- Email: [email protected]
Guideline Development Process in a Public Workers’ Compensation System
Guideline Development P ro c e s s in a P u b l i c Wo r k e r s ’ C o m p e n s a t i o n S y s t e m Simone P. Javaher,
RN, BSN, MPA
KEYWORDS Medical guideline Treatment guideline Clinical practice guideline Workers’ compensation Injured workers KEY POINTS Evidence-based clinical practice guidelines are developed and implemented in Washington state workers’ compensation using a rigorous and transparent process. Collaboration, dedicated staff, transparency, and process integrity are keys to success. Community clinicians partner with government in the development of these guidelines, leading to their broad acceptance.
INTRODUCTION
Evidence-based medicine has become the generally accepted approach in today’s health care system for determining what constitutes safe, effective, and costeffective care, whereas in the past, it was more likely to be “eminence-based medicine” (ie, relying on opinions from senior clinicians without any standardized process and safeguards against bias).1–3 The caveat with evidence-based medicine is that the advent of new technologies, devices, surgical techniques, and emerging or alternative treatments outpaces the availability of high-quality unbiased research such that it is often insufficient to support the use of these health services. Formally developed clinical practice guidelines help fill this gap, although even rigorously developed guidelines do not ensure they will be accepted in clinical practice.4 Since 1992, when the national Institute of Medicine (IOM) published its report, “Guidelines for Clinical Practice: From Development to Use,” the number of evidence-based clinical practice guidelines has skyrocketed. The Guidelines International Network (GIN) was founded in 2002 and has since counted (6509 guidelines across 96 organizations in 79
Conflicts of Interest: None. Office of the Medical Director, Labor and Industries, PO Box 44321, Olympia, WA 98504-4321, USA E-mail address: [email protected] Phys Med Rehabil Clin N Am 26 (2015) 427–434 http://dx.doi.org/10.1016/j.pmr.2015.04.009 1047-9651/15/$ – see front matter Ó 2015 Elsevier Inc. All rights reserved.
pmr.theclinics.com
428
Javaher
countries as of May 20155). The challenge is translating the plethora of scientific evidence into recommendations that are useful for the everyday practitioner. The National Guideline Clearinghouse (NGC), which is part of the US Health and Human Services Agency for Healthcare Research and Quality, maintains a central repository of national and international guidelines based on inclusion criteria established by the IOM in 2008.6 Fig. 1 illustrates this trend.
Fig. 1. Number of new guidelines published each year on the NGC. (Data from Javaher SP. National Guideline Clearinghouse. Available at: www.guideline.gov. Accessed December 13, 2014.)
These guidelines are not a substitute for sound clinical decision making; rather, they inform and facilitate sound clinical decision making. If developed using a rigorous method, clinical practice guidelines can provide easy-to-follow criteria, algorithms, and decision-making tools that help optimize patient care, improve treatment outcomes, and prevent harm. Although they are based on scientific evidence, they also draw on the expertise of researchers, clinicians, policy makers, and myriad others who can dive deeply into critical questions and nuances that the literature may not elucidate. Although variation exists among expert opinions and experience, systematically synthesized information derived from high-quality studies and a consensus of expert opinion can enhance the individual provider’s ability to deliver high-quality care. In addition, by using a transparent, rigorous, and trustworthy process, guidelines can have greater relevance and credibility for the clinician and withstand scrutiny in the era of accountable care. Since the 1980s, the Office of the Medical Director (OMD) in Washington state’s workers’ compensation system (part of Department of Labor and Industries [L&I]) has developed clinical practice guidelines (called medical treatment guidelines [MTGs]), and was the first workers’ compensation program to publish them on the NGC in 2002. To date, Colorado is the only other public workers’ compensation agency to post their guidelines on the NGC (starting in 2009). OMDs guidelines are used in the utilization review (UR) program and are regularly reviewed and updated as necessary. Furthermore, providers who treat Washington’s injured workers must be in our network and as such, are required by statute to use our MTGs (Revised Code of Washington 51.36.010). This article describes the rigorous guideline development process that OMD has refined during the last 7 years, which grew out of a model of collaboration and cooperation with our medical advisors, the health care
Guidelines in Workers’ Compensation
community, and the public. These partnerships have been rewarding and crucial to the success of our work. HOW IT STARTED
In 2007, the Industrial Insurance Medical Advisory Committee (IIMAC) was formed through passage of agency-sponsored legislation (SSB 5801, CH 6 [2011]; codified as Revised Code of Washington 51.36.140). Fourteen physicians are nominated by their specialty societies or institutions and appointed by the L&I director to be members. These physicians are required to be practicing clinicians representing family medicine, orthopedics, neurology, neurosurgery, general surgery, physical medicine and rehabilitation, psychiatry, internal medicine, osteopathic, pain medicine, and occupational medicine. At least two are required to have special expertise in evidence-based medicine. Although such a committee could have been formed by agency executive action, the statute provided two unique legal authorities: members are protected from legal action by the full extent of State legal authority; and members may be reimbursed for their work. In addition, all IIMAC meetings must be open to the public, so transparency is a built-in expectation. The law also established an Industrial Insurance Chiropractic Advisory Committee (IICAC), charged with using evidence to ensure workers receive high-quality chiropractic care. IICAC members are also nominated from their professional societies and institutions, and they follow a similar rigorous process for developing conservative care “practice resources” that summarize available evidence for common occupational musculoskeletal conditions. These practice resources complement the IIMAC guidelines and are also included on the NGC Web site (www.guidelines. gov). Led by an IIMAC member with expertise in the chosen topic, specially assigned subcommittees are formed to develop MTGs. Additional clinicians who are highly recognized leaders in the community are invited to complement subcommittee’s expertise. All clinical contributors to the guidelines must not have financial or nonfinancial conflicts of interest, and outside sponsorship or funding of a guideline is never accepted. The effectiveness and popularity of the IIMAC and IICAC work have generated so much interest that there is a waiting list of providers who want to join them. The success of OMD is largely because of agency leadership that led to the statutory establishment of these partnerships with community providers, dedicated resources to build staff capacity, and integrity in the guideline development process. But the glue that binds these elements together to truly make it work is constructive engagement, trust, and high-quality work, making the highest level of collaboration possible (Box 1). In February 2015, the IIMAC began work on its 15th guideline.
Box 1 Hallmarks of success 1. Leadership/statutory authority 2. Dedicated resources 3. Collaboration 4. Transparency 5. Process integrity
429
430
Javaher
SELECTION CRITERIA
Guideline development begins with prioritizing and selecting the topics. In consultation with IIMAC advisors and the L&I UR program managers and vendor, prioritization is based on the following criteria: Is there a cause for concern? a. Patient safety: is there a quality concern that poses a risk to the patient? b. Efficacy: are we seeing poor outcome data? c. Utilization and cost: what is the prevalence? d. Practice variation: is there wide variation from best practice? e. Rapidly emerging or diffusing technology: what are the implications? What are the business needs? a. From our partners: IIMAC members, clinicians, or self-insured employers? b. In our UR program? c. Controversy regarding a procedure, technology, or device? d. Legal requirements (eg, decisions or rulings from state and federal agencies)? Can we leverage resources? a. Can we group guidelines that require the same medical specialists? b. Are other state agencies and payers working on an issue/guideline for which there may be a mutual interest? How old is the guideline? a. Does new scientific literature indicate an update is needed? Has there been a sudden increase in cost and utilization, or is it due to expire on the NGC (must be updated every 5 years)? The typical view of an insurer’s role in using guidelines is that they are intended to save money. Although cost and use patterns may be a factor in selecting what guideline to develop, they are rarely primary influences. The mission of OMD is to help injured workers heal and return to work by ensuring appropriate high-quality care is provided and harm is avoided. To preserve the integrity of these goals, OMD is separated from that part of the agency that regulates reimbursement for health care services. Furthermore, Washington has many statewide evidence-based health care policy and purchasing requirements so there are built-in checks and balances for accuracy, consistency, and quality. Additionally, the workers’ compensation program has a long-standing research relationship with the University of Washington’s Occupational and Environmental Health Program to independently investigate, evaluate, and inform many of the agency’s guideline development efforts. This has established an iterative culture of policy needs informing research agendas and research findings informing policy development. Most importantly, this unique capacity to inform guideline development with outcomes research has led to improved outcomes for injured workers.7 DEVELOPMENT PROCESS
There are two ways to discuss this process: the standards we use, and how we go about implementing them. We follow most of the standards set by the IOM for developing trustworthy clinical practice guidelines (Box 2). Once a guideline topic is selected and the scope and objectives are identified, we begin the process of actual development. First, our epidemiologist does a systematic review of the literature based on key words and questions, and summarizes the findings into evidence tables using the grading schema from the American Academy of Neurology.8 Then, over the course of 3 to 5 months, the epidemiologist and OMD
Guidelines in Workers’ Compensation
Box 2 Institute of Medicine’s guideline development standards 1. Establish transparency 2. Management and disclosure of conflict of interest 3. Multidisciplinary and diverse group participation 4. Systematic review of the literature 5. Strength rating for the clinical recommendations 6. Clearly articulated clinical recommendations 7. External review of guidelines 8. Keeping guidelines updated Data from Institute of Medicine. Clinical practice guidelines we can trust. In: Graham R, et al, editors. Washington, DC: The National Academies Press; 2011. p. 33–4.
clinical staff meet with IIMAC subcommittee members, invited consulting practitioners, and clinicians from our UR vendor to hammer out the language and criteria. Each guideline typically includes the sections shown in Box 3, some of which are customized for an injured worker population. Box 3 Typical table of contents in Washington state’s workers’ compensation guideline A. Introduction B. Establishing work-relatedness C. Making the diagnosis 1. Case definition (symptoms and signs) 2. Relevant diagnostic tests (eg, imaging, electrodiagnostic, laboratory, and so forth) D. Clinical recommendations 1. Conservative treatment 2. Surgical treatment E. Return to work 1. Early assessment, including occupational health quality indicators 2. Returning to work following surgery F. Worksheets, tools, forms G. Guideline summary or algorithm for professional nurse reviewers (this may be at the start)
Subcommittee members critique and revise the draft guideline language as it is developed based on what is most useful for the clinician, the UR program, and any additional evidence or expert opinions that are brought to their attention. This typically means creating evaluation and review criteria in a table format so the recommendations are clear and easy to use. A final draft of the guideline is posted on the agency Web site for public comment for 4 weeks. After all public comments are received and reviewed, responses are provided by the subcommittee and posted on the Web site.
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Javaher
The subcommittee may make further revisions to the draft guideline until they present the final draft to the full advisory committee during one of its quarterly public meetings. Any member of the public can give oral comments at the meeting and changes may still be made. Once the full committee makes the advisory recommendation to adopt the guideline, OMD makes the final decision, and it usually becomes final 30 days later. Although we do not typically involve injured workers in the development process, they can access and comment on the guidelines when they are posted online or presented at the full IIMAC meeting. It is more our statutory relationships with business and labor leaders that give the process a great deal of credibility in our workers’ compensation authorizing environment. Strength ratings of published scientific evidence are typically included; however, our process does not try to summarize overall strength of recommendations. This is rather unique to a public process of guideline development where the expectation is that guidelines serve as provider education and as review criteria for our UR vendor.5 The latter requires specific enough guidance to allow a coverage decision to be made; highly nuanced summaries of strength of recommendations would make such decisions in the public sector very difficult. Every guideline has limitations, and a guideline that is too technical or overly comprehensive can create a burden when clinicians try to adopt it, leading to underuse of otherwise excellent evidence-based guidance. Thus, in addition to internal and external validity, including expert consensus by respected community clinicians gives face validity to the guideline, resulting in clear recommendations that are user-friendly and acceptable to the clinician. IMPLEMENTATION AND UPDATES
Probably equal to the challenge of writing guidelines, is making sure there is implementation validity in that they can be put into practice at all levels (eg, in the clinic, by the UR vendor, and by claim adjudicators). At L&I, most guidelines are implemented within the UR program. Although proprietary guidelines and criteria may be used, L&I guidelines have priority because they are highly credible within our health care provider community. Reviewers apply each guideline as a standard for most requests. Effective communication is also an integral part of the implementation process. The communication plan includes health care providers, claim managers, our UR staff and vendor, policy makers within the agency, and our self-insured employers and their third-party administrators (which account for about a third of Washington’s workforce). We share guidelines at conferences and CME courses, and we post them on the L&I external Web site, which in 2014 had 85,441 downloads (70,315 medical and 15,126 chiropractic) on the L&I Web site alone (www.lni.wa.gov). With the ongoing changes in health technologies and procedures and emerging scientific evidence, and with the continued need to devote resources to new guidelines, we keep to a schedule of regular review of the guidelines as they age. We depend heavily on our epidemiologist for this review and revision work, and all potential changes and updates are presented to the full IIMAC for their recommendations. GUIDELINE EVALUATION
Evaluating the quality and impact of our guidelines is also part of our process. We informally follow evaluation criteria, such as that provided by Appraisal of Guidelines for Research and Evaluation II, which is fairly straightforward because it is complimentary to the IOM process criteria (Box 4)
Guidelines in Workers’ Compensation
Box 4 Six domains of Appraisal of Guidelines for Research and Evaluation II evaluation criteria 1. Explicit scope and purpose (clear objective and clear target population) 2. Stakeholder involvement (Appraisal of Guidelines for Research and Evaluation II also cites patient involvement, but we use provider involvement) 3. Rigor of development (proper use of evidence, external review, guards against bias, risks vs benefits are considered) 4. Clarity of presentation (clinical recommendations are easy to identify and use, summary tables, and so forth) 5. Applicability (impacts, costs, and monitoring) 6. Editorial independence (no industry funding or conflicts of interest among developers) Data from Institute of Medicine. Clinical practice guidelines we can trust. In: Graham R, et al, editors. Washington, DC: The National Academies Press; 2011. p. 33–4.
Evaluating the impact of our guidelines on the quality of care received by injured workers is complex. We know that surgical guidelines work when approved requests for workers who truly require surgery increase, and requests are denied when the worker’s clinical presentation does not meet the guideline’s criteria. Additionally, we know our guidelines provide educational value to providers around the world. In the future, we may offer financial incentives for providers to use our guidelines as a measure of occupational medicine best practices. We continue to look for ways to evaluate their impact on more hard to get-at data, such as how readily correct diagnoses are made, or the extent to which disability is reduced, or whether they help prevent overuse of opioids. As technology changes (eg, the adoption of electronic medical records and the availability of prescription monitoring programs) it is possible we can gain these insights in the future, so Washington’s workers’ compensation program will continue to resource this important and effective effort. Visit the L&I Web site to review our guidelines and our IIMAC committee work at www.lni. wa.gov. SUMMARY/DISCUSSION
Whether they are called clinical practice or medical treatment guidelines, and whether they are developed by a government agency, a for-profit organization, or a private nonprofit professional association, the common goal is to produce “recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.”1 Although motives and methods may vary, guideline authors must stay true to the principles of evidence-based medicine and quality guideline standards so practitioners who make the day-to-day clinical decisions have current, valid, and reliable information. The days of “eminence-based medicine” are gone, and guideline developers cannot properly evaluate the benefits of a guideline unless clinicians adopt and apply them. Guidelines need to have an institutional home where a process of developing trustworthy guidelines can be sustained.2 In Washington, the workers’ compensation system has established this institutional home in the L&I OMD. Through collaboration with a statutory advisory committee, dedicated resources, collaboration, transparency, and process integrity, a successful method of producing high-quality MTGs has been established and its future for continued improvement is ensured.
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REFERENCES
1. Institute of Medicine. Clinical practice guidelines we can trust. In: Graham R, Mancher M, Wolman DM, et al, editors. Washington, DC: The National Academies Press; 2011. p. 33–4. 2. Ransohoff DF, Pignone M, Sox HC. How to decide whether a clinical practice guideline is worthy. JAMA 2013;309:139–40. 3. Szajewska H. Clinical practice guidelines: based on eminence or evidence? Ann Nutr Metab 2014;64:325–31. 4. Nuckols TK, Yee-Wei L, Wynn BO. Rigorous development does not ensure that guidelines are acceptable to a panel of knowledgeable providers. J Gen Intern Med 2007;23:37–44. 5. Guidelines International Network. Resources/international guideline library. guidelines international network. 2011. Available at: http://www.g-i-n.net/library/ international-guidelines-library. Accessed December 13, 2014. 6. Institute of Medicine. Committee on reviewing evidence to identify highly effective clinical services. In: Eden J, Wheatley B, McNeil B, et al, editors. Knowing what works in health care, a roadmap for the nation. Washington, DC: The National Academies Press; 2008. Available at: http://www.guideline.gov/about/inclusioncriteria.aspx. Accessed May 15, 2015. 7. Martin BI, Franklin GM, Deyo RA. How do coverage policies influence practice patterns, safety, and cost of initial lumbar fusion surgery? A population-based comparison of workers’ compensation systems. Spine J 2014;14:1237–46. 8. American Academy of Neurology. Clinical practice guideline process manual. St Paul (MN): The American Academy of Neurology; 2011.
RN, BSN, MPA
KEYWORDS Medical guideline Treatment guideline Clinical practice guideline Workers’ compensation Injured workers KEY POINTS Evidence-based clinical practice guidelines are developed and implemented in Washington state workers’ compensation using a rigorous and transparent process. Collaboration, dedicated staff, transparency, and process integrity are keys to success. Community clinicians partner with government in the development of these guidelines, leading to their broad acceptance.
INTRODUCTION
Evidence-based medicine has become the generally accepted approach in today’s health care system for determining what constitutes safe, effective, and costeffective care, whereas in the past, it was more likely to be “eminence-based medicine” (ie, relying on opinions from senior clinicians without any standardized process and safeguards against bias).1–3 The caveat with evidence-based medicine is that the advent of new technologies, devices, surgical techniques, and emerging or alternative treatments outpaces the availability of high-quality unbiased research such that it is often insufficient to support the use of these health services. Formally developed clinical practice guidelines help fill this gap, although even rigorously developed guidelines do not ensure they will be accepted in clinical practice.4 Since 1992, when the national Institute of Medicine (IOM) published its report, “Guidelines for Clinical Practice: From Development to Use,” the number of evidence-based clinical practice guidelines has skyrocketed. The Guidelines International Network (GIN) was founded in 2002 and has since counted (6509 guidelines across 96 organizations in 79
Conflicts of Interest: None. Office of the Medical Director, Labor and Industries, PO Box 44321, Olympia, WA 98504-4321, USA E-mail address: [email protected] Phys Med Rehabil Clin N Am 26 (2015) 427–434 http://dx.doi.org/10.1016/j.pmr.2015.04.009 1047-9651/15/$ – see front matter Ó 2015 Elsevier Inc. All rights reserved.
pmr.theclinics.com
428
Javaher
countries as of May 20155). The challenge is translating the plethora of scientific evidence into recommendations that are useful for the everyday practitioner. The National Guideline Clearinghouse (NGC), which is part of the US Health and Human Services Agency for Healthcare Research and Quality, maintains a central repository of national and international guidelines based on inclusion criteria established by the IOM in 2008.6 Fig. 1 illustrates this trend.
Fig. 1. Number of new guidelines published each year on the NGC. (Data from Javaher SP. National Guideline Clearinghouse. Available at: www.guideline.gov. Accessed December 13, 2014.)
These guidelines are not a substitute for sound clinical decision making; rather, they inform and facilitate sound clinical decision making. If developed using a rigorous method, clinical practice guidelines can provide easy-to-follow criteria, algorithms, and decision-making tools that help optimize patient care, improve treatment outcomes, and prevent harm. Although they are based on scientific evidence, they also draw on the expertise of researchers, clinicians, policy makers, and myriad others who can dive deeply into critical questions and nuances that the literature may not elucidate. Although variation exists among expert opinions and experience, systematically synthesized information derived from high-quality studies and a consensus of expert opinion can enhance the individual provider’s ability to deliver high-quality care. In addition, by using a transparent, rigorous, and trustworthy process, guidelines can have greater relevance and credibility for the clinician and withstand scrutiny in the era of accountable care. Since the 1980s, the Office of the Medical Director (OMD) in Washington state’s workers’ compensation system (part of Department of Labor and Industries [L&I]) has developed clinical practice guidelines (called medical treatment guidelines [MTGs]), and was the first workers’ compensation program to publish them on the NGC in 2002. To date, Colorado is the only other public workers’ compensation agency to post their guidelines on the NGC (starting in 2009). OMDs guidelines are used in the utilization review (UR) program and are regularly reviewed and updated as necessary. Furthermore, providers who treat Washington’s injured workers must be in our network and as such, are required by statute to use our MTGs (Revised Code of Washington 51.36.010). This article describes the rigorous guideline development process that OMD has refined during the last 7 years, which grew out of a model of collaboration and cooperation with our medical advisors, the health care
Guidelines in Workers’ Compensation
community, and the public. These partnerships have been rewarding and crucial to the success of our work. HOW IT STARTED
In 2007, the Industrial Insurance Medical Advisory Committee (IIMAC) was formed through passage of agency-sponsored legislation (SSB 5801, CH 6 [2011]; codified as Revised Code of Washington 51.36.140). Fourteen physicians are nominated by their specialty societies or institutions and appointed by the L&I director to be members. These physicians are required to be practicing clinicians representing family medicine, orthopedics, neurology, neurosurgery, general surgery, physical medicine and rehabilitation, psychiatry, internal medicine, osteopathic, pain medicine, and occupational medicine. At least two are required to have special expertise in evidence-based medicine. Although such a committee could have been formed by agency executive action, the statute provided two unique legal authorities: members are protected from legal action by the full extent of State legal authority; and members may be reimbursed for their work. In addition, all IIMAC meetings must be open to the public, so transparency is a built-in expectation. The law also established an Industrial Insurance Chiropractic Advisory Committee (IICAC), charged with using evidence to ensure workers receive high-quality chiropractic care. IICAC members are also nominated from their professional societies and institutions, and they follow a similar rigorous process for developing conservative care “practice resources” that summarize available evidence for common occupational musculoskeletal conditions. These practice resources complement the IIMAC guidelines and are also included on the NGC Web site (www.guidelines. gov). Led by an IIMAC member with expertise in the chosen topic, specially assigned subcommittees are formed to develop MTGs. Additional clinicians who are highly recognized leaders in the community are invited to complement subcommittee’s expertise. All clinical contributors to the guidelines must not have financial or nonfinancial conflicts of interest, and outside sponsorship or funding of a guideline is never accepted. The effectiveness and popularity of the IIMAC and IICAC work have generated so much interest that there is a waiting list of providers who want to join them. The success of OMD is largely because of agency leadership that led to the statutory establishment of these partnerships with community providers, dedicated resources to build staff capacity, and integrity in the guideline development process. But the glue that binds these elements together to truly make it work is constructive engagement, trust, and high-quality work, making the highest level of collaboration possible (Box 1). In February 2015, the IIMAC began work on its 15th guideline.
Box 1 Hallmarks of success 1. Leadership/statutory authority 2. Dedicated resources 3. Collaboration 4. Transparency 5. Process integrity
429
430
Javaher
SELECTION CRITERIA
Guideline development begins with prioritizing and selecting the topics. In consultation with IIMAC advisors and the L&I UR program managers and vendor, prioritization is based on the following criteria: Is there a cause for concern? a. Patient safety: is there a quality concern that poses a risk to the patient? b. Efficacy: are we seeing poor outcome data? c. Utilization and cost: what is the prevalence? d. Practice variation: is there wide variation from best practice? e. Rapidly emerging or diffusing technology: what are the implications? What are the business needs? a. From our partners: IIMAC members, clinicians, or self-insured employers? b. In our UR program? c. Controversy regarding a procedure, technology, or device? d. Legal requirements (eg, decisions or rulings from state and federal agencies)? Can we leverage resources? a. Can we group guidelines that require the same medical specialists? b. Are other state agencies and payers working on an issue/guideline for which there may be a mutual interest? How old is the guideline? a. Does new scientific literature indicate an update is needed? Has there been a sudden increase in cost and utilization, or is it due to expire on the NGC (must be updated every 5 years)? The typical view of an insurer’s role in using guidelines is that they are intended to save money. Although cost and use patterns may be a factor in selecting what guideline to develop, they are rarely primary influences. The mission of OMD is to help injured workers heal and return to work by ensuring appropriate high-quality care is provided and harm is avoided. To preserve the integrity of these goals, OMD is separated from that part of the agency that regulates reimbursement for health care services. Furthermore, Washington has many statewide evidence-based health care policy and purchasing requirements so there are built-in checks and balances for accuracy, consistency, and quality. Additionally, the workers’ compensation program has a long-standing research relationship with the University of Washington’s Occupational and Environmental Health Program to independently investigate, evaluate, and inform many of the agency’s guideline development efforts. This has established an iterative culture of policy needs informing research agendas and research findings informing policy development. Most importantly, this unique capacity to inform guideline development with outcomes research has led to improved outcomes for injured workers.7 DEVELOPMENT PROCESS
There are two ways to discuss this process: the standards we use, and how we go about implementing them. We follow most of the standards set by the IOM for developing trustworthy clinical practice guidelines (Box 2). Once a guideline topic is selected and the scope and objectives are identified, we begin the process of actual development. First, our epidemiologist does a systematic review of the literature based on key words and questions, and summarizes the findings into evidence tables using the grading schema from the American Academy of Neurology.8 Then, over the course of 3 to 5 months, the epidemiologist and OMD
Guidelines in Workers’ Compensation
Box 2 Institute of Medicine’s guideline development standards 1. Establish transparency 2. Management and disclosure of conflict of interest 3. Multidisciplinary and diverse group participation 4. Systematic review of the literature 5. Strength rating for the clinical recommendations 6. Clearly articulated clinical recommendations 7. External review of guidelines 8. Keeping guidelines updated Data from Institute of Medicine. Clinical practice guidelines we can trust. In: Graham R, et al, editors. Washington, DC: The National Academies Press; 2011. p. 33–4.
clinical staff meet with IIMAC subcommittee members, invited consulting practitioners, and clinicians from our UR vendor to hammer out the language and criteria. Each guideline typically includes the sections shown in Box 3, some of which are customized for an injured worker population. Box 3 Typical table of contents in Washington state’s workers’ compensation guideline A. Introduction B. Establishing work-relatedness C. Making the diagnosis 1. Case definition (symptoms and signs) 2. Relevant diagnostic tests (eg, imaging, electrodiagnostic, laboratory, and so forth) D. Clinical recommendations 1. Conservative treatment 2. Surgical treatment E. Return to work 1. Early assessment, including occupational health quality indicators 2. Returning to work following surgery F. Worksheets, tools, forms G. Guideline summary or algorithm for professional nurse reviewers (this may be at the start)
Subcommittee members critique and revise the draft guideline language as it is developed based on what is most useful for the clinician, the UR program, and any additional evidence or expert opinions that are brought to their attention. This typically means creating evaluation and review criteria in a table format so the recommendations are clear and easy to use. A final draft of the guideline is posted on the agency Web site for public comment for 4 weeks. After all public comments are received and reviewed, responses are provided by the subcommittee and posted on the Web site.
431
432
Javaher
The subcommittee may make further revisions to the draft guideline until they present the final draft to the full advisory committee during one of its quarterly public meetings. Any member of the public can give oral comments at the meeting and changes may still be made. Once the full committee makes the advisory recommendation to adopt the guideline, OMD makes the final decision, and it usually becomes final 30 days later. Although we do not typically involve injured workers in the development process, they can access and comment on the guidelines when they are posted online or presented at the full IIMAC meeting. It is more our statutory relationships with business and labor leaders that give the process a great deal of credibility in our workers’ compensation authorizing environment. Strength ratings of published scientific evidence are typically included; however, our process does not try to summarize overall strength of recommendations. This is rather unique to a public process of guideline development where the expectation is that guidelines serve as provider education and as review criteria for our UR vendor.5 The latter requires specific enough guidance to allow a coverage decision to be made; highly nuanced summaries of strength of recommendations would make such decisions in the public sector very difficult. Every guideline has limitations, and a guideline that is too technical or overly comprehensive can create a burden when clinicians try to adopt it, leading to underuse of otherwise excellent evidence-based guidance. Thus, in addition to internal and external validity, including expert consensus by respected community clinicians gives face validity to the guideline, resulting in clear recommendations that are user-friendly and acceptable to the clinician. IMPLEMENTATION AND UPDATES
Probably equal to the challenge of writing guidelines, is making sure there is implementation validity in that they can be put into practice at all levels (eg, in the clinic, by the UR vendor, and by claim adjudicators). At L&I, most guidelines are implemented within the UR program. Although proprietary guidelines and criteria may be used, L&I guidelines have priority because they are highly credible within our health care provider community. Reviewers apply each guideline as a standard for most requests. Effective communication is also an integral part of the implementation process. The communication plan includes health care providers, claim managers, our UR staff and vendor, policy makers within the agency, and our self-insured employers and their third-party administrators (which account for about a third of Washington’s workforce). We share guidelines at conferences and CME courses, and we post them on the L&I external Web site, which in 2014 had 85,441 downloads (70,315 medical and 15,126 chiropractic) on the L&I Web site alone (www.lni.wa.gov). With the ongoing changes in health technologies and procedures and emerging scientific evidence, and with the continued need to devote resources to new guidelines, we keep to a schedule of regular review of the guidelines as they age. We depend heavily on our epidemiologist for this review and revision work, and all potential changes and updates are presented to the full IIMAC for their recommendations. GUIDELINE EVALUATION
Evaluating the quality and impact of our guidelines is also part of our process. We informally follow evaluation criteria, such as that provided by Appraisal of Guidelines for Research and Evaluation II, which is fairly straightforward because it is complimentary to the IOM process criteria (Box 4)
Guidelines in Workers’ Compensation
Box 4 Six domains of Appraisal of Guidelines for Research and Evaluation II evaluation criteria 1. Explicit scope and purpose (clear objective and clear target population) 2. Stakeholder involvement (Appraisal of Guidelines for Research and Evaluation II also cites patient involvement, but we use provider involvement) 3. Rigor of development (proper use of evidence, external review, guards against bias, risks vs benefits are considered) 4. Clarity of presentation (clinical recommendations are easy to identify and use, summary tables, and so forth) 5. Applicability (impacts, costs, and monitoring) 6. Editorial independence (no industry funding or conflicts of interest among developers) Data from Institute of Medicine. Clinical practice guidelines we can trust. In: Graham R, et al, editors. Washington, DC: The National Academies Press; 2011. p. 33–4.
Evaluating the impact of our guidelines on the quality of care received by injured workers is complex. We know that surgical guidelines work when approved requests for workers who truly require surgery increase, and requests are denied when the worker’s clinical presentation does not meet the guideline’s criteria. Additionally, we know our guidelines provide educational value to providers around the world. In the future, we may offer financial incentives for providers to use our guidelines as a measure of occupational medicine best practices. We continue to look for ways to evaluate their impact on more hard to get-at data, such as how readily correct diagnoses are made, or the extent to which disability is reduced, or whether they help prevent overuse of opioids. As technology changes (eg, the adoption of electronic medical records and the availability of prescription monitoring programs) it is possible we can gain these insights in the future, so Washington’s workers’ compensation program will continue to resource this important and effective effort. Visit the L&I Web site to review our guidelines and our IIMAC committee work at www.lni. wa.gov. SUMMARY/DISCUSSION
Whether they are called clinical practice or medical treatment guidelines, and whether they are developed by a government agency, a for-profit organization, or a private nonprofit professional association, the common goal is to produce “recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.”1 Although motives and methods may vary, guideline authors must stay true to the principles of evidence-based medicine and quality guideline standards so practitioners who make the day-to-day clinical decisions have current, valid, and reliable information. The days of “eminence-based medicine” are gone, and guideline developers cannot properly evaluate the benefits of a guideline unless clinicians adopt and apply them. Guidelines need to have an institutional home where a process of developing trustworthy guidelines can be sustained.2 In Washington, the workers’ compensation system has established this institutional home in the L&I OMD. Through collaboration with a statutory advisory committee, dedicated resources, collaboration, transparency, and process integrity, a successful method of producing high-quality MTGs has been established and its future for continued improvement is ensured.
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REFERENCES
1. Institute of Medicine. Clinical practice guidelines we can trust. In: Graham R, Mancher M, Wolman DM, et al, editors. Washington, DC: The National Academies Press; 2011. p. 33–4. 2. Ransohoff DF, Pignone M, Sox HC. How to decide whether a clinical practice guideline is worthy. JAMA 2013;309:139–40. 3. Szajewska H. Clinical practice guidelines: based on eminence or evidence? Ann Nutr Metab 2014;64:325–31. 4. Nuckols TK, Yee-Wei L, Wynn BO. Rigorous development does not ensure that guidelines are acceptable to a panel of knowledgeable providers. J Gen Intern Med 2007;23:37–44. 5. Guidelines International Network. Resources/international guideline library. guidelines international network. 2011. Available at: http://www.g-i-n.net/library/ international-guidelines-library. Accessed December 13, 2014. 6. Institute of Medicine. Committee on reviewing evidence to identify highly effective clinical services. In: Eden J, Wheatley B, McNeil B, et al, editors. Knowing what works in health care, a roadmap for the nation. Washington, DC: The National Academies Press; 2008. Available at: http://www.guideline.gov/about/inclusioncriteria.aspx. Accessed May 15, 2015. 7. Martin BI, Franklin GM, Deyo RA. How do coverage policies influence practice patterns, safety, and cost of initial lumbar fusion surgery? A population-based comparison of workers’ compensation systems. Spine J 2014;14:1237–46. 8. American Academy of Neurology. Clinical practice guideline process manual. St Paul (MN): The American Academy of Neurology; 2011.