NCT01760551

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
Last Updated

January 4, 2013

Status Verified

January 1, 2013

Enrollment Period

2 years

First QC Date

December 28, 2012

Last Update Submit

January 3, 2013

Conditions

Keywords

FractureTraumaimpairment

Outcome Measures

Primary Outcomes (1)

  • Fifth or Sixth AMA Guide impairment rating

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

    Once at assessment of impairment consultation 1hour

Secondary Outcomes (1)

  • RAND 36

    Once at assessment during impairment consultation for app 1hour

Other Outcomes (1)

  • DASH

    Once at assessment during impairment consultation for app 1hour

Study Arms (2)

Patients assessed with AMA guide fifth edition

Patients assessed with AMA guide sixth edition

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • All subjects who have had a medical legal examination

You may not qualify if:

  • Age under 14 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Onze Lieve Vrouwe Gasthuis

Amsterdam, North Holland, 1091AC, Netherlands

Location

MeSH Terms

Conditions

Wounds and InjuriesFractures, Bone

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2012

First Posted

January 4, 2013

Study Start

December 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 4, 2013

Record last verified: 2013-01

Locations