Quality improvement in neurology: Distal Symmetric Polyneuropathy Quality Measures

John D. England, MD1; Gary Franklin, MD, MPH2; Gina Gjorvad3; Rebecca Swain-Eng, MS4; Thomas H. Brannagan, III, MD5; William S. David, MD, PhD6; Richard M. Dubinsky, MD, MPH7; Benn E. Smith, MD8

Author Institutions

1. Department of Neurology, Louisiana State University Health Sciences Center School of Medicine, New Orleans, LA

2. University of Washington, School of Public Health, Department of Environmental and Occupational Sciences, Neurology, and Health Services, Seattle, WA

3. American Academy of Neurology, Minneapolis, MN

4. American Academy of Neurology, Minneapolis, MN

5. Columbia University, Neurological Institute, Peripheral Neuropathy Center, New York, NY

6. Massachusetts General Hospital, Boston, MA

7. Dept. of Neurology, University of Kansas Medical Center

8. Dept. of Neurology, Mayo Clinic in Arizona

Address correspondence and reprint requests to:

American Academy of Neurology

201 Chicago Avenue

Minneapolis, MN 55415

(612) 928-6100

Title character count (with spaces):76

Abstract word count: 261

Manuscript word count: 2801


Author Contributions

Dr. England assisted with study concept and design, critical revision of the manuscript for important intellectual content and analysis and interpretation.

Dr. Franklin assisted with study concept and design, critical revision of the manuscript for important intellectual content and analysis and interpretation.

Ms. Gjorvad assisted with assisted with study concept and design, analysis and interpretation and study supervision.

Ms. Swain-Eng assisted with study concept and design, analysis and interpretation, critical revision of the manuscript for important intellectual content and study supervision.

Dr. David assisted with analysis and interpretation.

Dr. Dubinsky assisted with analysis and interpretation.

Dr. Smith assisted with analysis and interpretation.

Study Funding

No targeted funding reported

Disclosure

J. England reports disclosures for NIH-NINDS grant (Grant No: 5 RO1 NS048952), Gamunex-C Advisory Board, and Editor-in-Chief for the Journal of Neurological Sciences.

G. Franklin reports no disclosures relevant to the manuscript.

G. Gjorvad is a full-time employee of the American Academy of Neurology.

R. Swain-Eng is a full-time employee of the American Academy of Neurology.

W. David Reports no disclosures relevant to the manuscript.

R. Dubinsky reports disclosures for relationships with Allergan Pharmaceuticals, NIH, and AHRQ.

B. Smith reports no disclosures relevant to the manuscript.

Distal Symmetric Polyneuropathy measurement set approved by the AAN Board of Directors on July 31, 2012 and by the American Association of Neuromuscular Electrodiagnostic Medicine (AANEM) on October 11, 2013.

ABSTRACT

Objective: To describe new quality measures for distal symmetric polyneuropathy (DSP) management derived through a standardized, rigorous, evidence-based consensus process and their suitability for quality improvement activities, pay-for-reporting initiatives and maintenance of certification requirements.

Methods: The DSP measures were developed using the American Academy of Neurology (AAN) measure development process. Guidelines and consensus papers published from 2006 to 2011 were evaluated to determine their acceptability as the evidence base for development into a quality measure. Candidate recommendations from acceptable evidence sources were documented, reviewed, and prioritized by the work group based upon the level of evidence and strength of recommendation, the link to desired patient outcomes, gaps or variations in care, face validity, and feasibility to collect data. The prioritized recommendation statements were then developed into draft measures. A period of public comment was followed by review and approval from the AAN and supporting organizations.

Results: The literature search identified 128 relevant recommendation statements from 23 clinical practice guidelines, consensus papers and systematic reviews. Systematic assessment of the recommendations resulted in the development of 6 quality measures for DSP. The measures are focused on the diagnosis of DSP, screening for diabetes, screening for unhealthy use of alcohol, querying about pain and pain interference with function, and querying about falls.

Conclusion: DSP represents a significant health problem because it is a chronic, high-cost disease that can lead to significant morbidity, increased mortality and impaired quality of life. The AAN DSP quality measurement set defines basic and yet critical DSP quality measures in an effort to improve health outcomes for patients with DSP.

INTRODUCTION

Peripheral Neuropathy is a common neurological disorder, affecting at least 2 to 8 % of the population in population-based studies with confirmation by neurologist examination,1-3 and estimated to affect more than 20 million Americans.4 The prevalence of peripheral neuropathy increases with age, and affects approximately 15% of individuals over the age of 40 and 24% of individuals over the age 70.5,6 In 1999, 8.6% of Medicare beneficiaries had neuropathy as a primary or secondary diagnosis, and the cost of treatment was estimated at 3.5 billion dollars (CPT adjusted to 2013 $4.9 billion), which did not include outpatient medications.7 Peripheral neuropathy has many causes and varies in regard to its clinical manifestations and severity.

A major variety of peripheral neuropathy is distal symmetric polyneuropathy (DSP), which can result in weakness, sensory loss, pain, autonomic dysfunction, gait impairment, falls, disability and impaired quality of life.1 DSP represents a significant health problem because it is a chronic, high-cost disease and is often linked to severe neuropathic pain and significant morbidity, increased mortality and impaired quality of life.8-10 When caused by diabetes, DSP is a major risk factor for foot ulcerations and amputations.11,12 Treatments for DSP are directed at both the causes and symptoms.

Early identification and treatment, when available, is important to avoid irreversible nerve damage. In evaluating a patient with DSP, the clinical pattern of involvement, nerve conduction studies (NCSs) and laboratory tests are usually obtained to diagnose the condition and to identify potential etiologies.3 The collaborative case definition of DSP developed by the American Academy of Neurology (AAN), the American Association of Neuromuscular Electrodiagnostic Medicine (AANEM), and the American Academy of Physical Medicine and Rehabilitation (AAPMR) recommends that the combination of symptoms, signs and NCSs provides the highest level of diagnostic accuracy.13 NCSs can confirm a peripheral neuropathy and separate it from other entities as well as provide important information to identify the cause, with assessment for demyelination or axonal loss, multifocal involvement, and distribution of nerve fiber involvement or severity. Recent studies have demonstrated that these diagnostic studies are often not performed in patients with peripheral neuropathy.14 The practice parameter on the evaluation of DSP also recommend that patients with DSP be tested for the presence of diabetes, B12 deficiency and monoclonal gammopathy.15 A performance measurement set for peripheral neuropathy has the potential to improve care and improve the quality of life for people with peripheral neuropathy.

Measuring quality of health care is a central part of current concepts of health care plans and physician reimbursement. A quality measure includes a definition of the desired action and outcome and the applicable patient population, as well as subpopulations that should be excluded. The AAN has developed a performance in practice module based upon these DSP measures to satisfy the American Board of Psychiatry and Neurology Maintenance of Certification (MOC) Performance in Practice requirement16 The AAN DSP measures may also be suitable for use in a pay-for-reporting or quality improvement programs. The AAN has produced quality measures for stroke and stroke rehabilitation17, Parkinson disease18, epilepsy19, dementia20, amyotrophic lateral sclerosis21 and is developing measurement sets for other neurologic conditions including headache, muscular dystrophies and multiple sclerosis. This report describes the development of quality measures for the care of patients with DSP through the established AAN measure development process.22

METHODS

The DSP measure development process followed the AAN Quality Measurement and Reporting Subcommittee process for measure development.22 The steps in the measure development process require submitting the topic for selection, completing an evidence-based literature search, constructing draft measures and technical specifications, convening a multidisciplinary work group to review candidate measures, soliciting public comments during a 30 day period, refining the final measures and corresponding technical specifications, and obtaining approvals from the AAN DSP quality measure expert work group, AAN committees and the AAN Board of Directors. In addition, the measurement set was reviewed by the American Medical Association’s Performance Measurement Advisory Group to assign Current Procedural terminology (CPT)-II codes.

Topic selection. Neuropathy was selected as the topic as it is a clinical priority for neurology, has a high burden of illness, has demonstrated gaps in care with room for improvement, and has unexplained variations in care. The scope of neuropathy was narrowed down to DSP because the majority of the available evidence that would meet a gap in care focused on DSP and because of the prevalence of DSP. DSP measure development was also supported by the move toward quality improvement by medical professional societies and patient advocacy groups with a special interest in peripheral neuropathy, including the American Association of Neuromuscular Electrodiagnostic Medicine, American Academy of Physical Medicine and Rehabilitation, American Diabetes Association and The Neuropathy Association.

Work group formation. The AAN convened a multi-disciplinary AAN DSP quality measures work group to identify and define quality measures toward improving outcomes for patients with DSP. The work group was composed of a broad representation of key stakeholders with members from physician associations, neuropathy patient advocacy groups, the American Diabetes Association, health plans, and large group employers. Sixteen neuromuscular specialists from the AAN Neuromuscular, Clinical Neurophysiology, and Autonomic Nervous System sections responded to a call for serving on the work group and were independently screened by the co-chairs based on their experience in development of performance measures, quality improvement efforts, and clinical activities. The final work group (see end of manuscript for list of work group members and contributing organizations) included s 24 members: 14 neuromuscular clinicians representing five organizations, 1 general neurologist, 1 facilitator, 2 patient organization representatives, 2 insurance group representatives, 1 PCPI representative, 3 staff from the AAN, and 2 members of the AAN’s Quality Measurement and Reporting subcommittee. All AAN DSP quality measure work group members completed a profile and material interest disclosure statement (COI form). The work group was convened according to the AAN’s conflict of interest policy.23

Evidence-based literature search strategy. The literature search included peer reviewed articles in English with the following search terms: neuropathy, diabetic neuropathy, neuropathic pain, polyneuropathy, peripheral neuropathy, distal symmetric polyneuropathy; and all of these terms paired with falls, diabetes and carpal tunnel syndrome. The search included available published data from 2006 to 2011. Databases included the National Guideline Clearinghouse (NGC), National Measures Clearinghouse (NCMC), Ovid MEDLINE, Ovid EMBASE, Scopus, PubMed, and the Cochrane Library. Internet searches were carried out on relevant neuropathy websites. The main searches were supplemented by material identified by individual members of the work group. All available guidelines, measures and consensus papers were evaluated using the American Medical Association convened Physician Consortium for Performance Improvement® (PCPI)’s Framework for Determining Acceptability of Guidelines and other Evidence Review Documents.24

Evidence-based evaluation supporting development and writing of measures. The AAN DSP quality measure work group leadership screened each relevant full-text guideline or consensus paper against the PCPI framework for determining the acceptability of guidelines and other evidence review documents.24 If the inclusion of an article based on eligibility criteria was unclear, the expert work group co-chairs and facilitators were consulted. The recommendation statements and their corresponding level of evidence (as defined by the guideline developers’ rating scheme methodology) were then extracted from eligible guidelines and consensus papers. Candidate recommendations were documented, reviewed, and ranked by the co-chairs and facilitators based on face validity, feasibility to collect data, and gaps or variations in care. Measure specifications were carefully drafted with an experienced methodologist to include a full measure description, a numerator, a denominator, and applicable exceptions to the measures.

RESULTS

The literature search identified 128 relevant recommendations from 23 guidelines.13,15,25-45 Review by the co-chairs and facilitator resulted in 15 recommendation statements that were rated highest on importance, validity, strength of evidence, and gaps in care to serve as the evidence base for 9 candidate measures. The work group revised the draft measures and eliminated 3 of the measures at a face-to-face meeting on May 14, 2011. The remaining 6 measures were posted for a 30-day public comment. A total of 78 comments were received from physicians, patients, insurers, and other interested individuals. These comments were used to refine the draft measures. The 6 final measures were approved by the AMA Performance Measurement Advisory Group for CPT II codes effective July 1, 2012. The final set of measures was approved by the expert work group, appropriate AAN committees, and the AAN Board of Directors. This set of measures will be revised periodically with an extensive review every 3 years.

Brief measure titles and measure statements for each of the 6 DSP Performance Measures are listed in Table 1. The measurement set includes measures addressing appropriate diagnosis (measures 1 and 2), a measure addressing screening for diabetes (measure 3), a measure addressing unhealthy alcohol use (measure 4), a measure addressing pain and function (measure 5), and a measure addressing patient safety (measure 6). For the full measure specifications, and exceptions, see appendix e-2 on the Neurology® website at www.neurology.org .

DISCUSSION

DSP is one of the most common neurological disorders encountered by neurologists in practice, and is a major source of referral to practitioners, who are asked to clarify the diagnosis and specify treatment options. Starting in 2005, a collaboration between the American Academy of Neurology, the American Association of Neuromuscular Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation produced a specific research case definition of distal symmetric polyneuropathy intended to improve consistency and specificity of diagnostic criteria across population-based and clinical trial studies.13 The research case definition has been cited in nearly 175 peer reviewed studies on Web of Science in the past 7 years. To bridge the gap between the research enterprise and clinical practice, the Quality Measurement and Reporting Subcommittee of the AAN produced these six quality measures reflective of the best available evidence and best practice.

Measure 1, DSP diagnosis criteria: symptoms and signs and Measure 2, DSP diagnosis criteria: electrodiagnostic studies

These measures are separate but paired measures that were developed to reflect the evidence based diagnostic criteria for DSP.13 As such, these measures should both be performed together in order to appropriately diagnosis the patient for DSP. Polyneuropathy is often misdiagnosed or mistaken for other conditions, and this may lead to delays in treatment or inappropriate treatment.4 There is consensus that the combination of neuropathic symptoms, signs and abnormal electrodiagnostic studies provides the most accurate diagnosis of DSP.13 For these measures, the eligible patient population (denominator) is all patients age 18 years and older with a diagnosis of DSP as identified by the International Classification of Diseases-9 (ICD-9) codes for polyneuropathy. (For the full measure specifications with ICD-9 codes, see appendix e-2 on the Neurology® website at www.neurology.org)