Validation of the JH-SEFAC Questionnaire on Knowledge on Insulin Management by Patients with Diabetes in Community Pharmacies

INTRODUCTION

Lack of adherence to treatment is a serious health problem, as it can have consequences derived from ineffective or unsafe medication, such as exacerbation of symptoms, hospital readmissions, increased use of emergency services, increased health care costs and a higher risk of death [1,2]. It can reach 50% in hypertension (HBP), dyslipidemia or diabetes; and it is usually lower, around 30%, in acute pathologies [3]. In patients with type 2 diabetes (DM), non-adherence was found to be 24% in bolus insulin and 36% in basal insulin [4].

On the other hand, studies show that to obtain the best results from insulin therapy a very good injection technique is necessary [5] so that educational programs that include training in injection techniques achieve notable decreases in glycosylated hemoglobin (A1c) levels [6], finding that errors in injection technique are one of the reasons for lack of effectiveness in patients using insulin [5]:

• Faulty flushing of the pen or its omission may result in erratic dosing.
• Incorrect choice of injection site modifies the insulin absorption rate. The injection site should be chosen according to the type and rate of absorption desired for that moment.
• The lack of rotation of the injection sites may cause lipohypertrophy that hinders absorption.

 

The community pharmacy is a suitable place to carry out therapeutic education activities aimed at improving the use of medicines. The pharmacist is the health professional most accessible to the population. Patients go for medical consultation every 6 to 12 months, whereas a polymedicated person goes to the pharmacy sometimes every week to withdraw his or her regular medication [7]. Community pharmacies carry out therapeutic training actions for patients with numerous chronic pathologies such as diabetes, cardiovascular diseases, osteoporosis, etc. [7]. The reasons for the lack of adherence can be detected, treating insecurities, lack of information about the treatment and errors in its use, especially in the handling of administration devices of a certain complexity such as those for the injection of insulin and other parenteral hypoglycemic agents.

There are questionnaires on knowledge of the insulin injection technique [8,9], but we have not found questionnaires in our setting that assess the correct handling of insulin injection devices. We consider it important to have a validated instrument as a previous tool for therapeutic education in community pharmacies, in which all the actions of the injection process are completely and accurately assessed, for the planning of specific educational actions aimed at improving the use of these drugs, and in this sense, the starting questionnaire, developed by Joaquina Huarte [10], has been used in some previous studies [10,11] in which it has been shown as an important support, but so far it had not been validated following the scientific methodology.

Consequently, this project aims to review, evaluate and validate the JH-SEFAC questionnaire of knowledge on the correct use of insulin injectables in diabetic patients for use in Spanish community pharmacies.

OBJECTIVES

General objective:

• To review and validate a questionnaire of knowledge of patients with diabetes on the correct use of insulin injectables in community pharmacies (JH-SEFAC Questionnaire).

 

Specific objectives:

• To review and adapt the design of the insulin use knowledge questionnaire.
• To pilot the questionnaire, checking the feasibility of its incorporation into routine patient care.
• To analyze by means of the corresponding statistical techniques its validity, reliability and reproducibility.
• To quantify the level of knowledge of the participating patients on the correct use of insulins.

 

METHODS

Study design

Validation study of a questionnaire including a prospective observational study (test/retest) of knowledge on the management of insulin injectables to be carried out by community pharmacists’ (CPs) members of SEFAC, in Spanish pharmacies during the first half of 2023.

Subjects

Patients: for the process of evaluating construct validity, reliability and reproducibility (test/retest), patients were selected who were diagnosed with and/or being treated for DM, of legal age, on insulin treatment, able to understand and answer the questionnaire and who consented to participate. Non-diabetics or diabetics without insulin treatment, and diabetics on insulin with severe cognitive or social problems that prevented them from answering the questionnaire or who did not want to do so, were excluded. Also excluded were those patients who were not regular users of the pharmacy or who had other reasons that made it difficult to complete the questionnaire a second time.

Collaborating pharmacists: for the reproducibility evaluation process (test/retest), the collaboration of 20 community pharmacists who are members of the Spanish Society of Clinical, Family and Community Pharmacy (SEFAC), practicing in pharmacies in as many autonomous communities as possible, was requested. Participation was offered preferably to CPs belonging to the SEFAC Diabetes Working Group and to other members with training in the management of insulins and the care of patients who use them. Each would propose the participation of 6-8 diabetic patients, selected from among the regulars of each pharmacy in order to be able to summon them for the retest. Recruitment was opportunistic, since the pharmacies did not have enough patients to carry out a randomization, the first patients of each day who met the inclusion criteria and came to the pharmacy for any reason were successively recruited.

 The collaborating pharmacists received online training by the research group to achieve the greatest possible homogeneity in the administration of the questionnaire.

Variables

The main variables of the study are determined by the specific tests of each property of the questionnaire and are defined in the corresponding section of the procedure.

In the reproducibility study (test/retest), the score obtained by the patients in the JH-SEFAC questionnaire was determined as a secondary variable: total score; partial scores, by dimensions or areas.

Sociodemographic and clinical variables: sex (male/female); age (years); years of diabetes evolution (years); years of insulin use (years); medications: number of oral antidiabetic drugs (OADs); number of glucagon like peptide 1 (GLP1) analogs; number of insulins. Type of insulin (solution/suspension); Technique angle (45º/ 90º); Fold (WITHOUT/WITH).

PROCEDURE

Questionnaire design

The questionnaires developed by Joaquina Huarte (community pharmacist, member of the SEFAC diabetes group) [10] (Annex 0) were used as a starting point. A group of experts in the use of antidiabetic drugs made modifications to the questionnaire based on the recommendations on insulin use and injection techniques [1,11-14] and piloted the feasibility of its administration. After this process, version V.01 (Annex 1) was obtained. This version of the questionnaire consists of 31 items grouped into 10 sections or dimensions.

Questionnaire validation process

The usual indicators and statistical tests for the validation of this type of instrument were used [15-18].

Content validity: version V.01 of the questionnaire was provided to medical, nursing and pharmacy professionals with expertise in diabetes for its evaluation, in order to determine the content validity. Each expert answered 10 questions related to the questionnaire, with a Likert score scale from 1 to 5 (1=Strongly disagree, 2=Disagree, 3=Not sure, 4=Agree and 5=Strongly agree) (Annex 2). For the statistical validation tests of the questionnaire, items 6 and 9 were not taken into consideration because they were intended to be answered only by patients who met one or the other condition.

At the suggestion of the experts and in response to their comments, small changes were made to the wording of some questions and their order in the questionnaire. The instructions for its administration (to be provided in a separate document) were also simplified in order to facilitate its handling. This resulted in the V.02 (Annex 3), which would go on to the next phase of the validation process.

Construct validity: a principal component factor analysis was performed, which groups the responses according to underlying factors (factorial validity). By means of this technique, the interrelationships between a set of variables are analyzed. We expected to find the same dimensions that were defined when the questionnaire was designed. The adequacy of the factor analysis was checked by varimax normalization, the Kaiser-Meyer-Olkin (KMO) measure and Bartlett's test of sphericity.

Reliability: the internal consistency of the questionnaire was evaluated by calculating Cronbach's alpha coefficient (values between 0 and 1), which is used to evaluate the homogeneity of the different items of the same dimension or section and of the overall questionnaire.

Reproducibility: to determine the reproducibility of the questionnaire or test-retest reliability, the questionnaire was administered twice within 2-3 weeks to the selected sample of patients and the intraclass correlation coefficient (ICC) was calculated.

The collaborating pharmacists, after obtaining informed consent, recorded the demographic data of the participating patients (age, sex, educational level, antidiabetic drugs used, etc.) and telephone number in order to summon them for the repetition of the questionnaire.

Figure 1 summarizes the validation procedure of the JH-SEFAC questionnaire.

 

 

 Figure 1 Schematic diagram of the JH-SEFAC questionnaire validation process.

 

 

After statistical analysis and administration to patients in the reproducibility test, the drafting group made some modifications to the questionnaire in terms of the wording of some items, their numbering and organization, resulting in the final version V.03 (Annex 4).

Sample size

To achieve a power of 90.0% with a precision of 10%, to detect possible differences of 20% between the two moments of administration of the questionnaires, with a significance level of 5% and considering possible losses of 10% due to not being able to repeat the questionnaire, it was calculated necessary to include 127 patients in the repeatability test. This proposed participation by incorporating into the study, if accepted, the first patient of the day who met the inclusion criteria, until the assigned number of patients was reached. 

 

Statistical analysis

The statistical treatment of the data was carried out using the SPSS 29.0® statistical program for Windows®. Qualitative variables are expressed as percentages and quantitative variables as mean (m) and standard deviation (SD).

Confidence limits were calculated at 95% (CI), using the chi-square test for qualitative variables and, in the case of small samples, Fisher's technique. Student's t test for quantitative variables when the distributions were normal (Kolmogorov test with Lilliefors corrections) and Mann-Withney (Wilcoxon) for variables without normal distribution.

Correlations were determined using Pearson's r or Spearman's Rho, depending on whether or not the variables were parametric. Statistical significance was set at p <0.05.

Ethical considerations

The study was carried out in accordance with the standards of Good Clinical Practice of the International Conference on Harmonization (ICH E6) for a study of these characteristics. The autonomy of the participants was respected in all cases, following the ethical principles of the Declaration of Helsinki in force and the Organic Law 3/2018, of December 5, on the Protection of Personal Data and Guarantee of Digital Rights.

The record sheets remained guarded in the collaborating pharmacies complying with the high-level security measures for this purpose, complying with the provisions of the Data Protection Act for high security level files. The data recorded, after being subjected to a coding and dissociation process, were dumped into an Excel® sheet prior to their communication to the research team, so that the latter was never aware of any identifying or identifiable data of the participants.

The collaborating pharmacist adequately informed the patients, verbally and in writing, of the purpose and characteristics of the study, indicating that their participation was free and voluntary, and that they could discontinue it at any time, requesting their written consent and assuring them of the absolute confidentiality of the data.

The study was approved by the Clinical Research Ethics Committee of Aragón with code PI22/375.

Table 1 Results of the content assessment by health professionals.

 

 

Twenty pharmacies from thirteen Autonomous Communities participated in the construct validation, reliability and reproducibility study. Figure 2 shows their location.

Figure 2. Distribution of participating community pharmacies.
Map: Author: HansenBCN and Miguillen. Public domain license.
https://commons.wikimedia.org/wiki/File:Spain_2_location_map.svg

The questionnaire was initially administered to a total of 131 patients with diabetes, selected among the regular patients of each pharmacy in order to be able to quote them for the retest. Table 2 shows the sociodemographic and clinical characteristics of the patients with regard to their pathology and antidiabetic medication.

Table 2. Sociodemographic and clinical characteristics of the patients.

 

 

Tabla 2. Sociodemographic and clinical characteristics of the patients. (Continued)

  

90 (68.7%) participants were prescribed oral antidiabetics (OADs), 40 (72.7%) men and 50 (65.8%) women, p=0.3372 and 27(20.6%) other injectables, 11(20.0%) men and 16 (21.1%) women, p=0.8839.

Construct validity

The Kaiser-Meyer-Olkin sample adequacy test was 0.626 and Bartlett's test of sphericity was significant (p<0.001), which allowed performing the factor analysis. This revealed 11 dimensions explaining a variance of 71.21% of the total variance of the results.

Reliability/Reproducibility

In the analysis of internal consistency, a Cronbach's alpha of 0.804 was obtained for the global questionnaire. No item was eliminated because of its low discriminant power or its low correlation with the total questionnaire (Table 3).

To check test-retest reliability, all patients were summoned after 2-3 weeks. The intraclass correlation coefficient (ICC) was 0.902, indicating good agreement between the responses in the two applications (Table 4).

Patient knowledge

The mean total score of the questionnaire was 15.98 (6.19) points and in the repetition 15.74 (7.32), p=0.7709. The highest score was 29 points and the lowest was 0 points, with 31 being the maximum possible and -8 the minimum. The questions in which most patients failed were: question 15, in which 75.6% of the patients failed, question 16 with 79.4% and question 18 with 65.7%. On the other hand, 97.7% of patients answered question 1 correctly, 96.2% answered question 20 and 95.42% answered question 14 correctly. The mean scores distributed by sex corresponding to the sections are shown in Table 5.

 

Table 3 Total/item statistics: score, and internal consistency of the dimensions.

 

Table 4 Two-factor mixed-effects model in which person effects are random and measure effects are fixed.

 

 

Table 5. The mean scores distributed by sex corresponding to the sections are shown in table 5.

  

Table 6 Patients who answered correctly, by sections.*

 

* They are not included in the evaluation because they are questions intended to be answered only by a part of the participating patients

Of the demographic and clinical variables analyzed, only the level of education seems to be positively related to the score obtained in the questionnaire; sex, age, and years since the diagnosis of DM or since the beginning of the use of injectable hypoglycemic agents do not seem to have any influence. We have not been able to contrast these results because we have not found studies that analyze similar data in the literature reviewed.

All this indicates that the community pharmacist can and should be a fundamental collaborator for the healthcare team that cares for patients with diabetes, with whom he or she should coordinate and integrate effectively. Insulin dispensing is for the community pharmacist a professional opportunity and at the same time an unavoidable responsibility. He/she must ensure that the patient is fully aware of everything necessary for its use to guarantee its effectiveness and safety [25], especially the newly diagnosed patient or the one with a first prescription of an injectable insulin device, and must accompany him/her in its use, periodically evaluating the correctness of his/her technique, to resolve all the doubts that may arise, also checking the introduction of possible changes that require new educational interventions.

To this end, the community pharmacist needs to have validated instruments, not available until now, that allow him to check patients' knowledge of the use of the drugs prescribed to them, in particular, insulin injectable devices. With the validation of this JH-SEFAC questionnaire, the pharmacist will have at his disposal a very useful tool to incorporate into the strategies for the provision of professional pharmaceutical services in the care of patients with diabetes in community pharmacies. This will make it easier, in a more efficient way, to focus diabetological education, placing special emphasis on the specific aspects in which deficiencies or management errors have been detected.

The administration of the questionnaire before and after an educational intervention, whether isolated or included in pharmacotherapeutic follow-up programs, will make it possible to evaluate the effectiveness of this intervention.

BIBLIOGRAPHIC REFERENCES

1. Fundación redGDPS. Guía de diabetes tipo 2 para clínicos: Recomendaciones de la redGDPS [Internet]. España: redGDPS; 2018. [Consultado 12/7/2024]. 261 p. Disponible en: https://www.redgdps.org/ guia-de-diabetes-tipo-2-para-clinicos/
2. Gómez-Peralta F, Fornos Pérez JA, Molinero A, Sánchez M, Arranz E, Martínez-Pérez P, et al. Adherence to antidiabetic treatment and impaired hypoglycemia awareness in type 2 diabetes mellitus assessed in Spanish community pharmacies: the ADHIFAC study. BMJ Open Diab Res Care. 2021;9:e002148. doi:10.1136/bmjdrc-2021-002148
3. Sociedad Española de Farmacia Familiar y Comunitaria. Dispensación, adherencia y uso adecuado del tratamiento: guía práctica para el farmacéutico comunitario [Internet]. EDITTEC; 2017 [Consultado 15/7/2022]. 63 p. Disponible en: https://www.sefac.org/sites/default/ files/2017-11/Adherencia_0.pdf
4. López Simarro F, Escribano Serrano J. Adherencia terapéutica. Revisión de la literatura (2017-2019). Diabetes Práctica. 2019;10(1):1-36. Disponible en https://shorturl.at/WETrt
5. Mehrabbeik A, Namiranian N, Azizi R, Aghaee Meybody M, Shariati M, Mahmoudi Kohani HA. Investigation of Association Between Insulin Injection Technique and Blood Glucose Control in Patients with Type 2 Diabetes. Int J Endocrinol Metab. 2022;20(4):e128392. https://doi.org/10.5812/ijem-128392
6. Grassi G, Scuntero P, Trepiccioni R, Marubbi F, Strauss K. Optimizing insulin injection technique and its effect on blood glucose control. J Clin Transl Endocrinol. 2014;1(4):145-150. doi: 10.1016/j. jcte.2014.07.006
7. Leites-Docío A, García-Rodríguez P, Fernández-Cordeiro M, Tenorio-Salgueiro L, Fornos-Pérez JA, Andrés-Rodríguez NF. Evaluación de la no adherencia al tratamiento hipoglucemiante en la farmacia comunitaria. Farm Comunitarios. 2019;11(1):5-13. https://www.doi.org/10.5672/FC.2173-9218.(2019/Vol11).001.02
8. Frid AH, Hirsch LH, Menchior AR, Morel DR, Strauss KW. Worldwide Injection Technique Questionnaire Study: Population Parameters and Injection Practices Mayo Clin Proc. 2016;91(9):1212-23. https:// doi.org/10.1016/j.mayocp.2016.06.011
9. Barnard-Kelly KD, Mahoney E, Baccari L, Oliveria T, Glezer S, Berard L, et al. Injection Technique: Development of a Novel Questionnaire and User Guide. Diabetes Spectr. 2021;34(2):156-165.https://doi.org/10.2337/ds20-0054.
10. Huarte Royo J, Alonso Núñez M. Proyecto de promoción de los servicios profesionales farmacéuticos asistenciales “El farmacéutico que necesitas”. Carpas de salud 2017-2018-2019. Servicio de educación en insulinización y uso de hipoglucemiantes. Farm Comunitarios. 2020;12(Supl 2):490. https://www.farmaceuticoscomunitarios.org/es/journal-article/proyecto-promocion-servicios-profesionales-farmaceuticos-asistenciales-3
11. Fernández Bamio S. Intervención farmacéutica en la mejora del uso de insulinas [Trabajo de Fin de Grado]. Santiago de Compostela: Facultad de Farmacia USC; 2021.
12. FIT Forum for Injection Technique Canada. Recommendations for Best Practice in Injection Technique 2020, 4ª ed. Enero 2021. [Consultado 17/7/2024]. Disponible en: https://fit4diabetes.com/wp-con- tent/uploads/2024/02/FIT_Recommendations_2020-ENGLISH.pdf
13. Frid AH, Kreugel G, Grassi G, Halimi S, Hicks D, Hirsh LJ, et al. New insulin delivery recommendations. Mayo Clin Proc. 2016;91(9):1231– 1255. http://dx.doi.org/10.1016/j.mayocp.2016.06.010
14. American Diabetes Association. 9 Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes 2020. Diabetes Care 2020;43(Suppl.1):S98–S110. https://doi.org/10.2337/dc20-S009
15. Casas Anguita J, Repullo Labrador JR, Donado Campos J. La encuesta como técnica de investigación. Elaboración de cuestionarios y tratamiento estadístico de los datos (I). Aten Primaria 2003;31(8):527-538. https://www.sciencedirect.com/science/article/pii/S0212656703707288
16. Casas Anguita J, Repullo Labrador JR, Donado Campos J. La encuesta como técnica de investigación. Elaboración de cuestionarios y tratamiento estadístico de los datos (II). Aten Primaria 2003;31(9):592600. https://doi.org/10.1016/S0212-6567(03)79222-1
17. Andrés Iglesias J, Fornos Pérez JA, Andrés Rodríguez NF. Introducción a la investigación en farmacia comunitaria. Guía práctica para el diseño y la comunicación de estudios científicos. Vigo: Los autores y Aula Cofano; 2010.
18. Argimón Pallás JM, Jiménez Villa J. Métodos de investigación clínica y epidemiológica. 4ª Ed, Barcelona: Elsevier España; 2013
19. American Diabetes Association. Professional Practice Committee. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2024. Diabetes Care 2024;47(Suppl.1):S158–S178. https://doi.org/10.2337/dc24-S009
20. Nunnally JC, Bernstein IH. Psychometric theory (3rd ed.). Nueva York: Mcgraw-Hill, 1994.
21. Rodríguez-Rodríguez J, Reguant-Álvarez M. Calcular la fiabilidad de un cuestionario o escala mediante el SPSS: el coeficiente alfa de Cronbach. REIRE Revista d’Innovació i Recerca en Educació 2020;13(2):1-13. https://doi.org/10.1344/reire2020.13.230048
22. Martínez Pérez JA, Pérez Martin PS. Coeficiente de correlación intraclase. Medicina de Familia. SEMERGEN 2023;49:101907. https://doi. org/10.1016/j.semerg.2022.101907
23. Kalra S, Pathan F, Kshanti IAM, Bay NQ, Nagase T, Oliveria T, et al. Optimizing Insulin Injection Techniques to Improve Diabetes Outcomes. Diabetes Ther. 2023;14:1785-1799. https://doi.org/10.1007/ s13300-023-01460-y
24. Frid AH, Hirsch LJ, Menchior AR, Morel DR, Strauss KW. Worldwide Injection Technique Questionnaire Study: Injecting Complications and the Role of the Professional. Mayo Clin Proc. 2016;91(9):12241230 https://doi.org/10.1016/j.mayocp.2016.06.012
25. Foro de Atención Farmacéutica-Farmacia Comunitaria (Foro AF-FC), panel de expertos. Guía práctica para los Servicios Profesionales Farmacéuticos Asistenciales desde la Farmacia Comunitaria. Madrid: Consejo General de Colegios Oficiales de Farmacéuticos; 2024. https://www.farmaceuticos.com/wp-content/uploads/2024/02/ GUIA_SPFA_FORO_2024_V15_AC-digital.pdf

 

ANNEXES: 0, 1, 2, 3 y 4

See annexes