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Medical professional liability risk and mitigation: An overview for early-career gastroenterologists
Disclaimer: This article is for educational purposes only. All examples are hypothetical and aim to illustrate common clinical scenarios and challenges gastroenterologists may encounter within their scope of practice. The content herein should not be interpreted as legal advice for individual cases nor a substitute for seeking the advice of an attorney.
There are unique potential stressors faced by the gastroenterologist at each career stage, some more so early on. One such stressor, and one particularly important in a procedure-intensive specialty like GI, is medical professional liability (MPL), historically termed “medical malpractice.” Between 2009 and 2018, GI was the second-highest internal medicine subspecialty in both MPL claims made and claims paid,1 yet instruction on MPL risk and mitigation is scarce in fellowship, as is the available GI-related literature on the topic. This scarcity may generate untoward stress and unnecessarily expose gastroenterologists to avoidable MPL pitfalls. Therefore, it is vital for GI trainees, early-career gastroenterologists, and even seasoned gastroenterologists to have a working and updated knowledge of the general principles of MPL and GI-specific considerations. Such understanding can help preserve physician well-being, increase professional satisfaction, strengthen the doctor-patient relationship, and improve health care outcomes.2
To this end, we herein provide a focused review of the following: key MPL concepts, trends in MPL claims, GI-related MPL risk scenarios and considerations, adverse provider defensive mechanisms, documentation tenets, challenges posed by telemedicine, and the concept of “vicarious liability.”
Key MPL concepts
MPL falls under the umbrella of tort law, which itself falls under the umbrella of civil law; that is, civil (as opposed to criminal) justice governs torts – including but not limited to MPL claims – as well as other areas of law concerning noncriminal injury.3 A “tort” is a “civil wrong that unfairly causes another to experience loss or harm resulting in legal liability.”3 MPL claims assert the tort of negligence (similar to the concept of “incompetence”) and endeavor to compensate the harmed patient/individual while simultaneously dissuading suboptimal medical care by the provider in the future.4,5 A successful MPL claim must prove four overlapping elements: that the tortfeasor (here, the gastroenterologist) owed a duty of care to the injured party and breached that duty, which caused damages.6 Given that MPL cases exist within tort law rather than criminal law, the burden of proof for these cases is not “beyond a reasonable doubt”; instead, it’s “to a reasonable medical probability.”7
Trends in MPL claims
According to data compiled by the MPL Association, 278,220 MPL claims were made in the United States from 1985 to 2012.3,8-10 Among these, 1.8% involved gastroenterologists, which puts it at 17th place out of the 20 specialties surveyed.9 While the number of paid claims over this time frame decreased in GI by 34.6% (from 18.5 to 12.1 cases per 1,000 physician-years), there was a concurrent 23.3% increase in average claim compensation; essentially, there were fewer paid GI-related claims but there were higher payouts per paid claim.11,12 From 2009 to 2018, average legal defense costs for paid GI-related claims were $97,392, and average paid amount was $330,876.1
GI-related MPL risk scenarios and considerations
Many MPL claims relate to situations involving medical errors or adverse events (AEs), be they procedural or nonprocedural. However other aspects of GI also carry MPL risk.
Informed consent
MPL claims may be made not only on the grounds of inadequately informed consent but also inadequately informed refusal.5,13,14 While standards for adequate informed consent vary by state, most states apply the “reasonable patient standard,” i.e., assuming an average patient with enough information to be an active participant in the medical decision-making process. Generally, informed consent should ensure that the patient understands the nature of the procedure/treatment being proposed, there is a discussion of the risks and benefits of undergoing and not undergoing the procedure/treatment, reasonable alternatives are presented, the risks and benefits associated with these alternatives are discussed, and the patient’s comprehension of these things is assessed (Figure).15 Additionally, informed consent should be tailored to each patient and GI procedure/treatment on a case-by-case basis rather than using a one-size-fits-all approach. Moreover, documentation of the patient’s understanding of the (tailored) information provided can concurrently improve quality of the consent and potentially decrease MPL risk (Figure).16
Endoscopic procedures
Procedure-related MPL claims represent approximately 25% of all GI-related claims (8,17). Among these, 52% involve colonoscopy, 16% involve endoscopic retrograde cholangiopancreatography (ERCP), and 11% involve esophagogastroduodenoscopy.8 Albeit generally safe, colonoscopy, as with esophagogastroduodenoscopy, is subject to rare but serious AEs.18,19 Risk of these AEs may be accentuated in certain scenarios (such as severe colonic inflammation or coagulopathy) and, as discussed earlier, may merit tailored informed consent. Regardless of the procedure, in the event of postprocedural development of signs/symptoms (such as tachycardia, fever, chest or abdominal discomfort, or hypotension) indicating a potential AE, stabilizing measures and evaluation (such as blood work and imaging) should be undertaken, and hospital admission (if not already hospitalized) should be considered until discharge is deemed safe.19
ERCP-related MPL claims, for many years, have had the highest average compensation of any GI procedure.11 Though discussion of advanced procedures is beyond the scope of this article, it is worth mentioning the observation that most of such claims involve an allegation that the procedure was not indicated (for example, that it was performed based on inadequate evidence of pancreatobiliary pathology), or was for diagnostic purposes (for example, being done instead of noninvasive imaging) rather than therapeutic.20-23 This emphasizes the importance of appropriate procedure indications.
Percutaneous endoscopic gastrostomy (PEG) placement merits special mention given it can be complicated by ethical challenges (for example, needing a surrogate decision-maker’s consent or representing medical futility) and has a relatively high potential for MPL claims. PEG placement carries a low AE rate (0.1%-1%), but these AEs may result in high morbidity/mortality, in part because of the underlying comorbidities of patients needing PEG placement.24,25 Also, timing of a patient’s demise may coincide with PEG placement, thereby prompting (possibly unfounded) perceptions of causality.24-27 Therefore, such scenarios merit unique additional preprocedure safeguards. For instance, for patients lacking capacity to provide informed consent, especially when family members may differ on whether PEG should be placed, it is advisable to ask the family to select one surrogate decision-maker (if there’s no advance directive) to whom the gastroenterologist should discuss both the risks, benefits, and goals of PEG placement in the context of the patient’s overall clinical trajectory/life expectancy and the need for consent (or refusal) based on what the patient would have wished. In addition, having a medical professional witness this discussion may be useful.27
Antithrombotic agents 
Periprocedural management of antithrombotics, including anticoagulants and antiplatelets, can pose challenges for the gastroenterologist. While clinical practice guidelines exist to guide decision-making in this regard, the variables involved may extend beyond the expertise of the gastroenterologist.28 For instance, in addition to the procedural risk for bleeding, the indication for antithrombotic therapy, risk of a thrombotic event, duration of action of the antithrombotic, and available bridging options should all be considered according to recommendations.28,29 While requiring more time on the part of the gastroenterologist, the optimal periprocedural management of antithrombotic agents would usually involve discussion with the provider managing antithrombotic therapy to best conduct a risk-benefit assessment regarding if (and how long) the antithrombotic therapy should be held (Figure). This shared decision-making, which should also include the patient, may help decrease MPL risk and improve outcomes.
Provider defense mechanisms
Physicians may engage in various defensive behaviors in an attempt to mitigate MPL risk; however, these behaviors may, paradoxically, increase risk.30,31
Assurance behaviors
Assurance behaviors refer to the practice of recommending or performing additional services (such as medications, imaging, procedures, and referrals) that are not clearly indicated.2,30,31 Assurance behaviors are driven by fear of MPL risk and/or missing a potential diagnosis. Recent studies have estimated that more than 50% of gastroenterologists worldwide have performed additional invasive procedures without clear indications, and that nearly one-third of endoscopic procedures annually have questionable indications.30,32 While assurance behaviors may seem likely to decrease MPL risk, overall, they may inadvertently increase AE and MPL risk, as well as health care expenditures.3,30,32
Avoidance behaviors
Avoidance behaviors refer to providers avoiding participation in potentially high-risk clinical interventions (for example, the actual procedures), including those for which they are credentialed/certified proficient.30,31 Two clinical scenarios that illustrate this behavior include the following: An advanced endoscopist credentialed to perform ERCP might refer a “high-risk” elderly patient with cholangitis to another provider to perform said ERCP or for percutaneous transhepatic drainage (in the absence of a clear benefit to such), or a gastroenterologist might refer a patient to interventional gastroenterology for resection of a large polyp even though gastroenterologists are usually proficient in this skill and may feel comfortable performing the resection themselves. Avoidance behaviors are driven by a fear of MPL risk and can have several negative consequences.33 For example, patients may not receive indicated interventions. Additionally, patients may have to wait longer for an intervention because they are referred to another provider, which also increases potential for loss to follow-up.2,30,31 This may be viewed as noncompliance with the standard of care, among other hazards, thereby increasing MPL risk.
Documentation tenets
Thorough documentation can decrease MPL risk, especially since it is often used as legal evidence.16 Documenting, for instance, preprocedure discussion of potential risk of AEs (such as bleeding or perforation) or procedural failure (for example, missed lesions)can protect gastroenterologists (Figure).16 While, as discussed previously, these should be covered in the informed consent process (which itself reduces MPL risk), proof of compliance in providing adequate informed consent must come in the form of documentation that indicates that the process took place and specifically what topics were discussed therein. MPL risk may be further decreased by documenting steps taken during a procedure and anatomic landmarks encountered to offer proof of technical competency and compliance with standards of care (Figure).16,34 In this context, it is worth recalling the adage: “If it’s not documented, it did not occur.”
Curbside consults versus consultation
Also germane here is the topic of whether documentation is needed for “curbside consults.” The uncertainty is, in part, semantic; that is, at what point does a “curbside” become a consultation? A curbside is a general question or query (such as anything that could also be answered by searching the Internet or reference materials) in response to which information is provided; once it involves provision of medical advice for a specific patient (for example, when patient identifiers have been shared or their EHR has been accessed), it constitutes a consultation. Based on these definitions, a curbside need not be documented, whereas a consultation – even if seemingly trivial – should be.
Consideration of language and cultural factors
Language barriers should be considered when the gastroenterologist is communicating with the patient, and such efforts, whenever made, should be documented to best protect against MPL.16,35 These considerations arise not only during the consent process but when obtaining a history, providing postprocedure instructions, and during follow-ups. To this end, 24/7 telephone interpreter services may assist the gastroenterologist (when one is communicating with non–English speakers and is not medically certified in the patient’s native/preferred language) and strengthen trust in the provider-patient relationship.36 Additionally, written materials (such as consent forms, procedural information) in patients’ native/preferred languages should be provided, when available, to enhance patient understanding and participation in care (Figure).35
Challenges posed by telemedicine
The COVID-19 pandemic has rapidly led to more virtual encounters. While increased utilization of telemedicine platforms may make health care more accessible, it does not lessen the clinicians’ duty to patients and may actually expose them to greater MPL risk.18,37,38 Therefore, the provider must be cognizant of two key principles to mitigate MPL risk in the context of telemedicine encounters. First, the same standard of care applies to virtual and in-person encounters.18,37,38 Second, patient privacy and HIPAA regulations are not waived during telemedicine encounters, and breaches of such may result in an MPL claim.18,37,38
With regard to the first principle, for patients who have not been physically examined (such as when a telemedicine visit was substituted for an in-person clinic encounter), gastroenterologists should not overlook requesting timely preprocedure anesthesia consultation or obtaining additional laboratory studies as needed to ensure safety and the same standard of care. Moreover, particularly in the context of pandemic-related decreased procedural capacity, triaging procedures can be especially challenging. Standardized institutional criteria which prioritize certain diagnoses/conditions over others, leaving room for justifiable exceptions, are advisable.
Vicarious liability
“Vicarious liability” is defined as that extending to persons who have not committed a wrong but on whose behalf wrongdoers acted.39 Therefore, gastroenterologists may be liable not only for their own actions but also for those of personnel they supervise (such as fellow trainees and non–physician practitioners).39 Vicarious liability aims to ensure that systemic checks and balances are in place so that, if failure occurs, harm can still be mitigated and/or avoided, as illustrated by Reason’s “Swiss Cheese Model.”40
Conclusion
Any gastroenterologist can experience an MPL claim. Such an experience can be especially stressful and confusing to early-career clinicians, especially if they’re unfamiliar with legal proceedings. Although MPL principles are not often taught in medical school or residency, it is important for gastroenterologists to be informed regarding tenets of MPL and cognizant of clinical situations which have relatively higher MPL risk. This can assuage untoward angst regarding MPL and highlight proactive risk-mitigation strategies. In general, gastroenterologist practices that can mitigate MPL risk include effective communication; adequate informed consent/refusal; documentation of preprocedure counseling, periprocedure events, and postprocedure recommendations; and maintenance of proper certification and privileging.
Dr. Azizian and Dr. Dalai are with the University of California, Los Angeles and the department of medicine at Olive View–UCLA Medical Center, Sylmar, Calif. They are co–first authors of this paper. Dr. Dalai is also with the division of gastroenterology at the University of New Mexico, Albuquerque. Dr. Adams is with the Center for Clinical Management Research in Veterans Affairs Ann Arbor Healthcare System, the division of gastroenterology at the University of Michigan Health System, and the Institute for Healthcare Policy and Innovation, all in Ann Arbor, Mich. Dr. Tabibian is with UCLA and the division of gastroenterology at Olive View–UCLA Medical Center. The authors have no conflicts of interest.
References
1. 2020 Data Sharing Project Gastroenterology 2009-2018. Inside Medical Liability: Second Quarter. Accessed 2020 Dec 6.
2. Mello MM et al. Health Aff (Millwood). 2004 Jul-Aug;23(4):42-53.
3. Adams MA et al. JAMA. 2014 Oct;312(13):1348-9.
4. Pegalis SE. American Law of Medical Malpractice 3d, Vol. 2. St. Paul, Minn.: Thomson Reuters, 2005.
5. Feld LD et al. Am J Gastroenterol. 2018 Nov;113(11):1577-9.
6. Sawyer v. Wight, 196 F. Supp. 2d 220, 226 (E.D.N.Y. 2002).
7. Michael A. Sita v. Long Island Jewish-Hillside Medical Center, 22 A.D.3d 743 (N.Y. App. Div. 2005).
8. Conklin LS et al. Clin Gastroenterol Hepatol. 2008 Jun;6(6):677-81.
9. Jena AB et al. N Engl J Med. 2011 Aug 18;365(7):629-36.
10. Kane CK. “Policy Research Perspectives Medical Liability Claim Frequency: A 2007-2008 Snapshot of Physicians.” Chicago: American Medical Association, 2010.
11. Hernandez LV et al. World J Gastrointest Endosc. 2013 Apr 16;5(4):169-73.
12. Schaffer AC et al. JAMA Intern Med. 2017 May 1;177(5):710-8.
13. Natanson v. Kline, 186 Kan. 393, 409, 350 P.2d 1093, 1106, decision clarified on denial of reh’g, 187 Kan. 186, 354 P.2d 670 (1960).
14. Truman v. Thomas, 27 Cal. 3d 285, 292, 611 P.2d 902, 906 (1980).
15. Shah P et al. Informed Consent, in “StatPearls.” Treasure Island, Fla.: StatPearls Publishing, 2020 Jan. Updated 2020 Aug 22.
16. Rex DK. Clin Gastroenterol Hepatol. 2013 Jul;11(7):768-73.
17. Gerstenberger PD, Plumeri PA. Gastrointest Endosc. Mar-Apr 1993;39(2):132-8.
18. Adams MA and Allen JI. Clin Gastroenterol Hepatol. 2019 Nov;17(12):2392-6.e1.
19. Ahlawat R et al. Esophagogastroduodenoscopy, in “StatPearls.” Treasure Island, Fla.: StatPearls Publishing, 2020 Jan. Updated 2020 Dec 9.
20. Cotton PB. Gastrointest Endosc. 2006 Mar;63(3):378-82.
21. Cotton PB. Gastrointest Endosc. 2010 Oct;72(4):904.
22. Adamson TE et al. West J Med. 1989 Mar;150(3):356-60.
23. Trap R et al. Endoscopy. 1999 Feb;31(2):125-30.
24. Funaki B. Semin Intervent Radiol. 2015 Mar;32(1):61-4.
25. Feeding Tube Nursing Home and Hospital Malpractice. Miller & Zois, Attorneys at Law. Accessed 2020 Jun 20.
26. Medical Malpractice Lawsuit Brings $750,000 Settlement: Death of 82-year-old woman from sepsis due to improper placement of feeding tube. Lubin & Meyers PC. Accessed 2020 Jun 20.
27. Brendel RW et al. Med Clin North Am. 2010 Nov;94(6):1229-40, xi-ii.
28. ASGE Standards of Practice Committee; Acosta RD et al. Gastrointest Endosc. 2016 Jan;83(1):3-16.
29. Saleem S and Thomas AL. Cureus. 2018 Jun 25;10(6):e2878.
30. Hiyama T et al. World J Gastroenterol. 2006 Dec 21;12(47):7671-5.
31. Studdert DM et al. JAMA. 2005 Jun 1;293(21):2609-17.
32. Shaheen NJ et al. Gastroenterology. 2018 May;154(7):1993-2003.
33. Oza VM et al. Clin Gastroenterol Hepatol. 2016 Feb;14(2):172-4.
34. Feld AD. Gastrointest Endosc Clin N Am. 2002 Jan;12(1):171-9, viii-ix.
35. Lee JS et al. J Gen Intern Med. 2017 Aug;32(8):863-70.
36. Forrow L and Kontrimas JC. J Gen Intern Med. 2017 Aug;32(8):855-7.
37. Moses RE et al. Am J Gastroenterol. 2014 Aug;109(8):1128-32.
38. Tabibian JH. “The Evolution of Telehealth.” Guidepoint: Legal Solutions Blog. Accessed 2020 Aug 12.
39. Feld AD. Am J Gastroenterol. 2004 Sep;99(9):1641-4.
40. Reason J. BMJ. 2000;320(7237):768‐70.
Disclaimer: This article is for educational purposes only. All examples are hypothetical and aim to illustrate common clinical scenarios and challenges gastroenterologists may encounter within their scope of practice. The content herein should not be interpreted as legal advice for individual cases nor a substitute for seeking the advice of an attorney.
There are unique potential stressors faced by the gastroenterologist at each career stage, some more so early on. One such stressor, and one particularly important in a procedure-intensive specialty like GI, is medical professional liability (MPL), historically termed “medical malpractice.” Between 2009 and 2018, GI was the second-highest internal medicine subspecialty in both MPL claims made and claims paid,1 yet instruction on MPL risk and mitigation is scarce in fellowship, as is the available GI-related literature on the topic. This scarcity may generate untoward stress and unnecessarily expose gastroenterologists to avoidable MPL pitfalls. Therefore, it is vital for GI trainees, early-career gastroenterologists, and even seasoned gastroenterologists to have a working and updated knowledge of the general principles of MPL and GI-specific considerations. Such understanding can help preserve physician well-being, increase professional satisfaction, strengthen the doctor-patient relationship, and improve health care outcomes.2
To this end, we herein provide a focused review of the following: key MPL concepts, trends in MPL claims, GI-related MPL risk scenarios and considerations, adverse provider defensive mechanisms, documentation tenets, challenges posed by telemedicine, and the concept of “vicarious liability.”
Key MPL concepts
MPL falls under the umbrella of tort law, which itself falls under the umbrella of civil law; that is, civil (as opposed to criminal) justice governs torts – including but not limited to MPL claims – as well as other areas of law concerning noncriminal injury.3 A “tort” is a “civil wrong that unfairly causes another to experience loss or harm resulting in legal liability.”3 MPL claims assert the tort of negligence (similar to the concept of “incompetence”) and endeavor to compensate the harmed patient/individual while simultaneously dissuading suboptimal medical care by the provider in the future.4,5 A successful MPL claim must prove four overlapping elements: that the tortfeasor (here, the gastroenterologist) owed a duty of care to the injured party and breached that duty, which caused damages.6 Given that MPL cases exist within tort law rather than criminal law, the burden of proof for these cases is not “beyond a reasonable doubt”; instead, it’s “to a reasonable medical probability.”7
Trends in MPL claims
According to data compiled by the MPL Association, 278,220 MPL claims were made in the United States from 1985 to 2012.3,8-10 Among these, 1.8% involved gastroenterologists, which puts it at 17th place out of the 20 specialties surveyed.9 While the number of paid claims over this time frame decreased in GI by 34.6% (from 18.5 to 12.1 cases per 1,000 physician-years), there was a concurrent 23.3% increase in average claim compensation; essentially, there were fewer paid GI-related claims but there were higher payouts per paid claim.11,12 From 2009 to 2018, average legal defense costs for paid GI-related claims were $97,392, and average paid amount was $330,876.1
GI-related MPL risk scenarios and considerations
Many MPL claims relate to situations involving medical errors or adverse events (AEs), be they procedural or nonprocedural. However other aspects of GI also carry MPL risk.
Informed consent
MPL claims may be made not only on the grounds of inadequately informed consent but also inadequately informed refusal.5,13,14 While standards for adequate informed consent vary by state, most states apply the “reasonable patient standard,” i.e., assuming an average patient with enough information to be an active participant in the medical decision-making process. Generally, informed consent should ensure that the patient understands the nature of the procedure/treatment being proposed, there is a discussion of the risks and benefits of undergoing and not undergoing the procedure/treatment, reasonable alternatives are presented, the risks and benefits associated with these alternatives are discussed, and the patient’s comprehension of these things is assessed (Figure).15 Additionally, informed consent should be tailored to each patient and GI procedure/treatment on a case-by-case basis rather than using a one-size-fits-all approach. Moreover, documentation of the patient’s understanding of the (tailored) information provided can concurrently improve quality of the consent and potentially decrease MPL risk (Figure).16
Endoscopic procedures
Procedure-related MPL claims represent approximately 25% of all GI-related claims (8,17). Among these, 52% involve colonoscopy, 16% involve endoscopic retrograde cholangiopancreatography (ERCP), and 11% involve esophagogastroduodenoscopy.8 Albeit generally safe, colonoscopy, as with esophagogastroduodenoscopy, is subject to rare but serious AEs.18,19 Risk of these AEs may be accentuated in certain scenarios (such as severe colonic inflammation or coagulopathy) and, as discussed earlier, may merit tailored informed consent. Regardless of the procedure, in the event of postprocedural development of signs/symptoms (such as tachycardia, fever, chest or abdominal discomfort, or hypotension) indicating a potential AE, stabilizing measures and evaluation (such as blood work and imaging) should be undertaken, and hospital admission (if not already hospitalized) should be considered until discharge is deemed safe.19
ERCP-related MPL claims, for many years, have had the highest average compensation of any GI procedure.11 Though discussion of advanced procedures is beyond the scope of this article, it is worth mentioning the observation that most of such claims involve an allegation that the procedure was not indicated (for example, that it was performed based on inadequate evidence of pancreatobiliary pathology), or was for diagnostic purposes (for example, being done instead of noninvasive imaging) rather than therapeutic.20-23 This emphasizes the importance of appropriate procedure indications.
Percutaneous endoscopic gastrostomy (PEG) placement merits special mention given it can be complicated by ethical challenges (for example, needing a surrogate decision-maker’s consent or representing medical futility) and has a relatively high potential for MPL claims. PEG placement carries a low AE rate (0.1%-1%), but these AEs may result in high morbidity/mortality, in part because of the underlying comorbidities of patients needing PEG placement.24,25 Also, timing of a patient’s demise may coincide with PEG placement, thereby prompting (possibly unfounded) perceptions of causality.24-27 Therefore, such scenarios merit unique additional preprocedure safeguards. For instance, for patients lacking capacity to provide informed consent, especially when family members may differ on whether PEG should be placed, it is advisable to ask the family to select one surrogate decision-maker (if there’s no advance directive) to whom the gastroenterologist should discuss both the risks, benefits, and goals of PEG placement in the context of the patient’s overall clinical trajectory/life expectancy and the need for consent (or refusal) based on what the patient would have wished. In addition, having a medical professional witness this discussion may be useful.27
Antithrombotic agents
Periprocedural management of antithrombotics, including anticoagulants and antiplatelets, can pose challenges for the gastroenterologist. While clinical practice guidelines exist to guide decision-making in this regard, the variables involved may extend beyond the expertise of the gastroenterologist.28 For instance, in addition to the procedural risk for bleeding, the indication for antithrombotic therapy, risk of a thrombotic event, duration of action of the antithrombotic, and available bridging options should all be considered according to recommendations.28,29 While requiring more time on the part of the gastroenterologist, the optimal periprocedural management of antithrombotic agents would usually involve discussion with the provider managing antithrombotic therapy to best conduct a risk-benefit assessment regarding if (and how long) the antithrombotic therapy should be held (Figure). This shared decision-making, which should also include the patient, may help decrease MPL risk and improve outcomes.
Provider defense mechanisms
Physicians may engage in various defensive behaviors in an attempt to mitigate MPL risk; however, these behaviors may, paradoxically, increase risk.30,31
Assurance behaviors
Assurance behaviors refer to the practice of recommending or performing additional services (such as medications, imaging, procedures, and referrals) that are not clearly indicated.2,30,31 Assurance behaviors are driven by fear of MPL risk and/or missing a potential diagnosis. Recent studies have estimated that more than 50% of gastroenterologists worldwide have performed additional invasive procedures without clear indications, and that nearly one-third of endoscopic procedures annually have questionable indications.30,32 While assurance behaviors may seem likely to decrease MPL risk, overall, they may inadvertently increase AE and MPL risk, as well as health care expenditures.3,30,32
Avoidance behaviors
Avoidance behaviors refer to providers avoiding participation in potentially high-risk clinical interventions (for example, the actual procedures), including those for which they are credentialed/certified proficient.30,31 Two clinical scenarios that illustrate this behavior include the following: An advanced endoscopist credentialed to perform ERCP might refer a “high-risk” elderly patient with cholangitis to another provider to perform said ERCP or for percutaneous transhepatic drainage (in the absence of a clear benefit to such), or a gastroenterologist might refer a patient to interventional gastroenterology for resection of a large polyp even though gastroenterologists are usually proficient in this skill and may feel comfortable performing the resection themselves. Avoidance behaviors are driven by a fear of MPL risk and can have several negative consequences.33 For example, patients may not receive indicated interventions. Additionally, patients may have to wait longer for an intervention because they are referred to another provider, which also increases potential for loss to follow-up.2,30,31 This may be viewed as noncompliance with the standard of care, among other hazards, thereby increasing MPL risk.
Documentation tenets
Thorough documentation can decrease MPL risk, especially since it is often used as legal evidence.16 Documenting, for instance, preprocedure discussion of potential risk of AEs (such as bleeding or perforation) or procedural failure (for example, missed lesions)can protect gastroenterologists (Figure).16 While, as discussed previously, these should be covered in the informed consent process (which itself reduces MPL risk), proof of compliance in providing adequate informed consent must come in the form of documentation that indicates that the process took place and specifically what topics were discussed therein. MPL risk may be further decreased by documenting steps taken during a procedure and anatomic landmarks encountered to offer proof of technical competency and compliance with standards of care (Figure).16,34 In this context, it is worth recalling the adage: “If it’s not documented, it did not occur.”
Curbside consults versus consultation
Also germane here is the topic of whether documentation is needed for “curbside consults.” The uncertainty is, in part, semantic; that is, at what point does a “curbside” become a consultation? A curbside is a general question or query (such as anything that could also be answered by searching the Internet or reference materials) in response to which information is provided; once it involves provision of medical advice for a specific patient (for example, when patient identifiers have been shared or their EHR has been accessed), it constitutes a consultation. Based on these definitions, a curbside need not be documented, whereas a consultation – even if seemingly trivial – should be.
Consideration of language and cultural factors
Language barriers should be considered when the gastroenterologist is communicating with the patient, and such efforts, whenever made, should be documented to best protect against MPL.16,35 These considerations arise not only during the consent process but when obtaining a history, providing postprocedure instructions, and during follow-ups. To this end, 24/7 telephone interpreter services may assist the gastroenterologist (when one is communicating with non–English speakers and is not medically certified in the patient’s native/preferred language) and strengthen trust in the provider-patient relationship.36 Additionally, written materials (such as consent forms, procedural information) in patients’ native/preferred languages should be provided, when available, to enhance patient understanding and participation in care (Figure).35
Challenges posed by telemedicine
The COVID-19 pandemic has rapidly led to more virtual encounters. While increased utilization of telemedicine platforms may make health care more accessible, it does not lessen the clinicians’ duty to patients and may actually expose them to greater MPL risk.18,37,38 Therefore, the provider must be cognizant of two key principles to mitigate MPL risk in the context of telemedicine encounters. First, the same standard of care applies to virtual and in-person encounters.18,37,38 Second, patient privacy and HIPAA regulations are not waived during telemedicine encounters, and breaches of such may result in an MPL claim.18,37,38
With regard to the first principle, for patients who have not been physically examined (such as when a telemedicine visit was substituted for an in-person clinic encounter), gastroenterologists should not overlook requesting timely preprocedure anesthesia consultation or obtaining additional laboratory studies as needed to ensure safety and the same standard of care. Moreover, particularly in the context of pandemic-related decreased procedural capacity, triaging procedures can be especially challenging. Standardized institutional criteria which prioritize certain diagnoses/conditions over others, leaving room for justifiable exceptions, are advisable.
Vicarious liability
“Vicarious liability” is defined as that extending to persons who have not committed a wrong but on whose behalf wrongdoers acted.39 Therefore, gastroenterologists may be liable not only for their own actions but also for those of personnel they supervise (such as fellow trainees and non–physician practitioners).39 Vicarious liability aims to ensure that systemic checks and balances are in place so that, if failure occurs, harm can still be mitigated and/or avoided, as illustrated by Reason’s “Swiss Cheese Model.”40
Conclusion
Any gastroenterologist can experience an MPL claim. Such an experience can be especially stressful and confusing to early-career clinicians, especially if they’re unfamiliar with legal proceedings. Although MPL principles are not often taught in medical school or residency, it is important for gastroenterologists to be informed regarding tenets of MPL and cognizant of clinical situations which have relatively higher MPL risk. This can assuage untoward angst regarding MPL and highlight proactive risk-mitigation strategies. In general, gastroenterologist practices that can mitigate MPL risk include effective communication; adequate informed consent/refusal; documentation of preprocedure counseling, periprocedure events, and postprocedure recommendations; and maintenance of proper certification and privileging.
Dr. Azizian and Dr. Dalai are with the University of California, Los Angeles and the department of medicine at Olive View–UCLA Medical Center, Sylmar, Calif. They are co–first authors of this paper. Dr. Dalai is also with the division of gastroenterology at the University of New Mexico, Albuquerque. Dr. Adams is with the Center for Clinical Management Research in Veterans Affairs Ann Arbor Healthcare System, the division of gastroenterology at the University of Michigan Health System, and the Institute for Healthcare Policy and Innovation, all in Ann Arbor, Mich. Dr. Tabibian is with UCLA and the division of gastroenterology at Olive View–UCLA Medical Center. The authors have no conflicts of interest.
References
1. 2020 Data Sharing Project Gastroenterology 2009-2018. Inside Medical Liability: Second Quarter. Accessed 2020 Dec 6.
2. Mello MM et al. Health Aff (Millwood). 2004 Jul-Aug;23(4):42-53.
3. Adams MA et al. JAMA. 2014 Oct;312(13):1348-9.
4. Pegalis SE. American Law of Medical Malpractice 3d, Vol. 2. St. Paul, Minn.: Thomson Reuters, 2005.
5. Feld LD et al. Am J Gastroenterol. 2018 Nov;113(11):1577-9.
6. Sawyer v. Wight, 196 F. Supp. 2d 220, 226 (E.D.N.Y. 2002).
7. Michael A. Sita v. Long Island Jewish-Hillside Medical Center, 22 A.D.3d 743 (N.Y. App. Div. 2005).
8. Conklin LS et al. Clin Gastroenterol Hepatol. 2008 Jun;6(6):677-81.
9. Jena AB et al. N Engl J Med. 2011 Aug 18;365(7):629-36.
10. Kane CK. “Policy Research Perspectives Medical Liability Claim Frequency: A 2007-2008 Snapshot of Physicians.” Chicago: American Medical Association, 2010.
11. Hernandez LV et al. World J Gastrointest Endosc. 2013 Apr 16;5(4):169-73.
12. Schaffer AC et al. JAMA Intern Med. 2017 May 1;177(5):710-8.
13. Natanson v. Kline, 186 Kan. 393, 409, 350 P.2d 1093, 1106, decision clarified on denial of reh’g, 187 Kan. 186, 354 P.2d 670 (1960).
14. Truman v. Thomas, 27 Cal. 3d 285, 292, 611 P.2d 902, 906 (1980).
15. Shah P et al. Informed Consent, in “StatPearls.” Treasure Island, Fla.: StatPearls Publishing, 2020 Jan. Updated 2020 Aug 22.
16. Rex DK. Clin Gastroenterol Hepatol. 2013 Jul;11(7):768-73.
17. Gerstenberger PD, Plumeri PA. Gastrointest Endosc. Mar-Apr 1993;39(2):132-8.
18. Adams MA and Allen JI. Clin Gastroenterol Hepatol. 2019 Nov;17(12):2392-6.e1.
19. Ahlawat R et al. Esophagogastroduodenoscopy, in “StatPearls.” Treasure Island, Fla.: StatPearls Publishing, 2020 Jan. Updated 2020 Dec 9.
20. Cotton PB. Gastrointest Endosc. 2006 Mar;63(3):378-82.
21. Cotton PB. Gastrointest Endosc. 2010 Oct;72(4):904.
22. Adamson TE et al. West J Med. 1989 Mar;150(3):356-60.
23. Trap R et al. Endoscopy. 1999 Feb;31(2):125-30.
24. Funaki B. Semin Intervent Radiol. 2015 Mar;32(1):61-4.
25. Feeding Tube Nursing Home and Hospital Malpractice. Miller & Zois, Attorneys at Law. Accessed 2020 Jun 20.
26. Medical Malpractice Lawsuit Brings $750,000 Settlement: Death of 82-year-old woman from sepsis due to improper placement of feeding tube. Lubin & Meyers PC. Accessed 2020 Jun 20.
27. Brendel RW et al. Med Clin North Am. 2010 Nov;94(6):1229-40, xi-ii.
28. ASGE Standards of Practice Committee; Acosta RD et al. Gastrointest Endosc. 2016 Jan;83(1):3-16.
29. Saleem S and Thomas AL. Cureus. 2018 Jun 25;10(6):e2878.
30. Hiyama T et al. World J Gastroenterol. 2006 Dec 21;12(47):7671-5.
31. Studdert DM et al. JAMA. 2005 Jun 1;293(21):2609-17.
32. Shaheen NJ et al. Gastroenterology. 2018 May;154(7):1993-2003.
33. Oza VM et al. Clin Gastroenterol Hepatol. 2016 Feb;14(2):172-4.
34. Feld AD. Gastrointest Endosc Clin N Am. 2002 Jan;12(1):171-9, viii-ix.
35. Lee JS et al. J Gen Intern Med. 2017 Aug;32(8):863-70.
36. Forrow L and Kontrimas JC. J Gen Intern Med. 2017 Aug;32(8):855-7.
37. Moses RE et al. Am J Gastroenterol. 2014 Aug;109(8):1128-32.
38. Tabibian JH. “The Evolution of Telehealth.” Guidepoint: Legal Solutions Blog. Accessed 2020 Aug 12.
39. Feld AD. Am J Gastroenterol. 2004 Sep;99(9):1641-4.
40. Reason J. BMJ. 2000;320(7237):768‐70.
Disclaimer: This article is for educational purposes only. All examples are hypothetical and aim to illustrate common clinical scenarios and challenges gastroenterologists may encounter within their scope of practice. The content herein should not be interpreted as legal advice for individual cases nor a substitute for seeking the advice of an attorney.
There are unique potential stressors faced by the gastroenterologist at each career stage, some more so early on. One such stressor, and one particularly important in a procedure-intensive specialty like GI, is medical professional liability (MPL), historically termed “medical malpractice.” Between 2009 and 2018, GI was the second-highest internal medicine subspecialty in both MPL claims made and claims paid,1 yet instruction on MPL risk and mitigation is scarce in fellowship, as is the available GI-related literature on the topic. This scarcity may generate untoward stress and unnecessarily expose gastroenterologists to avoidable MPL pitfalls. Therefore, it is vital for GI trainees, early-career gastroenterologists, and even seasoned gastroenterologists to have a working and updated knowledge of the general principles of MPL and GI-specific considerations. Such understanding can help preserve physician well-being, increase professional satisfaction, strengthen the doctor-patient relationship, and improve health care outcomes.2
To this end, we herein provide a focused review of the following: key MPL concepts, trends in MPL claims, GI-related MPL risk scenarios and considerations, adverse provider defensive mechanisms, documentation tenets, challenges posed by telemedicine, and the concept of “vicarious liability.”
Key MPL concepts
MPL falls under the umbrella of tort law, which itself falls under the umbrella of civil law; that is, civil (as opposed to criminal) justice governs torts – including but not limited to MPL claims – as well as other areas of law concerning noncriminal injury.3 A “tort” is a “civil wrong that unfairly causes another to experience loss or harm resulting in legal liability.”3 MPL claims assert the tort of negligence (similar to the concept of “incompetence”) and endeavor to compensate the harmed patient/individual while simultaneously dissuading suboptimal medical care by the provider in the future.4,5 A successful MPL claim must prove four overlapping elements: that the tortfeasor (here, the gastroenterologist) owed a duty of care to the injured party and breached that duty, which caused damages.6 Given that MPL cases exist within tort law rather than criminal law, the burden of proof for these cases is not “beyond a reasonable doubt”; instead, it’s “to a reasonable medical probability.”7
Trends in MPL claims
According to data compiled by the MPL Association, 278,220 MPL claims were made in the United States from 1985 to 2012.3,8-10 Among these, 1.8% involved gastroenterologists, which puts it at 17th place out of the 20 specialties surveyed.9 While the number of paid claims over this time frame decreased in GI by 34.6% (from 18.5 to 12.1 cases per 1,000 physician-years), there was a concurrent 23.3% increase in average claim compensation; essentially, there were fewer paid GI-related claims but there were higher payouts per paid claim.11,12 From 2009 to 2018, average legal defense costs for paid GI-related claims were $97,392, and average paid amount was $330,876.1
GI-related MPL risk scenarios and considerations
Many MPL claims relate to situations involving medical errors or adverse events (AEs), be they procedural or nonprocedural. However other aspects of GI also carry MPL risk.
Informed consent
MPL claims may be made not only on the grounds of inadequately informed consent but also inadequately informed refusal.5,13,14 While standards for adequate informed consent vary by state, most states apply the “reasonable patient standard,” i.e., assuming an average patient with enough information to be an active participant in the medical decision-making process. Generally, informed consent should ensure that the patient understands the nature of the procedure/treatment being proposed, there is a discussion of the risks and benefits of undergoing and not undergoing the procedure/treatment, reasonable alternatives are presented, the risks and benefits associated with these alternatives are discussed, and the patient’s comprehension of these things is assessed (Figure).15 Additionally, informed consent should be tailored to each patient and GI procedure/treatment on a case-by-case basis rather than using a one-size-fits-all approach. Moreover, documentation of the patient’s understanding of the (tailored) information provided can concurrently improve quality of the consent and potentially decrease MPL risk (Figure).16
Endoscopic procedures
Procedure-related MPL claims represent approximately 25% of all GI-related claims (8,17). Among these, 52% involve colonoscopy, 16% involve endoscopic retrograde cholangiopancreatography (ERCP), and 11% involve esophagogastroduodenoscopy.8 Albeit generally safe, colonoscopy, as with esophagogastroduodenoscopy, is subject to rare but serious AEs.18,19 Risk of these AEs may be accentuated in certain scenarios (such as severe colonic inflammation or coagulopathy) and, as discussed earlier, may merit tailored informed consent. Regardless of the procedure, in the event of postprocedural development of signs/symptoms (such as tachycardia, fever, chest or abdominal discomfort, or hypotension) indicating a potential AE, stabilizing measures and evaluation (such as blood work and imaging) should be undertaken, and hospital admission (if not already hospitalized) should be considered until discharge is deemed safe.19
ERCP-related MPL claims, for many years, have had the highest average compensation of any GI procedure.11 Though discussion of advanced procedures is beyond the scope of this article, it is worth mentioning the observation that most of such claims involve an allegation that the procedure was not indicated (for example, that it was performed based on inadequate evidence of pancreatobiliary pathology), or was for diagnostic purposes (for example, being done instead of noninvasive imaging) rather than therapeutic.20-23 This emphasizes the importance of appropriate procedure indications.
Percutaneous endoscopic gastrostomy (PEG) placement merits special mention given it can be complicated by ethical challenges (for example, needing a surrogate decision-maker’s consent or representing medical futility) and has a relatively high potential for MPL claims. PEG placement carries a low AE rate (0.1%-1%), but these AEs may result in high morbidity/mortality, in part because of the underlying comorbidities of patients needing PEG placement.24,25 Also, timing of a patient’s demise may coincide with PEG placement, thereby prompting (possibly unfounded) perceptions of causality.24-27 Therefore, such scenarios merit unique additional preprocedure safeguards. For instance, for patients lacking capacity to provide informed consent, especially when family members may differ on whether PEG should be placed, it is advisable to ask the family to select one surrogate decision-maker (if there’s no advance directive) to whom the gastroenterologist should discuss both the risks, benefits, and goals of PEG placement in the context of the patient’s overall clinical trajectory/life expectancy and the need for consent (or refusal) based on what the patient would have wished. In addition, having a medical professional witness this discussion may be useful.27
Antithrombotic agents
Periprocedural management of antithrombotics, including anticoagulants and antiplatelets, can pose challenges for the gastroenterologist. While clinical practice guidelines exist to guide decision-making in this regard, the variables involved may extend beyond the expertise of the gastroenterologist.28 For instance, in addition to the procedural risk for bleeding, the indication for antithrombotic therapy, risk of a thrombotic event, duration of action of the antithrombotic, and available bridging options should all be considered according to recommendations.28,29 While requiring more time on the part of the gastroenterologist, the optimal periprocedural management of antithrombotic agents would usually involve discussion with the provider managing antithrombotic therapy to best conduct a risk-benefit assessment regarding if (and how long) the antithrombotic therapy should be held (Figure). This shared decision-making, which should also include the patient, may help decrease MPL risk and improve outcomes.
Provider defense mechanisms
Physicians may engage in various defensive behaviors in an attempt to mitigate MPL risk; however, these behaviors may, paradoxically, increase risk.30,31
Assurance behaviors
Assurance behaviors refer to the practice of recommending or performing additional services (such as medications, imaging, procedures, and referrals) that are not clearly indicated.2,30,31 Assurance behaviors are driven by fear of MPL risk and/or missing a potential diagnosis. Recent studies have estimated that more than 50% of gastroenterologists worldwide have performed additional invasive procedures without clear indications, and that nearly one-third of endoscopic procedures annually have questionable indications.30,32 While assurance behaviors may seem likely to decrease MPL risk, overall, they may inadvertently increase AE and MPL risk, as well as health care expenditures.3,30,32
Avoidance behaviors
Avoidance behaviors refer to providers avoiding participation in potentially high-risk clinical interventions (for example, the actual procedures), including those for which they are credentialed/certified proficient.30,31 Two clinical scenarios that illustrate this behavior include the following: An advanced endoscopist credentialed to perform ERCP might refer a “high-risk” elderly patient with cholangitis to another provider to perform said ERCP or for percutaneous transhepatic drainage (in the absence of a clear benefit to such), or a gastroenterologist might refer a patient to interventional gastroenterology for resection of a large polyp even though gastroenterologists are usually proficient in this skill and may feel comfortable performing the resection themselves. Avoidance behaviors are driven by a fear of MPL risk and can have several negative consequences.33 For example, patients may not receive indicated interventions. Additionally, patients may have to wait longer for an intervention because they are referred to another provider, which also increases potential for loss to follow-up.2,30,31 This may be viewed as noncompliance with the standard of care, among other hazards, thereby increasing MPL risk.
Documentation tenets
Thorough documentation can decrease MPL risk, especially since it is often used as legal evidence.16 Documenting, for instance, preprocedure discussion of potential risk of AEs (such as bleeding or perforation) or procedural failure (for example, missed lesions)can protect gastroenterologists (Figure).16 While, as discussed previously, these should be covered in the informed consent process (which itself reduces MPL risk), proof of compliance in providing adequate informed consent must come in the form of documentation that indicates that the process took place and specifically what topics were discussed therein. MPL risk may be further decreased by documenting steps taken during a procedure and anatomic landmarks encountered to offer proof of technical competency and compliance with standards of care (Figure).16,34 In this context, it is worth recalling the adage: “If it’s not documented, it did not occur.”
Curbside consults versus consultation
Also germane here is the topic of whether documentation is needed for “curbside consults.” The uncertainty is, in part, semantic; that is, at what point does a “curbside” become a consultation? A curbside is a general question or query (such as anything that could also be answered by searching the Internet or reference materials) in response to which information is provided; once it involves provision of medical advice for a specific patient (for example, when patient identifiers have been shared or their EHR has been accessed), it constitutes a consultation. Based on these definitions, a curbside need not be documented, whereas a consultation – even if seemingly trivial – should be.
Consideration of language and cultural factors
Language barriers should be considered when the gastroenterologist is communicating with the patient, and such efforts, whenever made, should be documented to best protect against MPL.16,35 These considerations arise not only during the consent process but when obtaining a history, providing postprocedure instructions, and during follow-ups. To this end, 24/7 telephone interpreter services may assist the gastroenterologist (when one is communicating with non–English speakers and is not medically certified in the patient’s native/preferred language) and strengthen trust in the provider-patient relationship.36 Additionally, written materials (such as consent forms, procedural information) in patients’ native/preferred languages should be provided, when available, to enhance patient understanding and participation in care (Figure).35
Challenges posed by telemedicine
The COVID-19 pandemic has rapidly led to more virtual encounters. While increased utilization of telemedicine platforms may make health care more accessible, it does not lessen the clinicians’ duty to patients and may actually expose them to greater MPL risk.18,37,38 Therefore, the provider must be cognizant of two key principles to mitigate MPL risk in the context of telemedicine encounters. First, the same standard of care applies to virtual and in-person encounters.18,37,38 Second, patient privacy and HIPAA regulations are not waived during telemedicine encounters, and breaches of such may result in an MPL claim.18,37,38
With regard to the first principle, for patients who have not been physically examined (such as when a telemedicine visit was substituted for an in-person clinic encounter), gastroenterologists should not overlook requesting timely preprocedure anesthesia consultation or obtaining additional laboratory studies as needed to ensure safety and the same standard of care. Moreover, particularly in the context of pandemic-related decreased procedural capacity, triaging procedures can be especially challenging. Standardized institutional criteria which prioritize certain diagnoses/conditions over others, leaving room for justifiable exceptions, are advisable.
Vicarious liability
“Vicarious liability” is defined as that extending to persons who have not committed a wrong but on whose behalf wrongdoers acted.39 Therefore, gastroenterologists may be liable not only for their own actions but also for those of personnel they supervise (such as fellow trainees and non–physician practitioners).39 Vicarious liability aims to ensure that systemic checks and balances are in place so that, if failure occurs, harm can still be mitigated and/or avoided, as illustrated by Reason’s “Swiss Cheese Model.”40
Conclusion
Any gastroenterologist can experience an MPL claim. Such an experience can be especially stressful and confusing to early-career clinicians, especially if they’re unfamiliar with legal proceedings. Although MPL principles are not often taught in medical school or residency, it is important for gastroenterologists to be informed regarding tenets of MPL and cognizant of clinical situations which have relatively higher MPL risk. This can assuage untoward angst regarding MPL and highlight proactive risk-mitigation strategies. In general, gastroenterologist practices that can mitigate MPL risk include effective communication; adequate informed consent/refusal; documentation of preprocedure counseling, periprocedure events, and postprocedure recommendations; and maintenance of proper certification and privileging.
Dr. Azizian and Dr. Dalai are with the University of California, Los Angeles and the department of medicine at Olive View–UCLA Medical Center, Sylmar, Calif. They are co–first authors of this paper. Dr. Dalai is also with the division of gastroenterology at the University of New Mexico, Albuquerque. Dr. Adams is with the Center for Clinical Management Research in Veterans Affairs Ann Arbor Healthcare System, the division of gastroenterology at the University of Michigan Health System, and the Institute for Healthcare Policy and Innovation, all in Ann Arbor, Mich. Dr. Tabibian is with UCLA and the division of gastroenterology at Olive View–UCLA Medical Center. The authors have no conflicts of interest.
References
1. 2020 Data Sharing Project Gastroenterology 2009-2018. Inside Medical Liability: Second Quarter. Accessed 2020 Dec 6.
2. Mello MM et al. Health Aff (Millwood). 2004 Jul-Aug;23(4):42-53.
3. Adams MA et al. JAMA. 2014 Oct;312(13):1348-9.
4. Pegalis SE. American Law of Medical Malpractice 3d, Vol. 2. St. Paul, Minn.: Thomson Reuters, 2005.
5. Feld LD et al. Am J Gastroenterol. 2018 Nov;113(11):1577-9.
6. Sawyer v. Wight, 196 F. Supp. 2d 220, 226 (E.D.N.Y. 2002).
7. Michael A. Sita v. Long Island Jewish-Hillside Medical Center, 22 A.D.3d 743 (N.Y. App. Div. 2005).
8. Conklin LS et al. Clin Gastroenterol Hepatol. 2008 Jun;6(6):677-81.
9. Jena AB et al. N Engl J Med. 2011 Aug 18;365(7):629-36.
10. Kane CK. “Policy Research Perspectives Medical Liability Claim Frequency: A 2007-2008 Snapshot of Physicians.” Chicago: American Medical Association, 2010.
11. Hernandez LV et al. World J Gastrointest Endosc. 2013 Apr 16;5(4):169-73.
12. Schaffer AC et al. JAMA Intern Med. 2017 May 1;177(5):710-8.
13. Natanson v. Kline, 186 Kan. 393, 409, 350 P.2d 1093, 1106, decision clarified on denial of reh’g, 187 Kan. 186, 354 P.2d 670 (1960).
14. Truman v. Thomas, 27 Cal. 3d 285, 292, 611 P.2d 902, 906 (1980).
15. Shah P et al. Informed Consent, in “StatPearls.” Treasure Island, Fla.: StatPearls Publishing, 2020 Jan. Updated 2020 Aug 22.
16. Rex DK. Clin Gastroenterol Hepatol. 2013 Jul;11(7):768-73.
17. Gerstenberger PD, Plumeri PA. Gastrointest Endosc. Mar-Apr 1993;39(2):132-8.
18. Adams MA and Allen JI. Clin Gastroenterol Hepatol. 2019 Nov;17(12):2392-6.e1.
19. Ahlawat R et al. Esophagogastroduodenoscopy, in “StatPearls.” Treasure Island, Fla.: StatPearls Publishing, 2020 Jan. Updated 2020 Dec 9.
20. Cotton PB. Gastrointest Endosc. 2006 Mar;63(3):378-82.
21. Cotton PB. Gastrointest Endosc. 2010 Oct;72(4):904.
22. Adamson TE et al. West J Med. 1989 Mar;150(3):356-60.
23. Trap R et al. Endoscopy. 1999 Feb;31(2):125-30.
24. Funaki B. Semin Intervent Radiol. 2015 Mar;32(1):61-4.
25. Feeding Tube Nursing Home and Hospital Malpractice. Miller & Zois, Attorneys at Law. Accessed 2020 Jun 20.
26. Medical Malpractice Lawsuit Brings $750,000 Settlement: Death of 82-year-old woman from sepsis due to improper placement of feeding tube. Lubin & Meyers PC. Accessed 2020 Jun 20.
27. Brendel RW et al. Med Clin North Am. 2010 Nov;94(6):1229-40, xi-ii.
28. ASGE Standards of Practice Committee; Acosta RD et al. Gastrointest Endosc. 2016 Jan;83(1):3-16.
29. Saleem S and Thomas AL. Cureus. 2018 Jun 25;10(6):e2878.
30. Hiyama T et al. World J Gastroenterol. 2006 Dec 21;12(47):7671-5.
31. Studdert DM et al. JAMA. 2005 Jun 1;293(21):2609-17.
32. Shaheen NJ et al. Gastroenterology. 2018 May;154(7):1993-2003.
33. Oza VM et al. Clin Gastroenterol Hepatol. 2016 Feb;14(2):172-4.
34. Feld AD. Gastrointest Endosc Clin N Am. 2002 Jan;12(1):171-9, viii-ix.
35. Lee JS et al. J Gen Intern Med. 2017 Aug;32(8):863-70.
36. Forrow L and Kontrimas JC. J Gen Intern Med. 2017 Aug;32(8):855-7.
37. Moses RE et al. Am J Gastroenterol. 2014 Aug;109(8):1128-32.
38. Tabibian JH. “The Evolution of Telehealth.” Guidepoint: Legal Solutions Blog. Accessed 2020 Aug 12.
39. Feld AD. Am J Gastroenterol. 2004 Sep;99(9):1641-4.
40. Reason J. BMJ. 2000;320(7237):768‐70.
Impact of female hormonal exposure on risk of RA
Key clinical point: Early age at first pregnancy (less than 22 years) and early menopause (45 years and earlier) were associated with a higher risk of rheumatoid arthritis (RA), whereas long-term progestogen use (more than 24 months) before menopause was associated with a reduced risk.
Major finding: The risk of RA was a significantly increased with early age at first pregnancy (less than 22 vs. 27 or more years; hazard ratio [HR], 1.34; Ptrend = .028) and menopause (45 or less vs. 53 or more years; HR, 1.40; Ptrend = .039). Risk of RA was inversely related to exposure to progestogen only in perimenopause (more than 24 vs. 0 months; multi-adjusted HR, 0.77; Ptrend = .004).
Study details: This study included 78,452 women, with 698 incident cases of RA using data from the French E3N-EPIC cohort study.
Disclosures: The study was funded by a research grant from FOREUM Foundation for Research in Rheumatology. The authors declared no conflicts of interest.
Source: Salliot C et al. Rheumatology (Oxford). 2021 Feb 6. doi: 10.1093/rheumatology/keab101.
Key clinical point: Early age at first pregnancy (less than 22 years) and early menopause (45 years and earlier) were associated with a higher risk of rheumatoid arthritis (RA), whereas long-term progestogen use (more than 24 months) before menopause was associated with a reduced risk.
Major finding: The risk of RA was a significantly increased with early age at first pregnancy (less than 22 vs. 27 or more years; hazard ratio [HR], 1.34; Ptrend = .028) and menopause (45 or less vs. 53 or more years; HR, 1.40; Ptrend = .039). Risk of RA was inversely related to exposure to progestogen only in perimenopause (more than 24 vs. 0 months; multi-adjusted HR, 0.77; Ptrend = .004).
Study details: This study included 78,452 women, with 698 incident cases of RA using data from the French E3N-EPIC cohort study.
Disclosures: The study was funded by a research grant from FOREUM Foundation for Research in Rheumatology. The authors declared no conflicts of interest.
Source: Salliot C et al. Rheumatology (Oxford). 2021 Feb 6. doi: 10.1093/rheumatology/keab101.
Key clinical point: Early age at first pregnancy (less than 22 years) and early menopause (45 years and earlier) were associated with a higher risk of rheumatoid arthritis (RA), whereas long-term progestogen use (more than 24 months) before menopause was associated with a reduced risk.
Major finding: The risk of RA was a significantly increased with early age at first pregnancy (less than 22 vs. 27 or more years; hazard ratio [HR], 1.34; Ptrend = .028) and menopause (45 or less vs. 53 or more years; HR, 1.40; Ptrend = .039). Risk of RA was inversely related to exposure to progestogen only in perimenopause (more than 24 vs. 0 months; multi-adjusted HR, 0.77; Ptrend = .004).
Study details: This study included 78,452 women, with 698 incident cases of RA using data from the French E3N-EPIC cohort study.
Disclosures: The study was funded by a research grant from FOREUM Foundation for Research in Rheumatology. The authors declared no conflicts of interest.
Source: Salliot C et al. Rheumatology (Oxford). 2021 Feb 6. doi: 10.1093/rheumatology/keab101.
Modern treatment approach results in LDA and remission in pregnant patients with RA
Key clinical point: A modern treat-to-target (T2T) approach with the use of tumor necrosis factor inhibitors (TNFi) resulted in low disease activity (LDA) and remission in 90% of pregnant patients with rheumatoid arthritis (RA).
Major finding: Among patients treated with T2T, 90.4% and 76.1% of patients were in LDA or remission, respectively, in the third trimester. Mean disease activity over time was lower in patients treated with the T2T approach vs. reference cohort (P less than .001).
Study details: Findings are from an analysis of 309 patients with RA from the PreCARA cohort who wished to conceive or were pregnant. Patients were treated with a T2T approach with the use of TNFi and/or a combination of disease-modifying antirheumatic drugs along with obvious pregnancy restrictions. The reference cohort consisted of pregnant patients with RA treated according to the 2002-2010 standards from the PARA study.
Disclosures: This investigator-initiated study was supported by UCB and Dutch Arthritis Foundation (ReumaNederland). The investigators did not report any competing interests.
Source: Smeele HTW et al. Ann Rheum Dis. 2021 Feb 10. doi: 10.1136/annrheumdis-2020-219547.
Key clinical point: A modern treat-to-target (T2T) approach with the use of tumor necrosis factor inhibitors (TNFi) resulted in low disease activity (LDA) and remission in 90% of pregnant patients with rheumatoid arthritis (RA).
Major finding: Among patients treated with T2T, 90.4% and 76.1% of patients were in LDA or remission, respectively, in the third trimester. Mean disease activity over time was lower in patients treated with the T2T approach vs. reference cohort (P less than .001).
Study details: Findings are from an analysis of 309 patients with RA from the PreCARA cohort who wished to conceive or were pregnant. Patients were treated with a T2T approach with the use of TNFi and/or a combination of disease-modifying antirheumatic drugs along with obvious pregnancy restrictions. The reference cohort consisted of pregnant patients with RA treated according to the 2002-2010 standards from the PARA study.
Disclosures: This investigator-initiated study was supported by UCB and Dutch Arthritis Foundation (ReumaNederland). The investigators did not report any competing interests.
Source: Smeele HTW et al. Ann Rheum Dis. 2021 Feb 10. doi: 10.1136/annrheumdis-2020-219547.
Key clinical point: A modern treat-to-target (T2T) approach with the use of tumor necrosis factor inhibitors (TNFi) resulted in low disease activity (LDA) and remission in 90% of pregnant patients with rheumatoid arthritis (RA).
Major finding: Among patients treated with T2T, 90.4% and 76.1% of patients were in LDA or remission, respectively, in the third trimester. Mean disease activity over time was lower in patients treated with the T2T approach vs. reference cohort (P less than .001).
Study details: Findings are from an analysis of 309 patients with RA from the PreCARA cohort who wished to conceive or were pregnant. Patients were treated with a T2T approach with the use of TNFi and/or a combination of disease-modifying antirheumatic drugs along with obvious pregnancy restrictions. The reference cohort consisted of pregnant patients with RA treated according to the 2002-2010 standards from the PARA study.
Disclosures: This investigator-initiated study was supported by UCB and Dutch Arthritis Foundation (ReumaNederland). The investigators did not report any competing interests.
Source: Smeele HTW et al. Ann Rheum Dis. 2021 Feb 10. doi: 10.1136/annrheumdis-2020-219547.
Safety and efficacy of biosimilar CT-P17 and adalimumab in RA
Key clinical point: Citrate-free adalimumab biosimilar (CT-P17) and European Union-approved adalimumab (EU-adalimumab) demonstrated equivalent efficacy and comparable safety in patients with rheumatoid arthritis (RA).
Major finding: At week 24, CT-P17 and EU-adalimumab groups showed similar 20% improvement by the American College of Rheumatology criteria response rate (82.7%). The 95% confidence interval (CI; −5.94 to 5.94) and 90% CI (−4.98 to 4.98) for estimated treatment difference were within predefined equivalence margin, demonstrating therapeutic equivalence. Overall, safety was similar between both treatment groups.
Study details: This was a randomized, double-blind phase 3 study of 648 patients with RA who were randomly allocated to receive 40 mg of either CT-P17 (n=324) or EU-adalimumab (n=324), every 2 weeks until week 48.
Disclosures: This study was funded by Celltrion, Inc. (Incheon, Republic of Korea). The authors reported receiving support, investigator fees, speaking fees, and/or consulting for various pharmaceutical companies including Celltrion, Inc. SJ Lee, YJ Bae, GE Yang, and JK Yoo reported being employees of Celltrion, Inc.
Source: Kay J et al. Arthritis Res Ther. 2021 Feb 5. doi: 10.1186/s13075-020-02394-7.
Key clinical point: Citrate-free adalimumab biosimilar (CT-P17) and European Union-approved adalimumab (EU-adalimumab) demonstrated equivalent efficacy and comparable safety in patients with rheumatoid arthritis (RA).
Major finding: At week 24, CT-P17 and EU-adalimumab groups showed similar 20% improvement by the American College of Rheumatology criteria response rate (82.7%). The 95% confidence interval (CI; −5.94 to 5.94) and 90% CI (−4.98 to 4.98) for estimated treatment difference were within predefined equivalence margin, demonstrating therapeutic equivalence. Overall, safety was similar between both treatment groups.
Study details: This was a randomized, double-blind phase 3 study of 648 patients with RA who were randomly allocated to receive 40 mg of either CT-P17 (n=324) or EU-adalimumab (n=324), every 2 weeks until week 48.
Disclosures: This study was funded by Celltrion, Inc. (Incheon, Republic of Korea). The authors reported receiving support, investigator fees, speaking fees, and/or consulting for various pharmaceutical companies including Celltrion, Inc. SJ Lee, YJ Bae, GE Yang, and JK Yoo reported being employees of Celltrion, Inc.
Source: Kay J et al. Arthritis Res Ther. 2021 Feb 5. doi: 10.1186/s13075-020-02394-7.
Key clinical point: Citrate-free adalimumab biosimilar (CT-P17) and European Union-approved adalimumab (EU-adalimumab) demonstrated equivalent efficacy and comparable safety in patients with rheumatoid arthritis (RA).
Major finding: At week 24, CT-P17 and EU-adalimumab groups showed similar 20% improvement by the American College of Rheumatology criteria response rate (82.7%). The 95% confidence interval (CI; −5.94 to 5.94) and 90% CI (−4.98 to 4.98) for estimated treatment difference were within predefined equivalence margin, demonstrating therapeutic equivalence. Overall, safety was similar between both treatment groups.
Study details: This was a randomized, double-blind phase 3 study of 648 patients with RA who were randomly allocated to receive 40 mg of either CT-P17 (n=324) or EU-adalimumab (n=324), every 2 weeks until week 48.
Disclosures: This study was funded by Celltrion, Inc. (Incheon, Republic of Korea). The authors reported receiving support, investigator fees, speaking fees, and/or consulting for various pharmaceutical companies including Celltrion, Inc. SJ Lee, YJ Bae, GE Yang, and JK Yoo reported being employees of Celltrion, Inc.
Source: Kay J et al. Arthritis Res Ther. 2021 Feb 5. doi: 10.1186/s13075-020-02394-7.
Anti-PAD3 positivity tied to higher disease activity and joint damage in RA
Key clinical point: Positivity for antipeptidyl-arginine deiminase type-3 (anti-PAD3) antibodies was associated with higher disease activity and joint damage scores in patients with rheumatoid arthritis (RA).
Major finding: Patients positive vs. negative for anti-PAD3 had significantly higher 28-swollen joint count (7.1 vs. 4.3; P less than .0001), 28-joint disease activity score-erythrocyte sedimentation rate (4.2 vs. 3.7; P = .005), and radiographic damage (14.9 vs. 8.8; P = .02).
Study details: Findings are from the assessment of biomarkers in 851 patients with RA and 516 disease controls (axial spondyloarthritis, n=320; psoriatic arthritis, n=196) from the Swiss Clinical Quality Management registry.
Disclosures: This work was supported by the De Reuter Foundation. M Mahler, C Bentow, and L Martinez-Prat declared being current or former employees at Inova Diagnostics. All the other authors declared no conflicts of interest.
Source: Lamacchia C et al. Rheumatology (Oxford). 2021 Jan 27. doi: 10.1093/rheumatology/keab050.
Key clinical point: Positivity for antipeptidyl-arginine deiminase type-3 (anti-PAD3) antibodies was associated with higher disease activity and joint damage scores in patients with rheumatoid arthritis (RA).
Major finding: Patients positive vs. negative for anti-PAD3 had significantly higher 28-swollen joint count (7.1 vs. 4.3; P less than .0001), 28-joint disease activity score-erythrocyte sedimentation rate (4.2 vs. 3.7; P = .005), and radiographic damage (14.9 vs. 8.8; P = .02).
Study details: Findings are from the assessment of biomarkers in 851 patients with RA and 516 disease controls (axial spondyloarthritis, n=320; psoriatic arthritis, n=196) from the Swiss Clinical Quality Management registry.
Disclosures: This work was supported by the De Reuter Foundation. M Mahler, C Bentow, and L Martinez-Prat declared being current or former employees at Inova Diagnostics. All the other authors declared no conflicts of interest.
Source: Lamacchia C et al. Rheumatology (Oxford). 2021 Jan 27. doi: 10.1093/rheumatology/keab050.
Key clinical point: Positivity for antipeptidyl-arginine deiminase type-3 (anti-PAD3) antibodies was associated with higher disease activity and joint damage scores in patients with rheumatoid arthritis (RA).
Major finding: Patients positive vs. negative for anti-PAD3 had significantly higher 28-swollen joint count (7.1 vs. 4.3; P less than .0001), 28-joint disease activity score-erythrocyte sedimentation rate (4.2 vs. 3.7; P = .005), and radiographic damage (14.9 vs. 8.8; P = .02).
Study details: Findings are from the assessment of biomarkers in 851 patients with RA and 516 disease controls (axial spondyloarthritis, n=320; psoriatic arthritis, n=196) from the Swiss Clinical Quality Management registry.
Disclosures: This work was supported by the De Reuter Foundation. M Mahler, C Bentow, and L Martinez-Prat declared being current or former employees at Inova Diagnostics. All the other authors declared no conflicts of interest.
Source: Lamacchia C et al. Rheumatology (Oxford). 2021 Jan 27. doi: 10.1093/rheumatology/keab050.
Filgotinib+MTX shows benefit in RA patients with inadequate response to MTX
Key clinical point: Treatment with filgotinib and methotrexate (MTX) reduced signs and symptoms of rheumatoid arthritis (RA) in patients with moderate-to-severe active RA and inadequate response to MTX.
Major finding: Proportion of patients achieving 20% improvement in American College of Rheumatology criteria at week 12 was significantly higher with filgotinib 200 mg (76.6%) and 100 mg (69.8%) vs. placebo (49.9%; P for all less than .001). Overall, both filgotinib doses were well tolerated.
Study details: Findings are from FINCH I phase 3 study including 1,755 patients with moderate-to-severe active RA and inadequate response to MTX. Patients were randomly assigned to once-daily oral filgotinib 200 mg or filgotinib 100 mg, subcutaneous adalimumab 40 mg biweekly, or placebo, all with stable background MTX.
Disclosures: The study was funded by Gilead Sciences. Study investigators including the lead author reported ties with various pharmaceutical companies, including Gilead Sciences. MC Genovese, F Matzkies, B Bartok, L Ye, and Y Guo declared being employees and shareholders of Gilead Sciences. JS Sundy, A Jahreis, and N Mozaffarian declared being former employees of Gilead Sciences and may hold shares. C Tasset declared being an employee and shareholder of Galapagos NV. JA Simon, U Kumar U, and S-C Bae report no disclosures.
Source: Combe B et al. Ann Rheum Dis. 2021 Jan 27. doi: 10.1136/annrheumdis-2020-219214.
Key clinical point: Treatment with filgotinib and methotrexate (MTX) reduced signs and symptoms of rheumatoid arthritis (RA) in patients with moderate-to-severe active RA and inadequate response to MTX.
Major finding: Proportion of patients achieving 20% improvement in American College of Rheumatology criteria at week 12 was significantly higher with filgotinib 200 mg (76.6%) and 100 mg (69.8%) vs. placebo (49.9%; P for all less than .001). Overall, both filgotinib doses were well tolerated.
Study details: Findings are from FINCH I phase 3 study including 1,755 patients with moderate-to-severe active RA and inadequate response to MTX. Patients were randomly assigned to once-daily oral filgotinib 200 mg or filgotinib 100 mg, subcutaneous adalimumab 40 mg biweekly, or placebo, all with stable background MTX.
Disclosures: The study was funded by Gilead Sciences. Study investigators including the lead author reported ties with various pharmaceutical companies, including Gilead Sciences. MC Genovese, F Matzkies, B Bartok, L Ye, and Y Guo declared being employees and shareholders of Gilead Sciences. JS Sundy, A Jahreis, and N Mozaffarian declared being former employees of Gilead Sciences and may hold shares. C Tasset declared being an employee and shareholder of Galapagos NV. JA Simon, U Kumar U, and S-C Bae report no disclosures.
Source: Combe B et al. Ann Rheum Dis. 2021 Jan 27. doi: 10.1136/annrheumdis-2020-219214.
Key clinical point: Treatment with filgotinib and methotrexate (MTX) reduced signs and symptoms of rheumatoid arthritis (RA) in patients with moderate-to-severe active RA and inadequate response to MTX.
Major finding: Proportion of patients achieving 20% improvement in American College of Rheumatology criteria at week 12 was significantly higher with filgotinib 200 mg (76.6%) and 100 mg (69.8%) vs. placebo (49.9%; P for all less than .001). Overall, both filgotinib doses were well tolerated.
Study details: Findings are from FINCH I phase 3 study including 1,755 patients with moderate-to-severe active RA and inadequate response to MTX. Patients were randomly assigned to once-daily oral filgotinib 200 mg or filgotinib 100 mg, subcutaneous adalimumab 40 mg biweekly, or placebo, all with stable background MTX.
Disclosures: The study was funded by Gilead Sciences. Study investigators including the lead author reported ties with various pharmaceutical companies, including Gilead Sciences. MC Genovese, F Matzkies, B Bartok, L Ye, and Y Guo declared being employees and shareholders of Gilead Sciences. JS Sundy, A Jahreis, and N Mozaffarian declared being former employees of Gilead Sciences and may hold shares. C Tasset declared being an employee and shareholder of Galapagos NV. JA Simon, U Kumar U, and S-C Bae report no disclosures.
Source: Combe B et al. Ann Rheum Dis. 2021 Jan 27. doi: 10.1136/annrheumdis-2020-219214.
Is board recertification worth it?
I passed the neurology boards, for the first time, in 1998. Then again in 2009, and most recently in 2019.
So I’m up again in 2029. Regrettably, I missed grandfathering in for life by a few years.
Some people don’t study for them, but I’m a little too compulsive not to. I’d guess I put 40-50 hours into doing so in the 3 months beforehand. I didn’t want to fail and have to pay a hefty fee to retake them (the test fee for once is enough as it is).
I’ll be 63 when my next certification is due.
So I wonder (if I’m still in practice) will it even be worthwhile to do it all again? I like what I do, but certainly don’t plan on practicing forever.
Board certification looks good on paper, but certainly isn’t a requirement to practice. One of the best cardiologists I know has never bothered to get his board certification and I don’t think any less of him for it. He also isn’t wanting for patients, and those he has think he’s awesome.
That said, there are things, like being involved in research and legal work, where board certification is strongly recommended, if not mandatory. Since I do both, I certainly wouldn’t want to do anything that might affect my participating in them – if I’m still doing this in 8 years.
By the same token, my office lease runs out when I’m 62. At that point I’ll have been in the same place for 17 years. I don’t consider that a bad thing. I like my current office, and will be perfectly happy to wrap up my career here.
It brings up the same question, though, with logistics that are an even bigger PIA. The last thing I want to do is move my office as my career is winding down. But a lease extension for a few years can be negotiated, a board certification can’t.
I can’t help but wonder: If I’ve already passed it three times, hopefully that means I know what I’m doing. One side will argue that it’s purely greed, as the people who run the boards need money and a way to justify their existence. On the other side are those who argue that maintenance of certification, while not perfect, is the only way we have of making sure practicing physicians are staying up to snuff.
The truth, as always, is somewhere in between.
But it still raises a question that I, fortunately, have another 8 years to think about. Because I’m not in a position to debate if it’s right or wrong, I just have to play by the rules.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
I passed the neurology boards, for the first time, in 1998. Then again in 2009, and most recently in 2019.
So I’m up again in 2029. Regrettably, I missed grandfathering in for life by a few years.
Some people don’t study for them, but I’m a little too compulsive not to. I’d guess I put 40-50 hours into doing so in the 3 months beforehand. I didn’t want to fail and have to pay a hefty fee to retake them (the test fee for once is enough as it is).
I’ll be 63 when my next certification is due.
So I wonder (if I’m still in practice) will it even be worthwhile to do it all again? I like what I do, but certainly don’t plan on practicing forever.
Board certification looks good on paper, but certainly isn’t a requirement to practice. One of the best cardiologists I know has never bothered to get his board certification and I don’t think any less of him for it. He also isn’t wanting for patients, and those he has think he’s awesome.
That said, there are things, like being involved in research and legal work, where board certification is strongly recommended, if not mandatory. Since I do both, I certainly wouldn’t want to do anything that might affect my participating in them – if I’m still doing this in 8 years.
By the same token, my office lease runs out when I’m 62. At that point I’ll have been in the same place for 17 years. I don’t consider that a bad thing. I like my current office, and will be perfectly happy to wrap up my career here.
It brings up the same question, though, with logistics that are an even bigger PIA. The last thing I want to do is move my office as my career is winding down. But a lease extension for a few years can be negotiated, a board certification can’t.
I can’t help but wonder: If I’ve already passed it three times, hopefully that means I know what I’m doing. One side will argue that it’s purely greed, as the people who run the boards need money and a way to justify their existence. On the other side are those who argue that maintenance of certification, while not perfect, is the only way we have of making sure practicing physicians are staying up to snuff.
The truth, as always, is somewhere in between.
But it still raises a question that I, fortunately, have another 8 years to think about. Because I’m not in a position to debate if it’s right or wrong, I just have to play by the rules.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
I passed the neurology boards, for the first time, in 1998. Then again in 2009, and most recently in 2019.
So I’m up again in 2029. Regrettably, I missed grandfathering in for life by a few years.
Some people don’t study for them, but I’m a little too compulsive not to. I’d guess I put 40-50 hours into doing so in the 3 months beforehand. I didn’t want to fail and have to pay a hefty fee to retake them (the test fee for once is enough as it is).
I’ll be 63 when my next certification is due.
So I wonder (if I’m still in practice) will it even be worthwhile to do it all again? I like what I do, but certainly don’t plan on practicing forever.
Board certification looks good on paper, but certainly isn’t a requirement to practice. One of the best cardiologists I know has never bothered to get his board certification and I don’t think any less of him for it. He also isn’t wanting for patients, and those he has think he’s awesome.
That said, there are things, like being involved in research and legal work, where board certification is strongly recommended, if not mandatory. Since I do both, I certainly wouldn’t want to do anything that might affect my participating in them – if I’m still doing this in 8 years.
By the same token, my office lease runs out when I’m 62. At that point I’ll have been in the same place for 17 years. I don’t consider that a bad thing. I like my current office, and will be perfectly happy to wrap up my career here.
It brings up the same question, though, with logistics that are an even bigger PIA. The last thing I want to do is move my office as my career is winding down. But a lease extension for a few years can be negotiated, a board certification can’t.
I can’t help but wonder: If I’ve already passed it three times, hopefully that means I know what I’m doing. One side will argue that it’s purely greed, as the people who run the boards need money and a way to justify their existence. On the other side are those who argue that maintenance of certification, while not perfect, is the only way we have of making sure practicing physicians are staying up to snuff.
The truth, as always, is somewhere in between.
But it still raises a question that I, fortunately, have another 8 years to think about. Because I’m not in a position to debate if it’s right or wrong, I just have to play by the rules.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
The surgical approach to the obliterated anterior cul-de-sac
Additional videos from SGS are available here, including these recent offerings:
• A minimally invasive modification for fascia lata mid-urethral sling
• Retroperitoneal anatomy and parametrial dissection in robotic uterine artery-sparing radical trachelectomy
• Maintaining and reclaiming hemostasis in laparoscopic surgery
Additional videos from SGS are available here, including these recent offerings:
• A minimally invasive modification for fascia lata mid-urethral sling
• Retroperitoneal anatomy and parametrial dissection in robotic uterine artery-sparing radical trachelectomy
• Maintaining and reclaiming hemostasis in laparoscopic surgery
Additional videos from SGS are available here, including these recent offerings:
• A minimally invasive modification for fascia lata mid-urethral sling
• Retroperitoneal anatomy and parametrial dissection in robotic uterine artery-sparing radical trachelectomy
• Maintaining and reclaiming hemostasis in laparoscopic surgery
Minorities underrepresented on liver transplant waiting lists
Non-Hispanic Black and Hispanic patients are underrepresented on many liver transplant waiting lists, whereas non-Hispanic White patients are often overrepresented, according to data from 109 centers.
While racial disparities “greatly diminished” after placement on a waiting list, which suggests recent progress in the field, pre–wait-listing disparities may be more challenging to overcome, reported lead author Curtis Warren, MPH, CPH, of the University of Florida, Gainesville, and colleagues.
“In 2020, the Organ Procurement and Transplantation Network implemented a new allocation system for liver transplantation based on concentric circles of geographic proximity rather than somewhat arbitrarily delineated Donor Service Areas (DSAs),” the investigators wrote in Journal of the American College of Surgeons. “Although this was a step toward improving and equalizing access to lifesaving organs for those on the liver transplant wait list, the listing process determining which patients will be considered for transplantation has continued to be a significant hurdle.”
The process is “rife with impediments to equal access to listing,” according to Dr. Warren and colleagues; getting on a waiting list can be affected by factors such as inequitable access to primary care, lack of private health insurance, and subjective selection by transplant centers.
To better characterize these impediments, the investigators gathered center-specific data from the Scientific Registry of Transplant Recipients and the U.S. Census Bureau. The final dataset included 30,353 patients from treated at 109 transplant centers, each of which performed more than 250 transplants between January 2013 and December 2018. The investigators compared waiting list data for each center with demographics from its DSA. Primary variables included race/ethnicity, education level, poverty, and insurance coverage.
Multiple logistic regression analysis was used to compare expected waiting list demographics with observed waiting list demographics with the aid of observed/expected ratios for each race/ethnicity. Univariate and multivariate analyses were used to identify significant predictors, including covariates such as age at listing, distance traveled to transplant center, and center type.
On an adjusted basis, the observed/expected ratios showed that non-Hispanic Black patients were underrepresented on waiting lists at 88 out of 109 centers (81%) and Hispanic patients were underrepresented at 68 centers (62%). In contrast, non-Hispanic White patients were overrepresented on waiting lists at 65 centers (58%). Non-Hispanic White patients were underrepresented on waiting lists at 49 centers, or 45%. Minority underrepresentation was further supported by mean MELD (Model for End-Stage Liver Disease) scores, which were significantly higher among non-Hispanic Black patients (20.2) and Hispanic patients (19.4), compared with non-Hispanic White patients (18.7) (P < .0001 for all) at the time of wait-listing.
Based on the multivariate model, underrepresentation among Black patients was most common in areas with a higher proportion of Black individuals in the population, longer travel distances to transplant centers, and a higher rate of private insurance among transplant recipients. For Hispanic patients, rates of private insurance alone predicted underrepresentation.
Once patients were listed, however, these disparities faded. Non-Hispanic Black patients accounted for 9.8% of all transplants across all hospitals, compared with 7.9% of wait-listed individuals (P < .0001). At approximately two out of three hospitals (65%), the transplanted percentage of Black patients exceeded the wait-listed percentage (P = .002).
“Data from this study show that the wait lists at many transplant centers in the United States underrepresent minority populations, compared with what would be expected based on their service areas,” the investigators concluded. “Future work will need to be devoted to increasing awareness of these trends to promote equitable access to listing for liver transplantation.”
Looking at social determinants of health
According to Lauren D. Nephew, MD, MSc, MAE, of Indiana University, Indianapolis, “The question of access to care is particularly important at this juncture as we examine the inequities that COVID-19 exposed in access to care for racial minorities, and as we prepare for potential changes to health insurance coverage with the new administration.”
Dr. Nephew noted that the reported racial disparities stem from social determinants of health, such as proximity to transplant centers and type of insurance coverage.
“Another striking finding was that the disparity in wait-listing non-Hispanic Black patients increased with the percentage of non-Hispanic Black patients living in the area, further highlighting barriers in access to care in majority Black neighborhoods,” she said. “Inequities such as these are unacceptable, given our mandate to distribute organs in a fair and equitable fashion, and they require prospective studies for further examination.”
Identifying discrimination
Lanla Conteh, MD, MPH, of the Ohio State University Wexner Medical Center, Columbus, described how these inequities are magnified through bias in patient selection.
“Often times two very similar patients may present with the same medical profile and social circumstances; however, one is turned down,” she said. “Often the patient turned down is the non-Hispanic Black patient while the non-Hispanic White patient is given a pass.”
Dr. Conteh suggested that the first step in fixing this bias is recognizing that it is a problem and calling it by its proper name.
“As transplant centers, in order to address and change these significant disparities, we must first be willing to acknowledge that they do exist,” she said. “Only then can we move to the next step of developing awareness and methods to actively combat what we should label as systemic discrimination in medicine. Transplantation is a lifesaving treatment for many patients with decompensated liver disease or liver cancer. Ensuring equitable access for all patients and populations is of paramount importance.”
The study was supported by a Health Resources and Services Administration contract, as well as grants from the National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases. The investigators and interviewees reported no conflicts of interest.
Non-Hispanic Black and Hispanic patients are underrepresented on many liver transplant waiting lists, whereas non-Hispanic White patients are often overrepresented, according to data from 109 centers.
While racial disparities “greatly diminished” after placement on a waiting list, which suggests recent progress in the field, pre–wait-listing disparities may be more challenging to overcome, reported lead author Curtis Warren, MPH, CPH, of the University of Florida, Gainesville, and colleagues.
“In 2020, the Organ Procurement and Transplantation Network implemented a new allocation system for liver transplantation based on concentric circles of geographic proximity rather than somewhat arbitrarily delineated Donor Service Areas (DSAs),” the investigators wrote in Journal of the American College of Surgeons. “Although this was a step toward improving and equalizing access to lifesaving organs for those on the liver transplant wait list, the listing process determining which patients will be considered for transplantation has continued to be a significant hurdle.”
The process is “rife with impediments to equal access to listing,” according to Dr. Warren and colleagues; getting on a waiting list can be affected by factors such as inequitable access to primary care, lack of private health insurance, and subjective selection by transplant centers.
To better characterize these impediments, the investigators gathered center-specific data from the Scientific Registry of Transplant Recipients and the U.S. Census Bureau. The final dataset included 30,353 patients from treated at 109 transplant centers, each of which performed more than 250 transplants between January 2013 and December 2018. The investigators compared waiting list data for each center with demographics from its DSA. Primary variables included race/ethnicity, education level, poverty, and insurance coverage.
Multiple logistic regression analysis was used to compare expected waiting list demographics with observed waiting list demographics with the aid of observed/expected ratios for each race/ethnicity. Univariate and multivariate analyses were used to identify significant predictors, including covariates such as age at listing, distance traveled to transplant center, and center type.
On an adjusted basis, the observed/expected ratios showed that non-Hispanic Black patients were underrepresented on waiting lists at 88 out of 109 centers (81%) and Hispanic patients were underrepresented at 68 centers (62%). In contrast, non-Hispanic White patients were overrepresented on waiting lists at 65 centers (58%). Non-Hispanic White patients were underrepresented on waiting lists at 49 centers, or 45%. Minority underrepresentation was further supported by mean MELD (Model for End-Stage Liver Disease) scores, which were significantly higher among non-Hispanic Black patients (20.2) and Hispanic patients (19.4), compared with non-Hispanic White patients (18.7) (P < .0001 for all) at the time of wait-listing.
Based on the multivariate model, underrepresentation among Black patients was most common in areas with a higher proportion of Black individuals in the population, longer travel distances to transplant centers, and a higher rate of private insurance among transplant recipients. For Hispanic patients, rates of private insurance alone predicted underrepresentation.
Once patients were listed, however, these disparities faded. Non-Hispanic Black patients accounted for 9.8% of all transplants across all hospitals, compared with 7.9% of wait-listed individuals (P < .0001). At approximately two out of three hospitals (65%), the transplanted percentage of Black patients exceeded the wait-listed percentage (P = .002).
“Data from this study show that the wait lists at many transplant centers in the United States underrepresent minority populations, compared with what would be expected based on their service areas,” the investigators concluded. “Future work will need to be devoted to increasing awareness of these trends to promote equitable access to listing for liver transplantation.”
Looking at social determinants of health
According to Lauren D. Nephew, MD, MSc, MAE, of Indiana University, Indianapolis, “The question of access to care is particularly important at this juncture as we examine the inequities that COVID-19 exposed in access to care for racial minorities, and as we prepare for potential changes to health insurance coverage with the new administration.”
Dr. Nephew noted that the reported racial disparities stem from social determinants of health, such as proximity to transplant centers and type of insurance coverage.
“Another striking finding was that the disparity in wait-listing non-Hispanic Black patients increased with the percentage of non-Hispanic Black patients living in the area, further highlighting barriers in access to care in majority Black neighborhoods,” she said. “Inequities such as these are unacceptable, given our mandate to distribute organs in a fair and equitable fashion, and they require prospective studies for further examination.”
Identifying discrimination
Lanla Conteh, MD, MPH, of the Ohio State University Wexner Medical Center, Columbus, described how these inequities are magnified through bias in patient selection.
“Often times two very similar patients may present with the same medical profile and social circumstances; however, one is turned down,” she said. “Often the patient turned down is the non-Hispanic Black patient while the non-Hispanic White patient is given a pass.”
Dr. Conteh suggested that the first step in fixing this bias is recognizing that it is a problem and calling it by its proper name.
“As transplant centers, in order to address and change these significant disparities, we must first be willing to acknowledge that they do exist,” she said. “Only then can we move to the next step of developing awareness and methods to actively combat what we should label as systemic discrimination in medicine. Transplantation is a lifesaving treatment for many patients with decompensated liver disease or liver cancer. Ensuring equitable access for all patients and populations is of paramount importance.”
The study was supported by a Health Resources and Services Administration contract, as well as grants from the National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases. The investigators and interviewees reported no conflicts of interest.
Non-Hispanic Black and Hispanic patients are underrepresented on many liver transplant waiting lists, whereas non-Hispanic White patients are often overrepresented, according to data from 109 centers.
While racial disparities “greatly diminished” after placement on a waiting list, which suggests recent progress in the field, pre–wait-listing disparities may be more challenging to overcome, reported lead author Curtis Warren, MPH, CPH, of the University of Florida, Gainesville, and colleagues.
“In 2020, the Organ Procurement and Transplantation Network implemented a new allocation system for liver transplantation based on concentric circles of geographic proximity rather than somewhat arbitrarily delineated Donor Service Areas (DSAs),” the investigators wrote in Journal of the American College of Surgeons. “Although this was a step toward improving and equalizing access to lifesaving organs for those on the liver transplant wait list, the listing process determining which patients will be considered for transplantation has continued to be a significant hurdle.”
The process is “rife with impediments to equal access to listing,” according to Dr. Warren and colleagues; getting on a waiting list can be affected by factors such as inequitable access to primary care, lack of private health insurance, and subjective selection by transplant centers.
To better characterize these impediments, the investigators gathered center-specific data from the Scientific Registry of Transplant Recipients and the U.S. Census Bureau. The final dataset included 30,353 patients from treated at 109 transplant centers, each of which performed more than 250 transplants between January 2013 and December 2018. The investigators compared waiting list data for each center with demographics from its DSA. Primary variables included race/ethnicity, education level, poverty, and insurance coverage.
Multiple logistic regression analysis was used to compare expected waiting list demographics with observed waiting list demographics with the aid of observed/expected ratios for each race/ethnicity. Univariate and multivariate analyses were used to identify significant predictors, including covariates such as age at listing, distance traveled to transplant center, and center type.
On an adjusted basis, the observed/expected ratios showed that non-Hispanic Black patients were underrepresented on waiting lists at 88 out of 109 centers (81%) and Hispanic patients were underrepresented at 68 centers (62%). In contrast, non-Hispanic White patients were overrepresented on waiting lists at 65 centers (58%). Non-Hispanic White patients were underrepresented on waiting lists at 49 centers, or 45%. Minority underrepresentation was further supported by mean MELD (Model for End-Stage Liver Disease) scores, which were significantly higher among non-Hispanic Black patients (20.2) and Hispanic patients (19.4), compared with non-Hispanic White patients (18.7) (P < .0001 for all) at the time of wait-listing.
Based on the multivariate model, underrepresentation among Black patients was most common in areas with a higher proportion of Black individuals in the population, longer travel distances to transplant centers, and a higher rate of private insurance among transplant recipients. For Hispanic patients, rates of private insurance alone predicted underrepresentation.
Once patients were listed, however, these disparities faded. Non-Hispanic Black patients accounted for 9.8% of all transplants across all hospitals, compared with 7.9% of wait-listed individuals (P < .0001). At approximately two out of three hospitals (65%), the transplanted percentage of Black patients exceeded the wait-listed percentage (P = .002).
“Data from this study show that the wait lists at many transplant centers in the United States underrepresent minority populations, compared with what would be expected based on their service areas,” the investigators concluded. “Future work will need to be devoted to increasing awareness of these trends to promote equitable access to listing for liver transplantation.”
Looking at social determinants of health
According to Lauren D. Nephew, MD, MSc, MAE, of Indiana University, Indianapolis, “The question of access to care is particularly important at this juncture as we examine the inequities that COVID-19 exposed in access to care for racial minorities, and as we prepare for potential changes to health insurance coverage with the new administration.”
Dr. Nephew noted that the reported racial disparities stem from social determinants of health, such as proximity to transplant centers and type of insurance coverage.
“Another striking finding was that the disparity in wait-listing non-Hispanic Black patients increased with the percentage of non-Hispanic Black patients living in the area, further highlighting barriers in access to care in majority Black neighborhoods,” she said. “Inequities such as these are unacceptable, given our mandate to distribute organs in a fair and equitable fashion, and they require prospective studies for further examination.”
Identifying discrimination
Lanla Conteh, MD, MPH, of the Ohio State University Wexner Medical Center, Columbus, described how these inequities are magnified through bias in patient selection.
“Often times two very similar patients may present with the same medical profile and social circumstances; however, one is turned down,” she said. “Often the patient turned down is the non-Hispanic Black patient while the non-Hispanic White patient is given a pass.”
Dr. Conteh suggested that the first step in fixing this bias is recognizing that it is a problem and calling it by its proper name.
“As transplant centers, in order to address and change these significant disparities, we must first be willing to acknowledge that they do exist,” she said. “Only then can we move to the next step of developing awareness and methods to actively combat what we should label as systemic discrimination in medicine. Transplantation is a lifesaving treatment for many patients with decompensated liver disease or liver cancer. Ensuring equitable access for all patients and populations is of paramount importance.”
The study was supported by a Health Resources and Services Administration contract, as well as grants from the National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases. The investigators and interviewees reported no conflicts of interest.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF SURGEONS
Anthracycline-free neoadjuvant regimen safe, effective for TNBC
The results come from a phase 2 trial that involved 100 women. The study was published online in February in Clinical Cancer Research.
The doublet provides a safe, effective alternative for patients who are not candidates for treatment with anthracyclines and should be explored further for neoadjuvant deescalation, according to investigators led by Priyanka Sharma, MD, TNBC specialist and professor at the University of Kansas Medical Center, Westwood.
The trial wasn’t powered to demonstrate noninferiority, so it “probably does not provide enough evidence to state that [taxane/platinum] should replace other regimens,” Dr. Sharma said in an interview.
A proper noninferiority trial would require more than 2,500 participants, she said, adding that such a trial is unlikely, because companies are focused on immunotherapies for neoadjuvant TNBC.
“Our study does, however, provide a very effective alternative for patients and providers who want to use or prefer an anthracycline-sparing neoadjuvant chemotherapy regimen. We are very encouraged” by the findings, Dr. Sharma said.
This is “a provocative study that should make us pause and reevaluate our current approach. Further study of this approach in early-stage TNBC is warranted,” Melinda L. Telli, MD, associate professor of medicine and director of the breast cancer program at Stanford (Calif.) University, said when asked for comment.
Avoiding the risks associated with anthracycline “is great. I would be particularly enthusiastic using this regimen in patients with known increased risk of cardiac toxicity,” said Amy Tiersten, MD, a breast cancer specialist and professor at Mount Sinai Hospital, New York.
Anthracycline-based regimens are the standard of care for neoadjuvant TNBC. They typically include a taxane with or without carboplatin plus an anthracycline/cyclophosphamide combination. The regimen is highly active, but there is a small but serious risk for cardiomyopathy and leukemia with anthracycline/cyclophosphamide. In the current trial, one woman in the anthracycline arm died of secondary acute myeloid leukemia.
Given its tolerability and effectiveness, a taxane/carboplatin doublet might serve as a good backbone for the addition of novel immunotherapies in trials. Dr. Sharma is the principal investigator in one such trial, a phase 2 trial of carboplatin/docetaxel plus pembrolizumab for stage I–III TNBC.
Study details
The Neoadjuvant Study of Two Platinum Regimens in Stage I–III Triple Negative Breast Cancer (NeoSTOP) involved 100 women with stage I–III TNBC.
In the experimental arm, 52 women received carboplatin AUC 6 plus docetaxel 75 mg/m2 every 21 days for six cycles.
In the standard-of-care anthracycline arm, 48 women received carboplatin AUC 6 every 21 days for four cycles plus paclitaxel 80 mg/m2 weekly for 12 weeks, followed by doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 every 2 weeks for four cycles.
Docetaxel and paclitaxel in the two regimens are interchangeable because they have shown equal efficacy in adjuvant trials, Dr. Sharma said.
At surgery, 54% of women in both arms had a breast/axilla pathologic complete response – the primary endpoint – and 67% in both arms had a residual cancer burden of 0-1. Event-free and overall survival (about 55% at 3 years for both) were similar with the two regimens.
Grade 3/4 adverse events were more common in the anthracycline arm. They included neutropenia, which occurred in 60% of women in the anthracycline arm, vs. 8% with the doublet; and febrile neutropenia, which occurred in 19% with anthracycline, vs. none with the doublet.
The toxicity profile of the anthracycline regimen was comparable to those in previous reports.
Ninety-two percent of the docetaxel/carboplatin group completed all six cycles; 72% of women in the anthracycline arm completed 10 or more doses of paclitaxel, and 85% completed all 4 carboplatin doses.
Mean costs of treatment, patient transportation, and lost productivity were $36,720 in the anthracycline arm, vs. $33,148 with the doublet.
The two arms were well balanced with respect to patient characteristics. The median age was 51 years, 30% of patients had axillary lymph node–positive disease, and 16% had ER/PgR expression of 1% to 10%. Of the study population, 17% carried deleterious BRCA1/2 mutations. Women were enrolled from July 2015 to May 2018. Median follow-up was 38 months.
Of the study population, 17% had stage I disease, so NeoSTOP included a lower-risk population than some neoadjuvant trials. However, there was no significant change in pathologic complete response rates in the two arms after exclusion of women with stage I disease (doublet, 50%; anthracycline, 54%).
The study was funded by the University of Kansas Cancer Center, the Breast Cancer Research Foundation, and the National Institute of General Medical Sciences. The investigators disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The results come from a phase 2 trial that involved 100 women. The study was published online in February in Clinical Cancer Research.
The doublet provides a safe, effective alternative for patients who are not candidates for treatment with anthracyclines and should be explored further for neoadjuvant deescalation, according to investigators led by Priyanka Sharma, MD, TNBC specialist and professor at the University of Kansas Medical Center, Westwood.
The trial wasn’t powered to demonstrate noninferiority, so it “probably does not provide enough evidence to state that [taxane/platinum] should replace other regimens,” Dr. Sharma said in an interview.
A proper noninferiority trial would require more than 2,500 participants, she said, adding that such a trial is unlikely, because companies are focused on immunotherapies for neoadjuvant TNBC.
“Our study does, however, provide a very effective alternative for patients and providers who want to use or prefer an anthracycline-sparing neoadjuvant chemotherapy regimen. We are very encouraged” by the findings, Dr. Sharma said.
This is “a provocative study that should make us pause and reevaluate our current approach. Further study of this approach in early-stage TNBC is warranted,” Melinda L. Telli, MD, associate professor of medicine and director of the breast cancer program at Stanford (Calif.) University, said when asked for comment.
Avoiding the risks associated with anthracycline “is great. I would be particularly enthusiastic using this regimen in patients with known increased risk of cardiac toxicity,” said Amy Tiersten, MD, a breast cancer specialist and professor at Mount Sinai Hospital, New York.
Anthracycline-based regimens are the standard of care for neoadjuvant TNBC. They typically include a taxane with or without carboplatin plus an anthracycline/cyclophosphamide combination. The regimen is highly active, but there is a small but serious risk for cardiomyopathy and leukemia with anthracycline/cyclophosphamide. In the current trial, one woman in the anthracycline arm died of secondary acute myeloid leukemia.
Given its tolerability and effectiveness, a taxane/carboplatin doublet might serve as a good backbone for the addition of novel immunotherapies in trials. Dr. Sharma is the principal investigator in one such trial, a phase 2 trial of carboplatin/docetaxel plus pembrolizumab for stage I–III TNBC.
Study details
The Neoadjuvant Study of Two Platinum Regimens in Stage I–III Triple Negative Breast Cancer (NeoSTOP) involved 100 women with stage I–III TNBC.
In the experimental arm, 52 women received carboplatin AUC 6 plus docetaxel 75 mg/m2 every 21 days for six cycles.
In the standard-of-care anthracycline arm, 48 women received carboplatin AUC 6 every 21 days for four cycles plus paclitaxel 80 mg/m2 weekly for 12 weeks, followed by doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 every 2 weeks for four cycles.
Docetaxel and paclitaxel in the two regimens are interchangeable because they have shown equal efficacy in adjuvant trials, Dr. Sharma said.
At surgery, 54% of women in both arms had a breast/axilla pathologic complete response – the primary endpoint – and 67% in both arms had a residual cancer burden of 0-1. Event-free and overall survival (about 55% at 3 years for both) were similar with the two regimens.
Grade 3/4 adverse events were more common in the anthracycline arm. They included neutropenia, which occurred in 60% of women in the anthracycline arm, vs. 8% with the doublet; and febrile neutropenia, which occurred in 19% with anthracycline, vs. none with the doublet.
The toxicity profile of the anthracycline regimen was comparable to those in previous reports.
Ninety-two percent of the docetaxel/carboplatin group completed all six cycles; 72% of women in the anthracycline arm completed 10 or more doses of paclitaxel, and 85% completed all 4 carboplatin doses.
Mean costs of treatment, patient transportation, and lost productivity were $36,720 in the anthracycline arm, vs. $33,148 with the doublet.
The two arms were well balanced with respect to patient characteristics. The median age was 51 years, 30% of patients had axillary lymph node–positive disease, and 16% had ER/PgR expression of 1% to 10%. Of the study population, 17% carried deleterious BRCA1/2 mutations. Women were enrolled from July 2015 to May 2018. Median follow-up was 38 months.
Of the study population, 17% had stage I disease, so NeoSTOP included a lower-risk population than some neoadjuvant trials. However, there was no significant change in pathologic complete response rates in the two arms after exclusion of women with stage I disease (doublet, 50%; anthracycline, 54%).
The study was funded by the University of Kansas Cancer Center, the Breast Cancer Research Foundation, and the National Institute of General Medical Sciences. The investigators disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The results come from a phase 2 trial that involved 100 women. The study was published online in February in Clinical Cancer Research.
The doublet provides a safe, effective alternative for patients who are not candidates for treatment with anthracyclines and should be explored further for neoadjuvant deescalation, according to investigators led by Priyanka Sharma, MD, TNBC specialist and professor at the University of Kansas Medical Center, Westwood.
The trial wasn’t powered to demonstrate noninferiority, so it “probably does not provide enough evidence to state that [taxane/platinum] should replace other regimens,” Dr. Sharma said in an interview.
A proper noninferiority trial would require more than 2,500 participants, she said, adding that such a trial is unlikely, because companies are focused on immunotherapies for neoadjuvant TNBC.
“Our study does, however, provide a very effective alternative for patients and providers who want to use or prefer an anthracycline-sparing neoadjuvant chemotherapy regimen. We are very encouraged” by the findings, Dr. Sharma said.
This is “a provocative study that should make us pause and reevaluate our current approach. Further study of this approach in early-stage TNBC is warranted,” Melinda L. Telli, MD, associate professor of medicine and director of the breast cancer program at Stanford (Calif.) University, said when asked for comment.
Avoiding the risks associated with anthracycline “is great. I would be particularly enthusiastic using this regimen in patients with known increased risk of cardiac toxicity,” said Amy Tiersten, MD, a breast cancer specialist and professor at Mount Sinai Hospital, New York.
Anthracycline-based regimens are the standard of care for neoadjuvant TNBC. They typically include a taxane with or without carboplatin plus an anthracycline/cyclophosphamide combination. The regimen is highly active, but there is a small but serious risk for cardiomyopathy and leukemia with anthracycline/cyclophosphamide. In the current trial, one woman in the anthracycline arm died of secondary acute myeloid leukemia.
Given its tolerability and effectiveness, a taxane/carboplatin doublet might serve as a good backbone for the addition of novel immunotherapies in trials. Dr. Sharma is the principal investigator in one such trial, a phase 2 trial of carboplatin/docetaxel plus pembrolizumab for stage I–III TNBC.
Study details
The Neoadjuvant Study of Two Platinum Regimens in Stage I–III Triple Negative Breast Cancer (NeoSTOP) involved 100 women with stage I–III TNBC.
In the experimental arm, 52 women received carboplatin AUC 6 plus docetaxel 75 mg/m2 every 21 days for six cycles.
In the standard-of-care anthracycline arm, 48 women received carboplatin AUC 6 every 21 days for four cycles plus paclitaxel 80 mg/m2 weekly for 12 weeks, followed by doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 every 2 weeks for four cycles.
Docetaxel and paclitaxel in the two regimens are interchangeable because they have shown equal efficacy in adjuvant trials, Dr. Sharma said.
At surgery, 54% of women in both arms had a breast/axilla pathologic complete response – the primary endpoint – and 67% in both arms had a residual cancer burden of 0-1. Event-free and overall survival (about 55% at 3 years for both) were similar with the two regimens.
Grade 3/4 adverse events were more common in the anthracycline arm. They included neutropenia, which occurred in 60% of women in the anthracycline arm, vs. 8% with the doublet; and febrile neutropenia, which occurred in 19% with anthracycline, vs. none with the doublet.
The toxicity profile of the anthracycline regimen was comparable to those in previous reports.
Ninety-two percent of the docetaxel/carboplatin group completed all six cycles; 72% of women in the anthracycline arm completed 10 or more doses of paclitaxel, and 85% completed all 4 carboplatin doses.
Mean costs of treatment, patient transportation, and lost productivity were $36,720 in the anthracycline arm, vs. $33,148 with the doublet.
The two arms were well balanced with respect to patient characteristics. The median age was 51 years, 30% of patients had axillary lymph node–positive disease, and 16% had ER/PgR expression of 1% to 10%. Of the study population, 17% carried deleterious BRCA1/2 mutations. Women were enrolled from July 2015 to May 2018. Median follow-up was 38 months.
Of the study population, 17% had stage I disease, so NeoSTOP included a lower-risk population than some neoadjuvant trials. However, there was no significant change in pathologic complete response rates in the two arms after exclusion of women with stage I disease (doublet, 50%; anthracycline, 54%).
The study was funded by the University of Kansas Cancer Center, the Breast Cancer Research Foundation, and the National Institute of General Medical Sciences. The investigators disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.