A hierarquia das evidências em cirurgia da mão nas revistas ortopédicas nacionais

CONTEXT AND OBJECTIVE: There is no systematic assessment of the quality of scientific production in the specialty of hand surgery in our setting. This study aimed to systematically assess the status of evidence generation relating to hand surgery and to evaluate the reproducibility of the classification method based on an evidence pyramid. DESIGN AND SETTING: Secondary study conducted at Universidade Federal de São Paulo (UNIFESP) and Faculdade Estadual de Medicina de Marília (Famema). METHODS: Two researchers independently conducted an electronic database search for hand surgery studies published between 2000 and 2009 in the two main Brazilian orthopedic journals (Acta Ortopédica Brasileira and Revista Brasileira de Ortopedia). The studies identified were subsequently classified according to methodological design (systematic review of the literature, randomized clinical trial, cohort study, case-control study, case series and other studies) and evidence level (I to V). RESULTS: A total of 1,150 articles were evaluated, and 83 (7.2%) were included in the final analysis. Studies with evidence level IV (case series) accounted for 41 (49%) of the published papers. Studies with evidence level V (other studies) accounted for 12 (14.5%) of the papers. Only two studies (2.4%) were ranked as level I or II. The inter-rater reproducibility was excellent (k = 0.94). CONCLUSIONS: Hand surgery articles corresponded to less than one tenth of Brazilian orthopedic production. Studies with evidence level IV were the commonest type. The reproducibility of the classification stratified by evidence level was almost perfect.CONTEXTO E OBJETIVO: Não há uma avaliação sistemática da qualidade da produção científica na especialidade de cirurgia da mão em nosso meio. Este estudo objetiva analisar o status da geração de evidências em cirurgia da mão, por meio de avaliação sistematizada, além de avaliar a reprodutibilidade da classificação baseada na pirâmide das evidências. TIPO DE ESTUDO E LOCAL: Estudo secundário realizado pela Universidade Federal de São Paulo (UNIFESP) e Faculdade Estadual de Medicina de Marília (Famema). MÉTODOS: De forma independente, dois pesquisadores promoveram uma busca eletrônica dos trabalhos envolvendo cirurgia da mão, no período de 2000-2009, para duas principais revistas na literatura ortopédica nacional (Acta Ortopédica Brasileira e Revista Brasileira de Ortopedia). Os trabalhos identificados foram subsequentemente classificados pelo tipo de delineamento metodológico (revisões sistemáticas da literatura, estudos clínicos randomizados, estudos de coorte, estudos caso-controle, séries de casos e outros estudos) e nível de evidência (I a V). RESULTADOS: Foram avaliados 1.150 artigos, sendo 83 (7,2%) considerados para a análise final. Estudos com nível de evidência IV (séries de caso) correspondem a 41 (49%) das publicações. Estudos nível de evidência V (outros estudos), corresponderam a 12 (14,5%) da amostra. Apenas dois estudos (2,4%) foram identificados como nível I ou II. A reprodutibilidade interobservadores foi excelente (k = 0.94). CONCLUSÕES: Os artigos de cirurgia da mão correspondem a menos de um décimo da produção ortopédica nacional. Estudos nível de evidência IV foram os mais encontrados na literatura nacional. A classificação estratificada por níveis de evidência apresenta reprodutibilidade quase perfeita.Universidade Federal de São Paulo (UNIFESP) Escola Paulista de MedicinaUniversidade Federal de São Paulo (UNIFESP) Department of Orthopedics and TraumatologyFaculdade Estadual de Medicina de MaríliaFaculdade Estadual de Medicina de Marília Department of Orthopedics and TraumatologyUniversidade Federal de São Paulo (UNIFESP)UNIFESP, EPMUNIFESP, Department of Orthopedics and TraumatologyUNIFESPSciEL

Outcomes in orthopedics and traumatology: translating research into practice

Clinical research is focused in generating evidence that is feasible to be applicable to practitioners. However, translating research-focused evidence into practice may be challenging and often misleading. This article aims is to pinpoint these challenges and suggest some methodological safeguards, taking platelet-rich plasma therapies and knee osteochondral injuries as examples. Studies and systematic reviews involving the following concepts will be investigated: clinically relevant outcomes, systematic errors on sample calculation, internal and external validity. Relevant studies on platelet-rich plasma for muscle-tendon lesions and updates on osteochondral lesions treatment were included in this analysis. Authors and clinicians should consider these concepts for the implementation and application of dissemination of the best evidence. Research results should be challenged by a weighted analysis of its methodological soundness and applicability. Level of Evidence V, Therapeutic Studies - Investigating the Results of Treatment.Universidade Federal de São Paulo (UNIFESP) Department of OrthopedicsUNIFESP, Department of OrthopedicsSciEL

Randomized Controlled Trials in orthopedics and traumatology: systematic analysis of the national evidence

OBJECTIVE: To assess whether there was an improvement in the quality and quantity of randomized controlled trials (RCTs) in nationally published journals through an application of standardized and validated scores. METHODS: We selected, electronically, for the period of 2000-2009, all RCTs published at the two indexed, orthopaedics-focused Brazilian journals: Acta Ortopédica Brasileira(AOB) and Revista Brasileira de Ortopedia (RBO). These RCTs were identified and scored by two independent researchers according to the JADAD scale and Cochrane Bone, Joint and Muscle Trauma Group score. The selected studies were grouped: 1) by publication period (2000-2004 and 2004-2009); 2) journal of publication (AOB and RBO). RESULTS: Twenty-two papers were selected, 10 from AOB and 12 from RBO. No statistically significant differences were found between the proportion (nRCT/nTotal of published papers) of RCTs published in the two journals (p=0.458), as well as for the JADAD score (p=0.722) and Cochrane score (p=0.630). CONCLUSION: The quality and quantity of randomized clinical trials in the period was similar in the journals analyzed. There is a trend of improvement of quality, yet there was no increase in the number of randomized clinical trials in both periods.OBJETIVO: Verificar se houve melhora da qualidade e quantidade dos ensaios clínicos randomizados (ECRs) publicados na literatura nacional, por meio da aplicação de escores estruturados e validados na literatura. MÉTODOS: Selecionamos, eletronicamente, todas as edições das duas revistas indexadas e de escopo ortopédico da literatura nacional - Acta Ortopédica Brasileira (AOB) e Revista Brasileira de Ortopedia (RBO), no período de 2000-2009, todos os ECRs publicados. Dois pesquisadores independentes identificaram e pontuaram os ECRs de acordo com as escalas de JADAD e do grupo de trauma musculoesquelético da Colaboração Cochrane. Os trabalhos selecionados foram agrupados: 1) pelo período de publicação 2000-2004 e 2004-2009; 2) periódico de publicação (AOB e RBO). RESULTADOS: Vinte e dois trabalhos foram selecionados, sendo10 da AOB e 12 da RBO. Não houve diferença entre o número proporcional (nECR/nTotal de trabalhos publicados) de ensaios clínicos randomizados publicados nos dois periódicos (p = 0,458), assim como para os escores de JADAD (p = 0,722) e da Colaboração Cochrane (p = 0,630). CONCLUSÃO: A qualidade e quantidade relativa de ensaios clínicos randomizados nos periódicos analisados foi semelhante. Há uma tendência de melhora da qualidade; contudo, não há acréscimo da quantidade de ensaios clínicos randomizados nos dois períodos analisados.Universidade Federal de São Paulo (UNIFESP) Departamento de Ortopedia e TraumatologiaUniversidade Federal de São Paulo (UNIFESP) Departamento de Ortopedia e Traumatologia Setor de Ombro e Cotovelo da Disciplina de Mão e Membro SuperiorUNIFESP, Depto. de Ortopedia e TraumatologiaUNIFESP, Depto. de Ortopedia e Traumatologia Setor de Ombro e Cotovelo da Disciplina de Mão e Membro SuperiorSciEL

Platelet rich therapies for musculoskeletal soft tissue injuries

Introdução: as lesões musculotendíneas (LMTs) são frequentes na prática ortopédica e acometem indivíduos jovens e/ou ativos. Há grande intersecção entre as modalidades de tratamento (conservadoras e cirúrgicas) para este grupo de lesões. Neste cenário, as terapias ricas em plaquetas (TRP) são uma opção de tratamento emergente. Esta tese tem como objetivo avaliar a efetividade (benefícios e malefícios) das TRP em pacientes com LMTs. Métodos: através de estratégia de busca definida, realizou-se a identificação e seleção de ECRs que comparem TRP versus placebo ou não intervenção. Incluímos as bases de dados até maio de 2013. Não houve restrições quanto ao idioma de publicação. O critério de inclusão dos estudos consistia em estudos randomizados ou quasi randomizados, que compararam a TRP versus placebo ou intervenções equivalentes ao placebo. Foram desfechos primários: função e dor, através de instrumentos validados e efeitos adversos. A avaliação da qualidade dos estudos foi realizada por meio da Cochrane Risk of Bias Tool. A Análise estatística consistiu de abordagem meta-analítica. Houve verificação dos efeitos dos tratamentos, por meio da mensuração da diferença entre as médias dos grupos para variáveis contínuas ou razão entre os riscos, para variáveis categóricas. As medidas-resumo foram acompanhadas de intervalos de confiança de 95%. Os métodos de meta-análise variaram ao longo da revisão e houve julgamento individual. Avaliação da heterogeneidade se baseou na estatística I2 e análise visual. Os dados foram apresentados em gráficos floresta. Para os fins da análise inferencial, optou-se por alfa de 5%. Resultados: incluímos 17 ECRs e 2 ensaios quasi randomizados (1088 pacientes). Três estudos foram considerados como com baixo risco de viés e outros 16 como risco elevado ou incerto. Metaanálises gerais (sem estratificação de doença) da função no curto (DPM 0,26; 95% IC -0,19 a 0,71; valor de p= 0,26; I2 = 51%; 162 participantes); médio (DPM -0,09, 95% IC -0,56 a 0,39; valor de p= 0,72; I2 = 50%; 151 participantes) e longo prazos (DPM 0,25, 95% IC -0,07 a 0,57; valor de p= 0,12; I2 = 66%; 484 participantes), demonstraram não haver diferenças entre a TRP e o placebo. Para dor, houve redução no grupo TRP no curto prazo, entretanto, com benefício clínico limítrofe (DM -0.95, 95% IC -1.41 a -0.48; valor de p<0,001; I2 = 0%; 175 participantes). Os efeitos adversos foram semelhantes entre os grupos (7/241 versus 5/245; RR 1.31, 95% IC 0.48 a 3.59; valor de p=0,60; I2 = 0%; 486 participantes). Nas meta-análises agrupadas por condição clínica, não se detectou qualquer diferença relevante entre os grupos, exceto para função (longo prazo) e dor (curto prazo), no grupo com lesão do manguito rotador, ambos de relevância clínica questionável. Ademais, algumas análises sofreram por elevada heterogeneidade e não foram realizadas. Conclusões: Nas avaliações gerais, para função, a TRP não é mais efetiva que o placebo no curto e longo prazo. Há benefício limítrofe (clinicamente irrelevante) em favor da TRP, para dor, no curto prazo. A taxa de complicações foi semelhante ao placebo. Na avaliação envolvendo lesões do manguito rotador, há benefício em favor da TRP para função (longo prazo) e dor (curto prazo), entretanto, clinicamente irrelevantes. Para outras condições (epicondilite lateral e lesão do LCA), as TRPs não se demonstraram efetivas. Para outras condições, são necessários mais estudos.Introduction: Platelet-rich therapies are being used increasingly in the treatment of musculoskeletal soft tissue injuries such as ligament, muscle and tendon tears and tendinopathies. These therapies can be used as the principal treatment or as an augmentation procedure (application after surgical repair or reconstruction). Platelet-rich therapies are produced by centrifuging a quantity of the patient’s own blood and extracting the active, platelet-rich, fraction. The platelet-rich fraction is applied to the injured tissue; for example, by injection. Platelets have the ability to produce several growth factors, so these therapies should enhance tissue healing. There is a need to assess whether this translates into clinical benefit. This thesis aims to assess the effects (benefits and harms) of platelet-rich therapies for treating musculoskeletal soft tissue injuries. Methods: Study selection derived from a dedicated search strategy (may 2013) We also searched trial registers and conference abstracts. No language or publication restrictions were applied. We included randomised and quasi-randomised controlled trials that compared platelet-rich therapy with either placebo, autologous whole blood, dry needling or no plateletrich therapy for people with acute or chronic musculoskeletal soft tissue injuries. Primary outcomes were functional status, pain and adverse effects. Treatment effects were assessed using risk ratios for dichotomous data and mean differences (MD) or standardised mean differences (SMD) for continuous data, together with 95% confidence intervals. Where appropriate, data were pooled using the fixed-effect model for RR and MD, and the random-effects model for SMD. The quality of the evidence for each outcome was assessed using Risk of Bias Tool. Results: We included data from 19 small single centre trials (17 randomised and two quasi-randomised; 1088 participants) that compared platelet-rich therapy with placebo, autologous whole blood, dry needling or no platelet-rich therapy. Three trials were judged as being at low risk of bias; the other 16 were at high or unclear risk of bias relating to selection, detection, attrition or selective reporting, or combinations of these. Data assessing function in the short term (up to three months) were pooled from four trials that assessed PRT in three clinical conditions and used four different measures. These showed no significant difference between PRT and control (SMD 0.26; 95% confidence interval (CI) -0.19 to 0.71; P value 0.26; I2 = 51%; 162 participants; positive values favour PRT). Medium-term function data (at six months) were pooled from five trials that assessed PRT in five clinical conditions and used five different measures. These also showed no difference between groups (SMD -0.09, 95% CI -0.56 to 0.39; P value 0.72; I2 = 50%; 151 participants). Long-term function data (at one year) were pooled from 10 trials that assessed PRT in five clinical conditions and used six different measures. These also showed no difference between groups (SMD 0.25, 95% CI -0.07 to 0.57; P value 0.12; I2 = 66%; 484 participants). Although the 95% confidence intervals indicate the possibility of a poorer outcome in the PRT group up to a moderate difference in favour of PRT at short- and long-term follow-up, these do not translate into clinically relevant differences. Data pooled from four trials that assessed PRT in three clinical conditions showed a small reduction in short-term pain in favour of PRT on a 10-point scale (MD -0.95, 95% CI - 1.41 to -0.48; I2 = 0%; 175 participants). The clinical significance of this result is marginal. Four trials reported adverse events; another seven trials reported an absence of adverse events. There was no difference between treatment groups in the numbers of participants with adverse effects (7/241 versus 5/245; RR 1.31, 95% CI 0.48 to 3.59; I2 = 0%; 486 participants. The available evidence is insufficient to indicate whether the effects of PRT will differ importantly in individual clinical conditions. Conclusions: TRP are not more effective than placebo in the functional assessment. There is a significant, clinical irrelevant benefit of PRT in pain improvement in the short term when compared to placebo. Adverse effects were similar between groups. Dedicated analysis did not show any clinically relevant benefits regarding to PRTs

Hierarchy of evidence relating to hand surgery in Brazilian orthopedic journals

CONTEXT AND OBJECTIVE: There is no systematic assessment of the quality of scientific production in the specialty of hand surgery in our setting. This study aimed to systematically assess the status of evidence generation relating to hand surgery and to evaluate the reproducibility of the classification method based on an evidence pyramid. DESIGN AND SETTING: Secondary study conducted at Universidade Federal de São Paulo (Unifesp) and Faculdade Estadual de Medicina de Marília (Famema). METHODS: Two researchers independently conducted an electronic database search for hand surgery studies published between 2000 and 2009 in the two main Brazilian orthopedic journals (Acta Ortopédica Brasileira and Revista Brasileira de Ortopedia). The studies identified were subsequently classified according to methodological design (systematic review of the literature, randomized clinical trial, cohort study, case-control study, case series and other studies) and evidence level (I to V). RESULTS: A total of 1,150 articles were evaluated, and 83 (7.2%) were included in the final analysis. Studies with evidence level IV (case series) accounted for 41 (49%) of the published papers. Studies with evidence level V (other studies) accounted for 12 (14.5%) of the papers. Only two studies (2.4%) were ranked as level I or II. The inter-rater reproducibility was excellent (k = 0.94). CONCLUSIONS: Hand surgery articles corresponded to less than one tenth of Brazilian orthopedic production. Studies with evidence level IV were the commonest type. The reproducibility of the classification stratified by evidence level was almost perfect

A systematic review of the quality of distal radius systematic reviews: Methodology and reporting assessment.

BackgroundMany systematic reviews (SRs) have been published about the various treatments for distal radius fractures (DRF). The heterogeneity of SRs results may come from the misuse of SR methods, and literature overviews have demonstrated that SRs should be considered with caution as they may not always be synonymous with high-quality standards. Our objective is to evaluate the quality of published SRs on the treatment of DRF through these tools.MethodsThe methods utilized in this review were previously published in the PROSPERO database. We considered SRs of surgical and nonsurgical interventions for acute DRF in adults. A comprehensive search strategy was performed in the MEDLINE database (inception to May 2017) and we manually searched the grey literature for non-indexed research. Data were independently extracted by two authors. We assessed SR internal validity and reporting using AMSTAR (Assessing the Methodological Quality of Systematic Reviews and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyzes). Scores were calculated as the sum of reported items. We also extracted article characteristics and provided Spearman's correlation measurements.ResultsForty-one articles fulfilled the eligibility criteria. The mean score for PRISMA was 15.90 (CI 95%, 13.9-17.89) and AMSTAR was 6.48 (CI 95% 5.72-7.23). SRs that considered only RCTs had better AMSTAR [7.56 (2.1) vs. 5.62 (2.3); p = 0.014] and PRISMA scores [18.61 (5.22) vs. 13.93 (6.47), p = 0.027]. The presence of meta-analysis on the SRs altered PRISMA scores [19.17 (4.75) vs. 10.21 (4.51), p = 0.001] and AMSTAR scores [7.68 (1.9) vs. 4.39 (1.66), p = 0.001]. Journal impact factor or declaration of conflict of interest did not change PRISMA and AMSTAR scores. We found substantial inter observer agreement for PRISMA (0.82, 95% CI 0.62-0.94; p = 0.01) and AMSTAR (0.65, 95% CI 0.43-0.81; p = 0.01), and moderate correlation between PRISMA and AMSTAR scores (0.83, 95% CI 0.62-0.92; p = 0.01).ConclusionsDRF RCT-only SRs have better PRISMA and AMSTAR scores. These tools have substantial inter-observer agreement and moderate inter-tool correlation. We exposed the current research panorama and pointed out some factors that can contribute to improvements on the topic