We read with great interest the head to head on reporting bias and the possible role of ethics committees in its control and the 3 accompanying responses available at this time.
Many interesting points have been addressed such as the need for resources, the complex issue of sanctions, the “waste” of research, the necessity to improve the information available in the data base and so on. Still the main question remains, “Should research ethics committee records be used to detect reporting bias?” as Simon E Kolstoe points out.
The research projects evaluated by ethics committees often lack in definition of outcomes, as well as in precise reporting about the interventions to be done and the population to be enrolled. This lack of fundamental informations makes almost impossible the monitoring and the detection of reporting bias, regardless of who is the actor of the monitoring process.
Population, interventions, comparators and outcomes definition, are the essential information to guarantee a valid and reliable judgement process.
The response of Michelle van der Vecht to the head to head recalls the availability of structured tools for the evaluation of research protocols (http://www.spirit-statement.org). These instruments, also inspired to Good Clinical Practice (http://www.ich.org), are also designed for the purpose of reporting bias control and are aligned to similar tools (http://www.consort-statement.org) adopted by all major biomedical journals.
The ethics committee of the Tuscany region is organized in four sections, one exclusively dedicated to clinical research in pediatrics, has adopted the SPIRIT Statement as an evaluation tool for interventional research protocols. The availability of a management software will allow the creation of a database of research projects including a clear definition of outcomes, interventions and populations to be enrolled. This database could be used for the monitoring and detection of reporting bias (and probably Publication bias).
We believe that the role of ethics committees could be crucial in the control of reporting bias since they are in a privileged position to begin the monitoring process. However, the availability of robust evidence to identify the reporting bias can be guaranteed only by an evaluation system of the ethical committees that use validated and standardized tools.
Competing interests:
No competing interests
17 April 2017
Alessandro Mugelli
President of the Pediatric Ethics Committee of the Tuscan Region
Salvatore De Masi,Technical-scientific Secretariat of the Pediatric Ethics Committee, Meyer Children’s Hospital, Florence, Italy
Department of Neuroscience, Drug Research and Child's Health (NeuroFarBa), Division of Pharmacology
Rapid Response:
The key role of ethics committees
We read with great interest the head to head on reporting bias and the possible role of ethics committees in its control and the 3 accompanying responses available at this time.
Many interesting points have been addressed such as the need for resources, the complex issue of sanctions, the “waste” of research, the necessity to improve the information available in the data base and so on. Still the main question remains, “Should research ethics committee records be used to detect reporting bias?” as Simon E Kolstoe points out.
The research projects evaluated by ethics committees often lack in definition of outcomes, as well as in precise reporting about the interventions to be done and the population to be enrolled. This lack of fundamental informations makes almost impossible the monitoring and the detection of reporting bias, regardless of who is the actor of the monitoring process.
Population, interventions, comparators and outcomes definition, are the essential information to guarantee a valid and reliable judgement process.
The response of Michelle van der Vecht to the head to head recalls the availability of structured tools for the evaluation of research protocols (http://www.spirit-statement.org). These instruments, also inspired to Good Clinical Practice (http://www.ich.org), are also designed for the purpose of reporting bias control and are aligned to similar tools (http://www.consort-statement.org) adopted by all major biomedical journals.
The ethics committee of the Tuscany region is organized in four sections, one exclusively dedicated to clinical research in pediatrics, has adopted the SPIRIT Statement as an evaluation tool for interventional research protocols. The availability of a management software will allow the creation of a database of research projects including a clear definition of outcomes, interventions and populations to be enrolled. This database could be used for the monitoring and detection of reporting bias (and probably Publication bias).
We believe that the role of ethics committees could be crucial in the control of reporting bias since they are in a privileged position to begin the monitoring process. However, the availability of robust evidence to identify the reporting bias can be guaranteed only by an evaluation system of the ethical committees that use validated and standardized tools.
Competing interests: No competing interests