Planejamento, síntese, modelagem molecular e avaliação biológica de novos potenciais inibidores duais HDAC/ MMP não-hidroxamatos / Design, synthesis, molecular modeling and biological evaluation of novel potential non-hydroxamate dual HDAC/ MMP inhibitors

A inibição de alvos específicos como metaloproteinase de matriz (MMP) e histona desacetilase (HDAC) é amplamente estudada para impedir o progresso do câncer. Foi estabelecido que a inibição concomitante de MMP e HDAC é eficaz no combate de tumores sólidos e hematológicos. Ambos os alvos possuem um íon Zn2+ em seu sítio ativo, fundamental para a atividade destas enzimas. A alta afinidade dos inibidores conhecidos de MMP e de HDAC é conferida, principalmente, por um potente grupo ligante de zinco (ZBG). O ácido hidroxâmico é o ZBG mais potente conhecido atualmente, entretanto, este apresenta instabilidade farmacocinética, levando a ineficácia e genotoxicidade em testes clínicos. Frente a este contexto, o presente trabalho teve como objetivo o planejamento, síntese, modelagem molecular e avaliação biológica de novos inibidores duais MMP/HDAC não-hidroxamatos. Os compostos foram planejados utilizando estratégias de hibridação molecular, a partir de arcabouços provenientes inibidores de HDAC e MMP, gerando compostos arilsulfonamídicos com variações no tipo de ZBG inserido e na sua respectiva posição relativa na estrutura geral. Foram sintetizados sete análogos, em duas a três etapas reacionais, utilizando métodos de sulfonilação e acoplamento com agentes condensantes, partindo dos ésteres para e meta aminobenzoicos. Os rendimentos globais variaram de 25% a 55% e os produtos obtidos foram caracterizados por RMN 1H e 13C, LC/MS, CLAE e ponto de fusão. Os compostos tiveram sua atividade citotóxica avaliada em células HOG (oligodendroma) e T98G (glioblastoma), dentre os quais o 6a, que possui o ZBG 2-amino anilida, foi o mais promissor, apresentando atividade nas duas linhagens na casa de nM. Ensaios de coordenação com Fe2+ comprovaram a capacidade quelante dos análogos contendo ácido hidroxâmico e dos demais compostos citotóxicos, 4a e 4b (ZBG-2, salicilal-hidrazona), o que não foi observado para o composto 6a. Os estudos de ancoramento molecular permitiram sugerir um modo de interação para todos os ZBG propostos frente aos respectivos alvos (HDAC e MMP), sendo observado que o ZBG 4 (2-amino anilida) faria a interação de modo monodentado com a HDAC, enquanto não seria possível o encaixe no sítio catalítico da MMP. Conclui-se, portanto, que o planejamento proposto permitiu a obtenção de compostos promissores como antitumorais, e que a substituição do ácido hidroxâmico por outros ZBG fornece moléculas ativas frente a células tumorais. Entretanto, a avaliação biológica frente à MMP e HDAC é necessária para confirmar o mecanismo de ação proposto

Inhibition of specific targets such as matrix metalloproteinase (MMP) and histone deacetylase (HDAC) is extensively studied regarding arrest cancer growth. Particularly, concomitant inhibition of MMP and HDAC is effective against solid and hematologic tumors. Both targets have an ion Zn2+ at their catalytic site, which is essential for respective enzymatic activity. High affinity of known MMP and HDAC inhibitors is mainly provided by a potent zinc binding group (ZBG). Hydroxamic acid is the most potent ZBG currently known; however, it presents low pharmacokinetics stability, which results in its ineffectiveness and genotoxicity along clinical trial. So, the aim of this work comprised the design, synthesis, molecular modeling and biological evaluation of novel potential non-hydroxamate dual HDAC/ MMP inhibitors. Compounds were designed by molecular hybridation, employing scaffolds from HDAC and MMP inhibitors, which provided arylsulfonamides with variation about the ZBG type and its respective relative position in the general structure. Seven compounds were synthesized, in two to three reaction steps, through methods that comprise sulfonilation and coupling with condensing agents, using para and meta-aminobenzoic esters as starting material. Compounds showed global yields around 25-55 % and were characterized by 1H and 13C NMR, LC/MS, HPLC and melting point. Compounds were evaluated about their cytotoxicity against HOG (oligodendroma) and T98G (glioblastoma) cells, which 6a, with ZBG 2-aminobenzamide, was the most promising molecules, presenting activity against both cell lines at nM range. Coordination assays with Fe2+ proved the chelating capacity of hydroxamate analogues as well as the cytotoxic compounds, 4a and 4b (ZBG-2, salicylal-hydrazone), which was not observed about 6a. Molecular docking allowed to suggest an interaction model for all proposed ZBG with the respective targets (MMP and HDAC), showing that (ZBG-4) 2-aminobenzamide interacts with HDAC by monodentate way, but does not docks at MMP catalytic site. We conclude that the proposed design allowed obtaining promising compounds as antitumors agents, and the replacement of hydroxamic acid by other ZBG provide active molecules against tumor cells. However, biological evaluation against MMP and HDAC is necessary to confirm the proposed action mechanism

Orientación de la atención primaria en las acciones contra la lepra: factores relacionados con los profesionales / Orientation of primary care in actions to control leprosy: factors relating to professionals

OBJETIVO: Identificar factores de los profesionales que se relacionan con el grado de orientación de la atención primaria de salud en el control de la lepra. MÉTODO: Estudio realizado en 70 unidades de la Estrategia de Salud Familiar de una capital de Brasil, entre julio y septiembre de 2014. Se utilizó un instrumento de evaluación aplicado a 408 profesionales de la salud. Se aplicó el modelo de regresión lineal múltiple-bootstrap para analizar la asociación de la puntuación general, esencial y derivada con los factores explicativos de los profesionales (tiempo de trabajo en la unidad y en servicios de atención primaria, realización de acciones de control, atención de caso y formación en lepra). RESULTADOS: En el análisis descriptivo, la mayoría de los profesionales no atendieron casos y no recibieron formación para realizar acciones contra la lepra. Se observó una fuerte orientación en la puntuación esencial y general de la atención primaria y la asociación con la formación en lepra. En la puntuación derivada, se observó una débil orientación y asociación con la formación de la enfermedad para médicos y agentes comunitarios de salud. CONCLUSIÓN: La experiencia profesional en la Estrategia de Salud Familiar y en la asistencia a la lepra es determinante para que el servicio sea proveedor de acciones de control orientadas según los atributos esenciales y derivados de la atención primaria de salud. Aunque Brasil ha avanzado en la reducción de la incidencia de la lepra, hay que aumentar la eficacia de la vigilancia en salud como forma de detección precoz y formación de los profesionales

OBJECTIVE: To identify factors of professionals that relate to the degree of primary health care orientation in the control of leprosy. METHOD: Study carried out in 70 units of Family Health Strategy of a capital of Brazil, between July and September 2014. An evaluation instrument applied to 408 health professionals was used. The multiple linear regression-bootstrap model was applied to analyze the association of the general, essential and derived score with the explanatory factors of the professionals (work time in the unit and in primary care services, control actions, case care and leprosy training). RESULTS: In the descriptive analysis most of the professionals did not attend cases and did not receive training to perform leprosy actions. A strong orientation was observed in the essential and general score of primary care and the association with leprosy education. In the derived score, weak orientation and association were observed with training in the disease for doctors and community health agents. CONCLUSION: Professional experience in the Family Health Strategy and leprosy care is crucial for the service to be a provider of control actions oriented according to the essential and derived attributes of primary health care. Brazil has made progress in reducing the incidence of leprosy; however, it is necessary to increase the effectiveness of health surveillance, as a means of early detection and training of professionals

Quality indicators for patients with traumatic brain injury in European intensive care units: a CENTER-TBI study.

BACKGROUND: The aim of this study is to validate a previously published consensus-based quality indicator set for the management of patients with traumatic brain injury (TBI) at intensive care units (ICUs) in Europe and to study its potential for quality measurement and improvement. METHODS: Our analysis was based on 2006 adult patients admitted to 54 ICUs between 2014 and 2018, enrolled in the CENTER-TBI study. Indicator scores were calculated as percentage adherence for structure and process indicators and as event rates or median scores for outcome indicators. Feasibility was quantified by the completeness of the variables. Discriminability was determined by the between-centre variation, estimated with a random effect regression model adjusted for case-mix severity and quantified by the median odds ratio (MOR). Statistical uncertainty of outcome indicators was determined by the median number of events per centre, using a cut-off of 10. RESULTS: A total of 26/42 indicators could be calculated from the CENTER-TBI database. Most quality indicators proved feasible to obtain with more than 70% completeness. Sub-optimal adherence was found for most quality indicators, ranging from 26 to 93% and 20 to 99% for structure and process indicators. Significant (p < 0.001) between-centre variation was found in seven process and five outcome indicators with MORs ranging from 1.51 to 4.14. Statistical uncertainty of outcome indicators was generally high; five out of seven had less than 10 events per centre. CONCLUSIONS: Overall, nine structures, five processes, but none of the outcome indicators showed potential for quality improvement purposes for TBI patients in the ICU. Future research should focus on implementation efforts and continuous reevaluation of quality indicators. TRIAL REGISTRATION: The core study was registered with ClinicalTrials.gov, number NCT02210221, registered on August 06, 2014, with Resource Identification Portal (RRID: SCR_015582).

Measurement and Validation of Primary Care Nursing Indicators Based on a Wound Care Tracer Condition.

BACKGROUND: Access to both valid and reliable nursing-sensitive indicators is currently limited in primary care. PURPOSE: The objectives were to (1) measure primary care nursing indicators using a wound care tracer condition and (2) study the associations between process and outcome indicators. METHODS: We conducted a longitudinal study in an ambulatory care clinic in Quebec, Canada. The sample included 482 episodes of care. We studied 5 indicators related to processes and 3 to outcomes. RESULTS: Performance levels were moderately high for indicators of initial assessment and duration and low for those of continuity and education. Associations between nursing follow-up and continuity indicators and 3 outcome indicators were highly significant. CONCLUSION: Continuity and nursing follow-up are associated with improved outcomes. Increasing these indicators' performance level can improve both nursing processes and patient outcomes.

Musculoskeletal injury quality outcome indicators for the emergency department.

High standards of care for musculoskeletal injuries presenting to emergency departments (ED) must be maintained despite financial constraints, the model of care in place, or the pressure to reach time-based performance measures. Outcome quality indicators (QIs) provide a tangible way of assessing and improving the outcomes of health-care delivery. This study aimed to develop a set of outcome QIs for musculoskeletal injuries in the ED that are meaningful, valid, feasible to collect, simple to use for clinical quality improvement and chosen by experts in the field. The study used a multi-phase mixed methods design, commencing with a systematic review of available outcome QIs. An expert panel then developed a set of preliminary QIs based on the available scientific evidence. Prospective observational data collection was undertaken across eight EDs with subsequent retrospective chart audits, follow-up phone calls and audit of administrative databases. After statistical analysis, validated results were presented to the expert panel who discussed, refined and formally voted on a final outcome QI set. A total of 41 preliminary outcome QIs were field tested in EDs, with data collected on 633 patients. Using the field study results, the expert panel voted 11 outcome QIs into the final set. These covered effectiveness of pain management, timeliness to discharge, re-presentations to the ED and unplanned visits to health professionals in the community, missed injuries, opioids side effects and the patient experience. An evidence-based set of outcome quality indicators is now available to support clinical quality improvement of musculoskeletal injury care in the ED setting.

Outcome measures for oncology alternative payment models: practical considerations and recommendations.

OBJECTIVES: This paper aims to synthesize existing scholarship on quality measures in oncology, with a specific focus on outcome-based quality measures, which are often underutilized. We also present a set of "core outcome measures" that may be considered in future oncology alternative payment models (APMs). STUDY DESIGN: Our research consists of a focused literature review, content analysis, and quality measure synthesis and categorization. METHODS: We conducted a focused literature review to generate key evidence on quality measures in oncology. We studied 7 oncology quality assessment frameworks, encompassing 142 quality metrics, and synthesized recommendations using the Center for Medicare and Medicaid Innovation APM toolkit, focusing on outcome measures. RESULTS: We present 34 outcome-based oncology quality measures for consideration, which are classified into 5 domains: clinical care (eg, hospital and emergency department visits, treatment effectiveness, mortality), safety (eg, infections, hospital adverse events), care coordination (for hospital and hospice care), patient and caregiver experience, and population health and prevention. Both general and indication-specific outcome measures should be considered in oncology APMs, as appropriate. Utilizing outcome-based measures will require addressing multiple challenges, ranging from risk adjustment to data quality assurance. CONCLUSIONS: Oncology care will benefit from a more rigorous approach to quality assessment. The success of oncology APMs will require a robust set of quality measures that are relevant to patients, providers, and payers.

Recomendaciones para el diseño e implementación de un programa de aseguramiento de la calidad de la fase preanalítica / Recommendations for the design and implementation of a Pre-analytical Phase Quality Assurance Program

El aseguramiento de la calidad de la fase preanalítica se orienta hacia 2 aspectos clave: la gestión de los errores preanalíticos desde la perspectiva de la seguridad del paciente, y la mejora y armonización de los procedimientos, basada en la aplicación de normativa además de recomendaciones profesionales. Al igual que el resto de las fases, debe incluir un programa interno de aseguramiento y la participación en programas de intercomparación entre laboratorios. El control de calidad interno debe basarse fundamentalmente en la identificación de riesgos, detección sistemática de errores y establecimiento de indicadores. La selección de los indicadores priorizando el impacto en el paciente, la forma de detectar y registrar los errores de forma sistemática y fácilmente explotable, así como las variables utilizadas en su cálculo, son aspectos importantes para medir la eficacia de las acciones de mejora y permitir la comparabilidad entre laboratorios. En este sentido, los programas externos de la calidad de la fase preanalítica basados en la comparación de indicadores, son una herramienta útil para el diseño e implantación de un programa de aseguramiento de la calidad. Este documento pretende servir de apoyo para que cada laboratorio seleccione, implante y evalúe sus propios indicadores, de acuerdo a las características individuales de sus procedimientos preanalíticos, pero sin perder de vista la armonización entre laboratorios

The quality assurance of the pre-analytical phase is oriented towards two key aspects; the management of pre-analytical errors from the perspective of patient safety, and the improvement and harmonisation of procedures, based on the application of regulations and professional recommendations. Like the rest of the phases, it should include an internal quality assurance program, as well as the participation in external quality assurance programs. The internal quality control should mainly be based on the identification of risks, systematic detection of errors, and establishment of indicators. The selection of indicators prioritising the impact on the patient, the way to detect and record errors in a systematic and easily exploitable manner, and also the variables used in the calculations, are important aspects to measure the effectiveness of improvement actions and to allow comparability between laboratories. In this sense, the external quality assurance programs of the pre-analytical phase based on the comparison of indicators are a useful tool for the design and implementation of a quality assurance program. This document is intended as a support for each laboratory to select, implement, and evaluate its own indicators, according to the individual characteristics of its pre-analytical procedures, but without losing sight of the harmonisation between laboratories

Implementation of health care quality indicators for out-of-hospital emergencies: a systematic review. / Utilización e implementación de indicadores de calidad para evaluar la atención en las emergencias extrahospitalarias: revisión sistemática.

ABSTRACT: Although many health care quality indicators have been defined for establishing a common, homogeneous, and reliable system for assessing emergency department care, less information is available on the use of indicators of quality in attending emergencies outside the hospital. We aimed to identify and analyze quality indicators that have appeared in the literature on out-of-hospital emergencies. This systematic review of the literature followed the ations of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). We developed protocols for searching 5 databases to locate studies using quality indicators to evaluate care in out-of-hospital emergencies. Studies were published between July 2017 and July 2018 in either English or Spanish. We identified 22 studies naming 333 quality indicators in out-of-hospital emergencies. The indicators were classified as clinical or nonclinical; within each of these 2 sets, we also identified domains, or subcategories. As nonclinical quality identifiers were more numerous in the literature, it seems that they are the ones most often used to assess out-of-hospital emergency care at this time. This finding leaves the door open to designing and implementing new indicators able to measure quality of care in this clinical setting.

RESUMEN: Aunque son muchos los indicadores de calidad (IC) definidos para establecer un sistema común, homogéneo y fiable de evaluación sobre la actividad en los servicios de urgencias, es escasa la información acerca de los IC relacionados con las emergencias atendidas en el ámbito extrahospitalario. El objetivo de este trabajo es identificar y analizar, a través de la literatura científica publicada, los IC específicos de dicha atención ante emergencias fuera del contexto hospitalario. Se realizó una revisión sistemática de la literatura según las recomendaciones PRISMA. Se exploraron 5 bases de datos y se elaboraron protocolos de búsqueda para localizar estudios que aportasen información sobre IC para evaluar la atención en emergencias extrahospitalarias, entre noviembre de 2017 y julio de 2018, tanto en inglés como en español. Se analizaron un total de 22 estudios y se identificaron un total de 333 IC en emergencias extrahospitalarias que fueron clasificados en clínicos y no clínicos, con sus subdominios correspondientes para cada grupo. El número de IC no clínicos identificados en la búsqueda fue superior, pudiendo concluir que son los más utilizados para evaluar la atención en las emergencias extrahospitalarias en la actualidad y dejando la puerta abierta para el diseño e implementación de nuevos IC capaces de evaluar la actividad fuera del contexto hospitalario.

Indicadores de calidad en gastroscopia. Procedimiento de la gastroscopia / Quality indicators in gastroscopy. Gastroscopy procedure

Enmarcado dentro del proyecto "Indicadores de calidad en endoscopia digestiva", liderado por la Sociedad Española de Patología Digestiva (SEPD), el objetivo de esta investigación es proponer los procedimientos e indicadores de estructura, proceso y resultado necesarios para aplicar y evaluar la calidad en la gastroscopia. Primero, se ha diseñado un diagrama con los pasos a seguir durante el procedimiento de gastroscopia. En segundo lugar, un grupo de expertos en calidad asistencial y/o endoscopia han realizado una revisión cualitativa de la literatura haciendo referencia a la búsqueda de indicadores de calidad en los procedimientos endoscópicos, incluidas las gastroscopias. Posteriormente, por un procedimiento de análisis por pares se ha hecho la selección y el análisis de la literatura seleccionada. Se ha identificado para gastroscopias un total de nueve indicadores de procesos (uno de preprocedimiento y ocho de procedimiento). La calidad de la evidencia se ha analizado aplicando la escala de clasificación utilizada en GRADE (Grading of Recommendations Assessment, Development and Evaluation)

Within the project "Quality indicators in digestive endoscopy", pioneered by the Spanish Society for Digestive Diseases (SEPD), the objective of this research is to suggest the structure, process, and results procedures and indicators necessary to implement and assess quality in the gastroscopy setting. First, a chart was designed with the steps to be followed during a gastroscopy procedure. Secondly, a team of experts in care quality and/or endoscopy performed a qualitative review of the literature searching for quality indicators for endoscopic procedures, including gastroscopies. Finally, using a paired analysis approach, a selection of the literature obtained was undertaken. For gastroscopy, a total of nine process indicators were identified (one preprocedure, eight intraprocedure). Evidence quality was assessed with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) classification scale

Validation of the Knowledge and Self-management Nursing Outcomes Classification for Adults With Diabetes.

People with diabetes have to self-manage their health conditions to promote, maintain, and restore their health. The Nursing Outcomes Classification provides two outcomes for people with diabetes to evaluate their knowledge and self-management behaviors. The purpose of this study was to validate these two Nursing Outcomes Classification outcomes for adults with diabetes. A descriptive exploratory design using the Delphi technique was used. Two groups of experts were invited for validation of the outcomes. Descriptive statistics were used to determine definition adequacy, clinical usefulness, and content similarity. The Outcome Content Validity method was used to evaluate each outcome and the indicators. A total of 16 nurse experts participated in this study. The definition adequacy of the two Nursing Outcomes Classification outcomes was rated higher than 4.0 out of 5. Clinical usefulness was rated higher than 4.0 out of 5. The range of content validity of the two Nursing Outcomes Classification outcomes was from 0.89 to 0.92 (perfect score is 1.0). The invited experts reported that the content of this outcome pair was very similar. By using validated Nursing Outcomes Classification outcomes, nurses who take care of patients with diabetes can evaluate patient outcomes effectively and determine the effect of nursing interventions accurately.

Quality indicators for responsible use of medicines: a systematic review.

OBJECTIVE: All healthcare systems require valid ways to evaluate service delivery. The objective of this study was to identify existing content validated quality indicators (QIs) for responsible use of medicines (RUM) and classify them using multiple frameworks to identify gaps in current quality measurements. DESIGN: Systematic review without meta-analysis. SETTING: All care settings. SEARCH STRATEGY: CINAHL, Embase, Global Health, International Pharmaceutical Abstract, MEDLINE, PubMed and Web of Science databases were searched up to April 2018. An internet search was also conducted. Articles were included if they described medication-related QIs developed using consensus methods. Government agency websites listing QIs for RUM were also included. ANALYSIS: Several multidimensional frameworks were selected to assess the scope of QI coverage. These included Donabedian's framework (structure, process and outcome), the Anatomical Therapeutic Chemical (ATC) classification system and a validated classification for causes of drug-related problems (c-DRPs; drug selection, drug form, dose selection, treatment duration, drug use process, logistics, monitoring, adverse drug reactions and others). RESULTS: 2431 content validated QIs were identified from 131 articles and 5 websites. Using Donabedian's framework, the majority of QIs were process indicators. Based on the ATC code, the largest number of QIs pertained to medicines for nervous system (ATC code: N), followed by anti-infectives for systemic use (J) and cardiovascular system (C). The most common c-DRPs pertained to 'drug selection', followed by 'monitoring' and 'drug use process'. CONCLUSIONS: This study was the first systematic review classifying QIs for RUM using multiple frameworks. The list of the identified QIs can be used as a database for evaluating the achievement of RUM. Although many QIs were identified, this approach allowed for the identification of gaps in quality measurement of RUM. In order to more effectively evaluate the extent to which RUM has been achieved, further development of QIs may be required.

A modified Delphi process to identify, rank and prioritize quality indicators for continuous renal replacement therapy (CRRT) care in critically ill patients.

BACKGROUND: Continuous renal replacement therapy (CRRT) is a complex and life-sustaining therapy, reserved for our most acutely ill patients, and should be delivered in a safe, consistent and high-quality manner. However valid evidence-based quality indicators (QIs) for CRRT care are lacking. The objective of this study was to develop a prioritized list of QIs for CRRT care that may be used in any CRRT program. METHOD: We conducted a modified three stage Delphi process. This consisted of two web-based rounds followed by an in-person meeting. We recruited an interdisciplinary panel of critical care nephrology experts and knowledge users. In each stage of the Delphi process panelists responded on whether a QI should be included in our final list. In the third round, any QI for which there was uncertainty to include was discussed and a final decision on whether to include was made. RESULTS: Forty-one panelists participated (18 from nephrology, 11 from intensive care, 7 educators, 2 decision-makers, 2 industry representatives and 1 pharmacist) from North America, Europe, Australasia and South America. Following the third Delphi round, 13 QIs for CRRT care were identified; 10 QIs were identified with a high level of agreement for face validity while 3 QIs were identified with a moderate level of agreement for face validity among panelists. CONCLUSIONS: We developed a prioritized list of 13 QIs for CRRT care. Future work should focus on developing validated benchmarks for these QIs and implementing them into CRRT programs.

[Quality of care and safety indicators in anticoagulated patients with non-valvular auricular fibrillation and deep venous thromboembolic disease]. / Indicadores de calidad y seguridad en el paciente anticoagulado con fibrilación auricular no valvular y enfermedad tromboembólica venosa profunda.

OBJECTIVES: To identify and prioritise indicators to assess the quality of care and safety of patients with non-valvular auricular fibrillation (NVAF) and deep vein thrombosis (DVT) treated with anticoagulants. MATERIALS AND METHODS: Using the consensus conference technique, a group of professionals and clinical experts, the determining factors of the NVAF and DVT care process were identified, in order to define the quality and safety criteria. A proposal was made for indicators of quality and safety that were prioritised, taking into account a series of pre-established attributes. The selected indicators were classified into indicators of context, safety, action, and outcomes of the intervention in the patient. RESULTS: A set of 114 health care and safety quality indicators were identified, of which 35 were prioritised: 15 for NVAF and 20 for DVT. About half (49%) of the indicators (40% for NVAF and 55% for DVT) applied to patient safety, and 26% (33% for NVAF and 20% for DVT) to the outcomes of interventions in the patient. CONCLUSIONS: The present work presents a set of agreed indicators by a group of expert professionals that can contribute to the improvement of the quality of care of patients with NVAF and DVT treated with anticoagulants.

Audit and feedback using the Robson classification to reduce caesarean section rates: a systematic review.

BACKGROUND: In most regions worldwide, caesarean section (CS) rates are increasing. In these settings, new strategies are needed to reduce CS rates. OBJECTIVES: To identify, critically appraise and synthesise studies using the Robson classification as a system to categorise and analyse data in clinical audit cycles to reduce CS rates. SEARCH STRATEGY: Medline, Embase, CINAHL and LILACS were searched from 2001 to 2016. SELECTION CRITERIA: Studies reporting use of the Robson classification to categorise and analyse data in clinical audit cycles to reduce CS rates. DATA COLLECTION: Data on study design, interventions used, CS rates, and perinatal outcomes were extracted. RESULTS: Of 385 citations, 30 were assessed for full text review and six studies, conducted in Brazil, Chile, Italy and Sweden, were included. All studies measured initial CS rates, provided feedback and monitored performance using the Robson classification. In two studies, the audit cycle consisted exclusively of feedback using the Robson classification; the other four used audit and feedback as part of a multifaceted intervention. Baseline CS rates ranged from 20 to 36.8%; after the intervention, CS rates ranged from 3.1 to 21.2%. No studies were randomised or controlled and all had a high risk of bias. CONCLUSION: We identified six studies using the Robson classification within clinical audit cycles to reduce CS rates. All six report reductions in CS rates; however, results should be interpreted with caution because of limited methodological quality. Future trials are needed to evaluate the role of the Robson classification within audit cycles aimed at reducing CS rates. TWEETABLE ABSTRACT: Use of the Robson classification in clinical audit cycles to reduce caesarean rates.

Desenvolvimento e validação de indicadores para avaliação da qualidade do acompanhamento farmacoterapêutico / Development and validation of indicators for quality assessment of medication management

Um dos elementos para melhoria da qualidade dos serviços farmacêuticos clínicos é medir a qualidade do cuidado prestado e os indicadores podem ser usados nesta avaliação. O presente trabalho teve como objetivos identificar estudos sobre indicadores de qualidade para serviços farmacêuticos clínicos e desenvolver e validar um instrumento de indicadores para avaliação dos serviços de acompanhamento farmacoterapêutico prestados para pacientes ambulatoriais. Para tanto, uma busca abrangente da literatura foi conduzida nas bases de dados PubMed/Medline, Scopus, Lilacs e DOAJ por esses estudos. Os instrumentos apresentados pelos estudos foram avaliados em relação à qualidade das propriedades psicométricas. A seguir, foi desenvolvido um instrumento de indicadores-chave de desempenho. O grupo de pesquisa estabeleceu sete indicadores possíveis para avaliação de especialistas da área através de duas rodadas da técnica Delphi para validação de conteúdo. Ainda, farmacêuticos foram convidados a participar por meio de um questionário para validação de construto e confiabilidade do instrumento. A busca bibliográfica identificou 3.276 registros, dos quais 12 estudos completaram os critérios de inclusão. No geral, o maior número de estudos foi baseado em pesquisas para avaliar a satisfação dos pacientes e usou a revisão da literatura combinada com opinião de especialistas para o desenvolvimento do instrumento. Todos os estudos apresentaram algumas propriedades psicométricas do instrumento. A consistência interna e a validade de conteúdo foram os critérios mais relatados dos estudos, e nenhum deles apresentou o critério de estabilidade. Onze (68,8%) especialistas participaram da primeira rodada da técnica Delphi e nove (81,8%) especialistas completaram as 2 rodadas. Um novo indicador foi desenvolvido após a avaliação do painel de especialistas na primeira rodada. No geral, a validade de conteúdo e construto foi alcançada para o instrumento final. Os resultados desta tese apontam que os instrumentos dos estudos identificados na revisão sistemática apresentaram propriedades psicométricas, porém de forma incompleta ou não satisfatória. Ainda, um instrumento com seis indicadores foi desenvolvido e validado para o Serviço de Acompanhamento Farmacoterapêutico prestado para pacientes ambulatoriais

One of the elements of quality improvement of medication management services is measuring the quality of care and key performance indicators (KPIs) can be used in this assessment. The study is aimed to identify quality indicators instruments in pharmaceutical care services and to develop and validate KPI instrument for medication management services provided for outpatients. For this, comprehensive literature search was performed in databases PubMed/Medline, Scopus, and Lilacs. The psychometric quality of the instruments was determined. In addition, a key performance indicators instrument was developed. A working group established 7 possible KPIs for assessment of the expert panel through an internet based 2-round Delphi approach. An internet questionnaire was developed for pharmacists in order to construct validity and reliability of the instrument. The literature search yielded 3,276 records, of which 12 studies satisfied the inclusion criteria. Overall, the greatest number of studies were based surveys to assess patients' satisfaction and used literature review combined with expert's opinion for the instrument development. All studies presented some psychometrics properties of the instrument. Internal consistency and content validity were the most reported criteria of the studies and none of them presented stability. Eleven (68.8%) experts participated in the Delphi round 1 and nine (81.8%) experts completed the 2 Delphi rounds. A new KPI was develop after expert panel assessment in the first round. Overall, content and construct validity were reached for final instrument. The results of this thesis point out that instrument of the studies identified in the systematic review presented some psychometrics properties, but did not describe them satisfactorily. In addition, a set of six key performance indicators was developed and validated for medication management services provided for outpatients

New classification system for indications for endoscopic retrograde cholangiopancreatography predicts diagnoses and adverse events.

BACKGROUND: Indications for endoscopic retrograde cholangiopancreatography (ERCP) have received little attention, especially in scientific or objective terms. AIM: To review the prevailing ERCP indications in the literature, and to propose and evaluate a new ERCP indication system, which relies on more objective pre-procedure parameters. METHODS: An analysis was conducted on 1758 consecutive ERCP procedures, in which contemporaneous use was made of an a-priori indication system. Indications were based on the objective pre-procedure parameters and divided into primary [cholangitis, clinical evidence of biliary leak, acute (biliary) pancreatitis, abnormal intraoperative cholangiogram (IOC), or change/removal of stent for benign/malignant disease] and secondary [combination of two or three of: pain attributable to biliary disease ('P'), imaging evidence of biliary disease ('I'), and abnormal liver function tests (LFTs) ('L')]. A secondary indication was only used if a primary indication was not present. The relationship between this newly developed classification system and ERCP findings and adverse events was examined. RESULTS: The indications of cholangitis and positive IOC were predictive of choledocholithiasis at ERCP (101/154 and 74/141 procedures, respectively). With respect to secondary indications, only if all three of 'P', 'I', and 'L' were present there was a statistically significant association with choledocholithiasis (χ2(1) = 35.3, p < .001). Adverse events were associated with an unusual indication leading to greater risk of unplanned hospitalization (χ2(1) = 17.0, p < .001). CONCLUSIONS: An a-priori-based indication system for ERCP, which relies on pre-ERCP objective parameters, provides a more useful and scientific classification system than is available currently.

Quality Indicators in Cranial Neurosurgery: Which Are Presently Substantiated? A Systematic Review.

BACKGROUND: Owing to the rising costs of health care delivery, the quality of delivered care has become a central issue across all medical specialties. Consequently, there is increasing pressure to create standardized frameworks for measuring quality of care. In the field of cranial neurosurgery, health care administrators have begun applying quality measures that are easily available but might be inaccurate in measuring the quality of care. METHODS: We performed a systematic literature review on quality indicators (QIs) that are presently used in this field, aiming to elucidate which QIs are scientifically founded and thus potentially justifiable as measures of quality. We found a total of 8 QIs, and methodologically evaluated published studies according to the AIRE (Appraisal of Indicators through Research and Evaluation) criteria. These criteria include length of hospital stay, all-cause readmission rate, and unplanned reoperation rate. RESULTS: Our review indicates that these presently used or proposed QIs for neurosurgery lack scientific rigor and are restricted to rudimentary measures, and that further research is necessary. CONCLUSIONS: Neurosurgeons need to define their own QIs and actively participate in the validation of these QIs to provide the best possible patient outcomes. More reliable clinical registries, obligatory for all neurosurgical services, should be established as a basis for establishing such indicators, with risk adjustment being an important element of any such indicators.

Protocol for a scoping review study to identify and classify patient-centred quality indicators.

INTRODUCTION: The concept of patient-centred care (PCC) is changing the way healthcare is understood, accepted and delivered. The Institute of Medicine has defined PCC as 1 of its 6 aims to improve healthcare quality. However, in Canada, there are currently no nationwide standards in place for measuring and evaluating healthcare from a patient-centred approach. In this paper, we outline our scoping review protocol to systematically review published and unpublished literature specific to patient-centred quality indicators that have been implemented and evaluated across various care settings. METHODS AND ANALYSIS: Arksey and O'Malley's scoping review methodology framework will guide the conduct of this scoping review. We will search electronic databases (MEDLINE, EMBASE, the Cochrane Library, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, Social Work Abstracts, Social Services Abstracts), grey literature sources and the reference lists of key studies to identify studies appropriate for inclusion. 2 reviewers will independently screen all abstracts and full-text studies for inclusion. We will include any study which focuses on quality indicators in the context of PCC. All bibliographic data, study characteristics and indicators will be collected and analysed using a tool developed through an iterative process by the research team. Indicators will be classified according to a predefined conceptual framework and categorised and described using qualitative content analysis. ETHICS AND DISSEMINATION: The scoping review will synthesise patient-centred quality indicators and their characteristics as described in the literature. This review will be the first step to formally identify what quality indicators have been used to evaluate PCC across the healthcare continuum, and will be used to inform a stakeholder consensus process exploring the development of a generic set of patient-centred quality indicators applicable to multiple care settings. The results will be disseminated through a peer-reviewed publication, conference presentations and a one-day stakeholder meeting.

Developing robust composite measures of healthcare quality - Ranking intervals and dominance relations for Scottish Health Boards.

Although composite indicators are widely used to inform health system performance comparisons, such measures typically embed contentious assumptions, for instance about the weights assigned to constituent indicators. Moreover, although many comparative measures are constructed as ratios, the choice of denominator is not always straightforward. The conventional approach is to determine a single set of weights and to choose a single denominator, even though this involves considerable methodological difficulties. This study proposes an alternative approach to handle incomplete information about an appropriate set of weights and about a defensible denominator in composite indicators which considers all feasible weights and can incorporate multiple denominators. We illustrate this approach for comparative quality assessments of Scottish Health Boards. The results (displayed as ranking intervals and dominance relations) help identify Boards which cannot be ranked, say, worse than 4th or better than 7th. Such rankings give policy-makers a sense of the uncertainty around ranks, indicating the extent to which action is warranted. By identifying the full range of rankings that the organizations under comparison may attain, the approach proposed here acknowledges imperfect information about the "correct" set of weights and the appropriate denominator and may thus help to increase transparency of and confidence in health system performance comparisons.

Uso de la clasificación de Robson en un Hospital Comarcal de España para reducir la tasa de cesáreas / Use of the Robson classification in a Regional Hospital in Spain to reduce the rate of cesarean sections

ANTECEDENTES: En las últimas décadas se ha producido un incremento extraordinario en la incidencia de cesáreas en todos los países desarrollados. La tasa de cesáreas en España registrada por el Ministerio de Sanidad es de 24,9%. OBJETIVO: Analizar las cesáreas en el Hospital La Inmaculada, mediante la clasificación de Robson para comparar con otros hospitales, tanto nacional como internacionalmente y establecer las intervenciones posibles para reducir la tasa de cesáreas. MÉTODOS: Se realiza una auditoría retrospectiva de cesáreas en función de la clasificación de diez grupos establecida por Robson desde el 1 enero de 2006 al 31 de diciembre de 2013. RESULTADOS: Se han analizado 9337 partos y 1507 cesáreas con un 16,14%. En la contribución al porcentaje de cesáreas en primer lugar con 25,2% corresponde a nulíparas con un feto único en presentación cefálica, de 37 semanas o más de embarazo. En segundo lugar las multíparas con al menos una cesárea previa, con un feto único en presentación cefálica, de 37 semanas o más de embarazo con 19,4%. En este grupo se ha realizado un 42,2% de cesáreas. En tercer lugar nulíparas con un feto único en presentación cefálica, de 37 semanas o más de embarazo, que han iniciado el parto de forma espontánea con 17,4%. CONCLUSIONES: El aumento de cesáreas en las últimas décadas hace necesario la realización de auditorías mediante un sistema de clasificación, como Robson, para establecer los grupos en los que es posible disminuir el número de cesáreas.

INTRODUCTION: In recent decades there has been a dramatic increase in cesarean section rate in all developed countries. The cesarean section rate in Spain, registered by the Ministry of Health was 24.9%. OBJECTIVE: To analyze cesarean section rate in Inmaculada Local Hospital, using Robson's classification to compare it with other hospitals, both at national and international level and establish potential interventions to reduce such rate. METHODS: A cesarean section rate retrospective audit was performed according to Robson's classification, from 1st January 2006 to 31st December 2013. RESULTS: 9337 deliveries and 1507 cesareans were analyzed on that period of time. The cesarean rate was 16.14%. Nulliparous women with a singleton pregnancy in cephalic presentation at 37 weeks or more and undergo a labor induction before the onset of labor represent the first group of the cesareans with 25.2% of the total. In second place comes multiparous women with at least one previous cesarean section with a singleton pregnancy in cephalic presentation, 37 weeks or more, representing 19.4% of the total cesareans. This group had a 42.2% cesarean rate. In third place (17.4%) we had nulliparous women with a singleton pregnancy in cephalic presentation, 37 weeks or more, who have started labor spontaneously. CONCLUSIONS: Increased cesarean section rate in recent years required audits using a classification system, like Robson's one, to establish the groups in which it is possible to reduce the number of cesareans.