ABSTRACT
To evaluate the intervention effects of randomized controlled trials (RCT) involved in theoretical efficacy and actual clinical outcome (effectiveness).Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) is a tool to help researchers make decisions in study design which is consistent with the intended purpose of their trial which can be used in the design of RCT to balance the intemal validity and external validity.The role of PRECIS has been gradually recognized in the practice of designing clinical trials.To ensure that the design choices are concordant with the intention and the facilitation of use set by patients,clinicians and policy makers,a new PRECIS-2 tool has been developed by mangy international team experts under modification and upgrading the existing PRECIS.The PRECIS-2 tool mainly focuses on trial design choices which determining the applicability of a trial.PRECIS-2 has nine domains,with each of them intends to help the researchers consider the consequences of that design decision in terms of the applicability of the results under particular setting.The purpose of this paper is to introduce the development,basic principle,characteristics and application of PRECIS-2 for the designers and decision makers when working on clinical trials.
ABSTRACT
To evaluate the intervention effects of randomized controlled trials (RCT) involved in theoretical efficacy and actual clinical outcome (effectiveness). Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) is a tool to help researchers make decisions in study design which is consistent with the intended purpose of their trial which can be used in the design of RCT to balance the internal validity and external validity. The role of PRECIS has been gradually recognized in the practice of designing clinical trials. To ensure that the design choices are concordant with the intention and the facilitation of use set by patients, clinicians and policy makers, a new PRECIS-2 tool has been developed by mangy international team experts under modification and upgrading the existing PRECIS. The PRECIS-2 tool mainly focuses on trial design choices which determining the applicability of a trial. PRECIS-2 has nine domains, with each of them intends to help the researchers consider the consequences of that design decision in terms of the applicability of the results under particular setting. The purpose of this paper is to introduce the development, basic principle, characteristics and application of PRECIS-2 for the designers and decision makers when working on clinical trials.
Subject(s)
Humans , Communication , Decision Making , Randomized Controlled Trials as Topic/methods , Research Design/standardsABSTRACT
Randomized controlled trial (RCT) can be designed as explanatory trial and pragmatic/practical trial (PCT) for clinical effect evaluation.The pragmatic/practical trial reflects the intervention effect under actual clinical condition,which has relatively good extrapolation,but its internal validity is relatively poor.In contrast,explanatory trials conducted under ideal conditions have better inner validity but inferior external validity.However,in the design of RCT,PCT and explanatory trials are not always opposite.Many RCTs have the properties of the two designs at the same time,Pragmatic-explanatory continuum indicator summary (PRECIS) can be used in the design of RCT for the balance between internal validity and external validity.There are few available reports about the application of PRECIS in China at present,so this paper summarizes the basic principles,characteristics of PRECIS and the application of PRECIS in order to provide reference for the clinical trial design in China.