hard endpoint.

Portuguese translation: Resultado objetivo/definitivo

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:hard endpoint.
Portuguese translation:Resultado objetivo/definitivo
Entered by: Edna Almeida

13:46 Jun 10, 2016
English to Portuguese translations [PRO]
Medical - Medical (general) / Technical
English term or phrase: hard endpoint.
Thanks.
Edna Almeida
Portugal
Local time: 20:30
Resultado objetivo/definitivo
Explanation:
The objectives of a trial must be stated in specific terms. Achieving objectives should not depend on observing a particular outcome of the trial, e.g. finding a difference in mean weight loss of exactly 2 kg, but in obtaining a valid result. For example, a randomized trial of 4 diets had as its objective, “To assess adherence rates and the effectiveness of 4 popular diets for weight loss and cardiac risk factor reduction.” (Dansinger et al. 2005).

The endpoints (or outcomes), determined for each study participant, are the quantitative measurements required by the objectives. In the Dansinger weight loss study, the primary endpoint was identified to be mean absolute change from baseline weight at 1 year. In a cancer chemotherapy trial the clinical objective is usually improved survival. Survival time is recorded for each patient; the primary outcome reported may be median survival time or it could be five-year survival.

Clinical trials typically have a primary objective or endpoint. Additional objectives and endpoints are secondary. The sample size calculation is based on the primary endpoint. Analysis involving a secondary objective has statistical power that is calculated based on the sample size for the primary objective.

"Hard" endpoints are well-defined in the study protocol, definitive with respect to the disease process, and require no subjectivity. "Soft" endpoints are those that do not relate strongly to the disease process or require subjective assessments by investigators and/or patients.
Selected response from:

Ana Costa
Portugal
Local time: 20:30
Grading comment
Obrigada.
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +1Resultado objetivo/definitivo
Ana Costa
4desfecho definitivo
J_Ricardo
3desfechos clinicamente relevantes
Paulo Celestino Guimaraes


  

Answers


14 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
Resultado objetivo/definitivo


Explanation:
The objectives of a trial must be stated in specific terms. Achieving objectives should not depend on observing a particular outcome of the trial, e.g. finding a difference in mean weight loss of exactly 2 kg, but in obtaining a valid result. For example, a randomized trial of 4 diets had as its objective, “To assess adherence rates and the effectiveness of 4 popular diets for weight loss and cardiac risk factor reduction.” (Dansinger et al. 2005).

The endpoints (or outcomes), determined for each study participant, are the quantitative measurements required by the objectives. In the Dansinger weight loss study, the primary endpoint was identified to be mean absolute change from baseline weight at 1 year. In a cancer chemotherapy trial the clinical objective is usually improved survival. Survival time is recorded for each patient; the primary outcome reported may be median survival time or it could be five-year survival.

Clinical trials typically have a primary objective or endpoint. Additional objectives and endpoints are secondary. The sample size calculation is based on the primary endpoint. Analysis involving a secondary objective has statistical power that is calculated based on the sample size for the primary objective.

"Hard" endpoints are well-defined in the study protocol, definitive with respect to the disease process, and require no subjectivity. "Soft" endpoints are those that do not relate strongly to the disease process or require subjective assessments by investigators and/or patients.



    https://onlinecourses.science.psu.edu/stat509/book/export/html/31
Ana Costa
Portugal
Local time: 20:30
Native speaker of: Native in EnglishEnglish, Native in PortuguesePortuguese
PRO pts in category: 28
Grading comment
Obrigada.

Peer comments on this answer (and responses from the answerer)
neutral  Clauwolf: é preciso usar outro termo (uso "desfecho"), pois os endpoints são as quantidades necessárias para os objetivos, não os objetivos (um pouco de semântica aqui)
6 hrs

agree  Matheus Chaud: Acho que a resposta está certa: ela não afirmou que hard endpoint = objetivo. A sugestão da Ana foi hard endpoint = resultado objetivo, o que é bem diferente e faz total sentido considerando-se a definição de hard endpoint.
10 hrs
  -> Obrigada Matheus!
Login to enter a peer comment (or grade)

9 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
desfechos clinicamente relevantes


Explanation:
Os desfechos dependem dos objetivos do estudo.
Soft endpoints (efeitos subjetivos, sujeito a viés de aferição)
Hard endpoints (desfechos clinicamente relevantes): Desfechos bem definidos no protocolo

Paulo Celestino Guimaraes
Brazil
Local time: 16:30
Works in field
Native speaker of: Portuguese
PRO pts in category: 27
Notes to answerer
Asker: Obrigada.

Login to enter a peer comment (or grade)

10 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
desfecho definitivo


Explanation:

Este é o termo que encontrei em um trabalho escrito especificamente sobre o tema, que, entretanto, é um trabalho de 2002 (veja o link).
Esse mesmo trabalho se refere a soft endpoint como desfecho substituto.


    Reference: http://departamentos.cardiol.br/dha/revista/9-1/007.pdf
J_Ricardo
Brazil
Local time: 16:30
Works in field
Native speaker of: Native in PortuguesePortuguese
PRO pts in category: 12
Notes to answerer
Asker: Obrigada.

Login to enter a peer comment (or grade)



Login or register (free and only takes a few minutes) to participate in this question.

You will also have access to many other tools and opportunities designed for those who have language-related jobs (or are passionate about them). Participation is free and the site has a strict confidentiality policy.

KudoZ™ translation help

The KudoZ network provides a framework for translators and others to assist each other with translations or explanations of terms and short phrases.


See also:

Your current localization setting

English

Select a language

Term search
  • All of ProZ.com
  • Term search
  • Jobs
  • Forums
  • Multiple search