Search

The COVID-19 pandemic has been associated with increased opioid prescribing. It is not known if perceived COVID-19 related stress is associated with increased odds of long-term opioid use.To determine if greater COVID-19-related stress and worsening pain attributed to the pandemic was associated with LTOT over a 6-month observation period.Longitudinal cohort.Patients (n=477) from two midwestern health care systems, with any acute or chronic non-cancer pain, starting a new period of 30-90-day prescription opioid use, were invited to participate in the Prescription Opioids and Depression Pathways Cohort Study, a longitudinal survey study of pain, opioid use, and mental health outcomes.Baseline and 6-month follow-up assessments were used to measure the association between perceived COVID-19 stressors, the perception that pain was made worse by the pandemic and the odds of persistent opioid use, i.e., remaining a prescription opioid user at 6-month follow-up. Multivariate models controlled for demographics, opioid dose, and change in pain characteristics, mental health measures, and social support.Participants were, on average, 53.9 (±11.4) years of age, 67.1% White race, and 70.9% female. The most frequently endorsed COVID-19 stressor was "worry about health of self/others" (85.7% endorsed) and the least endorsed was "worsened pain due to pandemic" (26.2%). After adjusting for all covariates, "worsened pain due to pandemic" (OR=2.88; 95%CI: 1.33-6.22), change in pain interference (OR=1.20; 95%CI: 1.04-1.38), and change in vital exhaustion (OR=0.90; 95%CI: 0.82-0.99) remained significantly associated with persistent opioid use.Patients who attribute worsening pain to the COVID-19 pandemic are more likely to be persistent opioid users. Further research is warranted to identify mechanisms underlying this association. Clinicians may consider discussing pain in the context of the pandemic to identify patients at high risk for persistent opioid use.

The COTAT (Collaborative Opioid Taper After Trauma) Study was a randomized trial of an opioid taper support program using a physician assistant (PA) to provide pain and opioid treatment guidance to primary care providers assuming care for adult patients with moderate to severe trauma discharged from a Level I trauma center on opioid therapy. Patients were recruited, assessed, and randomized individually by a surgery research recruitment team one to two days prior to discharge to home. Participants randomized to the opioid taper support program were contacted by phone within a few days of discharge by the PA interventionist to confirm enrollment and their primary care provider (PCP). The intervention consisted of PA support to the PCP as needed concerning pain and opioid care at weeks 1, 2, 4, 8, 12, 16, and 20 after discharge or until the PCP office indicated they no longer needed support or the patient had tapered off opioids. The PA was supervised by a pain physician-psychiatrist, a family physician, and a trauma surgeon. Patients randomized to usual care received standard hospital discharge instructions and written information on managing opioid medications after discharge. Trial results were analyzed using repeated measures analysis. 37 participants were randomized to the intervention and 36 were randomized to usual care. The primary outcomes of the trial were pain, enjoyment, general activity (PEG score) and mean daily opioid dose at 3 and 6 months after hospital discharge. Treatment was unblinded but assessment was blinded. No significant differences in PEG or opioid outcomes were noted at either time point. Physical function at 3 and 6 months and pain interference at 6 months were significantly better in the usual care group. No significant harms of the intervention were noted. COVID limited recruitment of high-risk opioid tolerant subjects, and limited contact between the PA interventionist and the participants and the PCPs. Our opioid taper support program failed to improve opioid and pain outcomes, since both control and intervention groups tapered opioids and improved PEG scores after discharge. Future trials of post-trauma opioid taper support with populations at higher risk of persistent opioid use are needed. This trial is registered at clinicaltrials.gov under NCT04275258 11/02/2020. This trial was funded by a grant from the Centers for Disease Control and Prevention to the University of Washington Harborview Injury Prevention & Research Center (R49 CE003087, PI: Monica S. Vavilala, MD). The funder had no role in the analysis or interpretation of the data.

This chapter argues that changes in our values about pain and opioids were much more important than increases in the prevalence of chronic pain in creating the opioid epidemic. Central to these changes was the argument that chronic pain is not just a symptom of disease, but also a disease itself that deserves its own treatment. Pain intensity measurement was used to determine the need for pain treatment and the success of that treatment. This assessment strategy was joined with the titrate-to-effect treatment strategy first utilized in cancer pain treatment that declared that the proper opioid dose is the dose that significantly reduces the pain intensity score. The pain-as-disease model is intended to increase the scientific and clinical legitimacy of chronic pain, but it tends to exclude the patient from the process of treatment and recovery and may produce iatrogenic harm.

This chapter argues that we cannot cure or abolish pain from human life. The utilitarians argued that all pain is bad, and professional pain medicine has argued that pain relief should be among the core universal human rights provided by all societies. We argue that health professionals have misunderstood not only opioids, but also pain itself. We work our way backward through the Western history of pain, gradually unwinding the tight knots of pain problems bequeathed to us: from pain conceived as a medical problem, to pain as a social problem, and finally to pain as an existential or religious problem. The great promise of the biomedical model is that chronic pain can be killed with pills or procedures while leaving the person untouched. This promise is one of the deep roots of our opioid epidemic.

This chapter argues that our mechanical causal theories about pain provide the basis for our moral theories about pain and our policies about opioids, including the right to pain relief. Our modern medical view of pain sees it as a natural event with causes but not reasons. We separate pain (as produced by impersonal mechanisms originating within the body) from suffering (as arising from personal and interpersonal meanings originating between bodies). Patients with pain have done nothing to cause or deserve the pain they experience. This causal passivity and its moral corollary, innocence, are the basis for the claim of a right to pain relief. That is why this right to pain relief is limited to the use of prescribed opioids for the treatment of physical pain, never for the rest of human suffering.

This chapter tells the story of pain shifting from being inevitable and essential suffering to becoming inessential suffering that did not need to be borne. The story begins with the birth of anesthesia, hailed as the conquering of pain. That event alone opened up many possibilities beyond opioids and alcohol for controlling pain, and changed the minds of many who saw pain as something that morally must be endured. The story continues with the pioneers of pain medicine, the narrowing of the goal of pain relief into simple intensity reduction, and the commandeering of the vision of pain medicine’s pioneers into a huge commercial venture that misunderstood the limitations of pain intensity reduction if divorced from the wider suffering caused by pain.

This chapter argues that the widely endorsed biopsychosocial (BPS) model is incomplete and was powerless to stop the opioid epidemic. The BPS model addresses a diverse set of psychological and social influences on chronic pain, but it doesn’t question the independence of the “objective biological event” of disease or pain. The BPS model focuses on biological causes of pain and psychosocial modifiers of that experience. Biological factors are allowed to stand on their own as causes of chronic pain, while psychological and social factors are not. Emotion is often conceived as a reaction to the pain sensation rather than a core component of pain. This means that the BPS model does not challenge the separation of mechanical pain from human suffering, including the idea of pain as passive suffering, which has supported the right to pain relief and the use of opioid painkillers.

This chapter examines the different kinds of problems that pain has posed over the past millennium. Until about 1500, pain was primarily understood as a religious problem. Pain and suffering challenged the truth of religious belief and the legitimacy of the Church. All pain and suffering happened for a reason. As our society became more secular over the next 300 years, pain came to be understood primarily as a social problem. Our modernizing society aimed to create the best environment for human flourishing by reducing the pain and suffering of everyone to the minimum possible. At least since 1900, we have separated pain as a medical problem from the remainder of human suffering. Now pain has causes rather than reasons. We have aimed to reduce this problem to a minimum through medical treatment. This quest has led us to our opioid epidemic.

This chapter reviews the experience of Reggie Winston, a mechanical engineer with chronic low back pain. It begins with his divorce, followed by the onset of his back pain after a fall while backpacking. He gets temporary relief from epidural steroid injections, but soon progresses to a lumbar fusion. This provides partial relief, but after a hard plane landing he is in significant pain again. He is treated with Percocet, then Oxycontin, with an initial good response. He continues drinking alcohol and gradually escalates his dose. After a breakup with a girlfriend, he accidentally overdoses on opioids and alcohol. He enters alcohol and drug rehabilitation, followed by a pain rehabilitation program. He readily takes to the exercise focus, but finds addressing his chronic anger to be more challenging.

This chapter describes how the discovery of an endogenous opioid system in humans in the mid-1970s radically changed our understanding of opioids. Whereas opioids had long been known as drugs that could produce pain relief or addiction, depending on circumstances, endogenous opioid systems revealed a role for opioids that extended far beyond simple pain relief or addiction. These systems, we now know, are critical in stress responses, and in learning protective actions and behaviors to allow the individual to function in a hostile world and in society. For humans, socialization is critical for survival. One of the greatest harms of opioid drugs, which commandeer endogenous opioid systems, is the attenuation of natural survival behaviors, including socialization. Here we describe how the discovery of an endogenous opioid system opened up a new understanding of pain itself, how the individual has power over pain, and how opioid drugs compromise the individual’s ability to self-manage pain.

This chapter describes the gradual establishment of a right to pain relief. After the Second World War, and because of the horrors that war, Western nations formed the United Nations, which saw the protection of human rights as part of its role. The United Nations wrote a Declaration of Human Rights in 1948. Although it did not initially establish a right to pain relief per se, later amendments established a right to pain relief at the end of life. Other bodies, including the U.S. Supreme Court, similarly established a right to pain relief at the end of life. Although these august bodies have never followed with statements of a right to the relief of all pain, the largest and most influential international pain society, the International Association for the Study of Pain, in 2011 wrote its own declaration, the Declaration of Montreal, which states that access to pain management is a “fundamental human right.”

This chapter describes a primary care physician’s experience with treating four returning patients and two new patients with chronic pain. The focus is on the personal challenge posed by these patients. Each patient has a unique set of medical and social problems, but each poses a challenge about continuing, escalating, tapering, discontinuing, or starting long-term opioid therapy. Difficulties in making correct medical and psychiatric diagnoses are reviewed.

This chapter examines how the ideal of managing complex chronic pain on a rehabilitation model was gradually eroded, particularly in the United States, as healthcare itself became increasingly focused on rapid results and short-term outcomes. Multidisciplinary management became hard to sustain, chronic pain management fell increasingly to primary care, and primary care became increasingly stressed by the burden of looking after intractable chronic conditions. The lure of opioids drew patients and their physicians into prescribing that promised much relief, but ultimately increased the burden of care. The framing of pain as a medical problem opened the floodgates for abuse of patients’ suffering based on profiteering and the offering of false hopes. Once the limitations of long-term opioid therapy became clear, the medical community turned back to the earlier recognition that over-reliance on medical solutions for chronic pain leaves the patient out of the recovery.

The current International Association for the Study of Pain (IASP) definition of pain as "An unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage" was recommended by the Subcommittee on Taxonomy and adopted by the IASP Council in 1979. This definition has become accepted widely by health care professionals and researchers in the pain field and adopted by several professional, governmental, and nongovernmental organizations, including the World Health Organization. In recent years, some in the field have reasoned that advances in our understanding of pain warrant a reevaluation of the definition and have proposed modifications. Therefore, in 2018, the IASP formed a 14-member, multinational Presidential Task Force comprising individuals with broad expertise in clinical and basic science related to pain, to evaluate the current definition and accompanying note and recommend whether they should be retained or changed. This review provides a synopsis of the critical concepts, the analysis of comments from the IASP membership and public, and the committee's final recommendations for revisions to the definition and notes, which were discussed over a 2-year period. The task force ultimately recommended that the definition of pain be revised to "An unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage," and that the accompanying notes be updated to a bulleted list that included the etymology. The revised definition and notes were unanimously accepted by the IASP Council early this year.

The biopsychosocial model (BPS) of chronic pain aspires to be comprehensive, incorporating psychological and social factors omitted from biomedical models. Although psychosocial factors are viewed as highly influential in understanding behavioral and psychological responses to pain, these factors are usually viewed as modifiers of biological causes of the experience of pain itself, rather than as equal contributors to pain. To further advance the BPS model, we re-examine a classic 1994 article by Wilbert "Bill" Fordyce, "Pain and suffering: what is the unit?" In this article, Fordyce suggested that pain-related disability and suffering should be viewed as "transdermal," as having causes both inside and outside the body. We consider Fordyce's article theoretically important because this concept allows us to more fully break free of the medical model of chronic pain than customary formulations of the BPS model. It makes it possible to place psychological and social factors on an equal footing with biological ones in explaining pain itself and to remove distinctions between pain mechanisms and pain meanings. The brain's salience network now offers a platform on which diverse influences on pain experience-from nociception to multisensory indicators of safety or danger-can be integrated, bridging the gap between impersonal nociceptive mechanisms and personal meanings. We also argue that Fordyce's article is practically important because this concept expands the BPS model beyond the bounds of the clinical encounter, opening the door to the full range of social, psychological, and biological interventions, empowering patients and nonmedical providers to tackle chronic pain.

Preventing depression in cancer patients on long-term opioid therapy should begin with depression screening before opioid initiation and repeated screening during treatment. In weighing the high morbidity of depression and opioid use disorder in patients with chronic cancer pain against a dearth of evidence-based therapies studied in this population, patients and clinicians are left to choose among imperfect but necessary treatment options. When possible, we advise engaging psychiatric and pain/palliative specialists through collaborative care models and recommending mindfulness and psychotherapy to all patients with significant depression alongside cancer pain. Medications for depression should be reserved for moderate to severe symptoms. We recommend escitalopram/citalopram or sertraline among selective serotonin reuptake inhibitors (SSRIs), or the serotonin and norepinephrine reuptake inhibitors (SNRIs) duloxetine, venlafaxine, or desvenlafaxine if patients have a significant component of neuropathic pain or fibromyalgia. Tricyclic antidepressants (TCAs) (consider nortriptyline or desipramine, which have better anticholinergic profiles) should be considered for patients who do not respond to or tolerate SSRI/SNRIs. Existing evidence is inadequate to definitively recommend methylphenidate or novel agents, such as ketamine or psilocybin, as adjunctive treatments for cancer-related depression and pain. Physicians who treat patients with cancer pain should utilize universal precautions to limit the risk of non-medical opioid use (non-medical opioid use). Patients should be screened for non-medical opioid use behaviors at initial consultation and at regular intervals during treatment using a non-judgmental approach that reduces stigma. Co-management with an addiction specialist may be indicated for patients at high risk of non-medical opioid use and opioid use disorder. Buprenorphine and methadone are indicated for the treatment of opioid use disorder, and while they have not been systematically studied for treatment of opioid use disorder in patients with cancer pain, they do provide analgesia for cancer pain. While an interdisciplinary team approach to manage psychological stress may be beneficial, this may not be possible for patients treated outside of comprehensive cancer centers.

It was not until the twentieth century that pain was considered a disease. Before that it was managed medically as a symptom. The motivations for declaring chronic pain a disease, whether of the body or of the brain, include increasing its legitimacy as clinical problem and research focus worthy of attention from healthcare and research organizations alike. But 1 problem with disease concepts is that having a disease favors medical solutions and tends to reduce patient participation. We argue that chronic pain, particularly chronic primary pain (recently designated a first tier pain diagnosis in International Diagnostic Codes 11), is a learned state that is not intransigent even if it has biological correlates. Chronic pain is sometimes a symptom, and may sometimes be its own disease. But here we question the value of a disease focus for much of chronic pain for which patient involvement is essential, and which may need a much broader societal approach than is suggested by the disease designation. PERSPECTIVE: This article examines whether designating chronic pain a disease of the body or brain is helpful or harmful to patients. Can the disease designation help advance treatment, and is it needed to achieve future therapeutic breakthrough? Or does it make patients over-reliant on medical intervention and reduce their engagement in the process of recovery?

BackgroundDecreasing exposure to prescription opioids is critical to lowering risk of opioid misuse, overdose and opioid use disorder. This study reports a secondary analysis of a randomized controlled trial implementing an opioid taper support program directed to primary care providers (PCPs) of patients discharged from a level I trauma center to their homes distant from the center, and shares lessons for trauma centers in supporting these patients.MethodsThis longitudinal descriptive mixed-methods study uses quantitative/qualitative data from trial intervention arm patients to examine implementation challenges and outcomes: adoption, acceptability, appropriateness, feasibility, fidelity. In the intervention, a physician assistant (PA) contacted patients after discharge to review their discharge instructions and pain management plan, confirm their PCP’s identity and encourage PCP follow-up. The PA reached out to the PCP to review the discharge instructions and offer ongoing opioid taper and pain management support.ResultsThe PA reached 32 of 37 patients randomized to the program. Of these 32, 81% discussed topics not targeted by the intervention (eg, social/financial). The PA identified and reached a PCP’s office for only 51% of patients. Of these, all PCP offices (100% adoption) received one to four consults (mean 1.9) per patient (fidelity). Few consults were with PCPs (22%); most were with medical assistants (56%) or nurses (22%). The PA reported that it was not routinely clear to patients or PCPs who was responsible for post-trauma care and opioid taper, and what the taper instructions were.ConclusionsThis level I trauma center successfully implemented a telephonic opioid taper support program during COVID-19 but adapted the program to allow nurses and medical assistants to receive it. This study demonstrates a critical need to improve care transition from hospitalization to home for patients discharged after trauma.Level of evidenceLevel IV.

Long-term opioid therapy (LTOT) is associated with increased risk for depression. It is not known if the frequency of opioid use during LTOT is associated with new-onset depression. We used Optum's de-identified Integrated Claims-Clinical dataset (2010-2018) to create a cohort of 5146 patients, 18 to 80 years of age, with an encounter or claims in the year before new LTOT. New LTOT was defined by90-day opioid use after remaining opioid free for 6 months. Opioid use frequency during the first 90 days of LTOT was categorized into occasional use (50% days covered), intermittent use (50% to80% days covered), frequent use (80% to90% days covered), and daily use (≥90% days covered). Propensity scores and inverse probability of exposure weighting controlled for confounding in models estimating risk for new-onset depression. Patients were on average 54.5 (SD ± 13.6) years of age, 55.7% were female, 72.5% were White, and 9.5% were African American. After controlling for confounding, daily users (hazard ratio = 1.40; 95% confidence interval: 1.14-1.73) and frequent users (hazard ratio = 1.34; 95% confidence interval: 1.05-1.71) were significantly more likely to develop new-onset depression compared with occasional users. This association remained after accounting for the contribution of post-index pain diagnoses and opioid use disorder. In LTOT, risk for new depression episodes is up to 40% greater in near-daily users compared with occasional users. Patients could reduce depression risk by avoiding opioid use on as many low pain days as possible. Repeated screening for depression during LTOT is warranted.

Inappropriate polypharmacy, prevalent among older patients, is associated with substantial harms.To develop measures of high-risk polypharmacy and pilot test novel electronic health record (EHR)-based nudges grounded in behavioral science to promote deprescribing.We developed and validated seven measures, then conducted a three-arm pilot from February to May 2019.Validation used data from 78,880 patients from a single large health system. Six physicians were pre-pilot test environment users. Sixty-nine physicians participated in the pilot.Rate of high-risk polypharmacy among patients aged 65 years or older. High-risk polypharmacy was defined as being prescribed ≥5 medications and satisfying ≥1 of the following high-risk criteria: drugs that increase fall risk among patients with fall history; drug-drug interactions that increase fall risk; thiazolidinedione, NSAID, or non-dihydropyridine calcium channel blocker in heart failure; and glyburide, glimepiride, or NSAID in chronic kidney disease.Physicians received EHR alerts when renewing or prescribing certain high-risk medications when criteria were met. One practice received a "commitment nudge" that offered a chance to commit to addressing high-risk polypharmacy at the next visit. One practice received a "justification nudge" that asked for a reason when high-risk polypharmacy was present. One practice received both.Among 55,107 patients 65 and older prescribed 5 or more medications, 6256 (7.9%) had one or more high-risk criteria. During the pilot, the mean (SD) number of nudges per physician per week was 1.7 (0.4) for commitment, 0.8 (0.5) for justification, and 1.9 (0.5) for both interventions. Physicians requested to be reminded to address high-risk polypharmacy for 236/833 (28.3%) of the commitment nudges and acknowledged 441 of 460 (95.9%) of justification nudges, providing a text response for 187 (40.7%).EHR-based measures and nudges addressing high-risk polypharmacy were feasible to develop and implement, and warrant further testing.

BACKGROUND: High levels of opioid prescribing in the United States has resulted in an alarming trend in opioid-related harms. The objective of Trial 2 of the Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS-2) is to dampen the intensity and frequency of opioid prescribing in accordance with the Centers for Disease Control and Prevention recommendation to “go low and slow”. We aim to accomplish this by notifying clinicians of harmful patient outcomes, which we expect to increase the mental availability of risks associated with opioid use. METHODS: The trial is multi-site. Random assignment determines if prescribers to persons who suffer an opioid overdose (fatal or nonfatal) learn of this event (intervention) or practice usual care (control). Clinicians in the intervention group receive a letter notifying them of their patient’s overdose. The primary outcome is the change in clinician weekly milligram morphine equivalent (MME) prescribed in a 6-month period before and after receiving the letter. Additional outcomes are the change in the proportion of patients prescribed at least 50 daily MME and in the proportion of patients referred to medication assisted treatment. Group differences in these outcomes will be compared using an intent-to-treat difference-in-differences framework with a mixed-effects regression model to estimate clinician MME. DISCUSSION: The AESOPS-2 trial will provide new knowledge about whether increasing prescribers’ awareness of patients’ opioid-related overdoses leads to a reduction in opioid prescribing. Additionally, this trial may better inform how to reduce opioid use disorder and opioid overdoses by lowering population exposure to these drugs. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04758637

The concept of psychogenic pain has a long and hoary history in both the clinical and philosophical literature on pain. Sensible modern scholars are expected to reject the concept of psychogenic pain with a quick toss of the head. The history of the psychiatric diagnosis of “psychogenic pain” is instructive. Before 1980, psychologically caused pain was understood in terms of psychodynamic processes. These concerned the dynamic interaction of emotional and motivational forces that affect behavior and states of mind. Sigmund Freud drew upon the work of Anton Mesmer and Jean Charcot that showed hypnosis could reverse paralysis and other conversion symptoms such as blindness or deafness. Cognitive-behavioral therapy (CBT) has become the most popular and well-tested psychological approach to managing patients with chronic pain. CBT grew out of behavioral therapies for chronic pain which sought to promote adaptive behavior using principles of learning theory.

The principal goals of health care are to help people “live longer and live better,” that is, to optimize both survival and health. In the American Heart Association’s (AHA) special report, “Defining and setting national goals for cardiovascular health promotion and disease reduction: the American Heart Association’s strategic Impact Goal through 2020 and beyond,” the AHA set the following goal: > “By 2020, to improve the cardiovascular health of all Americans by 20% while reducing deaths from cardiovascular diseases and stroke by 20%.” 1 The emphasis on improving cardiovascular health is laudable, yet it raises the question of how cardiovascular health is best measured. Indeed, the metrics of cardiovascular health have not been well delineated compared with other cardiovascular mortality and morbidity outcomes. The AHA’s strategic goals primarily focus on ideal health behaviors (eg, not smoking) and ideal health factors (eg, blood pressure control) as metrics of cardiovascular health.1 Although these are of clear import, they do not directly address the World Health Organization’s definition of health as “… a state of complete physical, mental and social well-being.”2 Moreover, the Institute of Medicine identified patient-centered care as 1 of the 6 domains of high-quality health care, wherein patient-centered care supports clinicians in “attending to their patients’ physical and emotional needs, and maintaining or improving their quality of life.”3 The Patient-Centered Outcomes Research Institute emphasizes the goal of “focusing on outcomes that people notice and care about such as survival, function, symptoms, and health related quality of life.”4 Recent concepts of value in health care and the “triple aim” center on improving patients’ health and experience with health care while reducing costs; each reinforces the importance of assessing the impact of disease and medical treatment on patients’ functional status and quality of life.5,6 The definition …

Patient action in chronic disease care may not be best understood as “behavior.” Healthy patients do not just emit healthy behaviors but act as agents in their own lives. Bandura revolutionized health psychology through his “agentic” approach that emphasized patient confidence or self-efficacy. Now, the personal importance of behavior change is elicited using techniques like motivational interviewing. These and other approaches that include personal goals and identity shift our focus from behavior to action. Health action includes not just management of a disease separate from the self, but self-transformation. Achieving lasting change in health actions requires attention to the autonomous quality of patient motivation. Self-determination theory offers a useful theory of intrinsic motivation and an understanding of the process of internalization of motivation. This helps us understand the promise of shared decision-making and its difference from informed consent. Ultimately, patient empowerment must be understood as fostering patient autonomy.

We don’t have a clear idea where health comes from. Our efforts to reform health care to make it more patient-centered and more responsive to the challenges of chronic illness have been too superficial. Three lessons for chronic illness care are derived: 1) we cannot assume that death and disease are the most important targets for health care, 2) we must draw on the patient’s perspective to define the nature of the clinical problem and the criteria of success for our clinical interventions, and 3) we must always aim toward increasing the patient’s capacity for self-care. The patient-centered care of chronic disease requires that we recognize the patient as the primary perceiver and producer of health. We must move not only from the passive patient to the informed and activated patient, but to the autonomous patient. Patient agency is both the primary means and primary end of health care.

Objective definitions of health and disease are favored because they promise a value-free measure of health problems and health care needs. But objective health does not simply cause the subjective experience of health. Self-rated health predicts mortality, disability, and hospitalizations for up to a decade after controlling for objective measures of health. Objective tissue abnormalities cannot be discovered to be pathological without reference to the experiences of patients acting in their natural environment. Patients adapt to chronic illness and its functional deficits over time with real improvements in their quality of life. Problems like pain and depression do not distort quality of life assessments, but are at their core. Since neither objective nor subjective models of health are valid, we must derive a different model: health as capacity for action. Any adequate approach to health must foster the patient’s sense of agency, her capacity to achieve her vital goals.

Despite accelerating expenditures on health care, the United States is falling behind peer countries in population health. The mismatch between dollars spent on health care and health achieved raises the question of the value of health services. How should we value these? The Affordable Care act expands access to care but does not question expert valuation of health states and health services. Rather than beginning with health insurance, a more productive path for our thinking proceeds from the nature of health to the nature of health care to the nature of health insurance. If we are to keep health care costs from rising no faster than GDP, we must make the patient the true customer for health care. Health policy should not aim to minimize objective disease or maximize subjective well-being, but to foster health capability. This encompasses the ability to enjoy health and to pursue it.

The roots of biological autonomy and health are the same. Goals make biology distinct as a science, for without goals, we cannot understand why a biological trait exists. Organisms are autonomous biological entities because they define what is inside and what is outside themselves. This boundary between inner and outer gives the organism a self-referential purpose. Claude Bernard made experimental physiology possible with his concept of the internal environment, but he was unable to explain how the organism established the boundary between itself and its environment. Hence, homeostasis portrays the organism as reactive not active. Autopoiesis is an alternative defining characteristic of living beings. It generates biological autonomy through additional biological constraint on chemical processes, not through a special vital force. Healthy organisms can construct their own environmental niche. For humans, this niche is social and is constructed with a social physiology. Both exercise and education increase health by increasing capacity for niche construction.

Patient autonomy on a personal level is ultimately rooted in biological autonomy on a subpersonal level. Patient decisional autonomy concerns the conscious choices patients make concerning treatments and lifestyle, whereas biological autonomy concerns the ability of patients to shape their environment. To understand the roots of health in this biological autonomy, we must bridge the chasm characteristic of modern natural science between personal meaning and impersonal mechanism. We will find that “health” and “action” represent blind spots for medical and biological theory, respectively. Modern medicine strongly distinguishes the impersonal disease from the patient who has the disease. Four disciplines at the margin of biomedicine are reviewed that challenge this separation: psychosomatics, placebo, alternative medicine, and geriatrics. Attention to personal goals during diagnosis and treatment is one way to bridge the gap between impersonal disease and the patient as person. But, ultimately, the impersonal biomedical disease model needs to be challenged.

Bioethics teaches us to respect patients as persons by respecting their decisional autonomy. We respect patient autonomy by seeking patients’ informed consent, a policy was first developed for clinical research, where it has worked reasonably well. In other areas, most notably end-of-life care, it has not worked as well. Respecting patient autonomy is not adequate respect for them as ill persons. Rather than opposing physician beneficence and patient autonomy, as is customary in bioethics, we should consider the promotion of patient autonomy as a part of physician beneficence. This recasts the conflict between beneficence and autonomy as the conflict between respecting and promoting patient autonomy. This autonomy needs to be understood not just as the ability to make decisions but also as the general ability to do and be things of value (i.e. agency). This autonomy is not just a value that qualifies care, but is a goal of care.

The importance of chronic illness has brought a new focus on patient-reported outcomes of clinical care. Health-Related Qualify of Life (HRQL) is a new goal for clinical care that combines a physician’s view of health as an objective biological fact and the patient’s view of health as a subjective experiential state. The diagnosis of an impersonal and objective disease separable from the patient arose after the French Revolution and helped to delimit the new right to health care. But objective mortality and morbidity metrics are not adequate for capturing the burden of chronic illness. HRQL was invented to capture the burden of chronic illness, but has not been successfully incorporated into clinical trials or clinical care. Chronic low back pain is presented as an example where both objective and subjective metrics of treatment success have failed. We need an openly patient-centered definition of health that is not just a supplement to objective disease diagnosis.

More fundamental than the patient’s capacity to perceive and value health is the capacity of the patient to produce health. Population and individual health do not originate from health care. Health care is not just inefficient at producing health; it can produce significant iatrogenic harm in clinical, social, and cultural ways. Patients may be overtreated. Non-patients may be overdiagnosed. Our culture is seduced into the belief that all death and disease can be controlled. Iatrogenesis transforms into expropriation as we become confused and forgetful about the sources of health itself. We have gradually strengthened our clinical safety net and weakened our social safety net. Yet, international studies suggest social spending improves population health more than clinical spending. The right to health is usually approximated as the right to health care. But this is inadequate and counterproductive. A better policy is a right to health capability.

Patient health behavior is crucially important in the care of chronic disease. Medication adherence and lifestyle health behaviors both make major contributions to individual and population health. Clinical interventions to improve adherence and lifestyle are contrasted with their natural determinants. The Chronic Care Model shifts our attention from promoting patient obedience to developing skills for self-management of chronic illness. We need to ask whether treatment of chronic illness, like diabetes, should be accomplished through or around patient. Two recent diabetes treatment trials, ACCORD and TEAMCARE, provide contrasting approaches to the nature of therapeutic action. The Diabetes Prevention Project demonstrated that it is possible to prevent the development of diabetes through exercise and diet or medication. Adherence to treatment appears to improve health outcomes, even if the treatment is inactive, through the “healthy adherer effect.” This suggests that an active approach to health may have intrinsic benefits.

Health care in the USA faces a double challenge, the crisis of chronic pain and the crisis of opioid misuse and overdose. Patients have been prescribed opioids at high doses with unclear indications for long periods of time, putting them at high risk for morbidity and mortality. A significant proportion of these patients have comorbid psychiatric or substance use disorders complicating their pain conditions. The challenges to treating these patients adequately are discussed, along with potential solutions to these issues at the level of the individual provider, healthcare systems, and society.

Diabet. Med. 29, e67–e74 (2012) Abstract Aims Post-hoc evaluation of relationships between first-year change in glycaemic control (HbA1c) and change in patient-reported outcomes among ACCORD health-related quality of life (HRQoL) substudy participants. Methods Data from 2053 glycaemia-trial subjects were analysed. We assessed physical and mental health status (36-Item Short Form Health Survey, Version-2), symptom count and severity (Diabetes Symptoms Distress Checklist) and treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire). Linear mixed models were used to test relationships between 1-year changes in HbA1c and patient reported outcomes sequentially adjusting for correlates (baseline characteristics, baseline patient reported outcomes, treatment assignment, frequency of clinical contact and post-randomization weight change plus new complications). Results Poorer baseline control of HbA1c and cardiovascular disease risk factors predicted greater one-year improvements in treatment satisfaction. Similarly, poorer baseline patient reported outcome scores all individually predicted greater 1-year improvement in that same outcome. Accounting for baseline and post-randomization characteristics and treatment arm, 1-year change in HbA1c was unrelated to changes in overall physical or mental health; however, every one percentage-point (10.9 mmol/mol) reduction in HbA1c was associated with lower symptom count (β = 0.599; P = 0.012), lower symptom distress (β = 0.051; P = 0.001), and higher treatment satisfaction (β = −2.514; P

To report chronic opioid therapy discontinuation rates after five years and identify factors associated with discontinuation.Medical and pharmacy claims records from January 2000 through December 2005 from a national private health network (HealthCore), and Arkansas (AR) Medicaid were used to identify ambulatory adult enrollees who had 90 days of opioids supplied. Recipients were followed until they discontinued opioid prescription fills or disenrolled. Kaplan Meier survival models and Cox proportional hazards models were estimated to identify factors associated with time until opioid discontinuation.There were 23,419 and 6,848 chronic opioid recipients followed for a mean of 1.9 and 2.3 years in the HealthCore and AR Medicaid samples. Over a maximum follow up of 4.8 years, 67.0% of HealthCore and 64.9% AR Medicaid recipients remained on opioids. Recipients on high daily opioid dose (greater than 120 milligrams morphine equivalent (MED)) were less likely to discontinue than recipients taking lower doses: HealthCore hazard ratio (HR) = 0.66 (95%CI: 0.57-0.76), AR Medicaid HR = 0.66 (95%CI: 0.50-0.82). Recipients with possible opioid misuse were also less likely to discontinue: HealthCore HR = 0.83 (95%CI: 0.78-0.89), AR Medicaid HR = 0.78 (95%CI: 0.67-0.90).Over half of persons receiving 90 days of continuous opioid therapy remain on opioids years later. Factors most strongly associated with continuation were intermittent prior opioid exposure, daily opioid dose ≥ 120 mg MED, and possible opioid misuse. Since high dose and opioid misuse have been shown to increase the risk of adverse outcomes special caution is warranted when prescribing more than 90 days of opioid therapy in these patients.

The use of chronic opioid therapy (COT) for chronic non-cancer pain (CNCP) has increased dramatically in the past two decades. There has also been a marked increase in the abuse of prescribed opioids and in accidental opioid overdose. Misuse of prescribed opioids may link these trends, but has thus far only been studied in small clinical samples. We therefore sought to validate an administrative indicator of opioid misuse among large samples of recipients of COT and determine the demographic, clinical, and pharmacological risks associated with possible and probable opioid misuse. A total of 21,685 enrollees in commercial insurance plans and 10,159 in Arkansas Medicaid who had at least 90 days of continuous opioid use 2000-2005 were studied for one year. Criteria were developed for possible and probable opioid misuse using administrative claims data concerning excess days supplied of short-acting and long-acting opioids, opioid prescribers and opioid pharmacies. We estimated possible misuse at 24% of COT recipients in the commercially insured sample and 20% in the Medicaid sample and probable misuse at 6% in commercially insured and at 3% in Medicaid. Among non-modifiable factors, younger age, back pain, multiple pain complaints and substance abuse disorders identify patients at high risk for misuse. Among modifiable factors, treatment with high daily dose opioids (especially >120 mg MED per day) and short-acting Schedule II opioids appears to increase the risk of misuse. The consistency of the findings across diverse patient populations and the varying levels of misuse suggest that these results will generalize broadly, but await confirmation in other studies.

Objective To report trends and characteristics of long-term opioid use for non-cancer pain. Methods CONSORT (CONsortium to Study Opioid Risks and Trends) includes adult enrollees of two health plans serving over 1 per cent of the US population. Using automated data, we constructed episodes of opioid use between 1997 and 2005. We estimated age–sex standardized rates of opioid use episodes beginning in each year (incident) and on-going in each year (prevalent), and the per cent change in rates annualized (PCA) over the 9-year period. Long-term episodes were defined as > 90 days with 120+ days supply or 10+ opioid prescriptions in a given year. Results Over the study period, incident long-term use increased from 8.5 to 12.1 per 1000 at Group Health (GH) (6.0% PCA), and 6.3 to 8.6 per 1000 at Kaiser Permanente of Northern California (KPNC) (5.5% PCA). Prevalent long-term use doubled from 23.9 to 46.8 per 1000 at GH (8.5% PCA), and 21.5 to 39.2 per 1000 at KPNC (8.1% PCA). Non-Schedule II opioids were the most commonly used opioid among patients engaged in long-term opioid therapy, particularly at KPNC. Long-term use of Schedule II opioids also increased substantially at both health plans. Among prevalent long-term users in 2005, 28.6% at GH and 30.2% at KPNC were also regular users of sedative hypnotics. Conclusion Long-term opioid therapy for non-cancer pain is increasingly prevalent, but the benefits and risks associated with such therapy are inadequately understood. Concurrent use of opioids and sedative-hypnotics was unexpectedly common and deserves further study. Copyright © 2009 John Wiley & Sons, Ltd.

Objectives: This paper describes characteristics of opioid use episodes for noncancer pain and defines thresholds for de facto long-term opioid therapy. Methods: CONSORT (CONsortium to Study Opioid Risks and Trends) includes adult members of 2 health plans serving over 1% of the US population. Opioid use episodes beginning in the years 1997 to 2005 were classified as acute, episodic, long-term/ lower dose, or long-term/higher dose. Results: On the basis of evaluation of the likelihood of opioid use continuing, long-term opioid therapy was defined by episodes lasting longer than 90 days with 10+ opioid prescriptions or 120+ days supply of opioids dispensed. Long-term/ higher dose episodes ( < 1.5% of all opioid use episodes) were characterized by daily or near daily use, a mean duration of about 1000 days, and an average daily dose of about 55mg. They accounted for more than half the total morphine equivalents dispensed from the years 1997 to 2006. Short-acting, non-Schedule II opioids (eg, hydrocodone with acetaminophen) were, by far, the most commonly prescribed medications for acute, episodic, and long-term episodes. Long-acting (sustained- release) opioids were the predominately prescribed medication in a minority of long-term episodes (6% to 12%). Discussion: Long-term opioid therapy was characterized by the diversity in medications prescribed, dosage levels, and frequency of use. The proposed threshold for long-term opioid therapy provides a checkpoint for physicians to review whether an explicit decision to sustain opioid therapy has been reached, and to ensure that a documented treatment plan and provisions for monitoring medication use and patient outcomes are in place.