or under the psychological pressure of consulting with their general practitioner. It is also possible that patients might have completed the questionnaires hastily without paying particular attention because they were probably focused on seeing their general practitioner and did not want to miss their turn.

Conclusion

This study reports the first results on HL for Southern Italy in outpatient medical facilities in general medicine. It showed a low level of HL. As the sample was not representative of the reference population, we cannot derive a corresponding conclusion for the general population of Southern Italy. Despite the important role of the general practitioners, they would appear to have had little influence in promoting the HL of their patients. Therefore, more data about HL in this area and in Italy are needed for a better understanding of the situation in the country and to plan actions to improve HL in our population.

Supporting information

S1 Data

(SAV)

Acknowledgments

The data presented here originate from a collaborative project led by Monika A. Rieger, Achim Siegel (University Hospital Tübingen, Institute of Occupational and Social Medicine and Health Services Research), the corresponding author Francesco Attena and the first author Sara Schiavone. In this project, amongst others, an Italian version of the measurement tool ‘Patient Enablement Scale– 13 Items’ (PEN-13) was developed and validated. The authors gratefully acknowledge the general practitioners who agreed to participate. A special thanks to Anna Ehmann, Dr. Achim Siegel and Prof. Monika A. Rieger for their professional advice and for their methodology suggestions.

Data Availability

All relevant data are within the manuscript and its Supporting Information files.

Funding Statement

The data presented in this work was partly funded by an Erasmus grant from a collaborative project involving both FA and SS. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Please confirm this update is appropriate and please remove the mention (partly funded by an Erasmus grant) from your Acknowledgements.

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Decision Letter 0

Stefano Federici

29 Apr 2020

PONE-D-20-09482

Measuring Health literacy in South Italy: A Cross-sectional Study

PLOS ONE

Dear Dr. Attena,

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Both Reviewers agree that the study is valuable, though not innovative in its contribution to the literature. In addition, both Reviewers point to shortcomings in language that not only have to do with the use of English, but also more specifically with methodological correctness. Finally, a lack of content and technical scientificity of the discussions and conclusions are highlighted. Therefore, I invite the Authors to proceed with a careful and in-depth revision of the whole manuscript, drawing on the rich annotations of the Reviewers.

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Reviewers' comments:

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Reviewer #1: Partly

Reviewer #2: Yes

**********

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Reviewer #1: Yes

Reviewer #2: Yes

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Reviewer #2: Yes

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Reviewer #1: This is an innovative paper from South of Italy which explores health literacy in patients attending outpatients facilities. It is a cross sectional study that explores correlations between health literacy and demographic and health and self-efficacy variables. Overall it is not a big advancement of the field.

- Abstract, pg 2 ll 20. Please avoid the use of the term “residents”; it is a bit misleading as your study population is composed by outpatients attending general practices.

- Abstract, pg 2, 36-39. Conclusion can be improved providing more implications derived from the results of the study.

- Introduction, pg 3 ll 66. A paragraph concerning the use and the potential implication of the measurements of health literacy in the primary health context is needed.

- Introduction, pg 4 ll 69. The study aim can result misleading, if so stated. This study is not assessing the level of HL in Naples and Caserta, but rather it is assessing the level of HL in patients attending outpatient clinics located in Naples and Caserta.

- Materials and Methods, pg5 ll 77-78. Please provide a more clear description of the type of outpatients medical facilities considered (i.e type of services carried out and type of patients visited). Where they general practices?

- Materials and Methods, pg5 ll 94-95. The final number of the subjects included in the study population should be moved to the Results section.

- Materials and Methods, pg 5 ll-93-103. Please provide more details concerning on how patients were enrolled and how the survey was carried out. Where the patients waiting for a medical visit when first contacted? Was their doctor involved in any part of the recruitment or survey process? The survey was administered by the researchers or was self-administered?

- Materials and Methods, pg 5 ll-101-103. The sentence “The presence the medical researcher during the completion of the questionnaire led to a high degree of response” is a consideration that have to be moved and further explained in the discussion section.

- Materials and Methods, pg 5 ll105-107. Please provide details concerning the total number of questions in the survey and the average duration of the survey

- Materials and Methods, pg 5 ll106. The HLS-EU-Q16 used in the study was an already validated version? if yes, please state which version

- Materials and Methods, pg 5 ll 105. Please provide more details on how chronic diseases were investigated in the survey

- Results pg 7 ll 150. Please provide data concerning the total number of subjects invited to participate in the study, the number of those who consent to participate and the number of refusal

- Results. pg 7 ll 173-174. Education was not the only variable significantly associated with HL, also General Self efficacy Score resulted significantly associated in your multivariate analysis.

- Results. pg 7 ll 173-174 and Table 2. Please provide the Odds ratio of the variables included in the multivariate model

- Results. pg 7 ll 178-179. The sentence “The HLS-EU-Q16 questionnaire has been validated in Italy with a Cronbach’s alpha of 0.799,” is not a result of the study and should be moved in the discussion and/or in the introduction sections.

- Results, pg 8 ll 175-176. Elaborate a table to report the stratified analysis mentioned here.

- Results p 8 ll177-178. The comparison between the different locations of the outpatients facilities is not necessary as the sample was not designed to be representative of the resident populations of the municipalities of Naples and Caserta, therefore results of this analysis provide little insights. Should the authors prefer to keep this comparison, data concerning these variable have to be reported in table 1 and 2, and the variable should be considered in the univariate and multivariate analyses.

- Discussion, pg 10 ll203-205; pg 11 ll 214-216. Direct comparison with data derived from population based sample should be avoided; the design of your study cannot allow any kind of comparison with other HL level. It is important that like is being compared with like. If different sampling strategies were used then the differences are likely to be sampling variations, not any population level differences. If the data are not comparable then the findings should not be compared.

- Discussion, general comment on the section. The authors need to consider internal and external validity. Given the sampling, and potential for misleading findings, the paper should mainly focus on results that arguably have internal validity – i.e., the antecedent analysis. Furthermore, I suggest to consider discussing the possible implications that the measurement of HL may have in the context of primary health care services

- Discussion, pg 11 217-224. The meaning of this paragraph in not clear, please rephrase it

- DIscussion, pg 11 ll 230-232. The mentioned “Medical doctor” is referred to the doctor with which they had the visit (e.g. the general practitioner) ? or the medical researcher? Please clarify the recruitment and survey process here and in the method section

- Discussion, please discuss the meaning and implications of the association between HL and the General Self-Efficacy Score

- Conclusion.pg 11-12 ll 240-242. Conclusion section have to be expanded to report the main findings of the study and their implications for primary care practices and research

- General comment: please carefully review the manuscripts for typo and grammar errors. For instance”

Reviewer #2: Generally, the article provides a good insight into the level of Health Literacy a sample in Italy. The authors did a good job working on an unexplored area in Italy. My comments are stratified by section down below.

The article is well reported and understandable, however some language modifications are recommended

Results:

Line 168: the concept of "low level of HL" is not introduced and identified until the results section

In table 2, HL levels were classified into "high" and "low", whereas the dichotomization were made into "adequate" and "not adequate" i.e problematic and inadequate earlier in the methodology section. The definitions were not clear as to what constitute low HL; does it mean inadequate only or inadequate and problematic combined together?

Similarly, the term “sufficient HL” was used in line 203 although this was referred to as "high HL" earlier in the table. Similarly, the term “sufficient HL” was used in line 203

I recommend to unify the terms used across the paper starting from the methodology and be specific with the definitions.

Line 191: "Indeed" is informal word to use.

Discussion:

Line 210-213: language needs to be improved

I’d like to read about your view of the implications of the study

Thank you for your time and effort

**********

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Reviewer #1: No

Reviewer #2: No

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PLoS One. 2020 Aug 6;15(8):e0236963. doi: 10.1371/journal.pone.0236963.r002

Author response to Decision Letter 0


27 Jun 2020

27 June 2020

Re: Manuscript PONE-D-20-09482

Measuring Health literacy in South Italy: A Cross-sectional Study

PLOS ONE

Dear Editor,

Please find attached a revised version of our manuscript titled “Measuring Health Literacy in Southern Italy: a cross-sectional study” which we would like to resubmit in PLOS ONE. The following pages contain our responses to the academic editor and reviewers’ comments. For clarity, we present the comments of the reviewers in italics and respond to each comment point-by-point. Revisions to the text are shown using yellow highlighting for additions.

We also added an Acknowledgments section.

Journal Requirements:

We provided PLOS ONE's style requirements and all relevant data within the paper.

REPLY TO EDITOR

We revised the language and the methodological correctness and improved the content and technical scientificity of the discussions and conclusions.

REPLIES TO REVIEWERS

R1- Abstract, pg 2 ll 20. Please avoid the use of the term “residents”; it is a bit misleading as your study population is composed by outpatients attending general practices.

REPLY: resident will be replaced with patients attending outpatient medical facility in general medicine.

REVISED VERSION, pg 2 ll 26: This study aims to assess the level of HL of the residents in patients attending outpatient medical facilities in general medicine located in of Naples and Caserta…

R1- Abstract, pg 2, 36-39. Conclusion can be improved providing more implications derived from the results of the study.

REPLY: we changed the conclusion.

REVISED VERSION pg 3, ll 48-52: Conclusion. This is the first study on HL for the Southern Italy. and cannot represent the entire geographical area. It showed a low level of HL. As the sample was not representative of the reference population, we cannot derive a corresponding conclusion for the general population of Southern Italy. Therefore, more data about HL in this area and in Italy are needed to better understand the situation in our country and to plan actions to for improveing HL our system.

R1- Introduction, pg 3 ll 66. A paragraph concerning the use and the potential implication of the measurements of health literacy in the primary health context is needed.

REPLY: Done.

REVISED VERSION pg 4 ll 77-82: General practitioners, also called family doctors, are the first contact for health concerns in the Italian health system. They have different responsibilities for their patients: solving health problems, controlling adherence to treatment, ensuring continuity of care, identifying the correct path within the complexity of the health service and carrying out health education for promoting health and well-being. Therefore, the general practitioner should be the first contact person in the health literacy process.

R1- Introduction, pg 4 ll 69. The study aim can result misleading, if so stated. This study is not assessing the level of HL in Naples and Caserta, but rather it is assessing the level of HL in patients attending outpatient clinics located in Naples and Caserta.

REPLY: Done.

REVISED VERSION pg 4 ll 91-94: This study aims to assess the level of HL in Naples and Caserta in patients attending outpatient medical facilities in general medicine located in Naples and Caserta using the short 16-items version of the European Health Literacy Survey questionnaire (HLS-EU-Q16) and investigate the association of HL with health behaviours and health status.

R1- Materials and Methods, pg5 ll 77-78. Please provide a more clear description of the type of outpatients medical facilities considered (i.e type of services carried out and type of patients visited). Where they general practices?

REPLY: Done.

REVISED VERSION pg 5 ll 102 -108: Fifteen medical doctors general practitioners working in outpatient medical facilities in general medicine located in Naples and Caserta were randomly selected from the register of the Local Health Authority of Naples and Caserta. Five of the selected medical doctors general practitioners did not consent to participate. The participating patients were citizens enrolled in these outpatient medical facilities. The study was, therefore, conducted in the waiting room of the remaining 10 medical facilities (5 in Naples and 5 in Caserta).

R1- Materials and Methods, pg5 ll 94-95. The final number of the subjects included in the study population should be moved to the Results section.

REPLY: The final number of the subjects has been moved to the results section.

REVISED VERSION pg 8 ll 188: In total, 503 patients completed the questionnaire and 42 (7.7%) declined to participate.

R1- Materials and Methods, pg 5 ll-93-103. Please provide more details concerning on how patients were enrolled and how the survey was carried out. Where the patients waiting for a medical visit when first contacted? Was their doctor involved in any part of the recruitment or survey process? The survey was administered by the researchers or was self-administered?

REPLY: Done.

REVISED VERSION pg 6 ll 121 -133: The study population comprised 503 attendees of the patients attending outpatient medical facilities in general medicine. The inclusion criteria were patients who could speak Italian and were at least 18 years old. The patients waiting for a medical consultation were advised of the research project by the secretary of the general practitioner. They were informed that participation was voluntary and that they could withdraw from the study at any time with no subsequent consequences. The medical researcher was available to the participants to answer questions relating to the protocol. The questionnaire was self-administered and In addition, the participants were asked to sign the informed consent form. The exclusion criteria were patients with cognitive impairment, severe psychiatric diseases and end-stage diseases. All the data were collected anonymously. The patients completed the questionnaire after the staff of the outpatient medical facilities gave them the opportunity to participate in the study. The presence of the medical researcher during the completion of the questionnaire led to a high degree of response.

R1- Materials and Methods, pg 5 ll-101-103. The sentence “The presence the medical researcher during the completion of the questionnaire led to a high degree of response” is a consideration that have to be moved and further explained in the discussion section.

REPLY: The consideration has been moved and explained in the discussion section.

REVISED VERSION pg 12 ll 246-249: The study investigated HL level among 503 outpatients attending medical facilities of in general medicine located in Naples and Caserta, in Southern Italy. We achieved a high response rate (92.3%) and a high level of completion of the questionnaire because the medical researcher was available to provide information to patients.

R1- Materials and Methods, pg 5 ll105-107. Please provide details concerning the total number of questions in the survey and the average duration of the survey.

REPLY: Done.

REVISED VERSION pg 6 ll 135-139: The questionnaire had sections such as sociodemographic information (age, sex, education level and chronic diseases), the HLS-EU-Q16, the general self-efficacy scale (GSE) and the EuroQol visual analogue scale (EQ-VAS) [31-33] and an Italian version of the PEN-13 (not evaluated because still under the Italian validation)[34]. The total number of questions was 44. The average duration to fill the questionnaire was 20 minutes.

R1- Materials and Methods, pg 5 ll106. The HLS-EU-Q16 used in the study was an already validated version? if yes, please state which version

REPLY: Done already in the Introduction section.

REVISED VERSION pg 4 ll 94-97: The short version HLS-EU-Q16 questionnaire was recently developed and validated in the Italian language with a Cronbach’s alpha of 0.799 [31]. This short version made measuring HL in the general population easier [11, 31]

R1 - Materials and Methods, pg 5 ll 105. Please provide more details on how chronic diseases were investigated in the survey.

REPLY: The question about chronic diseases reported in the questionnaire was:

Ha una o piú patologie croniche (es.: diabete, ipertensione, insufficienza cardiaca, osteoporosis)?

No

Si

Non lo so

Se Si, quali ____________________________

However, the medical researcher was willing to give further clarification and to explain the significance of a current chronic disease, as a disease that lasts for at least 3 months.

R1 - Results pg 7 ll 150. Please provide data concerning the total number of subjects invited to participate in the study, the number of those who consent to participate and the number of refusals.

REPLY: Done.

REVISED VERSION pg 6 ll 121-122: The study population comprised 503 attendees of the patients attending outpatient medical facilities in general medicine.

REVISED VERSION pg 8 ll 188: In total, 503 patients completed the questionnaire and 42 (7.7%) declined to participate.

R1 - Results. pg 7 ll 173-174. Education was not the only variable significantly associated with HL, also General Self efficacy Score resulted significantly associated in your multivariate analysis.

REPLY: Done.

REVISED VERSION pg 9 ll 213-215: In the multivariate analysis, only associations between high education and high HL were confirmed two variables remained associated with high HL: high education level and general self-efficacy score ≥30.

R1- Results. pg 7 ll 173-174 and Table 2. Please provide the Odds ratio of the variables included in the multivariate model

REPLY: Done.

Low Health Literacy High Health Literacy crude p-value Adjusted p-value* Adjusted

Odds Ratio*

Age

≥ 65 102 (76.7%) 31 (23.3%) 1

46 – 65 126 (60.6%) 82 (39.4%) <0.001 0.508 1.3 (C.I. 0.7 -2.4)

18 – 45 77 (51.3%) 73 (48.7%) 1.5 (C.I. 0.7 -2.9)

Total 305 (62.1%) 186 (37.9%)

Sex

Female 188 (62.0%) 115 (38.0%)

Male 120 (61.2%) 76 (38.8%) 0.854 - -

Total 308 (61.7%) 191 (38.3%)

Education Level

ISCED§ 0-2 148 (80.4%) 36 (19.6%) 1

ISCED 3-8 160 (50.6%) 156 (49.4%) <0.001 <0.001 1.2 (C.I. 1,1-1,3)

Total 308 (61.6%) 192 (38.4%)

Chronic Diseases

Yes 177 (69.4%) 78 (30.6%) 1

No 119 (52.0%) 110 (48.0%) <0.001 0.714 0.9 (C.I. 0.7- 1,2)

Total 296 (61.2%) 188 (38.8%)

GSE score

≤ 29 244 (74.6%) 83 (25.4%) 1

≥ 30 64 (36.8%) 110 (63.2%) <0.001 <0.001 3.8 (C.I. 2.5-5,8)

Total 308 (61.5%) 193 (38.5%)

Total 310 (61.6%) 193 (38.4%)

Table 2. Sociodemographic characteristics and health behaviours disaggregated for Health Literacy

* Multivariate logistic regression (in the model, the following variables with a p≤0.25 have been included: age, education level, chronic diseases and self-efficacy score).

§ International Standard Classification of Education.

R1- Results. pg 7 ll 178-179. The sentence “The HLS-EU-Q16 questionnaire has been validated in Italy with a Cronbach’s alpha of 0.799,” is not a result of the study and should be moved in the discussion and/or in the introduction sections.

REPLY: The sentence has been moved in the introduction section, pg 4 ll 94-96.

R1- Results, pg 8 ll 175-176. Elaborate a table to report the stratified analysis mentioned here.

REPLY: Done.

Table 3. Stratified analysis between Health Literacy and age by education.

Age

18-45 >45 Total

Education Level N % N % N % RR* p-value

ISCED§ 0-2 Low HL 22 73.3 125 82.8 147 81.2 1.11 (C.I. 0.91 – 1.36) 0.30

High HL 8 26.7 26 17.2 34 18.8

ISCED 3-8 Low HL 55 45.8 103 54.5 158 51.1 1.14 (C.I. 0.96 – 1.37) 0.16

High HL 65 54.2 86 45.5 151 48.9

Total Low HL 77 51.3 228 67.1 305 62.2 1.23 (C.I. 1.08 – 1.41) <0.00

High HL 73 48.7 112 32.9 185 37.8

§ International Standard Classification of Education.

*Relative risk.

R1- Results p 8 ll177-178. The comparison between the different locations of the outpatient facilities is not necessary as the sample was not designed to be representative of the resident populations of the municipalities of Naples and Caserta, therefore results of this analysis provide little insights. Should the authors prefer to keep this comparison, data concerning these variables have to be reported in table 1 and 2, and the variable should be considered in the univariate and multivariate analyses.

REPLY: The sentence has been deleted.

REVISED VERSION pg 10 ll 218-219: There were no differences between Napoli and Caserta in HL level and in the correlation of HL with other variables.

R1 - Discussion, pg 10 ll203-205; pg 11 ll 214-216. Direct comparison with data derived from population based sample should be avoided; the design of your study cannot allow any kind of comparison with other HL level. It is important that like is being compared with like. If different sampling strategies were used then the differences are likely to be sampling variations, not any population level differences. If the data are not comparable then the findings should not be compared.

REPLY TO 203-205: We removed the word “comparing”, and we specified the non-comparability between studies.

REVISED VERSION pg 12 ll 249-255: Although not representative of the reference population, our analysis revealed that 38.4% of the participants had a sufficient HL high level of HL. Comparing this percentage with the only two Italian studies with these methods, but Findings from two other studies conducted in Italy using a representative sample, one reported a higher level of HL using the HLS-EQ-Q47 in one [12], whereas the other study [11] showed a lower level using the HLS-EQ-Q16.

REPLY TO 214-216: we rewrote the sentence.

REVISED VERSION pg 12 ll 264-270: Our results, compared with other European studies, showed a low level of HL [4, 10, 20]. As regard the study of Sorensen et al. [4], it is a multicentric study that utilised the HLS-EQ-Q47 in eight European countries, in which only Bulgaria had a lower HL than our study.In Europe, Sorensen et al. [4] analysed HL level in eight countries (Austria, Bulgaria, Germany, Greece, Ireland, Netherlands, Poland and Spain). The highest level of HL was found in the Netherlands and the lowest level of HL in Bulgaria (respectively 71.4% and 37.9% of sufficient/excellent HL).

R1 - Discussion, general comment on the section. The authors need to consider internal and external validity. Given the sampling, and potential for misleading findings, the paper should mainly focus on results that arguably have internal validity – i.e., the antecedent analysis.

REPLY: comment about internal and external validity are reported in Limitation section. However, we better clarify these issues in that section.

REVISED VERSION pg 14 ll 294-305: Limitation. The main limitation of the study is related to its external and internal validity. Firstly, the respondents were a selected group of patients waiting in outpatient medical facilities in general medicine, and not a sample of the general population. Therefore, their HL level may be different from the general population. Moreover Secondly, they completed the questionnaire after the staff of the outpatient medical facilities secretary of the general practitioner gave them the opportunity to participate in the study. They voluntarily took part in the study but the presence of the medical doctor researcher during the completion of the questionnaire might have caused them not to answer the items truthfully, rather in a certain desired direction or under the psychological pressure of consulting with their medical doctor general practitioner. It is also possible that the patients might have completed the questionnaires hastily, without paying particular attention to the questions, because they were probably focused on seeing their doctor general practitioner and did not want to miss their turn.

R1 - Furthermore, I suggest to consider discussing the possible implications that the measurement of HL may have in the context of primary health care services.

REPLY: Done.

REVISED VERSION pg 14 ll 289-293: In our healthcare system, general practitioners might actively promote HL of their target group by providing information, advice, education and guidance. Their role should be important for the creation of an appropriate database to develop health literacy promotion strategies and to plan evidence-based interventions. However, the general practitioners included in our study would appear to have had little influence in promoting the HL of their patients.

R1 - Discussion, pg 11 217-224. The meaning of this paragraph in not clear, please rephrase it.

REPLY: Done.

REVISED VERSION pg 12 ll 271 -275: Many studies have shown that limited low level of HL is associated with one or more of these healthy and sociodemographic characteristics poorer health outcomes, older adults people, lower education level, poorer self-rated health, limited use of preventive health services, increased hospital visits and higher mortality rates as well as inferior physical and mental health [19, 23, 24, 44–48].

R1- Discussion, pg 11 ll 230-232. The mentioned “Medical doctor” is referred to the doctor with which they had the visit (e.g. the general practitioner) ? or the medical researcher? Please clarify the recruitment and survey process here and in the method section.

REPLY: Done.

REVISED VERSION pg 14 ll 297-302: Moreover Secondly, they completed the questionnaire after the staff of the outpatient medical facilities secretary of the general practitioner gave them the opportunity to participate in the study. They voluntarily took part in the study but the presence of the medical doctor researcher during the completion of the questionnaire might have caused them not to answer the items truthfully, rather in a certain desired direction or under the psychological pressure of consulting with their medical doctor general practitioner.

R1 - Discussion, please discuss the meaning and implications of the association between HL and the General Self-Efficacy Score.

REPLY: Done.

REVISED VERSION pg 13 ll 284-288: Health Literacy and self-efficacy are important factors contributing to health promotion behaviour. Therefore, it would be desirable for each person to have both high HL and high GSE. In our sample, these two factors were correlated, but this correlation was stronger when both factors were consistent (48.5% both low vs 21.9% both high). Therefore, only 21.9% of the respondents in our sample seem to have had means for health promotion behaviour.

R1 - Conclusion.pg 11-12 ll 240-242. Conclusion section have to be expanded to report the main findings of the study and their implications for primary care practices and research.

REPLY: Done.

REVISED VERSION pg 14 ll 308-315: This study reports the first results on HL for the Southern Italy in outpatient medical facilities in general medicine and cannot represent the entire geographical area. It showed a low level of HL. As the sample was not representative of the reference population, we cannot derive a corresponding conclusion for the general population of Southern Italy. Despite the important role of the general practitioners, they would appear to have had little influence in promoting the HL of their patients. Therefore, more data about HL in this area and in Italy are needed to for a better understanding of the situation in the our country and to plan actions to improve HL in our system population.

- General comment: please carefully review the manuscripts for typo and grammar errors. For instance”

REPLY: All the manuscript has been reviewed by a mother tongue revisor. The edits are underlined in the tracked version.

Reviewer #2: Generally, the article provides a good insight into the level of Health Literacy a sample in Italy. The authors did a good job working on an unexplored area in Italy. My comments are stratified by section down below.

The article is well reported and understandable, however some language modifications are recommended

R2 - Results: Line 168: the concept of "low level of HL" is not introduced and identified until the results section.

REPLY: We introduced the concept in the methods.

REVISED VERSION pg 7 ll 158-161: The categories were dichotomised into adequate and not adequate (inadequate and problematic). This approach has been utilised previously [7, 11, 20, 31]. The category with adequate HL is assumed to have high level of HL, the category with not adequate is assumed to have low level of HL.

R2 - In table 2, HL levels were classified into "high" and "low", whereas the dichotomization were made into "adequate" and "not adequate" i.e problematic and inadequate earlier in the methodology section. The definitions were not clear as to what constitute low HL; does it mean inadequate only or inadequate and problematic combined together?

REPLY: We added the definition in the methods section pg 7 ll 158-161.

R2 - Similarly, the term “sufficient HL” was used in line 203 although this was referred to as "high HL" earlier in the table. I recommend to unify the terms used across the paper starting from the methodology and be specific with the definitions.

REPLY: We unified the terms in the methods and discussion section.

REVISED VERSION pg 12 ll 249-251: Although not representative of the reference population, our analysis revealed that 38.4% of the participants have a sufficient HL high level of HL.

R2 - Line 191: "Indeed" is informal word to use.

REPLY: we deleted Indeed and used In particular.

REVISED VERSION pg 11 ll 238-240: Indeed In particular, a high strong positive correlation between the HL score and the GSE score was found (0.53), while a low weak positive correlation between the HL score and the assessment of personal health status using EQ-VAS was found (0.27).

R2 - Discussion: Line 210-213: language needs to be improved.

REPLY: Done.

REVISED VERSION pg 12 ll 260-263: Consequently, though yet to be demonstrated, northern patients in Northern Italy may have a higher HL than those in the South. If this were was true, any interventions to improve HL would should have to be differentiated between these two geographical areas.

R2 I’d like to read about your view of the implications of the study.

REPLY: we improve the implication of the study in the conclusion section.

REVISED VERSION pg 14 ll 308-315: This study reports the first results on HL for the Southern Italy in outpatient medical facilities in general medicine and cannot represent the entire geographical area. It showed a low level of HL. As the sample was not representative of the reference population, we cannot derive a corresponding conclusion for the general population of Southern Italy. Despite the important role of the general practitioners, they would appear to have had little influence in promoting the HL of their patients. Therefore, more data about HL in this area and in Italy are needed to for a better understanding of the situation in the our country and to plan actions to improve HL in our system population.

I hope that the revisions to the manuscript and the accompanying responses are acceptable, and that the manuscript is suitable for publication.

I look forward to hearing from you.

Yours sincerely,

Prof. Francesco Attena

Department of Experimental Medicine

University of Campania “Luigi Vanvitelli”

Via Luciano Armanni, 5

80138 Naples (Italy)

tel +39 081 5666012

e-mail francesco.attena@unicampania.it

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Decision Letter 1

Stefano Federici

17 Jul 2020

Measuring Health Literacy in Southern Italy: a cross-sectional study

PONE-D-20-09482R1

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Acceptance letter

Stefano Federici

28 Jul 2020

PONE-D-20-09482R1

Measuring Health Literacy in Southern Italy: a cross-sectional study

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