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TraumaNCT01760551

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

An observational study of Trauma, run by JointResearch at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 years and older
Conditions the study is for
Trauma
How many people
250 participants
Where
1 siteNetherlands
Study dates
Dec 2010to Dec 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • All subjects who have had a medical legal examination

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site
  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, North Holland, 1091AC

Other trials in Netherlands

About this study

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

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.

Conditions
Trauma
Keywords
Fracture, Trauma, impairment
Medical subject headings
Wounds and Injuries, Fractures, Bone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01760551
Study groupRoleWhat they receive
Patients assessed with AMA guide fifth editionNot described
Patients assessed with AMA guide sixth editionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Once at assessment of impairment consultation 1hour

Secondary outcomes (1)
  1. RAND 36

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

    Measured: Once at assessment during impairment consultation for app 1hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2013 (estimated)
  2. Study startDec 2010
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01760551
Sponsor's protocol ID
JR201201
Status last verified
Jan 2013
First submitted
28 Dec 2012
Last updated
4 Jan 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Trauma, run by JointResearch at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fifth or Sixth AMA Guide impairment rating (time frame: Once at assessment of impairment consultation 1hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2013.

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