Low-Risk Antenatal Care Enhanced by Telemedicine: A Practical Guideline Model / Atenção ao pré-natal de baixo risco potencializada por telemedicina: Diretriz clínica prática

Abstract Objective To develop a protocol for hybrid low-risk prenatal care adapted to Brazilian guidelines, merging reduced face-to-face consultations and remote monitoring. Methods The PubMed, Embase, and Cochrane Library databases were systematically searched on telemedicine and antenatal care perspectives and adaptation of the low-risk prenatal care protocols recommended by the Ministry of Health and by the Brazilian Federation of Gynecology and Obstetrics Associations. Results Five relevant articles and three manuals were included in the review, for presented criteria to develop this clinical guideline. We identified, in these studies, that the schedule of consultations is unevenly distributed among the gestational trimesters, and ranges from 7 to 14 appointments. In general, the authors propose one to two appointments in the first trimester, two to three appointments in the second trimester, and two to six appointments in the third trimester. Only three studies included puerperal evaluations. The routine exams recommended show minimal variations among authors. To date, there are no validated Brazilian protocols for prenatal care by telemedicine. The included studies showed that pregnant women were satisfied with this form of care, and the outcomes of interest, except for hypertensive diseases, were similar between the groups exposed to traditional and hybrid prenatal care. Conclusion The presented guideline comprises the Ministry of Health recommendations for low-risk prenatal care and reduces exposure to the hospital environment and care costs. A randomized clinical trial, to be developed by this group, will provide real-world data on safety, effectiveness, satisfaction, and costs.

Resumo Objetivo Desenvolver uma diretriz clínica híbrida para atendimento pré-natal de baixo risco, mesclando consultas presenciais e remotas por telemedicina, adapta às recomendações brasileiras. Métodos Revisão sistemática da literatura nas bases de dados PubMed, Embase e Cochrane e adaptação dos protocolos de atenção ao pré-natal de baixo risco preconizados pelo Ministério da Saúde e pela Federação Brasileira das Associações de Ginecologia e Obstetrícia. Resultados Cinco artigos relevantes e três manuais foram incluídos na revisão por preencherem critérios para o desenvolvimento desta diretriz clínica. Nos estudos incluídos, identificou-se que o cronograma de consultas se distribui de forma desigual entre os trimestres gestacionais, variando entre 07 e 14 encontros. De forma geral, os autores propõem uma a duas consultas no primeiro trimestre, duas a três consultas no segundo trimestre e duas a seis consultas no terceiro trimestre. Somente três estudos incluíram avaliações puerperais. A rotina de exames preconizada apresenta mínimas variações entre os autores. Até o momento, não existem protocolos brasileiros validados para atendimento pré-natal por telemedicina. Os estudos incluídos evidenciaram a satisfação das gestantes em relação a esta forma de atendimento, e os desfechos de interesse, excetuando doenças hipertensivas, foi semelhante entre os grupos expostos ao pré-natal tradicional e ao pré-natal híbrido. Conclusão A diretriz apresentada contempla as recomendações do Ministério da Saúde para atendimento pré-natal de gestantes de baixo risco, reduz a exposição ao ambiente hospitalar e os custos de atendimento. Seu emprego em um ensaio clínico randomizado, a ser desenvolvido por este grupo, proporcionará dados de mundo real, relativos à segurança, efetividade, satisfação e custos.

Comparison of Current Status of Drug Management in Clinical Trials between China and the United States / 中国药房

OBJECTIVE： To put forward the suggestions for improving drug management in clinical drug trials in China. METHODS： “Good clinical practice” “Clinical trials drug” “Drugs for clinical trials” “GCP” “Investigational drug products” as search terms， searching CNKI database， Wanfang database， PubMed database and OVID electronic journal full-text database during Jul. 2014-Jul. 2018. The differences of drug management guidelines and management systems （including management model， staffing and budget evaluation） in clinical drugs between China and the United States were summarized. The suggestions were put forward to the shortage of drugs management of clinical trials in China. RESULTS & CONCLUSIONS： A total of 154 literatures were retrieved， including 33 valid literatures. The guidelines for drug management in clinical trials in the United States were relatively perfect， such as the Guidelines for Drug Management in Clinical Trials promulgated by the American Society of Hospital Pharmacists， while China had not yet published such national guidelines. The drug management in clinical trials in the United States had two modes which is the management of part-time pharmacists in hospital pharmacy department and the management of several full-time pharmacists and pharmacy technicians. Pharmacists or pharmaceutical technicians participated in the whole process of management， and a lot of research was carried out on the budget evaluation of clinical trials drug management. Domestic clinical trials drug management included three modes which is full-time pharmacist management， full-time pharmacist and part-time nurse management， part-time pharmacist and part-time nurse management. Pharmacists and nurses jointly participated in the management， but the whole process management had not yet been achieved， and there were few studies on budget evaluation of clinical trials drug management. It is suggested that the management of clinical trials drug in China can improve the management efficiency and level of clinical trials drug by refining the management system of clinical trials drug， standardizing the management mode of clinical trials drug and carrying out management budget evaluation.

Treatment and Management of Late Complications in Hereditary Hemolytic Anemia / 임상소아혈액종양

Hereditary hemolytic anemia is a very heterogeneous disorder in which abnormalities of red blood cell structural protein, globin protein, or enzyme defect lead to shortened life span. There has been much progress in revealing its pathophysiology and genetic backgrounds, but the lifelong plans for caring these patients are not well established yet. All patients with hereditary hemolytic anemic have three common problems: transfusion dependency, iron overload and iron chelation therapy. Patients with hereditary spherocytosis (HS) usually manifest severe anemia in neonatal period and infancy, but transfusion requirements may decrease in adulthood. But patients with thalassemia or sickle cell disease usually transfusion-dependent throughout life. Maintaining the optimal hemoglobin (Hb) levels in these patients is crucial because correction of anemia and dilution of abnormal Hb helps prevent certain complications that frequently occur in these patients. Frequent transfusion leads to transfusion-mediated infection and hemochromatosis. Iron chelation therapy should be started early to prevent permanent organ damage. Folate therapy can be helpful in patients with hereditary spherocytosis. Regular evaluations for cholestasis should be started at age 5, and splenectomy with concurrent cholecystectomy can be considered if the patient has cholecystitis. Hydroxyurea can be used to reduce transfusion requirements and prevent complications in patients with β-thalassemia and sickle cell disease. Consensus on long-term management of patients with hereditary hemolytic anemia is lacking, especially for adult patients. But further efforts to build guidelines for long-term follow-up and management of the patients with hereditary hemolytic anemia in the context of Korean society are needed.

Treatment and Management of Late Complications in Hereditary Hemolytic Anemia / 임상소아혈액종양

Hereditary hemolytic anemia is a very heterogeneous disorder in which abnormalities of red blood cell structural protein, globin protein, or enzyme defect lead to shortened life span. There has been much progress in revealing its pathophysiology and genetic backgrounds, but the lifelong plans for caring these patients are not well established yet. All patients with hereditary hemolytic anemic have three common problems: transfusion dependency, iron overload and iron chelation therapy. Patients with hereditary spherocytosis (HS) usually manifest severe anemia in neonatal period and infancy, but transfusion requirements may decrease in adulthood. But patients with thalassemia or sickle cell disease usually transfusion-dependent throughout life. Maintaining the optimal hemoglobin (Hb) levels in these patients is crucial because correction of anemia and dilution of abnormal Hb helps prevent certain complications that frequently occur in these patients. Frequent transfusion leads to transfusion-mediated infection and hemochromatosis. Iron chelation therapy should be started early to prevent permanent organ damage. Folate therapy can be helpful in patients with hereditary spherocytosis. Regular evaluations for cholestasis should be started at age 5, and splenectomy with concurrent cholecystectomy can be considered if the patient has cholecystitis. Hydroxyurea can be used to reduce transfusion requirements and prevent complications in patients with β-thalassemia and sickle cell disease. Consensus on long-term management of patients with hereditary hemolytic anemia is lacking, especially for adult patients. But further efforts to build guidelines for long-term follow-up and management of the patients with hereditary hemolytic anemia in the context of Korean society are needed.

Management of Overweight and Obesity: Review of the "2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults" / 대한내과학회지

Obesity is a major contributor to many chronic diseases and a risk factor for cardiovascular disease. It is also associated with increased risk of all-cause and cardiovascular disease (CVD) mortality. Toward the goals of the American College of Cardiology (ACC) and American Heart Association (AHA) for preventing CVD and promoting cardiovascular health, the ACC and AHA have collaborated with the National Heart, Lung, and Blood Institute and professional organizations to develop the "2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults". The 2013 guideline is the second edition of the 'Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults: the Evidence Report' published in 1998. The new guideline maintains its focus on primary care practitioners (PCPs) and their patients in an effort to manage obesity more effectively and to reduce cardiovascular risk. The new guideline limits its scope by using five critical questions (CQs) and provides a summary of evidence-based recommendations and a treatment algorithm derived from the five CQs. The five CQs deal with the risks of overweight and obesity and the benefits of weight loss, and evaluate the following three treatment areas: diet, behavioral therapy, and surgical therapy. The recommendations and treatment algorithm serve as a guide for PCPs in the evaluation, prevention, and management of being overweight and obesity.

Development and Usability Test of a Website for Cancer Symptom Management / 대한의료정보학회지

OBJECTIVE: This study was conducted to develop cancer patients' symptom management guideline, and to develop and test the utility of the web-based guideline service system. METHODS: Based on the literature review, guidelines for symptom management for nausea/vomiting, fatigue, constipation, diarrhea, and oral mucositis were developed. A web-based cancer patients' symptom management system was developed on the basis of guideline developed in the first stage of the study. Forty-five oncology nurses were recruited and asked to evaluate and validate the system by rating level of satisfaction with function, content and effectiveness of the web-based service after they used the website for cancer patients care. RESULTS: Regarding the function of the system around 50% of oncology nurses expressed satisfaction with the system. Regarding the content of the system, nurses expressed highest satisfaction with reliability of information(66.7%) and lowest satisfaction with sufficiency of information (37.7%). Regarding the effectiveness of the system in terms of knowledge enhancement, about 40% of nurses indicated that they satisfied with the system. In terms of usefulness of the system, 48.9% of nurses expressed their satisfaction with the system. CONCLUSION: The result of this study has implications on future use of a web-based guideline for managing symptoms of cancer patients.