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2.
Cochrane Database Syst Rev ; 10: CD012936, 2019 Oct 22.
Artigo em Inglês | MEDLINE | ID: mdl-31637711

RESUMO

BACKGROUND: People with multiple sclerosis (MS) have complex symptoms and different types of needs. These demands include how to manage the burden of physical disability as well as how to organise daily life, restructure social roles in the family and at work, preserve personal identity and community roles, keep self-sufficiency in personal care, and how to be part of an integrated care network. Palliative care teams are trained to keep open full and competent lines of communication about symptoms and disease progression, advanced care planning, and end-of-life issues and wishes. Teams create a treatment plan for the total management of symptoms, supporting people and families on decision-making. Despite advances in research and the existence of many interventions to reduce disease activity or to slow the progression of MS, this condition remains a life-limiting disease with symptoms that impact negatively the lives of people with it and their families. OBJECTIVES: To assess the effects (benefits and harms) of palliative care interventions compared to usual care for people with any form of multiple sclerosis: relapsing-remitting MS (RRMS), secondary-progressive MS (SPMS), primary-progressive MS (PPMS), and progressive-relapsing MS (PRMS) We also aimed to compare the effects of different palliative care interventions. SEARCH METHODS: On 31 October 2018, we conducted a literature search in the specialised register of the Cochrane MS and Rare Diseases of the Central Nervous System Review Group, which contains trials from CENTRAL, MEDLINE, Embase, CINAHL, LILACS, Clinical trials.gov and the World Health Organization International Clinical Trials Registry Platform. We also searched PsycINFO, PEDro and Opengrey. We also handsearched relevant journals and screened the reference lists of published reviews. We contacted researchers in palliative care and multiple sclerosis. SELECTION CRITERIA: Randomised controlled trials (RCTs) and cluster randomised trials were eligible for inclusion, as well as the first phase of cross-over trials. We included studies that compared palliative care interventions versus usual care. We also included studies that compared palliative care interventions versus another type of palliative interventions. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. We summarised key results and certainty of evidence in a 'Summary of Finding' table that reported outcomes at six or more months of post-intervention. MAIN RESULTS: Three studies (146 participants) met our selection criteria. Two studies compared multidisciplinary, fast-track palliative care versus multidisciplinary standard care while on a waiting-list control, and one study compared a multidisciplinary palliative approach versus multidisciplinary standard care at different time points (12, 16, and 24 weeks). Two were RCTs with parallel design (total 94 participants) and one was a cross-over design (52 participants). The three studies assessed palliative care as a home-based intervention. One of the three studies included participants with 'neurodegenerative diseases', with MS people being a subset of the randomised population. We assessed the risk of bias of included studies using Cochrane's 'Risk of Bias' tool.We found no evidence of differences between intervention and control groups in long-time follow-up (> six months post-intervention) for the following outcomes: mean change in health-related quality of life (SEIQoL - higher scores mean better quality of life; MD 4.80, 95% CI -12.32 to 21.92; participants = 62; studies = 1; very low-certainty evidence), serious adverse events (RR 0.97, 95% CI 0.44 to 2.12; participants = 76; studies = 1, 22 events, low-certainty evidence) and hospital admission (RR 0.78, 95% CI 0.24 to 2.52; participants = 76; studies = 1, 10 events, low-certainty evidence).The three included studies did not assess the following outcomes at long term follow-up (> six months post intervention): fatigue, anxiety, depression, disability, cognitive function, relapse-free survival, and sustained progression-free survival.We did not find any trial that compared different types of palliative care with each other. AUTHORS' CONCLUSIONS: Based on the findings of the RCTs included in this review, we are uncertain whether palliative care interventions are beneficial for people with MS. There is low- or very low-certainty evidence regarding the difference between palliative care interventions versus usual care for long-term health-related quality of life, adverse events, and hospital admission in patients with MS. For intermediate-term follow-up, we are also uncertain about the effects of palliative care for the outcomes: health-related quality of life (measured by different assessments: SEIQoL or MSIS), disability, anxiety, and depression.

3.
Value Health Reg Issues ; 20: 172-179, 2019 Oct 14.
Artigo em Inglês | MEDLINE | ID: mdl-31622803

RESUMO

OBJECTIVES: To report on the translation procedures and psychometric properties of the DISCERN tool in Brazilian Portuguese. METHODS: Three people translated the DISCERN from English into Brazilian Portuguese. A committee of experts and community representatives evaluated the quality of the 3 versions in 2 online voting rounds. Two native speakers back-translated the questionnaire into English. We compared these versions to the original DISCERN and made small adjustments. The final Brazilian Portuguese version of DISCERN was tested twice by journalism students to evaluate the quality of a text about smoking cessation treatments. We evaluated participants' health literacy with the Short Assessment of Health Literacy for Portuguese-Speaking Adults (SAHL-PA) tool, assessed the internal consistency of the translated questionnaire with the Cronbach test, and measured its reproducibility with the intraclass correlation coefficient (ICC). We then investigated the relationship between DISCERN and SAHL-PA scores and demographic variables. RESULTS: The participants (n = 126) had no difficulty in using the questionnaire. Cronbach's alpha was 0.865 (95% confidence interval [CI], 0.826-0.898), and the ICC between the 2 evaluations was 0.845 (CI 0.717-0.912). The mean health literacy of the participants was adequate. There was no correlation between the DISCERN score and the SAHL-PA score, age, or sex (P > .05). CONCLUSIONS: The Brazilian Portuguese version of the DISCERN questionnaire has excellent internal consistency and good reproducibility. The evaluators' ages, sex, and health literacy did not interfere with the score resulting from the evaluation of the quality of the text.

4.
J Pain ; 2019 Sep 09.
Artigo em Inglês | MEDLINE | ID: mdl-31513934

RESUMO

This systematic review investigated the effectiveness and safety of botulinum toxin type A (BTX-A) for painful temporomandibular disorders. We searched for randomized controlled trials (RCTs) in 10 databases, from inception to February 12, 2019 (MEDLINE, EMBASE, CENTRAL, LILACS, BBO, Web of Science, Scopus, ClinicalTrials.gov, WHO and OpenGrey). We included 12 RCTs that compared BTX-A versus inactive or active interventions. BTX-A was slightly more effective than placebo for pain reduction at 1 month: mean difference -1.74 points (0-10 scale), 95% confidence interval -2.94 to -.54, 3 RCTs, 60 participants, I-square (I2) = 0%. However, there were no significant differences at 3 and 6 months. BTX-A was similar to no treatment for pain reduction at 3 and 6 months. BTX-A was more effective than conventional treatment and low-level laser therapy for pain reduction at 1, 6, and 12 months, but less effective than facial manipulation for pain reduction at 3 months. BTX-A was not associated with a significant increase in the risk of adverse events. The quality of the evidence was low, and results are insufficient to support the use of BTX-A for painful temporomandibular disorders. High-quality RCTs are needed to increase confidence in effect estimates. PERSPECTIVE: BTX-A for painful temporomandibular disorders appears to be well tolerated. For pain reduction, BTX-A is slightly more effective than placebo only at 1 month; conventional treatment and low-level laser at 1, 6, and 12 months. Low-quality evidence limits the applicability of these findings and precludes recommendations for practice.

5.
Cad. Ibero Am. Direito Sanit. (Impr.) ; 8(3): 48-59, jul.-set. 2019.
Artigo em Português | LILACS | ID: biblio-1022852

RESUMO

Objetivo: discutir o processo regulatório de medicamentos para doenças raras no Brasil, com base no caso Zolgensma®, e avaliar criticamente as evidências disponíveis até o momento sobre a eficácia e a segurança do Zolgensma® no tratamento da atrofia muscular espinhal (AME). Metodologia: estudo descritivo realizado no Núcleo de Avaliação de Tecnologias em Saúde do Hospital Sírio-Libanês (NATS-HSL) em junho de 2019. Resultados: em abril de 2019, o uso do Zolgensma® para AME foi regulamentado nos Estados Unidos com base em dois estudos clínicos abertos (sem mascaramento), sem grupo comparador paralelo (e, portanto, não randomizados). Essas limitações metodológicas aumentam a incerteza nos resultados encontrados. A Agência Nacional de Vigilância Sanitária (Anvisa) aprovou estratégias para regulamentar o processo e os prazos de análise das submissões de registro de novos medicamentos para doenças raras, caso do Zolgensma®. Conclusão: faz-se necessário ampliar o debate em torno do processo de regulamentação e de incorporação de medicamentos órfãos para doenças raras no Brasil. O debate deve incluir as evidências relacionadas aos efeitos ­ benefícios e riscos ­ desses medicamentos, e maior clareza nos critérios para concessão de registro e recomendação de incorporação em sistemas de saúde. (AU).


Objective: to discuss the regulatory process of drugs for rare diseases in Brazil, based on the Zolgensma® case, and to critically evaluate the evidence so far available on the efficacy and safety of Zolgensma® for treating spinal muscular atrophy (SMA). Methods: descriptive study conducted at the Health Technology Assessment Center of the Sírio Libanês Hospital (NATS-HSL) in June 2019. Results: in April 2019, the use of Zolgensma® for SMA was regulated in the United States based on two open-lable (unmasked), non-comparative (and therefore non-randomized) studies. These methodological limitations increase the uncertainty related to study results. The National Agency of Sanitary Surveillance (Anvisa) has approved strategies to regulate the process and specific deadlines for completing the appraisal process of new medicines for rare diseases, such as Zolgensma®. Conclusion: it is necessary to broaden the debate about the process of regulation and incorporation of orphan drugs for rare diseases in Brazil. This debate should include evidence related to the effects (benefits and risks) of these drugs, and greater transparency of the criteria indispensable for granting registration and recommendation of incorporation into health systems. (AU).


Objetivo: analizar el proceso de fármacos reguladores para enfermedades raras en Brasil, con base en el caso Zolgensma, y para evaluar críticamente la evidencia disponible hasta el momento sobre la eficacia y seguridad de Zolgensma® nel tratamiento de atrofia muscular espinal (AME). Métodos: estudio descriptivo realizado en el Centro de Evaluación de Tecnología de Salud del Hospital Sírio-Libanês (NATS-HSL) en junio de 2019. Resultados: en abril de 2019, el uso de Zolgensma® para la AME se reguló en los Estados Unidos basado en dos estudios abiertos (no enmascarados), no comparativos (y por lo tanto no aleatorios). Estas limitaciones metodológicas aumentan la incertidumbre en los resultados encontrados. La Agencia Nacional de Vigilancia Sanitaria en Brasil (Anvisa) ha aprobado estrategias para regular el proceso y los plazos de análisis de las solicitudes de registro de nuevos fármacos para enfermedades raras, el caso de Zolgensma. Conclusión: es necesario ampliar el debate sobre el proceso de regulación e incorporación de medicamentos huérfanos para enfermedades raras en Brasil. Este debate debe incluir evidencia relacionada con los efectos (beneficios y riesgos) de estos medicamentos y una mayor transparencia en los criterios para otorgar el registro y la recomendación de incorporación a los sistemas de salud. (AU).


Assuntos
Atrofia Muscular Espinal , Terapia Genética , Doenças Raras , Registro de Produtos , Medicamentos do Componente Especializado da Assistência Farmacêutica
6.
Int J Clin Pract ; 73(11): e13402, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31408240

RESUMO

INTRODUCTION: Platelet-rich plasma (PRP) is a blood component therapy with a supraphysiological concentration of platelets derived from allogenic or, more commonly, autologous blood. PRP has been used in different non-transfusion indications because of its role in the promotion of tissue repair and healing, in fields such as Traumatology, Dermatology and Dentistry. OBJECTIVE: To provide a synthesis of the efficacy of PRP for different clinical situations. METHODS: Systematic searches were carried out in MEDLINE, Embase, Cochrane Library and LILACS in July 2018 to identify systematic reviews (SRs) of randomized clinical trials (RCTs) focusing on PRP for non-transfusion use. Two authors independently screened all retrieved references in two stages (titles and abstracts at a first stage and full texts at a second stage). The methodological quality of SRs that met the eligibility criteria was appraised by AMSTAR 2. Conclusions were based on the most recent SRs with highest quality. RESULTS: One thousand two hundred and forty references were retrieved. After checking the inclusion criteria, 29 SRs of RCTs related to three different fields (wound care, Orthopedics and Dentistry) were included. The results suggest the benefit of PRP for different clinical situations, such as diabetic wounds, acute lesions of musculoskeletal system, rotator cuff lesions, tendinopathies, knee and hip osteoarthritis, total knee arthroplasty, allogenic bone graft for dental implants and periodontal intrabony defects. CONCLUSION: There is low to moderate quality evidence supporting the efficacy of PRP for specific clinical situations. The low quality of the evidence limits the certainty of these findings. Well-planned and well-conducted RCTs are still needed to further assess the efficacy of PRP.

7.
BMJ Evid Based Med ; 2019 Jul 02.
Artigo em Inglês | MEDLINE | ID: mdl-31266765

RESUMO

A review of systematic reviews (SRs) and a critical appraisal study was conducted at Escola Paulista de Medicina, Universidade Federal de São Paulo (Unifesp). The objectives of this review are (1) to identify all published SRs comparing the effectiveness and safety of carotid endarterectomy (CEA) versus carotid artery stenting (CAS) for carotid artery stenosis, (2) to assess their methodological quality and (3) to compare the primary studies contained in each SR. We included 17 SRs published between 2005 and 2017. None of the SRs fulfilled all items of AMSTAR-2. The overall confidence in the results was graded as critically low for 16 SRs (94%) and low for 1 SR (6%). Five items were judged inadequate in all SRs: reference to a published protocol, explanation to the selection of study design, comprehensive search of the literature, methods for statistical combination of findings and consideration of the risk of bias on the results of meta-analysis. In total, 15 randomised clinical trials (RCTs) were included at least in one SR. The number of included RCTs in each SR was inconsistent (4 to 15) and was not related to the year of publication of the SR. Our study found redundant and low methodological quality SR comparing CAS versus CEA for carotid stenosis.

8.
J Child Neurol ; 34(11): 679-686, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31179823

RESUMO

AIM: To assess the effects of neurodevelopmental treatment for children with cerebral palsy. METHODS: We conducted a systematic review following the recommendations of the Cochrane Handbook for Systematic Reviews of Interventions and reported in accordance to PRISMA Statement. Through a comprehensive literature search we considered all randomized clinical trials that compared neurodevelopmental treatment with conventional physical therapy for children with cerebral palsy. We used the Cochrane Risk of Bias Table to assess the risk of bias of the included randomized clinical trial, and the GRADE approach to evaluate the certainty of the body of the evidence. RESULTS: We found 3 randomized clinical trials (2 published and 1 ongoing) comprising 66 children. Published randomized clinical trials presented methodological and reporting limitations and only 1 provided data for outcomes of interest. No difference between neurodevelopmental treatment and conventional physical therapy was found for gross motor function (mean difference 1.40; 95% confidence interval -5.47 to 8.27, low certainty evidence). CONCLUSION: This review found that the effects of neurodevelopmental treatment for children with cerebral palsy are still uncertain. Further studies are required to assess the efficacy and safety of neurodevelopmental treatment for this purpose and until there, current evidence do not support its routinely use in practice. Number of protocol registration in PROSPERO database: CRD42017082817 (available from https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=82817 ).

9.
Diagn. tratamento ; 24(2): [59-63], abr - jun 2019. tab, fig
Artigo em Português | LILACS | ID: biblio-1015338

RESUMO

Introdução: Com o crescimento contínuo das informações disponíveis na área da saúde, é fundamental que o profissional da saúde desenvolva habilidades e competências para realizar buscas de evidências cientificas. Objetivo: Apresentar as principais bases da área da saúde e os mecanismos de busca específicos para cada uma delas. Métodos: Estudo descritivo desenvolvido na Disciplina de Medicina Baseada em Evidências da Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (Unifesp). Resultados: Este estudo apresentou os quatro passos do processo de busca em uma base de dados científica da área da saúde: (1) identificação da pergunta estruturada por meio dos acrônimos PICO/PECO, (2) escolha da base de dados (3) escolha e uso dos descritores em saúde apropriados para cada base (DeCS/MeSH/EMTREE) e (4) escolha e uso dos operadores booleanos (AND/OR/AND NOT). Conclusão: O processo de elaboração de uma estratégia de busca para bases de dados da área da saúde pode ser estruturado em quatro passos iniciais, que vão da identificação da pergunta estruturada ao uso dos operadores booleanos. Apropriar-se destes passos é fundamental para conseguir elaborar uma estratégia de busca adequada, capaz de recuperar os estudos de interesse e que abordem realmente a pergunta proposta.


Assuntos
Epidemiologia Descritiva , Bases de Dados Bibliográficas , Medicina Baseada em Evidências , Medical Subject Headings , Metodologia , Ferramenta de Busca
10.
Diagn. tratamento ; 24(2): [70-81], abr - jun 2019. tab
Artigo em Português | LILACS | ID: biblio-1015344

RESUMO

Contexto: A gota é uma doença articular metabólica inflamatória, caracterizada pelo acúmulo de cristais de monourato de sódio no líquido sinovial das articulações e em outros tecidos. Objetivo: apresentar as evidências de revisões sistemáticas Cochrane sobre efetividade e segurança de intervenções disponíveis para o manejo da gota. Métodos: Foram identificadas revisões sistemáticas a partir de busca na Biblioteca Cochrane. Dois autores avaliaram as revisões quanto aos critérios de elegibilidade das revisões encontradas e apresentaram síntese de seus achados. Resultados: Foram incluídas 13 revisões sistemáticas Cochrane (6 para gota aguda e 7 para gota crônica) que avaliaram intervenções medicamentosas sistêmicas e locais (tópica e intra-articular) e mudanças no estilo de vida. A confiança no corpo final das evidências encontradas variou de desconhecida a moderada entre os desfechos considerados. Os principais resultados mostraram que anti-inflamatórios não esteroidais (AINE) convencionais são tão efetivos quanto AINE inibidores da ciclo-oxigenase-2 e corticoides para controle da dor em pacientes com gota aguda. Para gota crônica, o alopurinol parece ser semelhante ao febuxostate e a benzbromarona na prevenção de crises de gota. Conclusão: Nenhum dos achados das revisões forneceu evidência de alta certeza sobre os efeitos das intervenções para gota, ou seja, estudos futuros podem, com variada probabilidade, modificar a estimativa que conhecemos hoje para os efeitos das intervenções avaliadas.


Assuntos
Revisão , Medicina Baseada em Evidências , Prática Clínica Baseada em Evidências , Tomada de Decisão Clínica , Gota
11.
Sao Paulo Med J ; 137(1): 82-91, 2019 May 08.
Artigo em Inglês | MEDLINE | ID: mdl-31116276

RESUMO

BACKGROUND: Irritable bowel syndrome (IBS) is a clinical disorder associated with high socioeconomic burden. Despite its importance, management of IBS remains difficult and several interventions have been hypothesized as beneficial for this condition. This study identified and summarized all Cochrane systematic reviews (SRs) about the effects of interventions for managing IBS patients. DESIGN AND SETTING: Review of systematic reviews, carried out in the Discipline of Evidence-Based Medicine, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (UNIFESP). METHODS: Review of Cochrane SRs addressing interventions for IBS. RESULTS: We included six SRs assessing acupuncture, bulking agents, antispasmodics, antidepressants, herbal medicines, homeopathy, hypnotherapy and psychological therapy for IBS. The certainty of evidence ranged from unknown to moderate, mainly due to imprecision in the estimates and high risk of bias from the primary studies included. There was moderate certainty of evidence that acupuncture had no important benefit regarding improvement of symptoms and quality of life, compared with sham acupuncture. There was also very low certainty of evidence that homeopathic asafoetida, used alone or in association with nux, was better than placebo regarding self-reported overall improvement. CONCLUSION: There was moderate certainty of evidence that acupuncture had no important benefit regarding improvement of symptoms and quality of life. Further well-designed and well-conducted randomized clinical trials are needed in order to reduce the uncertainties regarding the most commonly used interventions for patients with IBS.


Assuntos
Gerenciamento Clínico , Síndrome do Intestino Irritável/terapia , Revisão Sistemática como Assunto , Medicina Baseada em Evidências , Humanos , Síndrome do Intestino Irritável/psicologia , Psicoterapia/métodos , Resultado do Tratamento
12.
Diagn. tratamento ; 24(1): [25-36], jan -mar 2019. tab
Artigo em Português | LILACS, Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1005094

RESUMO

Contexto: O Ministério da Saúde do Brasil anunciou, em março de 2018, uma expansão das políticas para práticas integrativas em saúde dentro do Sistema Único de Saúde (SUS), incorporando 10 novos tipos de práticas integrativas à lista de procedimentos disponíveis no sistema público de saúde brasileiro. Objetivo: Identificar, sintetizar e avaliar criticamente evidências de revisões sistemáticas Cochrane sobre as novas práticas de medicina integrativa inseridas no SUS. Métodos: Revisão de revisões sistemáticas conduzida pela Disciplina de Medicina Baseada em Evidências, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (Unifesp), sobre as seguintes intervenções: apiterapia, aromaterapia, bioenergética, constelação familiar, terapia de florais, cromoterapia, geoterapia, hipnoterapia, imposição de mãos e ozonioterapia. Resultados: Foram incluídas 16 revisões sistemáticas: 4 sobre apiterapia, 4 sobre aromaterapia, 6 sobre hipnoterapia e 2 sobre ozonioterapia. Não foram encontradas revisões sistemáticas Cochrane referentes aos temas bioenergética, constelação familiar, cromoterapia, geoterapia, terapia de florais ou imposição de mãos. A única evidência de alta qualidade encontrada nessas revisões foi sobre o potencial benefício da apiterapia, especificamente para o uso de curativos de mel para cura parcial de feridas por queimadura, para redução de tosse entre crianças com tosse aguda e para prevenção de reações alérgicas a picadas de insetos. Conclusão: Exceto por alguns usos específicos da apiterapia (mel para lesões por queimadura e para tosse aguda e do veneno de abelhas para reações alérgicas às picadas de insetos), o uso das 10 práticas integrativas recentemente incorporadas ao SUS não é embasado por evidências de revisões sistemáticas Cochrane.


Assuntos
Revisão , Medicina Baseada em Evidências , Prática Clínica Baseada em Evidências , Medicina Integrativa , Tomada de Decisão Clínica
13.
Cochrane Database Syst Rev ; 3: CD010355, 2019 03 06.
Artigo em Inglês | MEDLINE | ID: mdl-30840317

RESUMO

BACKGROUND: Pulmonary complications are often seen during the postoperative period following lung resection for patients with lung cancer. Some situations such as intubation, a long stay in the intensive care unit, the high cost of antibiotics and mortality may be avoided with the prevention of postoperative pulmonary complications. Non-invasive positive pressure ventilation (NIPPV) is widely used in hospitals, and is thought to reduce the number of pulmonary complications and mortality after this type of surgery. Therefore, a systematic review is needed to critically assess the benefits and harms of NIPPV for patients undergoing lung resection. This is an update of a Cochrane review first published in 2015. OBJECTIVES: To assess the effectiveness and safety of NIPPV for preventing complications in patients following pulmonary resection for lung cancer. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, LILACS and PEDro until 21 December 2018, to identify potentially eligible trials. We did not use any date or language restrictions in the electronic searches. We searched the reference lists of relevant papers and contacted experts in the field for information about additional published and unpublished studies. We also searched the Register of Controlled Trials (www.controlled-trials.com) and ClinicalTrials.gov (clinicaltrials.gov) to identify ongoing studies. SELECTION CRITERIA: We considered randomised or quasi-randomised clinical trials that compared NIPPV in the immediate postoperative period after pulmonary resection with no intervention or conventional respiratory therapy. DATA COLLECTION AND ANALYSIS: Two authors collected data and assessed trial risk of bias. Where possible, we pooled data from the individual studies using a fixed-effect model (quantitative synthesis), but where this was not possible we tabulated or presented the data in the main text (qualitative synthesis). Where substantial heterogeneity existed, we applied a random-effects model. MAIN RESULTS: Of the 190 references retrieved from the searches, 7 randomised clinical trials (RCTs) (1 identified with the new search) and 1 quasi-randomised trial fulfilled the eligibility criteria for this review, including a total of 486 patients. Five studies described quantitative measures of pulmonary complications, with pooled data showing no difference between NIPPV compared with no intervention (RR 1.03; 95% CI 0.72 to 1.47). Three studies reported intubation rates and there was no significant difference between the intervention and control groups (RR 0.55; 95% CI 0.25 to 1.20). Five studies reported measures of mortality on completion of the intervention period. There was no statistical difference between the groups for this outcome (RR 0.60; 95% CI 0.24 to 1.53). Similar results were observed in the subgroup analysis considering ventilatory mode (bi-level versus continuous positive airway pressure (CPAP). No study evaluated the postoperative use of antibiotics. Two studies reported the length of intensive care unit stay and there was no significant difference between the intervention and control groups (MD -0.75; 95% CI -3.93 to 2.43). Four studies reported the length of hospital stay and there was no significant difference between the intervention and control groups (MD -0.12; 95% CI -6.15 to 5.90). None of the studies described any complications related to NIPPV. Of the seven included studies, four studies were considered as 'low risk of bias' in all domains, two studies were considered 'high risk of bias' for the allocation concealment domain, and one of these was also considered 'high risk of bias' for random sequence generation. One other study was considered 'high risk of bias' for including participants with more severe disease. The new study identified could not be included in the meta-analysis as its intervention differed from the other studies (use of pre and postoperative NIPPV in the same population). AUTHORS' CONCLUSIONS: This review demonstrated that there was no additional benefit of using NIPPV in the postoperative period after pulmonary resection for all outcomes analysed (pulmonary complications, rate of intubation, mortality, postoperative consumption of antibiotics, length of intensive care unit stay, length of hospital stay and adverse effects related to NIPPV). However, the quality of evidence is 'very low', 'low' and 'moderate' since there were few studies, with small sample size and low frequency of outcomes. New well-designed and well-conducted randomised trials are needed to answer the questions of this review with greater certainty.


Assuntos
Pressão Positiva Contínua nas Vias Aéreas , Neoplasias Pulmonares/cirurgia , Ventilação não Invasiva , Pneumonectomia/efeitos adversos , Complicações Pós-Operatórias/prevenção & controle , Antibacterianos/uso terapêutico , Pressão Positiva Contínua nas Vias Aéreas/mortalidade , Pressão Positiva Contínua nas Vias Aéreas/estatística & dados numéricos , Humanos , Unidades de Terapia Intensiva/estatística & dados numéricos , Tempo de Internação , Ventilação não Invasiva/mortalidade , Ventilação não Invasiva/estatística & dados numéricos , Complicações Pós-Operatórias/epidemiologia , Ensaios Clínicos Controlados Aleatórios como Assunto
14.
Diagn. tratamento ; 24(1): [12-15], jan -mar 2019. fig
Artigo em Português | LILACS | ID: biblio-1005090

RESUMO

Introdução: A escolha dos desfechos de um ensaio clínico é complexa e, muitas vezes, subjetiva. Muitas variáveis podem interferir no processo de escolha, aumentando a heterogeneidade clínica entre os ensaios clínicos que se propõem a avaliar uma mesma questão clínica, além de aumentar o risco de viés de relato e levar a custos desnecessários com desfechos de pouca relevância. Objetivos: Apresentar a iniciativa COMET (Core Outcomes Measures in Effectiveness Trials, ou, em português, Medidas de Desfechos Principais em Ensaios Clínicos de Efetividade) e discutir a importância desta base de dados de desfechos para a avaliação da efetividade de intervenções em saúde. Métodos: Estudo descritivo realizado na Disciplina de Medicina Baseada em Evidências da Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (Unifesp). Resultados: A iniciativa COMET tem como objetivo identificar os desfechos mais relevantes para cada situação clínica e promover a sua disseminação. Por meio de uma base de dados, a iniciativa COMET disponibiliza os vários conjuntos de desfechos relevantes identificados. Esta base está disponível gratuitamente (http://www.comet-initiative.org/resources), ainda apenas na língua inglesa, para ser acessada por pesquisadores, gestores, profissionais da saúde e pacientes, e com o objetivo de orientar o processo de escolha dos desfechos de um ensaio clínico. Conclusão: A iniciativa COMET, por meio de sua base de dados, se apresenta como uma ferramenta útil para a definição dos desfechos mais relevantes em saúde, auxiliando o planejamento adequado de um ensaio clínico. Com a disseminação do uso desta base de dados, espera-se aumentar a homogeneidade entre os ensaios clínicos que avaliam uma mesma pergunta clínica, minimizar o risco de viés de relato seletivo dos desfechos e otimizar o uso de recursos no desenvolvimento de ensaios clínicos.


Assuntos
Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Avaliação de Resultados (Cuidados de Saúde) , Medicina Baseada em Evidências , Metodologia
15.
Cochrane Database Syst Rev ; 2: CD012357, 2019 Feb 12.
Artigo em Inglês | MEDLINE | ID: mdl-30746681

RESUMO

BACKGROUND: Helicobacter pylori (H pylori) is one of the most common pathogens to establish and cause infection in human beings, affecting about 50% of the world's population. Prevalence may be as high as 83% in Latin American countries and as low as 17% in North America. Approximately 20% of infected people will manifest disease; people at high risk include those who live in low- and middle-income countries with poor sanitary conditions, since the mechanism of transmission seems to be oral-oral or faecal-oral (mostly during infancy). There are several antibiotic regimens to treat the infection, but antibiotic resistance is growing around the world. New adjuvant drugs - such as probiotics, statins, curcumin, and N-acetylcysteine (NAC) - are being tested to enhance eradication rates.N-acetylcysteine can destabilise the biofilm structure; it also has synergic action with antibiotics, and bactericidal effects. In addition, NAC has antioxidant properties, and has a primary mucolytic effect by reducing the thickness of the gastric mucus layer, both of which may exert beneficial adjuvant effects on H pylori eradication. OBJECTIVES: To assess the efficacy and safety of N-acetylcysteine as an adjuvant therapy to antibiotics for Helicobacter pylori eradication. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (1966 to April 2018), Embase (1988 to April 2018), CINAHL (1982 to April 2018), LILACS (1982 to April 2018), grey literature databases and trials registries. We handsearched the reference lists of relevant studies. We screened 726 articles and assessed 18 for eligibility. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of any antibiotic regimen plus NAC, in adults infected with H pylori. To be included, trials had to use a control consisting of the same antibiotic regimen with or without placebo. Outcomes of interest were eradication rates, and gastrointestinal, toxic, and allergic adverse events. Reporting of the primary outcomes listed here was not an inclusion criterion for the review. DATA COLLECTION AND ANALYSIS: Two review authors independently reviewed and extracted data and completed the 'Risk of bias' assessments. A third review author independently confirmed the 'Risk of bias' assessments. We used Review Manager 5 software for data analysis. We contacted study authors if there was missing information. MAIN RESULTS: We included eight RCTs (with a total of 559 participants) in this review. The studies recruited outpatients aged between 17 and 76 years who were referred to endoscopy centres in several different countries. The certainty of evidence was reduced for most outcomes due to the poor methodological quality of included studies; issues mainly related to the generation of allocation sequence, allocation concealment, and blinding (this last domain related specifically to adverse outcomes).We are uncertain whether the addition of NAC to antibiotics improves H pylori eradication rates, compared with the addition of placebo or no NAC (38.8% versus 49.1%, risk ratio (RR) 0.74, 95% confidence interval (CI) 0.51 to 1.08; participants = 559; studies = eight; very low-certainty evidence). A post-hoc sensitivity analysis, in which we removed studies that tested antibiotic regimens no longer recommended in clinical practice, showed that the addition of NAC may improve eradication rates compared to control (27.2% versus 37.6%, RR 0.71, 95% CI 0.53 to 0.94; participants = 397; published studies = five).We are uncertain whether NAC is associated with a higher risk of gastrointestinal adverse events compared to control (23.9% versus 18.9%, RR 1.25, 95% CI 0.85 to 1.85; participants = 336; studies = five; very low-certaintyevidence), or allergic adverse events (2% versus 0%, RR 2.98, 95% CI 0.32 to 27.74; participants = 336; studies = five; very low-certainty evidence). There were no reports of toxic adverse events amongst included studies. AUTHORS' CONCLUSIONS: We are uncertain whether the addition of NAC to antibiotics improves H pylori eradication rates compared with the addition of placebo or no NAC. Due to the clinical, statistical and methodological heterogeneity found in included studies, and the uncertainty observed when analysing therapy subgroups, any possible beneficial effect of NAC should be regarded cautiously.We are uncertain whether NAC is associated with a higher risk of gastrointestinal or allergic adverse events compared with placebo or no NAC. There were no reports of toxic adverse events amongst the included studies.Further large, well-designed, randomised clinical studies should be conducted, with good reporting standards and appropriate collection of efficacy and safety outcomes, especially for current recommended antibiotic regimens.


Assuntos
Acetilcisteína/uso terapêutico , Antibacterianos/uso terapêutico , Infecções por Helicobacter/tratamento farmacológico , Helicobacter pylori , Acetilcisteína/efeitos adversos , Adolescente , Adulto , Idoso , Quimioterapia Adjuvante/efeitos adversos , Quimioterapia Adjuvante/métodos , Humanos , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Adulto Jovem
16.
Säo Paulo med. j ; 137(1): 82-91, Jan.-Feb. 2019. tab
Artigo em Inglês | LILACS-Express | ID: biblio-1004735

RESUMO

ABSTRACT BACKGROUND: Irritable bowel syndrome (IBS) is a clinical disorder associated with high socioeconomic burden. Despite its importance, management of IBS remains difficult and several interventions have been hypothesized as beneficial for this condition. This study identified and summarized all Cochrane systematic reviews (SRs) about the effects of interventions for managing IBS patients. DESIGN AND SETTING: Review of systematic reviews, carried out in the Discipline of Evidence-Based Medicine, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (UNIFESP). METHODS: Review of Cochrane SRs addressing interventions for IBS. RESULTS: We included six SRs assessing acupuncture, bulking agents, antispasmodics, antidepressants, herbal medicines, homeopathy, hypnotherapy and psychological therapy for IBS. The certainty of evidence ranged from unknown to moderate, mainly due to imprecision in the estimates and high risk of bias from the primary studies included. There was moderate certainty of evidence that acupuncture had no important benefit regarding improvement of symptoms and quality of life, compared with sham acupuncture. There was also very low certainty of evidence that homeopathic asafoetida, used alone or in association with nux, was better than placebo regarding self-reported overall improvement. CONCLUSION: There was moderate certainty of evidence that acupuncture had no important benefit regarding improvement of symptoms and quality of life. Further well-designed and well-conducted randomized clinical trials are needed in order to reduce the uncertainties regarding the most commonly used interventions for patients with IBS.

17.
Pediatr Neurol ; 87: 23-29, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30501885

RESUMO

BACKGROUND: Schizencephaly is a rare congenital cerebral malformation associated with serious neurological manifestations. The number of studies regarding schizencephaly is limited. METHODS: We conducted a literature review and extracted data from the case reports. Of 199 articles retrieved, 156 articles (734 patients) met our inclusion criteria. RESULTS: Patient characteristics included microcephaly (41.5% of patients), seizures (74.1%), bilateral cleft (41.4%), open lip (61.3%), septo-optic dysplasia (69.1%), and ventricular dilation (60.5%). The majority of clefts were in the frontal and parietal lobes. When these potential association factors were assessed by univariate logistic regression microcephaly (OR = 21.75, P < 0.001), corpus callosum agenesis (OR = 9, P < 0.001), motor impairments (OR = 6.21, P < 0.001), and bilateral clefts (OR = 6.31, P < 0.001) seems to have the strongest association, but also age at diagnosis <10 years (OR = 1.05, P < 0.001), right (OR = 1.85, P = 0.001) or left (OR = 2.71, P < 0.001) side clefts and septum pellucidum (OR = 3.7, P = 0.002) agenesis were associated with neurocognitive dysfunctions. CONCLUSIONS: We describe novel findings with practical implications for predicting neurocognitive outcomes in patients with schizencephaly. Most patients had neurological impairments including motor (90.0%) or cognitive (77.5%) dysfunctions. Bilateral clefts, motor impairment, microcephaly, and corpus callosum agenesis were strongly associated with neurocognitive impairment. A lack of large cohorts of patients with schizencephaly prevented comparison of our results; most previous studies are case reports or small case series.

18.
Säo Paulo med. j ; 136(6): 579-585, Nov.-Dec. 2018. tab
Artigo em Inglês | LILACS-Express | ID: biblio-991688

RESUMO

ABSTRACT CONTEXT AND OBJECTIVE: Insomnia is a frequent complaint that generates more than five million visits to doctors per year in the United States. This study summarizes all Cochrane systematic reviews (SRs) that evaluated interventions to treat insomnia. DESIGN AND SETTING: Review of SRs, conducted in the Discipline of Evidence-Based Medicine, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (UNIFESP). METHODS: A sensitive search was carried out in the Cochrane Database of Systematic Reviews to identify Cochrane SRs that assessed the effects of any type of intervention for people with insomnia. The results, main characteristics of the SRs and the certainty of the evidence obtained from them were synthesized and discussed. RESULTS: Seven SRs were included. They addressed the benefits and harm of acupuncture (n = 1), behavioral interventions (n = 1), music (n = 1), pharmacotherapy (n = 2), phototherapy (n = 1) and physical exercise (n = 1). The certainty of the evidence ranged from moderate to very low. CONCLUSION: Acupuncture, music, physical exercise, paroxetine, doxepin, trimipramine and trazodone seem to present some benefit for patients with insomnia. However, the uncertainty around these results means that no robust and definitive recommendations for clinical practice can be made until the benefits and harms from each intervention for patients with insomnia have been confirmed through further studies.

19.
Cochrane Database Syst Rev ; 11: CD009435, 2018 Nov 24.
Artigo em Inglês | MEDLINE | ID: mdl-30484286

RESUMO

BACKGROUND: Acne vulgaris, a chronic inflammatory disease of the pilosebaceous unit associated with socialisation and mental health problems, may affect more than 80% of teenagers. Isotretinoin is the only drug that targets all primary causal factors of acne; however, it may cause adverse effects. OBJECTIVES: To assess efficacy and safety of oral isotretinoin for acne vulgaris. SEARCH METHODS: We searched the following databases up to July 2017: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO and LILACS. We updated this search in March 2018, but these results have not yet been incorporated in the review. We also searched five trial registries, checked the reference lists of retrieved studies for further references to relevant trials, and handsearched dermatology conference proceedings. A separate search for adverse effects of oral isotretinoin was undertaken in MEDLINE and Embase up to September 2013. SELECTION CRITERIA: Randomised clinical trials (RCTs) of oral isotretinoin in participants with clinically diagnosed acne compared against placebo, any other systemic or topical active therapy, and itself in different formulation, doses, regimens, or course duration. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. MAIN RESULTS: We included 31 RCTs, involving 3836 participants (12 to 55 years) with mild to severe acne. There were twice as many male participants as females.Most studies were undertaken in Asia, Europe, and North America. Outcomes were generally measured between eight to 32 weeks (mean 19.7 weeks) of therapy.Assessed comparisons included oral isotretinoin versus placebo or other treatments such as antibiotics. In addition, different doses, regimens, or formulations of oral isotretinoin were assessed, as well as oral isotretinoin with the addition of topical agents.Pharmaceutical companies funded 12 included trials. All, except three studies, had high risk of bias in at least one domain.Oral isotretinoin compared with oral antibiotics plus topical agentsThese studies included participants with moderate or severe acne and assessed outcomes immediately after 20 to 24 weeks of treatment (short-term). Three studies (400 participants) showed isotretinoin makes no difference in terms of decreasing trial investigator-assessed inflammatory lesion count (RR 1.01 95% CI 0.96 to 1.06), with only one serious adverse effect found, which was Stevens-Johnson syndrome in the isotretinoin group (RR 3.00, 95% CI 0.12 to 72.98). However, we are uncertain about these results as they were based on very low-quality evidence.Isotretinoin may slightly improve (by 15%) acne severity, assessed by physician's global evaluation (RR 1.15, 95% CI 1.00 to 1.32; 351 participants; 2 studies), but resulted in more less serious adverse effects (67% higher risk) (RR 1.67, 95% CI 1.42 to 1.98; 351 participants; 2 studies), such as dry lips/skin, cheilitis, vomiting, nausea (both outcomes, low-quality evidence).Different doses/therapeutic regimens of oral isotretinoinFor our primary efficacy outcome, we found three RCTs, but heterogeneity precluded meta-analysis. One study (154 participants) reported 79%, 80% and 84% decrease in total inflammatory lesion count after 20 weeks of 0.05, 0.1, or 0.2 mg/kg/d of oral isotretinoin for severe acne (low-quality evidence). Another trial (150 participants, severe acne) compared 0.1, 0.5, and 1 mg/kg/d oral isotretinoin for 20 weeks and, respectively, 58%, 80% and 90% of participants achieved 95% decrease in total inflammatory lesion count. One RCT, of participants with moderate acne, compared isotretinoin for 24 weeks at (a) continuous low dose (0.25 to 0.4 mg/kg/day), (b) continuous conventional dose (0.5 to 0.7 mg/kg/day), and (c) intermittent regimen (0.5 to 0.7 mg/kg/day, for one week in a month). Continuous low dose (MD 3.72 lesions; 95% CI 2.13 to 5.31; 40 participants; one study) and conventional dose (MD 3.87 lesions; 95% CI 2.31 to 5.43; 40 participants; one study) had a greater decrease in inflammatory lesion counts compared to intermittent treatment (all outcomes, low-quality evidence).Fourteen RCTs (906 participants, severe and moderate acne) reported that no serious adverse events were observed when comparing different doses/therapeutic regimens of oral isotretinoin during treatment (from 12 to 32 weeks) or follow-up after end of treatment (up to 48 weeks). Thirteen RCTs (858 participants) analysed frequency of less serious adverse effects, which included skin dryness, hair loss, and itching, but heterogeneity regarding the assessment of the outcome precluded data pooling; hence, there is uncertainty about the results (low- to very-low quality evidence, where assessed).Improvement in acne severity, assessed by physician's global evaluation, was not measured for this comparison.None of the included RCTs reported birth defects. AUTHORS' CONCLUSIONS: Evidence was low-quality for most assessed outcomes.We are unsure if isotretinoin improves acne severity compared with standard oral antibiotic and topical treatment when assessed by a decrease in total inflammatory lesion count, but it may slightly improve physician-assessed acne severity. Only one serious adverse event was reported in the isotretinoin group, which means we are uncertain of the risk of serious adverse effects; however, isotretinoin may result in more minor adverse effects.Heterogeneity in the studies comparing different regimens, doses, or formulations of oral isotretinoin meant we were unable to undertake meta-analysis. Daily treatment may be more effective than treatment for one week each month. None of the studies in this comparison reported serious adverse effects, or measured improvement in acne severity assessed by physician's global evaluation. We are uncertain if there is a difference in number of minor adverse effects, such as skin dryness, between doses/regimens.Evidence quality was lessened due to imprecision and attrition bias. Further studies should ensure clearly reported long- and short-term standardised assessment of improvement in total inflammatory lesion counts, participant-reported outcomes, and full safety accounts. Oral isotretinoin for acne that has not responded to oral antibiotics plus topical agents needs further assessment, as well as different dose/regimens of oral isotretinoin in acne of all severities.

20.
Int J Clin Pract ; : e13295, 2018 Nov 16.
Artigo em Inglês | MEDLINE | ID: mdl-30444561

RESUMO

INTRODUCTION: Stroke is a major cause of death and disability worldwide. The use of modafinil, a wakefulness-promoting agent, is hypothesized to benefit stroke patients. METHODS: We performed a systematic review in accordance with the Cochrane Handbook for Systematic Reviews of Interventions recommendations to assess the efficacy and safety of modafinil in post stroke patients. We prospectively registered the review protocol in PROSPERO (CRD42017078465) and reported the systematic review following the PRISMA statement. RESULTS: Two published studies (77 participants) and one ongoing randomized controlled trial, with limited methodological quality, assessed the effects of modafinil (200mg or 400mg) for adults from 14 days post-stroke up to 3 months pos-stroke and fulfilled our inclusion criteria and. The clinical and methodological variability between studies precluded meta-analyses. Overall, these studies showed some benefit of modafinil for fatigue, but no benefit for disability, cognition and for subscores of stroke-specific quality of life. Data for adverse events were scarce and mortality was not considered by studies. Due to very low quality related to the evidence, we are uncertain about the effects of modafinil for all outcomes assessed by our systematic review. CONCLUSION: Based on two small randomized controlled trial, which provided very low quality evidence, the effects (benefits and harms) of modafinil for stroke patients are unclear and do not support its routinely use in clinical practice for this clinical situation. This article is protected by copyright. All rights reserved.

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