Letters

Annals of Internal Medicine COMMENTS

AND

RESPONSES

Opioid Prescribing TO THE EDITOR: Nuckols and colleagues’ systematic review and

critical appraisal of guidelines for the use of opioids for chronic pain (1) is problematic in that it may not meet the criteria of evidencebased medicine and suffers from issues of professionalism. Nuckols and colleagues included guidelines that raise concerns about bias, specifically those from the American Pain Society and the American Academy of Pain Medicine (APS-AAPM) (2), which barely met inclusion criteria because they were published in 2009 (that is, the literature search ended in October 2008, so these guidelines were 5 years old when this review was published). Evidence-based medicine is a dynamic subject that continues to transform as opioid use and abuse changes more rapidly. We posit that in the rapidly evolving world of opioid use and abuse, 5 years may be too long an inclusion time. The authors also have given these guidelines the highest score even though Chou and Huffman were the only authors of the original guideline prepared for the APSAAPM (3). The original guideline consisted of multiple systematic reviews. In a separate article (4), we highlight concerns about perceived conflict of interest in guideline preparation and acknowledge the interplay among academic centers, investigators, and societies that may have a preconceived notion (and, hence, bias). Pharmaceutical companies that manufacture opioids provided funding to the APS, which then provided funding to the Oregon Health & Science University. We believe that disclosure requirements and conflict of interest are real issues and simply note that Congress is paying attention to opioid abuse and the role that industry funding might play. To drive home this point, the American Pain Foundation closed its doors soon after these investigations began. We believe that the authors have done an injustice to the American Society of Interventional Pain Physicians guideline (5), which had an up-to-date literature search, included systematic reviews, was not externally funded, and involved an extensive process of identifying conflicts of interest. It is notable that this guideline, which we wrote, recommends more restrictive use than other guidelines. Performing systematic reviews with critical appraisal of the literature is a major service to the public. However, it would be more appropriate if these reviews were performed without bias. Laxmaiah Manchikanti, MD Pain Management Center of Paducah Paducah, Kentucky Frank J.E. Falco, MD Temple University Philadelphia, Pennsylvania Joshua A. Hirsch, MD Massachusetts General Hospital Boston, Massachusetts Disclosures: Disclosures can be viewed at www.acponline.org/authors /icmje/ConflictOfInterestForms.do?msNum⫽L14-1115.

References 1. Nuckols TK, Anderson L, Popescu I, Diamant AL, Doyle B, Di Capua P, et al. Opioid prescribing: a systematic review and critical appraisal of guidelines for chronic pain. Ann Intern Med. 2014;160:38-47. [PMID: 24217469] 2. Chou R, Fanciullo GJ, Fine PG, Adler JA, Ballantyne JC, Davies P, et al; American Pain Society-American Academy of Pain Medicine Opioids Guidelines Panel. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009;10:113-30. [PMID: 19187889] 3. Chou R, Huffman L. Guideline for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain: Evidence Review. Glenview, IL: American Pain Soc; 2009. 4. Manchikanti L, Benyamin RM, Falco FJ, Caraway DL, Datta S, Hirsch JA. Guidelines warfare over interventional techniques: is there a lack of discourse or straw man? Pain Physician. 2012;15:E1-E26. [PMID: 22270745] 5. Manchikanti L, Falco FJ, Singh V, Benyamin RM, Racz GB, Helm S 2nd, et al. An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part I: introduction and general considerations. Pain Physician. 2013;16:S1-48. [PMID: 23615882]

IN RESPONSE: We appreciate Dr. Manchikanti and colleagues’ in-

terest but would like to correct some factual inaccuracies in their comment. First, we applied well-established, prespecified selection and evaluation criteria consistently across all guidelines. Criteria did not include whether guidelines were “restrictive” in the use of opioids. The Appraisal of Guidelines for Research and Evaluation II instrument and A Measurement Tool to Assess Systematic Reviews address potential conflicts of interest and funding (1). In terms of updating, we used a cutoff of 5 years based on a study that found that about one half of 17 guidelines were out of date by 6 years (2). According to the Institute of Medicine, guidelines should be updated when new evidence suggests that key recommendations warrant modification (3, 4). We found no indication that recommendations in the APS-AAPM guideline were considered out of date. To the contrary, more recent guidelines—including the 2012 American Society of Interventional Pain Physicians guideline by Dr. Manchikanti and colleagues—frequently cite the APS-AAPM guideline (5). Second, we have already disclosed all potential conflicts of interest and funding for our review. The California Commission on Health and Safety and Workers’ Compensation funded this review, and a Career Development Award from the Agency for Healthcare Research and Quality supported the principal investigator. We received no funding from other sources. Dr. Chou provided input on content and methods for evaluating guidelines and systematic reviews. As noted in the Methods section, he did not evaluate individual guidelines. Guideline evaluators, based at the University of California, Los Angeles, were unaffiliated with guideline developers. Third, the APS provided funding for the APS-AAPM guideline directly to Oregon Health & Science University. We have disclosed all potential conflicts of interest and funding sources for this guideline and its associated systematic review. Pharmaceutical companies did not provide input or have contact with guideline developers. Finally, the APS-AAPM guideline has no connection to the American Pain Foundation and had more than a dozen authors in addition to Drs. Chou and Huffman. Teryl J. Nuckols, MD, MSHS David Geffen School of Medicine at University of California, Los Angeles Los Angeles, California © 2014 American College of Physicians 737

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Letters Roger Chou, MD Oregon Health & Science University Portland, Oregon

far more than renaming. It is health care transformation. It offers the promise of restoring us to world leadership in cost-effective health care. We physicians need to lead it. It is the right thing to do.

Disclosures: Disclosures can be viewed at www.acponline.org/authors /icmje/ConflictOfInterestForms.do?msNum⫽M13-1193.

Richard Blakely, MD Memorial Hermann Physician Network (MHMD) Houston, Texas

References 1. Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, et al; AGREE Next Steps Consortium. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ. 2010;182:E839-42. [PMID: 20603348] 2. Shekelle PG, Ortiz E, Rhodes S, Morton SC, Eccles MP, Grimshaw JM, et al. Validity of the Agency for Healthcare Research and Quality clinical practice guidelines: how quickly do guidelines become outdated? JAMA. 2001;286:1461-7. [PMID: 11572738] 3. Institute of Medicine. Clinical Practice Guidelines We Can Trust. Washington, DC: National Academies Pr; 2011. 4. Shea BJ, Hamel C, Wells GA, Bouter LM, Kristjansson E, Grimshaw J, et al. AMSTAR is a reliable and valid measurement tool to assess the methodological quality of systematic reviews. J Clin Epidemiol. 2009;62:1013-20. [PMID: 19230606] 5. Manchikanti L, Abdi S, Atluri S, Balog CC, Benyamin RM, Boswell MV, et al; American Society of Interventional Pain Physicians. American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic noncancer pain: part 2—guidance. Pain Physician. 2012;15:S67-116. [PMID: 22786449]

Recycling TO THE EDITOR: King (1) mentions that he is “bemused” by what he calls a new career field in renaming traditional models of health care. He believes that the concepts of a medical home, patientcentered care, evidence-based medicine, and accountable care organization are merely the renaming of the multispecialty group practice, patient-directed care, decision making based on evidence, and the HMO and notes that care has always been patient-centered. That King finds these concepts bewildering is emblematic of the problem of medicine in this country. Substantially more money is spent per capita on health care in the United States than in any other industrialized country, but our outcomes are no better. We talk about care of the “highest quality” but mean that we provide excellent care in our practices rather than ensure that our patients (and communities of persons) receive the best possible care. The differences are huge: A patient may go from physician to physician, getting high-quality care in each setting, yet face the difficult task of trying to coordinate the care being given and dealing with a health system that rewards illness rather than wellness. The concepts of the “medical home” and “patient-centered care,” rather than simply being a bureaucratic exercise in renaming old concepts, actually describe physician-led initiatives that focus on care received by the patients and communities we serve. Built into the accountable care organization is the word “accountable,” meaning that all health care providers in the organization are held accountable by each other and by a payment system that incentivizes not volume but wellness, coordination of care, avoidance of unnecessary and duplicative interventions, and a strong commitment to practice in a manner consistent with current scientific evidence. Moreover, inherent in the accountable care organization are data, analytics, and transparency of outcomes reporting so that physicians remain informed about opportunities to keep doing better. Although I agree with King that these “renamed” terms are all too often being used as marketing tools, the underlying principle is

Disclosures: None. Forms can be viewed at www.acponline.org/authors /icmje/ConflictOfInterestForms.do?msNum⫽L14-0112. Reference 1. King JH. Recycling. Ann Intern Med. 2014;160:68. [PMID: 24395465]

TO THE EDITOR: I appreciate King’s (1) concise criticism of forces

that have undermined the integrity, peace of mind, and very soul of medicine. Clearly, masters of business administration have usurped the control of medicine. Like King, I find that “medical home,” “patient-centered care,” and “accountable care organizations” are just buzzwords meant mostly for policymakers to use in their relentless efforts to extend their control over the practice of medicine. And for all the theoretical good that electronic health records may do, they have not made me a more capable physician. However, I was disappointed that King said that he “shall offer no complaint” to the policymakers who push these changes. It seems that too many physicians are too accepting and tolerant toward the forces that are too eager to define medicine in their terms. Clearly, “complaint” is exactly what is needed in the new world of medicine. Since the early 1990s, professionalism in medicine has slowly and steadily eroded. Effective and sustained complaint has been shamefully missing from our medical leadership and from physicians in general. Until physicians are ready to complain and to do so in a loud, collective voice, the light in medicine will eventually be extinguished. Physicians would do well, in the words of Dylan Thomas, to “[r]age, rage against the dying of the light.” Edward Volpintesta, MD Danbury Hospital Danbury, Connecticut Disclosures: Disclosures can be viewed at www.acponline.org/authors /icmje/ConflictOfInterestForms.do?msNum⫽L14-1115. Reference 1. King JH. Recycling. Ann Intern Med. 2014;160:68. [PMID: 24395465]

IN RESPONSE: Dr. Blakely seems to not realize that my commentary was ironic. I don’t really think that the patient-centered medical home is indeed synonymous with a multispecialty group practice, but the definition of the medical home that its proponents give is synonymous with a multispecialty practice. The patient-centered medical home is actually an inadequate attempt to deliver primary care by committee without benefit of primary care physicians. This idea is certainly transformative, but the question is, “What is being transformed, and to what is it being transformed?” The definition of “patient-centered care” varies from “the customer is always right” to a vague suggestion that we should listen more to our patients. Some articles describe it as directly opposing evidence-based medicine. Bensing (1) defines it as “a humanistic, biopsychosocial perspective, combining ethical values on the ideal physician, with psychotherapeutic theories on facilitating patients’

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Letters disclosure of real worries, and negotiation theories on decision making.” I suggest that a phrase that means whatever the author chooses it to mean in fact means nothing. The concept of the accountable care organization is essentially economic, not clinical. It is concerned with managing populations, reducing average lengths of stay, and preventing hospital readmissions rather than individually caring for every patient every time. Dr. Blakely’s incentivizing of wellness and “data, analytics, and transparency of outcomes reporting” are what we in the flyover part of the country call “lipstick on a pig.” I agree with Dr. Volpintesta that “[u]ntil physicians are ready to complain . . . in a loud, collective voice, the light in medicine will eventually be extinguished.” I’ve been waiting to hear that loud, collective voice for more than 40 years. How’s that working for us? Physicians would do well to rage against the dying of the light, but that light is already very dim—probably too dim to be revived. James H. King, MD OSF Galesburg Clinic Galesburg, Illinois Disclosures: Disclosures can be viewed at www.acponline.org/authors /icmje/ConflictOfInterestForms.do?msNum⫽L14-1114. Reference 1. Bensing J. Bridging the gap. The separate worlds of evidence-based medicine and patient-centered medicine. Patient Educ Couns. 2000;39:17-25. [PMID: 11013544]

OBSERVATION Continuous Involuntary Tut-Tutting: A Case Report Background: What Japanese speakers refer to as shitauchi involves a tongue movement similar to what English speakers refer to as “tut-tutting” but has a different connotation. In the Japanese social setting, this tongue clicking is equivalent to uttering a common 4-letter English obscenity. Objective: To report a case of continuous involuntary tut-tutting caused by a variant type of rhythmic palatal myoclonus. Case Report: An 80-year-old woman visited our clinic because of continuous involuntary tongue clicking for approximately a decade that prevented her from attending most social events. It occurred while she was active during the day but not during sleep. She was in good health with no history of disease or trauma and did not smoke cigarettes, consume alcohol, or receive psychotropic medication. She had no family history of neurologic or psychiatric disorders, including a tic. During the past 10 years, she had consulted primary care physicians, neurologists, otorhinolaryngologists, and psychiatrists for her condition. Many diagnoses had been considered, including a psychogenic origin, tic, palatal tremor, and dystonic tremor, and she had many procedures, such as magnetic resonance imaging, electromyography, electroencephalography, and nasolaryngeal fiberscopy. No treatment had been attempted, in part because a diagnosis could not be established. As we observed her neck, her hyoid bone and thyroid cartilage quickly jerked upward simultaneously with the clicking sound (view Supplement Videos 1 and 2, available at www.annals.org). Laryngeal fiberscopy through the nose showed that the clicking sound occurred when her tongue moved downward inside the oral cavity without

contraction of the palate or pharyngeal constrictor muscles or involvement of the vocal fold or esophagus. We concluded that the mechanism involved a rhythmic myoclonic jerk of the extrinsic laryngeal and tongue muscles. Magnetic resonance imaging scans of the brain and brainstem were unremarkable. She declined further electromyographic examination. We prescribed a 2-week course of baclofen, 0.5 mg/d, to relax her laryngeal and tongue muscles, but the clicking did not decrease. We then prescribed clonazepam, 0.5 mg/d, and after 14 days, the clicking had stopped. At 1-year follow-up, the clicking has remained well-controlled by clonazepam, 0.5 mg/d, and she has been able to go to the theater, the cinema, the library, and concerts without committing the social faux pas of shitauchi. Discussion: Similar clicking sounds have been reported in cases of rhythmic palatal myoclonus. However, these cases usually were associated with hypertrophic degeneration of the inferior olivary nucleus, whereas this patient’s magnetic resonance imaging scan found no evidence of that lesion (1–3). We believe that this patient has a variant type of rhythmic palatal myoclonus involving contraction of the hyoglossus muscle that causes movement of the tongue and hyoid bone, and we suspect that she has an unidentified brainstem lesion that led to changes in neurotransmitter mechanisms, including the ␥-aminobutyric acid system, which are responsible for her symptoms. Clonazepam, anticholinergic agents, 5-hydroxytryptophan, L-dihydroxyphenylalanine, baclofen, piracetam, and anticonvulsants are used to treat palatal myoclonus (1–3). This patient’s response to therapy indicates that ␥-aminobutyric acid A rather than ␥aminobutyric acid B receptors were involved. Koichi Tsunoda, MD, PhD National Hospital Organization, National Tokyo Medical Center, National Institute of Sensory Organs Tokyo, Japan Yohko Morita, MD, PhD National Hospital Organization, National Tokyo Medical Center Tokyo, Japan Takao Yabe, MD, PhD Tokyo Metropolitan Hospital Tokyo, Japan Atsunobu Tsunoda, MD, PhD Tokyo Medical and Dental University Tokyo, Japan Maiko Saito, MD National Hospital Organization, Tokyo Medical Center Tokyo, Japan Disclosures: None. Forms can be viewed at www.acponline.org/authors /icmje/ConflictOfInterestForms.do?msNum⫽L13-1161. References 1. Deuschl G, Mischke G, Schenck E, Schulte-Mo¨nting J, Lu¨cking CH. Symptomatic and essential rhythmic palatal myoclonus. Brain. 1990;113 (Pt 6):1645-72. [PMID: 2276039] 2. Fabiani G, Teive HA, Sa´ D, Kay CK, Scola RH, Martins M, et al. Palatal myoclonus: report of two cases. Arq Neuropsiquiatr. 2000;58:901-4. [PMID: 11018829] 3. Vieregge P, Klein C, Gehrking E, Ko¨rtke D, Ko¨mpf D. The diagnosis of ‘essential palatal tremor.’ Neurology. 1997;49:248-9. [PMID: 9222198]

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