International Validation Study Of The Algoplus Scale In Five Languages (ALGOPLUS LE)

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.

Study Overview

• Status: Unknown
• Conditions: Pain; Communication Disorders; Elderly
• Intervention / Treatment: Other: algoplus

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • CHU de Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

elderly patients

Description

Inclusion Criteria:

• - males or females aged 65 or above 65, with communication disorders
• with or without suspected acute pain

Exclusion Criteria:

• - are too agitated,
• have acute pain needing immediate pain management,
• change of treatment between the two evaluations ( t and t+4 hours ),
• refuse to participate

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
testretest relaibility; 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	Other: algoplus
statistical test; 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	Other: algoplus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter-rater scale and intra-rater comparisons of the filled Algoplus® scale.	The scale includes five items (facial expression, sight expression, complaints, bodily attitudes and finally the general behaviour).. The presence of one behaviour in each of the items is sufficient to score "yes" for the item under consideration. Each item marked "yes" is scored one point and the sum of the items provides a total score out of five	at time 1 (Physician N and M), at time 2 (t+4 hours) by physician M.

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: University Hospital, Grenoble; Dr Gisèle PICKERING; Dr M Fisher Dr. Ulrike Bornschlegel; Dr M Schuler; Dr Pat Schofield; Dr D Lussier; Dr S Gibson; Dr Joan ESPAULELLA PANICOT; Dr Joan Manuel PEREZ CASTEJON; Gambassi, Giovanni, M.D.; Dr Patrizio ODETTI; Dr Fiametta MONACELLI; Dr Hirondina GUARDA, Dr Sónia SANTOS; Dr Valérie LEGOUT; Dr Patrice Rat; Dr Bernard WARY
• Investigators: Principal Investigator: Gisèle PICKERING, CHU de Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): October 1, 2014
• Study Completion (Anticipated): January 1, 2015

Study Registration Dates

• First Submitted: December 6, 2013
• First Submitted That Met QC Criteria: December 17, 2013
• First Posted (Estimate): December 23, 2013

Study Record Updates

• Last Update Posted (Estimate): July 8, 2014
• Last Update Submitted That Met QC Criteria: July 4, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Pain; elderly; Algoplus® scale; aged 65 or above 65; communication disorders
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Communication Disorders
• Other Study ID Numbers: CHU-0172