VALIDATION OF AN INSTRUMENT FOR THE NUTRITION MONITORING OF THE ELDERLY TO BE USED BY CAREGIVERS WITHOUT SPECIFIC TRAINING Lilian Fernanda Galesi1, Juliana A D B Campos2, José Eduardo Corrente,3 Maria Rita M. de Oliveira4 1 Doctorate student/Alimentos e Nutrição/ Fcfar-Unesp, Araraquara, Brasil, [email protected] 2 Alimentos e Nutrição/Fcfar-UNESP, Araraquara, Brasil, [email protected] 3 Bioestatística/ IBB -UNESP, Botucatu, Brasil, [email protected] 4 Educação/ IBB -UNESP, Botucatu, Brasil, [email protected] reality. This monitoring should be based on an instrument that can effectively detect individuals at nutritional risk and be technically viable. Abstract - A nutritional screening instrument to be used by laypersons who provide care for elderly individuals was established. The temporary data indicate that the instrument has reproducibility and appropriate internal consistency. If the instrument does not lose its good characteristics after factor analysis, the instrument development was successful. Nevertheless, for a clinical diagnostic or screening instrument to be used correctly and produce valid, reliable and reproducible data, it needs to be validated 13. Keywords: elderly, nutritional assessment, validation study. 2.PURPOSE This study aims to validate an instrument for the nutrition monitoring of the elderly to be used by caregivers without specific training. 1. INTRODUCTION Projections for 2025 indicate that the elderly Brazilian population can exceed 30 million, which would correspond to 14% of the total population 1. In 50 years this number is estimated to be 58 million, which would correspond to 23.6% of the Brazilian population 2. 3.METHODS The entire validation process of the instrument involved 124 caregivers and 100 elderly individuals recruited from a long stay institution and homes. The interviewers were trained and calibrated. The validation consisted of face validation (done in a previous study), content validation, reliability study and criterion validity. Higher life expectancy associated with a higher rate of chronic diseases has increased the rates of elderly people with cognitive and mechanical disabilities, generating a scenario of survival of dependent elderly 3. A high prevalence of malnutrition can be expected among the elderly that live in institutions 4,5 usually because they need care – ranging from 20 to 80% 5,6,7,8,9 . Because of its resemblance with the signs and symptoms that are characteristic of the aging process, malnutrition can be examined without meticulousness and its importance underestimated 10,11. For content validation, 10 judges from the academic area and that work with the elderly classified each question of the instrument as essential, useful but not essential, and unnecessary. The number of judges that deemed a question essential was assessed. When more than half of the judges felt that the question was essential, this question was given some content validity. The content validity ratio was used for this assessment and expressed as follows: Caregivers without specific training often do not notice nutritional problems and the need of personalized nutritional care and little attention is given to the identification of elderly individuals who have benefited from having their malnutrition detected 6. If this morbid condition is not detected, it can contribute to worsen the clinical manifestations of numerous chronic diseases and increase mortality 12. Nutritional assessment presupposes diagnosis of the nutritional status, an activity done by a professional with higher education. However, there is a work of monitoring the nutritional status that should be done continuously and that does not require someone with a higher degree to do it, thus embracing the Brazilian Where CVR is the content validity ratio, n is the number of judges who deemed the question to be essential and N is the total number of judges. The reliability study included internal consistency (using the KR-20 Coefficient – Kuder- 1 Proceedings of the 9th Brazilian Conference on Dynamics Control and their Applications Serra Negra, SP - ISSN 2178-3667 1119 Once the MNA and the instrument were filled out, the calculations began to determine the cut-off point and analyze the discriminatory power of the instrument. The ROC (receiver operating characteristic) curve was used for the analyses. Richardson Coefficient – classified according to Sneed & Herman (1990)14) and reproducibility (using Kappa statistics, classified according to Landis & Koch (1977)15). Of the 124 caregivers who participated in the study, 109 were approached twice for intra-caregiver assessment. All scores obtained from the questionnaires filled out by the caregivers (attributing one point for each answer with positive characteristic for malnutrition) were used to generate the ROC curve. Sensitivity and specificity were determined for each score. A graph of sensitivity as a function of specificity was then constructed. The best cut-off point for the classification of nutritional status was given by the balance between sensitivity and specificity. In all approaches, the caregivers were asked to answer the instrument without providing any prior explanation or help during the filling-out process. This was done to assess how the caregivers understood the questions, which would be confirmed in the reproducibility study. A protocol in the form of a table was prepared for the filling-out process so that the caregivers could place an “x” on what was being asked. The discriminatory power of the instrument was verified by calculating the area under the ROC curve and classified according to Hosmer & Lemeshow (2000)17. The interval between approaches was of one week so that it would be short enough to prevent the clinical condition of usually frail elderly individuals who require care to worsen quickly, thereby affecting their nutritional status, and long enough for the answers given by the caregiver in the second approach not to be influenced by memory. 4. RESULTS In the content validation process, the questions were classified as essential, useful but not essential, and unnecessary, and the content validity ratio was then calculated as shown in Table 1. Criterion validity was done with the MNA (Mini Nutritional Assessment), a recognized and internationally validated instrument for the nutritional assessment of the elderly, considered “gold standard” because of its sensitivity (96%) and specificity (98%) 16. Table 1. Content validity ratio (CVR) of the questions of the instrument Essential Useful, but not essential Unnecessary CVR Does the elderly use a wheelchair? 9 1 0 0.8 Does the elderly urinate or defecate in his/her pants? 8 2 0 0.6 Does the elderly need diapers all the time? 7 3 0 0.4 Has the elderly been isolating him/herself and sad? 9 1 0 0.8 Questions Has the elderly been worried and nervous? 7 3 0 0.4 Do you think the elderly is losing weight? 10 0 0 1.0 Is the elderly toothless and does not use a denture? 10 0 0 1.0 Can the elderly eat without somebody putting the food in his/her mouth? 10 0 0 1.0 Can the elderly walk without somebody’s help? 7 3 0 0.4 Can the elderly get out of bed by him/herself? 6 4 0 0.2 Can the elderly take a shower without help? 7 3 0 0.4 Can the elderly get dressed without help? 6 2 2 0.2 Does the elderly know what day of the week it is? (Monday, Tuesday, Wednesday, Thursday...)? 7 2 1 0.4 Does the elderly know what day of the month it is? (1,2,3,4,5...)? 7 2 1 0.4 Does the elderly know what year it is? 6 2 2 0.2 Does the elderly have some idea of what time it is? 6 3 1 0.2 Does the elderly know the name of the city s/he lives in? 6 2 2 0.2 If you ask, can the elderly repeat the words “vase, car and window”? 6 2 2 0.2 Does the elderly have breakfast, lunch and supper every day? 10 0 0 1.0 Does the elderly eat egg or meat (any kind of meat such as beef, poultry, pork, fish) every day? 10 0 0 1.0 Does the elderly drink at least 6 cups of filtered water per day? 9 1 0 0.8 2 Proceedings of the 9th Brazilian Conference on Dynamics Control and their Applications Serra Negra, SP - ISSN 2178-3667 1120 Table 2. Analysis of internal consistency using the KR-20 coefficient QUESTIONS inter-item r KR-20 Does the elderly use a wheelchair? 0.1785 0.8130 Does the elderly urinate or defecate in his/her pants? 0.1761 0.8104 Does the elderly need diapers all the time? 0.1724 0.8064 Has the elderly been isolating him/herself and sad? 0.2010 0.8342 Has the elderly been worried and nervous? 0.1971 0.8308 Do you think the elderly is losing weight? 0.1937 0.8278 Is the elderly toothless and does not use a denture? 0.1950 0.8289 Can the elderly eat without somebody putting the food in his/her mouth? 0.1802 0.8147 Can the elderly walk without somebody’s help? 0.1752 0.8094 Can the elderly get out of bed by him/herself? 0.1726 0.8067 Can the elderly take a shower without help? 0.1681 0.8016 Can the elderly get dressed without help? 0.1704 0.8042 Does the elderly know what day of the week it is? (Monday, Tuesday, Wednesday, Thursday...)? 0.1721 0.8061 Does the elderly know what day of the month it is? (1,2,3,4,5...)? 0.1702 0.8040 Does the elderly know what year it is? 0.1722 0.8062 Does the elderly have some idea of what time it is? 0.1742 0.8083 Does the elderly know the name of the city s/he lives in? 0.1794 0.8139 If you ask, can the elderly repeat the words “vase, car and window”? 0.1849 0.8194 Does the elderly have breakfast, lunch and supper every day? 0.1957 0.8295 Does the elderly eat egg or meat (any kind of meat such as beef, poultry, pork, fish) every day? 0.1964 0.8301 Does the elderly drink at least 6 cups of filtered water per day? 0.1981 0.8317 INSTRUMENT 0.1821 0.8238 results. Table 2 shows KR-20 and the inter-item correlation of each question and the instrument. Both the instrument and all the questions presented excellent internal consistency according to Sneed’s & Herman’s classification (1990) 14, that is, when the value of KR-20 exceeds 0.8. In inter-item analysis, relatively similar values were verified. These data show that the instrument has good homogeneity. The questions regarding getting out of bed, getting dressed, knowing the year, time and city, and being capable of repeating three words were the ones with the worst CVR. However, these questions presented some content validity and were therefore kept in the instrument. Once content validation was finished, the reliability study and criterion validation were done. The reliability study, which included internal consistency (using the KR-20 Coefficient) and reproducibility (using Kappa statistics) presented good 3 Proceedings of the 9th Brazilian Conference on Dynamics Control and their Applications Serra Negra, SP - ISSN 2178-3667 1121 Table 3. Analysis of the reproducibility of the instrument using Kappa statistics κ CLASSIFICATION Does the elderly use a wheelchair? 1.0000 Perfect Does the elderly urinate or defecate in his/her pants? 0.8705 Excellent Does the elderly need diapers all the time? 0.9632 Excellent Has the elderly been isolating him/herself and sad? 0.8688 Excellent Has the elderly been worried and nervous? 0.7545 Good Do you think the elderly is losing weight? 0.7538 Good Is the elderly toothless and does not use a denture? 0.7704 Good Can the elderly eat without somebody putting the food in his/her mouth? 0.6675 Good Can the elderly walk without somebody’s help? 0.9057 Excellent Can the elderly get out of bed by him/herself? 0.8817 Excellent Can the elderly take a shower without help? 0.8827 Excellent Can the elderly get dressed without help? 0.9259 Excellent Does the elderly know what day of the week it is? (Monday, Tuesday, Wednesday, Thursday...)? 0.9243 Excellent Does the elderly know what day of the month it is? (1,2,3,4,5...)? 0.8703 Excellent Does the elderly know what year it is? 0.9430 Excellent Does the elderly have some idea of what time it is? 0.8032 Excellent Does the elderly know the name of the city s/he lives in? 0.8688 Excellent If you ask, can the elderly repeat the words “vase, car and window”? 0.6598 Good Does the elderly have breakfast, lunch and supper every day? 0.5958 Regular Does the elderly eat egg or meat (any kind of meat such as beef, poultry, pork, fish) every day? 0.7315 Good Does the elderly drink at least 6 cups of filtered water per day? 0.8291 Excellent QUESTIONS The test-retest reproducibility of the instrument is shown in Table 3. The reproducibility was considered appropriate, with most of the questions presenting excellent agreement, ranging from perfect (only the question on wheelchair use) and regular (the question on meals), according to the criteria established by Landis & Koch (1977) 15. The ROC curves were generated for two distinctive situations. The first (Figure 1) illustrates the power of the instrument for discriminating risk of malnutrition and the second (Figure 2) for discriminating malnutrition. 4 Proceedings of the 9th Brazilian Conference on Dynamics Control and their Applications Serra Negra, SP - ISSN 2178-3667 1122 Figure 1. Sensitivity and specificity of the instrument for risk of malnutrition for each cut-off point determined by the ROC curve Figure 2. Sensitivity and specificity of the instrument for malnutrition for each cut-off point determined by the ROC curve 5 Proceedings of the 9th Brazilian Conference on Dynamics Control and their Applications Serra Negra, SP - ISSN 2178-3667 1123 those at risk of malnutrition; and 84.5 and 76.2 in the cut-off point 9 to discriminate those at risk of malnutrition from the malnourished. Since this is a monitoring instrument, greater sensitivity than specificity were preferred. From the possible cut-off points that could be chosen in this study, a sensitivity of 93.6 and a specificity of 65.2 in the cut-off point 4 were chosen to discriminate well-nourished individuals from Thus, by adding the points with the positive characteristics for malnutrition, the final score of the and it does not change within a week’s period. Meanwhile, the question regarding having breakfast, lunch and supper can be influenced by the elderly’s eating behavior on the assessment day or in days close to the assessment, which can easily change within a week’s period. instrument can classify the elderly into the following: individuals with less than 4 points are classified as wellnourished; individuals with 4 to 9 points are classified as being at risk of malnutrition; and those with more than 10 points are malnourished. High reproducibility does not ensure validity. A test can be reproducible (have identical or close results when it is repeated) but not capable of making correct discriminations. If a diagnostic test of extremely low validity is used, many people will be classified incorrectly 19 . The discriminatory power of the instrument determined by the area under the ROC curve was considered good (area=0.852) for risk of malnutrition and excellent (area=0.925) for malnutrition according to the classification proposed by Hosmer & Lemeshow (2000) 17. A good screening test should have high sensitivity to avoid missing the disease cases in the tested population, and high specificity to reduce the number of false-positive results that require further investigation 13. However, since the objective of this study is an instrument capable of nutritional monitoring, the essential requirement is high sensitivity to detect all elderly individuals with nutritional deficits. Although more importance was given to sensitivity and since specificity is also important, the cut-off point was determined by finding the best balance between the two characteristics. It should be emphasized that this study is about the validation of a screening instrument and even a cut-off point with greater specificity, capable of separating malnourished individuals from other individuals, does not have diagnostic power. This is a warning to demand further investigations by qualified professionals. 5. DISCUSSION The validation of this instrument is the second stage of a doctorate project, whose first stage consisted of developing it. Since this is a new instrument, there are no data from other authors discussing its validation process. Content validation allowed specialist dieticians to assess the presence of each question in the instrument. The questions regarding the capability of feeding oneself, weight and teeth loss, number of meals and intake of protein sources were unanimously classified as “essential” by the judges. This classification may have occurred because these questions are more directly related to food intake and nutritional status. It is necessary to make an exception to discuss the final result of this validation. Exploratory factor analysis was not done in this study. It should be done before reliability study and criterion validity. This analysis should be done because this instrument contains many variables. Once it is done, dimensions in the instrument can be defined and even the number of variables or questions can be reduced. The results after an exploratory factor analysis can differ from the current results, so the psychometric characteristics of the instrument should not be taken as definitive. The screening test should also take only a few minutes to be done and be easy to use 13. Concern with the time required from the caregiver and ease of administration was always present during the development of this work. If factor analysis leads to a reduction in the number of questions, it will also contribute to these aspects, improving the quality of the instrument. It is hoped that once the analyses are finished and more reliable results are available, the instrument can contribute to turn the caregiver without specific training into someone who is capable of doing the nutritional monitoring of elderly individuals exposed to nutritional risks, such as those who require daily care. The temporary data indicate an excellent internal consistency, both for the instrument and for all the questions. The internal consistency reflects the dimension with which the items of a questionnaire can measure the same phenomenon, thereby allowing its reliability to be assessed 18. 6. CONCLUSION The temporary data indicate that the instrument proposed here is of good quality, has adequate reproducibility and internal consistency, in addition to the ability to discriminate between well-nourished, at risk of malnourishment and malnourished elderly individuals, using the MNA as the “gold standard.” The test-retest reproducibility was also considered adequate for all the questions of the instrument. Two questions stood out because they were either classified as having perfect reproducibility (the use of a wheelchair) or regular reproducibility (meals per day). This profile for the questions could be caused by variations in the caregiver’s judgment during the assessment. The question regarding the use of a wheelchair is very objective, its use is continuous 6 Proceedings of the 9th Brazilian Conference on Dynamics Control and their Applications Serra Negra, SP - ISSN 2178-3667 1124 REFERENCES 1. BRASIL. Instituto Brasileiro de Geografia e Estatística. 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