Correlation Between the American Medical Association Guides to the Evaluation of Permanent Impairment and the Medical Outcomes Study 36-Item Short Form

• ClinicalTrials.gov Identifier: NCT01760551
• Recruitment Status: Completed
• First Posted: January 4, 2013
• Last Update Posted: January 4, 2013
• Sponsor: JointResearch
• Collaborators: McMaster University; Onze Lieve Vrouwe Gasthuis
• Information provided by (Responsible Party): JointResearch

Tracking Information

• First Submitted Date: December 28, 2012
• First Posted Date: January 4, 2013
• Last Update Posted Date: January 4, 2013
• Study Start Date: December 2010
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 3, 2013)

Fifth or Sixth AMA Guide impairment rating [ Time Frame: Once at assessment of impairment consultation 1hour ]

https://catalog.ama-assn.org/Catalog/product/product_detail.jsp?productId=OP025400 https://catalog.ama-assn.org/Catalog/product/product_detail.jsp?productId=prod920005

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: January 3, 2013)

RAND 36 [ Time Frame: Once at assessment during impairment consultation for app 1hour ]

http://www.ncbi.nlm.nih.gov/pubmed/19364637

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: January 3, 2013)

DASH [ Time Frame: Once at assessment during impairment consultation for app 1hour ]

http://www.ncbi.nlm.nih.gov/pubmed/18473398

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Correlation Between the American Medical Association Guides to the Evaluation of Permanent Impairment and the Medical Outcomes Study 36-Item Short Form
• Official Title: Correlation Between the American Medical Association Guides to the Evaluation of Permanent Impairment and the Medical Outcomes Study 36-Item Short Form.

Brief Summary

The American Medical Association's (AMA) Guides to the Evaluation of Permanent Impairment is used to rate loss of function and determine compensation and ability to work after injury or illness. The AMA Guides are used by many different systems to determine compensable levels of impairment. However, there are few studies that evaluate reliability or construct validity. (1) In the professional community there exists considerable controversy regarding the accuracy and usefulness of the AMA Guides. (2,3) Commentaries have noted that the AMA Guides do not provide a valid, reliable, evidence-based system for the rating of impairments. (4) Some have argued that the impairment ratings do not reflect an individual's actual loss of function and quality of life (QOL). The AMA guides 5th edition was based on loss of range of motion (ROM). The new 6th edition of the AMA guides is based on diagnosis and inclusion of functional outcomes assessments in the determination of impairment ratings. (5) In the orthopaedic literature the use of patient-derived, objective outcome measures has substantially expanded QOL instruments are categorized as general health or as condition-specific questionnaires. The Medical Outcomes Study 36-Item Short Form (SF-36) is a general health-based survey of quality of life. It has been validated and is used widely across medical disciplines. (6) The SF-36 was constructed to survey health status in the Medical Outcomes Study. It was designed for use in clinical practice and research, health policy evaluations, and general population surveys. The SF-36 was constructed for self-administration by persons 14 years of age and older, and for administration by a trained interviewer in person or by telephone. (7) The SF-36 is perhaps the most widely used health-related quality of life (HRQoL) survey instrument in the world today. It is comprised of 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Physical and mental health summary scores are also derived from the eight RAND-36 scales. (8) The aim of this study is to determine the amount of correlation between the by orthopaedic surgeon objectively calculated percentage of impairment scored by the American Medical Association guides to the evaluation of permanent impairment and the by patient subjectively indicated health-related quality of life scored by the SF-36.

Hypotheses: Because of and inclusion of functional outcomes assessments in the determination of impairment ratings the AMA guide 6th edition will have a better correlation with the SF-36. The 6th edition of the AMA guide is based on diagnosis en yield lower impairment percentages than the AMA guide 5th edition that is based on loss of ROM. The SF-36 will have better correlation with the impairment ratings for lower extremities injuries than for upper extremities because it is less valid for the upper extremities.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Patients who have had a medical legal examination by an orthopaedic surgeon working at "Orthopedisch Expertise Centrum" and have completed a to Dutch translated SF-36 form.
• Condition: Trauma
• Intervention: Not Provided

Study Groups/Cohorts

• Patients assessed with AMA guide fifth edition
• Patients assessed with AMA guide sixth edition

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 3, 2013): 250
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 2012
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• All subjects who have had a medical legal examination

Exclusion Criteria:

• exclusion if there is no calculation of the percentage of impairment by the American Medical Association guides to the evaluation of permanent impairment.

Age under 14 years

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 14 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT01760551
• Other Study ID Numbers: JR201201
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: JointResearch
• Study Sponsor: JointResearch

Collaborators

• McMaster University
• Onze Lieve Vrouwe Gasthuis

• Investigators: Not Provided
• PRS Account: JointResearch
• Verification Date: January 2013