1. Introduction
Rheumatoid arthritis (RA) is a chronic inflammatory illness of the joints with a prevalence of between 0.3% and 1.5% of the total world population [
1,
2].
Of all patients with RA, 85% to 100% experience RA-related issues with their feet. The progression of this RA-related issues is related to the length and severity of the illness [
1].
The most frequent deformities in these patients are rearfoot valgus, Hallux Abductus Valgus, and other deformities in the smaller toes [
2], increasing plantar pressure and causing musculoskeletal pain [
1,
2,
3,
4].
RA can lead to a loss of function, a reduction of mobility, and a negative impact on quality of life [
5]. The recommendations in both clinical practice guides and standard care, support the need of early podiatric intervention. Research has shown that it would be appropriate to include a podiatrist in the multidisciplinary team for patients with RA [
5,
6]. Therapeutic education is considered a key part of podiatrist-related treatment for patients with RA [
7].
Therapeutic education plays a fundamental role in all chronic illnesses. The aim of the patients is to be able to improve their life [
8]. There is evidence that early intervention for both potential or existing foot problems can improve the long-term results [
9]. In general, patients with RA are ignorant of the podiatrist’s role and of RA-related feet problems [
6].
There is currently a limited amount of research that describes the results of overall foot educational interventions in these patients [
10]. Due to this need, we have proposed carrying out sessions of podiatric therapeutic education in patients with RA. These sessions consist of a health education seminar, followed by a talk. To carry out this educational intervention, and to be able to value its effectiveness, it was necessary to elaborate and validate a questionnaire that covered these aspects. Due to the limited literature on the subject [
10], there is currently no validated questionnaire. For this reason, the main aim of this work was to validate a questionnaire, through the Delphi method, to increase our knowledge of different aspects of overall foot health in patients with RA.
2. Methods
A questionnaire was designed and validated through the Delphi method [
11,
12] to evaluate the patients’ knowledge about RA, the repercussions on their feet, overall foot care, and the role of nursing in their care.
This Delphi method has been widely demonstrated to be useful in achieving consensus in an area where there is a lack of empirical evidence [
13]. This method is an efficient and systematic procedure that aims to compile expert opinions about a particular topic. Furthermore, a questionnaire enables a deeper understanding of these opinions [
14].
The Delphi method is classified as one of the general prospective methods that seeks to achieve a better consensus of an expert group based on the analysis of and reflection on a concrete problem [
13]. It is used to determine the validity of the content of an instrument; the degree to which a test appropriately represents what has been carried out [
15,
16]. This type of validation has been widely used in the scientific literature to validate questionnaires in different areas [
11,
12,
14,
15,
16,
17,
18,
19,
20,
21,
22].
The study was carried out between March 2017 and April 2017. An Ethics Committee approval was obtained from the Junta de Andalucía, Spain (fe524a8b7e8159db98f0645027de03e6451e3595, application data 12 October 2016.) Two groups took part in the study: A coordinating group and an expert panel. The coordinating group was made up of two podiatrists and a professional nurse whose work takes place at the University of Seville. All of them have a Ph.D. The coordinating group worked on the design of the initial questionnaire, with a total of nine items with closed answers (
Appendix A). The objective of this questionnaire was to evaluate the knowledge of these patients about four fundamental aspects related to the overall health of their feet: The repercussions of RA on their feet, the use of appropriate footwear, the importance of self-care, and the skills of nursing.
The 16 experts included in the panel answered questions of affiliation, as well as their degree of knowledge concerning RA. The questionnaire was sent by e-mail to evaluate each question on a five-point Likert scale. The contributions of each of the items were collated.
Two phases were carried out in the validation process: The preliminary phase and the exploratory phase. In the preliminary phase, the coordinator group was in charge of studying and approving the work protocol, as well as studying and ratifying the list of experts taking part. Having done this stage, the exploratory stage began in the coordinator group with four sub-stages: First, questionnaires were sent out (Likert-type scale) with a letter of presentation; second, the answers were analyzed, the following questionnaires were prepared, and the appropriate feedback was delivered; third, the results were interpreted; and fourth, the research was correctly supervised, with corrective measures taken when necessary. In a parallel manner to these sub-stages, the expert panel was in charge of answering the questionnaires [
11,
12].
The exploratory phase was developed through two rounds. The first round where, after analyzing the answers of the expert panel, some modifications were carried out according to its contributions, and a second round that collated the contributions in each of the items of the questionnaire, also carrying out some modifications and adding two new questions about nail cutting and treating corns.
The computer program used in the statistical analysis was SPSS version 22.0. For the study of the quantitative variables, age and years of experience, we used the average and the standard deviation. For the qualitative variables (degree, current job post, professional practice, and teaching category), we calculated the frequencies and percentages.
In each of the rounds we carried out the Cronbach alpha statistical test for each of the items and the questionnaire in general. The method of internal consistency based on Cronbach’s alpha enables the estimation of the reliability of a measurement instrument through a set of items, which it is expected will measure the same construct or theoretical dimension. The closer the alpha value is to one, the greater the internal consistency of the items analyzed is. Polit and Hungler [
23], like Burns and Grove [
24], consider that a reliability coefficient over a minimum value of 0.70 is in general acceptable.
3. Results
The coordinator group was set up as explained in the previous section. In the preliminary phase this coordinator group selected the expert panel to validate the questionnaires.
The expert panel comprised of 62.5% podiatrists, 18.8% nurses, and 18.8% who belonged to other health professions. Regarding their current jobs, 87.5% were teachers and 12.5% carried out their professional abilities in the private care area. In the following table we describe the teaching category of the members of the expert panel (
Table 1). In total, 75% had PhDs, 12.5% had a university degree, and 12.5% had a masters. The degree of knowledge of the experts concerning RA on a scale of 1 to 10 was on average 6.9 ± 1.7 (range of 3 to 10). The average years of experience was 19.6 ± 5.8 years (range of 13 to 31 years).
As was described in the previous section, the initial questionnaire was designed and sent to the experts for their validation (
Appendix A).
In the second part, we calculated the mean value and the standard deviation, and found the frequencies of all the different answers for each of the items. It should be highlighted that all the items obtained the qualification of very appropriate or quite appropriate from more than 70% of the experts. Items 1 and 2 attained the highest values, obtaining these qualifications from more than 90% of the experts. The Cronbach alpha statistical test was carried out for each of the items individually and for the set of them. The values were over 0.70 in all the cases, the total for the questionnaire being 0.855 (
Table 2).
We analyzed the contributions of the expert panel. Some formal aspects of the different items were modified and a new item on nail cutting and the removal of corns was added. The questionnaires with these modifications were sent back to the expert panel to be valued anew (
Appendix B).
In the third part, we again worked out the frequency of the answers of the expert panel regarding the different items. All of them attained a qualification of very appropriate or quite appropriate from more than 75% of the experts, attaining 100% in these qualifications for items 1, 2, and 10. Cronbach’s alpha was done again. The values were over 0.70 in all the cases, the total for the questionnaire being 0.790 (
Table 3).
The contributions were analyzed anew and we modified the writing of items 9 and 10. We added a new, open-answer item in which we asked what the patients did when their feet hurt. In the last phase we had the result of the final questionnaire, which would be used later for the investigation (
Appendix C).
Finally, to validate the content of this questionnaire, a pilot test was done to calculate the validity and reliability. Eleven subjects participated in this study. Cronbach’s alpha was done, the total for the questionnaire being 0.792.
4. Discussion
Various studies have been done that show the positive effect of therapeutic education on patients with RA about their knowledge of the illness [
25], their general state [
26], the degree of pain [
26], the self-handling of the illness [
26,
27,
28], the level of control of the illness, the patient’s activity [
26], the physical function [
29], their perception of general health [
30], and satisfaction [
27]. Therapeutic education plays a fundamental role in adhering to treatments in chronic illnesses and therefore increases the quality of life of these patients [
31].
In 2008, Riemsma et al. [
32] published a systematic review about the effects of therapeutic education in patients with RA. This type of intervention produces beneficial effects in the short term on disability, joint counts, the patient’s global evaluation, his/her psychological status, and depression. We believe that the lack of evidence of the benefits of the therapeutic treatment of patients with RA is due to there being few studies of the matter.
Foot problems are one of the most frequent in patients with RA [
1,
2,
33]. Therapeutic education provides the appropriate information concerning the role of the podiatrist and the RA-related foot problems. It is an important tool to improve these patients’ quality of life. Various works about the opinions of patients with RA and podiatrists reflect the need for podiatric education in this group [
10,
34]. Graham et al. [
10] carried out a literature review about podiatric therapeutic education for patients with RA. They determined that there were no specific investigations regarding the development and effects of therapeutic education in patients with RA. According to the results of these authors, there is an evident need to carry out podiatric education activities.
In 2010, Juarez et al. [
34] evaluated the prevalence of foot health problems of patients with inflammatory arthritis—68% had foot problems. Only 21% were informed regarding the consequences of illness-related foot problems and general health, and 9% about footwear. The data of this study ratify the need to carry out activities about education for podiatric health.
In general, there is a lack of formal overall foot education [
6]. This is why we had proposed carrying out podiatric therapeutic education sessions in patients with RA.
In our study, the average, the standard deviation, and Cronbach’s alpha was calculated for each of the items. In the Cronbach alpha statistical test values over 0.7 were obtained in all the items and as an average value of the questionnaire. All of the items attained a qualification of very appropriate or quite appropriate in more than 75% of the items, even achieving values of 100% in these categories for items 1, 2, and 10. It was considered that the items were valid if the degree of appropriateness was over 70%.
After validating the content of this questionnaire, a pilot test was done to calculate the validity and reliability. Foot Health Promotion activities will be carried out later.
Among the limitations of this work was that the expert panel might have preconceived ideas concerning the group of people with RA.