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Validity and reliability of the Health Literacy Assessment Scale for adherence to drug treatment among diabetics

Validity and reliability of the Health Literacy Assessment Scale for adherence to drug treatment... ORIGINAL ARTICLE Validity and reliability of the Health Official Publication of the Instituto Israelita de Ensino e Pesquisa Albert Einstein Literacy Assessment Scale for adherence to drug treatment among diabetics ISSN: 1679-4508 | e-ISSN: 2317-6385 Validade e confiabilidade da Escala de Avaliação da Alfabetização em Saúde quanto à adesão medicamentosa entre diabéticos 1 1 Maria Clara Lélis Ramos Cardoso , Aline Soares Figueiredo Santos , 1 1 Adélia Dayane Guimarães Fonseca , Renê Ferreira da Silva-Junior , 1 1 Priscilla Durães de Carvalho , Andrea Maria Eleutério de Barros Lima Martins Universidade Estadual de Montes Claros, Montes Claros, MG, Brazil. DOI: 10.31744/einstein_journal/2019AO4405 ❚ ABSTRACT Objective: To prepare an instrument to evaluate health literacy with regard to adherence to drug treatment among diabetics, identify the validity of its content, and estimate its reliability. Methods: Pilot study, with the following stages of instrument construction: literature review, content validation, reliability estimation (internal consistency/Cronbach’s alpha and reproducibility/ Kappa). Results: The validity of content was completed and presented alpha=0.77 and Kappa values ranged from 0.31 to 1.00. Conclusion: The instrument was approved regarding content validity, presented acceptable internal consistency and reproducibility. However, when applied, measurement errors it can produce must be considered. How to cite this article: Cardoso MC, Santos AS, Fonseca AD, Keywords: Health literacy; Diabetes mellitus; Medication adherence; Validation studies; Reproducibility Silva-Junior RF, Carvalho PD, Martins AM. of results Validity and reliability of the Health Literacy Assessment Scale for adherence to drug treatment among diabetics. einstein (São Paulo). 2019;17(2):eAO4405. http://dx.doi.org/ ❚ RESUMO 10.31744/einstein_journal/2019AO4405 Objetivo: Elaborar um instrumento para avaliar a alfabetização em saúde relacionada à adesão Corresponding author medicamentosa entre diabéticos, identificar a validade de seu conteúdo e estimar sua confiabilidade. Andrea Maria Eleutério de Barros Lima Martins Department of Dentistry, Universidade Métodos: Estudo piloto, cujas etapas de construção do instrumento foram revisão de literatura, Estadual de Montes Claros validação de conteúdo e estimativa da confiabilidade (consistência interna/alfa de Cronbach e Avenida Dr. Ruy Braga, S/N − Vila Mauriceia reprodutibilidade/Kappa). Resultados: A validade de conteúdo foi concluída e apresentou valor Zip code: 39401-089 – Montes Claros, MG, Brazil de alfa=0,77 e o Kappa variou de 0,31 a 1,00. Conclusão: O instrumento foi aprovado quanto à Phone: (55 38) 3229-8284 E-mail: martins.andreamebl@gmail.com validade de conteúdo, apresentou consistência interna e reprodutibilidade aceitáveis. No entanto, ao ser utilizado, devem ser considerados os erros de medida que ele pode produzir. Received on: Jan 31, 2018 Descritores: Alfabetização em saúde; Diabetes mellitus; Adesão à medicação; Estudos de validação; Accepted on: Reprodutibilidade dos testes July 24, 2018 Conflict of interest: none. ❚ INTRODUCTION Copyright 2019 The demographic and nutritional transitions observed in the last decades have This content is licensed increased morbidity and mortality from chronic non-communicable diseases under a Creative Commons (1) Attribution 4.0 International License. (CNCD). Physiological and/or functional alterations during the aging process einstein (São Paulo). 2019;17(2):1-9 1 Cardoso MC, Santos AS, Fonseca AD, Silva-Junior RF, Carvalho PD, Martins AM (13) (14) (15) (13) increase the risk of CNCDs. In 2011, diabetes mellitus sex, age, marital status, socioeconomic status, (2) (15) (DM) stood out among CNCDs in the world, and knowledge and understanding of the disease, (1) (15) in Brazil, and is considered a pandemic and one of perception of health risks related to DM; and the ten major causes of death. Mortality from DM knowledge about the costs and benefits of adequate (15) decreased between 1996 and 2011, and among Brazilian care. The studies also evaluate conditions that are adults ≤69 years old. However, the prevalence of DM is not directly related to the patients, but that may affect still high, especially among elderly Brazilian individuals, adherence to drug treatment, such as difficulty to (3) affecting about 20% of individuals ≥60 years old. In obtain the medication and/or medical care; social (16) 1985, there were an estimated 30 million adults with support; and therapeutic complexity. Although these DM worldwide. Such estimation reached 135 million investigations bring a lot of knowledge, there is still in 1995, 173 million in 2002, and is expected to reach a lot of ground to cover, and they do not definitively (4) 300 million by 2030. explain the large resistance patients have to strictly Diabetes mellitus is a metabolic disease characterized follow drug treatments. by hyperglycemia caused by problems with insulin The hypotheses about factors that affect adherence secretion and/or action, which also affects lipid and to drug treatment seem to be directly related to the (5) protein metabolism. The main risk factors of type patient’s health literacy level, which is an emerging 2 DM (DM2) are modifiable and include smoking, a theme in the literature, especially due to its association sedentary life style, unhealthy eating habits, and excessive to poorer health outcomes. Health literacy is about (6) alcohol consumption. Social determinants include personal, cognitive and social skills that determine social inequalities, access to goods and services, low levels one’s ability to assess, understand and use the health- (7) of education, and discrepant access to information. related information that is necessary to promote (17) Diabetes mellitus requires continuous treatment, and and/or maintain good health conditions. A low patients need to have healthy habits, adhere to the level of health literacy affects appropriate adherence recommended pharmacological and non-pharmacological to treatment because the complex pharmacological therapies, and be mindful of self-care with regards to treatment for DM requires patients to understand (8) (8,9) levels of physical activity, dietary habits, smoking, and apply their knowledge and they are often not able (9) (18) (13,19) alcohol consumption, and prevention of complications to do that. Previous studies suggested a direct (9) from DM. Moreover, adherence to pharmacological relation between health literacy and adherence to therapy must be seen as indispensable to control DM drug treatment, when relating level of education to (10) and ensure a successful treatment. adherence or non-adherence to treatment, and show Non-adherence to drug therapy for DM is among that the lower the level of education, the higher the the major problems faced by specialists. It also increases probability patients will give up treatment. costs for healthcare systems due to the low rate of DM We need an instrument that measures health literacy control, which leads to high morbidity and mortality levels regarding adherence to drug therapy among DM (11) rates from DM. The global treatment cost for the patients. Such measurements can help us find more healthcare system in European countries is, on average, effective strategies to ensure diabetic patients have 1.5-fold higher than the per capita cost of care in relation adequate adherence to therapy and, therefore, a better to the general population. Moreover, these costs increase control of the disease, avoiding complications and by 2 to 3.5-fold for patients who do not properly follow having a better quality of life. the drug therapy, and thus develop avoidable micro- When creating and assessing quantitative evaluation (11) and macrovascular complications. Adherence to instruments, which aim to evaluate health-related medical treatment is the degree of agreement between events, we must consider the results of a Delphi study, medical advice and patient behavior, and is considered an international and multidisciplinary consensus, a process in which the subjects involved are influenced carried out by 43 experts. It aimed to guide such by several factors that determine treatment continuity instruments and analyze the methodological quality of (12) or discontinuity. the studies on these events. The product of this Delphi Considering the importance of this subject, several study was the COnsensus-based Standards for the (10,11,13) studies about adherence to drug therapy have selection of health Measurement Instruments (COSMIN), been developed. Investigations include the association and the study established a set of parameters organized between adherence to drug treatment and a few into four domains: reliability, validity, responsiveness, (20) personal and/or sociodemographic characteristics, such as and interpretability. Reliability is about the einstein (São Paulo). 2019;17(2):1-9 2 Validity and reliability of the Health Literacy Assessment Scale quality of the study, considering internal consistency, Medicamentosa entre Diabéticos (ASAM-D) (Health reproducibility, and control of random and systematic Literacy Related to Adherence to Drug Treatment errors. Internal consistency describes the presence of a among Diabetic Patients). correlation between the different items that compose After the literature review, the instrument was structured with base on the Short Assessment of Health an instrument and between each item and the total score of the scale; that is, the homogeneity of the Literacy for Portuguese-speaking Adults (SAHLPA-18) instrument. Reproducibility is the ability to consistently (Annex 1), which estimates the health literacy level of adults by evaluating their skills of association and reproduce a result in space and time, with the same or (22) comprehension of common medical terminology. different observers, showing stability, homogeneity and equivalence among different observers. Measurement ASAM-D included 18 words related to DM and its treatment. errors refer to random or systematic errors of a study During the second stage, we verified the adequacy participant’s score, which is not attributed to true and consistency of items included in ASAM-D through changes in the construct to be measured; that is, in the the content validation technique, which lets us health-related event that is being investigated among a (20,21) identify, through the analysis of experts, if the variables study’s participants. The validity of a measurement established in the evaluative components can in fact instrument is about its ability to accurately measure (24) make the assessment as proposed. The instrument the studied phenomenon. Responsiveness is about an was presented to and evaluated by five expert judges instrument’s ability to detect changes in the construct (two endocrinologists, two nurses, and one dental to be measured considering time, when events that surgeon) who were invited by convenience due to their could promote said changes are observed. Lastly, professional experience with DM patient care. The interpretability is the degree to which someone could instrument content validity was tested by the Committee infer qualitative results and quantitative values from of Evaluators composed by the abovementioned a construct designed from the assessment of a health- professionals. related event. It is worth noting that interpretability is (20,21) The steps of the validation process were: step not considered a measurement property. one – we requested the participation of professionals There are, in the literature, instruments that assess (22) as evaluators, and they signed the acceptance and levels of health literacy, such as instruments that (23) authorization form. The judges were also told, through evaluate health literacy among individuals with DM. a short instruction text, that, at first, they were only However, no records were found of one instrument to give their confidential, individual opinion in the that assesses the level of health literacy specifically instrument, and that the instrument was created with related to adherence to drug treatment among diabetics. base on the searched literature and epidemiological studies that were previously used in other works. They ❚ OBJECTIVE were also informed about the objectives, methods To prepare an instrument that evaluates health literacy and rationale used to design the instrument, and that they would later participate in a collective meeting related to adherence to drug treatment among diabetic with the instrument designers, in order to reach a patient, identify validity of its content, and estimate its reliability. final version. Once the judges agreed to participate, the second step was to ask them to evaluate every word in the ❚ METHODS document, considering their properties and ability to This is a pilot study. The first stage used to create evaluate health literacy regarding pharmacological the instrument to evaluate health literacy regarding adherence among DM patients. The judges were asked adherence to drug treatment among DM patients to write suggestions and comments to improve the (25) was a literature review, taking into account studies evaluated words. that assessed health literacy and adherence to drug The third and final step of the content validity therapy, independently and through other methods. process happened with the discussion group that We also used available publications about DM, its included all the judges that evaluated the instrument, treatment and management. The instrument was so that a final version, with all necessary adjustments, named Alfabetização em Saúde Relacionada à Adesão could be made. einstein (São Paulo). 2019;17(2):1-9 3 Cardoso MC, Santos AS, Fonseca AD, Silva-Junior RF, Carvalho PD, Martins AM Table 1. Sociodemographic data of patients registered in the Family Health After including all suggestions, the instrument Strategy program was ready to be applied to part of the population Variables n (%) to be studied, aiming to determine the instrument’s Sex reliability; that is, to guarantee that the results obtained Male 10 (16.1) would be the same when the instrument was used at a Female 52 (83.9) different time, a different place, and by other people Stratified age, years (24-26) with the same purpose. 20-39 4 (6.5) In the third stage, we estimated ASAM-D’s reliability, 40-59 37 (59.7) which was determined through its application with the 60-79 21 (33.9) test/retest method on a sample of 62 diabetic patients Level of education, full years of schooling registered in Family Health Strategy units (ESF - 0 5 (8.1) Estratégia Saúde da Família) (Brazilian health program). 1-4 25 (40.3) The interval between the test and the retest was between 5-8 19 (30.6) 7 and 14 days. Before the interview, participants were 9-11 10 (16.1) asked to read and sign the informed consent form. We ≥12 3 (4.8) used the following inclusion criteria: being registered Occupation at ESF centers, aged over 18 years, and, in the case of elderly patients, having reached the minimum required Homemaker 42 (67.7) score in the Mini-Mental State Examination. Retired 5 (8.1) After the application of the test/retest, the database Recyclable waste picker 1 (1.6) was consolidated, and statistical analyses were performed Hairdresser 1 (1.6) using the software Statistical Package for the Social Teacher 2 (3.2) Sciences (SPSS), version 20.0 for Windows and Excel. Retailer 1 (1.6) The evaluation of the internal consistency of items Rural worker 1 (1.6) that compose the instrument was carried out through Brick-layer 3 (4.8) Cronbach’s alpha. The following thresholds were used Small business owner 1 (1.6) as reference: alpha <0.30 (very low); alpha between Seamstress 1 (1.6) 0.30 and 0.60 (low); alpha between 0.60 and 0.75 Lens surfacing technician 1 (1.6) (moderate); alpha between 0.75 and 0.90 (high); alpha Merchant 2 (3.2) (27) >0.90 (very high). The instrument’s reliability was measured through the calculation of the agreement by estimating Kappa coefficients. The following criteria of Kappa value interpretation were considered: no agreement (<0); poor agreement (0 to 0.19); reasonable Table 2 shows the results of the content validation agreement (0.20 to 0.39); moderate agreement (0.40 process, with the variables and corresponding items to 0.59); substantial agreement (0.60 to 0.79); and that made up the initial and the final ASAM-D versions. (28) excellent agreement (0.80 to 1.00). The first version was assessed by the evaluators so This research project was approved by the Research it could be improved, and thus a final version of the Ethics Committee of Universidade Estadual de Montes instrument was reached. A total of 18 cards were made Claros (UNIMONTES), under no. 764.743/2014, CAAE: and presented to the participants. The final version 34687414.0.0000.5146. of ASAM-D shows the correct association in bold, in order to make it easier for the interviewer to see and ❚ RESULTS consolidate the results. At the end of the content validation stage, the Of the 62 study participants, 83.9% were female. Mean psychometric properties of the measurement instrument age was 54.9 years (SD=9.97), minimum age was 29 were ready to be evaluated. For the internal consistency and maximum was 77 years. Level of education varied of ASAM-D, results showed a total Cronbach’s alpha between 0 and 12 years or more of schooling (X=5.63; of 0.77 on the test/retest, which demonstrated elevated SD=3.99), and 40.3% of individuals studied between consistency among all items of the scale that assessed 1 and 4 years in total. Among the participants, 59.7% the health literacy of DM patients in relation to were aged between 40 and 59 years. The most frequent occupation was homemaker, as shown in table 1. adherence to drug therapy. einstein (São Paulo). 2019;17(2):1-9 4 Validity and reliability of the Health Literacy Assessment Scale Table 2. Main alterations between the first and the last version of the health literacy assessment instrument related to adherence to drug treatment among DM patients (ASAM-D) Item First version (words) Last version (suggestions) 1 Insulin – Injectable/oral Insulin – injection/food 2 Hyperglycemia – high glucose/sweating High glucose – Hyperglycemia/sweating 3 Tablet – measurement/oral Tablet – length/oral 4 Diabetes – salt/disease Diabetes – pressure/disease 5 Glycemia – hypertension/test Glycemia – hypertension/test 6 Hypoglycemia – malaise /iron Hypoglycemia – malaise/anemia 7 Per oris – muscle/mouth Per oris – mouth/leg 8 Medication – control/candy Medication – tablet/candy 9 Glucose – salt/sugar Glucose – flour/sugar 10 Dose – quantity/sweet Dose – quantity/validity 11 Injectable – subcutaneous/plaster Injectable – subcutaneous/foot 12 Package insert – cake/orientation Package insert – advertising/orientation 13 Prescription – dessert/medical Prescription – salt/medical prescription 14 Treatment – control/cure Treatment – control/cure 15 Decompensated – expensive/altered Decompensated – expensive/uncontrolled 16 Continuous use – uninterrupted/large Continuous use – uninterrupted/long 17 Prescription – Medical/discretion Prescription – Medical/discretion 18 Side-effect – lateral/unwanted Side-effect – lateral/unwanted Final version of ASAM-D Main word Association word Points 1. Insulin ( ) Injection ( ) Food ( ) I don’t know 2. High glucose ( ) Hyperglycemia ( ) Sweating ( ) I don’t know 3. Tablet ( ) Length ( ) Oral ( ) I don’t know 4. Diabetes ( ) Pressure ( ) Disease ( ) I don’t know 5. Glycemia ( ) Hypertension ( ) Test ( ) I don’t know 6. Hypoglycemia ( ) Malaise ( ) Anemia ( ) I don’t know 7. Per oris ( ) Mouth ( ) Leg ( ) I don’t know 8. Medication ( ) Tablet ( ) Candy ( ) I don’t know 9. Glucose ( ) Flour ( ) Sugar ( ) I don’t know 10. Dose ( ) Quantity ( ) Validity ( ) I don’t know 11. Injectable ( ) Subcutaneous ( ) Foot ( ) I don’t know 12. Package insert ( ) Advertising ( ) Orientation ( ) I don’t know 13. Prescription ( ) Salt ( ) Medical prescription ( ) I don’t know 14. Treatment ( ) Control ( ) Cure ( ) I don’t know 15. Decompensated ( ) Expensive ( ) Uncontrolled ( ) I don’t know 16. Continuous use ( ) Uninterrupted ( ) Long ( ) I don’t know 17. Prescription ( ) Medical ( ) Discretion ( ) I don’t know 18. Side-effect ( ) Lateral ( ) Unwanted ( ) I don’t know Example of the cards shown to participants Insuline Injection Food As shown in table 3, the instrument’s reliability reasonable to excellent agreement for items that showed a variation of Kappa values between 0.31 and 1.00 assess the health literacy of diabetic patients in relation for the items included in ASAM-D, thus demonstrating to pharmacological adherence. The lowest Kappa value einstein (São Paulo). 2019;17(2):1-9 5 Cardoso MC, Santos AS, Fonseca AD, Silva-Junior RF, Carvalho PD, Martins AM Table 3. Reproducibility estimation (simple Kappa coefficient) of the assessment the task of checking the instrument’s validity through instrument health literacy related to adherence to drug treatment among diabetic content verification and by checking if the tool is on patients (ASAM-D) par with the reality to be researched and with the target Main word Association words Kappa (25) audience for whom it was developed. 1. Insulin Injection Food 0.77 The literature states that new research instruments, 2. High glucose Hyperglycemia Sweating 0.31 before being applied to their target population, should 3. Tablet Length Oral 0.81 be evaluated for their psychometric properties. In this 4. Diabetes Pressure Disease 0.70 study, they were tested through a reliability calculation. 5. Glycemia Hypertension Test 0.96 To determine ASAM-D’s reliability, we followed 6. Hypoglycemia Malaise Anemia 0.95 the parameters recommended by the international 7. Per oris Mouth Leg 0.91 literature, organized and established according to the 8. Medication Tablet Candy 1.00 domains of the checklist COSMIN, and the adjustability 9. Glucose Flour Sugar 1.00 of this quantitative evaluation instrument was tested 10. Dose Quantity Validity 0.93 through the estimations of its reliability: internal 11. Injectable Subcutaneous Foot 0.87 (20,21) consistency and reproducibility. 12. Insert Advertising Orientation 1.00 The results related to internal consistency of 13. Prescription Salt Medical prescription 1.00 ASAM-D showed a Cronbach’s alpha of 0.773, 14. Treatment Control Cure 1.00 which demonstrates the stability and consistency 15. Decompensated Expensive Uncontrolled 0.79 (21,25) of the instrument proposed by this study. The 16. Continuous use Uninterrupted Long 0.93 reproducibility, reliability or the test/retest method 17. Prescription Medical Discretion 0.95 estimate the total variance, which is the outcome of 18. Side-effect Lateral Unwanted 1.00 “true” differences between the participant’s answers and/or of results from interviews conducted at two different moments. The instrument ASAM-D presented satisfactory reproducibility because the results found for most items included in the scale show was 0.31 and was found in the item “high glucose – excellent agreement, without disagreement between hyperglycemia/sweating”, which shows reasonable the data collections and interviews, and that the items agreement. The highest Kappa value was 1.00, found used in the scale to evaluate health literacy among in 5 of the 18 items of the scale, showing excellent DM patients, regarding adherence to treatment, are agreement. The rest of the items showed agreement that stable and consistent, as shown by the Kappa values. varied between substantial and excellent. This proves that the reproducibility here presented guarantees that temporal variations in the indicators show real variations in the behavior of the population, ❚ DISCUSSION (25) and not an instability of the indicators. When constructing a new measurement instrument The analyses of the results related to the 18 items about health-related events, it is necessary to define the included in the instrument ASAM-D show that the domains, items and response scales based on behavior, lowest Kappa value found was 0.31 for the item “high objectiveness, simplicity, clarity, precision, validity, glucose – hyperglycemia/sweating”. Although this value relevance, and interpretability criteria. When ASAM-D suggests reasonable agreement, it may show that the was created, all these factors were taken into account to item includes concepts that are not understood by remove any item that was ambiguous, incomprehensible, the participants, considering all other items showed vague, that included double questions, jargons and/or Kappa values between 0.70 and 1.00, demonstrating (20,23,25) that might suggest opinions or values. substantial to excellent agreement. Using this instrument When a researchers create a measurement instrument, to assess health literacy levels can help us provide they are always aware that it is not always possible assistance to DM patients. The meaning of the word to guarantee that every domain/item involved in the “hyperglycemia” was clear among the participants of researched theme will be contemplated, but the attempt this study; however, if a DM patient does not know is to always address the most representative aspects what hyperglycemia means, that is a cause for concern of each studied dimension or subject – that is why it is considering patients adherence to a healthy life style crucial to submit the instrument to a group of expert can be improved if they understand their own health judges, as was done in this case. The evaluators have condition. einstein (São Paulo). 2019;17(2):1-9 6 Validity and reliability of the Health Literacy Assessment Scale Regarding the reproducibility of the instrument ❚ AUTHORS’ INFORMATION ASAM-D, it is noteworthy that, of the 18 items included Cardoso MC: http://orcid.org/0000-0002-9360-609X in the scale, 13 obtained Kappa values above 0.80, Santos AS: http://orcid.org/0000-0002-3244-2378 showing excellent agreement. Fonseca AD: http://orcid.org/0000-0002-1168-7106 This study has a few limitations. We evaluated the Silva-Junior RF: http://orcid.org/0000-0002-3462-3930 instrument’s psychometric properties (reliability and Carvalho PD: http://orcid.org/0000-0002-4486-5159 Martins AM: http://orcid.org/0000-0002-1205-9910 internal consistency), and it is important to highlight that they are not static, that is, they may vary depending on the target population of the study, which, in this case, consisted of patients from only two primary care ❚ REFERENCES units. 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Cazarini RP, Zanetti ML, Ribeiro KP, Pace AE, Foss MC. Adesão a um grupo Physiol Ther. 2011;34(4):261-72. educativo de pessoas portadoras de diabetes mellitus: porcentagem e 25. Coluci MZ, Alexandre NM, Milani D. Construção de instrumentos de medida causas. Medicina (Ribeirão Preto). 2002;35:142-50. na área da saúde. Cien Saude Colet. 2015;20(3):925-36. 19. Kalichman SC, Ramachandran B, Catz S. Adherence to combination 26. Raymundo VP. Construção e validação de instrumentos: um desafio para a antiretroviral therapies in HIV patients of low health literacy. J Gen Intern psicolinguística. Let Hoje. 2009;44(3):86-93. Med. 1999;14(5):267-73. 27. Pasquali L. Princípios de elaboração de escalas psicológicas. Rev Psiq Clin. 1998;25(5):206-13. 20. Mokkink LB, Terwee CB, Knol DL, Stratford PW, Alonso J, Patrick DL, et al. Protocol of the COSMIN study: COnsensus-based Standards for the selection 28. Landis JR, Koch GG. The measurement of observer agreement for categorical of health Measurement INstruments. BMC Med Res Methodol. 2006;6(1):2. data. Biometrics. 1977;33(1):159-74. einstein (São Paulo). 2019;17(2):1-9 8 Validity and reliability of the Health Literacy Assessment Scale Annex 1 Short Assessment of Health Literacy for Portuguese-Speaking Adults (SAHLPA-18)* Instructions for the examiner SAHLPA-18 evaluates a patient’s ability to pronounce and understand common medical terminology. The test can be used by healthcare professionals or researchers to estimate health literacy levels among adults. The test must be administered with printed cards that contain the medical term in bold and the two association words underneath. Instructions for the examiner: Before beginning, have the flash cards and the score sheet to write down the answers. Say: «I will now show you a few cards with three words. First, I would like you to read the word at the top out loud. Then, I will read the two bottom words and I would like you to tell me which of them is more related to the word at the top. If you do not know the answer, say “I don’t know” – don’t try to guess.» Show the first card. Say: «Now, please read the word at the top out loud.» Then, read the two association words and say: «Which of these words is more related to the word at the top. If you do not know the answer, say “I don’t know”.» Repeat the instructions for the following items until the patient is comfortable with the process. The item is considered correct only when the patient has both the pronunciation and the association right. Each correct item is worth 1 point and the total score is obtained by adding all the items, varying between 0 and 18. A score between 0 and 14 suggests inadequate health literacy. Main word Association words 1. Osteoporosis ( ) Bone ( ) Muscle ( ) I don’t know 2. Pap smear ( ) Test ( ) Vaccine ( ) I don’t know 3. Miscarriage ( ) Marriage ( ) Loss ( ) I don’t know 4. Hemorrhoids ( ) Veins ( ) Heart ( ) I don’t know 5. Abnormal ( ) Similar ( ) Different ( ) I don’t know 6. Menstrual ( ) Monthly ( ) Daily ( ) I don’t know 7. Behavior ( ) Thought ( ) Conduct ( ) I don’t know 8. Seizure ( ) Dizzy ( ) Calm ( ) I don’t know 9. Rectal ( ) Watering can ( ) Suppository ( ) I don’t know 10. Appendix ( ) Itchiness ( ) Pain ( ) I don’t know 11. Arthritis ( ) Stomach ( ) Joints ( ) I don’t know 12. Caffeine ( ) Energy ( ) Water ( ) I don’t know 13. Colitis ( ) Intestine ( ) Bladder ( ) I don’t know 14. Gallbladder ( ) Artery ( ) Organ ( ) I don’t know 15. Jaundice ( ) Yellow ( ) White ( ) I don’t know 16. Prostate ( ) Circulation ( ) Gland ( ) I don’t know 17. Incest ( ) Family ( ) Neighbors ( ) I don’t know 18. Testicle ( ) Egg ( ) Sperm ( ) I don’t know (22) * Original instrument translated into Portuguese granted by the author. einstein (São Paulo). 2019;17(2):1-9 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Einstein (São Paulo) Unpaywall

Validity and reliability of the Health Literacy Assessment Scale for adherence to drug treatment among diabetics

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ORIGINAL ARTICLE Validity and reliability of the Health Official Publication of the Instituto Israelita de Ensino e Pesquisa Albert Einstein Literacy Assessment Scale for adherence to drug treatment among diabetics ISSN: 1679-4508 | e-ISSN: 2317-6385 Validade e confiabilidade da Escala de Avaliação da Alfabetização em Saúde quanto à adesão medicamentosa entre diabéticos 1 1 Maria Clara Lélis Ramos Cardoso , Aline Soares Figueiredo Santos , 1 1 Adélia Dayane Guimarães Fonseca , Renê Ferreira da Silva-Junior , 1 1 Priscilla Durães de Carvalho , Andrea Maria Eleutério de Barros Lima Martins Universidade Estadual de Montes Claros, Montes Claros, MG, Brazil. DOI: 10.31744/einstein_journal/2019AO4405 ❚ ABSTRACT Objective: To prepare an instrument to evaluate health literacy with regard to adherence to drug treatment among diabetics, identify the validity of its content, and estimate its reliability. Methods: Pilot study, with the following stages of instrument construction: literature review, content validation, reliability estimation (internal consistency/Cronbach’s alpha and reproducibility/ Kappa). Results: The validity of content was completed and presented alpha=0.77 and Kappa values ranged from 0.31 to 1.00. Conclusion: The instrument was approved regarding content validity, presented acceptable internal consistency and reproducibility. However, when applied, measurement errors it can produce must be considered. How to cite this article: Cardoso MC, Santos AS, Fonseca AD, Keywords: Health literacy; Diabetes mellitus; Medication adherence; Validation studies; Reproducibility Silva-Junior RF, Carvalho PD, Martins AM. of results Validity and reliability of the Health Literacy Assessment Scale for adherence to drug treatment among diabetics. einstein (São Paulo). 2019;17(2):eAO4405. http://dx.doi.org/ ❚ RESUMO 10.31744/einstein_journal/2019AO4405 Objetivo: Elaborar um instrumento para avaliar a alfabetização em saúde relacionada à adesão Corresponding author medicamentosa entre diabéticos, identificar a validade de seu conteúdo e estimar sua confiabilidade. Andrea Maria Eleutério de Barros Lima Martins Department of Dentistry, Universidade Métodos: Estudo piloto, cujas etapas de construção do instrumento foram revisão de literatura, Estadual de Montes Claros validação de conteúdo e estimativa da confiabilidade (consistência interna/alfa de Cronbach e Avenida Dr. Ruy Braga, S/N − Vila Mauriceia reprodutibilidade/Kappa). Resultados: A validade de conteúdo foi concluída e apresentou valor Zip code: 39401-089 – Montes Claros, MG, Brazil de alfa=0,77 e o Kappa variou de 0,31 a 1,00. Conclusão: O instrumento foi aprovado quanto à Phone: (55 38) 3229-8284 E-mail: martins.andreamebl@gmail.com validade de conteúdo, apresentou consistência interna e reprodutibilidade aceitáveis. No entanto, ao ser utilizado, devem ser considerados os erros de medida que ele pode produzir. Received on: Jan 31, 2018 Descritores: Alfabetização em saúde; Diabetes mellitus; Adesão à medicação; Estudos de validação; Accepted on: Reprodutibilidade dos testes July 24, 2018 Conflict of interest: none. ❚ INTRODUCTION Copyright 2019 The demographic and nutritional transitions observed in the last decades have This content is licensed increased morbidity and mortality from chronic non-communicable diseases under a Creative Commons (1) Attribution 4.0 International License. (CNCD). Physiological and/or functional alterations during the aging process einstein (São Paulo). 2019;17(2):1-9 1 Cardoso MC, Santos AS, Fonseca AD, Silva-Junior RF, Carvalho PD, Martins AM (13) (14) (15) (13) increase the risk of CNCDs. In 2011, diabetes mellitus sex, age, marital status, socioeconomic status, (2) (15) (DM) stood out among CNCDs in the world, and knowledge and understanding of the disease, (1) (15) in Brazil, and is considered a pandemic and one of perception of health risks related to DM; and the ten major causes of death. Mortality from DM knowledge about the costs and benefits of adequate (15) decreased between 1996 and 2011, and among Brazilian care. The studies also evaluate conditions that are adults ≤69 years old. However, the prevalence of DM is not directly related to the patients, but that may affect still high, especially among elderly Brazilian individuals, adherence to drug treatment, such as difficulty to (3) affecting about 20% of individuals ≥60 years old. In obtain the medication and/or medical care; social (16) 1985, there were an estimated 30 million adults with support; and therapeutic complexity. Although these DM worldwide. Such estimation reached 135 million investigations bring a lot of knowledge, there is still in 1995, 173 million in 2002, and is expected to reach a lot of ground to cover, and they do not definitively (4) 300 million by 2030. explain the large resistance patients have to strictly Diabetes mellitus is a metabolic disease characterized follow drug treatments. by hyperglycemia caused by problems with insulin The hypotheses about factors that affect adherence secretion and/or action, which also affects lipid and to drug treatment seem to be directly related to the (5) protein metabolism. The main risk factors of type patient’s health literacy level, which is an emerging 2 DM (DM2) are modifiable and include smoking, a theme in the literature, especially due to its association sedentary life style, unhealthy eating habits, and excessive to poorer health outcomes. Health literacy is about (6) alcohol consumption. Social determinants include personal, cognitive and social skills that determine social inequalities, access to goods and services, low levels one’s ability to assess, understand and use the health- (7) of education, and discrepant access to information. related information that is necessary to promote (17) Diabetes mellitus requires continuous treatment, and and/or maintain good health conditions. A low patients need to have healthy habits, adhere to the level of health literacy affects appropriate adherence recommended pharmacological and non-pharmacological to treatment because the complex pharmacological therapies, and be mindful of self-care with regards to treatment for DM requires patients to understand (8) (8,9) levels of physical activity, dietary habits, smoking, and apply their knowledge and they are often not able (9) (18) (13,19) alcohol consumption, and prevention of complications to do that. Previous studies suggested a direct (9) from DM. Moreover, adherence to pharmacological relation between health literacy and adherence to therapy must be seen as indispensable to control DM drug treatment, when relating level of education to (10) and ensure a successful treatment. adherence or non-adherence to treatment, and show Non-adherence to drug therapy for DM is among that the lower the level of education, the higher the the major problems faced by specialists. It also increases probability patients will give up treatment. costs for healthcare systems due to the low rate of DM We need an instrument that measures health literacy control, which leads to high morbidity and mortality levels regarding adherence to drug therapy among DM (11) rates from DM. The global treatment cost for the patients. Such measurements can help us find more healthcare system in European countries is, on average, effective strategies to ensure diabetic patients have 1.5-fold higher than the per capita cost of care in relation adequate adherence to therapy and, therefore, a better to the general population. Moreover, these costs increase control of the disease, avoiding complications and by 2 to 3.5-fold for patients who do not properly follow having a better quality of life. the drug therapy, and thus develop avoidable micro- When creating and assessing quantitative evaluation (11) and macrovascular complications. Adherence to instruments, which aim to evaluate health-related medical treatment is the degree of agreement between events, we must consider the results of a Delphi study, medical advice and patient behavior, and is considered an international and multidisciplinary consensus, a process in which the subjects involved are influenced carried out by 43 experts. It aimed to guide such by several factors that determine treatment continuity instruments and analyze the methodological quality of (12) or discontinuity. the studies on these events. The product of this Delphi Considering the importance of this subject, several study was the COnsensus-based Standards for the (10,11,13) studies about adherence to drug therapy have selection of health Measurement Instruments (COSMIN), been developed. Investigations include the association and the study established a set of parameters organized between adherence to drug treatment and a few into four domains: reliability, validity, responsiveness, (20) personal and/or sociodemographic characteristics, such as and interpretability. Reliability is about the einstein (São Paulo). 2019;17(2):1-9 2 Validity and reliability of the Health Literacy Assessment Scale quality of the study, considering internal consistency, Medicamentosa entre Diabéticos (ASAM-D) (Health reproducibility, and control of random and systematic Literacy Related to Adherence to Drug Treatment errors. Internal consistency describes the presence of a among Diabetic Patients). correlation between the different items that compose After the literature review, the instrument was structured with base on the Short Assessment of Health an instrument and between each item and the total score of the scale; that is, the homogeneity of the Literacy for Portuguese-speaking Adults (SAHLPA-18) instrument. Reproducibility is the ability to consistently (Annex 1), which estimates the health literacy level of adults by evaluating their skills of association and reproduce a result in space and time, with the same or (22) comprehension of common medical terminology. different observers, showing stability, homogeneity and equivalence among different observers. Measurement ASAM-D included 18 words related to DM and its treatment. errors refer to random or systematic errors of a study During the second stage, we verified the adequacy participant’s score, which is not attributed to true and consistency of items included in ASAM-D through changes in the construct to be measured; that is, in the the content validation technique, which lets us health-related event that is being investigated among a (20,21) identify, through the analysis of experts, if the variables study’s participants. The validity of a measurement established in the evaluative components can in fact instrument is about its ability to accurately measure (24) make the assessment as proposed. The instrument the studied phenomenon. Responsiveness is about an was presented to and evaluated by five expert judges instrument’s ability to detect changes in the construct (two endocrinologists, two nurses, and one dental to be measured considering time, when events that surgeon) who were invited by convenience due to their could promote said changes are observed. Lastly, professional experience with DM patient care. The interpretability is the degree to which someone could instrument content validity was tested by the Committee infer qualitative results and quantitative values from of Evaluators composed by the abovementioned a construct designed from the assessment of a health- professionals. related event. It is worth noting that interpretability is (20,21) The steps of the validation process were: step not considered a measurement property. one – we requested the participation of professionals There are, in the literature, instruments that assess (22) as evaluators, and they signed the acceptance and levels of health literacy, such as instruments that (23) authorization form. The judges were also told, through evaluate health literacy among individuals with DM. a short instruction text, that, at first, they were only However, no records were found of one instrument to give their confidential, individual opinion in the that assesses the level of health literacy specifically instrument, and that the instrument was created with related to adherence to drug treatment among diabetics. base on the searched literature and epidemiological studies that were previously used in other works. They ❚ OBJECTIVE were also informed about the objectives, methods To prepare an instrument that evaluates health literacy and rationale used to design the instrument, and that they would later participate in a collective meeting related to adherence to drug treatment among diabetic with the instrument designers, in order to reach a patient, identify validity of its content, and estimate its reliability. final version. Once the judges agreed to participate, the second step was to ask them to evaluate every word in the ❚ METHODS document, considering their properties and ability to This is a pilot study. The first stage used to create evaluate health literacy regarding pharmacological the instrument to evaluate health literacy regarding adherence among DM patients. The judges were asked adherence to drug treatment among DM patients to write suggestions and comments to improve the (25) was a literature review, taking into account studies evaluated words. that assessed health literacy and adherence to drug The third and final step of the content validity therapy, independently and through other methods. process happened with the discussion group that We also used available publications about DM, its included all the judges that evaluated the instrument, treatment and management. The instrument was so that a final version, with all necessary adjustments, named Alfabetização em Saúde Relacionada à Adesão could be made. einstein (São Paulo). 2019;17(2):1-9 3 Cardoso MC, Santos AS, Fonseca AD, Silva-Junior RF, Carvalho PD, Martins AM Table 1. Sociodemographic data of patients registered in the Family Health After including all suggestions, the instrument Strategy program was ready to be applied to part of the population Variables n (%) to be studied, aiming to determine the instrument’s Sex reliability; that is, to guarantee that the results obtained Male 10 (16.1) would be the same when the instrument was used at a Female 52 (83.9) different time, a different place, and by other people Stratified age, years (24-26) with the same purpose. 20-39 4 (6.5) In the third stage, we estimated ASAM-D’s reliability, 40-59 37 (59.7) which was determined through its application with the 60-79 21 (33.9) test/retest method on a sample of 62 diabetic patients Level of education, full years of schooling registered in Family Health Strategy units (ESF - 0 5 (8.1) Estratégia Saúde da Família) (Brazilian health program). 1-4 25 (40.3) The interval between the test and the retest was between 5-8 19 (30.6) 7 and 14 days. Before the interview, participants were 9-11 10 (16.1) asked to read and sign the informed consent form. We ≥12 3 (4.8) used the following inclusion criteria: being registered Occupation at ESF centers, aged over 18 years, and, in the case of elderly patients, having reached the minimum required Homemaker 42 (67.7) score in the Mini-Mental State Examination. Retired 5 (8.1) After the application of the test/retest, the database Recyclable waste picker 1 (1.6) was consolidated, and statistical analyses were performed Hairdresser 1 (1.6) using the software Statistical Package for the Social Teacher 2 (3.2) Sciences (SPSS), version 20.0 for Windows and Excel. Retailer 1 (1.6) The evaluation of the internal consistency of items Rural worker 1 (1.6) that compose the instrument was carried out through Brick-layer 3 (4.8) Cronbach’s alpha. The following thresholds were used Small business owner 1 (1.6) as reference: alpha <0.30 (very low); alpha between Seamstress 1 (1.6) 0.30 and 0.60 (low); alpha between 0.60 and 0.75 Lens surfacing technician 1 (1.6) (moderate); alpha between 0.75 and 0.90 (high); alpha Merchant 2 (3.2) (27) >0.90 (very high). The instrument’s reliability was measured through the calculation of the agreement by estimating Kappa coefficients. The following criteria of Kappa value interpretation were considered: no agreement (<0); poor agreement (0 to 0.19); reasonable Table 2 shows the results of the content validation agreement (0.20 to 0.39); moderate agreement (0.40 process, with the variables and corresponding items to 0.59); substantial agreement (0.60 to 0.79); and that made up the initial and the final ASAM-D versions. (28) excellent agreement (0.80 to 1.00). The first version was assessed by the evaluators so This research project was approved by the Research it could be improved, and thus a final version of the Ethics Committee of Universidade Estadual de Montes instrument was reached. A total of 18 cards were made Claros (UNIMONTES), under no. 764.743/2014, CAAE: and presented to the participants. The final version 34687414.0.0000.5146. of ASAM-D shows the correct association in bold, in order to make it easier for the interviewer to see and ❚ RESULTS consolidate the results. At the end of the content validation stage, the Of the 62 study participants, 83.9% were female. Mean psychometric properties of the measurement instrument age was 54.9 years (SD=9.97), minimum age was 29 were ready to be evaluated. For the internal consistency and maximum was 77 years. Level of education varied of ASAM-D, results showed a total Cronbach’s alpha between 0 and 12 years or more of schooling (X=5.63; of 0.77 on the test/retest, which demonstrated elevated SD=3.99), and 40.3% of individuals studied between consistency among all items of the scale that assessed 1 and 4 years in total. Among the participants, 59.7% the health literacy of DM patients in relation to were aged between 40 and 59 years. The most frequent occupation was homemaker, as shown in table 1. adherence to drug therapy. einstein (São Paulo). 2019;17(2):1-9 4 Validity and reliability of the Health Literacy Assessment Scale Table 2. Main alterations between the first and the last version of the health literacy assessment instrument related to adherence to drug treatment among DM patients (ASAM-D) Item First version (words) Last version (suggestions) 1 Insulin – Injectable/oral Insulin – injection/food 2 Hyperglycemia – high glucose/sweating High glucose – Hyperglycemia/sweating 3 Tablet – measurement/oral Tablet – length/oral 4 Diabetes – salt/disease Diabetes – pressure/disease 5 Glycemia – hypertension/test Glycemia – hypertension/test 6 Hypoglycemia – malaise /iron Hypoglycemia – malaise/anemia 7 Per oris – muscle/mouth Per oris – mouth/leg 8 Medication – control/candy Medication – tablet/candy 9 Glucose – salt/sugar Glucose – flour/sugar 10 Dose – quantity/sweet Dose – quantity/validity 11 Injectable – subcutaneous/plaster Injectable – subcutaneous/foot 12 Package insert – cake/orientation Package insert – advertising/orientation 13 Prescription – dessert/medical Prescription – salt/medical prescription 14 Treatment – control/cure Treatment – control/cure 15 Decompensated – expensive/altered Decompensated – expensive/uncontrolled 16 Continuous use – uninterrupted/large Continuous use – uninterrupted/long 17 Prescription – Medical/discretion Prescription – Medical/discretion 18 Side-effect – lateral/unwanted Side-effect – lateral/unwanted Final version of ASAM-D Main word Association word Points 1. Insulin ( ) Injection ( ) Food ( ) I don’t know 2. High glucose ( ) Hyperglycemia ( ) Sweating ( ) I don’t know 3. Tablet ( ) Length ( ) Oral ( ) I don’t know 4. Diabetes ( ) Pressure ( ) Disease ( ) I don’t know 5. Glycemia ( ) Hypertension ( ) Test ( ) I don’t know 6. Hypoglycemia ( ) Malaise ( ) Anemia ( ) I don’t know 7. Per oris ( ) Mouth ( ) Leg ( ) I don’t know 8. Medication ( ) Tablet ( ) Candy ( ) I don’t know 9. Glucose ( ) Flour ( ) Sugar ( ) I don’t know 10. Dose ( ) Quantity ( ) Validity ( ) I don’t know 11. Injectable ( ) Subcutaneous ( ) Foot ( ) I don’t know 12. Package insert ( ) Advertising ( ) Orientation ( ) I don’t know 13. Prescription ( ) Salt ( ) Medical prescription ( ) I don’t know 14. Treatment ( ) Control ( ) Cure ( ) I don’t know 15. Decompensated ( ) Expensive ( ) Uncontrolled ( ) I don’t know 16. Continuous use ( ) Uninterrupted ( ) Long ( ) I don’t know 17. Prescription ( ) Medical ( ) Discretion ( ) I don’t know 18. Side-effect ( ) Lateral ( ) Unwanted ( ) I don’t know Example of the cards shown to participants Insuline Injection Food As shown in table 3, the instrument’s reliability reasonable to excellent agreement for items that showed a variation of Kappa values between 0.31 and 1.00 assess the health literacy of diabetic patients in relation for the items included in ASAM-D, thus demonstrating to pharmacological adherence. The lowest Kappa value einstein (São Paulo). 2019;17(2):1-9 5 Cardoso MC, Santos AS, Fonseca AD, Silva-Junior RF, Carvalho PD, Martins AM Table 3. Reproducibility estimation (simple Kappa coefficient) of the assessment the task of checking the instrument’s validity through instrument health literacy related to adherence to drug treatment among diabetic content verification and by checking if the tool is on patients (ASAM-D) par with the reality to be researched and with the target Main word Association words Kappa (25) audience for whom it was developed. 1. Insulin Injection Food 0.77 The literature states that new research instruments, 2. High glucose Hyperglycemia Sweating 0.31 before being applied to their target population, should 3. Tablet Length Oral 0.81 be evaluated for their psychometric properties. In this 4. Diabetes Pressure Disease 0.70 study, they were tested through a reliability calculation. 5. Glycemia Hypertension Test 0.96 To determine ASAM-D’s reliability, we followed 6. Hypoglycemia Malaise Anemia 0.95 the parameters recommended by the international 7. Per oris Mouth Leg 0.91 literature, organized and established according to the 8. Medication Tablet Candy 1.00 domains of the checklist COSMIN, and the adjustability 9. Glucose Flour Sugar 1.00 of this quantitative evaluation instrument was tested 10. Dose Quantity Validity 0.93 through the estimations of its reliability: internal 11. Injectable Subcutaneous Foot 0.87 (20,21) consistency and reproducibility. 12. Insert Advertising Orientation 1.00 The results related to internal consistency of 13. Prescription Salt Medical prescription 1.00 ASAM-D showed a Cronbach’s alpha of 0.773, 14. Treatment Control Cure 1.00 which demonstrates the stability and consistency 15. Decompensated Expensive Uncontrolled 0.79 (21,25) of the instrument proposed by this study. The 16. Continuous use Uninterrupted Long 0.93 reproducibility, reliability or the test/retest method 17. Prescription Medical Discretion 0.95 estimate the total variance, which is the outcome of 18. Side-effect Lateral Unwanted 1.00 “true” differences between the participant’s answers and/or of results from interviews conducted at two different moments. The instrument ASAM-D presented satisfactory reproducibility because the results found for most items included in the scale show was 0.31 and was found in the item “high glucose – excellent agreement, without disagreement between hyperglycemia/sweating”, which shows reasonable the data collections and interviews, and that the items agreement. The highest Kappa value was 1.00, found used in the scale to evaluate health literacy among in 5 of the 18 items of the scale, showing excellent DM patients, regarding adherence to treatment, are agreement. The rest of the items showed agreement that stable and consistent, as shown by the Kappa values. varied between substantial and excellent. This proves that the reproducibility here presented guarantees that temporal variations in the indicators show real variations in the behavior of the population, ❚ DISCUSSION (25) and not an instability of the indicators. When constructing a new measurement instrument The analyses of the results related to the 18 items about health-related events, it is necessary to define the included in the instrument ASAM-D show that the domains, items and response scales based on behavior, lowest Kappa value found was 0.31 for the item “high objectiveness, simplicity, clarity, precision, validity, glucose – hyperglycemia/sweating”. Although this value relevance, and interpretability criteria. When ASAM-D suggests reasonable agreement, it may show that the was created, all these factors were taken into account to item includes concepts that are not understood by remove any item that was ambiguous, incomprehensible, the participants, considering all other items showed vague, that included double questions, jargons and/or Kappa values between 0.70 and 1.00, demonstrating (20,23,25) that might suggest opinions or values. substantial to excellent agreement. Using this instrument When a researchers create a measurement instrument, to assess health literacy levels can help us provide they are always aware that it is not always possible assistance to DM patients. The meaning of the word to guarantee that every domain/item involved in the “hyperglycemia” was clear among the participants of researched theme will be contemplated, but the attempt this study; however, if a DM patient does not know is to always address the most representative aspects what hyperglycemia means, that is a cause for concern of each studied dimension or subject – that is why it is considering patients adherence to a healthy life style crucial to submit the instrument to a group of expert can be improved if they understand their own health judges, as was done in this case. The evaluators have condition. einstein (São Paulo). 2019;17(2):1-9 6 Validity and reliability of the Health Literacy Assessment Scale Regarding the reproducibility of the instrument ❚ AUTHORS’ INFORMATION ASAM-D, it is noteworthy that, of the 18 items included Cardoso MC: http://orcid.org/0000-0002-9360-609X in the scale, 13 obtained Kappa values above 0.80, Santos AS: http://orcid.org/0000-0002-3244-2378 showing excellent agreement. Fonseca AD: http://orcid.org/0000-0002-1168-7106 This study has a few limitations. We evaluated the Silva-Junior RF: http://orcid.org/0000-0002-3462-3930 instrument’s psychometric properties (reliability and Carvalho PD: http://orcid.org/0000-0002-4486-5159 Martins AM: http://orcid.org/0000-0002-1205-9910 internal consistency), and it is important to highlight that they are not static, that is, they may vary depending on the target population of the study, which, in this case, consisted of patients from only two primary care ❚ REFERENCES units. 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Diabetes mellitus: fatores associados à prevalência em idosos, medidas e did not conduct a construct analysis (factorial analysis) práticas de controle e uso dos serviços de saúde em São Paulo, Brasil. Cad Saúde Pública. 2011;27(6):1233-43. because the number of interviewees was not enough 4. Sociedade Brasileira de Diabetes (SBD). Tratamento e acompanhamento do for that. Other investigations can identify possible Diabetes Mellitus. Diretrizes da Sociedade Brasileira de Diabetes [Internet]. dimensions of the construct. São Paulo: SBD; 2007 [citado 2018 Fev 22]. Disponível em: http://www.cff. On the other hand, the use of this instrument in org.br/userfiles/file/noticias/Diretrizes_SBD_2007%5B1%5D.pdf longitudinal studies can identify its responsiveness and 5. American Diabetes Association (ADA). Diagnosis and classification of diabetes contribute to optimize and establish priorities regarding mellitus. Diabetes Care. 2014;37(Suppl 1):S81-90. a better adherence to drug treatment among DM 6. Meisinger C, Döring A, Thorand B, Löwel H. Association of cigarette smoking and tar and nicotine intake with development of type 2 diabetes mellitus in patients, and work as a source to build health indicators men and women from the general population: the MONICA/KORA Augsburg and health maintenance tools. Cohort Study. Diabetologia. 2006;49(8):1770-6. 7. Brasil. Ministério da Saúde. Secretaria de Vigilância em Saúde. Departamento de Análise de Situação de Saúde. Plano de ações estratégicas para o ❚ CONCLUSION enfrentamento das Doenças Crônicas Não Transmissíveis (DCNT) no Brasil The items in the instrument are clear and adequate to 2011-2022 [Internet]. Brasília (DF): Ministério da Saúde; 2011 [citado 2018 Fev 22]. Disponível em: http://bvsms.saude.gov.br/bvs/publicacoes/plano_acoes_ reach the proposed objectives, which means the choice enfrent_dcnt_2011.pdf of theory was appropriate and the results of the content 8. Sales AT, Fregonezi GA, Silva AG, Ribeiro CT, Dourado-Junior ME, Sousa AG, validation process suggest that all necessary changes et al. Identification of peripheral arterial disease in diabetic patients and its to the adopted model were made. The evaluation association with quality of life, physical activity and body composition. J Vasc instrument for health literacy related to adherence to Bras. 2015;14(1):46-54. drug therapy among diabetics patients was considered 9. Hu FB. Globalization of diabetes: the role of diet, lifestyle, and genes. Diabetes Care. 2011;34(6):1249-57. reliable because it showed stability; that is, acceptable 10. Maldaner CR, Beuter M, Brondani CM, Budó ML, Pauletto MR. Fatores que internal consistency and reproducibility. However, influenciam a adesão ao tratamento na doença crônica: o doente em terapia when using the instrument, one must consider the hemodialítica. Rev Gaucha Enferm. 2008;29(4):647-53. measurement errors it might produce. 11. World Health Organization (WHO). Adherence to Long Therm Therapies - Evidence for Actions [Internet]. Genebra: WHO; 2003 [cited 2018 Feb 22]. Available from: http://www.who.int/chp/knowledge/publications/adherence_ ❚ ACKNOWLEDGEMENTS full_report.pdf We would like to thank the Universidade Estadual de 12. Dosse C, Cesarino CB, Martin JF, Castedo MC. Fatores associados à não adesão dos pacientes ao tratamento de hipertensão arterial. Rev Latino-Am Montes Claros (UNIMONTES), the Municipal Health Enferm. 2009;17(2):1-7. Department of Montes Claros, the Fundação de 13. Gimenes HT, Zanetti ML, Haas VJ. Fatores relacionados à adesão do paciente Amparo a Pesquisa de Minas Gerais (FAPEMIG) and diabético à terapêutica medicamentosa. 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Cazarini RP, Zanetti ML, Ribeiro KP, Pace AE, Foss MC. Adesão a um grupo Physiol Ther. 2011;34(4):261-72. educativo de pessoas portadoras de diabetes mellitus: porcentagem e 25. Coluci MZ, Alexandre NM, Milani D. Construção de instrumentos de medida causas. Medicina (Ribeirão Preto). 2002;35:142-50. na área da saúde. Cien Saude Colet. 2015;20(3):925-36. 19. Kalichman SC, Ramachandran B, Catz S. Adherence to combination 26. Raymundo VP. Construção e validação de instrumentos: um desafio para a antiretroviral therapies in HIV patients of low health literacy. J Gen Intern psicolinguística. Let Hoje. 2009;44(3):86-93. Med. 1999;14(5):267-73. 27. Pasquali L. Princípios de elaboração de escalas psicológicas. Rev Psiq Clin. 1998;25(5):206-13. 20. Mokkink LB, Terwee CB, Knol DL, Stratford PW, Alonso J, Patrick DL, et al. Protocol of the COSMIN study: COnsensus-based Standards for the selection 28. Landis JR, Koch GG. The measurement of observer agreement for categorical of health Measurement INstruments. BMC Med Res Methodol. 2006;6(1):2. data. Biometrics. 1977;33(1):159-74. einstein (São Paulo). 2019;17(2):1-9 8 Validity and reliability of the Health Literacy Assessment Scale Annex 1 Short Assessment of Health Literacy for Portuguese-Speaking Adults (SAHLPA-18)* Instructions for the examiner SAHLPA-18 evaluates a patient’s ability to pronounce and understand common medical terminology. The test can be used by healthcare professionals or researchers to estimate health literacy levels among adults. The test must be administered with printed cards that contain the medical term in bold and the two association words underneath. Instructions for the examiner: Before beginning, have the flash cards and the score sheet to write down the answers. Say: «I will now show you a few cards with three words. First, I would like you to read the word at the top out loud. Then, I will read the two bottom words and I would like you to tell me which of them is more related to the word at the top. If you do not know the answer, say “I don’t know” – don’t try to guess.» Show the first card. Say: «Now, please read the word at the top out loud.» Then, read the two association words and say: «Which of these words is more related to the word at the top. If you do not know the answer, say “I don’t know”.» Repeat the instructions for the following items until the patient is comfortable with the process. The item is considered correct only when the patient has both the pronunciation and the association right. Each correct item is worth 1 point and the total score is obtained by adding all the items, varying between 0 and 18. A score between 0 and 14 suggests inadequate health literacy. Main word Association words 1. Osteoporosis ( ) Bone ( ) Muscle ( ) I don’t know 2. Pap smear ( ) Test ( ) Vaccine ( ) I don’t know 3. Miscarriage ( ) Marriage ( ) Loss ( ) I don’t know 4. Hemorrhoids ( ) Veins ( ) Heart ( ) I don’t know 5. Abnormal ( ) Similar ( ) Different ( ) I don’t know 6. Menstrual ( ) Monthly ( ) Daily ( ) I don’t know 7. Behavior ( ) Thought ( ) Conduct ( ) I don’t know 8. Seizure ( ) Dizzy ( ) Calm ( ) I don’t know 9. Rectal ( ) Watering can ( ) Suppository ( ) I don’t know 10. Appendix ( ) Itchiness ( ) Pain ( ) I don’t know 11. Arthritis ( ) Stomach ( ) Joints ( ) I don’t know 12. Caffeine ( ) Energy ( ) Water ( ) I don’t know 13. Colitis ( ) Intestine ( ) Bladder ( ) I don’t know 14. Gallbladder ( ) Artery ( ) Organ ( ) I don’t know 15. Jaundice ( ) Yellow ( ) White ( ) I don’t know 16. Prostate ( ) Circulation ( ) Gland ( ) I don’t know 17. Incest ( ) Family ( ) Neighbors ( ) I don’t know 18. Testicle ( ) Egg ( ) Sperm ( ) I don’t know (22) * Original instrument translated into Portuguese granted by the author. einstein (São Paulo). 2019;17(2):1-9

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