Creation Of Clinical Guidelines Research Articles

396. Clinical Characterization of Long COVID in Mexico

Abstract Background Long COVID is defined as the persistence of symptoms after 4 weeks of an acute picture. There is talk of 65 million people affected in the world. In Mexico there are no statistics or studies that explore this entity in the population. Methods A descriptive, cross-sectional, and prospective study was carried out using an online survey, in adults who wish to participate and who are living in Mexico from January to March 2023, whose main objective is to characterize patients who present symptoms of Long COVID Results 336 participants with an average age of 41 years (range 18-79 years), the most affected gender is female (69%); Risk factors are Obesity 41%, Diabetes 16%, Hypertension 15.8%; 43.5% commented that they were healthy before COVID-19. Cases of acute COVID they have suffered, 42.3% comment that 2 previous infections, 29.5% had one and 28.3% 3 or more. 77% refer to mild COVID, 13% to severe COVID, and 10% both. Regarding vaccination, 45% have 3 or more vaccines, 36% 2 vaccines, 9% have one vaccine and 10% have not been vaccinated against COVID-19. The most prevalent symptoms are Neuropsychiatric 90%, Musculoskeletal 88%, Cardiovascular 82%, Gastrointestinal 78%, and Pulmonary 71%. The most frequent Neuropsychiatric symptoms: fatigue 76%, memory disorder 72%, anxiety 65%; Musculoskeletal symptoms are arthralgia 71.4%, myalgia 40%, arthritis 28%. Cardiovascular symptoms are palpitations 58%, tachycardia 38%, precordial pain 27%. Gastrointestinal symptoms are diarrhea 43%, abdominal pain 41%, Colitis 26%. Pulmonary symptoms are chronic cough 40%, persistent expectoration 29%, dyspnea 23%. Other symptoms are alopecia 53.3%, chronic dermatitis 38%, frequent infections after COVID-19 20%, menstrual disorders 17%, thyroid disease 12%, development of autoimmune diseases 9.5%, sexual dysfunction 9%, COVID tests persistently positive 6%, thrombotic events 3.6% (cerebral 0.9%, pulmonary thromboembolism 0.6%, myocardial infarction 0.3%), myocarditis 3.3%, chronic renal failure 2.4% and cancer 1.8%. Conclusion It is important to characterize this population since it has particularities that make it susceptible to this new entity and the creation of clinical guidelines in the country should be encouraged to begin limiting sequelae. Disclosures All Authors: No reported disclosures

Management of neonates with Neonatal Chronic Obstructive Cholangiopathy. Kasai surgery

Introduction: Kasai surgery is a relevant clinical treatment to eliminate bile duct defects outside the liver. Objective: identify the management of neonatal patients with chronic obstructive cholangiopathy undergoing Kasai surgery and describe the care, approach, treatment and management of patients framed in line 4 of epidemiological research of the Faculty of Health Sciences of University. Methods: the study was conducted according to the PRISMA guidelines for systematic reviews. The methodology is descriptive and qualitative. Results: the treatment proves to be effective, close care of postoperative complications has a positive effect to improve the surgical effect and delay the progression of the disease, to this is added the low importance of the psychological state of the caregiver, which can lead to a poor communication and coordination, thus affecting the treatment and rehabilitation of newborns. Conclusion: chronic obstructive cholangiopathy mainly requires care focused on the needs of the newborn, better adherence to medication, nutrition and postoperative complications. Research on the specific care to be implemented in this pathology is not established, there are few studies related to the subject. Therefore, health personnel should emphasize the investigation of this pathology to improve the level of care, focusing on the creation of clinical guidelines that support the processes applied in neonates

Retrospective study of older patient characteristics that increase the likelihood that a fracture was associated with abuse

ABSTRACT Searching for clinical manifestations of elder abuse may help healthcare professionals identify cases of elder abuse. The aim of the present study was to explore characteristics of older patients with fractures that increase the likelihood that the fracture was associated with abuse. This is a retrospective chart review study of 1,000 patients aged 65 and older who presented to an emergency department in northern-central Israel with a fracture during 2019. The chart review included participant characteristics – sociodemographic data, medical data, data regarding the fracture, and data on the presence of forensic markers of elder abuse in individual patients. Descriptive statistics and regression models were used for the analyses. Older age, presence of dementia, and hand and facial fractures were associated with the presence of forensic markers, and were also found to predict having at least one forensic factor. This study provides further support for the creation of clinical guidelines for identification of elder abuse.

The normative legal regulation of medical care support of rare (orphan) diseases in adult population of The Russian Federation

Law database was analyzed in terms of current orders of medical care provision, standards of medical care, and clinical guidelines for rare diseases from "List-24" regarding to adult patients. It is concluded that there are no determined rules of medical care provision to adult population in case of rare diseases from "List-24". There are standards of medical care on 6 rare diseases (25% of total diseases amount) from this list for adult patients. However, based on content analysis data of approved standards it was established that there are only 3 from 11 standards (27.28%) for primary medical care support, 4 standards (33.34%) for medical care provision in planned condition, and only 1 standard (9.09%) had appropriate legal basis for its development (clinical guidelines availability). Nevertheless, there is negative prognosis for this the only standard due to legal necessity of all clinical guidelines revision till the end of 2021. Revision and creation of clinical guidelines and standards of medical care afterwards are needed for adult patients treatment with rare diseases from "List-24". The conclusion was made in terms of medical care standardization improvement for adult patients suffering from rare diseases from "List-24" based on its alignment with current legal regulation.

Clinical practice guidelines appraisal and utilisation by Pharm.D. students

Objective: To assess the appraisal and utilisation of clinical practice guidelines (CPGs) by pharmacy final-year students. Methods: Four CPGs of 2017 were appraised by pharmacy students using the AGREE-II instrument. The utilisation of CPGs by pharmacy students was assessed using a cross-sectional survey and results were analysed using the Wilcoxon Signed Ranks test. Results: Of the six AGREE-II domains for CPGs, two domains were mid to high (>90%), two domains 76% each, and the last two domains <60%. The utilisation of CPGs by pharmacy students as a reference in reports/presentations were high. Students felt that they are relatively better able in lower Bloom's cognitive levels (knowledge and comprehension) than the higher abilities of application, evaluation, and creation of clinical guidelines, (p-value 0.006). Conclusions: Among AGREE-II domains, lower scores for CPGs were in editorial independence and applicability. Evaluation of CPGs by students is a useful tool to comprehend differences in their quality. More CPGs-related training in higher Bloom's cognitive levels is required for the Pharm.D. students.

Guidelines for sedation in gastroenterological endoscopy (second edition).

Sedation in gastroenterological endoscopy has become an important medical option in routine clinical care. Here, the Japan Gastroenterological Endoscopy Society and the Japanese Society of Anesthesiologists together provide the revised "Guidelines for sedation in gastroenterological endoscopy" as a second edition to address on-site clinical questions and issues raised for safe examination and treatment using sedated endoscopy. Twenty clinical questions were determined and the strength of recommendation and evidence quality (strength) were expressed according to the "MINDS Manual for Guideline Development 2017." We were able to release up-to-date statements related to clinical questions and current issues relevant to sedation in gastroenterological endoscopy (henceforth, "endoscopy"). There are few reports from Japan in this field (e.g., meta-analyses), and many aspects have been based only on a specialist consensus. In the current scenario, benzodiazepine drugs primarily used for sedation during gastroenterological endoscopy are not approved by national health insurance in Japan, and investigations regarding expense-related disadvantages have not been conducted. Furthermore, including the perspective of beneficiaries (i.e., patients and citizens) during the creation of clinical guidelines should be considered. These guidelines are standardized based on up-to-date evidence quality (strength) and supports on-site clinical decision-making by patients and medical staff. Therefore, these guidelines need to be flexible with regard to the wishes, age, complications, and social conditions of the patient, as well as the conditions of the facility and discretion of the physician.

Dentists' restorative decision-making and implications for an 'amalgamless' profession. Part 5: knowledge factors.

A phase-down of amalgam in Australia is possible given the Australian Government intends to ratify the Minamata Convention. There is little research as to the influence of a dentist's knowledge on decision-making, which may be of use when determining the impact of any change. An online survey relating to aspects of and attitudes to use of direct restorative materials was distributed to all dentists who were members of the Australian Dental Association or Members or Fellows of the Royal Australasian College of Dental Surgeons. There were 408 respondents. Fifty-eight per cent agreed that there was consistency in undergraduate teaching. Fifty-two per cent stated that there was a difference between undergraduate teaching and the 'real world'. Postgraduate education was ranked the most important influence on decision-making. Ninety-six per cent stated that knowledge of the evidence base is important and 89% believed that they practised evidence-based dentistry. Dental schools need to maintain teachers' and students' understanding of the evolving technology of direct restorative materials. There is a perceived disconnect between undergraduate teaching and the 'real' world. The evidence base is viewed as confusing, contradictory and not readily understandable. The creation of clinical guidelines would be useful.

Designing Radiology Outcomes Studies—Essential Principles

Health outcomes research is essential to align radiology with current standards of high-value patient care, through the assessment of end results of diagnostic tests, interventions, or policy on patient health. To bridge studies of diagnostic test accuracy and health outcomes research, key considerations include: (1) how to determine when a diagnostic test merits evaluation of impact on outcomes, (2) when study of intermediate/surrogate outcomes can be useful, (3) how to consider the possible harms as well as potential benefits of a test, and (4) how to integrate evidence of an imaging test's efficacy/effectiveness with clinical data to assess outcomes. Due to challenges in conducting studies of long-term outcomes consequent to imaging use, intermediate health outcomes may capture a test's impact on successful diagnosis and therapy, and can provide readily measurable, incremental insights into the role of imaging in health-care delivery and efficiency. In an era marked by recognition of quality and value of care, outcomes research will provide essential evidence to inform radiologists' guidance of imaging use toward improved patient care, creation of clinical guidelines, and policy decisions.

PHP42 - Analysis of Brazilian Public Funding Process for New Biologic Drugs

To ascertain if the Brazilian HTA body CONITEC, which replaced CITEC in December 2011, is delivering on Ministry of Health (MoH) promises of transparency and set assessment timelines whilst adopting mandatory evidence requirements for new biologic drug funding decisions via the Unified Healthcare System (SUS). Secondary research based on CONITEC’s final reimbursement recommendation reports, evaluating existing and sponsor submitted data. These reports include deliberations from a plenary assembly of representatives from the MoH, drug regulator ANVISA and supplementary health regulator ANS, as well as public consultation contributions. CONITEC has delivered on transparency with publications of the rationale behind each of its recommendations, thus enabling pharmaceutical firms to understand how to respond. The 180 day initial analysis phase deadline is being met but evaluation of the implementation phase timeline is premature. Out of the final recommendations published to date for biologics, about 40% correspond to a funding rejection. Biologic medicines have been denied funding from psoriasis to wet AMD due to lack of cost-effectiveness as well as efficacy and safety studies of short duration and small patient populations. The rejection of everolimus for a rare brain tumour shows that orphan drugs are not being treated differently. Positive endorsements of biologics from breast cancer to rheumatoid arthritis come with recommendations of significant price cuts and creation of clinical guidelines. Manufacturers are struggling to adjust to evidence requirements needed in supporting funding applications for new biologics, including orphan drugs. Transparency is evident in CONITEC’s analysis phase but is absent after a positive recommendation, when the MoH ascertains how the medicine will be offered by SUS. Nonetheless, this is an advance compared to the CITEC process, whereby decisions were not made public and there were no clear timelines.

Pseudomonas aeruginosa infection in patients with cystic fibrosis: scientific evidence regarding clinical impact, diagnosis, and treatment

Evidence-based techniques have been increasingly used in the creation of clinical guidelines and the development of recommendations for medical practice. The use of levels of evidence allows the reader to identify the quality of scientific information that supports the recommendations made by experts. The objective of this review was to address current concepts related to the clinical impact, diagnosis, and treatment of Pseudomonas aeruginosa infections in patients with cystic fibrosis. For the preparation of this review, the authors defined a group of questions that would be answered in accordance with the principles of PICO–an acronym based on questions regarding the Patients of interest, Intervention being studied, Comparison of the intervention, and Outcome of interest. For each question, a structured review of the literature was performed using the Medline database in order to identify the studies with the methodological design most appropriate to answering the question. The questions were designed so that each of the authors could write a response. A first draft was prepared and discussed by the group. Recommendations were then made on the basis of the level of scientific evidence, in accordance with the classification system devised by the Oxford Centre for Evidence-Based Medicine, as well as the level of agreement among the members of the group.

Assister la création de guides de bonnes pratiques par des techniques de recherche d’information

Objective: While the broad use of antibiotics has reached its limits with the apparition of bacterial resistance, it became of major importance to regulate antibiotic prescriptions. In this paper, we present KART, a system to facilitate the creation of clinical guidelines in the context of infectious diseases. Methods: This system is composed of three main modules. The first module aims at facilitating the step of systematic reviews with the use of question-answering techniques, in order to create recommendations by querying a question-answering engine. Then, the second module proposes an approach to semi-automatically normalize the different parameters forming clinical recommendations. Finally, the third module aims to automatically formalize and store the generated recommendations into a knowledge repository. Results: The question-answering module is able to answer about two thirds of the queries correctly. The normalization, however, has had very mixed success upon evaluation of the system by infectious diseases specialists. Conclusion: In conclusion, KART is an innovative and promising system to create clinical guidelines; however, preliminary qualitative and quantitative evaluations show the need for further improvements.

The role of group decision making processes in the creation of clinical guidelines

Guideline development groups are an integral part of evidence-based healthcare and will remain so for the foreseeable future. There is a need for the efficient production of high-quality guidelines both to ensure high standards of care and to conserve resources. Social psychological research on group processes provides valuable information that can be applied to studying the functioning of guideline development groups, including the methods they use to develop recommendations. This article describes four key concepts in the group process literature: information sharing, systematic processing, group development, and group potential productivity. We evaluate their importance for guideline development groups and conclude with methodological suggestions for the study of these complex processes.

La otitis media aguda en la era de la vacunación antineumocócica

Acute otitis media (AOM) is one of the most common childhood diseases and the main reason for prescribing antibiotics in developed countries. Indiscriminate treatment of children with an inconclusive diagnosis has favored the development of resistance, and this has led to the creation of clinical guidelines to promote judicious antibiotic use. AOM has shown high rates of spontaneous resolution and minimal benefits from antibiotics; hence a policy of observation for 48-72 hours before initiating treatment is justified in many children. In recent years, attention has been focused on developing effective vaccines against the most common causative pathogens, Streptococcus pneumoniae and Haemophilus influenzae. The H. influenzae type b conjugate vaccine has little impact on AOM since most strains are nontypable. The 7-valent pneumococcal conjugate vaccine has an efficacy of 55% in AOM caused by vaccine serotypes, but replacement with nonvaccine serotypes and nontypable H. influenzae reduce the overall efficacy of the vaccine to 6-8%. An overall decrease of pneumococcal resistance to penicillin has been seen in vaccinated children, but there is a trend to an increase in antibiotic resistance in non-vaccine serotypes. High-dose amoxicillin is the treatment of choice for AOM, but the increase of H. influenzae in pneumococcal-vaccinated children may require reconsideration of this recommendation in forthcoming guidelines.

Checklist for the qualitative evaluation of clinical studies with particular focus on external validity and model validity.

BackgroundIt is often stated that external validity is not sufficiently considered in the assessment of clinical studies. Although tools for its evaluation have been established, there is a lack of awareness of their significance and application. In this article, a comprehensive checklist is presented addressing these relevant criteria.MethodsThe checklist was developed by listing the most commonly used assessment criteria for clinical studies. Additionally, specific lists for individual applications were included. The categories of biases of internal validity (selection, performance, attrition and detection bias) correspond to structural, treatment-related and observational differences between the test and control groups. Analogously, we have extended these categories to address external validity and model validity, regarding similarity between the study population/conditions and the general population/conditions related to structure, treatment and observation.ResultsA checklist is presented, in which the evaluation criteria concerning external validity and model validity are systemised and transformed into a questionnaire format.ConclusionThe checklist presented in this article can be applied to both planning and evaluating of clinical studies. We encourage the prospective user to modify the checklists according to the respective application and research question. The higher expenditure needed for the evaluation of clinical studies in systematic reviews is justified, particularly in the light of the influential nature of their conclusions on therapeutic decisions and the creation of clinical guidelines.