RESUMEN
INTRODUCCIÓN: La anticoncepción es un derecho, y es obligación del Estado garantizar el acceso a métodos anticonceptivos efectivos, seguros y de calidad. Se realizó una evaluación de tecnología sanitaria sobre los parches anticonceptivos transdérmicos. MÉTODOS: Un equipo multidisciplinario e independiente designado por el Comité Provincial de Biotecnologías de Neuquén buscó información epidemiológica, regulatoria y evidencias científicas sobre eficacia, seguridad y adherencia. Se analizó y sistematizó siguiendo metodología GRADE (Grading of Recommendations Assessment, Development and Evaluation) y CASPe (Critical Appraisal Skills Programme Español). RESULTADOS: El único parche autorizado en Argentina para su comercialización libera 33,9 µg/día de etinilestradiol y 203 µg/día de norelgestromina. Su prospecto en Argentina, EE.UU. y Europa lo asocia al doble de riesgo de enfermedad tromboembólica venosa si se compara con las píldoras anticonceptivas que provee el Estado. Esto coincide con resultados de estudios de cohortes de alta calidad. Los parches proveen similar eficacia anticonceptiva a corto plazo, pero con altas tasas de abandono en el seguimiento. La Organización Mundial de la Salud no los ha incluido en su listado de medicamentos esenciales. Los parches son más costosos que otros métodos disponibles. DISCUSIÓN: Sobre la base de los principios de beneficencia, no maleficencia, de precaución y de proporcionalidad, no se recomienda la incorporación de parches.(AU)
INTRODUCTION: Contraception is a right, being an obligation of the State to guarantee access to effective, safe and quality contraceptive methods. A health technology assessment was carried out on transdermal contraceptive patches. METHODS: A multidisciplinary and independent team appointed by the Provincial Biotechnology Committee of Neuquén searched for epidemiological and regulatory information and scientific evidence on efficacy, safety and adherence. It was analyzed and systematized following the GRADE (Grading of Recommendations Assessment, Development and Evaluation) and CASPe (Critical Appraisal Skills Programme Español) methodology. RESULTS: The only patch authorized for commercialization in Argentina releases 33.9 µg/day of ethinylestradiol and 203 µg/day of norelgestromin. Its package insert in Argentina, the US and Europe highlights that the risk of venous thromboembolic disease is twice as high compared to the contraceptive pills provided by the State. This is consistent with results from high-quality cohort studies. Patches provide similar short-term contraceptive efficacy, but with high dropout rates at follow-up. The World Health Organization has not included them in its list of essential medicines. Patches are more expensive than other available methods. DISCUSSION: Based on the principles of beneficence, non-maleficence, precaution and proportionality, the incorporation of patches is not recommended.(AU)
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Humanos , Evaluación de la Tecnología Biomédica , Anticonceptivos , Parche Transdérmico , Parche Transdérmico/provisión & distribución , Enfoque GRADE/métodosRESUMEN
ABSTRACT Objective: To investigate whether children with premature birth (PB) and/or with low birth weight (LBW) have different tooth eruption patterns than those born at term or with normal weight. Material and Methods: Searches were performed in the PubMed, Cochrane Library, Sc1opus, Web of Science, LILACS, and BBO databases as well as the grey literature. Three independent reviewers were involved in study selection, data extraction, and bias assessment. The risk of bias was assessed using the Modified Newcastle-Ottawa Scale. Meta-analysis was conducted to compute the mean difference (MD) in mean chronological or adjusted age at the eruption of the first deciduous tooth between preterm children and those born at full term. The GRADE approach was used. Results: Among a total of 316 articles identified, 21 were eligible for inclusion and three were included in the meta-analysis. PB was associated with the delay in the first tooth deciduous eruption when chronological age was considered (MD: 1.36; 95%CI: 1.02-1.69) but not when considering adjusted age (MD: -0.30; 95%CI: -0.67-0.07). The evidence was graded as having very low quality. Conclusion: Based on a low certainty of evidence the PB is associated with the delayed eruption of the first deciduous tooth when considering chronological age but not when adjusted age is considered.
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Recién Nacido de Bajo Peso , Enfoque GRADE/métodosRESUMEN
OBJECTIVE: To identify and describe the use of the GRADE approach for rating the certainty of evidence in nutrition systematic reviews (SRs). STUDY DESIGN AND SETTING: We systematically searched for SRs using GRADE that were published between 2015 and 2019 in the 10 "nutrition" journals with the highest impact factor according to the JCR 2018. RESULTS: Out of 800 SRs, 55 SRs of randomized control trials (RCTs) and/or nonrandomized studies (NRSs) used GRADE. Forty-seven SRs (5.9%) rated the outcome specific certainty of evidence (n = 36 in 2018/2019). We identified a total of 465 certainty of evidence outcome ratings (n = 335 RCT ratings), ranging from very-low (28.8%) to low (41%), moderate (26.5%), and high (3.7%). Very-low and high certainty of evidence ratings accounted for 61.4% and 0.8% of ratings in SRs of NRSs, compared to 16.1% and 4.8% in SRs of RCTs. Certainty of evidence was downgraded mostly for risk of bias (37.8%) and imprecision (33%) in SRs of RCTs and for imprecision (32.7%), risk of bias (29.4%) and inconsistency (29%) in SRs of NRSs. CONCLUSION: Our study suggests a need for directing more attention toward strengthening acceptance of GRADE as well as building knowledge of the GRADE methodology in nutrition evidence synthesis.
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Enfoque GRADE/métodos , Factor de Impacto de la Revista , Ciencias de la Nutrición/métodos , Publicaciones Periódicas como Asunto/estadística & datos numéricos , Revisiones Sistemáticas como Asunto/métodos , Ensayos Clínicos como Asunto/métodos , Enfoque GRADE/estadística & datos numéricos , HumanosRESUMEN
BACKGROUND AND OBJECTIVE: This article explores the need for conceptual advances and practical guidance in the application of the GRADE approach within public health contexts. METHODS: We convened an expert workshop and conducted a scoping review to identify challenges experienced by GRADE users in public health contexts. We developed this concept article through thematic analysis and an iterative process of consultation and discussion conducted with members electronically and at three GRADE Working Group meetings. RESULTS: Five priority issues can pose challenges for public health guideline developers and systematic reviewers when applying GRADE: (1) incorporating the perspectives of diverse stakeholders; (2) selecting and prioritizing health and "nonhealth" outcomes; (3) interpreting outcomes and identifying a threshold for decision-making; (4) assessing certainty of evidence from diverse sources, including nonrandomized studies; and (5) addressing implications for decision makers, including concerns about conditional recommendations. We illustrate these challenges with examples from public health guidelines and systematic reviews, identifying gaps where conceptual advances may facilitate the consistent application or further development of the methodology and provide solutions. CONCLUSION: The GRADE Public Health Group will respond to these challenges with solutions that are coherent with existing guidance and can be consistently implemented across public health decision-making contexts.
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Enfoque GRADE/métodos , Guías como Asunto , Salud Pública/métodos , Revisiones Sistemáticas como Asunto , Medicina Basada en la Evidencia , HumanosRESUMEN
ETHNOPHARMACOLOGICAL RELEVANCE: Breviscapine injections (DengZhanHuaSu, DZHS) is a famous Chinese patent medicine authorized by China Food and Drug Administration, which is widely used to treat acute cerebral infarction (ACI) in China. AIM OF THE STUDY: In the present study, meta-analysis has been performed in determining the efficacy and safety of DZHS combined with conventional treatment (CT) for ACI and GRADE assessment. MATERIALS AND METHODS: Randomized controlled trials (RCTs) testing the use of DZHS for treating ACI were screened by searching the databases of the Cochrane Library, PubMed, Embase, and Web of Science as well as four Chinese databases. Meta-analysis was carried out with RevMan 5.3 and Stata 16.0 software. The quality of research evidence was assessed by the GRADEprofiler (GRADEpro version: 3.6). RESULTS: Forty-three studies (n = 4618) were included. When compared to the control groups, the total effective rate of the national institutes of health stroke scale (NIHSS) was higher in the experimental group with DZHS (RR = 1.23, 95% CI = 1.19 to 1.28, P < 0.001; RR = 1.29, 95% CI = 1.21 to 1.38, P < 0.001); clinical symptoms and signs were improved in the experimental group with DZHS (RR = 1.17, 95% CI = 1.10 to 1.24, P < 0.001; RR = 1.25, 95% CI = 1.11 to 1.42, P < 0.001); the incidence of adverse reactions was reduced in the experimental group with DZHS (RR = 0.50, 95% CI = 0.26 to 0.98, P = 0.044); and the NIHSS score was decreased in the experimental group with DZHS (WMD = -3.30, 95% CI = -3.86 to -2.73, P < 0.001). CONCLUSIONS: DZHS combined with CT is conditionally recommended to improve the total effective rate of the NIHSS, clinical symptoms, and neurological deficits and reduce the incidence of adverse reactions, and no serious adverse reactions were noted. The GRADE assessment indicates that the overall certainty quality of evidence is low. Further large-scale, well-designed and high-quality RCTs are needed to confirm the positive results. PROSPERO registration No. CRD42019128856.
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Infarto Cerebral/tratamiento farmacológico , Medicina Basada en la Evidencia/normas , Flavonoides/administración & dosificación , Enfoque GRADE/normas , Infarto Cerebral/diagnóstico , Infarto Cerebral/epidemiología , China/epidemiología , Medicina Basada en la Evidencia/métodos , Enfoque GRADE/métodos , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto/normasRESUMEN
OBJECTIVES: The Grading of Recommendations Assessment, Development, and Evaluations (GRADE) working group has recognized some scenarios in which strong recommendations may be supported by low-quality evidence, the so-called paradigmatic situations. The adherence to these paradigmatic situations by the American Thyroid Association (ATA) guidelines, however, remains unknown. STUDY DESIGN AND SETTING: Clinical guidelines from the ATA were retrieved and deemed eligible if created using GRADE or the American College of Physicians (ACP) system. Reviewers, independently and in duplicate, assessed all strong recommendations based on low-quality evidence and judged their alignment with GRADE paradigmatic situations. The study was conducted at KER Unit Mexico. RESULTS: A total of five clinical guidelines, one using the GRADE and four using the ACP system, were eligible for analysis. We assessed a total of 518 recommendations, of which 355 (69%) were labeled as "strong" and 163 (31%) as "weak". A total of 151 strong recommendations were based on low-quality evidence, of which 36 (24%) were congruent with one of the five GRADE paradigmatic situations, whereas 115 (76%) were not consistent with any paradigmatic situations and should have been categorized as weak (23% [26/115]) or best-practice recommendations (77% [89/115]). CONCLUSION: ATA clinical guidelines are discordant with GRADE guidance. Future guidelines should carefully evaluate the quality of evidence and recognize its limitations when developing recommendations.
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Enfoque GRADE/métodos , Guías de Práctica Clínica como Asunto , Enfermedades de la Tiroides/diagnóstico , Enfermedades de la Tiroides/terapia , Estudios Epidemiológicos , Humanos , Sociedades Médicas , Estados UnidosRESUMEN
OBJECTIVES: We assessed whether guidelines published by organizations based in the United States comply with published criteria for the use of the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. STUDY DESIGN AND SETTING: We performed a cross-sectional study of all clinical practice guidelines that indicated the use of the GRADE approach, were published between 2011 and 2018, and listed in the National Guidelines Clearinghouse. RESULTS: We included 67 guideline documents from 44 of 135 (32.6%) US-based organizations that indicated the use of the GRADE approach. The majority (60/67, 89.6%) of guidelines defined the certainty of evidence consistent with GRADE, but only approximately 1 in 10 (7/67, 10.4%) explicitly reported consideration of all eight criteria to assess the certainty in the evidence for rating down and up. A majority of guidelines (36/67, 53.7%) provided a summary of the evidence, described explicit consideration of all four central domains (36/67, 53.7%), and rated the strength of recommendation consistent with GRADE (36/67, 53.7%). CONCLUSION: Approximately one in three US-based organizations developing evidence-based guidelines report the use of GRADE, but adherence to published criteria is inconsistent. As uptake of the GRADE approach increases in the United States, continued efforts to train guideline methodologists and panel members are important.
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Enfoque GRADE/métodos , Guías de Práctica Clínica como Asunto/normas , Estudios Transversales , Humanos , Reproducibilidad de los Resultados , Estados UnidosRESUMEN
Due to velopharyngeal incompetence, airflow overflows from the oral cavity to the nasal cavity, which results in hypernasality. Hypernasality greatly reduces speech intelligibility and affects the daily communication of patients with cleft palate. Accurate assessment of hypernasality grades can provide assisted diagnosis for speech-language pathologists (SLPs) in clinical settings. Utilizing a support vector machine (SVM), this paper classifies speech recordings into four grades (normal, mild, moderate and severe hypernasality) based on vocal tract characteristics. Linear prediction (LP) analysis is widely used to model the vocal tract. Glottal source information may be included in the LP-based spectrum. The stabilized weighted linear prediction (SWLP) method, which imposes the temporal weights on the closed-phase interval of the glottal cycle, is a more robust approach for modeling the vocal tract. The extended weighted linear prediction (XLP) method weights each lagged speech signal separately, which achieves a finer time scale on the spectral envelope than the SWLP method. Tested speech recordings were collected from 60 subjects with cleft palate and 20 control subjects, and included a total of 4640 Mandarin syllables. The experimental results showed that the spectral envelope of normal speech decreases faster than that of hypernasal speech in the high-frequency part. The experimental results also indicate that the SWLP- and XLP-based methods have smaller correlation coefficients between normal and hypernasal speech than the LP method. Thus, the SWLP and XLP methods have better ability to distinguish hypernasal from normal speech than the LP method. The classification accuracies of the four hypernasality grades using the SWLP and XLP methods range from 83.86% to 97.47%. The selection of the model order and the size of the weight function are also discussed in this paper.
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Fisura del Paladar/fisiopatología , Enfoque GRADE/métodos , Humanos , Habla/fisiología , Insuficiencia VelofaríngeaRESUMEN
Abstract Aim: to investigate through a systematic review of randomized controlled trials (RCTs) the effects of interactive media on the cognitive, language, and motor development of children and adolescents. Methods: Searches were performed with the Medline, AMED, Embase, PEDro, Cochrane, Psychinfo, and ERIC databases in May 2017 with updated in July 2020. For the search strategy, we used descriptors related to "randomized controlled trial", "interactive media" and "children and adolescents up to 18 years old". RCTs that investigated the effectiveness of interactive media in cognitive, motor, and language development of children and adolescents up to 18 years of age with typical development were included. When appropriate, meta-analyses were conducted using a random-effects model. Pooled data were presented using standardized mean difference and 95% confidence interval. We assessed the quality of evidence using the GRADE methodology and the methodological quality using the PEDro scale. Results: of the trials found, 14 references were eligible for this study. The GRADE methodology was used in 13 RCTs. Estimates showed a low level of evidence of a small effect of media use on cognitive development compared to that in the control group and another intervention. No effect on motor and language development. Conclusion: The results of this systematic review do not support claims about the advantages or disadvantages of interactive media in child development. High-quality evidence was found that interactive media is not superior to other interventions for cognitive and language development outcomes and quality of moderate evidence for motor and language development.
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Humanos , Preescolar , Niño , Adolescente , Desarrollo Infantil , Cognición , Desarrollo del Adolescente , Tecnología Digital/tendencias , Desarrollo del Lenguaje , Enfoque GRADE/métodosRESUMEN
This article presents official guidance from the Grading of Recommendations Assessments, Development, and Evaluation (GRADE) working group on how to address incoherence when assessing the certainty in the evidence from network meta-analysis. Incoherence represents important differences between direct and indirect estimates that contribute to a network estimate. Bias due to limitations in study design or publication bias, indirectness, and intransitivity may be responsible for incoherence. Addressing incoherence requires a judgment regarding the importance of the impact on the network estimate. Reviewers need to be alert to the possibility of misguidedly arriving at excessively low ratings of certainty by rating down for both incoherence and other closely related GRADE domains. This article describes and illustrates each of these issues and provides explicit guidance on how to deal with them.
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Medicina Basada en la Evidencia/métodos , Enfoque GRADE/métodos , Metaanálisis en Red , Interpretación Estadística de Datos , Medicina Basada en la Evidencia/normas , Humanos , Sesgo de Publicación , Revisiones Sistemáticas como AsuntoRESUMEN
OBJECTIVES: It is unclear how guidelines panelists discuss and consider factors (criteria) that are formally and not formally included in the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. To describe the use of decision criteria, we explored how panelists adhered to GRADE criteria and sought to identify any emerging non-GRADE criteria when the panelists used the Evidence to Decision (EtD) framework as part of GRADE application. STUDY DESIGN AND SETTING: We used conventional and summative qualitative analyses to identify themes emerging from face-to-face, panel meeting discussions. Forty-eight members from 12 countries participated in the development of five guidelines for the management of venous thromboembolism by the American Society of Hematology. RESULTS: Ten themes corresponded to the GRADE approach and represented all panel discussions. Over half (53%) of the total panel discussions concerned the use of research evidence. When evidence was considered sufficient and clear, the decision-making process proved rapid. CONCLUSION: The GRADE EtD framework provides structure to guidelines panel meetings, and ensures that the panelists consider all established formal GRADE criteria as they decide on the recommendation text, strength, and direction (for or against an intervention). This is the first study assessing the use of GRADE's EtD framework during real-time guidelines development using panel discussions. Given the widespread use of GRADE, this study provides important information for practice recommendations generated when guidelines panels explicitly follow, in a transparent and systematic manner, the structured GRADE EtD framework. By recognizing the extent to which panels discuss and consider GRADE and other (non-GRADE) criteria for producing guideline recommendations, we are one step closer to understanding the decision-making process in panels that use a structured framework such as the GRADE EtD framework.
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Medicina Basada en la Evidencia/normas , Enfoque GRADE/métodos , Toma de Decisiones , Estudios de Evaluación como Asunto , Procesos de Grupo , Adhesión a Directriz , Guías como Asunto , Humanos , Guías de Práctica Clínica como AsuntoRESUMEN
INTRODUCTION: The purpose of this systematic review is to provide supporting evidence for a clinical practice guideline on the use of actigraphy. METHODS: The American Academy of Sleep Medicine commissioned a task force of experts in sleep medicine. A systematic review was conducted to identify studies that compared the use of actigraphy, sleep logs, and/or polysomnography. Statistical analyses were performed to determine the clinical significance of using actigraphy as an objective measure of sleep and circadian parameters. Finally, the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process was used to assess the evidence for making recommendations. RESULTS: The literature search resulted in 81 studies that met inclusion criteria; all 81 studies provided data suitable for statistical analyses. These data demonstrate that actigraphy provides consistent objective data that is often unique from patient-reported sleep logs for some sleep parameters in adult and pediatric patients with suspected or diagnosed insomnia, circadian rhythm sleep-wake disorders, sleep-disordered breathing, central disorders of hypersomnolence, and adults with insufficient sleep syndrome. These data also demonstrate that actigraphy is not a reliable measure of periodic limb movements in adult and pediatric patients. The task force provided a detailed summary of the evidence along with the quality of evidence, the balance of benefits and harms, patient values and preferences, and resource use considerations.
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Actigrafía/métodos , Enfoque GRADE/métodos , Medicina del Sueño , Trastornos del Sueño-Vigilia/diagnóstico , Academias e Institutos , Humanos , Trastornos del Sueño del Ritmo Circadiano/diagnóstico , Estados UnidosRESUMEN
OBJECTIVE: To explore the impact of applying the Grading of Recommendations and Assessment, Development, and Evaluation (GRADE) approach to assess the certainty of the evidence in a published network meta-analysis (NMA) of antidepressant therapies. STUDY DESIGN AND SETTINGS: We applied the GRADE approach to rate the certainty of the evidence for two outcomes, efficacy and acceptability, in each of the 66 paired comparisons within a previously published NMA assessing the relative efficacy and acceptability of 12 new-generation antidepressants. RESULTS: For the outcome of efficacy, of the 25 comparisons in which the 95% CrI of OR excluded 1, 18 had certainty of evidence rated high or moderate. For the outcome of acceptability, of the 13 comparisons whose 95% CrI excluded 1, 10 had certainty of evidence rated high or moderate. Of the 11 comparisons involving sertraline, the antidepressants that the authors of the NMA suggested to be best, only 3 demonstrated it to be more effective and only 3 showed better tolerance, based on a 95% CrI excluding 1 and a high or moderate rating of certainty. CONCLUSIONS: In this example, application of GRADE highlighted varying evidence certainty, led to more conservative conclusions, and potentially avoided unwarranted strong inferences based on low certainty evidence.
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Antidepresivos/uso terapéutico , Trastorno Depresivo/tratamiento farmacológico , Enfoque GRADE/métodos , Medicina Basada en la Evidencia , Humanos , Metaanálisis en Red , Resultado del TratamientoRESUMEN
Objective To propose how to incorporate equity issues, using the GRADE approach, into the development and implementation of Colombian Clinical Practice Guidelines. Methodology This proposal was developed in four phases: 1. Included a literature review and the development of a preliminary proposal about how to include equity issues; 2. Involved an informal discussion to reach a consensus on improving the first proposal; 3. Was a survey of the researchers' acceptance levels of the proposal, and; 4. A final informal consensus was formed to adjust the proposal. Results A proposal on how to incorporate equity issues into the GRADE approach was developed. It places particular emphasis on the recognition of disadvantaged populations in the development and implementation of the suggested guideline. PROGRESS-Plus is recommended for use in exploring the various categories of disadvantaged people. The proposal suggests that evidence be rated differentially by giving higher ratings to studies that consider equity issues than those that do not. The proposal also suggests the inclusion of indicators to monitor the impacts of the implementation of CPGs on disadvantaged people. Conclusions A consideration of equity in the development and implementation of clinical practice guidelines and quality assessments of the evidence would achieve more in the participation of potential actors in the process and reflect on the effectiveness of the proposed interventions across all social groups.(AU)
Objetivo Proponer como incorporar temas de equidad en el desarrollo e implementación de guías de práctica clínica colombianas utilizando el acercamiento GRADE. Metodología Esta propuesta fue desarrollada en 4 fases: una revisión de la literatura y desarrollo de una propuesta preliminar sobre como incluir temas de equidad, discusión informal para alcanzar un consenso que mejore la primera propuesta; una encuesta sobre los niveles de aceptación de la propuesta y un consenso informal final para ajustar la propuesta. Resultados Se desarrolló una propuesta sobre como incorporar temas de equidad con el acercamiento GRADE. Este hace énfasis especial en el reconocimiento de poblaciones en desventaja al desarrollar e implementar guías. Se recomienda el uso del PROGRESS-Plus para explorar las categorías de las poblaciones en desventaja. La propuesta sugiere una calificación diferencial de la evidencia dando clasificaciones superiores a los estudios que toman en consideración temas de equidad. Esta propuesta también sugiere la inclusión de indicadores que monitoreen el impacto de la implementación de GPC en personas en desventaja. Conclusiones Tener en cuenta la equidad en el desarrollo e implementación de las guías de práctica clínica y la evaluación de calidad de la evidencia puede lograr más en la participación de los actores potenciales del proceso y reflejarse en la efectividad de las intervenciones propuestas en todos los grupos sociales.(AU)