Pain Clinical Trial
Official title:
INTERNATIONAL VALIDATION STUDY OF THE ALGOPLUS SCALE IN FIVE LANGUAGES
Acute pain is responsible for unnecessary suffering. Among elderly patients, acute pain is
frequent and underestimated, especially when these patients have cognitive disorders. The
expression of pain is then modified and the conventional tools for evaluating pain cannot be
used. Thus the existence of pain must be detected on the basis of a behavioural assessment.
It is nonetheless necessary to have the assistance of standardised and validated tools. In
France, the Doloplus Group has proposed a scale called Doloplus, validated in January 1999,
and is now proposing a new scale for acute pain, Algoplus that has been validated in French
(4). Doloplus has been recently translated and validated in 5 languages and an identical
methodology will be used in this protocol.
Internationally, although several teams are working on the development of scales that can be
used for non-communicating elderly subjects, there is as yet no validated tool for acute
pain assessment.
Considering 1- the lack of tools at an international level and 2- the frequent request from
many practitioners worldwide, the Doloplus group has offered to validate the Algoplus® scale
in 5 foreign languages, English, German, Spanish, Italian, Portuguese. A rigorous
methodology with the help of a statistician will be used in this validation process.
50 patients per language will be explored : t1 = time t Physician M Physician N t2 = time
t+4 hours Physician M
The methodology of the validation of our translation procedure consists of studying the
reliability of the scale in two major steps:
- Data from a sample of 50 patients will be used to explore the test-retest reliability
of the scale administered by the same trained clinician, on two occasions four hours
apart, without any treatment in between. The ALGOPLUS® scores obtained from the
patients at a time t will be compared with their (t + 4 hours) scores to assess
test-retest reliability.
- For a sample of at least 50 patients, two physicians trained for the use of ALGOPLUS,
will assess pain independently. A statistical test will be used to compare the results
for the inter-rater reliability.
;
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