The following written comments were submitted by IFFGD president, Ceciel T. Rooker, to the US Social Security Administration (SSA) in response to Docket No. SSA-2018-0017 calling for public comments regarding the “Consideration of Pain in the Disability Determination Process.”
On behalf of the millions of Americans living with a chronic, and often painful, gastrointestinal (GI) illness, the International Foundation for Gastrointestinal Disorders (IFFGD) thanks the U.S. Social Security Administration (SSA) for the opportunity to provide comments regarding Docket No. SSA-2018-0017, “Consideration of Pain in the Disability Determination Process.”
Established in 1991, IFFGD is a 501(c)(3) patient-driven nonprofit organization dedicated to assisting adults and children affected by chronic GI illnesses by providing education and support for patients, family members, health care providers, and the public. IFFGD also works to advance critical research aimed at broadening our understanding of the basic mechanisms and clinical care of these conditions and providing patients with better treatment options, and perhaps one day, cures.
We are pleased to support all efforts of the SSA to provide financial protection to the American people, and, especially, to protect citizens unable to work due to a medical condition or injury. I am writing to you today in response to a call for public comments and supporting data to help guide how pain is considered by the SSA in adult and child disability claims.
According to a 2018 report of the U.S. Centers for Disease Control and Prevention (CDC), chronic pain affects an estimated 50 million U.S. adults, and approximately 20 million adults are currently living with high-impact chronic pain – pain considered severe enough to interfere with life or work activities most days. For these individuals and their caregivers, employment is not always possible. This extends to the caregivers of children affected by chronic pain. Data from the 2016 National Survey of Children’s Health (NSCH) revealed that among adolescents (ages 12-17) with chronic pain, 14% of parents reported that they were forced to cut back on paid work as a result of their child’s illness.
Chronic or intermittent abdominal pain is the predominant symptom experienced by many adults and children with a chronic GI condition including inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), functional abdominal pain, functional dyspepsia, and abdominal migraine and is associated with impaired health-related quality of life, increased utilization of health care resources, and work and school absenteeism. Among GI illnesses, rates of absenteeism positively correlate with highly stigmatized conditions (e.g. fecal incontinence) and the diagnosis of a pain-predominant disorder such as chronic abdominal pain, biliary pain, functional dyspepsia, and IBS.
At IFFGD, we hear from thousands of people who live daily with pain as a result of a chronic GI illness. As patient advocates, we have long believed that the frequency and severity of symptoms of these conditions, including chronic pain, are often underestimated by the medical and research communities, making it difficult for the needs of this patient population to be adequately evaluated. In response to this anticipated disconnect, we have worked to incorporate the perspectives of patients in research. For example, in 2009 IFFGD published the peer-reviewed article “International Survey of Patients with IBS: Symptom Features and Their Severity, Health Status, Treatments, and Risk Taking to Achieve Clinical Benefit” in the Journal of Clinical Gastroenterology in collaboration with the UNC Center for Functional GI and Motility Disorders. Findings from this web-based, international survey (72% U.S.) of 1,966 adults in the community with IBS revealed that pain is the predominant symptom for those affected, with 78% of participants experiencing continuous or frequently occurring abdominal pain during the last six months. This pain can be disabling, disrupting the lives of those affected and preventing them from fully engaging in daily activities. More than 38% of those surveyed reported that their abdominal pain interferes with their daily activities always or often and 13% reported being jobless due to their health situation. Severity was found to impact employment; nearly one-third (30%) of participants with severe symptoms reported being jobless compared to 5% of participants with mild to moderate symptoms.
More recently, in 2017 IFFGD sponsored another research survey in collaboration with clinical researchers from Temple University School of Medicine in Digestive Diseases and Sciences entitled “The Burdens, Concerns, and Quality of Life of Patients with Gastroparesis.” Like our 2009 survey of the IBS community, this web-based survey of 1,423 adults with gastroparesis was intended to document the impact of the condition on patients from the patient’s viewpoint to help us better understand how those affected suffer and help identify treatment priorities. They also bore startling similarities in findings. Like those with IBS, pain was identified as one of the most troubling symptoms for individuals with gastroparesis, with nearly half of respondents (46%) reporting stomach pain as the most troubling symptom when gastroparesis symptoms became severe. Pain associated with gastroparesis also impacted job status. Nearly one-third (30%) of respondents reported that they are not working because of their health situation, and of the 70% employed, 15% reported working limited hours because of their gastroparesis. These findings underscore the impact of chronic pain on the daily lives of those affected.
We are pleased that the SSA is seeking input from the public regarding the evaluation and documentation of pain as part of the disability determination process. Our specific recommendations are explained below.
Are there changes that we should consider about how we consider pain in the disability evaluation process? If so, what changes do you suggest we make? Please provide data, research, or any other evidence supporting your suggestions where applicable.
Section 404.1529 of the Code of Federal Regulations Title 20 – Employees’ Benefits states that “There must be objective medical evidence from an acceptable medical source that shows you have a medical impairment(s) which could reasonably be expected to produce the pain.” The qualifications of “objective medical evidence” are described later in the document as “evidence obtained from the application of medically acceptable clinical and laboratory diagnostic techniques, such as evidence of reduced joint motion, muscle spasm, sensory deficit or motor disruption.”
As “functional disorders,” many pain-predominant GI illnesses are characterized by abnormal functioning of the body’s normal activities and may include the following: motility disturbances, visceral hypersensitivity, altered mucosal and immune function, altered gut microbiota, and altered central nervous system (CNS) processing. However, no structural abnormalities can be seen by endoscopy, X-ray, or blood tests for these conditions, making the pain “invisible.” Individuals living with these conditions are also more likely to have other invisible pain-related disorders, including migraine headache, fibromyalgia, rheumatologic conditions, and chronic pelvic pain compared with the general population. While these conditions are invisible, their symptoms, including pain, exert a very real impact on the daily lives of those affected, often interfering with work and school opportunities.
While we recognize the acknowledgement made in the document that “symptoms sometimes suggest a greater severity of impairment than can be shown by objective medical evidence alone” and efforts will be made to “carefully consider any other information” submitted about symptoms, we urge the SSA to also consider symptoms, including pain, associated with clinical diagnoses made on the basis of symptom-based criteria rather than laboratory tests. Guidelines for symptom-based criteria are available for many pain-predominant conditions through sponsoring professional societies, such as the recently released Rome IV criteria published by the Rome Foundation for the diagnosis of functional GI disorders.
Within the United States, which standard scales, questionnaires, or other methods to evaluate the intensity and persistence of pain that are commonly accepted in the medical community do you recommend we consider and why? What information exists about the efficacy or accuracy of those scales, questionnaires, or other methods?
While we have a greater understanding of the neurophysiology of pain, the experience of pain remains a personal and highly variable entity. Pain intensity is not a one-to-one product of pathology, but is instead informed by biomedical, psychosocial (e.g. beliefs about pain, expectations, and fluctuations in mood), and behavioral (e.g. context, responses of loved ones) factors. Therefore, in order to effectively evaluate pain, each of these three factors must be considered. This may include outside reports (e.g. patient history, medical evaluation, screening interviews) as well as validated patient-reported instruments. For many pain-predominant conditions, pain has been found to drive health-related quality of life (HRQoL) scores, and routinely-used pain scales (e.g. numeric rating scales) have been calibrated to patient-reported outcomes measures for many chronic pain-predominant conditions, including IBS. And, new patient-centered instruments are currently being developed (e.g. Reneman MF, et al. 2018).
The personal experience of chronic pain is complex and is shaped by biomedical, psychosocial, and behavioral factors. However, validated patient-centered instruments are available and should be incorporated into any objective measurement of pain.
Should we evaluate chronic pain differently than acute pain? If so, why and how?
Acute pain can be defined as “a physiologic response to noxious stimuli that is sudden in onset and time-limited.” This definition differentiates acute pain from chronic pain both in terms of time (time-limited vs persisting or recurring long-term) and nature (provoked by a specific stimulus and serving a useful biological purpose vs outlasting the normal time of healing, if arising from a disease or injury, and without biological purpose or recognizable end-point). However, the lines differentiating these two definitions are blurred by the experience of acute pain “flares” in chronic and complex health conditions including, but not limited to, arthritis, migraine, and certain GI illnesses, such as IBD, IBS, and functional dyspepsia.
While complexities exist in these two definitions, it is our view that differences in the goals for treatment can help inform decisions about disability claims. For individuals with acute pain that is not associated with a chronic or recurring health condition, therapy is aimed at addressing and treating the underlying cause of the pain, interrupting nociceptive signals, and rehabilitating to optimize outcome within the shortest possible time necessary. For these patients, full recovery is expected, and long-term disability is not anticipated. In contrast, among individuals with chronic pain, including pain that recurs or “flares” over time, successful rehabilitation is not always possible. Special consideration should be paid to the limitations and needs of these individuals in cases of disability.
Should we evaluate nociceptive pain differently than neuropathic pain? If so, why and how? Please submit research or data that support your recommendation.
While we encourage the SSA to consider both nociceptive and neuropathic pain, we also urge the SSA to consider diagnoses of pain that may defy these classifications, such as fibromyalgia and IBS.
What information and evidence are available on the effectiveness and side effects of the traditional and alternative modalities for treating pain that we should consider?
We encourage the SSA to consider pain management recommendations outlined in the recent draft report released by the U.S. Department of Health and Human Services (HHS) Pain Management Best Practices Inter-Agency Task Force entitled “Pain Management Best Practices: Updates, Gaps, Inconsistencies, and Recommendations.” This report provides an overview of the benefits and limitations of different modalities for treating pain including pharmacological, restorative (e.g. massage therapy, transcutaneous electric nerve stimulation, therapeutic ultrasound), interventional (e.g. neuromodulation, peripheral and sympathetic nerve blocks, steroid injections), and behavioral (e.g. cognitive behavioral therapy, mindfulness) approaches.
We thank you for your consideration of our comments, and we welcome the opportunity to work with the SSA to further capture the patient perspective regarding pain and its impact on daily life. We believe that understanding the burden faced by patients living with chronic pain and their caregivers will provide greater clarity for decisions regarding disability by the SSA.