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1.
Physiother Res Int ; 29(2): e2088, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38581398

RESUMEN

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is an increasingly concerning global public health issue due to its high burden of morbidity and mortality. Pulmonary rehabilitation (PR) is a comprehensive intervention to improve patients' physical and psychological conditions, commonly involving oxygen supplementation. The potential benefits of high-flow nasal cannula (HFNC) have recently sparked interest as oxygen therapy. In this context, this study aims to assess the effects of HFNC during the exercise training component of a PR program in people with COPD. METHODS: Systematic review (CRD42022330929). We included randomised controlled trials (RCTs), including crossover RCTs with adults with stable COPD. We included trials using oxygen therapy with HFNC during the exercise training component of a PR programme. PRIMARY OUTCOMES: disease-specific health-related quality of life (HRQoL), exercise capacity (EC) and adverse events. SECONDARY OUTCOMES: treatment adherence, breathlessness and future exacerbations. RESULTS: We included five studies with 300 participants with moderate to severe COPD. The certainty of the evidence was primarily low or very low for all outcomes of interest due to risk of bias, inconsistency or imprecision. HFNC has little to no difference in HRQoL (4 studies, 129 participants, MD 0.17, 95% CI -1.20 to 1.54; I2 50%). HFNC may result in little to no difference in EC (3 studies, 212 participants, mean difference 18.73, 95% CI -20.49 to 28.94; I2 56%), and we are uncertain about the effect of HFNC on breathlessness (4 studies; 244 participants, MD of -0.07, 95% CI -0.4 to 0.26; I2 63%). Only one study with 44 participants reported a participant's withdrawal because of progressive dyspnoea during lower limb exercise. CONCLUSIONS: We are uncertain about the effect of HFNC during the exercise component of a PR programme in HRQoL, EC or dyspnoea compared to usual care or conventional supplementary oxygen. Non-domiciliary oxygen patients showed improvements in HRQoL, EC and dyspnoea.


Asunto(s)
Cánula , Enfermedad Pulmonar Obstructiva Crónica , Adulto , Humanos , Cánula/efectos adversos , Enfermedad Pulmonar Obstructiva Crónica/terapia , Calidad de Vida , Disnea/terapia , Oxígeno
2.
BMJ Med ; 3(1): e000723, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38293681

RESUMEN

Objective: To assess the impact of post-covid-19 conditions among adults. Design: Systematic review and meta-analysis of health outcomes in controlled studies. Data sources: Two sources were searched from database inception to 20 October 2022: Cochrane covid-19 study register (comprising Cochrane Central Register of Controlled Trials, Medline, Embase, clinicalTrials.gov, World Health Organization's International Clinical Trials Registry Platform, medRxiv) and WHO's covid-19 research database. Eligibility criteria: Cohort studies recruiting more than 100 participants with a control group and a follow-up of at least 12 weeks were included. Adults who were documented to have SARS-CoV-2 infection based on clinical, imaging, or laboratory criteria were included. Data extraction and synthesis: Two independent reviewers extracted data. The main outcomes included quality of life, functionality in daily activities, use of resources, recovery rates (cluster of symptoms), and the incidence of new medical diagnoses. Data were pooled using a random effects model. The risk of bias was assessed with the Joanna Briggs Institute critical appraisal tool for cohort studies. Results: We included 63 controlled cohort studies, encompassing more than 96 million participants. Based on five studies, we found a reduction in overall quality of life between individuals with confirmed SARS-CoV-2 infection versus controls at six to 24 months follow-up, although heterogeneity was very high (mean difference in EQ-5D scale -5.28 (95% confidence interval -7.88 to 2.68; I2=93.81%). Evidence from ten studies, which could not be pooled in a meta-analysis, indicated that an increased rate of functional impairment associated with SARS-CoV-2 infection. Use of care increased compared with controls at six to 24 months follow-up at intensive care units (risk ratio 2.00 (95% confidence interval 0.69 to 5.80), five studies, I2=91.96%) and in outpatient care (1.12 (1.01 to 1.24), seven studies, I2=99.51%). Regarding persistent symptoms, individuals with documented SARS-CoV-2 infection had an increased risk of having two or more persistent symptoms at follow-up, especially those related to neurological clusters (ie, risk ratio 1.51 (95% confidence interval 1.17 to 1.93), I2=98.91%). Evidence also showed an increased incidence of a wide variety of metabolic, cardiovascular, neurological, respiratory, haematological and other incident diagnoses. Conclusion: Evidence suggests functional impairment after SARS-CoV-2 infection, in addition to a higher use of resources and a higher incidence of widely varying medical diagnoses. These results should be interpreted with caution, considering the high heterogeneity across studies and study limitations related to outcome measurement and attrition of participants. Systematic review registration: Open Science Framework, osf.io/drm39.

3.
Cochrane Database Syst Rev ; 9: MR000054, 2023 09 08.
Artículo en Inglés | MEDLINE | ID: mdl-37681507

RESUMEN

BACKGROUND: Bibliographic databases provide access to an international body of scientific literature in health and medical sciences. Systematic reviews are an important source of evidence for clinicians, researchers, consumers, and policymakers as they address a specific health-related question and use explicit methods to identify, appraise and synthesize evidence from which conclusions can be drawn and decisions made. Methodological search filters help database end-users search the literature effectively with different levels of sensitivity and specificity. These filters have been developed for various study designs and have been found to be particularly useful for intervention studies. Other filters have been developed for finding systematic reviews. Considering the variety and number of available search filters for systematic reviews, there is a need for a review of them in order to provide evidence about their retrieval properties at the time they were developed. OBJECTIVES: To review systematically empirical studies that report the development, evaluation, or comparison of search filters to retrieve reports of systematic reviews in MEDLINE and Embase. SEARCH METHODS: We searched the following databases from inception to January 2023: MEDLINE, Embase, PsycINFO; Library, Information Science & Technology Abstracts (LISTA) and Science Citation Index (Web of Science). SELECTION CRITERIA: We included studies if one of their primary objectives is the development, evaluation, or comparison of a search filter that could be used to retrieve systematic reviews on MEDLINE, Embase, or both. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data using a pre-specified and piloted data extraction form using InterTASC Information Specialist Subgroup (ISSG) Search Filter Evaluation Checklist. MAIN RESULTS: We identified eight studies that developed filters for MEDLINE and three studies that developed filters for Embase. Most studies are very old and some were limited to systematic reviews in specific clinical areas. Six included studies reported the sensitivity of their developed filter. Seven studies reported precision and six studies reported specificity. Only one study reported the number needed to read and positive predictive value. None of the filters were designed to differentiate systematic reviews on the basis of their methodological quality. For MEDLINE, all filters showed similar sensitivity and precision, and one filter showed higher levels of specificity. For Embase, filters showed variable sensitivity and precision, with limited study reports that may affect accuracy assessments. The report of these studies had some limitations, and the assessments of their accuracy may suffer from indirectness, considering that they were mostly developed before the release of the PRISMA 2009 statement or due to their limited scope in the selection of systematic review topics. Search filters for MEDLINE Three studies produced filters with sensitivity > 90% with variable degrees of precision, and only one of them was developed and validated in a gold-standard database, which allowed the calculation of specificity. The other two search filters had lower levels of sensitivity. One of these produced a filter with higher levels of specificity (> 90%). All filters showed similar sensitivity and precision in the external validation, except for one which was not externally validated and another one which was conceptually derived and only externally validated. Search filters for Embase We identified three studies that developed filters for this database. One of these studies developed filters with variable sensitivity and precision, including highly sensitive strategies (> 90%); however, it was not externally validated. The other study produced a filter with a lower sensitivity (72.7%) but high specificity (99.1%) with a similar performance in the external validation. AUTHORS' CONCLUSIONS: Studies reporting the development, evaluation, or comparison of search filters to retrieve reports of systematic reviews in MEDLINE showed similar sensitivity and precision, with one filter showing higher levels of specificity. For Embase, filters showed variable sensitivity and precision, with limited information about how the filter was produced, which leaves us uncertain about their performance assessments. Newer filters had limitations in their methods or scope, including very focused subject topics for their gold standards, limiting their applicability across other topics. Our findings highlight that consensus guidance on the conduct of search filters and standardized reporting of search filters are needed, as we found highly heterogeneous development methods, accuracy assessments and outcome selection. New strategies adaptable across interfaces could enhance their usability. Moreover, the performance of existing filters needs to be evaluated in light of the impact of reporting guidelines, including the PRISMA 2009, on how systematic reviews are reported. Finally, future filter developments should also consider comparing the filters against a common reference set to establish comparative performance and assess the quality of systematic reviews retrieved by strategies.


Asunto(s)
Lista de Verificación , Revisiones Sistemáticas como Asunto , Humanos , Bases de Datos Bibliográficas , MEDLINE
4.
Prev Med ; 172: 107534, 2023 07.
Artículo en Inglés | MEDLINE | ID: mdl-37146731

RESUMEN

BACKGROUND: In 2010 the American Heart Association defined the concept of ideal cardiovascular health to renew the focus on primordial prevention for cardiovascular disease. Evidence primarily from high-income countries suggests ideal CVH prevalence is low and decreases with age, with vulnerable populations differentially affected. We aimed to identify and characterize the evidence relevant to CVH metrics in low- and middle-income countries (LMICs). METHODS: We followed the Joanna Briggs Institute guideline for the conduct of this scoping review. We searched MEDLINE, Embase, LILACS and study registers from inception to 14 March 2022. We included cross-sectional and cohort studies in populations representing a geographically-defined unit (urban or rural) in LMICs, and with data on CVH metrics i.e. all health or clinical factors (cholesterol, blood pressure, glycemia and body mass index) and at least one health behavior (smoking, diet or physical activity). We report findings following the PRISMA-Scr extension for scoping reviews. RESULTS: We included 251 studies; 85% were cross-sectional. Most studies (70.9%) came from just ten countries. Only 6.8% included children younger than 12 years old. Only 34.7% reported seven metrics; 25.1%, six. Health behaviors were mostly self-reported; 45.0% of studies assessed diet, 58.6% physical activity, and 90.0% smoking status. CONCLUSIONS: We identified a substantial and heterogeneous body of research presenting CVH metrics in LMICs. Few studies assessed all components of CVH, especially in children and in low-income settings. This review will facilitate the design of future studies to bridge the evidence gap. This scoping review protocol was previously registered on OSF: https://osf.io/sajnh.


Asunto(s)
Enfermedades Cardiovasculares , Sistema Cardiovascular , Niño , Humanos , Presión Sanguínea , Enfermedades Cardiovasculares/prevención & control , Países en Desarrollo , Dieta , Estado de Salud , Indicadores de Calidad de la Atención de Salud , Factores de Riesgo
6.
Artículo en Inglés | MEDLINE | ID: mdl-36361269

RESUMEN

Post-COVID conditions in children and adolescents were mostly investigated as the incidence of individual or clusters of symptoms. We aimed to describe the findings of studies assessing key outcomes related to global wellbeing and recovery in children and adolescents from a public health perspective. We searched the Cochrane COVID-19 Study Register and WHO COVID-19 Global literature on coronavirus disease database on 5 November 2021 and tracked ongoing studies published after this date. We included observational studies on children and adolescents with a follow-up greater than 12 weeks and focused on the outcomes of quality of life, recovery/duration of symptoms, school attendance and resource use/rehabilitation. We assessed their methodological quality, and we prepared a narrative synthesis of the results. We included 21 longitudinal and 4 cross-sectional studies (6 with a control group) with over 68 thousand unvaccinated children and adolescents with mostly asymptomatic or mild disease. Study limitations included convenience sampling, a poor description of their study population and heterogeneous definitions of outcomes. Quality of life was not largely affected in adolescents following COVID-19, but there might be greater impairment in young children and in those with more severe forms of the disease (4 studies). There might also be an impairment in daily activities and increased school absenteeism following COVID-19, but the findings were heterogeneous (5 studies). A total of 22 studies provided highly variable estimates based on heterogeneous definitions of overall persistence of symptoms (recovery), ranging from 0 to 67% at 8-12 weeks and 8 to 51% at 6-12 months. We found limited data on resource use and the need for rehabilitation. One controlled study indicated that the quality of life of infected children and adolescents might not substantially differ from controls. All controlled studies found a higher burden of persistent symptoms in COVID-19 cases compared with test-negative controls or cases of influenza. There is limited evidence on the short and long-term well-being of children following SARS-CoV-2 infection. High-quality longitudinal studies with control groups are needed to describe the outcomes in this population, especially in vaccinated children and those affected by new variants of the virus.


Asunto(s)
COVID-19 , Gripe Humana , Niño , Adolescente , Humanos , Preescolar , COVID-19/epidemiología , SARS-CoV-2 , Estudios Transversales , Instituciones Académicas
7.
Artículo en Inglés | MEDLINE | ID: mdl-36011562

RESUMEN

Post-COVID-19 conditions, also known as 'Long-COVID-19', describe a longer and more complex course of illness than acute COVID-19 with no widely accepted uniform case definition. We aimed to map the available evidence on persistent symptoms and sequelae following SARS-CoV-2 in children and adults. We searched the Cochrane COVID-19 Study Register and the WHO COVID-19 Global literature on coronavirus disease database on 5 November 2021. We included longitudinal and cross-sectional studies and we extracted their characteristics, including the type of core outcomes for post-COVID-19 conditions. We included 565 studies (657 records). Most studies were uncontrolled cohort studies. The median follow-up time was 13 weeks (IQR 9 to 24). Only 72% of studies were conducted in high-income countries, 93% included unvaccinated adults with mild-to-critical disease, only 10% included children and adolescents, and less than 5% included children under the age of five. While most studies focused on health symptoms, including respiratory symptoms (71%), neurological symptoms (57%), fatigue (54%), pain (50%), mental functioning (43%), cardiovascular functioning (40%), and post-exertion symptoms (28%), cognitive function (26%), fewer studies assessed other symptoms such as overall recovery (24%), the need for rehabilitation (18%), health-related quality of life (16%), changes in work/occupation and study (10%), or survival related to long-COVID-19 (4%). There is a need for controlled cohort studies with long-term follow-up and a focus on overall recovery, health-related quality of life, and the ability to perform daily tasks. Studies need to be extended to later phases of the pandemic and countries with low resources.


Asunto(s)
COVID-19 , Adolescente , Adulto , COVID-19/complicaciones , Niño , Estudios Transversales , Humanos , Calidad de Vida , SARS-CoV-2 , Síndrome Post Agudo de COVID-19
8.
Rev. Hosp. Ital. B. Aires (2004) ; 42(2): 77-83, jun. 2022. ilus, tab
Artículo en Español | LILACS, UNISALUD, BINACIS | ID: biblio-1378671

RESUMEN

Introducción: el impacto de la resistencia antimicrobiana (RAM) generará un aumento de las muertes relacionadas de 10 millones anuales hacia 2050. El 70% de la dispensación de antimicrobianos (ATB) se utiliza en la agroveterinaria y no en salud humana. Es fundamental conocer la portación de RAM en trabajadores de cría de animales y en los animales, para acciones tempranas de salud pública. Métodos: bajo metodología PRISMA se realizó la búsqueda bibliográfica en distintas fuentes disponibles hasta octubre de 2020. Se priorizaron revisiones sistemáticas, metanálisis, ensayos clínicos y estudios observacionales para determinar la RAM en trabajadores de cría de cerdos. De 990 artículos identificados se incluyeron 8 estudios. Resultados: la tasa de colonización por Staphylococcus aureus resistente a la meticilina (SAMR) en trabajadores fue mayor que la de la población general. La prevalencia de SAMR fue significativamente mayor en trabajadores en contacto directo con animales y los de granjas de cría intensiva con respecto a los de extensiva. En cerdos, la prevalencia de RAM en cría intensiva fue significativamente mayor que la de los de cría extensiva. También fue significativa la asociación entre el suministro de antibióticos en la cría intensiva y la presencia de RAM. Las granjas de más de 1250 cerdos presentaron mayor prevalencia de RAM (p < 0,001). El fenotipo de SAMR en cerdos, trabajadores y el ambiente fue el mismo. Conclusiones: existe evidencia de asociación entre la producción agrícola de cría intensiva y la RAM en cerdos y trabajadores. No se encontraron estudios de vigilancia epidemiológica en la Argentina en trabajadores de cría de animales. (AU)


Introduction: it is estimated that the impact of antimicrobial resistance (AMR) will generate an increase of 10 million deaths by 2050, being reflected to a greater extent in low-income countries. 70% of the annual use of antimicrobials is concentrated in agroveterinary but not in human health. Considering the presence of AMR in ranchers and agricultural workers is essential for early public health actions. Methods: using the PRISMA methodology, bibliography was searched in different sources until October 2020. Systematic reviews, meta-analyses, clinical trials and observational studies were prioritized to determine AMR in pig workers. Eight studies of the 990 found have been included. Results: the rate of colonization by methicillin-resistant Staphylococcus aureus (MRSA) in farming workers was higher than the general population. MRSA prevalence was significantly higher in workers who reported direct contact with animals. And also in those workers of intensive farms compared to those of extensive farms. The same situation is observed in swines, in which the prevalence of AMR in intensive farming was significantly higher than in extensive farming. The association between the supply of antibiotics in intensive farming workers and the presence of AMR was also significant. Farms with more than 1,250 swines had a higher prevalence of AMR (p<0.001). The MRSA phenotype found in swine, agricultural workers, and the environment was the same. Conclusions: there is scientific evidence of an association between agricultural production in intensive livestock farming and AMR in swine and farming workers. There aren't Argentine studies of epidemiological surveillance in farming workers. (AU)


Asunto(s)
Humanos , Animales , Farmacorresistencia Bacteriana , Staphylococcus aureus Resistente a Meticilina , Agricultores/estadística & datos numéricos , Antiinfecciosos/farmacología , Porcinos , Salud Pública , Evaluación de Resultado en la Atención de Salud/estadística & datos numéricos , Estudios Observacionales como Asunto , Revisiones Sistemáticas como Asunto , Antibacterianos/administración & dosificación
10.
World J Mens Health ; 40(1): 127-138, 2022 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-34448377

RESUMEN

PURPOSE: To assess the effects of transurethral microwave thermotherapy (TUMT) for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: We performed a comprehensive search using multiple databases up to May 2021, with no language or publication status restrictions. We included parallel-group randomized controlled trials of participants with BPH who underwent TUMT. We used standard Cochrane methods, including a GRADE assessment of the certainty of the evidence (CoE). RESULTS: In this update of a previous Cochrane review, we included 16 trials with 1,919 participants. TUMT probably results in little to no difference in urologic symptom scores at short-term follow-up compared to transurethral resection of the prostate (TURP). There is likely to be little to no difference in the quality of life. TUMT likely results in fewer major adverse events. TUMT, however, probably results in a large increase in the need for retreatment. There may be little to no difference in erectile function between these interventions. However, TUMT may result in fewer cases of ejaculatory dysfunction compared to TURP. The overall CoE was moderate to low. CONCLUSIONS: TUMT provides a similar reduction in urinary symptoms compared to TURP, with fewer major adverse events and fewer cases of ejaculatory dysfunction at short-term follow-up. However, TUMT probably results in a large increase in retreatment rates. Study limitations and imprecision reduced the confidence we can place in these results.

12.
BMJ Evid Based Med ; 27(1): 21-26, 2022 02.
Artículo en Inglés | MEDLINE | ID: mdl-33674258

RESUMEN

BACKGROUND: It is recommended that patients actively participate in clinical practice guideline (CPG) development, which allows consideration of their values and preferences and improves adherence to recommendations. The development of CPGs throughout Latin America is variable and diverse, and the inclusion of patients' participation is unknown. OBJECTIVES: To evaluate the methods of patients' participation in government-sponsored CPGs in Latin America, the type of CPG development and the use of Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methods. DESIGN: Cross-sectional study. We included CPGs developed over the last 10 years through a comprehensive hand search in official national government websites and biomedical databases. MAIN OUTCOME MEASURE: The type of patients' participation was coded according to five predefined categories. We also report the proportion of application of GRADE methods. RESULTS: We included 408 CPGs from 10 countries: 74% (n=303) were de novo development, 13%(n=55) used an adaptation method and 10%(n=41) used both adaptation and de novo methods. Only 45% (n=185) applied the GRADE approach, ranging from 14% (n=12) of CPGs in Brazil to 89% (n=56) of CPGs in Colombia. Only 23% (n=95) of CPGs included at least one method of patients' participation. Mexico was one of the largest CPG producers (100 CPGs), but none included methods of patients' participation; in turn, in countries with lower production of government-sponsored CPGs, patients' participation was found in almost 88%. Guidelines using the GRADE approach were more likely to use methods of patients' participation. These methods were highly variable: 46% (n=44) incorporated patients in the panel, 81% (n=77) searched for evidence about patients' values and preferences, 43% (n=39) used an external review of the draft recommendations by patients, 38% (n=36) used public comments, and 2% included other methods for stakeholders' participation. CONCLUSION: Only one quarter of government-sponsored CPGs in the Latin American region incorporated a method for patients' participation, which varied considerably across the selected countries. These findings highlight the need to improve CPG development methods to systematically incorporate patients' values and preferences when drafting recommendations.


Asunto(s)
Gobierno , Participación del Paciente , Estudios Transversales , Bases de Datos Factuales , Humanos , América Latina
13.
BJU Int ; 130(2): 142-156, 2022 08.
Artículo en Inglés | MEDLINE | ID: mdl-34820997

RESUMEN

OBJECTIVE: To assess the comparative effectiveness and ranking of minimally invasive treatments (MITs) for lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: We searched multiple databases up to 24 February 2021. We included randomized controlled trials assessing the following treatments: convective radiofrequency water vapour thermal therapy (WVTT; or Rezum); prostatic arterial embolization (PAE); prostatic urethral lift (PUL; or Urolift); temporary implantable nitinol device (TIND); and transurethral microwave thermotherapy (TUMT) compared to transurethral resection of the prostate (TURP) or sham surgery. We performed a frequentist network meta-analysis. RESULTS: We included 27 trials involving 3017 men. The overall certainty of the evidence of most outcomes according to GRADE was low to very low. Compared to TURP, we found that PUL and PAE may result in little to no difference in urological symptoms, while WVTT, TUMT and TIND may result in worse urological symptoms. MITs may result in little to no difference in quality of life, compared to TURP. MITs may result in a large reduction in major adverse events compared to TURP. We were uncertain about the effects of PAE and PUL on retreatment compared to TURP, however, TUMT may result in higher retreatment rates. We were very uncertain of the effects of MITs on erectile function and ejaculatory function. Among MITs, PUL and PAE had the highest likelihood of being the most efficacious for urinary symptoms and quality of life, TUMT for major adverse events, WVTT and TIND for erectile function and PUL for ejaculatory function. Excluding WVTT and TIND, for which there were only studies with short-term (3-month) follow-up, PUL had the highest likelihood of being the most efficacious for retreatment. CONCLUSIONS: Minimally invasive treatments may result in similar or worse effects concerning urinary symptoms and quality of life compared to TURP at short-term follow-up.


Asunto(s)
Disfunción Eréctil , Síntomas del Sistema Urinario Inferior , Hiperplasia Prostática , Resección Transuretral de la Próstata , Disfunción Eréctil/etiología , Humanos , Síntomas del Sistema Urinario Inferior/etiología , Síntomas del Sistema Urinario Inferior/cirugía , Masculino , Procedimientos Quirúrgicos Mínimamente Invasivos , Metaanálisis en Red , Hiperplasia Prostática/complicaciones , Hiperplasia Prostática/cirugía , Calidad de Vida , Resección Transuretral de la Próstata/efectos adversos , Resultado del Tratamiento
14.
Cochrane Database Syst Rev ; 12: CD013720, 2021 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-34850383

RESUMEN

BACKGROUND: Duchenne muscular dystrophy (DMD) is an X-linked recessive disorder characterised by progressive muscle weakness beginning in early childhood. Respiratory failure and weak cough develop in all patients as a consequence of muscle weakness leading to a risk of atelectasis, pneumonia, or the need for ventilatory support. There is no curative treatment for DMD. Corticosteroids are the only pharmacological intervention proven to delay the onset and progression of muscle weakness and thus respiratory decline in DMD. Antioxidant treatment has been proposed to try to reduce muscle weakness in general, and respiratory decline in particular.  OBJECTIVES: To assess the effects of antioxidant agents on preventing respiratory decline in people with Duchenne muscular dystrophy during the respiratory decline phase of the condition.  SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, and two trials registers to 23 March 2021, together with reference checking, citation searching, and contact with study authors to identify additional studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs that met our inclusion criteria. We included male patients with a diagnosis of DMD who had respiratory decline evidenced by a forced vital capacity (FVC%) less than 80% but greater than 30% of predicted values, receiving any antioxidant agent compared with other therapies for the management of DMD or placebo.  DATA COLLECTION AND ANALYSIS: Two review authors screened studies for eligibility, assessed risk of bias of studies, and extracted data. We used standard methods expected by Cochrane. We assessed the certainty of the evidence using the GRADE approach. The primary outcomes were FVC and hospitalisation due to respiratory infections. Secondary outcomes were quality of life, adverse events, change in muscle function, forced expiratory volume in the first second (FEV1), and peak expiratory flow (PEF).  MAIN RESULTS: We included one study with 66 participants who were not co-treated with corticosteroids, which was the only study to contribute data to our main analysis. We also included a study that enrolled 255 participants treated with corticosteroids, which was only available as a press release without numerical results. The studies were parallel-group RCTs that assessed the effect of idebenone on respiratory function compared to placebo. The trial that contributed numerical data included patients with a mean (standard deviation) age of 14.3 (2.7) years at the time of inclusion, with a documented diagnosis of DMD or severe dystrophinopathy with clinical features consistent with typical DMD. The overall risk of bias across most outcomes was similar and judged as 'low'.  Idebenone may result in a slightly less of a decline in FVC from baseline to one year compared to placebo (mean difference (MD) 3.28%, 95% confidence interval (CI) -0.41 to 6.97; 64 participants; low-certainty evidence), and probably has little or no effect on change in quality of life (MD -3.80, 95% CI -10.09 to 2.49; 63 participants; moderate-certainty evidence) (Pediatric Quality of Life Inventory (PedsQL), range 0 to 100, 0 = worst, 100 = best quality of life). As a related but secondary outcome, idebenone may result in less of a decline from baseline in FEV1 (MD 8.28%, 95% CI 0.89 to 15.67; 53 participants) and PEF (MD 6.27%, 95% CI 0.61 to 11.93; 1 trial, 64 participants) compared to placebo. Idebenone was associated with fewer serious adverse events (RR 0.42, 95% CI 0.09 to 2.04; 66 participants; low-certainty evidence) and little to no difference in non-serious adverse events (RR 1.00, 95% CI 0.88 to 1.13; 66 participants; low-certainty evidence) compared to placebo. Idebenone may result in little to no difference in change in arm muscle function (MD -2.45 N, 95% CI -8.60 to 3.70 for elbow flexors and MD -1.06 N, 95% CI -6.77 to 4.65 for elbow extensors; both 52 participants) compared to placebo. We found no studies evaluating the outcome hospitalisation due to respiratory infection.  The second trial, involving 255 participants, for which data were available only as a press release without numerical data, was prematurely discontinued due to futility after an interim efficacy analysis based on FVC. There were no safety concerns. The certainty of the evidence was low for most outcomes due to imprecision and publication bias (the lack of a full report of the larger trial, which was prematurely terminated). AUTHORS' CONCLUSIONS: Idebenone is the only antioxidant agent tested in RCTs for preventing respiratory decline in people with DMD for which evidence was available for assessment. Idebenone may result in slightly less of a decline in FVC and less of a decline in FEV1 and PEF, but probably has little to no measurable effect on change in quality of life. Idebenone is associated with fewer serious adverse events than placebo. Idebenone may result in little to no difference in change in muscle function. Discontinuation due to the futility of the SIDEROS trial and its expanded access programmes may indicate that idebenone research in this condition is no longer needed, but we await the trial data. Further research is needed to establish the effect of different antioxidant agents on preventing respiratory decline in people with DMD during the respiratory decline phase of the condition.


Asunto(s)
Antioxidantes , Distrofia Muscular de Duchenne , Adolescente , Corticoesteroides/uso terapéutico , Antioxidantes/uso terapéutico , Niño , Volumen Espiratorio Forzado , Humanos , Masculino , Distrofia Muscular de Duchenne/complicaciones , Distrofia Muscular de Duchenne/tratamiento farmacológico , Capacidad Vital
15.
Cochrane Database Syst Rev ; 11: CD013757, 2021 11 16.
Artículo en Inglés | MEDLINE | ID: mdl-34783356

RESUMEN

BACKGROUND: Respiratory viruses are the leading cause of lower respiratory tract infection (LRTI) and hospitalisation in infants and young children. Respiratory syncytial virus (RSV) is the main infectious agent in this population. Palivizumab is administered intramuscularly every month during five months in the first RSV season to prevent serious RSV LRTI in children. Given its high cost, it is essential to know if palivizumab continues to be effective in preventing severe RSV disease in children. OBJECTIVES: To assess the effects of palivizumab for preventing severe RSV infection in children. SEARCH METHODS: We searched CENTRAL, MEDLINE, three other databases and two trials registers to 14 October 2021, together with reference checking, citation searching and contact with study authors to identify additional studies. We searched Embase to October 2020, as we did not have access to this database for 2021. SELECTION CRITERIA: We included randomised controlled trials (RCTs), including cluster-RCTs, comparing palivizumab given at a dose of 15 mg/kg once a month (maximum five doses) with placebo, no intervention or standard care in children 0 to 24 months of age from both genders, regardless of RSV infection history.  DATA COLLECTION AND ANALYSIS: We used Cochrane's Screen4Me workflow to help assess the search results. Two review authors screened studies for selection, assessed risk of bias and extracted data. We used standard Cochrane methods. We used GRADE to assess the certainty of the evidence. The primary outcomes were hospitalisation due to RSV infection, all-cause mortality and adverse events. Secondary outcomes were hospitalisation due to respiratory-related illness, length of hospital stay, RSV infection, number of wheezing days, days of supplemental oxygen, intensive care unit length of stay and mechanical ventilation days. MAIN RESULTS: We included five studies with  a total of 3343 participants. All studies were parallel RCTs, assessing the effects of 15 mg/kg of palivizumab every month up to five months compared to placebo or no intervention in an outpatient setting, although one study also included hospitalised infants. Most of the included studies were conducted in children with a high risk of RSV infection due to comorbidities like bronchopulmonary dysplasia and congenital heart disease. The risk of bias of outcomes across all studies was similar and predominately low.  Palivizumab reduces hospitalisation due to RSV infection at two years' follow-up (risk ratio (RR) 0.44, 95% confidence interval (CI) 0.30 to 0.64; 5 studies, 3343 participants; high certainty evidence). Based on 98 hospitalisations per 1000 participants in the placebo group, this corresponds to 43 (29 to 62) per 1000 participants in the palivizumab group. Palivizumab probably results in little to no difference in mortality at two years' follow-up (RR 0.69, 95% CI 0.42 to 1.15; 5 studies, 3343 participants; moderate certainty evidence). Based on 23 deaths per 1000 participants in the placebo group, this corresponds to 16 (10 to 27) per 1000 participants in the palivizumab group. Palivizumab probably results in little to no difference in adverse events at 150 days' follow-up (RR 1.09, 95% CI 0.85 to 1.39; 3 studies, 2831 participants; moderate certainty evidence). Based on 84 cases per 1000 participants in the placebo group, this corresponds to 91 (71 to 117) per 1000 participants in the palivizumab group. Palivizumab probably results in a slight reduction in hospitalisation due to respiratory-related illness at two years' follow-up (RR 0.78, 95% CI 0.62 to 0.97; 5 studies, 3343 participants; moderate certainty evidence). Palivizumab may result in a large reduction in RSV infection at two years' follow-up (RR 0.33, 95% CI 0.20 to 0.55; 3 studies, 554 participants; low certainty evidence). Based on 195 cases of RSV infection per 1000 participants in the placebo group, this corresponds to 64 (39 to 107) per 1000 participants in the palivizumab group. Palivizumab also reduces the number of wheezing days at one year's follow-up (RR 0.39, 95% CI 0.35 to 0.44; 1 study, 429 participants; high certainty evidence). AUTHORS' CONCLUSIONS: The available evidence suggests that prophylaxis with palivizumab reduces hospitalisation due to RSV infection and results in little to no difference in mortality or adverse events. Moreover, palivizumab results in a slight reduction in hospitalisation due to respiratory-related illness and may result in a large reduction in RSV infections. Palivizumab also reduces the number of wheezing days. These results may be applicable to children with a high risk of RSV infection due to comorbidities. Further research is needed to establish the effect of palivizumab on children with other comorbidities known as risk factors for severe RSV disease (e.g. immune deficiencies) and other social determinants of the disease, including children living in low- and middle-income countries, tropical regions, children lacking breastfeeding, living in poverty, or members of families in overcrowded situations.


Asunto(s)
Infecciones por Virus Sincitial Respiratorio , Niño , Preescolar , Hospitalización , Humanos , Lactante , Recién Nacido , Tiempo de Internación , Palivizumab/uso terapéutico , Infecciones por Virus Sincitial Respiratorio/prevención & control , Virus Sincitiales Respiratorios
16.
Cochrane Database Syst Rev ; 11: CD013720, 2021 11 08.
Artículo en Inglés | MEDLINE | ID: mdl-34748221

RESUMEN

BACKGROUND: Duchenne muscular dystrophy (DMD) is an X-linked recessive disorder characterised by progressive muscle weakness beginning in early childhood. Respiratory failure and weak cough develop in all patients as a consequence of muscle weakness leading to a risk of atelectasis, pneumonia, or the need for ventilatory support. There is no curative treatment for DMD. Corticosteroids are the only pharmacological intervention proven to delay the onset and progression of muscle weakness and thus respiratory decline in DMD. Antioxidant treatment has been proposed to try to reduce muscle weakness in general, and respiratory decline in particular.  OBJECTIVES: To assess the effects of antioxidant agents on preventing respiratory decline in people with Duchenne muscular dystrophy during the respiratory decline phase of the condition.  SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, and two trials registers to 23 March 2021, together with reference checking, citation searching, and contact with study authors to identify additional studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs that met our inclusion criteria. We included male patients with a diagnosis of DMD who had respiratory decline evidenced by a forced vital capacity (FVC%) less than 80% but greater than 30% of predicted values, receiving any antioxidant agent compared with other therapies for the management of DMD or placebo.  DATA COLLECTION AND ANALYSIS: Two review authors screened studies for eligibility, assessed risk of bias of studies, and extracted data. We used standard methods expected by Cochrane. We assessed the certainty of the evidence using the GRADE approach. The primary outcomes were FVC and hospitalisation due to respiratory infections. Secondary outcomes were quality of life, adverse events, change in muscle function, forced expiratory volume in the first second (FEV1), and peak expiratory flow (PEF).  MAIN RESULTS: We included one study with 66 participants who were not co-treated with corticosteroids, which was the only study to contribute data to our main analysis. We also included a study that enrolled 255 participants treated with corticosteroids, which was only available as a press release without numerical results. The studies were parallel-group RCTs that assessed the effect of idebenone on respiratory function compared to placebo. The trial that contributed numerical data included patients with a mean (standard deviation) age of 14.3 (2.7) years at the time of inclusion, with a documented diagnosis of DMD or severe dystrophinopathy with clinical features consistent with typical DMD. The overall risk of bias across most outcomes was similar and judged as 'low'.  Idebenone may result in a slightly less of a decline in FVC from baseline to one year compared to placebo (mean difference (MD) 3.28%, 95% confidence interval (CI) -0.41 to 6.97; 64 participants; low-certainty evidence), and probably has little or no effect on change in quality of life (MD -3.80, 95% CI -10.09 to 2.49; 63 participants; moderate-certainty evidence) (Pediatric Quality of Life Inventory (PedsQL), range 0 to 100, 0 = worst, 100 = best quality of life). As a related but secondary outcome, idebenone may result in less of a decline from baseline in FEV1 (MD 8.28%, 95% CI 0.89 to 15.67; 53 participants) and PEF (MD 6.27%, 95% CI 0.61 to 11.93; 1 trial, 64 participants) compared to placebo. Idebenone was associated with fewer serious adverse events (RR 0.42, 95% CI 0.09 to 2.04; 66 participants; low-certainty evidence) and little to no difference in non-serious adverse events (RR 1.00, 95% CI 0.88 to 1.13; 66 participants; low-certainty evidence) compared to placebo. Idebenone may result in little to no difference in change in arm muscle function (MD -2.45 N, 95% CI -8.60 to 3.70 for elbow flexors and MD -1.06 N, 95% CI -6.77 to 4.65 for elbow extensors; both 52 participants) compared to placebo. We found no studies evaluating the outcome hospitalisation due to respiratory infection.  The second trial, involving 255 participants, for which data were available only as a press release without numerical data, was prematurely discontinued due to futility after an interim efficacy analysis based on FVC. There were no safety concerns. The certainty of the evidence was low for most outcomes due to imprecision and publication bias (the lack of a full report of the larger trial, which was prematurely terminated). AUTHORS' CONCLUSIONS: Idebenone is the only antioxidant agent tested in RCTs for preventing respiratory decline in people with DMD for which evidence was available for assessment. Idebenone may result in slightly less of a decline in FVC and less of a decline in FEV1 and PEF, but probably has little to no measurable effect on change in quality of life. Idebenone is associated with fewer serious adverse events than placebo. Idebenone may result in little to no difference in change in muscle function. Discontinuation due to the futility of the SIDEROS trial and its expanded access programmes may indicate that idebenone research in this condition is no longer needed, but we await the trial data. Further research is needed to establish the effect of different antioxidant agents on preventing respiratory decline in people with DMD during the respiratory decline phase of the condition.


Asunto(s)
Antioxidantes , Distrofia Muscular de Duchenne , Adolescente , Corticoesteroides/uso terapéutico , Antioxidantes/uso terapéutico , Niño , Volumen Espiratorio Forzado , Humanos , Masculino , Distrofia Muscular de Duchenne/complicaciones , Distrofia Muscular de Duchenne/tratamiento farmacológico , Capacidad Vital
17.
Cochrane Database Syst Rev ; 7: CD013656, 2021 07 15.
Artículo en Inglés | MEDLINE | ID: mdl-34693990

RESUMEN

BACKGROUND: A variety of minimally invasive treatments are available as an alternative to transurethral resection of the prostate (TURP) for management of lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). However, it is unclear which treatments provide better results. OBJECTIVES: Our primary objective was to assess the comparative effectiveness of minimally invasive treatments for lower urinary tract symptoms in men with BPH through a network meta-analysis. Our secondary objective was to obtain an estimate of relative ranking of these minimally invasive treatments, according to their effects. SEARCH METHODS: We performed a comprehensive search of multiple databases (CENTRAL, MEDLINE, Embase, Scopus, Web of Science and LILACS), trials registries, other sources of grey literature, and conference proceedings, up to 24 February 2021. We had no restrictions on language of publication or publication status. SELECTION CRITERIA: We included parallel-group randomized controlled trials assessing the effects of the following minimally invasive treatments, compared to TURP or sham treatment, on men with moderate to severe LUTS due to BPH: convective radiofrequency water vapor therapy (CRFWVT); prostatic arterial embolization (PAE); prostatic urethral lift (PUL); temporary implantable nitinol device (TIND); and transurethral microwave thermotherapy (TUMT). DATA COLLECTION AND ANALYSIS: Two review authors independently screened the literature, extracted data, and assessed risk of bias. We performed statistical analyses using a random-effects model for pair-wise comparisons and a frequentist network meta-analysis for combined estimates. We interpreted them according to Cochrane methods. We planned subgroup analyses by age, prostate volume, and severity of baseline symptoms. We used risk ratios (RRs) with 95% confidence intervals (CIs) to express dichotomous data and mean differences (MDs) with 95% CIs to express continuous data. We used the GRADE approach to rate the certainty of evidence. MAIN RESULTS: We included 27 trials involving 3017 men, mostly over age 50, with severe LUTS due to BPH. The overall certainty of evidence was low to very low due to concerns regarding bias, imprecision, inconsistency (heterogeneity), and incoherence. Based on the network meta-analysis, results for our main outcomes were as follows. Urologic symptoms (19 studies, 1847 participants): PUL and PAE may result in little to no difference in urologic symptoms scores (MD of International Prostate Symptoms Score [IPSS]) compared to TURP (3 to 12 months; MD range 0 to 35; higher scores indicate worse symptoms; PUL: 1.47, 95% CI -4.00 to 6.93; PAE: 1.55, 95% CI -1.23 to 4.33; low-certainty evidence). CRFWVT, TUMT, and TIND may result in worse urologic symptoms scores compared to TURP at short-term follow-up, but the CIs include little to no difference (CRFWVT: 3.6, 95% CI -4.25 to 11.46; TUMT: 3.98, 95% CI 0.85 to 7.10; TIND: 7.5, 95% CI -0.68 to 15.69; low-certainty evidence). Quality of life (QoL) (13 studies, 1459 participants): All interventions may result in little to no difference in the QoL scores, compared to TURP (3 to 12 months; MD of IPSS-QoL score; MD range 0 to 6; higher scores indicate worse symptoms; PUL: 0.06, 95% CI -1.17 to 1.30; PAE: 0.09, 95% CI -0.57 to 0.75; CRFWVT: 0.37, 95% CI -1.45 to 2.20; TUMT: 0.65, 95% CI -0.48 to 1.78; TIND: 0.87, 95% CI -1.04 to 2.79; low-certainty evidence). Major adverse events (15 studies, 1573 participants): TUMT probably results in a large reduction of major adverse events compared to TURP (RR 0.20, 95% CI 0.09 to 0.43; moderate-certainty evidence). PUL, CRFWVT, TIND and PAE may also result in a large reduction in major adverse events, but CIs include substantial benefits and harms at three months to 36 months; PUL: RR 0.30, 95% CI 0.04 to 2.22; CRFWVT: RR 0.37, 95% CI 0.01 to 18.62; TIND: RR 0.52, 95% CI 0.01 to 24.46; PAE: RR 0.65, 95% CI 0.25 to 1.68; low-certainty evidence). Retreatment (10 studies, 799 participants): We are uncertain about the effects of PAE and PUL on retreatment compared to TURP (12 to 60 months; PUL: RR 2.39, 95% CI 0.51 to 11.1; PAE: RR 4.39, 95% CI 1.25 to 15.44; very low-certainty evidence). TUMT may result in higher retreatment rates (RR 9.71, 95% CI 2.35 to 40.13; low-certainty evidence). Erectile function (six studies, 640 participants): We are very uncertain of the effects of minimally invasive treatments on erectile function (MD of International Index of Erectile Function [IIEF-5]; range 5 to 25; higher scores indicates better function; CRFWVT: 6.49, 95% CI -8.13 to 21.12; TIND: 5.19, 95% CI -9.36 to 19.74; PUL: 3.00, 95% CI -5.45 to 11.44; PAE: -0.03, 95% CI -6.38, 6.32; very low-certainty evidence). Ejaculatory dysfunction (eight studies, 461 participants): We are uncertain of the effects of PUL, PAE and TUMT on ejaculatory dysfunction compared to TURP (3 to 12 months; PUL: RR 0.05, 95 % CI 0.00 to 1.06; PAE: RR 0.35, 95% CI 0.13 to 0.92; TUMT: RR 0.34, 95% CI 0.17 to 0.68; low-certainty evidence). TURP is the reference treatment with the highest likelihood of being the most efficacious for urinary symptoms, QoL and retreatment, but the least favorable in terms of major adverse events, erectile function and ejaculatory function. Among minimally invasive procedures, PUL and PAE have the highest likelihood of being the most efficacious for urinary symptoms and QoL, TUMT for major adverse events, PUL for retreatment, CRFWVT and TIND for erectile function and PUL for ejaculatory function. AUTHORS' CONCLUSIONS: Minimally invasive treatments may result in similar or worse effects concerning urinary symptoms and QoL compared to TURP at short-term follow-up. They may result in fewer major adverse events, especially in the case of PUL and PAE; resulting in better rankings for symptoms scores. PUL may result in fewer retreatments compared to other interventions, especially TUMT, which had the highest retreatment rates at long-term follow-up. We are very uncertain about the effects of these interventions on erectile function. There was limited long-term data, especially for CRFWVT and TIND. Future high-quality studies with more extended follow-up, comparing different, active treatment modalities, and adequately reporting critical outcomes relevant to patients, including those related to sexual function, could provide more information on the relative effectiveness of these interventions.


Asunto(s)
Síntomas del Sistema Urinario Inferior , Hiperplasia Prostática , Resección Transuretral de la Próstata , Humanos , Síntomas del Sistema Urinario Inferior/cirugía , Síntomas del Sistema Urinario Inferior/terapia , Masculino , Persona de Mediana Edad , Metaanálisis en Red , Hiperplasia Prostática/complicaciones , Hiperplasia Prostática/cirugía , Calidad de Vida , Resección Transuretral de la Próstata/efectos adversos
18.
Medwave ; 21(6): e8315, 2021 Jul 15.
Artículo en Español, Inglés | MEDLINE | ID: mdl-34292922

RESUMEN

This article belongs to a collaborative methodological series of narrative reviews about biostatistics and clinical epidemiology. The goal is to present basics concepts concerning the systematics reviews of multiple treatments comparisons with network meta-analysis. For clinical ques-tions with several therapeutic alternatives to be compared, the central question is how to classify or rank their effectiveness (benefit and harm) to choose the best option. The network meta-analysis aims to answer questions related to the effectiveness and safety of comparing multiple treatments by the simultaneous analysis of results raised from direct and indirect comparisons. The network geometry is the general graphical representation of the network meta-analysis and allows to understand and assess the strength of comparisons. The network meta-analysis should check several assumptions to be valid, especially the transitivity assumption, which allows assuming that there are no systematic differences among the included comparisons, except their compared interventions. Thus, it is possible to know the relative therapeutic effectiveness of each pair of interventions included in the network meta-analysis and their ranking in terms of categorization. It has been proposed to use a modified Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) approach considering the distinctive features of network meta-analysis to assess the certainty of the evidence for each comparison and the ranking of interventions.


Este artículo forma parte de una serie metodológica colaborativa de revisiones narrativas sobre bioestadística y epidemiología clínica. El objetivo de este trabajo es presentar conceptos básicos respecto de las revisiones sistemáticas de intervenciones múltiples con metanálisis en red. Para las preguntas clínicas en las que hay muchas alternativas terapéuticas que compiten (o se comparan) entre sí. La pregunta central es cómo clasificar u ordenar jerárquicamente su efecto (beneficio y/o daño) para escoger la mejor opción. Los metanálisis en red buscan responder a preguntas relacionadas con la efectividad o seguridad de múltiples tratamientos comparados entre sí, mediante el análisis simultáneo de resultados surgidos tanto de comparaciones directas como de comparaciones indirectas. La geometría de la red (network geometry) es la representación gráfica general de los metanálisis en red y permite comprender e incluso evaluar la fuerza de las comparaciones. Para que un metanálisis de comparaciones múltiples sea válido debe cumplir una serie de supuestos, destacándose el supuesto de transitividad que permite asumir que no hay diferencias sistemáticas entre las comparaciones disponibles, a excepción de las intervenciones comparadas. Así, es posible conocer la efectividad terapéutica relativa entre cualquier par de intervenciones del metanálisis en red y el orden de las intervenciones en términos de su categorización. Se ha propuesto utilizar el modelo Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) modificado en cuanto a las particularidades de los metanálisis en red para valorar la certeza de la evidencia, tanto para cada comparación como para la jerarquización de intervenciones.


Asunto(s)
Metaanálisis en Red , Revisiones Sistemáticas como Asunto , Toma de Decisiones , Humanos
19.
Medwave ; 21(6): e8315, jul. 2021.
Artículo en Inglés, Español | LILACS | ID: biblio-1284255

RESUMEN

Este artículo forma parte de una serie metodológica colaborativa de revisiones narrativas sobre bioestadística y epidemiología clínica. El objetivo de este trabajo es presentar conceptos básicos respecto de las revisiones sistemáticas de intervenciones múltiples con metanálisis en red. Para las preguntas clínicas en las que hay muchas alternativas terapéuticas que compiten (o se comparan) entre sí. La pregunta central es cómo clasificar u ordenar jerárquicamente su efecto (beneficio y/o daño) para escoger la mejor opción. Los metanálisis en red buscan responder a preguntas relacionadas con la efectividad o seguridad de múltiples tratamientos comparados entre sí, mediante el análisis simultáneo de resultados surgidos tanto de comparaciones directas como de comparaciones indirectas. La geometría de la red (network geometry) es la representación gráfica general de los metanálisis en red y permite comprender e incluso evaluar la fuerza de las comparaciones. Para que un metanálisis de comparaciones múltiples sea válido debe cumplir una serie de supuestos, destacándose el supuesto de transitividad que permite asumir que no hay diferencias sistemáticas entre las comparaciones disponibles, a excepción de las intervenciones comparadas. Así, es posible conocer la efectividad terapéutica relativa entre cualquier par de intervenciones del metanálisis en red y el orden de las intervenciones en términos de su categorización. Se ha propuesto utilizar el modelo Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) modificado en cuanto a las particularidades de los metanálisis en red para valorar la certeza de la evidencia, tanto para cada comparación como para la jerarquización de intervenciones.


This article belongs to a collaborative methodological series of narrative reviews about biostatistics and clinical epidemiology. The goal is to present basics concepts concerning the systematics reviews of multiple treatments comparisons with network meta-analysis. For clinical ques-tions with several therapeutic alternatives to be compared, the central question is how to classify or rank their effectiveness (benefit and harm) to choose the best option. The network meta-analysis aims to answer questions related to the effectiveness and safety of comparing multiple treatments by the simultaneous analysis of results raised from direct and indirect comparisons. The network geometry is the general graphical representation of the network meta-analysis and allows to understand and assess the strength of comparisons. The network meta-analysis should check several assumptions to be valid, especially the transitivity assumption, which allows assuming that there are no systematic differences among the included comparisons, except their compared interventions. Thus, it is possible to know the relative therapeutic effectiveness of each pair of interventions included in the network meta-analysis and their ranking in terms of categorization. It has been proposed to use a modified Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) approach considering the distinctive features of network meta-analysis to assess the certainty of the evidence for each comparison and the ranking of interventions.


Asunto(s)
Humanos , Metaanálisis en Red , Revisiones Sistemáticas como Asunto , Toma de Decisiones
20.
Cochrane Database Syst Rev ; 6: CD004135, 2021 06 28.
Artículo en Inglés | MEDLINE | ID: mdl-34180047

RESUMEN

BACKGROUND: Transurethral resection of the prostate (TURP) has been the gold-standard treatment for alleviating urinary symptoms and improving urinary flow in men with symptomatic benign prostatic hyperplasia (BPH). However, the morbidity of TURP approaches 20%, and less invasive techniques have been developed for treating BPH. Transurethral microwave thermotherapy (TUMT) is an alternative, minimally-invasive treatment that delivers microwave energy to produce coagulation necrosis in prostatic tissue. This is an update of a review last published in 2012. OBJECTIVES: To assess the effects of transurethral microwave thermotherapy for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia. SEARCH METHODS: We performed a comprehensive search using multiple databases (the Cochrane Library, MEDLINE, Embase, Scopus, Web of Science, and LILACS), trials registries, other sources of grey literature, and conference proceedings published up to 31 May 2021, with no restrictions by language or publication status. SELECTION CRITERIA: We included parallel-group randomized controlled trials (RCTs) and cluster-RCTs of participants with BPH who underwent TUMT. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion at each stage and undertook data extraction and risk of bias and GRADE assessments of the certainty of the evidence (CoE). We considered review outcomes measured up to 12 months after randomization as short-term and beyond 12 months as long-term. Our main outcomes included: urologic symptoms scores, quality of life, major adverse events, retreatment, and ejaculatory and erectile function. MAIN RESULTS: In this update, we identified no new RCTs, but we included data from studies excluded in the previous version of this review. We included 16 trials with 1919 participants, with a median age of 69 and moderate lower urinary tract symptoms. The certainty of the evidence for most comparisons was moderate-to-low, due to an overall high risk of bias across studies and imprecision (few participants and events). TUMT versus TURP Based on data from four studies with 306 participants, when compared to TURP, TUMT probably results in little to no difference in urologic symptom scores measured by the International Prostatic Symptom Score (IPSS) on a scale from 0 to 35, with higher scores indicating worse symptoms at short-term follow-up (mean difference (MD) 1.00, 95% confidence interval (CI) -0.03 to 2.03; moderate certainty). There is likely to be little to no difference in the quality of life (MD -0.10, 95% CI -0.67 to 0.47; 1 study, 136 participants, moderate certainty). TUMT likely results in fewer major adverse events (RR 0.20, 95% CI 0.09 to 0.43; 6 studies, 525 participants, moderate certainty); based on 168 cases per 1000 men in the TURP group, this corresponds to 135 fewer (153 to 96 fewer) per 1000 men in the TUMT group. TUMT, however, probably results in a large increase in the need for retreatment (risk ratio (RR) 7.07, 95% CI 1.94 to 25.82; 5 studies, 337 participants, moderate certainty) (usually by repeated TUMT or TURP); based on zero cases per 1000 men in the TURP group, this corresponds to 90 more (40 to 150 more) per 1000 men in the TUMT group. There may be little to no difference in erectile function between these interventions (RR 0.63, 95% CI 0.24 to 1.63; 5 studies, 337 participants; low certainty). However, TUMT may result in fewer cases of ejaculatory dysfunction compared to TURP (RR 0.36, 95% CI 0.24 to 0.53; 4 studies, 241 participants; low certainty). TUMT versus sham Based on data from four studies with 483 participants we found that, when compared to sham, TUMT probably reduces urologic symptom scores using the IPSS at short-term follow-up (MD -5.40, 95% CI -6.97 to -3.84; moderate certainty). TUMT may cause little to no difference in the quality of life (MD -0.95, 95% CI -1.14 to -0.77; 2 studies, 347 participants; low certainty) as measured by the IPSS quality-of-life question on a scale from 0 to 6, with higher scores indicating a worse quality of life. We are very uncertain about the effects on major adverse events, since most studies reported no events or isolated lesions of the urinary tract. TUMT may also reduce the need for retreatment compared to sham (RR 0.27, 95% CI 0.08 to 0.88; 2 studies, 82 participants, low certainty); based on 194 retreatments per 1000 men in the sham group, this corresponds to 141 fewer (178 to 23 fewer) per 1000 men in the TUMT group. We are very uncertain of the effects on erectile and ejaculatory function (very low certainty), since we found isolated reports of impotence and ejaculatory disorders (anejaculation and hematospermia). There were no data available for the comparisons of TUMT versus convective radiofrequency water vapor therapy, prostatic urethral lift, prostatic arterial embolization or temporary implantable nitinol device. AUTHORS' CONCLUSIONS: TUMT provides a similar reduction in urinary symptoms compared to the standard treatment (TURP), with fewer major adverse events and fewer cases of ejaculatory dysfunction at short-term follow-up. However, TUMT probably results in a large increase in retreatment rates. Study limitations and imprecision reduced the confidence we can place in these results. Furthermore, most studies were performed over 20 years ago. Given the emergence of newer minimally-invasive treatments, high-quality head-to-head trials with longer follow-up are needed to clarify their relative effectiveness. Patients' values and preferences, their comorbidities and the effects of other available minimally-invasive procedures, among other factors, can guide clinicians when choosing the optimal treatment for this condition.


Asunto(s)
Hipertermia Inducida/métodos , Síntomas del Sistema Urinario Inferior/terapia , Microondas/uso terapéutico , Hiperplasia Prostática/terapia , Terapia por Radiofrecuencia/métodos , Antagonistas Adrenérgicos alfa/uso terapéutico , Anciano , Eyaculación , Humanos , Síntomas del Sistema Urinario Inferior/etiología , Masculino , Microondas/efectos adversos , Erección Peniana , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Retratamiento , Resección Transuretral de la Próstata/efectos adversos
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