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.
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
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 group | Role | What they receive |
|---|---|---|
| Patients assessed with AMA guide fifth edition | Not described | |
| Patients assessed with AMA guide sixth edition | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted4 Jan 2013 (estimated)
- Study startDec 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- JointResearch
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University, Onze Lieve Vrouwe Gasthuis
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between the American Medical Association Guides to the Evaluation of Permanent Impairment and the Medical Outcomes Study 36-Item Short Form.
- ClinicalTrials.gov ID
- NCT01760551
- Acronym / sponsor ID
- JR201201
- Conditions
- Trauma
- Keywords
- Fracture, Trauma, impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- JointResearchUniversity, hospital or other
- Collaborators
- McMaster University, Onze Lieve Vrouwe Gasthuis
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 4 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients assessed with AMA guide fifth edition | – | – |
| Patients assessed with AMA guide sixth edition | – | – |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- All subjects who have had a medical legal examination
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
RAND 36
Time frame: Once at assessment during impairment consultation for app 1hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.