Nonadherence to Immunosuppressant Therapy of Kidney Transplant Candidate Patients: External Validation of the KATITA-25 Scale.

BACKGROUND: The self-administered Kidney AlloTransplant Immunosuppressive Therapy Adherence (KATITA-25) questionnaire is a multidimensional scale for use in the pretransplant setting that evaluates the predisposition to nonadherence of patients who are candidates to kidney transplant. The scale has shown adequate internal consistency and test-retest reliability. This study presents the results of an external validation study of the KATITA-25 scale. METHODS: Patients >18 y old scheduled for kidney transplant were included in this multicenter study. The KATITA-25 scale was administered before surgery and then at 3-mo posttransplantation for evaluation of scale sensitivity to change. At this time, 2 validated medication adherence scales were applied for assessment of concurrent validity. For evaluation of predictive validity, nonadherence to immunosuppressive medication was assessed at 6 and 12 mo after transplantation by 3 independent methods: patient self-report of nonadherence using the Morisky-Green-Levine Medication Assessment Questionnaire scale, serum trough levels of immunosuppressants, and pharmacy refills. RESULTS: Three twenty-two patients were available for evaluation of concurrent validity and 311 patients of predictive validity. After kidney transplant, the median KATITA-25 score decreased from 20 to 8 (P < 0.001), demonstrating scale sensitivity to change, and the KATITA-25 score showed correlation with the Basel Assessment of Adherence to Immunosuppressive Medication Scale score (Spearman's ρ 0.18, P = 0.002) and the Cuestionario para la Evaluación de la Adhesión al Tratamiento Antiretroviral scores (ρ -0.17, P = 0.002), confirming concurrent validity. The nonadherence rate was 57.6%. The scale predictive validity was demonstrated by the area under the receiver operating characteristics curve (0.68), sensitivity (59.8%), specificity (68.2%), and positive predictive value (71.8%). CONCLUSIONS: This external validation study of KATITA-25 scale provided evidence of sensitivity to change, and structural, criterion, and predictive validity.

Development and Internal Validation of a Questionnaire Assessing Predisposition to Nonadherence to Immunosuppressive Medication in Kidney Pretransplant Patients.

BACKGROUND: After kidney transplant, nonadherence to immunosuppressive therapy is the main cause of impaired kidney function and graft loss. The objective of this study was the development and internal validation of a clinical questionnaire for assessing the predisposition to adherence to immunosuppressive therapy in kidney pretransplant patients. METHODS: Multicenter prospective study conducted in 7 kidney hemodialysis and 6 kidney transplant centers of 3 Brazilian state capitals. Kidney transplant candidate patients of both sexes and >18-y-old were included. Retransplanted patients were excluded. A 72-item pilot version of the questionnaire, created through literature review complemented with a focus group of 8 kidney pretransplant patients, was administered to 541 kidney transplant candidate patients. Factor analysis with varimax rotation was used for questionnaire development. Internal validity evaluation used Cronbach's alpha and test-retest reliability. Construct validity was assessed by differentiation by known groups. RESULTS: The final questionnaire, named Kidney AlloTransplant Immunosuppressive Therapy Adherence (KATITA) Questionnaire, consisting of 25 items in 3 dimensions, presented good internal consistency reliability (Cronbach's alpha 0.81). The 3 dimensions and respective Cronbach's alpha were "Carelessness" (14 items, 0.81), "Skepticism" (6 items, 0.57), and "Concern" (5 items, 0.62). The interdimension correlation matrix showed low correlation coefficients (<0.35). Test-retest reliability, evaluated with 154 patients, showed an intraclass correlation coefficient of 0.62 (moderate agreement). The scale showed construct validity. CONCLUSIONS: The KATITA-25 questionnaire is the first psychometric instrument for evaluation of predisposition to nonadherence to immunosuppressive medication in candidate patients for kidney transplant in the pretransplant setting.

Análise das prescrições de pacientes com covid-19 em uso de hidroxicloroquina em uma unidade de terapia intensiva / Analysis of prescriptions of patients with COVID-19 using hydroxychloroquine in an Intensive Care Unit / Análisis de las prescripciones de pacientes con COVID-19 en uso hidroxicloroquina en una unidad de terapia intensiva

Mesmo em emergências sanitárias, quando terapias experimentais são empregadas, é importante prezar pela segurança e eficácia no uso de medicamentos, e a análise de prescrições médicas é uma das maneiras de monitorar aspectos de segurança. Objetivo: Quantificar e classificar as interações medicamentosas potenciais com hidroxicloroquina de acordo com o riscoem prescrições de pacientes com COVID-19 em pacientes com COVID-19 em uso de hidroxicloroquina admitidos em uma unidade de terapia intensiva de um Hospital de Ensino.Metodologia:Este estudo transversal baseou-se na análise de 162 prescrições de 38 pacientes admitidos em uma unidade de terapia intensiva de um Hospital de ensino entre abril e junho de 2020.O Micromedex® e o UpToDate® foram as bases de dados de apoio à conduta clínica utilizadas para estabelecer as interações medicamentosas potenciais. Resultados:A média de dias de internamento foi de 16,1 ± 14,0 e a média de dias em uso de hidroxicloroquina foi de 4,26 ± 1,74. 87,14% das prescrições apresentaram interações medicamentosas potenciais e a mais comum foi entre hidroxicloroquina e azitromicina. 76,4% das prescrições analisadas apresentaram interações medicamentosas potenciais com hidroxicloroquina. 73,5% das prescrições tiverampelo menos uma interação medicamentosa potencial entre medicamentos que prolongam o intervalo QT. Conclusões: Tendo em vista os riscos da exposição de pacientes críticos às interações medicamentosas, este estudo demonstra a necessidade de fortalecer nas instituições hospitalares a cultura de monitoramento de parâmetros de segurança e eficáciano uso de medicamentos, inclusive em terapias experimentais com a utilização de medicamentos off-labelpara minimizar riscos e ampliar possíveis benefícios (AU).

Even in health emergencies, when experimental therapies are employed, it is important to ensure the safety and efficacy of medicines, and the analysis of medical prescriptions is one of the ways to monitor safety aspects.Objective: Quantify and rank potential drug interactions with hydroxychloroquine according to risk in prescriptions of COVID-19 patients taking hydroxychloroquine admitted to an intensive care unit of a TeachingHospital.Methodology: This cross-sectional study was based on the analysis of 162 prescriptions of 38 patients admitted to an intensive care unit of a teaching hospital between April and June 2020. Micromedex® and UpToDate® were the clinical practice support databases used to establish potential drug interactions. Results: The mean number of days of hospitalization was 16.1 ± 14.0 and the mean number of days of days on hydroxychloroquine was 4.26 ± 1.74. 87.14% of the prescriptions presented potential drug interactions and the most common was between hydroxychloroquine and azithromycin. 76.4% of the analyzed prescriptions had potential drug interactions with hydroxychloroquine. 73.5% of prescriptions had at least one potential drug interaction between drugs that prolong the QT interval. Conclusions: In view of the risks of exposure of critically ill patients to drug interactions, this study interactions, this study demonstrates the need to strengthen in hospital institutions the culture of institutions the culture of monitoring safety and efficacy parameters in the use of medicines, including experimental therapies with the use of off-label drugs to minimize risks and increase possible benefits (AU).

Aunque en médio aemergencias sanitarias, cuando son empleadas terapias experimentales, es importante estimar la seguridad y eficacia en el uso de los medicamentos, y el análisis de prescripciones es una de las formas de acompanhar los aspectos de seguridad. Objetivo:Cuantificar y clasificar las interaciones farmacologicas potenciales con hidroxicloroquina de acuerdo com el riesgo em prescripciones de pacientes com Covid-19 em uso de hidroxicloroquina andmitidos em unidad de terapia intensiva de um Hospital Docente. Metodología: Este estudio transversal se asienta en el análisis de 162 prescripciones de 38 pacientes admitidos em uma unidad de terapia intensiva de um Hospital Docente entre abril y junio de 2020. El Micromedex®ï¸y el UpToDate®ï¸fueron las bases de datos de apoyo a la actuación clínica utilizadas para establecer las interacciones farmacológicas potenciales. Resultados:El promedio de días de internamiento fue de 16,1 ± 14,0 y el promedio de días en uso hidroxicloroquina fuede 4,26 ± 1,74. 87,14% de las prescripciones presentaron interacciones farmacológicas potenciales y la más común fue entre hidroxicloroquina y azitromicina. 76,4% de las prescripciones analizadas presentaron interaciones farmacológicas com hidroxicloroquina. 73,5% de las prescripciones tuvierion por lo menos uma interacción farmacológica potencial entre medicamentos que prolongam el intervalo QT. Conclusiones:Tenendo a la vista los riesgos de la exposición de pacientes críticos a las interaciones farmacológicas, este estudio demuestra la necesidad de reforzar em las instituiciones hospitalarias la cultura de monitoreo de parâmetros de seguridade y eficacio em el uso de medicamentos, incluso en terapias experimentales con utilización de medicamentos off-label, para minorar riesgos y ampliar los posibles beneficios (AU).

Redução da taxa de filtração glomerular em pacientes críticos em uso de vancomicina: um estudo transversal / Decrease of the glomerular filtration rate in critically ill patients using vancomycin: a cross-sectional study

Objetivo: o presente trabalho teve como objetivo avaliar os fatores clínicos e medicamentosos relacionados com a redução da Taxa de Filtração Glomerular (TFG) em pacientes críticos em uso de vancomicina. Métodos: trata-se de um estudo transversal em que pacientes em uso de vancomicina, maiores de 18 anos, hospitalizados em terapia intensiva, foram selecionados no período de agosto a dezembro de 2019. Foram excluídos os pacientes que tiveram permanência inferior a 48h na unidade, aqueles com doença renal crônica e/ou que tiveram antimicrobiano suspenso nas primeiras 48h. Os dados clínicos e laboratoriais foram coletados do prontuário nas mesmas datas das coletas de amostras sanguíneas. As amostras de sangue foram coletadas no vale a partir do terceiro dia de tratamento. Os níveis de vancomicina foram medidos usando VANC VITROS ®. Os dados foram analisados através do software R. Resultados: 54 pacientes foram incluídos, sendo 68,5% do sexo masculino, 98,1% em ventilação mecânica, com foco respiratório (51,2%) e isolado Acinetobacter baumanni (38,0%). As concentrações de vancomicina variaram entre 5,0 e 50,0µg/mL, média 21,6 (DP: 10,6) µg/mL; 50% dos pacientes apresentaram concentração acima de 20µg/mL e 66,7% piora da TFG após o tratamento. A concentração de vancomicina foi a única variável diretamente relacionada com o desenvolvimento da alteração na função renal (p=0.0037). Não foi possível estabelecer a influência da comedicação na redução da taxa de filtração glomerular (TFG). Conclusão: as doses usuais de vancomicina ajustadas por meio da função renal não atingiram os níveis séricos terapêuticos recomendados de vancomicina, sendo relacionados à nefrotoxicidade.

Objective: we aimed to evaluate clinical and drug factors related to the Glomerular Filtration Rate (GFR) reduction in critically ill patients using vancomycin. Methods: This is a cross-sectional study where critically ill patients using vancomycin, aged over 18 years, were selected from August to December 2019. Patients were excluded when hospitalized for less than 48 hours in the unit, those with chronic kidney disease, and/or who had their antimicrobial suspended in the first 48 hours. Clinical and laboratory data were collected from the medical record on the same days as the blood sample collection. All blood samples were collected at the trough during the third day of vancomycin treatment. Vancomycin levels were measured using VANC VITROS ®. Data analysis was analyzed by R software. Results: 54 patients were included, 68.5% male, 98.1% mechanical ventilation, respiratory focus (51.2%), and isolation of Acinetobacter baumanni (38.0%). Vancomycin concentrations ranged between 5.0 and 50.0µg/mL, mean of 21.6 (SD: 10.6) µg/mL; 50% of patients with concentrations above 20µg/mL and 66.7% worsened GFR after vancomycin treatment. Vancomycin concentration was the only variable directly related to the development of renal malfunction (p=0.0037). It was not possible to establish the influence of co-medication in the reduction of the glomerular filtration rate (GFR). Conclusion: the usual doses of vancomycin adjusted by renal function did not reach the recommended therapeutic serum levels of vancomycin, being related to nephrotoxicity.

Critical analysis on the use of cholecalciferol as a COVID-19 intervention: a narrative review.

BACKGROUND: The World Health Organization has declared that a pandemic situation exists in relation to the disease caused by the new coronavirus, COVID-19. So far, the absence of a vaccine against the new coronavirus has led people worldwide to seek various therapeutic alternatives, including use of cholecalciferol. DESIGN AND SETTING: Narrative review developed by a research group at a public university in Recife (PE), Brazil. METHODS: We searched the literature on the use of cholecalciferol for prevention or treatment of COVID-19, using the MEDLINE and LILACS databases, with the keywords "vitamin D", "cholecalciferol", "SARS-CoV-2", "COVID-19" and "coronavirus", from January 1, 2020, to June 10, 2020. Narrative reviews, cohort studies and ecological studies were selected. RESULTS: We retrieved 32 references, of which 8 were considered eligible for intensive review and critical analysis. These comprised five narrative reviews, two observational studies and one protocol proposal. Most of the studies selected reported positive effects from use of vitamin D for prevention or treatment of COVID-19. However, there was little quantitative data to assess the real impact of using this vitamin as an intervention against this disease. CONCLUSIONS: Current studies on vitamin D used for purposes other than bone health promotion cannot be taken as support to justify its use in a disease as recent as COVID-19. Studies of greater robustness, with higher levels of clinical evidence, need to be conducted. Rational use of this vitamin needs to be ensured, thereby minimizing the impacts on the patient and the public healthcare system.

Critical analysis on the use of cholecalciferol as a COVID-19 intervention: a narrative review

ABSTRACT BACKGROUND: The World Health Organization has declared that a pandemic situation exists in relation to the disease caused by the new coronavirus, COVID-19. So far, the absence of a vaccine against the new coronavirus has led people worldwide to seek various therapeutic alternatives, including use of cholecalciferol. DESIGN AND SETTING: Narrative review developed by a research group at a public university in Recife (PE), Brazil. METHODS: We searched the literature on the use of cholecalciferol for prevention or treatment of COVID-19, using the MEDLINE and LILACS databases, with the keywords "vitamin D", "cholecalciferol", "SARS-CoV-2", "COVID-19" and "coronavirus", from January 1, 2020, to June 10, 2020. Narrative reviews, cohort studies and ecological studies were selected. RESULTS: We retrieved 32 references, of which 8 were considered eligible for intensive review and critical analysis. These comprised five narrative reviews, two observational studies and one protocol proposal. Most of the studies selected reported positive effects from use of vitamin D for prevention or treatment of COVID-19. However, there was little quantitative data to assess the real impact of using this vitamin as an intervention against this disease. CONCLUSIONS: Current studies on vitamin D used for purposes other than bone health promotion cannot be taken as support to justify its use in a disease as recent as COVID-19. Studies of greater robustness, with higher levels of clinical evidence, need to be conducted. Rational use of this vitamin needs to be ensured, thereby minimizing the impacts on the patient and the public healthcare system.

Use of potentially inappropriate medications in institutionalized elderly: prevalence and associated factors. / Uso de medicamentos potencialmente inapropriados em idosos institucionalizados: prevalência e fatores associados.

This study aimed to verify the prevalence of the use of Potentially Inappropriate Medications (PIM) for elderly living in Long-Term Care Institutions for the Elderly (LTCIE), as well as the types of medications and their associated factors. This is a cross-sectional study carried out in 10 LTCIEs in the city of Natal in the period October-December 2013. Potentially inappropriate medications were classified according to the 2015 American Geriatric Society Beers Criteria for Potentially Inappropriate Medication Use in Older Adults - 2015. Sociodemographic, LTCIE-related and health-related variables were considered. Univariate and multivariate analyses were performed between the primary variable (PIM use) and the independent variables using Poisson regression. The sample consisted of 321 older people, of whom 304 used medications. The prevalence of PIM use was 54.6% (95% CI: 48.9-60.2) and was associated with polypharmacy and dementia in the final model. The most common PIMs were antipsychotics and benzodiazepines. The study revealed a high prevalence of PIM use among the elderly of the LTCIEs, evidencing the need to adopt indicators on the use of these drugs and the implementation of strategies that make drug therapy safer and more adequate for older adults.

Este trabalho teve como objetivo verificar a prevalência do uso de medicamento potencialmente inapropriado (MPI) para idosos residentes em Instituições de Longa Permanência para Idosos (ILPI), assim como os tipos de medicamentos e seus fatores associados. Trata-se de estudo transversal realizado em 10 ILPI da cidade do Natal, entre outubro e dezembro de 2013. Os medicamentos inapropriados foram classificados de acordo com os Critérios de Beers da American Geriatric Society 2015. Foram analisadas variáveis sociodemográficas, relacionadas à ILPI e às condições de saúde. Para as análises univariada e multivariada entre a variável principal (uso de MPI) e as demais foi utilizada a regressão de Poisson. A amostra foi composta por 321 idosos e, destes, 304 utilizavam medicamentos. A prevalência de uso de MPI foi de 54,6% (IC 95%: 48,9-60,2) e no modelo final esteve associada à polifarmácia e à demência. As classes terapêuticas de MPI mais identificadas foram antipsicóticos e benzodiazepínicos. O estudo revelou alta prevalência de MPI entre os idosos das ILPI, configurando a necessidade de adoção de indicadores do uso destes medicamentos e a implantação de estratégias que tornem a farmacoterapia mais segura e adequada aos idosos.

Uso de medicamentos potencialmente inapropriados em idosos institucionalizados: prevalência e fatores associados / Use of potentially inappropriate medications in institutionalized elderly: prevalence and associated factors

Resumo Este trabalho teve como objetivo verificar a prevalência do uso de medicamento potencialmente inapropriado (MPI) para idosos residentes em Instituições de Longa Permanência para Idosos (ILPI), assim como os tipos de medicamentos e seus fatores associados. Trata-se de estudo transversal realizado em 10 ILPI da cidade do Natal, entre outubro e dezembro de 2013. Os medicamentos inapropriados foram classificados de acordo com os Critérios de Beers da American Geriatric Society 2015. Foram analisadas variáveis sociodemográficas, relacionadas à ILPI e às condições de saúde. Para as análises univariada e multivariada entre a variável principal (uso de MPI) e as demais foi utilizada a regressão de Poisson. A amostra foi composta por 321 idosos e, destes, 304 utilizavam medicamentos. A prevalência de uso de MPI foi de 54,6% (IC 95%: 48,9-60,2) e no modelo final esteve associada à polifarmácia e à demência. As classes terapêuticas de MPI mais identificadas foram antipsicóticos e benzodiazepínicos. O estudo revelou alta prevalência de MPI entre os idosos das ILPI, configurando a necessidade de adoção de indicadores do uso destes medicamentos e a implantação de estratégias que tornem a farmacoterapia mais segura e adequada aos idosos.

Abstract This study aimed to verify the prevalence of the use of Potentially Inappropriate Medications (PIM) for elderly living in Long-Term Care Institutions for the Elderly (LTCIE), as well as the types of medications and their associated factors. This is a cross-sectional study carried out in 10 LTCIEs in the city of Natal in the period October-December 2013. Potentially inappropriate medications were classified according to the 2015 American Geriatric Society Beers Criteria for Potentially Inappropriate Medication Use in Older Adults - 2015. Sociodemographic, LTCIE-related and health-related variables were considered. Univariate and multivariate analyses were performed between the primary variable (PIM use) and the independent variables using Poisson regression. The sample consisted of 321 older people, of whom 304 used medications. The prevalence of PIM use was 54.6% (95% CI: 48.9-60.2) and was associated with polypharmacy and dementia in the final model. The most common PIMs were antipsychotics and benzodiazepines. The study revealed a high prevalence of PIM use among the elderly of the LTCIEs, evidencing the need to adopt indicators on the use of these drugs and the implementation of strategies that make drug therapy safer and more adequate for older adults.

Predicting continence decline in institutionalized older people: A longitudinal analysis.

AIMS: To verify the incidence of urinary continence decline and the probability of maintaining urinary continence, as well as identify the prognostic factors of urinary continence decline in institutionalized older people. METHODS: A 2-year longitudinal study (with five 6-month waves) was conducted with subjects ≥60 years old who lived in 10 nursing homes in the city of Natal-RN (Brazil). Urinary incontinence was assessed by the Minimum Data Set version 3.0. Sociodemographic, institution-related and health-related variables were considered to establish the baseline. Time-dependent variables included cognitive decline, functional decline, and incidences of falls, hospitalizations, and fractures during the period. The actuarial method, the log-rank test, and Cox's regression were applied as statistical methods. RESULTS: Among the cohort of 196 older adults, 105 (53.6%) individuals maintained the continence status during the period, 21 (10.7%) improved it at one or more assessments, and 76 (38.8%) subjects declined. The cumulative probability of maintaining continence status was 82.6% (confidence interval [CI], 95%: 76.5%-87.3%), 74.7% (CI, 95%: 67.8%-80.4%), 66.9% (CI, 95%: 59.4%-73.2%), and 49.3% (CI, 95%: 40.1%-57.9%) at 6, 12, 18, and 24 months, respectively. Predicting factors for continence decline were: disability (hazard ratio [HR] = 4.03; P < 0.001), functional decline (HR = 3.02; P = 0.001) and potentially inappropriate medication (HR = 1.84; P = 0.008). CONCLUSIONS: The incidence of continence decline and the cumulative probability of maintaining continence status in institutionalized older adults was approximately 39% and 49%, respectively, at the 2-year follow-up. Disability and potentially inappropriate drugs at baseline and functional decline across the period predicted continence decline in this cohort.

Associação entre medicamentos de uso contínuo e tontura em idosos institucionalizados / Association between continuous use drugs and dizziness in institutionalized elderly people

RESUMO Objetivo: associar medicamentos de uso contínuo com a presença de tontura em idosos institucionalizados. Métodos: trata-se de um estudo transversal realizado em 10 Instituições de longa permanência para idosos. Foram incluídos todos os idosos a partir de 60 anos que fossem capazes de deambular e que apresentassem bom nível cognitivo. Foram coletadas as medicações de uso contínuo e dados referentes à Instituição. Ao idoso, foi questionado se apresentou tontura no último ano. Para análise estatística, utilizou-se os testes do Qui-quadrado e Exato de Fisher para análise bivariada e regressão logística para análise múltipla stepwise forward, com nível de significância de 5%. Resultados: dos 92 idosos avaliados, 35 afirmaram terem apresentado tontura nos últimos 12 meses (23,8%). Foram associados à tontura os antiepilépticos (p=0,034, RR= 2,26, IC95% 1,06-4,78), anti-trombóticos (p=0,008, RR= 0,21, IC95% 0,07-0,67) e diuréticos (p=0,024, RR= 2,29, IC95% 1,11-4,70), ajustados pelos psicolépticos. Conclusão: a tontura nos idosos institucionalizados esteve associada ao uso crônico de anti-epilépticos e diuréticos.

ABSTRACT Purpose: to associate continuous use drugs with the presence of dizziness in institutionalized elderly people. Methods: a cross-sectional study performed in 10 nursing homes. People aged 60 years or older, able to walk and who presented good cognitive level were included in this study. Data on medications for continuous treatment and data referring to the Institution were collected. The elderly were asked if they had experienced dizziness in the previous year. The Chi-squared and Fisher exact tests were used for bivariate analysis and stepwise forward logistic regression to perform multiple analysis, with a significance level of 5%. Results: out of 92 elderly, 35 reported dizziness in the previous year (23.8%). The anti-epileptics (p=0.034, RR=2.26, CI95% 1.06-4.78), antithrombotics (p=0.008, RR=0.21, CI95% 0.07-0.67) and diuretics (p=0.024, RR=2.29, CI95% 1.11-4.70) were associated to dizziness, adjusted by psycholeptics. Conclusion: dizziness in these institutionalized elderly people was associated with the chronic use of anti-epileptics and diuretic drugs.