Estudos clínicos de não-inferioridade: fundamentos e controvérsias

Pinto, Valdair Ferreira

doi:10.1590/s1677-54492010000300009

Cited by 26 publications

(27 citation statements)

References 19 publications

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“…We believe that, although evidence-based medicine would require randomized controlled clinical studies, comparing conventional and alternative treatments, for example using non-inferiority screening 46 , we questioned whether study would be feasible, even at multi-institutional level, since the number of patients needed in each arm would be very high, associated with the lack of early cases eligible for the method. The ethical discussion in randomizing this group of patients is associated with this fact, offering for them a treatment with greater morbidity and similar oncological results, as already demonstrated in the literature and the results presented here.…”

Section: Lip and Oral Cavity Tumorsmentioning

confidence: 99%

Sentinel lymph node biopsy in early oral cavity tumors: evaluation of the oncologic efficacy compared to elective neck dissection

Seferin¹,

Pinto²,

Lin³

et al. 2018

Arch. Head Neck Surg.

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Introduction:In recent years, there has been a polarization around the discussion of neck management in patients with oral malignant neoplasm without evidence of lymph node involvement, regarding selective neck dissection (SND) of levels I, II and III, sentinel lymph node biopsy (SLB) and just surveillance. Objective: To describe the oncological results of a prospective study in the use of sentinel lymph node biopsy as part of the surgical treatment of squamous cell carcinoma T1/T2N0 of the oral cavity in comparison to the results of patients submitted to levels I, II and III SND. Methods: It was a prospective study in which seventy patients were divided into two groups, 35 being submitted to SND and the other 35 to SLB. Results: In the SND group, locoregional recurrence occurred in 17.1%, with a 2.9% development of distant metastasis and 8.8% evolved with a second primary tumor. In the SLB, locoregional recurrence was observed in 7 patients (20.0%), 5.7% developed distant metastasis, and 5.7% had a second primary tumor. There was no significant difference between the two groups for both overall (p = 0.521) and disease-free survival (p = 0.753). Conclusion: A SLB is reliable for the management of clinically negative neck in patients with oral T1/T2N0 squamous cell carcinoma.

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Section: Lip and Oral Cavity Tumorsmentioning

confidence: 99%

Sentinel lymph node biopsy in early oral cavity tumors: evaluation of the oncologic efficacy compared to elective neck dissection

Seferin¹,

Pinto²,

Lin³

et al. 2018

Arch. Head Neck Surg.

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“…In addition, multivariate analyses, comparison of subgroups to different numerical proportions, or multiple longitudinal comparisons, also involve higher complexity in sample sizing calculation. All these items exceed the scope of this paper 1,5,[7][8][9][10] .…”

Section: Infinite Populationmentioning

confidence: 99%

Tamanho da amostra em estudos clínicos e experimentais

Miot

2011

J. vasc. bras.

275

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“…comparative efficacy studies, which are performed to compare a new treatment with a traditional treatment in order to show that the new one is not inferior, but also not superior, to the existing treatment. 13 Use of statins in cases with a known history of cerebral, peripheral or vascular disease, in which the patient remains functionally independent for activities of daily living and the life expectancy is more than five years, was also discussed and included for discussion in the second phase of the study. In this second phase, a consensus was achieved with regard to the evidence showing that the long-term benefit of statins in cerebral or peripheral atherosclerotic artery disease is poorer than that for coronary artery disease.…”

Section: Discussionmentioning

confidence: 99%

Cross-cultural adaptation and content validation of START

Luz¹,

Oliveira

Noblat

2016

Sao Paulo Med. J.

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CONTEXT AND OBJECTIVE: Non-treatment of diseases or clinical conditions has been considered to constitute omission of care in several countries. The aim of the present study was to develop a transcultural adaptation of the Screening Tool to Alert Doctors to the Right Treatment (START) to Brazilian Portuguese and to validate the tool's content. DESIGN AND SETTING: Cultural adaptation and validation of the START criteria using the Delphi consensus technique. METHOD: START was translated from its original language into Brazilian Portuguese, followed by backtranslation and validation by means of the modified Delphi technique. For this, an electronic form was developed and sent to 20 experts, who were asked to use a Likert scale to assess the statements included in START, in relation to their pertinence to Brazilian realities. All of the statements that exhibited mean scores greater than 4.0 were considered to have attained consensus. The experts' identities were kept confidential throughout the validation process. RESULTS:In the first phase of the validation process, 63.6% (14/22) of the statements in START attained consensus. The remaining statements were returned to the experts so that they could have the opportunity to review their comments and statements and to assess them again, based on the Likert scale used earlier. In this phase, 100% of the START instrument attained consensus. CONCLUSION: The content of START was entirely validated for Brazil, with all of the original criteria maintained.RESUMO CONTEXTO E OBJETIVO: O não tratamento de doenças ou condições clínicas tem sido apontado como omissão no cuidado em diversos países. O objetivo deste estudo foi realizar a adaptação transcultural para o português brasileiro e sua validação de conteúdo do questionário START (Screening Tool to Alert Doctors to the Right Treatment). TIPO DE ESTUDO E LOCAL:Adaptação cultural e validação dos critérios START através da técnica de consenso Delphi. MÉTODO: O START foi submetido à tradução da língua original para o Português (Brasil), tradução reversa e validação de conteúdo por meio da técnica Delphi modificada. Para isso, um formulário eletrônico foi desenvolvido e enviado a 20 especialistas para o julgamento das proposições presentes na ferramenta START conforme sua pertinência para a realidade brasileira, utilizando uma escala de Likert. Foram consideradas consensuais todas as proposições que apresentaram média superior a 4,0. A identificação de cada especialista foi mantida em confidencialidade durante o todo o processo. RESULTADOS: Na primeira fase da validação, foi obtido consenso em 63,6% (14/22) das proposições contidas na ferramenta START. As proposições não consensuais foram reencaminhadas para os especialistas, que tiveram a oportunidade de rever seus comentários e proposições e julgá-las com base na escala de Likert utilizada previamente. Nessa fase, foi obtido consenso em 100% do instrumento START. CONCLUSÃO: O conteúdo do START foi validado para o Brasil na sua totalidade, com todos os critérios origina...

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Estudos clínicos de não-inferioridade: fundamentos e controvérsias

Cited by 26 publications

References 19 publications

Sentinel lymph node biopsy in early oral cavity tumors: evaluation of the oncologic efficacy compared to elective neck dissection

Sentinel lymph node biopsy in early oral cavity tumors: evaluation of the oncologic efficacy compared to elective neck dissection

Tamanho da amostra em estudos clínicos e experimentais

Cross-cultural adaptation and content validation of START

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