Appendix A
ODG Treatment in Workers'
Comp
Methodology Description
using the AGREE Instrument[1]
AGREE stands for "Appraisal of Guidelines Research and Evaluation". It originates from an international collaboration of researchers and policy makers who work together to improve the quality and effectiveness of clinical practice guidelines by establishing a shared framework for their development, reporting and assessment. www.agreecollaboration.org
In mid-2004 the RAND Corporation used the AGREE Instrument to compete the study, "Evaluating Medical Treatment Guideline Sets for Injured Workers in California." This study was prepared for the Commission on Health and Safety and Workers’ Compensation and the Division of Workers’ Compensation, California Department of Industrial Relations, and first published in November 2004. After identifying 73 relevant guidelines, Rand narrowed the list to five guideline sets meeting all the screening criteria, and they performed a detailed technical evaluation using AGREE. The results of this evaluation are reported on page 32 of the study as Table 5.2 (as well as page xx of the Executive Summary as Table S.2)[2] as shown here.
|
Rand Study Table S.2 |
|||||
|
Technical Quality Evaluation AGREE Instrument Results (Standardized Domain
Scores) |
|||||
|
Domain |
AAOS |
ACOEM |
Intracorp |
McKesson |
ODG |
|
Scope & purpose |
1.00 |
0.89 |
0.89 |
1.00 |
1.00 |
|
Stakeholder involvement |
0.54 |
0.79 |
0.79 |
0.88 |
0.79 |
|
Rigor of development |
0.81 |
0.88 |
0.83 |
0.88 |
0.81 |
|
Clarity & presentation |
0.96 |
0.88 |
1.00 |
1.00 |
0.96 |
|
Applicability |
0.17 |
0.33 |
0.33 |
0.61 |
0.72 |
|
Editorial independence |
1.00 |
1.00 |
0.75 |
1.00 |
0.92 |
|
|
|
|
|
|
|
|
Average Rating |
0.75 |
0.80 |
0.77 |
0.90 |
0.87 |
Taking the average rating for each guideline, McKesson was first, ODG was second, ACOEM was third, Intracorp was fourth, and AAOS was fifth. Since this evaluation was based on the first edition of ODG Treatment in Workers’ Comp, the purpose of this document is to provide updated information on ODG according to the AGREE Instrument, using the 2007 edition of ODG Treatment, the fifth edition.
Scope and purpose (items 1-3): The scope and purpose of ODG Treatment in Workers’ Comp (ODG-TWC) is to improve outcomes for any claim that might be seen in a jurisdictional workers’ compensation system. Therefore, critically important to achieving this scope is comprehensiveness. If conditions are missing from a treatment guideline, or treatments are not covered for any condition, there will be uncertainty, and the guideline cannot accomplish its purpose. Delays in treating injured workers or under treatment can result, because providers will not have confidence about reimbursement, and payers may deny necessary care if a treatment is not covered in the guideline. The scope of ODG-TWC is fully comprehensive -- it covers virtually any condition seen in workers’ compensation, as well as any possible treatment for those conditions. Being comprehensive also means covering new technologies as they are introduced, requiring frequent updating. While the overall scope of patients to whom the guideline is meant to apply covers all workers’ comp patients, the focus of the guideline recommendations is on patient selection, i.e., not just whether or not a specific treatment should be approved, but, if it works, what types of patients can it be recommended for.
Stakeholder involvement (items 4-7): The guideline development group includes individuals from all the relevant professional groups (primary care physicians, occupational health specialists, orthopedic surgeons, neurologists, neurosurgeons, physical medicine specialists, physical therapists, chiropractors, radiologists, and others). ODG is independent of any medical specialty group and multidisciplinary in scope, and represents all medical specialties. ODG also strives for patient involvement in the process, and ODG added a Patient Information Resource section in 2006, designed to provide patient education and self care techniques to improve outcomes. Because of the ongoing update process used by ODG, along with ODG’s encouragement of stakeholder suggestions, combined with the widespread use of ODG, ODG receives many editorial suggestions from patient advocacy groups, and these suggestions may prompt additional research into the scientific evidence, and in some cases, updates to the guidelines. This open process is one reason that stakeholders have described ODG as “fair and balanced.” With more editions and more users than any other WC medical treatment guideline, ODG has been well tested. ODG has also been adopted, and is being used successfully, by more states than any other guidelines.
Rigor of development (items 8-14): ODG Treatment in Workers Comp is the most thoroughly developed guideline used in workers’ comp. ODG is unique in taking evidence-based guidelines to their logical end point; the conclusions are linked directly to the evidence in the studies and references. ODG Treatment is based on a comprehensive and ongoing medical literature review with preference given to high-quality systematic reviews, meta-analyses and clinical trials. Each recommendation is linked to a summary of the supporting medical evidence, provided in abstract form, which has been ranked, highlighted and indexed. Full text copies of these studies are used by physician editors in formulating recommendations and are available on request. ODG is continuously updated reflecting the findings of new studies as they are conducted and released; subscribers are always up to date. ODG undergoes a comprehensive annual update process based on scientific medical literature review, survey data analysis and expert panel validation. In addition, as new studies are released, the Web version is updated throughout the year to reflect these new studies. WLDI is in the guideline business, focused on researching and publishing evidence based medical guidelines. As new technologies are introduced, evidence reviews are initiated and new summaries are added to the Procedure Summaries. This also happens when users contact the help desk because they cannot find something, and ODG editors discover that the topic has not been sufficiently covered. In the five years of previous editions of ODG Treatment, there have been a total over 42,000 paid users, far more than any other medical treatment guideline used in workers’ comp, so these users represent a powerful force for suggesting updates.
Clarity and presentation (items 15-18): Ease-of-use and clarity are the hallmark of ODG, and they reduce uncertainty and facilitate early access to treatment for the injured worker. While hard copy books are published each year with each annual edition, ODG is primarily accessed in a user-friendly Web-based version, which users can access from any location with an Internet connection. ODG Treatment is designed to be used for utilization review (UR) as well as clinical practice, so ODG seeks clarity and lack of ambiguity in recommendations, and ODG allows the ability to copy & paste, saving time and effort in documenting approvals or denials of treatment. Entries in the Procedure Summaries always start with the words, “Recommended,” “Not recommended,” or “Under study.” ODG can be integrated into claims management systems. The ODG ICD9-CPT© Crosswalk UR Advisor file contains every possible combination of ICD9 diagnosis code and CPT procedure code seen in workers’ comp. For each ICD9-CPT combination, it provides information on frequency as well as number of visits, plus recommendations from ODG. The file also provides a "Bill Review Payment Flag" which is Green, Yellow, Red, or Black, for use in automating claims management decision-making. The ODG guidelines have integrated both medical treatment guidelines and return-to-work guidelines (also known as lost time guidelines or disability duration guidelines). Treatment and duration guidelines must work together to be effective (timeframes for duration correspond precisely to treatment pathways). There are many specific tools available to help use the guidelines.
Applicability (items 19-21): There is extensive training available so that the guidelines can be applied successfully, and there are tools to monitor and review outcomes compared to the guidelines. There are many training options for ODG customers, including complimentary online demos of ODG Treatment before or after purchase of the product, the ODG Helpdesk for general questions and guidance about the product, several versions of self-paced training online training presentations, and in depth courses offering CME or CE credit. Tools to monitor outcomes include the ODG Crosswalk UR Advisor and the ODG Benchmarking Absence tool. ODG is cost effective for all types of users, and in states that have adopted ODG, users within those states can purchase the guidelines at a 50% discount, bringing the cost down to $162.50. There are also substantial discounts available to organizations with quantity users. In addition, because ODG has been accepted by AHRQ for inclusion in the National Guidelines Clearinghouse, summaries of the guidelines are available at no charge on www.guidelines.gov, and these summaries may be all some users need, including providers doing a limited amount of workers’ comp, as well as small employers and even some injured workers. The goal is for the guidelines to be a communication tool so that all parties are on the same page when it comes to expectations for treatment and return to work. For guidelines to be successful, they need to facilitate early access to appropriate care for the injured worker, when all providers know up-front that they will get paid if they follow the guidelines. ODG has been proven. The 2007 edition of Official Disability Guidelines is the 12th annual edition of these leading return-to-work guidelines, and the 2007 edition of ODG Treatment is the 5th annual edition of those leading treatment guidelines. And studies have shown that outcomes are significantly improved through use of ODG. In fact, one study showed that after adoption of ODG, medical costs were reduced by 64% and lost work days were reduced by 69%, while at the same time injured workers got earlier access to appropriate care and doctors praised the program.
Editorial independence
(items 22-23): ODG is independent of any medical specialty group and
multidisciplinary in scope, and represents all medical specialties, and not
just occupational medicine doctors, orthopaedic surgeons, chiropractors,
physical therapists, etc. ODG has
realized considerable provider acceptance (including adoption by 16 states and
provinces – more than any other guideline) because ODG is evidence based, and
recommendations are linked directly to the most up to date studies; the results
of that research are reflected in the constant updating of the guidelines.
These studies are focused on one outcome: What is best for the injured
worker. WLDI is in the guideline
business, focused on researching and publishing evidence based medical
guidelines. The funding body for ODG Treatment in Workers Comp is the
subscribers who purchase the guideline. With 42,000 paid ODG users from all
types of stakeholders in workers’ comp, this is a diverse group with many
different interests. The employees of WLDI who guide the editorial process are
independent of this funding body, and their overriding objective is to publish
the highest quality guideline, one that is evidence based and defensible before
all of these different interests, as these customers make decisions about which
guideline to purchase or adopt. Ultimately, the recommendations in ODG may not
please each of these subscribers, but they do agree that ODG is fair and
balanced, and accurately summarizes the scientific evidence. ODG has been more
successful in this than any other workers’ compensation medical treatment
guideline, which attests to the editorial independence of ODG. It has proven to
be the only guideline that employers, insurers, providers, and labor can all
get behind and support. The only measure of success for the ODG editors is that
they have created a high quality product that succeeds in the marketplace. This
is in contrast to guidelines produced by special interest groups, such as
insurance companies or medical specialty societies, whose interests go beyond
just sales of the guideline, and whose agenda may be to advance the success of
their own members.
##########################################
Scope and purpose (items 1-3)
1. The overall objective is specifically described.
2. The clinical questions covered by the guidelines are specifically described.
3. The patients
to whom the guideline is meant to apply are specifically described.
Stakeholder involvement (items 4-7)
4. The guideline development group includes individuals from all the relevant professional groups.
5. The patients’ views and preferences have been sought.
6. The target users of the guidelines are clearly defined.
7. The guideline
has been piloted among target users.
Rigor
of development (items 8-14)
8. Systematic methods were used to search for evidence.
9. The criteria for selecting the evidence are clearly described.
10. The methods used for formulating the recommendations are clearly described.
11. The health benefits, side effects, and risks have been considered in formulating the recommendations.
12. There is an explicit link between the recommendations and the supporting evidence.
13. The guideline has been externally reviewed by experts prior to its publication.
14. A
procedure for updating the guideline is provided.
Clarity and presentation (items 15-18)
15. The recommendations are specific and unambiguous.
16. The different options for management of conditions are clearly presented.
17. Key recommendations are easily identifiable.
18. The guideline is supported with tools for application.
Applicability (items 19-21)
19. The potential organizational barriers to applying the recommendations have been discussed.
20. The potential cost implications of applying the recommendations have been considered.
21. Key review criteria are included for monitoring and review purposes.
Editorial independence (items 22-23)
22. The guideline is editorially independent from the funding body.
23. Conflicts of interest of guideline development members have been recorded.
Exhibit A - Background on AGREE
Exhibit B - Thirteen unique and major advantages of ODG
Exhibit C - Procedure Summary/Sample Search Terms Used
Exhibit D - Editorial Advisory Board, ODG/ODG Treatment
Exhibit E - ODG Methodology Outline
Exhibit F - Explanation of Medical
Literature Ratings
##########################################
Summary. The scope and purpose of ODG Treatment in Workers’ Comp (ODG-TWC) is to improve outcomes for any claim that might be seen in a jurisdictional workers’ compensation system. Therefore, critically important to achieving this scope is comprehensiveness. If conditions are missing from a treatment guideline, or treatments are not covered for a condition, there will be uncertainty, and the guideline cannot accomplish its purpose. Delays in treating injured workers or under treatment can result, because providers will not have confidence about reimbursement, and payers may deny necessary care if a treatment is not covered in the guideline. The scope of ODG-TWC is fully comprehensive -- it covers virtually any condition seen in workers’ compensation, as well as any possible treatment for those conditions. See Exhibit B, ODG is comprehensive. Being comprehensive also means covering new technologies as they are introduced, requiring frequent updating. The comprehensiveness of ODG has also been validated by ODG’s national workers’ compensation claims database, representing over 2 million claims, covering almost 50 million paid invoices on medical encounters for those claims. The focus of the guideline recommendations is on patient selection, i.e., not just whether or not a specific treatment should be approved, but, if it works, what types of patients can it be recommended for.
1. The
overall objective is specifically described.
ODG Treatment in Workers’ Comp (ODG-TWC) is designed to help improve outcomes for any claim that might be seen in a jurisdictional workers’ compensation system, and to be comprehensive in doing this so that no diagnoses or treatments are missing. Being comprehensive also means covering new technologies as they are introduced, requiring frequent updating. Specific objectives of ODG Treatment in Workers Comp include the following:
2. The clinical questions covered by the guidelines are specifically described.
ODG Treatment in Workers’ Comp contains 14 core
chapters, broken into three sections each.
In general, the first section,
the Treatment Planning, answers the following major question:
Based on the
characteristics of each case, what is the ideal treatment plan towards
restoration of function that should be followed after injury of… the lower back
(for example)?
Within the
guideline, hundreds of other questions are answered, depending on the nature of
injuries in each chapter. Cases branch
out based on symptoms/signs/tests/demographics.
Below are only a few
examples answered in various stages of the Low Back Treatment Planning:
a. For the first visit, what percentages of cases are likely to see a primary care physician MD/DO, an orthopedist or a chiropractor?
b. For cases with lower back pain, what are the signs of radiculopathy?
c. For cases with radiculopathy, under what circumstances is an epidural steroid injection (ESI) considered? What are the risks or side effects, if any, of ESI’s? Would a 2nd ESI ever be considered? What would be the maximum allowable ESI’s? What is the benchmark cost of an ESI?
d. Under what circumstances is surgery appropriate? What procedure(s) are recommended for candidates for surgery? What are the inherent risks?
e. What is the expected length of disability following each procedure? What activity modifications are appropriate in the early stages of recovery?
f. What are the recommended frequency and duration of chiropractic care?
The second section
in each chapter, Codes for Auto-Approval, maps CPT codes to ICD9 codes based on
the Treatment Plan, with a field for “Maximum Occurrences”, for auto-approval
of universally supported treatment methods, to answer questions for utilization
management: What CPT procedure codes are recommended/allowed for each
diagnosis, and how many occurrences?
The third section in
each chapter, the Procedure Summary, lists all the potential therapies for each
condition and provides summaries of their effectiveness based on existing
medical evidence. The recommendations
are linked to summaries of the supporting studies in abstract form.
The Procedure Summaries were developed to answer the questions: What proven efficacy, if any, does each treatment method have for each condition, and what potential risks or side effects exist? Are there patient selection criteria that should be met? There may be hundreds listed in the Procedure Summary of each chapter. For a sample from the Low Back chapter, see Exhibit C.
3. The
patients to whom the guideline is meant to apply are specifically described.
As implied by its name, ODG Treatment in Workers Comp is designed to apply to patients ill or injured while on the job. Essentially, these are working-age adults (18-65) of both genders stricken with conditions commonly associated with occupation, including musculoskeletal and other disorders. Core chapters currently include Ankle/Foot, Burns, Carpal Tunnel Syndrome, Elbow, Eye, Fitness for Duty, Forearm/Wrist/Hand, Head, Hernia, Hip, Knee, Low Back, Neck, Pain, Shoulder and Stress/Mental. Impairment Guides are also provided in ODG Treatment in Workers Comp from the International Association of Industrial Accident Boards and Commissions (IAIABC). Within the Procedure Summaries, there are often specific Patient Selection Criteria that may be highlighted in blue, where the scientific evidence shows that a treatment may work on some patients and not others. For example, for knee meniscus tears, ODG says, “Patient selection criteria: Patients younger than 35 with clear evidence of a meniscus tear may benefit from arthroscopic partial meniscectomy or arthroscopic meniscal repair. For older patients with degenerative tears, possibly indicating osteoarthritis, surgery may not be as beneficial.” http://www.odg-twc.com/odgtwc/knee.htm#Codes Here is another example, for Low Back Physical Therapy, “Patient Selection Criteria: Multiple studies have shown that patients with a high level of fear-avoidance do much better in a supervised physical therapy exercise program, and patients with low fear-avoidance do better following a self-directed exercise program. When using the Fear-Avoidance Beliefs Questionnaire (FABQ), scores greater than 34 predicted success with PT supervised care.” http://www.odg-twc.com/odgtwc/low_back.htm#Physicaltherapy
Stakeholder involvement (items 4-7)
Summary. The guideline development group includes individuals from all the relevant professional groups (primary care physicians, occupational health specialists, orthopedic surgeons, neurologists, neurosurgeons, physical medicine specialists, physical therapists, chiropractors, radiologists, and others). ODG is independent of any medical specialty group and multidisciplinary in scope, and represents all medical specialties, and not just occupational medicine doctors, orthopaedic surgeons, chiropractors, physical therapists, etc. ODG has realized considerable provider acceptance (including adoption by 16 states and provinces – more than any other guideline) because ODG is evidence based, and recommendations are linked directly to the most up to date studies; the results of that research are reflected in the constant updating of the guidelines. These studies are focused on one outcome: What is best for the injured worker. Unlike medical specialty society guidelines, ODG does not represent the interests of any one provider-group over other providers. ODG is serious about patient involvement in the process. ODG now has a Patient Information Resource appendix, designed to provide patient education and self care techniques to improve outcomes. Because of the ongoing update process used by ODG, along with ODG’s encouragement of stakeholder suggestions, combined with the widespread use of ODG, ODG receives many editorial suggestions from patient advocacy groups. These suggestions may prompt additional research into the scientific evidence, and in some cases, updates to the guidelines. This open process is one reason that stakeholders have described ODG as “fair and balanced.” With more editions and more users than any other WC medical treatment guideline, ODG has been well tested. ODG has also been adopted, and is being used successfully, by more states than any other guidelines.
4. The
guideline development group includes individuals from all the relevant professional
groups.
The guideline development group includes individuals from all the relevant professional groups (primary care physicians, occupational health specialists, orthopedic surgeons, neurologists, neurosurgeons, physical medicine specialists, physical therapists, chiropractors, radiologists, and others). ODG is independent of any medical specialty group and multidisciplinary in scope, and represents all medical specialties, and not just occupational medicine doctors, orthopaedic surgeons, chiropractors, physical therapists, etc. Unlike medical specialty society guidelines, ODG does not represent the interests of any one provider-group over other providers. See Exhibit D, the ODG Treatment in Workers Comp Editorial Advisory Board.
Editor-in-Chief, Philip L. Denniston, Jr. and Senior Medical Editor, Charles W. Kennedy, MD, together pilot the group of approximately 80 members. Senior Chiropractic Editor is Preston B. Fitzgerald, DC CDE CICE CIFCME (President, National Board of Forensic Chiropractors) and Senior Physical Therapy Editor is Stuart H. Platt, MSPT, PT (Principal, Appropriate Utilization Group). Research analysts and medical editorial assistants are on staff at WLDI.
o
Medical Device Register (MDR) – an annually
updated directory of hospital equipment and supplies first published in 1981
and acquired by Thomson
Corporation in 1985, along with Distributor
Profiles, Product SOS, and Homecare
Product Directory, also created by Phil. While under contract with Thomson, the Directory of Hospital Personnel and the HMO/PPO Directory were developed. Phil later became CEO of Medical Economics Data with
responsibility for the Physicians’
Desk Reference (PDR) and
American Health Consultants, publisher of Occupational Health Management, Case Management Advisor, Disease State
Management, Home Care Case Management, Employee Health & Fitness, and
Hospital Case Management.
o
Physicians’ GenRx –
a complete annual reference on branded and generic prescription drugs used by
physicians and pharmacists to determine when generic substitution is
appropriate and when it is not. With
the GenRx database, Phil later became charter provider to Physicians’ Online. Physicians’
GenRx was acquired by Mosby-YearBook (now part of Harcourt Brace) in
1994.
Due largely to a reputation for evidence-based medicine instilled under the direction of Philip Denniston, Work Loss Data Institute was selected by the American College of Occupational and Environmental Medicine (ACOEM) as the medical library research contractor in the development of the second edition of the ACOEM Occupational Medicine Practice Guidelines. Work Loss Data Institute has also recently been chosen by the Council on Chiropractic Guidelines and Practice Parameters (CCGPP) to lead research and development for an evidence-based guideline for chiropractic professional care, which is scheduled for completion and publication by Work Loss Data Institute in conjunction with CCGPP in 2005.
Charles W. Kennedy, MD, Senior Medical Editor, has been extensively involved in the workers’ compensation process and involved with the development of guidelines by the American Academy of Orthopaedic Surgeons (AAOS) for the spine and lower extremities. He was on the Guidelines Development Committee for the American Academy of Orthopaedic Surgeons and also the Task Force for Disability Testing Phase 1 of the Spine Treatment Guidelines for the American Academy of Orthopaedic Surgery. He is a founding member of the Evidence Analysis Committee for AAOS. He was past Board of Counselor member of the American Academy of Orthopaedic Surgery and is a current member of the Complementary and Alternative medicine Committee of the American Academy of Orthopaedic Surgery.
Dr. Kennedy was the original co-chairman of the Designated Doctor training as taught by the American Academy of Disability Evaluating Physicians and has been a frequent lecturer on disability issues. He is on the Board of Directors of the American Academy of Disability Evaluating physicians.
Dr. Kennedy has been
either chairman or co-chairman of the Texas Orthopaedic Workers’ Compensation
Committee for a ten-year period. He was
the original alternate physician for the Medical Advisory Committee to the
Texas Workers’ Compensation Commission.
He was also on the Task Force for the Spine Treatment Guideline
development for the Texas Workers’ Compensation Commission. He is a former president of the Texas
Orthopaedic Association.
Currently, Dr. Kennedy is a frequent lecturer
to case managers and other physicians on workers’ compensation issues. His orthopedic practice now specializes in
the integrative medicine approach to treatment of industrial problems. He serves as President of the Disability
Evaluating Center of Texas and has been active in disability evaluation over the
last ten years.
5. The
patients’ views and preferences have been sought.
Patient satisfaction is one of many outcomes considered. The studies considered in ODG are focused on one primary outcome, whether or not the treatment under consideration helped the patient get better.
In addition, a new “Patient Information Resources” section was added in 2006 to Official Disability Guidelines Treatment in Workers’ Comp. This enhancement to ODG contains prescreened links to credible patient-friendly treatment resources available on the Web. Patient Information is provided for all workers’ comp conditions including those pertaining to Ankle & Foot, Burns, Carpal Tunnel Syndrome, Elbow, Eye, Forearm, Wrist, & Hand, Head, Hernia, Hip & Pelvis, Knee & Leg, Low Back, Neck & Upper Back, Pain, Shoulder and Stress/Mental.
The links are followed by a short description or excerpt from each of the website’s contents so, without having to filter through hundreds of online and hardcopy resources, healthcare providers can quickly provide their patient with a personal aid to recovery by printing the list of selected links or clicking on the links and printing the most relevant pages within the selected websites. ODG’s Patient Information Resources section efficiently connects the patient and provider to pertinent information such as a basic understanding of the injury, self-help methods for speeding recovery and suggested therapies for regaining functionality and productivity.
The Patient Information Resource appendix is designed to provide patient education and self care techniques to improve outcomes. ODG Senior Medical Editor, Dr. Charles W. Kennedy, initiated the idea behind this section. According to Dr. Kennedy, “Blending the principals of holistic medicine which recognize and encourage an individual’s responsibility for his own well-being with the latest evidence-based treatment protocols creates an ideal environment for maximum healing and preventive care.”
The Patient Information Resources appendix also includes ODG’s disability duration guidelines for common conditions. It is part of WLDI’s philosophy that the educated patient, who is made aware of the best practices for treatment and disability duration through effective communication with his or her provider, will be more likely to return to work sooner and in better health.
This section enables the treating physician to conveniently empower their patients with relevant and targeted recovery information from some of the finest resources available. Patient education links referenced include the National Library of Medicine, the American Association of Family Physicians, the Mayo Clinic and the American Association of Orthopaedic Surgeons, and others.
The new appendix, entitled “Appendix B, Patient Information Resources,” is available to online subscribers of ODG Treatment in Workers’ Comp and was also included in the hard-copy book beginning with the 2007 edition.
ODG is serious about patient involvement in the process. Because of the ongoing update process used by ODG, along with ODG’s encouragement of stakeholder suggestions, combined with the widespread use of ODG, ODG receives many editorial suggestions from patient advocacy groups. These suggestions may prompt additional research into the scientific evidence, and in some cases, updates to the guidelines. This open process is one reason that stakeholders have described ODG as “fair and balanced.”
6. The target users of the guidelines are clearly defined.
As indicated in the first chapter, Background and Description,
ODG Treatment in Workers Comp is designed
for use by independent treating physicians, allied healthcare providers,
insurance claims professionals, nurse case managers, state and federal workers’
comp authorities, and employer representatives. Without any specific affiliation, Work Loss Data Institute is
unique in its ability to bridge the interests of the many professional groups
involved in diagnosing and treating the various conditions associated with
workers’ compensation.
7. The
guideline has been piloted among target users.
Draft editions of ODG Treatment in Workers Comp have been released to clients of Work Loss Data Institute from each of the above groups for testing and response prior to publication.
The 2008 edition of ODG Treatment in Workers Comp will be the 6th annual edition, and draft copies of this edition have already been circulated to members of the ODG Editorial Advisory Board. See Exhibit D.
In addition, in the five years of previous editions of ODG Treatment, there have been a total over 42,000 paid users, far more than any other medical treatment guideline used in workers’ comp, so ODG Treatment in Workers Comp has clearly stood the test of time. With more editions and more users than any other WC medical treatment guideline, ODG has been well tested. ODG has also been adopted, and is being used successfully, by more states than any other guidelines.
Rigor of development (items 8-14)
Summary: ODG Treatment in Workers Comp is the most thoroughly developed guideline used in workers’ comp. ODG is unique in taking evidence-based guidelines to their logical end point; the conclusions are linked directly to the evidence in the studies and references. ODG Treatment is based on a comprehensive and ongoing medical literature review with preference given to high-quality systematic reviews, meta-analyses and clinical trials. Each recommendation is linked to a summary of the supporting medical evidence, provided in abstract form, which has been ranked, highlighted and indexed. Full text copies of these studies are used by physician editors in formulating recommendations and are available on request. ODG is continuously updated reflecting the findings of new studies as they are conducted and released; subscribers are always up to date. ODG undergoes a comprehensive annual update process based on scientific medical literature review, survey data analysis and expert panel validation. In addition, as new studies are released, the Web version is updated throughout the year to reflect these new studies. WLDI is in the guideline business, focused on researching and publishing evidence based medical guidelines. As new technologies are introduced, evidence reviews are initiated and new summaries are added to the Procedure Summaries. This also happens when users contact the help desk because they cannot find something, and ODG editors discover that the topic has not been sufficiently covered. In the five years of previous editions of ODG Treatment, there have been a total over 42,000 paid users, far more than any other medical treatment guideline used in workers’ comp, so these users represent a powerful force for suggesting updates.
8.
Systematic methods were used to search for evidence.
As indicated in the first chapter in ODG Treatment in Workers’ Comp, Background & Description http://www.odg-disability.com/ODG Treatment in Workers.htm, Work Loss Data Institute conducted a comprehensive medical literature review (now ongoing) with preference given to high quality systematic reviews, meta-analyses, and clinical trials published since 1993, plus existing nationally recognized treatment guidelines from the leading specialty societies. WLDI primarily searched MEDLINE and the Cochrane Library. In addition, WLDI also reviewed other relevant treatment guidelines, including those in the National Guideline Clearinghouse, as well as state guidelines and proprietary guidelines maintained in the WLDI guideline library. These guidelines were also used to suggest references or search terms that may otherwise have been missed. In addition, Work Loss Data Institute also searched other databases, including MD Consult, eMedicine, CINAHL, and conference proceedings in occupational health (i.e. ACOEM) and disability evaluation (i.e. AADEP, ABIME). Search terms and questions were diagnosis, treatment, symptom, sign, and/or body-part driven, generated based on new or previously indexed existing evidence, treatment parameters and experience.
In searching the medical literature, answers to the
following questions were sought: (1) If
the diagnostic criteria for a given condition have changed since 1993, what are
the new diagnostic criteria? (2) What
occupational exposures or activities are associated causally with the
condition? (3) What are the most
effective methods and approaches for the early identification and diagnosis of
the condition? (4) What historical
information, clinical examination findings or ancillary test results (such as
laboratory or x-ray studies) are of value in determining whether a condition
was caused by the patient’s employment?
(5) What are the most effective methods and approaches for treating the
condition? (6) What are the specific
indications, if any, for surgery as a means of treating the condition? (7) What are the relative benefits and harms
of the various surgical and non-surgical interventions that may be used to
treat the condition? (8) What is the
relationship, if any, between a patient’s age, gender, socioeconomic status
and/or racial or ethnic grouping and specific treatment outcomes for the
condition? (9) What instruments or
techniques, if any, accurately assess functional limitations in an individual
with the condition? (10) What is the
natural history of the disorder? (11)
Prior to treatment, what are the typical functional limitations for an
individual with the condition?
(12) Following treatment, what
are the typical functional limitations for an individual with the
condition? (13) Following treatment,
what are the most cost-effective methods for preventing the recurrence of signs
or symptoms of the condition, and how does this vary depending upon
patient-specific matters such as underlying health problems? Chapter-specific reference lists are found
within ODG Treatment in Workers Comp.
9. The
criteria for selecting the evidence are clearly described.
As indicated in Exhibit E, ODG Methodology Outline, and Exhibit F, Explanation of Medical Literature Ratings:
Preference was given to evidence that met the following criteria: (1) The article was written in the English language, and the article had any of the following attributes: (2) It was a systematic review of the relevant medical literature, or (3) The article reported a controlled trial – randomized or controlled, or (4) The article reports a cohort study, whether prospective or retrospective, or (5) The article reports a case control series involving at least 25 subjects, in which the assessment of outcome was determined by a person or entity independent from the persons or institution that performed the intervention the outcome of which is being assessed.
Especially when articles on a specific topic that met the
above criteria were limited in number and quality, Work Loss Data Institute
also reviewed other articles that did not meet the above criteria, but all
evidence was ranked alphanumerically using the methodology in Explanation of Medical
Literature Ratings (and found in second chapter of ODG Treatment) so
that the quality of evidence could be clearly weighted and taken into
consideration when formulating recommendations. This ranking used an alphanumeric rating system ranging from 1a
to 10c, based on Ranking by Type of Evidence (1. Systematic
Review/Meta-Analysis, 2. Controlled Trial – Randomized (RCT) or Controlled, 3.
Cohort Study - Prospective or Retrospective, 4. Case Series, 5. Unstructured
Review, 6. Nationally Recognized Treatment Guideline (from guidelines.gov), 7.
State Treatment Guideline, 8. Other Treatment Guideline, 9. Textbook, 10.
Conference Proceedings/Presentation Slides), and Ranking by Quality within Type
of Evidence (a. High Quality, b. Medium Quality, or c. Low Quality, as defined
in Ranking by Quality).
WLDI reviewed each article that was relevant to answering the question at issue, with priority given to those that met the following criteria: (1) The article was written in the English language, and the article had any of the following attributes: (2) It was a systematic review of the relevant medical literature, or (3) The article reported a controlled trial – randomized or controlled, or (4) The article reported a cohort study, whether prospective or retrospective, or (5) The article reported a case control series involving at least 10 subjects, in which the assessment of outcome was determined by a person or entity independent from the persons or institution that performed the intervention the outcome of which is being assessed.
Especially when articles on a specific topic that met the
above criteria were limited in number and quality, WLDI also reviewed other
articles that did not meet the above criteria, but all the evidence provided
was ranked using the methodology described above, so that the quality of
evidence could be clearly determined when making decisions about what to recommend
in the Guidelines. Articles with a
Ranking by Type of Evidence of (11) Case Reports and Case Series were not used
in the evidence base for the Guidelines.
These articles were not included because of their low quality (i.e.,
they tend to be anecdotal descriptions of what happened with no attempt to
control for variables that might effect outcome). Not all the evidence provided by WLDI was eventually listed in
the bibliography of the published Guidelines.
Only the higher quality references were listed. The criteria for inclusion was a final
ranking of 1a to 4b (the original inclusion criteria suggested the methodology
subgroup), or if the Ranking by Type of Evidence was 5 to 10, the quality
ranking should be an “a”.
Chapter-specific reference lists are found within ODG Treatment in
Workers Comp.
10. The
methods used for formulating the recommendations are clearly described.
As indicated in Exhibit E, ODG Methodology Outline, and in Exhibit F, Explanation of Medical Literature Ratings:
Link between evidence and
recommendations:
o
ODG
Treatment in Workers' Comp
is being updated monthly on the Web.
From the Contents page the last date updated for each chapter is
identified. There is a hard copy
version once a year, but this is not recommended since it does not link into
the actual studies, and it is not current.
o
The heart of
each chapter in ODG Treatment in Workers' Comp is the "Procedure
Summary", which provides a summary of effectiveness, if any, based on
existing medical evidence, hyper-linked directly into the studies on which they
are based, in abstract form, which have been ranked, highlighted and
indexed. The "Treatment
Protocol" identifies the ideal treatment pathway that should be followed,
based on the "Procedure Summary".
"Codes for Automated-Approval" links CPT procedure codes to
ICD-9 diagnosis codes based on the ideal treatment protocol, with a field for
“maximum occurrences”, for auto-approval of charges that meet the guideline.
o
For example, in
the Low Back chapter, under Fusion, it says, "There is no good evidence
from controlled trials that spinal fusion is effective for treatment of any
type of low back problem, in the absence of spinal fracture or dislocation, or
spondylolisthesis...” so the Treatment Protocol does not include fusion. Same for IDET, facet injections, etc.,
etc. Under Epidural injections, it
says, "Although epidural injections of steroids may afford short-term
improvement in leg pain and sensory deficits in patients with sciatica due to a
herniated nucleus pulposus, this treatment offers no significant long-term
functional benefit, and the number of injections should be limited to
two", so the Treatment Protocol for "With Radiculopathy"
includes 2 ESIs, and the Codes for Auto Approval includes CPT code 62311
(Epidural steroid injection) 2 times for ICD9 722.x (Intervertebral disc
disorders), but not for ICD9 847.2 (Lumbar sprain).
o
This effort to
translate the evidence into specific auto-authorization protocols is unique,
for pre-approval of treatment plans and triage of claims management. Of course, most cases will not meet this
ideal protocol, and that is where the many other listings in the Procedure
Summary come into play.
Link between evidence and
recommendations:
The heart of each
chapter in ODG Treatment in Workers Comp is the Procedure Summary, which
provides a concise synopsis of effectiveness, if any, of each treatment method
based on existing medical evidence.
Each summary and subsequent recommendation is hyper-linked into the
studies on which they are based, in abstract form, which have been ranked,
highlighted and indexed. The Treatment
Protocol identifies the ideal utilization plans that should be followed after
illness or injury, based on the recommendations in the Procedure Summary. Codes for Automated-Approval map CPT codes
to ICD-9 codes based on the Treatment Protocol, with a field for “maximum
occurrences”, for auto-approval of charges that meet the guideline.
For example, the Low
Back chapter Procedure Summary indicates there is no good evidence that spinal
fusion is effective for the treatment of any type of low back problem in the
absence of spinal fracture, dislocation, or spondylolisthesis. Fusion for general back pain or
degenerative disc disease seldom cures the patient, and there is significant
risk, including a 17% complication rate. This summary is linked to about ten
supporting studies, in abstract form, which can be consulted by end-users. As a result of this evidence, fusion is not
recommended in the Low Back Treatment Protocol. The same can be said for IDET, facet injections, etc. Under epidural injections, on the other
hand, the Procedure Summary indicates that although epidural injections of
steroids may afford short-term improvement in leg pain and sensory deficits in
patients with sciatica due to a herniated nucleus pulposus, this treatment
offers no significant long-term functional benefit and the number of injections
should be limited to two. This summary
is linked to five supporting studies, in abstract form, which can be consulted
and quoted by end-users, if desired. As
a result of the evidence, the Low Back Treatment Protocol includes up to 2
ESI's for cases with radiculopathy (to reduce pain and inflammation,
restoring range of motion and thereby facilitating progress in more active
treatment programs), and Codes for
Auto-Approval include CPT code 62311 (ESI) up to 2 times for ICD9 722.x
(intervertebral disc disorders).
This process to
translate the evidence into specific auto-authorization protocols is unique,
for pre-approval of treatment plans and triage of utilization management. Of course, for those treatments that do not
meet the recommended Treatment Protocol, the Procedure Summary lists all
potential therapies and indicates a summary as to their effectiveness, as well
as why they may not be recommended based on the evidence. While there are some physical medicine
modalities for which adequate trials are scarce, as a general rule, they should
be avoided entirely when significant risk exists, and otherwise, it
would not be advisable to use these modalities beyond 2-3 weeks if signs of
objective progress towards functional restoration are not demonstrated. Each is identified as such in the Procedure
Summaries within ODG Treatment in Workers Comp.
11. The
health benefits, side effects, and risks have been considered in formulating
the recommendations.
Many outcomes are considered, including health benefits (long and short term), side effects and risks. For example, for cases with intervertebral disc disorders, epidural steroid injections are shown to provide short-term improvement in leg pain and sensory deficits. However, these injections offer no significant long-term functional benefit. Therefore, the number of injections should be limited to two, used to reduce pain and inflammation, restore range of motion and thereby facilitate progress in more active treatment programs (with long-term functional benefit).
Each treatment is summarized with respect to health benefits, side effects and risks, within the Procedure Summary of each chapter in ODG Treatment in Workers Comp. Restoration of function is a driving force for many recommendations, because as the evidence indicates, it is associated with pain relief, health benefits, quality of life, patient satisfaction and limited risk. When formulating treatment recommendations, side effects and risks are balanced against the potential benefits, and the strength of evidence supporting those benefits. An intervention that is invasive, with high risks, would require stronger evidence for a recommendation than a relatively conservative, low-cost intervention.
12. There
is an explicit link between the recommendations and the supporting
evidence.
Within the Procedure Summary for each chapter in ODG Treatment in Workers Comp, each summary of the medical evidence and subsequent recommendation provides a list of references that are hyper-linked to the supporting studies, provided in abstract form. These studies can be consulted and quoted (copy/paste) by end-users at the click of a mouse, and have been ranked, highlighted and indexed by Work Loss Data Institute. The Procedure Summaries are the bulk of the text and the driving force behind all recommendations in ODG Treatment in Workers Comp.
There is an explicit link between the recommendations and the supporting evidence, which is actually summarized in abstract form, so that users can quote it specifically, if desired.
13. The
guideline has been externally reviewed by experts prior to its publication.
Prior to publication, select organizations and individuals making up a cross-section of medical specialties and typical end-users externally reviewed ODG Treatment in Workers Comp. See Exhibit E, ODG Methodology Outline. Complimentary review access is also made available to all major medical specialty groups as well as other stakeholders. Among those groups providing feedback are American Academy of Disability Evaluating Physicians, American Academy of Neurology, American Association of Occupational Health Nurses, American Academy of Orthopaedic Surgeons, American Academy of Pain Medicine, American Academy of Physical Medicine and Rehabilitation, American Association of Neurological Surgeons, American Board of Independent Medical Examiners, American Chiropractic Association, American College of Radiology, American Federation of Labor and Congress of Industrial Organizations, American Pain Society, American Physical Therapy Association, American Society of Anesthesiologists, American Society of Interventional Pain Physicians, California Guidelines Evaluation Committee, California Society of Industrial Medicine and Surgery, Canadian Chiropractic Association, Congress of Neurological Surgeons, Council of Acupuncture and Oriental Medicine Associations, Council on Chiropractic Guidelines and Practice Parameters, Department of Defense, Insurance Council of Texas, Kaiser Permanente, North American Neuromodulation Society, North American Spine Society, Reflex Sympathetic Dystrophy Syndrome Association, Texas Medical Association, & Texas Orthopedic Association.
14. A procedure for updating the
guideline is provided.
The Official Disability Guidelines product line, including ODG Treatment in Workers Comp, is updated annually, as it has been since the first release in 1996. The comprehensive update process is literally in continuous operation with annual publication of new editions. This process includes an ongoing literature search of peer-reviewed medical studies and marked input from the ODG Editorial Advisory Board. New data is also received each year from alliances with the CDC National Health Interview Survey and BLS/OSHA Survey of Occupational Injuries and Illnesses. The compilation is analyzed to understand the effectiveness (outcome-based), risks, and cost-benefits of potential existing and emerging therapies for work-related conditions, as well as trends in length of disability and return-to-work, including vocational rehabilitation and modified duty. Work Loss Data Institute would be happy to investigate and respond to any formal comment from specialty societies or other vested interests during each update year.
Ongoing Updates
The literature search is repeated for every chapter of ODG Treatment at least every six months, and for major chapters at least quarterly. As new technologies are introduced, evidence reviews are initiated and new summaries are added to the Procedure Summaries. This also happens when users contact the help desk because they cannot find something, and ODG editors discover that the topic has not been sufficiently covered. In the five years of previous editions of ODG Treatment, there have been a total over 42,000 paid users, far more than any other medical treatment guideline used in workers’ comp, so these users represent a powerful force for suggesting updates.
Clarity and presentation (items 15-18)
Summary: Ease-of-use and clarity are the hallmark of ODG, and they reduce uncertainty and facilitate early access to treatment for the injured worker. While hard copy books are published each year with each annual edition, ODG is primarily accessed in a user-friendly Web-based version, which users can access from any location with an Internet connection. ODG Treatment is designed to be used for utilization review (UR) as well as clinical practice, so ODG seeks clarity and lack of ambiguity in recommendations, and ODG allows the ability to copy & paste, saving time and effort in documenting approvals or denials of treatment. Entries in the Procedure Summaries always start with the words, “Recommended,” “Not recommended,” or “Under study.” ODG can be integrated into claims management systems. The ODG ICD9-CPT© Crosswalk UR Advisor file contains every possible combination of ICD9 diagnosis code and CPT procedure code seen in workers’ comp. For each ICD9-CPT combination, it provides information on frequency as well as number of visits, plus recommendations from ODG. The file also provides a "Bill Review Payment Flag" which is Green, Yellow, Red, or Black, for use in automating claims management decision-making. The ODG guidelines have integrated both medical treatment guidelines and return-to-work guidelines (also known as lost time guidelines or disability duration guidelines). Treatment and duration guidelines must work together to be effective (timeframes for duration correspond precisely to treatment pathways). There are many specific tools available to help use the guidelines.
15. The
recommendations are specific and unambiguous.
Ease-of-use and clarity are the hallmark of ODG, and they reduce uncertainty and facilitate early access to treatment for the injured worker. ODG is not written like a medical textbook, which may be vague in its recommendations, and may also suffer from conflicting recommendations in different sections written by different authors.
As indicated in the first chapter in ODG Treatment in Workers’ Comp, Background & Description http://www.odg-disability.com/ODG Treatment in Workers.htm:
The Procedure Summary is the most important section in ODG Treatment, and the first two sections, the Treatment Planning and the Codes for Automated Approval, are based on the conclusions from the evidence in the Procedure Summary. Many cases may involve a procedure that is not covered in the Treatment Planning, so then the Procedure Summary is used to help evaluate whether that procedure is appropriate. This section lists all possible therapies and diagnostic methods, as well as other issues that apply for each condition, and provides a summary of the latest evidence from the highest quality medical studies, beginning with the words “Recommended”, “Not recommended”, or “Under study”. The studies providing this evidence are referenced and hyper linked so that they can be consulted directly, and if necessary, copied and pasted into a claims report or a patient record, or even shared with the patient in some cases. For each condition, there may be as many as 200 separate listings covered in this fashion. Many of these procedures are being performed regularly, but are not supported by the quality medical evidence as summarized in this guideline, and in some cases, are proven to be harmful. On the other hand, there are some therapies that are not well known, but which may have excellent outcomes. When patient selection is important to the success of a procedure, the criteria for patient selection is also outlined, and the appropriate study is referenced.
16. The
different options for management of conditions are clearly presented.
For each condition in the Treatment Planning section, specific pathways are identified that each treatment plan should focus on. Emphasis is given to key determinants that distinguish how to handle a case. For example, with low back problems this may be the presence of radiculopathy, or for carpal tunnel syndrome it may be severity and electrodiagnostic confirmation of the condition. The treatment protocols also identify the percent of cases following different pathways, along with benchmark costs, as well as the expected disability durations from Official Disability Guidelines. Since these treatment protocols focus on the most common treatment pathways, they are not meant to apply to every case. There are many other types of treatments that may be appropriate, and the Procedure Summary contains a list of all of them.
In the Procedure Summary for each chapter, there may be over 200 entries for different treatment options. Many of these therapies are recommended and many are not, but there is not any one approach that is right for every patient. Providers and patients can select from a comprehensive list depending on provider experience and patient preferences.
ODG is also unique in providing extensive guidelines for all of the specific pharmaceuticals that may be used in workers’ comp. These guidelines appear in each appropriate chapter, but there is an extensive listing in the Pain Chapter.
17. Key
recommendations are easily identifiable.
Every therapy is listed alphabetically, with cross references for alternative descriptions. Entries in the Procedure Summaries always start with the words, “Recommended,” “Not recommended,” or “Under study.” In addition, whenever there is confusion about the description of a diagnosis or procedure, the Crosswalk UR Advisor can be used. Every medical bill must have a CPT Procedure Code along with an ICD9 diagnosis code. The ODG ICD9-CPT© Crosswalk UR Advisor file contains every possible combination of ICD9 diagnosis code and CPT procedure code seen in workers’ comp. For each ICD9-CPT combination, it provides recommendations from ODG. Whenever there is uncertainty about the recommendation for a specific treatment, all the user needs to find the recommendation is a CPT Procedure Code along with an ICD9 diagnosis code. These codes would be available because they would also be required for reimbursement.
18. The
guideline is supported with tools for application.
While hard copy books are published each year with each annual edition, ODG is primarily accessed in a user-friendly Web-based version, which users can access from any location with an Internet connection. ODG allows the ability to copy & paste, saving time and effort in documenting approvals or denials of treatment. ODG can also be integrated into claims management systems. The ODG ICD9-CPT© Crosswalk UR Advisor file contains every possible combination of ICD9 diagnosis code and CPT procedure code seen in workers’ comp. For each ICD9-CPT combination, it provides information on frequency as well as number of visits, plus recommendations from ODG. The file also provides a "Bill Review Payment Flag" which is Green, Yellow, Red, or Black, for use in automating claims management decision-making. Major claims management software vendors have already integrated ODG. See a description of offerings from American Technical Services, EnableComp, Insurity, McKesson Health Solutions, Medgate, MECC, & Unique Software Solutions, at http://www.odg-disability.com/casemanagement.htm. ODG also provides standard benchmarking tools to measure compliance with the guideline. Some of these are explained the AAOHN Journal, in the Feature Article (offering CE Credit), "Benchmarking Medical Absence: Measuring the Impact of Occupational Health Nursing". http://www.odg-disability.com/benchmarking_lost_time.htm Tools are also available to use ODG along with provider profiling, and “pay for performance” programs.
Summary: ODG support is provided so that the guidelines can be applied successfully. There are many training options for ODG customers: (1) Telephone Demo: WLDI staff are happy to conduct a complimentary online demo of ODG Treatment before or after purchase of the product; (2) ODG Helpdesk: The helpdesk is always open for general questions and guidance about the product, by calling 1-800-488-5548 or e-mailing odg@worklossdata.com with any questions; (3) Self-paced training: Depending on how much time is available, there are a few versions of ODG self-training tools, including an online self-paced interactive training demo of ODG Treatment in a Microsoft PowerPoint® presentation, requiring up to one hour to complete, an abbreviated ODG training demo narrative in the MP3 format lasting about thirty minutes, and a short 15-minute overview of ODG in a Microsoft PowerPoint® presentation. (4) In depth courses: Courses in how to apply the guidelines, using case studies, are offered by specialized training organizations that are independent of WLDI, and completion of these courses may result in CME or CE credit. WLDI recommends the courses offered by AADEP. For information on their courses, go to www.aadep.org, or call AADEP at 800-456-6095. In addition, for Texans, the Texas Medical Association offers many courses throughout Texas; go to www.texmed.org or call TMA at 800-880-1300. http://www.worklossdata.com/odgtraining.htm
ODG is cost effective for all types of users, and in states that have adopted ODG, users within those states can purchase the guidelines at a 50% discount, bringing the cost down to $162.50. There are also substantial discounts available to organizations with quantity users. In addition, because ODG has been accepted by AHRQ for inclusion in the National Guidelines Clearinghouse, summaries of the guidelines are available at no charge on www.guidelines.gov, and these summaries may be all some users need, including providers doing a limited amount of workers’ comp, as well as small employers and even some injured workers. The goal is for the guidelines to be a communication tool so that all parties are on the same page when it comes to expectations for treatment and return to work. For guidelines to be successful, they need to facilitate early access to appropriate care for the injured worker, when all providers know up-front that they will get paid if they follow the guidelines.
ODG has been proven. The 2007 edition of Official Disability Guidelines is the 12th annual edition of these leading return-to-work guidelines, and the 2007 edition of ODG Treatment is the 5th annual edition of those leading treatment guidelines. While other publishers may promise better guidelines in the future, ODG keeps delivering. And studies have shown that outcomes are significantly improved through use of ODG. In fact, one study showed that after adoption of ODG, medical costs were reduced by 64% and lost work days were reduced by 69%, while at the same time injured workers got earlier access to appropriate care and doctors praised the program.
19. The
potential organizational barriers to applying the recommendations have been
discussed.
Depending on the organization in question, potential barriers may exist. For example, if an organization were performing unnecessary spinal fusions on a regular basis, ODG Treatment in Workers Comp would not authorize this activity. In general though, this would not be considered a barrier for the State, but an opportunity to create order, improve outcomes, reduce risk and cut costs in medical benefit delivery in the California workers’ compensation system.
The recommendations in ODG Treatment in Workers Comp are clear, including frequency and duration parameters for physical therapy or chiropractic care, and each recommendation is linked explicitly to the evidence on which it is based; so organizational barriers should be limited.
20. The
potential cost implications of applying the recommendations have been
considered.
Given the current state of medical benefit delivery in workers’ compensation systems, including what is often described as excessive utilization of medical services, there are no specific additional cost implications or resources required to apply the recommendations.
While not required, to maximize the potential health and cost-benefits, employers may accommodate modified duty in the early stages of recovery. Specific activity modifications and job restrictions are identified in ODG Treatment in Workers Comp, so they can be compared with a job analysis form or copied and pasted directly into an employer’s return-to-work form.
Not only good for productivity and profitability, these programs have the best impact on the injured worker as well. In fact, as found in ODG Treatment in Workers Comp (under “Return-To-Work” in the Procedure Summary for Low Back), the strongest medical evidence regarding potential therapies for low back pain indicates that returning the patient to normal activities has the best long term outcome. There are many therapies, both invasive and noninvasive, whose purpose is to cure the pain, but no strong evidence that they accomplish this as successfully as those that focus on restoring functional ability, without focusing on the pain.
Regarding purchasing costs, ODG Treatment in Workers Comp is available in textbook and electronic (Web, CD and raw data) formats. Published prices range from $143 - $325 per user/unit, depending on quantity. Enterprise licensing is also available.
Additionally, state adoption discounts may be negotiated. For example, when the State of Texas and the State of Ohio Bureau of Workers Comp adopted ODG Treatment in Workers Comp for their states, they negotiated a 50% discount for all treating doctors on the Web version of ODG Treatment in Workers Comp, excluding the textbook.
21. Key
review criteria are included for monitoring and review purposes.
The key review criteria for monitoring adherence are the sections called Codes for Auto-Approval. In ODG Treatment in Workers Comp, each Treatment Protocol is mapped out in a CPT/ICD9 crosswalk section, called Codes for Auto-Approval. Only procedures that meet the guideline (therefore are supported by the medical evidence) are fit for “auto-approval”, and only up until the point of “maximum occurrences”. For cases that exceed this limit, the Procedure Summary can be used to identify if additional treatment may be appropriate on a case-by-case basis, including if there is any patient selection criteria that should be met for each.
Retrospectively, organizations can review charges to determine the level of adherence. For example, for lumbar sprain, ICD9 847.2, the maximum occurrences for auto-approval for CPT 98940 (spinal manipulation, one to two regions) is 6, meaning chiropractic manipulation is approved for 6 visits for any case of lumbar sprain. If a provider requests additional visits, the Procedure Summary shows that up to 12 additional visits are allowed but only in cases of severe sprains where evidence is shown of objective functional improvement following the initial care.
Therefore, in any case of 847.2, chiropractic should never exceed 18 visits, and in most cases, should be capped at 6. By the same token (according to Codes for Auto-Approval and Procedure Summary), spinal fusions and trigger point injections should never be done (capped at zero) for 847.2. Organizations can monitor adherence and identify system abuse using these files.
In fact, the State of Ohio Bureau of Workers Comp just began this program, and one of the major Ohio MCO’s, CompManagement Health Systems, Inc., is beginning a project to track and quantify differences in savings, outcomes and utilization schedules in Ohio before and after the Codes for Auto-Approval crosswalk. Published results are expected in about one year.
The ODG ICD9-CPT© Crosswalk UR Advisor file contains every possible combination of ICD9 diagnosis code and CPT procedure code seen in workers’ comp. This clearly defined review criteria is derived from the guideline recommendations themselves. Usage of this tool to monitor and audit adherence to guideline recommendations can enhance their use.
ODG Treatment in Workers Comp also contains evidence-based disability duration guidelines within the medical treatment guidelines. Pathways are provided throughout the Treatment Protocol at each endpoint with expected time away from work based on severity and type of job. Demonstrating adherence to the disability durations communicates adherence to the protocol, at least in part. In addition to these expected duration pathways provided in the Treatment Protocol based on severity and type of job, ODG provides benchmark Summary Guidelines for each diagnosis, indicating when 50% (Midrange) and 90% (At-Risk) of claims return-to-work.
These benchmarks can be used as follows:
§
Identifying
and Harnessing Outliers: “Outliers”
is a term used to describe all claims having disability durations greater than
the ODG At-Risk date (at which 90% of have returned nationally). This small percentage of claims represents a
huge portion of costs.
o Divide the number of outliers by total # of
claims. Multiply result by 100 to get
“outlier percentage”. 10% is the
national benchmark, where lower is better.
If “outlier percentage” of a provider or claims entity notably exceeds
10%, they may be investigated and/or temporarily or permanently removed from a
network. Claims can be directed to
providers with the best outlier percentages (assuming all else is equal).
§
Performance
Measures (Grading RTW 101):
Organizations measure performance of RTW efforts by adding up actual internal
claims durations:
o Sum up corresponding At-Risk durations from ODG Summary Guidelines (with an ICD9 coded At-Risk date corresponding to each claim)
o Divide
the sum of the At-Risks minus the sum of internal claims durations by the sum
of the At-Risk dates: (sum of At-Risks – sum of claims)/sum of At-Risks
o
Multiply the result by 100 to get a percentage score:
Grading
Your Results
|
||||
|
A |
B |
C |
D |
F |
|
99-75% |
74-50% |
49-25% |
24-0% |
Negative |
Regardless of ultimate grade, the
value of these benchmarks is to create consistency across different conditions,
allowing for comparison of various claims entities or time-series evaluations of
new programs, despite the likelihood of heterogeneous case mixes.
§
Targets/Triggers – The Summary Guidelines are
used in selecting durations as the “number to hit” (Midrange) or the “number to
beat” (At-Risk). Cases beyond the
Midrange will trigger a yellow
flag, and may solicit more attention or specific action. Cases unresolved beyond the At-Risk date
will trigger a red flag,
as they become outliers. This date may trigger a search for factors that may be
retarding recovery (co-morbidities, psychosocial or job satisfaction issues,
chemical dependence, etc), or some other action.
Editorial independence (items 22-23)
Summary: ODG is independent of any medical specialty group and multidisciplinary in scope, and represents all medical specialties, and not just occupational medicine doctors, orthopaedic surgeons, chiropractors, physical therapists, etc. ODG has realized considerable provider acceptance (including adoption by 16 states and provinces – more than any other guideline) because ODG is evidence based, and recommendations are linked directly to the most up to date studies; the results of that research are reflected in the constant updating of the guidelines. These studies are focused on one outcome: What is best for the injured worker. WLDI is in the guideline business, focused on researching and publishing evidence based medical guidelines. The funding body for ODG Treatment in Workers Comp is the subscribers who purchase the guideline. With 42,000 paid ODG users from all categories of stakeholders in workers’ comp, this is a diverse group with many different interests. The employees of WLDI who guide the editorial process are independent of this funding body, and their overriding objective is to publish the highest quality guideline, one that is evidence based and defensible before all of these different interests, as these customers make decisions about which guideline to purchase or adopt. Ultimately, the recommendations in ODG may not please each of these subscribers, but they hopefully accede that ODG is fair and balanced. ODG has been more successful in this than any other workers’ compensation medical treatment guideline, which attests to the editorial independence of ODG. It has proven to be the only guideline that employers, insurers, providers, and labor can all get behind and support. The only measure of success for the ODG editors is that they have created a high quality product that succeeds in the marketplace. This is contrary to guidelines produced by special interest groups, such as insurance companies or medical specialty societies, whose interests go beyond just sales of the guideline, and whose agenda may be to advance the success of their own members.
22. The
guideline is editorially independent from the funding body.
Work Loss Data Institute is an independent database development company focused on workplace health and productivity, founded in 1995 to create, maintain and market information databases to implement standards for managing workforce productivity based on strict principals of evidence-based methodology, with ongoing focus on healthcare cost containment.
As indicated in the first chapter of ODG Treatment in
Workers Comp, Work Loss Data
Institute is without any
specific affiliation and therefore unique in being able to bridge the interests
of the many professional groups involved in diagnosing and treating workers
comp conditions.
The funding body for
ODG Treatment in Workers Comp is the subscribers who purchase the
guideline. With 42,000 paid ODG users from all categories of stakeholders in
workers’ comp, this is a diverse group with many different interests. The
employees of WLDI who guide the editorial process are independent of this
funding body, and their overriding objective is to publish the highest quality
guideline, one that is evidence based and defensible before all of these
different interests, as these customers make decisions about which guideline to
purchase or adopt. Ultimately, the recommendations in ODG may not please each
of these subscribers, but they hopefully accede that ODG is fair and balanced,
and ODG has been more successful in this than any other workers’ compensation
medical treatment guideline, which attests to the editorial independence of
ODG. It has proven to be the only guideline that employers, insurers,
providers, and labor can all get behind and support. The only measure of
success for the ODG editors is that they have created a high quality product
that succeeds in the marketplace. This is contrary to guidelines produced by
special interest groups, such as insurance companies or medical specialty
societies, whose interests go beyond just sales of the guideline, and whose
agenda is to advance the success of their own members.
23.
Conflicts of interest of guideline development members have been recorded.
Work Loss Data Institute is an independent database development company focused on workplace health and productivity, founded in 1995, to create, maintain and market information databases to implement standards for managing workforce productivity based on strict principals of evidence-based methodology, with ongoing focus on healthcare cost containment. There are no conflicts of interest among the guideline development members.
WLDI is a medical publishing company in the guideline business, focused on researching and publishing evidence based medical guidelines. WLDI does not rely solely on volunteer contributors, as do many medical specialty guidelines. In addition to an extensive internal editorial staff, WLDI retains doctors who are leaders in their fields to act as chapter leads on a compensated basis. Unlike volunteers who may have other priorities, these WLDI editors are incentivized to focus their efforts on one objective: creating the highest quality guideline. Where these contributors have experience that may reflect a bias, this is noted, and input is also sought by other contributors with no bias, or possibly even a counterbalancing bias. See Exhibit D - Editorial Advisory Board, ODG/ODG Treatment, for the specialties of different contributors. For some therapies, ODG must strive for agreement from contradictory interests, for example, orthopedic surgeons, physical therapists, and occupational physicians working for an employer or an insurance company.
Since ODG encourages editorial feedback from all
stakeholders, there may be bias on the part of some of these recommendations.
For example, medical staff employed by device manufacturers may be in the best
position to be familiar with scientific studies covering their products, so
their input is encouraged, but they would also be expected to have a clear
conflict of interest, and that is noted and taken into account when the ODG
editors evaluate their recommendations.
##########################################
AGREE stands for "Appraisal of Guidelines Research and Evaluation". It originates from an international collaboration of researchers and policy makers who work together to improve the quality and effectiveness of clinical practice guidelines by establishing a shared framework for their development, reporting and assessment. www.agreecollaboration.org
##########################################
(This document is also posted online at http://www.odg-disability.com/Advantages of Official Disability Guidelines.pdf.)
1.
ODG is unique in taking evidence-based
guidelines to their logical end point; the conclusions are linked
directly to the evidence in the studies and references.
ODG Treatment is based on a comprehensive and ongoing medical literature
review with preference given to high-quality systematic reviews, meta-analyses
and clinical trials. Each
recommendation is linked to the supporting medical evidence, provided in
abstract form, which has been ranked, highlighted and indexed. Full text copies of these studies are used
by physician editors in formulating recommendations and are available on
request. The ODG return-to-work
guidelines are based on an aggregate of over 10 million cases from CDC, OSHA,
and actual workers’ compensation claims.
For details on methodology, see www.odg-disability.com/methodology_outline.pdf. Accountability and transparency are the
hallmarks of the ODG development process.
2.
ODG is comprehensive. The treatment guidelines cover conditions
that represent over 99% of workers’ compensation costs, and the Procedure
Summaries cover virtually every treatment or procedure that may be performed
for those conditions, along with links to the scientific evidence. Treatment guidelines that are clear and
comprehensive can minimize uncertainty and unnecessary disputes between medical
providers and managed care entities, and ensure that injured workers get early
access to care. Because ODG Treatment
is comprehensive, it does not need to be supplemented with other guidelines to
cover missing treatments. The
return-to-work guidelines cover every reportable condition, all 10,000 ICD9
diagnosis codes.
3.
ODG is continuously updated
reflecting the findings of new studies as they are conducted and released;
subscribers are always up to date.
ODG undergoes a comprehensive annual update process based on scientific
medical literature review, survey data analysis and expert panel
validation. In addition, as new studies
are released, the Web version is updated throughout the year to reflect these
new studies.
4.
ODG is independent of any medical
specialty group and multidisciplinary in scope, and represents all medical
specialties, and not just occupational medicine doctors, orthopaedic surgeons,
chiropractors, physical therapists, etc.
ODG has realized considerable provider acceptance (including adoption by
16 states and provinces – more than any other guideline) because ODG is
evidence based, and recommendations are linked directly to the most up to date
studies; the results of that research are reflected in the constant updating of
the guidelines. These studies are focused on one outcome: What is best for the
injured worker. Unlike medical specialty
society guidelines, ODG does not represent the interests of any one
provider-group over other providers.
5.
WLDI is in the guideline business,
focused on researching and publishing evidence based medical guidelines. WLDI does not rely solely on volunteer contributors, as do many
medical specialty guidelines. In
addition to an extensive internal editorial staff, WLDI retains doctors who are
leaders in their fields to act as chapter leads on a compensated basis. Unlike volunteers who may have other
priorities, these WLDI editors are incentivized to focus their efforts on one
objective: creating the highest quality guideline.
6. ODG provides integrated guidelines, with both medical
treatment guidelines and return-to-work guidelines (also known as lost time
guidelines or disability duration guidelines).
Treatment and duration guidelines must work together to be effective
(timeframes for duration correspond precisely to treatment pathways).
7.
ODG is designed to be used for
utilization review (UR) as well as clinical practice, unlike other treatment
guidelines, which may recommend the same treatment for every patient (sometimes
referred to as "cookbook" medicine), and unlike nursing textbooks
that lack any basis for UR. ODG seeks
clarity and lack of ambiguity in recommendations, and ODG allows the ability to
copy & paste, saving time and effort in documenting approvals or denials of
treatment. Entries in the Procedure
Summaries always start with the words, “Recommended,” “Not recommended,” or
“Under study.”
8.
ODG is available in a Web-based
version, which users can access from any location with an Internet
connection, while the raw experience data from ODG is also available to clients
in tabular format to compare with internal claims data.
9.
ODG can be integrated into
claims management systems.
The ODG ICD9-CPT© Crosswalk UR Advisor file contains every
possible combination of ICD9 diagnosis code and CPT procedure code seen in
workers' comp. For each ICD9-CPT
combination, it provides information on frequency as well as number of visits,
plus recommendations from ODG. The file
also provides a "Bill Review Payment Flag" which is Green, Yellow,
Red, or Black, for use in automating claims management decision-making.
10. Training in ODG is readily available. Online training demos are provided by WLDI account executives at
no charge to users, and a Help Desk is available via toll-free telephone line
as well as email. In addition, the
American Academy of Disability Evaluating Physicians (AADEP) offers continuing
education courses on the use of ODG.
There is also a self-paced CD-ROM training option available.
11. ODG has met the stringent
criteria of the Federal Agency for Healthcare Research & Quality (AHRQ), and has been accepted for inclusion in the National Guidelines
Clearinghouse (NGC), located at www.guidelines.gov.
To be included a clinical practice guideline must provide corroborating documentation
that a systematic literature search and review of existing scientific evidence
published in peer reviewed journals was performed during the guideline
development, and documented evidence can be produced that the guideline is
up-to-date.
12. ODG is cost effective for all types of users, and in states that have
adopted ODG, users within those states can purchase the guidelines at a 50%
discount, bringing the cost down to $162.50.
There are also substantial discounts available to organizations with
quantity users. In addition, because
ODG has been accepted by AHRQ for inclusion in the National Guidelines
Clearinghouse, summaries of the guidelines are available at no charge on
www.guidelines.gov, and these summaries may be all some users need, including
providers doing a limited amount of workers’ comp, as well as small employers
and even some injured workers. The goal
is for the guidelines to be a communication tool so that all parties are on the
same page when it comes to expectations for treatment and return to work. For guidelines to be successful, they need
to facilitate early access to appropriate care for the injured worker, when all
providers know up-front that they will get paid if they follow the guidelines.
13. ODG has
been proven. The 2007 edition of Official Disability
Guidelines is the 12th annual edition of these leading
return-to-work guidelines, and the 2007 edition of ODG Treatment is the
5th annual edition of those leading treatment guidelines. While other publishers may promise better
guidelines in the future, ODG keeps delivering. And studies have shown that outcomes are significantly improved
through use of ODG. In fact, one study
showed that after adoption of ODG, medical costs were reduced by 64% and lost
work days were reduced by 69%, while at the same time injured workers got
earlier access to appropriate care and doctors praised the program.
##########################################
For the Low Back chapter in ODG Treatment in Workers
Comp, the following is a list of treatment methods covered in the Procedure
Summary. There are over 200 entries in
this table, many are recommended and many are not, but there is not any one
approach that is right for every patient. Providers and patients can select
from a comprehensive list depending on provider experience and patient
preferences. Each topic is listed with a summary of existing medical evidence
and recommendations for use. The
evidence summaries and subsequent recommendations are linked to the supporting
studies, in abstract form. As new technologies are introduced, evidence reviews
are initiated and new summaries are added to the Procedure Summaries. This is
also a partial list of search terms, used along with the words back or lumbar
or pain, in researching evidence for the Low Back chapter of ODG Treatment
in Workers Comp.
(This list is available online at http://www.odg-twc.com/odgtwc/low_back.htm#ProcedureSummary.)
Activity restrictions; Acupuncture; Acupressure; Adhesiolysis; Adhesiolysis, percutaneous; Adhesiolysis, spinal endoscopic; Adjacent segment disease/degeneration (fusion); Aerobic exercise; Age adjustment factors; Allograft transplantation; Annuloplasty (IDET); Antidepressants; Anti-inflammatory medications; Aquatic therapy; Arthrodesis; Arthroplasty; Artificial disk; Back brace; Back brace, post operative (fusion); Back schools; Bed rest; Behavioral treatment; Biofeedback; Bone-growth stimulators (BGS); Bone scan; Botulinum toxin (Botox); Bupropion (Wellbutrin®); ChariteÒ; Chemonucleolysis (chymopapain); Chiropractic; Chronic pain programs; Coblation nucleoplasty; Cognitive intervention; Colchicine; Cold/heat packs; Computerized range of motion (ROM); Conservative care; Corsets; Cryotherapy; CT & CT Myelography (computed tomography); Cutaneous laser treatment; Current perception threshold (CPT) testing; Cybex exercise machine; Dascor™ Disc Arthroplasty Nucleus; Decompression; Delayed treatment; Dermatosensory evoked potentials (DSEPs); Diagnostic imaging; DIAM (device for intervertebral assisted motion); Diathermy; Directional preference (DP) therapy; Differential Diagnosis; Disc prosthesis; Disc replacement; Disc transplantation; Discectomy/laminectomy; Discography; DRX (traction); Dynamic neutralization system (Dynesys); Dynesys®; Early access to treatment; Education; Electrical stimulators (E-stim); Electrodiagnostic studies (EDS); Electromagnetic pulsed therapy; EMGs (electromyography); Epidural steroid injections (ESIs); Epidural steroid injections, “series of three”; Epidural steroid injections, diagnostic; Ergonomics interventions; ESIs (epidural steroid injections); Etanercept (Enbrel); Evoked potential studies; Exercise; Facet joint diagnostic blocks (injections); Facet joint injections, lumbar; Facet joint injections, thoracic; Facet joint intra-articular injections (therapeutic blocks); Facet joint medial branch blocks (therapeutic injections); Facet joint pain, signs & symptoms; Facet joint radiofrequency neurotomy; Facet joint therapeutic blocks; Facet joint therapeutic steroid injections; Facet rhizotomy (radio frequency medial branch neurotomy); Fear-avoidance beliefs questionnaire (FABQ); Feldenkrais; Flexibility; Fluoroscopy (for ESI's); Foraminotomy; Functional anesthetic discography (FAD); Fusion (spinal); Fusion, endoscopic; F-wave tests; Gabapentin (Neurontin®); Hardware; Hardware injection (block); Heat therapy; Hemilaminectomy; Herbal medicines; Home health services; Hospitalization; H-reflex tests; H-wave stimulation (devices); IDD therapy (intervertebral disc decompression); IDET (intradiscal electrothermal anuloplasty); Imaging; Implantable drug-delivery systems (IDDSs); Implantable spinal cord stimulators; Implants; Infliximab (Remicade); Injections; Interdisciplinary rehabilitation programs; Interferential therapy; Intradiscal electrothermal therapy (IDET); Intradiscal steroid injection; Intrathecal drug administration system; Iontophoresis; Kyphoplasty; Laminectomy/laminotomy; Ligamentous injections; Lordex (traction); Low level laser therapy (LLLT); Lumbar extension exercise equipment; Lumbar supports; Magnet therapy; Magnetic resonance imaging; Manipulation; Manipulation under anesthesia (MUA) ; Massage; Mattress firmness; McKenzie method; Medications; MedX lumbar extension machine; Microcurrent electrical stimulation (MENS devices); Microdiscectomy; Modified duty; MR neurography; MRI’s (magnetic resonance imaging); Multidisciplinary pain programs; Muscle relaxants ; Myelography; Narcotics; NC-stat nerve conduction studies; Nerve conduction studies (NCS); Neurometer®; Neuromodulation devices; Neuromuscular electrical stimulators (NMES); Neuroplasty; Neuroreflexotherapy; Nonprescription medications; NSAIDs (non-steroidal anti-inflammatory drugs); Nucleoplasty; Occupational therapy (OT); Opioids; Oral corticosteroids; Orthotrac vest; Patient education; Percutaneous diskectomy (PCD); Percutaneous electrical nerve stimulation (PENS) ; Percutaneous endoscopic laser discectomy (PELD); Percutaneous epidural neuroplasty; Percutaneous intradiscal radiofrequency (thermocoagulation); Percutaneous neuromodulation therapy (PNT); Percutaneous vertebroplasty (PV); Phototherapy; Physical therapy (PT); Pilates; Powered traction devices; ProDiscÒ; Prolotherapy (sclerotherapy); Psychological screening; Psychological treatment; Pulsed radiofrequency treatment (PRF); Quantitative sensory threshold (QST) testing; Racz neurolysis; Radiofrequency neurotomy; Radiography (x-rays); Range of motion (ROM); Reassurance; Return to work; Roman chairs exercise equipment; Sacroiliac joint injections (SJI); Sclerotherapy; Segmental rigidity (diagnosis); Selective nerve root blocks; Sensory nerve conduction threshold (sNCT) device; Shoe insoles/shoe lifts; SPECT (single photon emission computed tomography); Spinal cord stimulation (SCS); SpineCATHÒ; Standing MRI; Stimulators, electrical; Stretching; Supports & braces; Surface electromyography (SEMG); Surgery; Sympathetic therapy; Tendon injections; TENS (transcutaneous electrical nerve stimulation); Thermography (infrared stress thermography); Traction; Training; Transcutaneous electrical neurostimulation (TENS) ; Transplantation, intervertebral disc; Trigger point injections; Tumor necrosis factor (TNF) modifiers; Ultrasound, diagnostic (imaging); Ultrasound, therapeutic; Vertebral axial decompression (VAX-D); Vertebroplasty; Videofluoroscopy (for range of motion); Work conditioning, work hardening; Work; X-rays; Yoga
##########################################
Editorial Advisory Board
ODG/ODG Treatment
(This is also posted online at http://www.odg-twc.com/editorial_advisory_board.htm)
Philip L. Denniston, Jr.
Editor-in-Chief
Charles W. Kennedy, Jr., MD
Senior Medical Editor
John C. Agee, DO
Clinical Medical Director
Bethlehem Steel Corp.
Chesterton, IN
Robert J. Barth, Ph.D.
Fellow, National Academy of
Neuropsychology
Barth NeuroScience, PC
Chattanooga, TN
Melissa Bean, DO, MBA, MPH
Medical Director
Coventry Health Care
Worker's Compensation
Hazelwood, MO
James Becker, MD
Medical Director
BrickStreet Insurance
Charleston, WV
Douglas Benner, MD
Occupational Health
Kaiser Permanente
Oakland, CA
Faiyaz A. Bhojani, MD, MPH
AVP Medical Environmental
& Health
Burlington Northern Santa Fe
Corporation
Fort Worth, TX
Timothy Bialecki, DC
Director Of Clinical
Services, Alignis, Inc.
Edison, NJ
Stanley J. Bigos, MD
Professor Emeritus
University of Washington
Seattle, WA
Susan G. Blitz, MD, MPH
Medical Director Employee
Health
University of Michigan
Ann Arbor, MI
H. F. Bonfili, MD, MPH
Medical Director
R. J. Reynolds
Winston-Salem, NC
David H. Brill, MD, MA, MPH
Saratoga Health &
Medical Services, P.C.
Saratoga Springs, NY
Charley Brooks, MD
Orthopedic Surgery/IME
Bellevue, WA
Paul J. Brownson, MD
Corporate Health Coordinator
Dow Chemical Company
Indianapolis, IN
Mary Capelli-Schellpfeffer, MD, MPA
President
CapSchell, Inc.
Chicago, IL
Pieter Coetzer, MBChB MSc FAADEP
Chief Medical Officer
Sanlam Insurance Group
Cape Town 7530, SOUTH AFRICA
Richard Cohen, MD, MPH
Former Dir. Corporate
Health/Safety
Varian Associates
Saratoga, CA
Alan Colledge, MD, FAADEP, CIME
Medical Director, Labor
Commission
State of Utah, Division of
Industrial Accidents
Salt Lake City, UT
Alberto M. Colombi, MD
Corporate Medical Director
PPG Industries, Inc.
Pittsburgh, PA
James P. Crossan, MD
Chief Medical Officer
Walt Disney Corporation
Anaheim, CA
Steve Demeter, MD, MPH
Disability Evaluations
Honolulu, HI
Deborah V. DiBenedetto, MBA
RN COHN-S/CM ABDA
Practice Leader Integrated
Health
Risk Navigation Group, LLC
Battle Creek, MI
Dennis DiGiorgi, DC, CCIC, DABQAURP
Diplomate: American Board of
Quality Assurance & Utilization Review Physicians
Whitestone, NY
James J. Edwards, Jr. , MD
Corp. Med. Dir., & Mgr.
Med. Services
Vought Aircraft Industries,
Inc.
Dallas, TX
Dennis G. Egnatz, MD
Former Corporate Medical
Director
Sara Lee Corporation
Winston-Salem, NC
Michael Erdil, MD, FACOEM
Medical Director
Johnson Medical Specialists,
P.C.
Enfield, CT
Marjorie Eskay-Auerbach, MD, JD
SpineCare and Forensic
Medicine, PLLC
Tucson, AZ
Steven Feinberg, MD
Associate Professor
Stanford University
Palo Alto, CA
Preston Fitzgerald, Sr. DC RN
Forensic Nurse and
Chiropractic Consultant
Medical University of South
Carolina
Mt. Pleasant, SC
Joseph A. Fortuna, MD
Medical Director
Delphi Automotive
Troy, MI
Gary C. Freeman, MD, JD
Orthopedic Surgeon
Houston, TX
Bob Gant, PhD
Clinical Psychology and
Neuropsychology
Colorado School of
Professional Psychology
Colorado Springs, CO
Diane Green,
AVP
Health Direct Inc.
Farmington, CT
Annette B. Haag, MA, RN,
COHN-S/CM
President
Health and Safety
Consultants
Simi Valley, CA
Paul D. Harris, MD, MPH
Medical Director
Kennecott Utah Copper Corp.
Magna, UT
T. Warner Hudson III, MD
FACOEM Director
Health Safety & Evironment
DST Output
El Dorado Hills, CA
Fikry W. Isaac, MD, MPH
Executive Director, WW
Health & Safety
Johnson & Johnson
New Brunswick, NJ
Stephen G. Jacobson, MD
VP Medical Director
Unum Provident Corp.
Chattanooga, TN
Gregory Jewell, MD, MS
Medical Director
Ohio Bureau of Workers'
Compensation
Columbus, OH
Pamella D. Johnston-Thomas, MD,
MPH
Medical Director
Lockheed Martin
Marietta, GA
Christine M. Kalina, MBA MS
RN FAAOHN
Director Global Occupational
Health
Wm Wrigley Jr. Company
Chicago, IL
Charles W. Kennedy, Jr., MD
Chairman
Musculoskeletal Wellness
Center
Corpus Christi, TX
Gary M. Kohn, MD
Corporate Medical Director
United Airlines Inc.
Chicago, IL
Ann Kuhnen, MD
Medical Director
SmithKline Beecham
Philadelphia, PA
Clement Leech, MB FFOM RCPI FAADEP
Deputy Chief Medical Adviser
Department of Social and
Family Affairs
Dublin 2, IRELAND
Lloyd J. Luke, MD
Medical Director
John Deere
Dubuque, IA
Michael G. Maroldo, MD
Medical Director
GPU Nuclear Corp.
Forked River, NJ
True Martin, MD, FAADEP
Tallahassee Neurological
Clinic
Tallahassee, FL
Douglas W. Martin, MD FAADEP
FAAFP
Medical Director
St. Luke's Center for
Occupational Health
Sioux City, IA
Edward G. Mauceri, MD
Corporate Medical Director
Novartis Pharmaceuticals
Corporation
East Hanover, NJ
Tom Mayer, MD
Orthopedic Surgery and
Rehabilitation
PRIDE
Dallas, TX
David K. McKenas, MD, MPH
President
Logos Medical Consulting
Carrollton, TX
J. Mark Melhorn, MD FAAOS FACS
Clinical Assistant Professor
University of Kansas School
of Medicine
Wichita, KS
Michael A. Meschke, MD
Medical Director
Eastman Chemical Company
Longview, TX
Laurence A. Miller, MD
Medical Director
Professional Dynamics
San Diego, CA
Dana B. Mirkin, MD DABPM
Medical Director
St. David's Occupational
Health Services
Austin, TX
Joseph Monkofsky, Jr., MD, MPH
Corporate Medical Director
U T C Carrier Corporation
Syracuse, NY
Vert Mooney, MD
Medical Director
U.S. Spine & Sport
San Diego, CA
Richard H. Nachtigall, MD
Professor of Clinical
Medicine
New York University Medical
Center
New York, NY
Wrendell R. Nealy, Sr., MD
Corporate Medical Director
Albemarie Corporation
Baton Rouge, LA
William Nemeth, MD
Medical Director
Texas Assoc of School Boards
Austin, TX
Trang Nguyen, MD, MPH
Assistant Professor
UT Southwestern Medical
School
Dallas, TX
Chet Nierenberg, MD
President, Academy of IME,
HI
Honolulu Sports Medical
Clinic Inc.
Honolulu, HI
Suzanne Novak, MD, Phd
Clinical Assistant Professor
University of Texas
Austin, TX
Mark C. Olesen, MD, MPH
Commanding Officer
Naval Hospital
Camp Lejeune, NC
Phillip Osborne, MD
Medical Director Occ. Med.
Health South Evaluation
Centers
Pilot Point, TX
Stuart H. Platt, MSPT, PT
Principal, Appropriate
Utilization Group
Atlanta, GA
Troy Prevot, PA-C MBA
LUBA Care - Manager
LUBA Worker's Comp
Baton Rouge, LA
Charles Prezzia, MD, MPH
General Mgr. Health Services
& Medical Dir.
United States Steel
Corporation
Pittsburgh, PA
Dave Randolph, MD, MPH, FAADEP
President
Midwest Occupational Health
Management Inc.
Milford, OH
James K. Ross, MD, MBA
Corporate Medical Director
Innovene USA LLC
Ashland, KY
E. Alannah Ruder, MD
Medical Director
Peoples Energy Corporation
Chicago, IL
Les Ruthven, Ph.D.
President & CEO
Preferred Mental Health
Management, Inc.
Wichita, KS
Steven Schneider, MD
Medical Director
Philip Morris Corp.
New York, NY
Frank Schneider, DC, MHA
Director of Rehabilitation
Services
Colorado Plains Medical
Center
Fort Morgan, CO
Joseph J. Schwerha, MD, MPH
Professor & Director,
Dept. of Occ. Health
University of Pittsburgh
Pittsburgh, PA
Howard Smith, MD, JD
Medical Advisor
Division of Workers'
Compensation
Austin, TX
David Teuscher, MD
President
Texas Orthopaedic
Association
Beaumont, TX
Melissa Tonn, MD MBA MPH
President and Chief Medical
Officer
OccMD Group
Dallas, TX
Russell Travis, MD
Past President
American Association of
Neurological Surgeons
Lexington, KY
Eugene A. Truchelut, MD
Medical Director, Florida
Healthcare Systems
Orlando, FL
Shannon Vissman, DPT
Chairman and CEO
Universal SmartComp
Washington, PA
William C. Watters III, MD
Assoc. Professor Baylor
College of Medicine
Bone and Joint Clinic of
Houston
Houston, TX
Clark Watts, MD, JD
Adjunct Professor
University of Texas School
of Law
Austin, TX
C.P. Wen, MD
Medical Department
Chevron Corporation
Houston, TX
John J. Williams, RN, COHN-S
Occupational Medicine
Oakwood Hospital &
Medical Centers
Flat Rock, MI
Gary C. Zigenfus, MS, PT
SVP National Therapy
Director
Concentra Inc.
Addison, TX
##########################################
ODG Methodology Outline
(This is posted online at http://www.odg-disability.com/methodology_outline.pdf)
Official Disability Guidelines
ODG
Treatment in Workers’ Comp (ODG/TWC)
Development/Update/Review Process
Followed by
Work Loss Data Institute
·
Preference given to
high quality systematic reviews, meta-analyses, and clinical trials published
since 1993
·
Nationally recognized
treatment guidelines from the leading specialty societies
· Primary searches: MEDLINE and the Cochrane Library
Review of Other Relevant Treatment Guidelines
(Note: These guidelines were also used to suggest references or search terms that may otherwise have been missed).
(Note: Search terms
and questions were diagnosis, treatment, symptom, sign, and/or body-part
driven, generated based on new or previously indexed existing evidence,
treatment parameters and experience).
Chapter-specific reference lists
are found within ODG/TWC
Criteria for Selecting the Evidence
Preference was given to evidence that met the following criteria:
· It was a systematic review of the relevant medical literature; or
· The article reported a controlled trial – randomized or controlled; or
· The article reports a cohort study, whether prospective or retrospective; or
· The article reports a case control series involving at least 25 subjects in which the assessment of outcome was determined by a person or entity independent from the persons or institution that performed the intervention the outcome of which is being assessed.
(Note: Especially when articles on a specific topic that met the above criteria were limited in number and quality, Work Loss Data Institute also reviewed other articles that did not meet the above criteria, but all evidence was ranked alphanumerically using the methodology in the second chapter of ODG Treatment so that the quality of evidence could be clearly weighted and taken into consideration when formulating recommendations. This ranking used an alphanumeric rating system ranging from 1a to 10c, based on Ranking by Type of Evidence: (1) Systematic Review/Meta-Analysis, (2) Controlled Trial - Randomized (RCT) or Controlled, (3) Cohort Study - Prospective or Retrospective, (4) Case Control Series, (5) Unstructured Review, (6) Nationally Recognized Treatment Guideline (from guidelines.gov), (7) State Treatment Guideline, (8) Other Treatment Guideline, (9) Textbook, or (10) Conference Proceedings/Presentation Slides; and also Ranking by Quality within Type of Evidence: (a) High Quality, (b) Medium Quality, or (c) Low Quality, as defined in the Ranking by Quality section of the second chapter.
The literature search is repeated for every chapter of ODG Treatment at least every six months, and for major chapters at least quarterly.
Link between evidence and
recommendations:
o
ODG
Treatment in Workers' Comp
is being updated monthly on the Web.
From the Contents page the last date updated for each chapter is
identified. There is a hard copy
version once a year, but this is not recommended since it does not link into
the actual studies, and it is not current.
o
The heart of
each chapter in ODG Treatment in Workers' Comp is the "Procedure
Summary", which provides a summary of effectiveness, if any, based on
existing medical evidence, hyper-linked directly into the studies on which they
are based, in abstract form, which have been ranked, highlighted and
indexed. The "Treatment
Protocol" identifies the ideal treatment pathway that should be followed,
based on the "Procedure Summary".
"Codes for Automated-Approval" links CPT procedure codes to
ICD-9 diagnosis codes based on the ideal treatment protocol, with a field for
“maximum occurrences”, for auto-approval of charges that meet the guideline.
o
For example, in
the Low Back chapter, under Fusion, it says, "There is no good evidence
from controlled trials that spinal fusion is effective for treatment of any
type of low back problem, in the absence of spinal fracture or dislocation, or
spondylolisthesis...” so the Treatment Protocol does not include fusion. Same for IDET, facet injections, etc.,
etc. Under Epidural injections, it
says, "Although epidural injections of steroids may afford short-term
improvement in leg pain and sensory deficits in patients with sciatica due to a
herniated nucleus pulposus, this treatment offers no significant long-term
functional benefit, and the number of injections should be limited to
two", so the Treatment Protocol for "With Radiculopathy"
includes 2 ESIs, and the Codes for Auto Approval includes CPT code 62311
(Epidural steroid injection) 2 times for ICD9 722.x (Intervertebral disc
disorders), but not for ICD9 847.2 (Lumbar sprain).
o
This effort to
translate the evidence into specific auto-authorization protocols is unique,
for pre-approval of treatment plans and triage of claims management. Of course, most cases will not meet this
ideal protocol, and that is where the many other listings in the Procedure
Summary come into play.
Other Considerations in Formulating the Recommendations
(Note: Restoration of function is a driving force for many recommendations, because as the evidence indicates, it is associated with pain relief, health benefits, quality of life, patient satisfaction and limited risk.)
Review by Experts
Use of the WLDI analysis of medical studies by other Treatment Guidelines
·
The ODG Treatment
Evidence Base, including WLDI’s review and summaries of studies in abstract form, which have been ranked,
highlighted and indexed, were provided
under contract to the American College of Occupational and Environmental
Medicine on April 15, 2002, as the medical evidence base used in creating the
ACOEM Practice Guidelines, 2nd Edition, published in December
2003. Note: While the studies were
provided by WLDI, the recommendations in the ACOEM Practice Guidelines were
authored by ACOEM, and not WLDI.
·
Also provided under
contract to the Council on Chiropractic Guidelines and Practice Parameters
(CCGPP) on June 19, 2004, as the medical evidence base to be used in creating
the CCGPP Best Practices For Chiropractic, to be published in January
2007. Note: While the studies were
provided by WLDI, the recommendations in the CCGPP Guidelines will be authored
by CCGPP, and not WLDI.
##########################################
Official Disability Guidelines (ODG)
Return-to-Work Guidelines
Development/Update/Review Process
Followed by
Work Loss Data Institute
o NHIS
is one of the oldest, most respected national health surveys in the U.S., in continuous
operation since July of 1957 and the principle data collection program for the
National Center for Health Statistics under the CDC.
o NHIS data are used widely throughout the
Department of Health and Human Services to monitor trends in illness and disability,
and both the public and private health research communities for epidemiological
data analysis.
o The Bureau of the Census under a contractual
agreement is the NHIS data collection agent.
o NHIS uses about 400 interviewers, trained and
directed by health survey supervisors in each of the 12 Bureau of the Census
Regional Offices. The supervisors are
career Civil Service employees whose primary responsibility is NHIS.
o The personal household interviewers are
selected through an examination and testing process, receiving thorough
training in interviewing procedures and concepts and procedures unique to
NHIS. The questionnaire is conducted
using a computer assisted personal interviewer (CAPI), administered using a
laptop computer where interviewers enter responses directly into the computer
during the interview, which offers distinct advantages in terms of timeliness
of the data and improved data quality.
o SOII is a Federal/State program in which employer's reports are collected annually from over 176,000 private industry establishments and processed by State agencies cooperating with the Bureau of Labor Statistics.
o SOII serves to track epidemiological records, trends and statistics on occupational safety & health, especially time away from work due to illness/injury.
o Summary information on the number of injuries and illnesses is copied directly from employer record keeping logs to the survey questionnaire.
o Injuries/illnesses logged by employers conform to definitions and record keeping guidelines set by OSHA, U.S. Dept of Labor.
o Employers keep separate counts by type of injury or illness and also identify and quantify for each whether a case involved days away from work or days of restricted work activity, or both, beyond the date of injury or onset of illness.
o Note: A recent study has suggested that the Bureau of Labor Statistics undercounts the number of illnesses and injuries that occur in U.S. workplaces each year, largely as a result of underreporting by employers. While of concern, this should not impact the disability duration data in ODG, as outlined below:
· Any possible undercounting will not effect expected duration on a per-injury basis, which is how the OSHA data is utilized in ODG.
· The undercounting is an important safety issue, not a disability duration issue. WLDI uses OSHA data (among other sources including client claims data and the CDC) to estimate expected disability duration for each condition on a per-injury basis. ODG is not using this data to gauge workplace safety (the likelihood of an injury).
· Undercounting does not affect expected time away from work on a per-injury basis, although it does make workplaces appear safer than they are in reality. For example, whether you have 246,000 back strains or twice that, the average duration would likely be the same.
· This undercounting would affect all sources of data. If employers are hiding injuries from OSHA (to keep insurance premiums down), then they are also hiding these injuries from their workers' comp insurance carriers. Therefore any disability duration database based on claims data would also be undercounting.
o Since 2003 all of the ODG disability duration data has been validated and enhanced by actual client claims data, and this is reflected in the Return-To-Work Summary Guidelines (Claims data Midrange and At-Risk) as well as the Return-To-Work "Best Practice" Guidelines, the RTW Claims Data (Calendar-days away from work by decile), and the RTW Post Surgery (Calendar-days away from work by decile).
(Note: Survey instruments were chosen for use as part of the ODG database because they are population-based and appropriately stratified, and therefore not restricted to any single or limited subdivision available from private claims entities. Furthermore, SOII and NHIS are the most credible and comprehensive workforce health survey instruments available, containing a wealth of information on time away from work due to illness and injury. They are referred to as “the most direct form of evidence that can be offered in court” under the newly revised Federal Rules of Evidence. The result is that ODG is independent, fair and defensible.
Use of the ODG Disability Duration data by other Guideline Publishers
·
In 2003
Guidelines Committee members of the American College of Occupational and
Environmental Medicine (ACOEM) decided to incorporate normative disability
duration data from ODG in the 2nd edition of the ACOEM Practice
Guidelines, published in December 2003.
This is the only return-to-work disability duration data from an
external source that is contained in the ACOEM Practice Guidelines.
·
In early 2004,
after an extensive evaluation, McKesson Health Solutions entered into an
agreement with Work Loss Data Institute whereby ODG would provide all of the
disability duration data in the McKesson InterQual treatment guidelines. Prior to this the McKesson Guidelines had an
agreement with the Medical Disability Advisor.
A Supplemental Outline: ODG Background, Features & Major Advantages
· Annually Updated. First edition of Official Disability Guidelines (ODG) released in 1996; now in its 11th edition
·
Evidence-Based - disability
duration norms from actual experience data from federal government databases,
including OSHA BLS (Occupational Safety and Health Administration – Bureau of
Labor Statistics) Survey of Occupational Injuries and Illnesses and CDC NCHS
(Centers for Disease Control and Prevention, National Center for Health
Statistics) National Health Interview Survey.
·
Designed to
enhance a timely and appropriate return-to-work for workers suffering from illness or injury. ODG allows for the systematic determination of
appropriate disability duration for each case within a condition based on key
indicators of severity, treatment and job
·
Fair to employees and defensible by management. The raw data
from CDC and OSHA is interpreted for end-users in the Summary and Best Practice
Guidelines, and remains in graphical form as supportive documentation, where it
is referred to as “the most direct form of evidence that can be offered in
court” under the Federal Rules of Evidence as amended in December 2000.
·
ODG Allows
Benchmarking Against National Norms using
the ODG Summary Guidelines, which are available for virtually every reportable
condition. These benchmarking methods (including “Grading RTW 101” &
“Outlier Percentage”) have become the standard for employers and their vendors,
as a way to compare outcomes to national data on a consistent basis.
· ODG includes Descriptions; Links to other resources (i.e. State Guidelines, Merck Manual, etc); Physical Therapy and Chiropractic Guidelines; Decile Tables for Benchmarking; Age Adjustment Multipliers; and Causality Indicators for determining work-relatedness
· Integrated with ODG Treatment Guidelines
##########################################
(Ratings “1a” through “11c” noted under summary of each study)
(This is posted online at http://www.odg-twc.com/odgtwc/ExplanationofMedicalLiteratureRatings.htm)
Ranking by Type of Evidence:
(click on links to go to explanation)
STUDIES
1. Systematic Review/Meta-Analysis
2. Controlled Trial – Randomized (RCT) or Controlled
3. Cohort Study - Prospective or Retrospective
OTHER:
6. Nationally Recognized
Treatment Guideline (from guidelines.gov)
10. Conference
Proceedings/Presentation Slides
11. Case Reports and Descriptions
Ranking by Quality within Type of Evidence:
(click on links to go to explanation)
Ranking
by Type of Evidence
1. Systematic
Review/Meta-Analysis
Systematic
Reviews: Written by reviewers who use explicit and
rigorous methods to identify, critically appraise, and synthesize relevant
studies from the published medical research.
They use the process of systematically locating, appraising and
synthesizing evidence from scientific studies in order to obtain a reliable
overview. The function of a systematic
review is: 1) to summarize the literature and 2) to provide new information
that may not be readily apparent from individual studies where the effects are
small, but become apparent in when the data from many studies are pooled
together. Example: Cochrane Database of Systematic Reviews.
Meta-analysis: A
type of systematic review that is an
overview and also uses quantitative methods to summarize the results. A quantitative method of combining the
results of independent studies (usually drawn from the published literature)
and synthesizing summaries and conclusions which may be used to evaluate
therapeutic effectiveness, plan new studies, etc., with application chiefly in
the areas of research and medicine. Any
study with the Level 1 ranking in ODG must have been accepted for publication
in a peer reviewed journal, and that journal must be one of the journals
accepted for inclusion in MEDLINE® by the National Library of
Medicine. For this Journal Selection
Criteria, see www.nlm.nih.gov/pubs/factsheets/jsel.html. Unpublished studies, or studies in magazines
that do not publish original research, would not receive this ranking.
2. Controlled Trial – Randomized (RCT) or
Controlled
These are analytical experimental studies, where variables can be better controlled on a prospective basis. In a RCT (Randomized Controlled Clinical Trial), a group of patients is randomized into an experimental group and a control group. These groups are followed up for the variables/outcomes of interest. Advantages: Unbiased distribution of confounders; Blinding more likely; Randomization facilitates statistical analysis. Disadvantages: Expensive: time and money; Volunteer selection bias; Ethically problematic at times. Any study with the Level 2 ranking in ODG must have been accepted for publication in a peer reviewed journal, and that journal must be one of the journals accepted for inclusion in MEDLINE® by the National Library of Medicine. Unpublished studies, or studies in magazines that do not publish original research, would not receive this ranking.
3. Cohort Study - Prospective or
Retrospective
Analytical observational studies involving identification of
two groups (cohorts) of patients, one which did receive the exposure of
interest, and one which did not, and following these cohorts forward for the
outcome of interest. Advantages: Ethically safe; Subjects
can be matched; Can establish timing and direction of events; Eligibility
criteria and outcome assessments can be standardized; Administratively easier
and cheaper than RCT. Disadvantages:
Controls may be difficult to identify; Exposure may be linked to a hidden confounder;
Blinding is difficult; Randomization
not present; For rare disease,
large sample sizes or long follow-up necessary. Any study with the
Level 3 ranking in ODG must have been accepted for publication in a peer
reviewed journal, and that journal must be one of the journals accepted for
inclusion in MEDLINE® by the National Library of Medicine.
Analytical observational studies
involving identifying groups of patients who have the outcome or treatment of
interest (cases) and quantifying the results.
Ideally, control patients without the same outcome are also tracked,
looking back to see if they had the exposure of interest. (The use of controls would influence the
quality rating of a Case Series.)
Generally, since the minimum ODG quality rating for studies (“c”)
requires at least 10 cases, there must be 10 or more cases for a study to be
classified as a Case Series, and otherwise the article would be classified in
ODG as Case Reports and Descriptions.
Advantages of Case Series: Quick and cheap; Only feasible method for
very rare disorders or those with long lag between exposure and outcome; Fewer subjects needed than cross-sectional
studies. Disadvantages: Reliance on
recall or records to determine exposure status; Confounders; Selection of
control groups is difficult; Potential bias: recall, selection. Any
study with the Level 4 ranking in ODG must have been accepted for publication
in a peer reviewed journal, and that journal must be one of the journals
accepted for inclusion in MEDLINE® by the National Library of
Medicine.
Descriptive (versus analytical) and
observational (versus experimental) studies, written by reviewers who describe current practice as well as relevant
studies from the published medical research, with no attempt to pool the results
analytically. Compared to Systematic
Reviews, an Unstructured Review makes little attempt to quantify outcomes based
on the body of evidence described. Any study with the Level 5 ranking in ODG
must have been accepted for publication in a peer reviewed journal, and that
journal must be one of the journals accepted for inclusion in MEDLINE®
by the National Library of Medicine.
6. Nationally Recognized
Treatment Guideline (from guidelines.gov)
Accepted for inclusion in the National Guideline Clearinghouse by the
Federal Agency for Healthcare Research & Quality (AHRQ), which requires
that the guideline recommendations be based on a systematic literature search
and review of scientific studies published in peer reviewed journals, and
revised on a regular basis to maintain currency with new studies.
Treatment guidelines created for use in a specific state in the U.S.,
or for use in a province in Canada, or for use by another governmental entity,
and they have the backing of the respective jurisdictional or governmental
authority.
Other treatment
guidelines. These are typically
national treatment guidelines not accepted in the National Guideline
Clearinghouse, in many cases because the guideline publishers have chosen not
to apply for inclusion (for example, commercial guidelines such as Milliman,
McKesson, InterQual, etc.), or because they are private guidelines created for
use under the terms of a specific health insurance policy (for example, Blue
Cross, Medicare, Aetna, Cigna, United Healthcare, etc.). Since studies by healthcare insurers are generally given a rating of Level 8, they are not characterized in ODG
as among the highest quality references when there are numerous other studies
available. However, when there are
limited studies available with the high quality ratings, it may be necessary to
identify other studies that could provide guidance on a subject. In fact, many of the healthcare insurance
provider structured reviews are very high quality, they represent a thorough
analysis and quantitative weighting of all available evidence on a subject,
including unpublished studies that the insurer may have conducted, and these
healthcare insurance reviews might even rank as Level 1 if they were published in the peer-reviewed literature and
available in MEDLINE®.
Furthermore, the fact that a particular treatment is either covered or
not covered by healthcare insurance should be relevant to coverage decisions in
workers’ compensation.
Medical reference texts, which may represent standards of practice, but
which in and of themselves, are not necessarily evidence based versus consensus
based or based primarily on the personal experiences of the authors.
10. Conference Proceedings/Presentation
Slides
These are studies that have not been published in peer reviewed
journals.
11. Case Reports and Descriptions
Descriptive articles published in the peer reviewed journals covering
individual cases, and lacking any comparisons to controls. Generally, since the minimum ODG
quality rating for studies (“c”) requires at least 10 cases, there must be 10
or more cases for a study to be classified as a Case Series, and otherwise the
article would be classified in ODG as Case Reports and Descriptions. These
articles were not included in the evidence base for any treatment guidelines
except for the Council on Chiropractic Guidelines for Practice Parameters
(CCGPP) chiropractic practice guidelines.
Ranking
by Quality within Type of Evidence:
In evaluating clinical trials ODG has adopted the standards from the "Cochrane Handbook for Systematic Reviews of Interventions," as updated in September 2006. (Higgins, 2006) Specific additional criteria used by ODG include the following:
Sample size: Generally over 300, but at least 100,
depending on other factors below.
Conflict of
interest: Authors and
researchers had no financial interest in the product or service being studied.
Study design: Ideally, blinded. No identifiable bias, including recall bias, confounding factors,
selection bias, compliance bias, non-response bias, or measurement bias. If a
case series, should be a case control series.
Statistical
significance: 99% Confidence
level that the outcomes likelihood ratio will not cross 1.0 (i.e., the p value
is .01).
Sample size: From 20-50 up to 100-300, depending on other
factors below.
Conflict of
interest: Authors and
researchers had no financial interest in the product or service being studied.
Study design: No significant bias, including recall bias,
confounding factors, selection bias, compliance bias, non-response bias, or
measurement bias. If a case series,
should be a case control series.
Statistical
significance: 95% Confidence
level that the likelihood ratio will not cross 1.0 (i.e., the p value is .05).
Sample size:
Generally under 20-50, depending on other factors below, but no less
than 10.
Conflict of
interest: Authors and
researchers may have had some financial interest in the product or service
being studied, even if the sample size was large.
Study design: Some obvious bias, including recall bias,
confounding factors, selection bias, compliance bias, non-response bias, or
measurement bias.
Statistical
significance: Does not meet
the 95% Confidence level that the likelihood ratio will not cross 1.0 (i.e.,
the p value is .05).
Link
between evidence and recommendations
ODG Treatment is being updated quarterly on the Web. The Contents page indicates the last date
updated for each chapter. The hard copy
version is published once a year, but this is not recommended since it does not
link into the actual studies, and it is not as current as the Web version.
The heart of each
chapter in ODG Treatment is the "Procedure Summary", which
provides a concise synopsis of effectiveness, if any, based on existing medical
evidence, hyper-linked directly into the studies on which they are based, in
abstract form, which have been ranked, highlighted and indexed. The "Treatment Planning" section
identifies the ideal treatment plans that may be followed after illness or
injury, based on the "Procedure Summary". "Codes for Automated-Approval" maps procedure codes to
ICD-9 diagnosis codes based on the ideal treatment protocol, with a field for
“maximum occurrences”, for auto-approval of charges that meet the guideline.
For example, in the
Low Back chapter, under Fusion, it says, "Not recommended in the absence
of fracture, dislocation, or instability", so the Treatment Protocol does
not include fusion. Same for IDET,
facet injections, etc., etc. Under
Epidural injections, it says, "Recommended as an option prior to surgery
when there are radicular signs… and the number of injections should be limited
to two...", so the Treatment Protocol for "With Radiculopathy"
includes 2 ESI's, and the Codes for Auto Approval includes CPT code 62311
(Epidural steroid injection) 2 times for ICD9 722.x (Intervertebral disc
disorders).
This effort to
translate the evidence into specific auto-authorization protocols is unique,
for pre-approval of treatment plans and triage of claims management. Of course, most cases will not meet this
ideal protocol, and that is where the many other listings in the Procedure
Summary come into play.
In a recent pilot
use of these Codes for Auto Approval reduced medical costs by 64%, cut lost
days by 69%, minimized treatment delays for injured workers, and drew
considerable praise from providers.
(Ohio ODG Pilot, Comp Management, 2005)
##########################################
Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of
Interventions 4.2.5. In: The Cochrane Library, Issue 3, 2005. Chichester, UK:
John Wiley & Sons, Ltd. September 2006.
6. ASSESSMENT OF
STUDY QUALITY
6.0 Quality
assessment of studies
Quality assessment
of individual studies that are summarized in systematic reviews is necessary to
limit bias in conducting the systematic review, gain insight into potential
comparisons, and guide interpretation of findings. Factors that warrant
assessment are those related to applicability of findings, validity of
individual studies, and certain design characteristics that affect
interpretation of results. Applicability, which is also called external
validity or generalize-ability by some, is related to the definition of the key
components of well-formulated questions outlined in section 4. Specifically,
whether a review's findings are applicable to a particular population,
intervention strategy or outcome is dependent upon the studies selected for
review, and on how the people, interventions and outcomes of interest were
defined by these studies and the authors (reviewers).
6.1 Validity
In the context of a
systematic review, the validity of a study is the extent to which its design
and conduct are likely to prevent systematic errors, or bias. An important
issue that should not be confused with validity is precision. Precision is a
measure of the likelihood of chance effects leading to random errors. It is
reflected in the confidence interval around the estimate of effect from each
study and the weight given to the results of each study when an overall
estimate of effect or weighted average is derived. More precise results are
given more weight.
6.2 Sources of
bias in trials of healthcare interventions
There are four
sources of systematic bias in trials of the effects of healthcare: selection
bias, performance bias, attrition bias and detection bias.
6.3 Selection
bias
Participants and those who recruit should remain unaware of
next assignment in sequence. Empirical research has shown that lack of
allocation concealment is associated with bias. For that reason trials should
use approaches such as allocation by a central office unaware of subject characteristics,
pre-numbered or coded identical containers which are administered serially to
participants, or an on-site computer system combined with allocations kept in
an unreadable file that can be accessed only after the characteristics of
enrolled participants have been entered.
6.4 Performance
bias
This refers to systematic differences in the care provided
to the participants in the comparison groups other than the intervention under
investigation. To protect against unintended differences in care and placebo
effects, those providing and receiving care can be "blinded" so that
they did not know the group to which the recipients of care have been
allocated.
6.5 Attrition
bias
This refers to systematic differences between comparison
groups in the loss of participants from the study. The study should consider
how losses of participants (withdrawals, dropouts and protocol deviations) are
handled.
6.6 Detection
bias
This refers to systematic differences between the comparison
groups in outcome assessment.
Rating:
1a
[2] Nuckols TK et al. Evaluating Medical Treatment Guideline Sets for Injured Workers in California. Published 2005 by the RAND Corporation, 1776 Main Street, P.O. Box 2138, Santa Monica, CA 90407-2138. Table 5.2, page 32. http://www.rand.org/pubs/monographs/2005/RAND_MG400.sum.pdf