Medical Hydrology and Balneology: Environmental Aspects

Medical Hydrology and Balneology: Environmental Aspects
Blinding
The method of blinding for all participants (patients, therapist, investigator, statistician)
must be planned and managed all along the trial. For non drug trial, it is
important to find a control treatment which is similar to the active treatment (in
order to equalize the placebo effect).
Statistical analysis
Must be planned precisely in the protocol and shouldn’t be modified after registration.
Between group comparison of the main criteria is the only important result
of the trial.
Registration of the protocol and legal dispositions
Protocol must be registered on www.clinicaltrial.gov before starting the recruitment.
It must be accepted by an ethic committee. In some countries, it must also be declared
to the health authorities and national committee of computerized databases.
Results
Health authorities and national committee of computerized databases.
Management of the trial
An appropriate management needs monitoring and secretariat to collect the data,
to call patients and investigators when necessary. The finality of management is to
limit the loss of data.
Recruitment
Recruitment methods are one of the main keys of the success of a trial. Most of
the trials are unsuccessful due to a lack of recruitment which leads to lack of statistical
power.
Data management
The data management of the trial must be realized precisely all along the trial.
Implementation of the intervention:
It is important to control if the active treatment and the comparator are delivered
as planned in the protocol.
Conclusions
Writing the article
Must follow the consort statement as close as possible.
Keywords: Protocole, Methodology, Clinical Trial
84
Balnea
2012, núm. 6, 83-84