Knowledge assessment among subjects with chronic venous leg ulcer in outpatient setting: Translation and adaptation of a tool to identify subjects at risk of poor understanding

Promotion of self‐care is an important issue in the treatment of chronic diseases such as venous leg ulcers, as adequate self‐care can prevent complications and ulcer recurrence. However, only a few tools have been developed and tested to assess the knowledge of patients with venous leg ulcers. This study aimed to translate, adapt and validate in an Italian language and context a questionnaire to assess the knowledge of patients with venous leg ulcers about their disease (pathophysiology, risk factors, lifestyle changes due to ulcer) and the proper management of the ulcer to prevent recurrence. This is a cross‐sectional study divided into two phases: (1) translation and cross‐cultural adaptation of the ‘Educational Interventions in Venous Leg Ulcer Patients’ tool in a six‐stage process and (2) validation and reliability study with patients with active ulceration. There was great agreement for the English‐to‐Italian translation. In content validation, the tool showed good applicability among experts. Adjustments were made to improve semantic equivalence, and the questionnaire was made to be easy and quick to administer. The results of the target population showed a low level of knowledge among the patients. Knowing the deficiencies of the patients makes it possible to create educational projects to improve their abilities. Now more than ever, it is necessary to improve self‐care and patient knowledge, allowing home care, improving autonomy, and avoiding hospital care that results in higher costs and risks. This questionnaire could be used in future studies to identify topics that need to be reinforced through education and to improve the awareness and self‐care of these patients.


| INTRODUCTION
In recent decades, the world has seen a significant growth in the elderly population due to an increase in life expectancy due to several factors such as living and work conditions, environment, economic well-being, increased training and scientific research.The fast and constant growth of the elderly population has also been observed in the last few years in Italy.On 1 January 2019, about 13.8 million people were 65 years and older (up to 22.8% of the total population), about 2 million more than in 2009. 1 At the same time, an increase was observed in older patients with chronic diseases, such as venous leg ulcers (VLU).In western countries, VLU affects about 1% of the total population and 3% of people over 80 years of age each year.They also have a high recurrence rate at 12 months (between 18% and 28%). 2 More than two million people are estimated to be affected by VLU in Italy, and this problem is increasing, considering the tendency to longevity in this country. 3U is a chronic source of pain, discomfort, and social distress and results in adverse effects on quality of life that are critical for patients with VLU. 4 Furthermore, considering the costs of diagnosis, treatment, and care, VLU represents up to 2% of the annual health budget of western societies, which is 600-900 million euros per year.5 VLUs are difficult to treat and often take years to heal.Compression therapy is the gold standard treatment administered with proper compression socks.6,7 However, in the long run, a patient with VLU tends to isolate himself due to sleep disorders, bad mood, discomfort due to heavy smell, depression, and anxiety.8 To avoid the risk of recurrence, it is necessary to adopt specific self-care behaviours, such as doing light physical activity, lifting the legs, maintaining a proper weight and having a balanced diet.8 Furthermore, it is recommended to continue compression therapy for the rest of life for a patient who has healed to reduce the risk of recurrence.9 VLU can be effectively managed at home, not only in hospital wards or speciality clinics. God home VLU management and adequate patient education to prevent recurrence would improve patient quality of life, both socially and psychologically, and create economic savings.10 However, many patients have been shown to not adhere to the recommended treatment.A previous study found that only 37% of VLU patients reported total or partial adherence and 63% had never used compression socks or left them after a trial period in the past.11 Furthermore, patients are often not consistent with therapy because they have not received adequate education.10 In this regard, few tools for assessing the knowledge of VLU patients are described in the literature, and only one, the 'Educational Interventions in Venous Leg Ulcer Patients' is validated.12 This questionnaire was used in 2015 in a study to evaluate and compare the effectiveness of two educational tools, a video and a written brochure, to improve patient knowledge about the disease and management of VLU.There are no Italian versions of this questionnaire available for researchers.
This study aims to translate, carry out cross-cultural adaptation, and validate the Italian version of the questionnaire to assess the knowledge of patients with VLU about their disease (pathophysiology, risk factors, lifestyle changes due to ulcer) and about proper management of the disease to prevent recurrence.

| METHODS
The tool 'Educational Interventions in Venous Leg Ulcer Patients' 12 evaluates knowledge about (i) the pathophysiology of the disease, (ii) its treatment, and (iii) the proper lifestyle to follow.It includes 15 multiple choice questions where one single answer is correct.
The translation and validation process to the Italian context was based on the procedure described by Sousa et al. 13

| Pilot study
After the conclusion of the translation process, the pre-final version was used for a pilot validation study (Step 5).The questionnaire was sent to students at the University of Padova who attended the third year of the Nursing degree course (between August and September 2020) and who participated in providing nursing care to the elderly population.Through open and closed questions, the pilot sample was asked to report any errors contained in both the questions and answers or difficulties in understanding them (from a point of view of the patients) to determine the clarity of the instructions, response format and sentence structure of the items (Table S1).

| Pre-final Italian version with a target population sample
After the pilot study, a survey was conducted (Step 6) between February and March 2021, administering the questionnaire to patients with VLU attending the Vulnological Outpatient Clinic at the 'Complesso Socio Sanitario Casa ai Colli' in Padua (Italy).
The complete questionnaire consists of collecting demographic and clinical data (age, sex, BMI, level of education, employment status, whether the currently treated VLU is a relapse, how long the patient had suffered from VLU, who managed the VLU, depth of the VLU described as superficial [epidermis and dermis] or deeper [subcutaneous tissue exposing soft tissue or bone], and whether the patient had received specific education about VLU and by whom) and a second part assessing the knowledge of patients with VLU (using the translated questionnaire).Patients completed a paper questionnaire with a healthcare professional before attending the scheduled outpatient visit.
The whole study design and its flow chart are described in

| Sample size calculation
In the absence of solid indications from previous investigations in contexts similar to the Italian case, the study was designed to exclude a random answer to questions, that is, a probability of a correct answer to each item of 50%.Therefore, assuming a prevalence of 50% of correct answers, with a confidence level of 0.95, a sample size between 50 and 60 subjects is compatible with a plausible scenario with a precision level between 10% and 20% (Table S2).A proportion of 0.5 is used for the sample size estimation as this approach provides a conservative estimate of the sample size. 14,15This is because the variability in the sample proportion decreases as the true proportion moves away from 0.5 (in both directions).Therefore, assuming a proportion of 0.5 yields to a conservative (higher) estimate of the needed sample size.Health of the University of Padova. 16,17REDCap is a secure webbased software platform designed to support data capture for research studies, providing (i) an intuitive interface for validated data capture, (ii) audit trails for tracking data manipulation and export procedures, (iii) automated export procedures for seamless data downloads to standard statistical packages, and (iv) procedures for data integration and interoperability with external sources.All data were managed according to pseudonymization rules.
Descriptive analysis of the target population sample was reported using the median and the interquartile range (IQR, I-III quartile) for continuous variables and frequencies and relative percentages for categorical ones.The study sample was stratified at baseline according to the education received about the disease (specific education on VLU or not).The presence of statistically significant differences between the two groups was assessed using the Wilcoxon test for continuous variables and the chi-square test for categorical variables.Statistical significance was established at a two-sided p-value <0.05.The Benjamini-Hochberg correction has been applied to control the false discovery rate due to multiple tests. 18,19All statistical analyses were performed using statistical software R (version 3.6.2). 20

| Translation process
In the first step of the translation process, two translators independently translated the '«Educational Interventions in Venous Leg Ulcer Patients' tool into Italian.Then, in the second phase, a third independent expert synthesised the two previous translations.In the third step, the last version was retranslated from Italian into English by another independent translator who did not know the original questionnaire.After the back translation, a committee of eight experts, comprising four professional nurses with more than 10 years of experience in VLU and a master degree in wound care, two physicians dedicated to wound care outpatient clinic, and two postdoc researchers experts in research methodology, developed the so-called pre-final version of the tool (Step 4).

| Pilot study
In the next step, a pre-test of the actual version was performed to assess comprehension and clarity of the items.Among the 64 nursing students of the University of Padova involved in providing care to the elderly population to whom the questionnaire was sent, 22 returned it completed.All subjects stated that the questionnaire was clear and suitable for the target population (patients with VLU).Few T A B L E 1 Baseline characteristics according to specific education received by patients about ulcers.S3).Most VLUs were superficial (n = 44, 70%), and only two patients had deep and superficial VLUs (Table 1).No differences in age, sex distribution, type of occupation, type of VLU, and duration of the VLU have been detected according to the presence of specific education on VLU received by patients.Most patients received specific VLU training from clinic staff (n = 39, 76%).There was a significant difference in the level of education of the patients as subjects who received a specific education in VLU had a higher level of education than the patients in the other group (p = 0.038).A significant difference between groups could also be observed in VLU management; patients without a specific education on VLU appeared to resort more often to clinic staff ( p = 0.009).

| Pre-final Italian version with a target population sample
Overall, the median score of the questionnaire 'Educational Interventions in Venous Leg Ulcer Patients' was 7.0 (IQR 4.5-9.5).When analysing the specific questions (Table 2), more than 50% of the patients (i) know the causes of VLU (item 1, Causes of VLU), (ii) know that the most important treatment is represented by compression therapy (item 8, Most important treatment for VLU), (iii) know that compression therapy should be worn even in case of healing (item 15, Wear compression therapy regularly) and (iv) know when to refer to the specialist (item 14, When to contact the specialist).(Figure 2), percentages are almost always lower in the first case than in the latter (except for three questions).These differences are almost always significant (Table 3).A similar pattern of responses could be observed between the two groups for questions related to the knowledge of the symptoms of VLU, risk factors for VLU, clinical indications for removal, strength, and regularity of compression stocking use.

| DISCUSSION
VLU is a common pathological condition that can cause significant discomfort in patients and negatively impact their quality of life.Adequate patient education is shown to help prevent recurrence and improve quality of life. 12The need for a validated tool to assess knowledge in patients with VLU is essential due to the lack of a widely accepted objective measure in this field.In 2015, Baquerizo et al.

developed and proposed the 'Educational Interventions in Venous
Leg Ulcer Patients' questionnaire to improve patient knowledge about VLU disease and management. 12The current study aimed to translate and culturally adapt this questionnaire into Italian.
The questionnaire was generally considered clear and suitable for patients with VLU in both the pilot study and the final study in subjects with active disease.Five out of 15 questions reached a 'correct answers' percentage of less than 40%.One is about the functioning of the treatments that help heal, and two concern compression stockings.This aspect is also confirmed to be a critical point in the first study using the same questionnaire, with 'correct answer' percentages less than 40%.This problem arises because compression therapy is the gold standard treatment for this condition. 2,6,10Edwards et al. 19 have already revealed that only 27% of patients with VLU wear compression stockings due to lack of knowledge.
Furthermore, incorrect adhering to compression therapy is associated with a double increase in healing time and higher (2-20 times) relapse rates. 21The third question with the most incorrect answers concerns the recognition of the symptoms of infections.Infections are important topics as they can seriously worsen the patient's condition 22 and lengthen the healing time. 23Considering that infections  play an important role in patient health and quality of life, patients must recognise these risk factors to seek prompt treatment.Lastly, approximately 70% of the patients do not realise that VLU is not contagious (Question 4).
In the other seven variables, most of which relate to the pathophysiology of VLU, the correct scores range from 40% to 60%.It has emerged that patients have a significant lack of knowledge about their pathology.Patients with VLU did not adequately understand the pathophysiology of their condition or preventive measures to pursue effective self-management, as already indicated in the literature. 10ong the questions with a higher percentage of correct answers, only 40% of the patients do not recognise the central problem underlying the development of VLU (Question 1), more than 70% of the patients recognise symptoms of a worsening of the disease (when it is necessary to contact the wound specialist) and 80% know that compression stockings should also be worn regularly in case of healing (Question 15).
From the target population sample (to whom the pre-final Italian version of the questionnaire was administered), a mean score of 7 was obtained (SD ± 3).There is not enough evidence from the literature to define this score as low in an absolute sense.The only possible comparison is with the original article by Baquerizo et al., 12 which does not report the average score.However, assuming that an optimal knowledge of the phenomenon will be described by a score of 15, the mean score observed in the study population could be considered quite low.
Even if an explanation is not possible simply by observing patient scores, it could still be inferred that patients probably have not been fully and sufficiently educated on the activities to be carried out to prevent relapse.When comparing the percentages of correct answers in individual items obtained from this cohort with those from the original study, 12 the latter seems to be higher in almost all items.This could be After a first Italian translation performed by two experts (Step 1), a first Italian version was made as a synthesis of the two translated versions (Step 2); it was subsequently translated into English by another expert who was unaware of the original version (blind backward translation, Step 3).After finishing the back-translation, an expert panel compared the original version of the test with the back-translated version for any necessary corrections or revisions.Then it was verified that the content equivalence of the two English versions (the original and the translation performed at Step 3) had been reached, developing a prefinal version of the tool (Step 4).Finally, a satisfactory Italian version of the text was reached.

Figure 1 .
Figure 1.The study was carried out according to the Declaration of Helsinki guidelines and the protocol was approved by the Institutional Review Board of the University of Padova and authorised by the local County Hospital (Azienda ULSS 6 Euganea) for the collection of personal data (compliance with the GDPR).All patients provided their informed consent to participate in the study.

2. 4 |
Data collection and statistical analysis Study data was collected and managed using REDCap (Research Electronic Data Capture) electronic data capture tools hosted in the Department of Cardiac, Thoracic and Vascular Sciences and Public After the pilot test (Step 5), a targeted sample of the population of interest completed the new pre-final Italian version (Step 6).Sixty-five patients with active VLU who consecutively attended the Vulnological Outpatient Clinic were enrolled.Most of the sample were male (45 patients, 69%).Most of them had more than two comorbidities, and more than half of them had chronic venous insufficiency 58% (n = 38) and hypertension 63% (n = 41).Twenty-eight percent (n = 18) of the patients were obese.The VLU-related pain was mostly well controlled, and 67% (N = 42) of the patients had only one VLU.
Topics related to compression are less known, including frequency of change in compression stockings (item 12, change of compression stocking), adequate compression strength (item 11, Strength of compression stocking), contraindications (item 9, Contraindications for compression), and mechanism of action (item 3, Therapies effect).Comparing the answers of the cohort involved in the present study with that of the original study 12
Questionnaire12 used in the original study proved helpful in capturing the level of knowledge perceived by patients who deal with their VLU and self-care skills.The Italian translation has only partially been modified/adapted from the original questionnaire and has been positively assessed by both samples involved in the present study.The percentage of correct answers provided by enrolled patients is lower in almost all questions compared to those described in the original study.11Italian patients with VLU appear to be older and need to learn better, and wound care specialist nurses should consider this need.The Italian version of the questionnaire can provide a beneficial screening and assessment tool, and its use should be encouraged in the outpatient setting for both care and research purposes.The latter should also be encouraged to describe the most effective interventions to improve patient knowledge and, accordingly, health outcomes.
or less experienced patients.The pre-final version of the tool was obtained after analysis of the pre-test results.Refer to the supplementary material for the Italian version (Table Comparison between current results and previous ones. 12e to the higher mean age of this study population (mean age 73 ± 13 vs. 62 ± 11), which can affect the learning ability of the patients.ment,improveautonomy, and avoid hospital management, leading to lower healthcare costs and risks.Further studies should also be carried out in home care settings (e.g., integrated care groups, general practitioner clinics, general medicine hospital wards, and internal medicine hospital wards) as patients may have different levels of knowledge in various care settings.T A B L E 3 a Results have been calculated based on data reported by Baquerizo et al.12