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Pediatric transfusion is a complex area of medicine covering a wide age range, from neonates to young adults. Compared to adult practice, there is a relative lack of high-quality research to inform evidence-based guidelines. We aimed to adapt the pre-existing high-quality practice guidelines for the transfusion of blood components in different pediatric age groups to be available for national use by general practitioners, pediatricians, and other health care professionals. The guideline panel included 17 key leaders from different Egyptian institutions. The panel used the Adapted ADAPTE methodology. The panel prioritized the health questions and recommendations according to their importance for clinicians and patients. The procedure included searching for existing guidelines, quality appraisal, and adaptation of the recommendations to the target context of use. The guideline covered all important aspects of the indications, dosing, and administration of packed red cells, platelets, and fresh frozen plasma. It also included transfusion in special situations, e.g., chronic hemolytic anemia and aplastic anemia, management of massive blood loss, malignancies, surgery, recommendations for safe transfusion practices, and recommendations for modifications of cellular blood components. The final version of the adapted clinical practice guideline (CPG) has been made after a thorough review by an external review panel and was guided by their official recommendations and modifications. A set of implementation tools included algorithms, tables, and flow charts to aid decision-making in practice. This adapted guideline serves as a tool for safe transfusion practices in different pediatric age groups.
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Transfusão de Componentes Sanguíneos , Medicina Baseada em Evidências , Adolescente , Criança , Pré-Escolar , Humanos , Lactente , Recém-Nascido , Adulto Jovem , Transfusão de Sangue , Egito , Medicina Baseada em Evidências/métodos , HemorragiaRESUMO
Background and Objectives: Low-birth-weight (LBW) neonates are at increased risk of morbidity and mortality which are inversely proportional to birth weight, while macrosomic babies are at risk of birth injuries and other related complications. Many maternal risk factors were associated with the extremes of birthweight. The objectives of this study are to investigate maternal risk factors for low and high birthweight and to report on the neonatal complications associated with abnormal birth weights. Materials and Methods: We conducted a retrospective analysis of medical records of deliveries ≥ 23 weeks. We classified the included participants according to birth weight into normal birth weight (NBW), LBW, very LBW (VLBW), and macrosomia. The following maternal risk factors were included, mother's age, parity, maternal body mass index (BMI), maternal diabetes, and hypertension. The neonatal outcomes were APGAR scores < 7, admission to neonatal intensive care unit (NICU), respiratory distress (RD), and hyperbilirubinemia. Data were analyzed using SAS Studio, multivariable logistic regression analyses were used to investigate the independent effect of maternal risk factors on birthweight categories and results were reported as an adjusted odds ratio (aOR) and 95% Confidence Interval (CI). Results: A total of 1855 were included in the study. There were 1638 neonates (88.3%) with NBW, 153 (8.2%) with LBW, 27 (1.5%) with VLBW, and 37 (2.0%) with macrosomia. LBW was associated with maternal hypertension (aOR = 3.5, 95% CI = 1.62-7.63), while increasing gestational age was less likely associated with LBW (aOR = 0.51, 95% CI = 0.46-0.57). Macrosomia was associated with maternal diabetes (aOR = 3.75, 95% CI = 1.67-8.41), in addition to maternal obesity (aOR = 3.18, 95% CI = 1.24-8.14). The odds of VLBW were reduced significantly with increasing gestational age (aOR = 0.41, 95% CI = 0.32-0.53). In total, 81.5% of VLBW neonates were admitted to the NICU, compared to 47.7% of LBW and 21.6% of those with macrosomia. RD was diagnosed in 59.3% of VLBW neonates, in 23% of LBW, in 2.7% of macrosomic and in 3% of normal-weight neonates. Hyperbilirubinemia was reported in 37.04%, 34.21%, 22.26%, and 18.92% of VLBW, LBW, NBW, and macrosomic newborns, respectively. Conclusions: Most neonates in this study had normal birthweights. Maternal hypertension and lower gestational age were associated with increased risk of LBW. Additionally, maternal obesity and diabetes increased the risk of macrosomia. Neonatal complications were predominantly concentrated in the LBW and VLBW, with a rising gradient as birthweight decreased. The main complications included respiratory distress and NICU admissions.
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Diabetes Gestacional , Hipertensão , Obesidade Materna , Pré-Eclâmpsia , Síndrome do Desconforto Respiratório , Recém-Nascido , Gravidez , Feminino , Humanos , Peso ao Nascer , Resultado da Gravidez/epidemiologia , Macrossomia Fetal/epidemiologia , Macrossomia Fetal/etiologia , Estudos Retrospectivos , Arábia Saudita/epidemiologia , Diabetes Gestacional/epidemiologia , Recém-Nascido de muito Baixo Peso , Fatores de Risco , HiperbilirrubinemiaRESUMO
BACKGROUND: Adaptation of existing guidelines can be an efficient way to develop contextualized recommendations. Transparent reporting of the adaptation approach can support the transparency and usability of the adapted guidelines. OBJECTIVE: To develop an extension of the RIGHT (Reporting Items for practice Guidelines in HealThcare) statement for the reporting of adapted guidelines (including recommendations that have been adopted, adapted, or developed de novo), the RIGHT-Ad@pt checklist. DESIGN: A multistep process was followed to develop the checklist: establishing a working group, generating an initial checklist, optimizing the checklist (through an initial assessment of adapted guidelines, semistructured interviews, a Delphi consensus survey, an external review, and a final assessment of adapted guidelines), and approval of the final checklist by the working group. SETTING: International collaboration. PARTICIPANTS: A total of 119 professionals participated in the development process. MEASUREMENTS: Participants' consensus on items in the checklist. RESULTS: The RIGHT-Ad@pt checklist contains 34 items grouped in 7 sections: basic information (7 items); scope (6 items); rigor of development (10 items); recommendations (4 items); external review and quality assurance (2 items); funding, declaration, and management of interest (2 items); and other information (3 items). A user guide with explanations and real-world examples for each item was developed to provide a better user experience. LIMITATION: The RIGHT-Ad@pt checklist requires further validation in real-life use. CONCLUSION: The RIGHT-Ad@pt checklist has been developed to improve the reporting of adapted guidelines, focusing on the standardization, rigor, and transparency of the process and the clarity and explicitness of adapted recommendations. PRIMARY FUNDING SOURCE: None.
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Lista de Checagem , Atenção à Saúde , HumanosRESUMO
BACKGROUND: Living practice guidelines are increasingly being used to ensure that recommendations are responsive to rapidly emerging evidence. OBJECTIVE: To develop a framework that characterizes the processes of development of living practice guidelines in health care. DESIGN: First, 3 background reviews were conducted: a scoping review of methods papers, a review of handbooks of guideline-producing organizations, and an analytic review of selected living practice guidelines. Second, the core team drafted the first version of the framework. Finally, the core team refined the framework through an online survey and online discussions with a multidisciplinary international group of stakeholders. SETTING: International. PARTICIPANTS: Multidisciplinary group of 51 persons who have experience with guidelines. MEASUREMENTS: Not applicable. RESULTS: A major principle of the framework is that the unit of update in a living guideline is the individual recommendation. In addition to providing definitions, the framework addresses several processes. The planning process should address the organization's adoption of the living methodology as well as each specific guideline project. The production process consists of initiation, maintenance, and retirement phases. The reporting should cover the evidence surveillance time stamp, the outcome of reassessment of the body of evidence (when applicable), and the outcome of revisiting a recommendation (when applicable). The dissemination process may necessitate the use of different venues, including one for formal publication. LIMITATION: This study does not provide detailed or practical guidance for how the described concepts would be best implemented. CONCLUSION: The framework will help guideline developers in planning, producing, reporting, and disseminating living guideline projects. It will also help research methodologists study the processes of living guidelines. PRIMARY FUNDING SOURCE: None.
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Atenção à Saúde , HumanosRESUMO
BACKGROUND: The development of rigorous, high-quality clinical guidelines increases the need for resources and skilled personnel within guideline-producing organizations. While collaboration between organizations provides a unique opportunity to pool resources and save time and effort, the collaboration presents its own unique challenges. OBJECTIVE: To assess the perceived needs and current challenges of guideline producers worldwide related to guideline development and collaboration efforts. DESIGN: Survey questions were developed by the Guidelines International Network and the US GRADE Network, pilot-tested among attendees of a guideline development workshop, and disseminated electronically using convenience and snowball sampling methods. PARTICIPANTS: A total of 171 respondents representing 30 countries and more than 112 unique organizations were included in this analysis. MAIN MEASURES: The survey included free-response, multiple-choice, and seven-point Likert-scale questions. Questions assessed respondents' perceived value of guidelines, resource availability and needs, guideline development processes, and collaboration efforts of their organization. KEY RESULTS: Time required to develop high-quality systematic reviews and guidelines was the most relevant need (median=7; IQR=5.5-7). In-house resources to conduct literature searches (median=4; IQR=3-6) and the resources to develop rigorous guidelines rapidly (median=4; IQR=2-5) were perceived as the least available resources. Difficulties reconciling differences in guideline methodology (median=6; IQR=4-7) and the time required to establish collaborative agreements (median=6; IQR=5-6) were the most relevant barriers to collaboration between organizations. Results also indicated a general need for improvement in conflict of interest (COI) disclosure policies. CONCLUSION: The survey identified organizational challenges in supporting rigorous guideline development, including the time, resources, and personnel required. Connecting guideline developers to existing databases of high-quality systematic reviews and the use of freely available online platforms may facilitate guideline development. Guideline-producing organizations may also consider allocating resources to hiring or training personnel with expertise in systematic review methodologies or utilizing resources more effectively by establishing collaborations with other organizations.
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Conflito de Interesses , Medicina Baseada em Evidências , Revelação , Medicina Baseada em Evidências/métodos , Humanos , Avaliação das Necessidades , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Choledocholithiasis presents in a considerable proportion of patients with gallbladder disease. There are several management options, including preoperative or intraoperative endoscopic cholangiopancreatography (ERCP), and laparoscopic common bile duct exploration (LCBDE). OBJECTIVE: To develop evidence-informed, interdisciplinary, European recommendations on the management of common bile duct stones in the context of intact gallbladder with a clinical decision to intervene to both the gallbladder and the common bile duct stones. METHODS: We updated a systematic review and network meta-analysis of LCBDE, preoperative, intraoperative, and postoperative ERCP. We formed evidence summaries using the GRADE and the CINeMA methodology, and a panel of general surgeons, gastroenterologists, and a patient representative contributed to the development of a GRADE evidence-to-decision framework to select among multiple interventions. RESULTS: The panel reached unanimous consensus on the first Delphi round. We suggest LCBDE over preoperative, intraoperative, or postoperative ERCP, when surgical experience and expertise are available; intraoperative ERCP over LCBDE, preoperative or postoperative ERCP, when this is logistically feasible in a given healthcare setting; and preoperative ERCP over LCBDE or postoperative ERCP, when intraoperative ERCP is not feasible and there is insufficient experience or expertise with LCBDE (weak recommendation). The evidence summaries and decision aids are available on the platform MAGICapp ( https://app.magicapp.org/#/guideline/nJ5zyL ). CONCLUSION: We developed a rapid guideline on the management of common bile duct stones in line with latest methodological standards. It can be used by healthcare professionals and other stakeholders to inform clinical and policy decisions. GUIDELINE REGISTRATION NUMBER: IPGRP-2022CN170.
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Colecistectomia Laparoscópica , Coledocolitíase , Cálculos Biliares , Humanos , Colangiopancreatografia Retrógrada Endoscópica/métodos , Colecistectomia Laparoscópica/métodos , Abordagem GRADE , Metanálise em Rede , Filmes Cinematográficos , Coledocolitíase/cirurgia , Cálculos Biliares/cirurgia , Ducto Colédoco/cirurgiaRESUMO
Children are the future of the world, but their health and future are facing great uncertainty because of the coronavirus disease 2019 (COVID-19) pandemic. In order to improve the management of children with COVID-19, an international, multidisciplinary panel of experts developed a rapid advice guideline at the beginning of the outbreak of COVID-19 in 2020. After publishing the first version of the rapid advice guideline, the panel has updated the guideline by including additional stakeholders in the panel and a comprehensive search of the latest evidence. All recommendations were supported by systematic reviews and graded using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. Expert judgment was used to develop good practice statements supplementary to the graded evidence-based recommendations. The updated guideline comprises nine recommendations and one good practice statement. It focuses on the key recommendations pertinent to the following issues: identification of prognostic factors for death or pediatric intensive care unit admission; the use of remdesivir, systemic glucocorticoids and antipyretics, intravenous immunoglobulin (IVIG) for multisystem inflammatory syndrome in children, and high-flow oxygen by nasal cannula or non-invasive ventilation for acute hypoxemic respiratory failure; breastfeeding; vaccination; and the management of pediatric mental health. CONCLUSION: This updated evidence-based guideline intends to provide clinicians, pediatricians, patients and other stakeholders with evidence-based recommendations for the prevention and management of COVID-19 in children and adolescents. Larger studies with longer follow-up to determine the effectiveness and safety of systemic glucocorticoids, IVIG, noninvasive ventilation, and the vaccines for COVID-19 in children and adolescents are encouraged. WHAT IS KNOWN: ⢠Several clinical practice guidelines for children with COVID-19 have been developed, but only few of them have been recently updated. ⢠We developed an evidence-based guideline at the beginning of the COVID-19 outbreak and have now updated it based on the results of a comprehensive search of the latest evidence. WHAT IS NEW: ⢠The updated guideline provides key recommendations pertinent to the following issues: identification of prognostic factors for death or pediatric intensive care unit admission; the use of remdesivir, systemic glucocorticoids and antipyretics, intravenous immunoglobulin for multisystem inflammatory syndrome in children, and high-flow oxygen by nasal cannula or non-invasive ventilation for acute hypoxemic respiratory failure; breastfeeding; vaccination; and the management of pediatric mental health.
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Antipiréticos , COVID-19 , Insuficiência Respiratória , Adolescente , Criança , Humanos , COVID-19/prevenção & controle , Vacinas contra COVID-19 , Imunoglobulinas Intravenosas , OxigênioRESUMO
BACKGROUND: Widespread recognition of the impact of healthcare adverse events has triggered incident reporting system implementation to promote patient safety. The aim was to assess the effectiveness, usability, enablers, and barriers of the Electronic Occurrence Variance Reporting System (eOVR) in addition to end user satisfaction. METHODS: This study comprised a cross-sectional survey two years after implementation of the eOVR. Secondary data analysis evaluated the volume of incident reporting before and after implementing the eOVR. OUTCOME MEASURES: Primary outcome measures: satisfaction and system usability, system security, workplace safety culture, training, and reporting trends. An overall satisfaction was collected. SECONDARY OUTCOME: rate of reported OVRs per 1000 admissions. Furthermore, barriers and enablers to the reporting process were explored. RESULTS: Study findings indicate that the eOVR has been successful in terms of high satisfaction according to respondents. Most of the respondents found the system easy to access, maintained patient confidentiality and reporting anonymity. Around half the respondents indicated having a non-punitive culture of reporting in their hospital. Physicians had significantly lower scores in all primary outcomes Incident reporting increased by 33.6% (p < 0.0001) after implementing the eOVR. CONCLUSION: Successful incident reporting systems should be easy and simple to use, accessible and include features that guarantee anonymity and confidentiality. End-users should be trained prior to launching such a system. The implementation of such systems needs to be combined with promoting a just culture in the organization, timely feedback, more involvement and focus on physicians and junior staff which will improve user satisfaction and reporting rates.
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Hospitais de Ensino , Gestão de Riscos , Estudos Transversais , Eletrônica , Humanos , Arábia SauditaRESUMO
OBJECTIVE: Venous thromboembolism (VTE) is an important patient safety concern. VTE leads to significant mortality and morbidity and a burden on healthcare resources. Despite the widespread availability of evidence-based clinical practice guidelines on VTE prophylaxis, we found that only 50.9% of our patients were receiving appropriate prophylaxis. The purpose of this study was to evaluate the impact of automation of an adapted VTE prophylaxis CPG using a clinical decision support system (the VTE-CDSS) on VTE prevention among hospitalised adult patients. DESIGN AND SETTING: A quasi-experimental study (pre- and post-implementation) was conducted at a large 900-bed tertiary teaching multi-specialty hospital in Riyadh, Saudi Arabia. PARTICIPANTS: The 1809 adult patients in the study included 871 enrolled during the pre-implementation stage and 938 enrolled during the post-implementation stage. INTERVENTION: Multi-faceted implementation interventions were utilised, including leadership engagement and support, quality and clinical champions, staff training and education and regular audit and feedback. MAIN OUTCOME MEASURE: Two rate-based process measures were calculated for each admission cohort (i.e. pre- and post-implementation): the percentage of inpatients who were assessed for VTE risk on admission and the percentage of inpatients who received appropriate VTE prophylaxis. Two outcome measures were calculated: the prevalence of hospital-acquired VTE (HA-VTE) events and the in-hospital all-cause mortality. RESULTS: The percentage of inpatients risk assessed for VTE on admission increased from 77.4% to 93.3% (P < 0.01). The percentage of patients who received appropriate VTE prophylaxis increased from 50.9% to 81.4% (P < 0.01). The HA-VTE events decreased by 50% from 0.33% to 0.15% (P < 0.01).All-cause in-hospital mortality did not significantly change after implementation of the VTE-CDSS compared with pre-implementation mortality (P > 0.05). CONCLUSION: The VTE-CDSS improved patient safety by enhancing adherence to the VTE prophylaxis best practice and adapted CPG. The multi-faceted implementation strategies approach improved the compliance rate of risk assessment and the adherence to prophylaxis recommendations and substantially reduced the HA-VTE prevalence. A successful CDSS requires a set of critical components to ensure better user compliance and positive patient outcomes.
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Sistemas de Apoio a Decisões Clínicas , Tromboembolia Venosa , Adulto , Anticoagulantes , Fidelidade a Diretrizes , Hospitalização , Humanos , Medição de Risco , Fatores de Risco , Arábia Saudita , Tromboembolia Venosa/prevenção & controleRESUMO
BACKGROUND: The management of pregnant women with sickle cell disease (SCD) poses a major challenge for maternal healthcare services owing to the potential for complications associated with morbidity and mortality. Trustworthy evidence-based clinical practice guidelines (CPGs) have a major impact on the positive outcomes of appropriate healthcare. The objective of this study was to critically appraise the quality of recent CPGs for SCD in pregnant women. METHODS: Clinical questions were identified and the relevant CPG and bibliographic databases were searched and screened for eligible CPGs. Each CPG was appraised by four independent appraisers using the AGREE II Instrument. Inter-rater analysis was conducted. RESULTS: Four eligible CPGs were appraised: American College of Obstetricians and Gynecologists (ACOG), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Health and Care Excellence (NICE), and Royal College of Obstetricians and Gynaecologists (RCOG). Among them, the overall assessments of three CPGs (NICE, RCOG, NHLBI) scored greater than 70%; these findings were consistent with the high scores in the six domains of AGREE II, including:[1] scope and purpose,[2] stakeholder involvement,[3] rigor of development,[4] clarity of presentation,[5] applicability, and [6] editorial independence domains. Domain [3] scored (90%, 73%, 71%), domain [5] (90%, 46%, 47%), and domain [6] (71%, 77%, 52%) for NICE, RCOG, and NHLBI, respectively. Overall, the clinical recommendations were not significantly different between the included CPGs. CONCLUSIONS: Three evidence-based CPGs presented superior methodological quality. NICE demonstrated the highest quality followed by RCOG and NHLBI and all three CPGs were recommended for use in practice.
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Anemia Falciforme/terapia , Prática Clínica Baseada em Evidências/normas , Obstetrícia/normas , Guias de Prática Clínica como Assunto/normas , Complicações Hematológicas na Gravidez/terapia , Prática Clínica Baseada em Evidências/métodos , Feminino , Humanos , Obstetrícia/métodos , GravidezRESUMO
BACKGROUND: Past research in population health trends has shown that injuries form a substantial burden of population health loss. Regular updates to injury burden assessments are critical. We report Global Burden of Disease (GBD) 2017 Study estimates on morbidity and mortality for all injuries. METHODS: We reviewed results for injuries from the GBD 2017 study. GBD 2017 measured injury-specific mortality and years of life lost (YLLs) using the Cause of Death Ensemble model. To measure non-fatal injuries, GBD 2017 modelled injury-specific incidence and converted this to prevalence and years lived with disability (YLDs). YLLs and YLDs were summed to calculate disability-adjusted life years (DALYs). FINDINGS: In 1990, there were 4 260 493 (4 085 700 to 4 396 138) injury deaths, which increased to 4 484 722 (4 332 010 to 4 585 554) deaths in 2017, while age-standardised mortality decreased from 1079 (1073 to 1086) to 738 (730 to 745) per 100 000. In 1990, there were 354 064 302 (95% uncertainty interval: 338 174 876 to 371 610 802) new cases of injury globally, which increased to 520 710 288 (493 430 247 to 547 988 635) new cases in 2017. During this time, age-standardised incidence decreased non-significantly from 6824 (6534 to 7147) to 6763 (6412 to 7118) per 100 000. Between 1990 and 2017, age-standardised DALYs decreased from 4947 (4655 to 5233) per 100 000 to 3267 (3058 to 3505). INTERPRETATION: Injuries are an important cause of health loss globally, though mortality has declined between 1990 and 2017. Future research in injury burden should focus on prevention in high-burden populations, improving data collection and ensuring access to medical care.
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Carga Global da Doença , Saúde Global , Ferimentos e Lesões , Humanos , Incidência , Expectativa de Vida , Morbidade , Anos de Vida Ajustados por Qualidade de Vida , Ferimentos e Lesões/mortalidadeRESUMO
BACKGROUND: While there is a long history of measuring death and disability from injuries, modern research methods must account for the wide spectrum of disability that can occur in an injury, and must provide estimates with sufficient demographic, geographical and temporal detail to be useful for policy makers. The Global Burden of Disease (GBD) 2017 study used methods to provide highly detailed estimates of global injury burden that meet these criteria. METHODS: In this study, we report and discuss the methods used in GBD 2017 for injury morbidity and mortality burden estimation. In summary, these methods included estimating cause-specific mortality for every cause of injury, and then estimating incidence for every cause of injury. Non-fatal disability for each cause is then calculated based on the probabilities of suffering from different types of bodily injury experienced. RESULTS: GBD 2017 produced morbidity and mortality estimates for 38 causes of injury. Estimates were produced in terms of incidence, prevalence, years lived with disability, cause-specific mortality, years of life lost and disability-adjusted life-years for a 28-year period for 22 age groups, 195 countries and both sexes. CONCLUSIONS: GBD 2017 demonstrated a complex and sophisticated series of analytical steps using the largest known database of morbidity and mortality data on injuries. GBD 2017 results should be used to help inform injury prevention policy making and resource allocation. We also identify important avenues for improving injury burden estimation in the future.
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Carga Global da Doença , Saúde Global , Ferimentos e Lesões , Feminino , Humanos , Incidência , Expectativa de Vida , Masculino , Morbidade , Anos de Vida Ajustados por Qualidade de Vida , Ferimentos e Lesões/mortalidadeRESUMO
BACKGROUND: The final adult height of untreated girls aged up to 18 years with Turner syndrome (TS) is approximately 20 cm shorter compared with healthy females. Treatment with growth hormone (GH) increases the adult height of people with TS. The effects of adding the androgen, oxandrolone, in addition to GH are unclear. Therefore, we conducted this systematic review to investigate the benefits and harms of oxandrolone as an adjuvant therapy for people with TS treated with GH. OBJECTIVES: To assess the effects of oxandrolone on growth hormone-treated girls aged up to 18 years with Turner syndrome. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, the ICTRP Search Portal and ClinicalTrials.gov. The date of the last search was October 2018. We applied no language restrictions. SELECTION CRITERIA: We included randomised controlled clinical trials (RCTs) that enrolled girls aged up to 18 years with TS who were treated with GH and oxandrolone compared with GH only treatment. DATA COLLECTION AND ANALYSIS: Three review authors independently screened titles and abstracts for relevance, selected trials, extracted data and assessed risk of bias. We resolved disagreements by consensus, or by consultation with a fourth review author. We assessed trials for overall certainty of the evidence using the GRADE instrument. MAIN RESULTS: We included six trials with 498 participants with TS, 267 participants were randomised to oxandrolone plus GH treatment and 231 participants were randomised to GH only treatment. The individual trial sample size ranged between 22 and 133 participants. The included trials were conducted in 65 different paediatric endocrinology healthcare facilities including clinics, centres, hospitals and academia in the USA and Europe. The duration of interventions ranged between 3 and 7.6 years. The mean age of participants at start of therapy ranged from 9 to 12 years. Overall, we judged only one trial at low risk of bias in all domains and another trial at high risk of bias in most domains. We downgraded the level of evidence mainly because of imprecision (low number of trials, low number of participants or both). Comparing oxandrolone plus GH with GH only for final adult height showed a mean difference (MD) of 2.7 cm in favour of oxandrolone plus GH treatment (95% confidence interval (CI) 1.3 to 4.1; P < 0.001; 5 trials, 270 participants; moderate-quality evidence). The 95% prediction interval ranged between 0.3 cm and 5.1 cm. For adverse events, we based our main analysis on reliable date from two trials with overall low risk of bias. There was no evidence of a difference between oxandrolone plus GH and GH for adverse events (RR 1.81, 95% CI 0.83 to 3.96; P = 0.14; 2 trials, 170 participants; low-quality evidence). Six out of 86 (18.6%) participants receiving oxandrolone plus GH compared with 8/84 (9.5%) participants receiving GH only reported adverse events, mainly signs of virilisation (e.g. deepening of the voice). One trial each investigated the effects of treatments on speech (voice frequency; 88 participants), cognition (51 participants) and psychological status (106 participants). The overall results for these comparisons were inconclusive (very low-quality evidence). No trial reported on health-related quality of life or all-cause mortality. AUTHORS' CONCLUSIONS: Addition of oxandrolone to the GH therapy led to a modest increase in the final adult height of girls aged up to 18 years with TS. Adverse effects identified included virilising effects such as deepening of the voice, but reporting was inadequate in some trials.
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Estatura/efeitos dos fármacos , Hormônio do Crescimento Humano/uso terapêutico , Oxandrolona/uso terapêutico , Síndrome de Turner/tratamento farmacológico , Adolescente , Androgênios/uso terapêutico , Feminino , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Síndrome de Turner/complicaçõesRESUMO
BACKGROUND: The widening gap between innovations in the medical field and the dissemination of such information to doctors may affect the quality of care. Offline computer-based digital education (OCDE) may be a potential solution to overcoming the geographical, financial, and temporal obstacles faced by doctors. OBJECTIVE: The objectives of this systematic review were to evaluate the effectiveness of OCDE compared with face-to-face learning, no intervention, or other types of digital learning for improving medical doctors' knowledge, cognitive skills, and patient-related outcomes. Secondary objectives were to assess the cost-effectiveness (CE) of OCDE and any adverse effects. METHODS: We searched major bibliographic databases from 1990 to August 2017 to identify relevant articles and followed the Cochrane methodology for systematic reviews of intervention. RESULTS: Overall, 27 randomized controlled trials (RCTs), 1 cluster RCT (cRCT), and 1 quasi-RCT were included in this review. The total number of participants was 1690 in addition to the cRCT, which included 24 practices. Due to the heterogeneity of the participants, interventions, and outcomes, meta-analysis was not feasible, and the results were presented as narrative summary. Compared with face-to-face learning, the effect of OCDE on knowledge gain is uncertain (ratio of the means [RM] range 0.95-1.17; 8 studies, 495 participants; very low grade of evidence). From the same comparison, the effect of OCDE on cognitive skill gain is uncertain (RM range 0.1-0.9; 8 studies, 375 participants; very low grade of evidence). OCDE may have little or no effect on patients' outcome compared with face-to-face education (2 studies, 62 participants; low grade of evidence). Compared with no intervention, OCDE may improve knowledge gain (RM range 1.36-0.98; 4 studies, 401 participants; low grade of evidence). From the same comparison, the effect of OCDE on cognitive skill gain is uncertain (RM range 1.1-1.15; 4 trials, 495 participants; very low grade of evidence). One cRCT, involving 24 practices, investigated patients' outcome in this comparison and showed no difference between the 2 groups with low-grade evidence. Compared with text-based learning, the effect of OCDE on cognitive skills gain is uncertain (RM range 0.91-1.46; 3 trials with 4 interventions; 68 participants; very low-grade evidence). No study in this comparison investigated knowledge gain or patients' outcomes. One study assessed the CE and showed that OCDE was cost-effective when compared with face-to-face learning if the cost is less than or equal to Can $200. No trial evaluated the adverse effect of OCDE. CONCLUSIONS: The effect of OCDE compared with other methods of education on medical doctors' knowledge and cognitive skill gain is uncertain. OCDE may improve doctors' knowledge compared with no intervention but its effect on doctors' cognitive skills is uncertain. OCDE may have little or no effect in improving patients' outcome.
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Instrução por Computador/métodos , Educação a Distância/métodos , Educação em Saúde/métodos , Médicos/normas , HumanosRESUMO
BACKGROUND: The presented evidence-based clinical practice guideline (CPG) is proposed as a National CPG where we adapted the international recommendations for the emergency management of seizures in children beyond the neonatal period to suit the health care in Egypt. The quality of evidence and the strength of recommendations are indicated. This study aimed to standardize the treatment of acute epileptic seizures and to provide an easy-to-apply acute treatment protocol that will allow immediate and appropriate seizure control. METHODS: This is part of a larger program by the Egyptian Pediatric Clinical Practice Guidelines Committee (EPG) in collaboration with the staff of pediatric departments of 15 Egyptian universities and the National Research Centre. EPG was affiliated later to the Supreme Council of the Egyptian University Hospitals aiming to define the topics of, assign authors to, and assist in the adaptation of pediatric evidence-based CPGs according to a national strategic plan (http://epg.edu.eg). The committee is guided by a formal CPG adaptation methodology: the "Adapted ADAPTE." RESULTS: The Egyptian Childhood Seizure Group (ECSG) reviewed the results of the Appraisal of Guidelines for Research and Evaluation II assessment and decided to adapt the recommendations of three source CPGs: American Epilepsy Society, Italian League Against Epilepsy, Neurocritical Care Society, and Neurologic & Psychiatric Society of Zambia. Eight implementation tools were included. A comprehensive set of multifaceted CPG implementation strategies was provided for the clinicians, patients, nurses, and other relevant stakeholders contextualized to the national settings. CONCLUSIONS: Our experience with this adaptation methodology provides useful insight into its national utilization in Egypt.
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Convulsões , Humanos , Convulsões/terapia , Convulsões/diagnóstico , Egito , Guias de Prática Clínica como Assunto/normas , Criança , Medicina Baseada em Evidências/normas , Serviços Médicos de Emergência/normasRESUMO
BACKGROUND: Thrombocytopenia is a prevalent presentation in childhood with a broad spectrum of etiologies, associated findings, and clinical outcomes. Establishing the cause of thrombocytopenia and its proper management have obvious clinical repercussions but may be challenging. This article provides an adaptation of the high-quality Clinical Practice Guidelines (CPGs) of pediatric thrombocytopenia management to suit Egypt's health care context. METHODS: The Adapted ADAPTE methodology was used to identify the high-quality CPGs published between 2010 and 2020. An expert panel screened, assessed and reviewed the CPGs and formulated the adapted consensus recommendations based on the best available evidence. DISCUSSION: The final CPG document provides consensus recommendations and implementation tools on the management of isolated thrombocytopenia in children and adolescents in Egypt. There is a scarcity of evidence to support recommendations for various management protocols. In general, complete clinical assessment, full blood count, and expert analysis of the peripheral blood smear are indicated at initial diagnosis to confirm a bleeding disorder, exclude secondary causes of thrombocytopenia and choose the type of work up required. The International Society of Hemostasis and thrombosis-Bleeding assessment tool (ISTH-SCC BAT) could be used for initial screening of bleeding manifestations. The diagnosis of immune thrombocytopenic purpura (ITP) is based principally on the exclusion of other causes of isolated thrombocytopenia. Future research should report the outcome of this adapted guideline and include cost-analysis evaluations.
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INTRODUCTION: The GRADE-ADOLOPMENT methodology has been widely used to adopt, adapt or de novo develop recommendations from existing or new guideline and evidence synthesis efforts. This guidance refines the operationalization for applying GRADE-ADOLOPMENT. METHODS: Through iterative discussions, online meetings and email communications, the GRADE-ADOLOPMENT Project Group drafted the updated guidance. We then conducted a review of handbooks of guideline-producing organizations, and a scoping review of published and planned Adolopment guideline projects. The lead authors refined the existing approach based on the scoping review findings and feedback from members of the GRADE Working Group. We presented the revised approach to the group in November 2022 (approximately 115 people), in May 2023 (approximately 100 people) and twice in September 2023 (approximately 60 and 90 people) for approval. RESULTS: This GRADE guidance shows how to effectively and efficiently contextualize recommendations using the GRADE-ADOLOPMENT approach by: (1) showcasing alternative pathways for starting an adolopment effort; (2) elaborating on the different essential steps of this approach, such as building on existing EtDs when available or developing new EtDs if necessary; and (3) providing examples from adolopment case studies to facilitate the application of the approach. We demonstrate how to use contextual evidence to make judgments about EtD criteria, and highlight the importance of making the resulting EtDs available to facilitate adolopment efforts by others. CONCLUSION: This updated GRADE guidance further operationalizes the application of GRADE-ADOLOPMENT based on over six years of experience. It serves to support uptake and application by end users interested in contextualizing recommendations to a local setting or specific reality in a short period of time or with limited resources.
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Background: Adapted clinical practice guidelines (CPGs) are based on existing recommendations from other developers. Aims: To produce a mapping summary of the methods used for adaptation of CPGs in the Eastern Mediterranean Region (EMR). Methods: We conducted a literature review of studies describing adaptation of CPGs in the EMR. Databases and official websites were searched for studies published between 2006 and 2022. We excluded de novo development of CPGs and adaptation of other types of guidelines such as public health guidelines. Results: As an overview of the current situation of CPG adaptation in the EMR, we identified the 2 main categories: informal and formal adaptation. Six formal adaptation frameworks were used in the EMR: ADAPTE, Adapted-ADAPTE, GRADE-ADOLOPMENT, RAPADAPTE, CAN-IMPLEMENT, and KSU-Modified-ADAPTE. The validation of adapted CPGs to the local context is not well defined in the literature. Conclusion: Despite the successful use of CPG formal adaptation frameworks, there is no international standardized guidance to identify which framework is most suitable for specific healthcare contexts in the EMR. Each institution has adapted its CPGs differently. A standardized selection tool is needed to enhance the appropriate selection of the adaptation method that fits the local resources and context. We encourage EMR countries and organizations to register their old and new CPG adaptation projects to avoid duplication in guideline synthesis.
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Atenção à Saúde , Medicina Baseada em Evidências , Humanos , Região do MediterrâneoRESUMO
Background: In Egypt, academic organizations, professional societies, and research groups develop clinical practice guidelines (CPGs) in order to improve patient quality care and safety. Although important improvements have been made over the past years, many of these consensus-based guideline documents still lack the transparency and methodological rigor of international standards and methodologies recommended by reference evidence-based healthcare and guideline organizations like the Guidelines International Network. Main body of the abstract: In the Egyptian Pediatric Clinical Practice Guidelines Committee (EPG), we have adopted one of the CPG formal adaptation methodological frameworks named the 'Adapted ADAPTE', relevant CPG resources (e.g., the Appraisal of Guidelines for Research and Evaluation or AGREE II Instrument), and involved key stakeholders including clinical and healthcare topic experts and guideline methodologists in producing 32 trustworthy national evidence-based CPGs and one protocol customized to the healthcare context and services provided for Egyptian children. An EPG online website was launched to make these CPGs available and accessible as CPG summaries for pediatricians and relevant healthcare providers. Short conclusion: The lessons learned, enablers, challenges, and solutions relevant to Egyptian National Pediatric CPGs identified in this paper could be used to address and enrich the debate on pediatric high-quality CPGs, especially for countries of similar contexts and systems. Supplementary Information: The online version contains supplementary material available at 10.1186/s42269-023-01059-0.
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BACKGROUND: Clinical practice guidelines (CPGs) improve clinical decision making and patient outcomes, but CPG implementation is poor. The success of CPGs is influenced by several factors related to barriers and facilitators. For this reason, it can be extremely useful to explore key barriers and facilitators of CPG implementation in the Middle East and North Africa (MENA). METHODS: A three-round Delphi study was performed using the input of 30 experts involved in the clinical practice guidelines. In the first two rounds, participants were asked to score each statement relevant to barriers or facilitators for CPG implementation on a five-point Likert scale. These statements were identified from existing systematic reviews and expert input. In round three, participants ranked the most important barriers and facilitators identified from rounds one and two. A descriptive analysis was conducted on the barrier and facilitators statements using frequencies, percentages, and medians to summarize the variables collected. RESULTS: We identified 10 unique barriers and 13 unique facilitators to CPG implementation within the MENA region. The two highest-ranked barriers related to communications and available research and skills. The most important facilitator was the availability of training courses for healthcare professionals. CONCLUSIONS: Key barriers and facilitators to the implementation of clinical practice guidelines seem to exist in professional, organizational, and external contexts, which should all be taken into account in order to increase implementation success within MENA region. The results of this study are useful in the design of future implementation strategies aimed at overcoming the barriers and leveraging the facilitators.