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OBJECTIVE: We aimed to compare the response rates between two different hepatitis B virus vaccination schedules for cirrhotic subjects who were non-responders to the first three 40 µg doses (month 0-1-2), and identify factors associated with the final response. DESIGN: A total of 120 cirrhotic patients (72.5% decompensated) were randomised at a 1:1 ratio to receive a single 40 µg booster vaccination at month 6 (classical arm) versus an additional round of three new 40 µg doses administered at monthly intervals (experimental arm). The main outcome was the rate of postvaccinal anti-hepatitis B surface antibodies levels ≥10 mIU/mL. RESULTS: Efficacy by ITT analysis was higher in the experimental arm (46.7%) than in the classical one (25%); OR 2.63, p=0.013. The experimental arm increased response rates compared with the classical one from 31% to 68% (OR 4.72; p=0.007), from 24.4% to 50% (OR 3.09; p=0.012) and from 24.4% to 53.8% (OR 3.62; p=0.007), in Child A, Model for End-Stage Liver Disease (MELD) <15 and MELD-Na<15 patients, respectively. Patients with more advanced liver disease did not benefit from the reinforced scheme. Both regimens showed similar safety profiles. Multivariable analysis showed that the experimental treatment was independently response associated when adjusted across three logistic regression models indicating equivalent cirrhosis severity. CONCLUSION: For cirrhotic patients, the revaccination of non-responders to the first three dose cycle, with three additional 40 µg doses, achieved significantly better response rates to those obtained with an isolated 40 µg booster dose. TRIAL REGISTRATION NUMBER: NCT01884415.
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Doença Hepática Terminal , Hepatite B , Criança , Humanos , Imunização Secundária , Anticorpos Anti-Hepatite B , Índice de Gravidade de Doença , Hepatite B/prevenção & controle , Cirrose Hepática/complicações , Vacinas contra Hepatite BRESUMO
We describe the technological development of a web platform named CHRONIC-PHARMA that integrates three prescription support tools for patients with chronic diseases: Anticholinergic Burden Calculator (ABC), LESS-CHRON criteria and TRIGGER-CHRON. They focus on the optimization and evaluation of pharmacotherapy in patients with chronic diseases, resulting in a useful, single platform that can facilitate the review of pharmacotherapy and improve the safety of chronically ill patients. This is achieved by estimating and reducing the anticholinergic risk (ABC), detecting opportunities for deprescribing drugs and monitoring its success (LESS-CHRON criteria), as well as calculating the risk of adverse drug events (TRIGGER-CHRON). The platform is freely accessible online ( https://chronic-pharma.com/ ) as well as through a mobile application, and therefore easily accessible among the healthcare community.
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Doença Crônica , HumanosRESUMO
OBJECTIVE: To assess the available scientific evidence regarding the efficacy of interventions aimed to enhance medication adherence in patients with multiple chronic conditions (PMCC). DESIGN: Overview of systematic reviews. DATA SOURCES: The following databases were consulted (September 2013): Pubmed, EMBASE, the Cochrane Library, CRD and WoS to identify interventions aimed to enhance medication adherence in PMCC, or otherwise, patients with chronic diseases common in the PMCC, or polypharmacy. STUDY SELECTION: Systematic reviews of clinical trials focused on PMCC or similar were included. They should compare the efficacy of any intervention aimed to improve compliance to prescribed and self-administered medications with clinical practice or other interventions. DATA EXTRACTION: Information about the study population, nature of intervention and efficacy in terms of improved adherence was extracted. RESULTS: 566 articles were retrieved of which 9 systematic reviews were included. None was specifically focused on PMCC but considered patients with chronic diseases common in the PMCC, patients with more than one chronic disease and polypharmacy. The overall effectiveness of interventions was modest without relevant differences between behavioural, educational and combined interventions. Some components of these interventions including patient counselling and regimen simplification appear to be effective tools in improving adherence in this population group. CONCLUSION: There is a large heterogeneity of interventions aimed to improve adherence with modest efficacy, none in PMCC.
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Adesão à Medicação , Múltiplas Afecções Crônicas/tratamento farmacológico , Polimedicação , HumanosRESUMO
BACKGROUND AND OBJECTIVE: There are barriers to deprescription that hinder its implementation in clinical practice. The objective of this study was to analyse the main barriers and limitations of the deprescription process perceived by physicians who care for multipathological patients. MATERIALS AND METHODS: The "deprescription questionnaire of elderly patients" was adapted to an online format and sent to physicians in geriatrics. Question 1 is a reference to establish agreement or disagreement with this practice. The influence of different aspects of deprescription was analysed via the demographic characteristics of the clinicians and perceptions of the various barriers (questions 2-9) by means of bivariate analysis. Based on the latter, a multivariate model was carried out to demonstrate the relationship between barriers and the degree of deprescription agreement among respondents. RESULTS: Of the 72 respondents, 72.2% were in favour of deprescribing. Regarding the analyses, the demographic characteristics did not influence rankings. The deprescription of preventive drugs and consensus with patients were associated with a positive attitude towards deprescribing, while withdrawing drugs prescribed by other professionals, time constraints and patient reluctance emerged as possible barriers. The only factor independently associated with deprescribing was lack of time. CONCLUSIONS: Time was found to be the main barrier to deprescription. Training, the creation of multidisciplinary teams and integrated health systems are key facilitators.
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OBJECTIVE: LESS-CHRON (List of Evidence-Based Deprescribing for Chronic Patients) and STOPPFrail (Screening Tool of Older Persons' Prescriptions in Frail adults with limited life expectancy) are criterion-based deprescribing tools. This study aimed to identify the prevalence of potentially inappropriate medications (PIMs) with these tools in an outpatient, polymedicated, older population with multimorbidity. DESIGN: Single-center cross-sectional observational study. SETTING AND PARTICIPANTS: PIMs and criteria subject to deprescribing identified by each tool were collected in patients who were being followed up on outpatient internal medicine consultation. METHODS: PIMs were identified by STOPPFrail and LESS-CHRON criteria reviewing medical histories and pharmacologic treatments of the patients in the electronic health card system. Sociodemographic, clinical, and pharmacologic variables were recorded. A correlation analysis between treatment tools and clinical values was performed using the nonparametric Spearman rho correlation. RESULTS: Eighty-three patients with a median of 14.4 (interquartile range 12-17) prescribed drugs were included. The total number of PIMs identified with LESS-CHRON was 158 vs 127 with STOPPFrail. Eight of the 27 criteria (29.6%) for LESS-CHRON and 15 of the 25 for STOPPFrail were found to be not applicable. A significant correlation was obtained for both tools with the number of prescribed drugs at the time of inclusion. The Profund, Barthel, and Frail-VIG index only showed a significant correlation with LESS-CHRON. CONCLUSION AND IMPLICATIONS: Both tools have shown the capacity to identify PIMs that can be deprescribed in the population studied. However, LESS-CHRON appears to have a greater detection potential in the subgroup of patients analyzed. STOPPFrail brings a certain complementarity in other areas of therapy not covered by LESS-CHRON.
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Prescrição Inadequada , Lista de Medicamentos Potencialmente Inapropriados , Humanos , Idoso , Idoso de 80 Anos ou mais , Multimorbidade , Prevalência , Estudos TransversaisRESUMO
Background and Objectives: Potentially inappropriate medication refers to the prescription of drugs whose risks outweigh the benefits. There are different pharmacotherapeutic optimization strategies to detect and avoid potentially inappropriate medications (PIMs), namely deprescription. The List of Evidence-Based Deprescribing for Chronic Patients (LESS-CHRON) criteria were designed as a tool to systematize the deprescribing process. LESS-CHRON has established itself as one of the most suitable to be applied in older (≥65 years) multimorbid patients. However, it has not been applied to these patients, to measure the impact on their treatment. For this reason, a pilot study was conducted to analyze the feasibility of implementing this tool in a care pathway. Research Design and Methods: A pre-post quasi-experimental study was conducted. Older outpatients with multimorbidity from the Internal Medicine Unit of a benchmark Hospital were included. The main variable was feasibility in clinical practice, understood as the likelihood that the deprescribing intervention recommended by the pharmacist would be applied to the patient. Success rate, therapeutic, and anticholinergic burden, and other variables related to health care utilization were analyzed. Results: A total of 95 deprescribing reports were prepared. Forty-three were evaluated by the physician who assessed the recommendations made by pharmacists. This translates into an implementation feasibility of 45.3%. The application of LESS-CHRON identified 92 PIMs. The acceptance rate was 76.7% and after 3 months 82.7% of the stopped drugs remained deprescribed. A reduction in anticholinergic burden and enhanced adherence was achieved. However, no improvement was found in clinical or health care utilization variables. Discussion and Implications: The implementation of the tool in a care pathway is feasible. The intervention has achieved great acceptance and deprescribing has been successful in a not insignificant percentage. Future studies with a larger sample size are necessary to obtain more robust results in clinical and health care utilization variables.
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BACKGROUND: Deprescription is the revision of the therapeutic plan with the aim of simplifying it, taking into account patient preferences, prognosis and environment. This strategy is particularly relevant in older patients, mostly polymedicated individuals, since they are exposed to numerous adverse effects and interactions and tend to have less adherence to treatments. OBJECTIVE: To identify the deprescribing tools for older patients available in the scientific literature, classify them according to their design and describe their main features and potential applicability in clinical practice. METHODS: A search was conducted in PubMed and EMBASE for relevant literature published before July 2021. The PRISMA-ScR method was applied, extracting variables related to study and tool characteristics as well as potential clinical applicability. The main inclusion criteria were studies focused on designing or developing deprescribing tools for older patients and those that indicated the features of the deprescribing tool used in detail. RESULTS: Fourteen of 723 papers met the inclusion criteria, and 12 tools were identified: 6 "algorithm-based tools" and 6 "criterion-based tools". Though all tools are aimed at older patients, there are certain peculiarities regarding their design, population, application setting and variables included. Of the 6 criterion-based tools found, 4 used the Delphi method for their design and development. Furthermore, most of them agree on the pharmacological groups that are likely to be deprescribed. CONCLUSIONS: Taking into account the importance of the clinical situation and priorities in the care plan in the deprescribing process, the authors believe that tools which help to evaluate these aspects are the most suitable for application in clinical practice. However, it is necessary to continue studying applicability in real-life clinical scenarios and to obtain health results.
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Desprescrições , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Idoso , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Humanos , PolimedicaçãoRESUMO
BACKGROUND AND OBJECTIVE: In 2017, a questionnaire was developed in Italian with the aim of determining clinicians' perceptions of deprescription in the elderly population. The objective was to translate and cross-culturally adapt this deprescription questionnaire to Spanish. METHODS: Forward and blind-back translations, followed by a synthesis and adaptation by a third translator. Development of an expert panel to evaluate the adequacy of the translation, the understandability of the translated question and the usefulness of each question. A comprehensibility analysis was carried out on physicians familiar with deprescription. RESULTS: The Spanish version of the questionnaire was obtained, where the average degree of difficulty in the direct and the back-translation was low/moderate. In the first phase of the panel of experts, 4 questions had sections considered "indeterminate" and one question was "doubtful". After the second phase, all the questions were considered "adequate" except for one. CONCLUSIONS: This is the first cross-cultural adaptation to Spanish of this questionnaire, which will provide a tool to assess clinicians' perception of this practice and establish improvements to carry out this activity.
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Comparação Transcultural , Traduções , Idoso , Humanos , Inquéritos e Questionários , Reprodutibilidade dos TestesRESUMO
BACKGROUND AND OBJECTIVE: The Multimorbidity Illness Perceptions Scale (MULTIPleS) analyzes whether suffering from two or more chronic diseases affects the quality of life, cost and clinical results of patients. The objective was to translate and cross-culturally adapt the MULTIPleS scale into Spanish. METHODS: Direct translation and back translation followed by synthesis and adaptation by a third translator and a panel of experts to guarantee the conceptual, semantic and content equivalence between both versions. Subsequently, a comprehensibility analysis was performed on a sample of patients. RESULTS: The Spanish version of the MULTIPleS scale was obtained. The medium degree of difficulty in the direct translation and the back translation of the title and the questions showed a low difficulty. In the synthesis and adaptation phase, 6 discrepancies were resolved. The comprehensibility analysis was performed in 10 patients, achieving the established requirement (> 80%) for all items. CONCLUSIONS: This is the first cross-cultural adaptation to Spanish of the MULTIPleS scale. Having this back-translated scale will make it possible to analyze patients' perception of the disease and thus apply improvements in their healthcare.
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Comparação Transcultural , Qualidade de Vida , Idoso , Doença Crônica , Humanos , Multimorbidade , Inquéritos e Questionários , TraduçõesRESUMO
OBJECTIVE: Deprescribing is considered one of the main strategies available for preparing an individualized therapeutic plan in patients with multiple pathologies or complex chronic conditions. However, despite the practice has been in place for some years, there is a need for studies that support the achievement of satisfactory health outcomes, as well as tools that help implement deprescribing in routine clinical practice. The bjective of this project is to analyze the impact of reducing polypharmacy, through the LESS-CHRON deprescribing tool, on a population of elderly polymedicated patients with multiple conditions. METHOD: This will be a quasi-experimental, pre-and-post intervention multicenter cohort study. The variables to be analyzed will be divided into two large groups: those related to pharmacology and those related to health outcomes. They will be collected at baseline, at 3 and at 6-12 months. A first screening phase will be carried out to recruit candidate patients and obtain information about the identified deprescribing opportunities. The second phase will constitute the intervention phase, where the LESS-CHRON tool will be applied and the actual deprescribing of the drugs will be carried out. DISCUSSION: LESS-CHRON has been proclaimed as a suitable deprescribing tool in clinical practice. Validation of LESS-CHRON will seek to show the results that can be achieved following the deprescribing of drugs, in addition to demonstrating that the tool can reliably be used by clinicians in their routine practice. On the other hand, the results of this project may provide information leading to improving or adapting the tool itself, giving rise to a second generation of more efficient version.
OBJETIVO: La desprescripción se considera una de las principales estrategias disponibles para el abordaje del plan terapéutico individualizado en pacientes pluripatológicos o crónicos complejos. Sin embargo, a pesar de ser una práctica ya instaurada desde hace algunos años, se reclama la necesidad de estudios que avalen la obtención de buenos resultados en salud, además de herramientas que ayuden a su desarrollo en la práctica clínica habitual. El objetivo de este proyecto es analizar el impacto en la disminución de la farmacoterapia mediante la desprescripción de fármacos, aplicando la herramienta LESS-CHRON, en una población de pacientes de edad avanzada, polimedicada y con múltiples patologías.Método: Estudio cuasiexperimental, pre-post, multicéntrico. Las variables a analizar se dividirán en dos grandes grupos: referidas a la esfera farmacológica y referidas a resultados en salud. Se recogerán en el momento basal, a los 3 y a los 6-12 meses. Se realizará una primera fase de screening para localizar a los pacientes candidatos, que permitirá obtener la información relativa a las oportunidades de desprescripción identificadas. La segunda constituirá la fase de intervención, en la que se aplicará la herramienta LESS-CHRON y se llevará a cabo la desprescripción real de los fármacos.Discusión: LESSCHRON se ha proclamado como una herramienta adecuada para llevar a cabo la desprescripción de fármacos en la práctica clínica. La validación de la herramienta LESS-CHRON tratará de poner de manifiesto los resultados que se logran tras efectuar la desprescripción, además de demostrar su fiabilidad como herramienta, de modo que los clínicos puedan usarla como parte de su actividad asistencial con total confianza. Por otro lado, los resultados de este proyecto podrán arrojar información para la mejora o adaptación de la propia herramienta, dando lugar a una segunda generación o futuras versiones mejoradas y más eficientes.
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Desprescrições , Multimorbidade , Idoso , Doença Crônica , Estudos de Coortes , Humanos , Estudos Multicêntricos como Assunto , PolimedicaçãoRESUMO
OBJECTIVE: The increase in chronic diseases as a consequence of the rising life expectancy calls for tools that allow us to analyze the difficulty that patients with multimorbidity present when performing healthcare-related tasks. To this end, we carried out a cross-cultural translation and adaptation into Spanish of the questionnaire "Healthcare Task Difficulty (HCTD) among Older Adults with Multimorbidity." METHODS: Direct translation and back translation were made, followed by a synthesis and adaptation by a third translator and a panel of experts in order to guarantee the conceptual, semantic, and content equivalence between the original questionnaire and the Spanish version. Additionally, an evaluation of the comprehension of the questionnaire in Spanish was carried out in a sample of elderly patients with multimorbidity. RESULTS: The Spanish version of the HCTD questionnaire (HCTD-E) was obtained. The overall difficulty of the translators to find an equivalent expression between both languages was low. In the synthesis and adaptation part, four discrepancies were resolved (two of them were adapted in order to use a terminology closer to our health system and the other two were completed with different examples). The comprehensibility analysis was conducted in a sample of ten elderly patients with multimorbidity, and they showed an excellent comprehensibility. CONCLUSIONS: This is the first cross-cultural adaptation to Spanish of the HCTD questionnaire. The methodology used through direct translation, back-translation and adaptation by a third translator and a panel of experts demonstrated a high level of comprehensibility of the HCTD-E, which was measured with cognitive interviews in a sample of patients.
OBJETIVO: El incremento de las enfermedades crónicas como consecuencia del aumento en la esperanza de vida, hace necesario disponer de herramientas que permitan analizar la dificultad que presentan los pacientes con multimorbilidad, a la hora de realizar tareas relacionadas con la asistencia sanitaria. Con este fin, se llevó a cabo una traducción y adaptación transcultural al español del cuestionario "Healthcare Task Difficulty (HCTD) among Older Adults with Multimorbidity". METODOS: Traducción directa y retrotraducción llevadas a cabo por dos traductores, seguidas de una síntesis y adaptación por parte de un tercer traductor. Posterior creación de un panel de expertos con el fin de garantizar la equivalencia conceptual, semántica y de contenido entre la versión original y la española. A continuación, se realizó una evaluación de la comprensión del cuestionario en español en una muestra de pacientes de edad avanzada con múltiples patologías. RESULTADOS: Se obtuvo la versión española del cuestionario HCTD (HCTD-E). La dificultad global encontrada por los traductores para hallar una expresión equivalente entre ambos idiomas fue baja. En la fase de síntesis y adaptación, se resolvieron 4 discrepancias con el fin de utilizar una terminología más cercana a nuestro sistema sanitario. El análisis de comprensibilidad se efectuó sobre una muestra de 10 pacientes, mayores y con multimorbilidad en seguimiento por Medicina Interna, el cual demostró una comprensibilidad excelente. CONCLUSIONES: Se trata de la primera adaptación transcultural al español del cuestionario HCTD. La metodología utilizada mediante traducción directa, retrotraducción y adaptación por parte de un tercer traductor y un panel de expertos, ha demostrado un alto nivel de comprensibilidad de la herramienta HCTD-E medida a través de entrevistas cognitivas realizadas en una muestra de pacientes.
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Idioma , Multimorbidade , Idoso , Atenção à Saúde , Humanos , Espanha , Inquéritos e Questionários , TraduçõesRESUMO
OBJECTIVE: The 'LESS-CHRON criteria' (List of Evidence-Based Deprescribing for Chronic Patients criteria) is a newly created tool with 27 criteria to guide deprescribing. It was developed using a Delphi methodology. Each criterion consists of drugs and their indications, conditions under which deprescribing would be considered, a health variable to be monitored after deprescribing and a follow-up period. The aim of our study was to evaluate the reliability of the LESS-CHRON criteria in a population of patients with multimorbidity to determine the possible usefulness of this tool in clinical practice. METHODS: We selected chronic patients with multimorbidity from an internal medicine unit who were older than 80 years old and were alive at the time of the study. To determine interobserver reliability, each professional (internist or hospital pharmacy specialist) applied the questionnaire under the same conditions and with the same resources. To determine intraobserver reliability, each health professional applied the tool at baseline and 2 months later. We measured interobserver and intraobserver reliability using the kappa coefficient. The proportion of overall agreement was also determined. RESULTS: We obtained a moderate overall kappa (ĸ=0.46, 95% CI 0.36 to 0.55) for interobserver reliability, and good (ĸ=0.65, 95% CI 0.57 to 0.78) and moderate (ĸ=0.59, 95% CI 0.49 to 0.74) values for intraobserver reliability for the internist and pharmacist, respectively. The proportion of overall agreement was very high: 92% (range: 62%-100%) for the interobserver, and 94% (80%-100%) and 93% (63%-100%) for the internist and pharmacist, respectively. CONCLUSIONS: The LESS-CHRON criteria shows early promise as a reliable method to help guide deprescribing in patients with multimorbidity. Further, more complete testing with a larger sample of prescribers is needed.
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BACKGROUND: Anticholinergic and sedative drugs are associated with adverse events such as cognitive and functional impairment in elderly. The Drug Burden Index (DBI) is a measure of an individual's total exposure to anticholinergic and sedative drugs. Objetive: The study aimed to evaluate the association between the total DBI and cognitive and functional impairment in patients with multimorbidity. SETTING: Patients with multimorbidity enrolled in the IMPACTO project. METHODS: Cross-sectional observational study. MAIN OUTCOME MEASURE: The anticholinergic and sedative exposure was calculated using DBI. The Pfeiffer Test (PT) was used for cognitive status and the Barthel Index (BI) for functional status. RESULTS: 336 patients were included (mean age 77.6 ± 8.7 years, 54.2% men and a mean of 11.5 ± 3.7 prescribed drugs). 180 patients (53.6%) exposed to anticholinergic and/or sedative drugs were identified. The median score obtained in PT was slightly higher in exposed patients (1 (IQR 0-2) and 2 (IQR 0-4), p = 0.082 in "non-exposed" and "exposed", respectively). The bivariate analysis showed an association [0.544 (95% CI 0.044-1.063, p = 0.03)]. The median obtained in the BI analysis was 85.0 (IQR 30.0) and 75.5 (IQR 42.5) p = 0.002, in "nonexposed" and "exposed", respectively. After the adjusted analysis, a relationship was obtained between both the variables [-9,558 (95% CI-15,794; -3,321, p = 0.03)]. CONCLUSION: Higher DBI is associated with the impairment of functional status and, slightly to the deterioration of cognitive function in patients with multimorbidity. DBI should be considered in patients with multimorbidity to optimize the pharmacological treatment of a group of special interest due to its vulnerability.
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Antagonistas Colinérgicos/uso terapêutico , Hipnóticos e Sedativos , Multimorbidade , Cognição/efeitos dos fármacos , Estudos Transversais , Humanos , Estudos RetrospectivosRESUMO
AIM: To create a tool to identify drugs and clinical situations that offers an opportunity of deprescribing in patients with multimorbidity. METHODS: A literature review completed with electronic brainstorming, and subsequently, a panel of experts using the Delphi methodology were applied. The experts assessed the criteria identified in the literature and brainstorming as possible situations for deprescribing. They were also asked to assess the influence of life prognosis in each criterion. A tool was composed of the most appropriate criteria according to the strength of their evidence, usefulness in patients with multimorbidity and applicability in clinical practice. RESULTS: Out of a total of 100, 27 criteria were selected to be included in the final list. It was named the LESS-CHRON criteria (List of Evidence-baSed depreScribing for CHRONic patients), and was organized by the anatomical group of the Anatomical, Therapeutic, Chemical (ATC) classification system of the drug to be deprescribed. Each criterion contains: drug indication for which it is prescribed, clinical situation that offers an opportunity to deprescribe, clinical variable to be monitored and the minimum time to follow up the patient after deprescribing. CONCLUSIONS: The "LESS-CHRON criteria" are the result of a comprehensive and standardized methodology to identify clinical situations for deprescribing drugs in chronic patients with multimorbidity. Geriatr Gerontol Int 2017; 17: 2200-2207.