Implementing a Preoperative Anemia Optimization Protocol for Cardiovascular Surgery Patients: A Quality Improvement Project.

BACKGROUND: Patients with anemia have poorer outcomes following cardiac surgery than do those without anemia. To improve outcomes, the Enhanced Recovery After Surgery cardiac recommendations include optimizing patients' condition, including treating anemia, before surgery. LOCAL PROBLEM: Despite implementing Enhanced Recovery After Surgery initiatives, a midwestern cardiothoracic surgery group recognized a care gap in preoperative patients with anemia. No standardized protocol was in use. METHODS: An anemia optimization protocol was developed for perioperative care of patients with anemia. Data from retrospective medical record review were analyzed to determine relationships between protocol use and secondary outcomes. The protocol was created using best evidence and expert consensus. Cardiac surgery and hematology specialists revised the protocol and agreed on a final version. The protocol was integrated into the consultation process for cardiac surgery patients. RESULTS: During the implementation period, 23 of 55 patients with anemia (42%) received interventions via the anemia optimization protocol. The mean quantity of packed red blood cells transfused perioperatively per patient was 1.9 U in the protocol group and 3.5 U in the nonprotocol group. In the subgroup of patients experiencing postoperative acute kidney injury, the mean increase in creatinine level was 0.65 mg/dL in the protocol group and 1.52 mg/dL in the nonprotocol group. Four patients in the protocol group (17%) and 6 patients in the nonprotocol group (19%) experienced postoperative acute kidney injury. CONCLUSION: Preoperative anemia is associated with poorer cardiac surgical outcomes. Incorporating the anemia optimization protocol into practice may mitigate the risk of postoperative complications for patients with anemia. Continued use of the protocol is recommended.

[Ethics of care: Assessment of the ethical issues in the protocols or consensuses on mechanical restraint in force in Spain]. / Ética de los cuidados: valoración de los contenidos éticos en los protocolos o consensos de contención mecánica vigentes en España.

INTRODUCTION: Mechanical restraints are widely used in health care practice, despite the numerous ethical conflicts they raise. The aim of this study is to evaluate the ethical considerations contemplated in the current protocols on mechanical restraint in Spain. METHOD: Systematic review in PubMed, WOS and Scopus, Google and Google Scholar. An ad hoc list of 30 items was used to evaluate the ethical content of the protocols. The quality of guidelines was assessed with AGREE II. RESULTS: The need for informed consent (IC) is reflected in 72% of the documents, the IC model sheet is included in only 41% of them, the rest of the analyzed characteristics on IC are fulfilled in percentages between 6% (the document includes the need to reevaluate the indication for IC) and 31% (the document contemplates to whom it should be requested). More than 20 ethical contents are reflected in 31% of them and less than 10 in 19% of the guidelines. The quality of the guides, according to AGREE II, ranged from 27 to 116 points (maximum possible 161), with a mean score of 68.7. Only 9% of the documents were classified as high quality. Finally, the correlation between ethical content and quality measured with AGREE II was 0.75. CONCLUSIONS: The variability of ethical contents in guidelines on mechanical restraints is very high. The ethical requirements to be included in protocols, consensus or Clinical Practice Guidelines should be defined.

Early-onset neonatal sepsis: Effectiveness of classification based on ante- and intrapartum risk factors and clinical monitoring.

INTRODUCTION: In 2017, the French public health authority HAS published new guidelines for the management of newborns at risk of early bacterial neonatal infection. These guidelines were based on ante- and intrapartum risk factors and clinical monitoring. In January 2021, we implemented a new protocol based on these guidelines in our tertiary maternity unit. OBJECTIVES: To assess the impact of the protocol implemented on neonates' antibiotic prescriptions. METHOD: An "old protocol" group comprising newborns hospitalized between July 1, 2020 and December 31, 2020, was compared to a "new protocol" group formed between January 14, 2021 and July 13, 2021. Data were collected on infectious risk factors, antibiotic prescriptions, and emergency room visits within 2 weeks for an infection or suspected infection. RESULTS: The "old protocol" population comprised 1565 children and the "new protocol" population 1513. Antibiotic therapy was prescribed for 29 newborns (1.85 %) in the old protocol group versus 15 (0.99 %) in the new one (p = 0.05). The median duration was 5 days and 2 days respectively (p = 0.08). With the new protocol, newborns in category B were about 20 times more likely (p = 0.01), and those in category C about 54 times more likely (p = 0.005) to have an infection than those classified in categories N or A. CONCLUSION: This study demonstrates that clinical monitoring criteria enable reduced use and duration of antibiotic therapy and are reliable.

Postarrest Care Bundle Improves Quality of Care and Clinical Outcomes in the Normothermia Era.

PURPOSE: Temperature targets in patients with cardiac arrest and return of spontaneous circulation (ROSC) have changed. Changes to higher temperature targets have been associated with higher breakthrough fevers and mortality. A post-ROSC normothermia bundle was developed to improve compliance with temperature targets. METHODS: In August 2021, "ad hoc" normothermia at the discretion of the attending intensivist was initiated. In December 2021, a post-ROSC normothermia protocol was implemented, incorporating a rigorous, stepwise approach to fever prevention (temperature ≥ 37.8). We conducted a before-after cohort study of all adult patients post-ROSC who survived to intensive care unit admission between August 1, 2021, and April 1, 2022. They were divided into "ad hoc" and "protocol" groups. Clinical outcomes compared included fevers, active cooling, and paralytic use. RESULTS: Fifty-eight post-ROSC patients were admitted; 24 in the "ad hoc" and 34 in the "protocol" groups. Patient demographics were similar between groups. The "ad hoc" group had more shockable rhythms (67% vs 24%, P = .001) and cardiac catheterizations (42% vs 15%, P = .03). The "protocol" group were significantly less likely to have a fever at 40 h (6% vs 40%, P < .001) and 72 h (14% vs 65%, P ≤ .001). Patients in the normothermia "protocol" used significantly less neuromuscular blocking agents (24% vs 50%, P = .05). The normothermia "protocol" resulted in similar mortality (56% vs 58%, P = 1.0). CONCLUSION: Use of a normothermia "protocol" resulted in fewer fevers and less neuromuscular blocker administration compared to "ad hoc" management. A protocolized approach for improved quality of care should be considered in institutions adopting normothermia.

Validação do conteúdo de um protocolo de avaliação da motricidade orofacial em lactentes / Content validation of an orofacial myofunctional assessment protocol for infants / Validación del contenido de un protocolo para la evaluación de la motricidad orofacial en bebés

Introdução: Muitos estudos têm se dedicado a compreender melhor a dinâmica da avaliação das estruturas e funções estomatognáticas de lactentes; até a presente pesquisa não foram encontrados estudos específicos para essa faixa etária, até recentemente. Objetivo: Validar o conteúdo de um instrumento fonoaudiológico de avaliação da motricidade orofacial para lactentes na faixa etária de um mês a dois anos. Metodologia: Foi elaborado o instrumento para "avaliação fonoaudiológica da motricidade orofacial de lactentes de um mês a dois anos" a partir dos dados obtidos na literatura. A validação do conteúdo do instrumento se deu por meio da avaliação de quatro juízes para clareza dos itens propostos no protocolo e da representatividade dos mesmos no processo de validação do conteúdo. Os juízes classificaram cada item quanto à clareza, a partir de uma escala tipo Likert de quatro pontos, sendo: (4) muito claro, (3) claro, (2) pouco claro, (1) sem clareza, com o propósito de realizar a validação do conteúdo por meio da aplicação da equação do Índice de Validação do Conteúdo (IVC). Resultados: O protocolo desenvolvido possui 8 itens e uma breve anamnese: Hábitos Orais; Avaliação Estrutural; Respiração; Voz; Avaliação Funcional; Alimentação e Deglutição - líquidos e alimentos em pedaços; Diagnóstico Fonoaudiológico. A etapa seguinte contou com a análise da representatividade e para clareza dos itens do protocolo pelos juízes, e após a segunda análise, a validação do conteúdo resultou na permanência dos 8 itens com Índice de Validade de Conteúdo total de 100%. Conclusão: O conteúdo do protocolo foi considerado válido para uso na avaliação do público-alvo, comprovado por profissionais com experiência na área. A versão final do Protocolo de avaliação fonoaudiológica da motricidade orofacial de bebês foi finalizada com 8 itens de avaliação. (AU)

Introduction: The instruments for evaluating the structures and functions of the stomatognathic system in babies have been lacking in studies. Objective: To validate the content of a speech-language instrument to assess orofacial motricity for babies aged between one month and two years old. Methodology: The instrument for "speech-language assessment of the orofacial motricity of babies from one month to two years old" was created based on the data obtained by the integrative review. The instrument's content was validated through the evaluation of four judges. The judges classified each item according to clarity, based on a four-point Likert scale, as follows: (4) very clear, (3) clear, (2) lightly clear, (1) unclear, to perform content validation by applying the Content Validation Index (CVI) equation. Results: The developed protocol has eight items and a brief anamnesis: Oral Habits; Structural Assessment; Breathing; Voice; Functional Assessment; Feeding and Swallowing - liquids and food in pieces; and Speech-Language Diagnosis. The next step included the analysis of the representativeness of the protocol items by the judges. After the second analysis, the validation of the content resulted in the permanence of the eight items with a total Content Validity Index of 100%. Conclusion: The content of the protocol was considered valid for use in the evaluation of the target audience, proven by people with experience in the area. The final version of the Protocol for the Speech-Language Pathology Assessment of Orofacial Motricity in Babies was completed with eight assessment items. (AU)

Introducción: Los instrumentos para la evaluación de las estructuras y funciones del sistema estomatognático en los bebés han mostrado falta de estudios. Objetivo: Validar el contenido de un instrumento de fonoaudiología para la evaluación de la motricidad orofacial en bebés de un mes a dos años de edad. Metodología: Inicialmente, se llevó a cabo la elaboración del instrumento para la "evaluación logopédica de la motricidad orofacial de bebés de un mes a dos años de edad" propiamente dicho, a partir de los datos obtenidos por la revisión integradora. La validación del contenido del instrumento se realizó a través de la evaluación de cuatro jueces. Los jueces calificaron cada ítem en términos de claridad, utilizando una escala de Likert de cuatro puntos, de la siguiente manera: (4) muy claro, (3) claro, (2) poco claro, (1) poco claro, con el propósito de realizar la validación de contenido a través de la aplicación de la ecuación del Índice de Validación de Contenido (CVI). Resultados: después de la lectura y discusión de los artículos, fue posible desarrollar el protocolo que contiene 8 ítems y una breve anamnesis, que son: Hábitos Orales; Evaluación Estructural; Respiración; Voz; Evaluación Funcional; Alimentación y deglución: líquidos y alimentos en trozos; y; Diagnóstico de Patología del Habla-Lenguaje. El siguiente paso fue el análisis de la representatividad de los ítems del protocolo por parte de los jueces, y luego del segundo análisis, la validación de contenido resultó en la permanencia de 8 ítems con un Índice de Validez de Contenido total del 100%. Conclusión: El contenido del protocolo se consideró válido para su uso en la evaluación del público objetivo, confirmado por personas con experiencia en el área. La versión final del Protocolo de evaluación de la patología del habla y el lenguaje para la motricidad orofacial en bebés se completó con 8 ítems de evaluación. (AU)

Com Ciência e Com Respeito: episódio 12

Neste segundo especial sobre a Cartilha dos Direitos dos Participantes de Pesquisa, vamos falar sobre o direito de entender a pesquisa, antes, durante e depois da mesma.

Com Ciência e Com Respeito: episódio 11

Por que projetos de pesquisa com metodologias das Ciências Humanas e Sociais precisam de análise ética? Quais os critérios dessas análises? Descubra essa e outras respostas no nosso 11º episódio."

Com Ciência e Com Respeito: episódio 10

Neste episódio, continuamos conversando sobre o que mudou, com a pandemia, na metodologia das pesquisas, e porque essas mudanças foram importantes para que os direitos dos participantes de pesquisa continuassem a ser protegidos.

A suggested protocol for the endocrine postoperative management of patients undergoing pituitary surgery.

PURPOSE: Endocrine disorders are the most frequent postoperative complications in patients undergoing pituitary surgery. Given the absence of recent guidelines on the postoperative care following pituitary surgery, this article summarizes the available evidence on the topic. METHOD: We conducted a systematic search of PubMed up to 2021 and updated the search in December 2022. We retrieved 119 articles and included 53 full-text papers. RESULTS: The early postoperative care consists of the assessment for cortisol deficiency and diabetes insipidus (DI). Experts suggest that all patients should receive a glucocorticoid (GC) stress dose followed by a rapid taper. The decision for GC replacement after discharge depends on the morning plasma cortisol level on day 3 after surgery. Experts suggest that patients with a morning plasma cortisol<10 mcg/dL should receive GC replacement at discharge, and those with 10-18 mcg/dL a morning dose only, with formal assessment of the hypothalamic-pituitary-adrenal axis at week 6 postoperatively. When the cortisol level is>18 mcg/dL, the patient can be discharged safely without GC, as suggested by observational studies. Postoperative care also includes a close monitoring of water balance. If DI develops, desmopressin is used only in case of uncomfortable polyuria or hypernatremia. The assessment of other hormones is indicated at 3 months postoperatively and beyond. CONCLUSION: The evaluation and treatment of patients following pituitary surgery are based on expert opinion and a few observational studies. Further research is needed to provide additional evidence on the most appropriate approach.

Protocolo clínico de atendimento de pneumonia adquirida na comunidade para Pronto-Socorro Infantil do Hospital do Servidor Público Municipal de São Paulo / Clinical protocol for community-acquired pneumonia care for the Children's Emergency Room of the Hospital do Servidor Público Municipal de São Paulo

A pneumonia adquirida na comunidade (PAC) é a infecção aguda do parênquima pulmonar que ocorre no meio comunitário. A PAC representa a maior causa de morbidade e mortalidade em todo o mundo em crianças abaixo de cinco anos. Nesta faixa etária, a etiologia viral é a mais comum; porém, dentre as causas bacterianas, o Streptoccocus pneumoniae é o mais prevalente. As manifestações clínicas variam de acordo com o patógeno, hospedeiro e da gravidade da doença, sendo geralmente descrita com tosse, febre e desconforto respiratório. A PAC complicada é a pneumonia que, apesar do uso de antibióticos, evolui com complicações locais ou sistêmicas. Nos pacientes hospitalizados, as hemoculturas devem ser consideradas para auxiliar no diagnóstico etiológico e planejamento terapêutico. O tratamento inicial deve ser iniciado empiricamente com antibióticos. Caso haja necessidade de hospitalização, hemoculturas devem ser consideradas para auxiliar na propedêutica. Após implementação das vacinas pneumocócicas, principalmente após introdução da vacina pneumocócica 13 valente (PCV 13), houve redução significativa dos casos de pneumonia bacteriana e também da necessidade hospitalização. Diante de tal realidade, a elaboração do trabalho possui como objetivo a melhora dos procedimentos e a padronização dos atendimentos da população pediátrica com um quadro clínico sugestivo pneumonia adquirida na comunidade, que procura o serviço de Pronto Atendimento Infantil do Hospital do Servidor Público Municipal de São Paulo (HSPM), ao construir um protocolo clínico de atendimento específico para a doença. O presente trabalho objetiva elaborar um protocolo clínico de atendimento de pneumonia adquirida na comunidade no Hospital do Servidor Público Municipal de São Paulo, contribuindo na assistência médica dos pacientes pediátricos. Apesar do grande avanço com a introdução das vacinas pneumocócicas, a PAC ainda representa uma importante causa de mortalidade na população infantil, sendo fundamental a elaboração de protocolos clínicos para abordar corretamente os pacientes que recorrem a um Pronto Socorro Infantil. Protocolos clínicos são diretrizes fundamentadas nas melhores práticas para a abordagem e tratamento de determinadas doenças, baseadas em evidência científica. O presente trabalho objetiva a melhora dos procedimentos e a uniformização dos atendimentos da população pediátrica com pneumonia, que procura o serviço de Pronto Atendimento Infantil do Hospital do Servidor Público Municipal de São Paulo (HSPM), com a construção de um protocolo clínico de atendimento específico para a doença, a partir da revisão de literatura atualizada, cujo período de vigência seguirá os progressos científicos sobre o tema. Palavras-chave: Pneumonia Adquirida da Comunidade. Protocolos clínicos. Pediatria. Serviços Médicos de Emergência. Vacinas Pneumocócicas

Guidelines for Reporting Outcomes in Trial Protocols: The SPIRIT-Outcomes 2022 Extension.

Importance: Complete information in a trial protocol regarding study outcomes is crucial for obtaining regulatory approvals, ensuring standardized trial conduct, reducing research waste, and providing transparency of methods to facilitate trial replication, critical appraisal, accurate reporting and interpretation of trial results, and knowledge synthesis. However, recommendations on what outcome-specific information should be included are diverse and inconsistent. To improve reporting practices promoting transparent and reproducible outcome selection, assessment, and analysis, a need for specific and harmonized guidance as to what outcome-specific information should be addressed in clinical trial protocols exists. Objective: To develop harmonized, evidence- and consensus-based standards for describing outcomes in clinical trial protocols through integration with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 statement. Evidence Review: Using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, the SPIRIT-Outcomes 2022 extension of the SPIRIT 2013 statement was developed by (1) generation and evaluation of candidate outcome reporting items via consultation with experts and a scoping review of existing guidance for reporting trial outcomes (published within the 10 years prior to March 19, 2018) identified through expert solicitation, electronic database searches of MEDLINE and the Cochrane Methodology Register, gray literature searches, and reference list searches; (2) a 3-round international Delphi voting process (November 2018-February 2019) completed by 124 panelists from 22 countries to rate and identify additional items; and (3) an in-person consensus meeting (April 9-10, 2019) attended by 25 panelists to identify essential items for outcome-specific reporting to be addressed in clinical trial protocols. Findings: The scoping review and consultation with experts identified 108 recommendations relevant to outcome-specific reporting to be addressed in trial protocols, the majority (72%) of which were not included in the SPIRIT 2013 statement. All recommendations were consolidated into 56 items for Delphi voting; after the Delphi survey process, 19 items met criteria for further evaluation at the consensus meeting and possible inclusion in the SPIRIT-Outcomes 2022 extension. The discussions during and after the consensus meeting yielded 9 items that elaborate on the SPIRIT 2013 statement checklist items and are related to completely defining and justifying the choice of primary, secondary, and other outcomes (SPIRIT 2013 statement checklist item 12) prospectively in the trial protocol, defining and justifying the target difference between treatment groups for the primary outcome used in the sample size calculations (SPIRIT 2013 statement checklist item 14), describing the responsiveness of the study instruments used to assess the outcome and providing details on the outcome assessors (SPIRIT 2013 statement checklist item 18a), and describing any planned methods to account for multiplicity relating to the analyses or interpretation of the results (SPIRIT 2013 statement checklist item 20a). Conclusions and Relevance: This SPIRIT-Outcomes 2022 extension of the SPIRIT 2013 statement provides 9 outcome-specific items that should be addressed in all trial protocols and may help increase trial utility, replicability, and transparency and may minimize the risk of selective nonreporting of trial results.

To Improve the Initial Inpatient Management of Adolescents Admitted with Severe Anorexia Nervosa: A Narrative Review and a Convenient Protocol.

Inadequate nutritional rehabilitation of severely malnourished adolescents with Anorexia Nervosa (AN) increases the risk of medical complications. There is no consensus on best practices for inpatient nutritional rehabilitation and medical stabilization for severe AN. This study aimed to elaborate an admission protocol for adolescents with severe AN based on a comprehensive narrative review of current evidence. A Pubmed search was conducted in July 2017 and updated in August 2020, using the keywords severe AN or eating disorders (ED), management guidelines and adolescent. Relevant references cited in these guidelines were retrieved. A secondary search was conducted using AN or ED and refeeding protocol, refeeding syndrome (RS), hypophosphatemia, hypoglycemia, cardiac monitoring or cardiac complications. Evidence obtained was used to develop the admission protocol. Selective blood tests were proposed during the first three days of nutritional rehabilitation. Higher initial caloric intake is supported by evidence. Continuous nasogastric tube feeding was proposed for patients with a BMI < 12 kg/m2. We monitor hypoglycemia for 72 h. Continuous cardiac monitoring for bradycardia <30 BPM and systematic phosphate supplementation should be considered. Developing protocols is necessary to improve standardization of care. We provide an example of an inpatient admission protocol for adolescents with severe AN.

STEP-WISE APPROACH TO THE MANAGEMENT OF SUBMACULAR HEMORRHAGE USING PNEUMATIC DISPLACEMENT AND VITRECTOMY: The Manchester Protocol.

PURPOSE: To evaluate a sequential approach of pneumatic displacement followed by vitrectomy (pars plana vitrectomy) in failed cases to deal with submacular hemorrhage (SMH) of various etiologies. METHODS: Retrospective, nonrandomized interventional case series of consecutive patients with SMH of up to 2 weeks' duration, who were treated with a stepwise approach. Step 1 involved intravitreal injection of 0.3 mL 100% C3F8 and recombinant tissue plasminogen activator 50 µg/0.1 mL. If unsuccessful, a prompt pars plana vitrectomy with subretinal recombinant tissue plasminogen activator 50 µg/0.1 mL and 20% SF6 gas tamponade was performed as a second attempt to displace the SMH. RESULTS: Thirty-one patients with SMH underwent pneumatic displacement; 24 (77.4%) had a successful outcome without further intervention. The mean presenting visual acuity of the "successful cohort" was 1.34 logMAR (20/440 Snellen), improving to 0.83 logMAR (20/135 Snellen) 1 month after treatment. Five of the seven patients with failed pneumatic displacement underwent pars plana vitrectomy with subretinal recombinant tissue plasminogen activator at an average of 5 days poststep 1, with successful SMH displacement in 3 patients, giving an overall success of 87.1% for this treatment protocol. CONCLUSION: A sequential approach of expansile gas injection followed by prompt pars plana vitrectomy, aided by recombinant tissue plasminogen activator at both steps, is a coherent, logical pathway to treat SMH with high anatomical and functional success.

Blood shortages and changes to massive transfusion protocols: Survey of hospital practices during the COVID-19 pandemic.

INTRODUCTION: The COVID-19 pandemic has resulted in severe ongoing blood shortages across the US, despite employment of numerous blood-conservation measures. Massive transfusion protocols (MTP) are one resource-intensive practice that utilize significant amounts of blood products. Alterations to the composition of MTP parameters to conserve scarce biologic resources have hitherto not been examined during the pandemic. METHODS: An anonymous 18-question survey was administered to 115 hospitals with valid email contact information. Survey questions addressed whether institutions have altered their MTPs due to the COVID-19 pandemic and blood shortages, and if so, what adjustments they have made. Additional details concerning potential differences in the number and cycles of MTPs and blood product wastage during the COVID-19 pandemic compared to the year prior were assessed. RESULTS: 50 responses were received (43 % response rate). 10 % (5/50) of institutions altered their MTPs utilizing a variety of approaches in attempt to conserve blood during the COVID-19 pandemic. Four additional institutions intend to alter them if it becomes necessary. Following onset of the COVID-19 pandemic, 24 % of institutions (12/50) reported an increase in monthly MTP activations, while 16 % (8/50) reported decreased activations compared to prior to the pandemic. 22 % (11/50) of institutions experienced increased blood wastage, whereas 16 % (8/50) reported decreased waste compared to pre-pandemic. DISCUSSION: The results of this survey highlight a variety of mechanisms by which institutions have attempted to conserve blood via altering MTPs. Whether an institution adjusted their MTP does not correlate with changes in blood product wastage compared to pre-pandemic.