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Surgery approach may improve survival in advanced ovarian cancer
TOPLINE:
Neoadjuvant chemotherapy followed by interval cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) significantly improves progression-free survival (PFS) and overall survival, compared with interval cytoreductive surgery alone, in patients with advanced ovarian cancer, new research shows.
METHODOLOGY:
- Several randomized controlled trials have shown survival benefits with HIPEC followed by interval cytoreductive surgery in advanced ovarian cancer. Despite the data, the use of HIPEC in clinical practice remains limited.
- Potential downsides of HIPEC include longer operative time and treatment-related complications.
- This prospective, multicenter, comparative effectiveness study evaluated the safety and effectiveness of interval cytoreductive surgery with HIPEC versus the surgery alone.
- The study, conducted at seven Korean Gynecologic Oncology Group institutions, included 196 patients (mean age, 58 years) with stage III or IV ovarian cancer who had received at least three cycles of neoadjuvant chemotherapy followed by interval cytoreductive surgery with HIPEC (n = 109) or without HIPEC (n = 87).
- The researchers reported progression-free survival as well as overall survival and treatment-related toxic effects.
TAKEAWAY:
- During a median follow-up of 28.2 months, 128 patients (65%) had a recurrence and 30 died (15.3%) – 8.3% in the HIPEC group and 24.1% in the non-HIPEC group.
- Compared with no HIPEC, interval cytoreductive surgery with HIPEC led to a significant improvement in median PFS (22.9 months vs. 14.2 months; P = .005) and median overall survival (not reached vs. 53 months; P = .002).
- The frequency of grade 3 or 4 postoperative complications was similar in both groups: 2.8% with HIPEC versus 3.4% without HIPEC.
- Among patients with recurrence, the frequency of peritoneal recurrence was significantly lower among those who received HIPEC (32.8% vs. 64.1% without HIPEC; P = .001).
IN PRACTICE:
“We observed a significantly superior survival benefit associated with [interval cytoreductive surgery] with HIPEC, without higher rates of postoperative complications,” the authors concluded, adding that “the survival benefit remained consistent, irrespective of maintenance therapy.”
SOURCE:
The study, led by Jung-Yun Lee, MD, PhD, Yonsei University College of Medicine, Seoul, Korea, was published online in JAMA Surgery.
LIMITATIONS:
The patients were not randomly assigned and the decision to give HIPEC was at the clinician’s discretion, introducing the possibility of selection and treatment bias. The different types of drugs used in HIPEC could result in bias in data interpretation.
DISCLOSURES:
The authors reported no conflicts of interest. The study had no specific funding.
A version of this article first appeared on Medscape.com.
TOPLINE:
Neoadjuvant chemotherapy followed by interval cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) significantly improves progression-free survival (PFS) and overall survival, compared with interval cytoreductive surgery alone, in patients with advanced ovarian cancer, new research shows.
METHODOLOGY:
- Several randomized controlled trials have shown survival benefits with HIPEC followed by interval cytoreductive surgery in advanced ovarian cancer. Despite the data, the use of HIPEC in clinical practice remains limited.
- Potential downsides of HIPEC include longer operative time and treatment-related complications.
- This prospective, multicenter, comparative effectiveness study evaluated the safety and effectiveness of interval cytoreductive surgery with HIPEC versus the surgery alone.
- The study, conducted at seven Korean Gynecologic Oncology Group institutions, included 196 patients (mean age, 58 years) with stage III or IV ovarian cancer who had received at least three cycles of neoadjuvant chemotherapy followed by interval cytoreductive surgery with HIPEC (n = 109) or without HIPEC (n = 87).
- The researchers reported progression-free survival as well as overall survival and treatment-related toxic effects.
TAKEAWAY:
- During a median follow-up of 28.2 months, 128 patients (65%) had a recurrence and 30 died (15.3%) – 8.3% in the HIPEC group and 24.1% in the non-HIPEC group.
- Compared with no HIPEC, interval cytoreductive surgery with HIPEC led to a significant improvement in median PFS (22.9 months vs. 14.2 months; P = .005) and median overall survival (not reached vs. 53 months; P = .002).
- The frequency of grade 3 or 4 postoperative complications was similar in both groups: 2.8% with HIPEC versus 3.4% without HIPEC.
- Among patients with recurrence, the frequency of peritoneal recurrence was significantly lower among those who received HIPEC (32.8% vs. 64.1% without HIPEC; P = .001).
IN PRACTICE:
“We observed a significantly superior survival benefit associated with [interval cytoreductive surgery] with HIPEC, without higher rates of postoperative complications,” the authors concluded, adding that “the survival benefit remained consistent, irrespective of maintenance therapy.”
SOURCE:
The study, led by Jung-Yun Lee, MD, PhD, Yonsei University College of Medicine, Seoul, Korea, was published online in JAMA Surgery.
LIMITATIONS:
The patients were not randomly assigned and the decision to give HIPEC was at the clinician’s discretion, introducing the possibility of selection and treatment bias. The different types of drugs used in HIPEC could result in bias in data interpretation.
DISCLOSURES:
The authors reported no conflicts of interest. The study had no specific funding.
A version of this article first appeared on Medscape.com.
TOPLINE:
Neoadjuvant chemotherapy followed by interval cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) significantly improves progression-free survival (PFS) and overall survival, compared with interval cytoreductive surgery alone, in patients with advanced ovarian cancer, new research shows.
METHODOLOGY:
- Several randomized controlled trials have shown survival benefits with HIPEC followed by interval cytoreductive surgery in advanced ovarian cancer. Despite the data, the use of HIPEC in clinical practice remains limited.
- Potential downsides of HIPEC include longer operative time and treatment-related complications.
- This prospective, multicenter, comparative effectiveness study evaluated the safety and effectiveness of interval cytoreductive surgery with HIPEC versus the surgery alone.
- The study, conducted at seven Korean Gynecologic Oncology Group institutions, included 196 patients (mean age, 58 years) with stage III or IV ovarian cancer who had received at least three cycles of neoadjuvant chemotherapy followed by interval cytoreductive surgery with HIPEC (n = 109) or without HIPEC (n = 87).
- The researchers reported progression-free survival as well as overall survival and treatment-related toxic effects.
TAKEAWAY:
- During a median follow-up of 28.2 months, 128 patients (65%) had a recurrence and 30 died (15.3%) – 8.3% in the HIPEC group and 24.1% in the non-HIPEC group.
- Compared with no HIPEC, interval cytoreductive surgery with HIPEC led to a significant improvement in median PFS (22.9 months vs. 14.2 months; P = .005) and median overall survival (not reached vs. 53 months; P = .002).
- The frequency of grade 3 or 4 postoperative complications was similar in both groups: 2.8% with HIPEC versus 3.4% without HIPEC.
- Among patients with recurrence, the frequency of peritoneal recurrence was significantly lower among those who received HIPEC (32.8% vs. 64.1% without HIPEC; P = .001).
IN PRACTICE:
“We observed a significantly superior survival benefit associated with [interval cytoreductive surgery] with HIPEC, without higher rates of postoperative complications,” the authors concluded, adding that “the survival benefit remained consistent, irrespective of maintenance therapy.”
SOURCE:
The study, led by Jung-Yun Lee, MD, PhD, Yonsei University College of Medicine, Seoul, Korea, was published online in JAMA Surgery.
LIMITATIONS:
The patients were not randomly assigned and the decision to give HIPEC was at the clinician’s discretion, introducing the possibility of selection and treatment bias. The different types of drugs used in HIPEC could result in bias in data interpretation.
DISCLOSURES:
The authors reported no conflicts of interest. The study had no specific funding.
A version of this article first appeared on Medscape.com.
FROM JAMA SURGERY
Artificial intelligence in your office
It is difficult to go through any publication or website these days without finding an article about artificial intelligence (AI). Many discuss its current status, while others speculate on potential future applications. Often, AI is described as an “existential threat to human health” by commentators who aren’t even aware of the definition of that term as Kierkegaard conceived it, the role of the individual to breathe meaning into life. Others characterize such cataclysmic predictions as “overblown and misdirected”.
The long-term potential for abuse of AI requires discussion, and should be addressed by policy makers, but that is beyond the scope of this column.
Meanwhile,
The most popular current AI-based medical applications are automated scribes. They transcribe live consultations between physician and patient automatically and create a searchable report, plus notes for charts and billing.
I’ve written about AI scribes before, but the quality and user-friendliness of these products have improved dramatically in recent years. Language processing capabilities now permit you to speak naturally, without having to memorize specific commands. Some scribes can mimic your writing style based on sample notes that you enter into the system. Others allow you to integrate your own knowledge base, or a bibliography of research studies. With some systems, you can dictate notes directly into most EHR software, ask questions regarding medication dosages, or access a patient’s medical history from hospitals or other offices.
Current popular medical scribe products include DeepCura, DeepScribe, Nuance, Suki, Augmedix, Tali AI, Iodine Software, and ScribeLink. Amazon Web Services recently launched its own product, HealthScribe, as well. (As always, I have no financial interest in any product or service mentioned in this column.)
AI scribes aren’t entirely autonomous, of course; you need to read the output and check for potential inaccuracies. Still, users claim that they substantially reduce documentation and charting time, permitting more patient visits and less after-hours work.
AI can also be used to provide useful content for your patients. If you are not particularly good at writing, or don’t have the time for it, generative algorithms like the much-vaunted ChatGPT can generate posts, FAQs, and other informational content for your website, blog, or social media pages. You can ask for ideas about timely health topics and write general information articles, or create content specific to your location or specialty. You can use it to write emails informing your patients about upcoming office events or educate them on a range of topics, from getting their annual flu shots to scheduling regular screening skin exams.
With some of the same techniques and additional software, you can create entire videos for your website at a fraction of the cost of hiring a video production team. After using ChatGPT to write the content – for example, a 5-minute script on the importance of sunscreen in preventing skin cancer – you can employ a text-to-speech algorithm such as Revoicer to transform the script into audio content, and then a preproduction algorithm like Yepic or Synthesia to generate a video with a synthetic human.
If you are unhappy with your current online presence, you can use AI to create an entire website. Through a series of questions, AI website builders such as Wix ADI, Jimdo, Hostinger, and 10Web gather all the information needed to set up a website draft that is already personalized with medical-specific content. Most offer the option to connect to Instagram, Facebook, Google My Business, and similar sites, to which they can import your office’s logo, images, and descriptive texts.
Some of them are capable of pulling up responsive site pages that automatically adjust to the device – mobile or computer – that the visitor is using. This is important, as I’ve written before, because more than half of all searches for doctors are now made on smartphones, so the more “mobile friendly” your site is, the higher it will be ranked. You can test how easily a visitor can use your website on a mobile device with Google’s free Mobile-Friendly Test.
If you give talks at medical meetings, you know how cumbersome and time-consuming it can be to create Powerpoint presentations. Once again, AI can save you time and trouble. Presentation designers such as Presentations.AI, Deck Robot, iA Presenter, and Beautiful.AI can assemble very acceptable presentations from your primary inputs. You typically choose a template, input your basic data, and AI will format the slides and offer you visuals, animations, voice-overs, and other fancy features. You will also have flexibility in changing segments or images or sizes you don’t like.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
It is difficult to go through any publication or website these days without finding an article about artificial intelligence (AI). Many discuss its current status, while others speculate on potential future applications. Often, AI is described as an “existential threat to human health” by commentators who aren’t even aware of the definition of that term as Kierkegaard conceived it, the role of the individual to breathe meaning into life. Others characterize such cataclysmic predictions as “overblown and misdirected”.
The long-term potential for abuse of AI requires discussion, and should be addressed by policy makers, but that is beyond the scope of this column.
Meanwhile,
The most popular current AI-based medical applications are automated scribes. They transcribe live consultations between physician and patient automatically and create a searchable report, plus notes for charts and billing.
I’ve written about AI scribes before, but the quality and user-friendliness of these products have improved dramatically in recent years. Language processing capabilities now permit you to speak naturally, without having to memorize specific commands. Some scribes can mimic your writing style based on sample notes that you enter into the system. Others allow you to integrate your own knowledge base, or a bibliography of research studies. With some systems, you can dictate notes directly into most EHR software, ask questions regarding medication dosages, or access a patient’s medical history from hospitals or other offices.
Current popular medical scribe products include DeepCura, DeepScribe, Nuance, Suki, Augmedix, Tali AI, Iodine Software, and ScribeLink. Amazon Web Services recently launched its own product, HealthScribe, as well. (As always, I have no financial interest in any product or service mentioned in this column.)
AI scribes aren’t entirely autonomous, of course; you need to read the output and check for potential inaccuracies. Still, users claim that they substantially reduce documentation and charting time, permitting more patient visits and less after-hours work.
AI can also be used to provide useful content for your patients. If you are not particularly good at writing, or don’t have the time for it, generative algorithms like the much-vaunted ChatGPT can generate posts, FAQs, and other informational content for your website, blog, or social media pages. You can ask for ideas about timely health topics and write general information articles, or create content specific to your location or specialty. You can use it to write emails informing your patients about upcoming office events or educate them on a range of topics, from getting their annual flu shots to scheduling regular screening skin exams.
With some of the same techniques and additional software, you can create entire videos for your website at a fraction of the cost of hiring a video production team. After using ChatGPT to write the content – for example, a 5-minute script on the importance of sunscreen in preventing skin cancer – you can employ a text-to-speech algorithm such as Revoicer to transform the script into audio content, and then a preproduction algorithm like Yepic or Synthesia to generate a video with a synthetic human.
If you are unhappy with your current online presence, you can use AI to create an entire website. Through a series of questions, AI website builders such as Wix ADI, Jimdo, Hostinger, and 10Web gather all the information needed to set up a website draft that is already personalized with medical-specific content. Most offer the option to connect to Instagram, Facebook, Google My Business, and similar sites, to which they can import your office’s logo, images, and descriptive texts.
Some of them are capable of pulling up responsive site pages that automatically adjust to the device – mobile or computer – that the visitor is using. This is important, as I’ve written before, because more than half of all searches for doctors are now made on smartphones, so the more “mobile friendly” your site is, the higher it will be ranked. You can test how easily a visitor can use your website on a mobile device with Google’s free Mobile-Friendly Test.
If you give talks at medical meetings, you know how cumbersome and time-consuming it can be to create Powerpoint presentations. Once again, AI can save you time and trouble. Presentation designers such as Presentations.AI, Deck Robot, iA Presenter, and Beautiful.AI can assemble very acceptable presentations from your primary inputs. You typically choose a template, input your basic data, and AI will format the slides and offer you visuals, animations, voice-overs, and other fancy features. You will also have flexibility in changing segments or images or sizes you don’t like.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
It is difficult to go through any publication or website these days without finding an article about artificial intelligence (AI). Many discuss its current status, while others speculate on potential future applications. Often, AI is described as an “existential threat to human health” by commentators who aren’t even aware of the definition of that term as Kierkegaard conceived it, the role of the individual to breathe meaning into life. Others characterize such cataclysmic predictions as “overblown and misdirected”.
The long-term potential for abuse of AI requires discussion, and should be addressed by policy makers, but that is beyond the scope of this column.
Meanwhile,
The most popular current AI-based medical applications are automated scribes. They transcribe live consultations between physician and patient automatically and create a searchable report, plus notes for charts and billing.
I’ve written about AI scribes before, but the quality and user-friendliness of these products have improved dramatically in recent years. Language processing capabilities now permit you to speak naturally, without having to memorize specific commands. Some scribes can mimic your writing style based on sample notes that you enter into the system. Others allow you to integrate your own knowledge base, or a bibliography of research studies. With some systems, you can dictate notes directly into most EHR software, ask questions regarding medication dosages, or access a patient’s medical history from hospitals or other offices.
Current popular medical scribe products include DeepCura, DeepScribe, Nuance, Suki, Augmedix, Tali AI, Iodine Software, and ScribeLink. Amazon Web Services recently launched its own product, HealthScribe, as well. (As always, I have no financial interest in any product or service mentioned in this column.)
AI scribes aren’t entirely autonomous, of course; you need to read the output and check for potential inaccuracies. Still, users claim that they substantially reduce documentation and charting time, permitting more patient visits and less after-hours work.
AI can also be used to provide useful content for your patients. If you are not particularly good at writing, or don’t have the time for it, generative algorithms like the much-vaunted ChatGPT can generate posts, FAQs, and other informational content for your website, blog, or social media pages. You can ask for ideas about timely health topics and write general information articles, or create content specific to your location or specialty. You can use it to write emails informing your patients about upcoming office events or educate them on a range of topics, from getting their annual flu shots to scheduling regular screening skin exams.
With some of the same techniques and additional software, you can create entire videos for your website at a fraction of the cost of hiring a video production team. After using ChatGPT to write the content – for example, a 5-minute script on the importance of sunscreen in preventing skin cancer – you can employ a text-to-speech algorithm such as Revoicer to transform the script into audio content, and then a preproduction algorithm like Yepic or Synthesia to generate a video with a synthetic human.
If you are unhappy with your current online presence, you can use AI to create an entire website. Through a series of questions, AI website builders such as Wix ADI, Jimdo, Hostinger, and 10Web gather all the information needed to set up a website draft that is already personalized with medical-specific content. Most offer the option to connect to Instagram, Facebook, Google My Business, and similar sites, to which they can import your office’s logo, images, and descriptive texts.
Some of them are capable of pulling up responsive site pages that automatically adjust to the device – mobile or computer – that the visitor is using. This is important, as I’ve written before, because more than half of all searches for doctors are now made on smartphones, so the more “mobile friendly” your site is, the higher it will be ranked. You can test how easily a visitor can use your website on a mobile device with Google’s free Mobile-Friendly Test.
If you give talks at medical meetings, you know how cumbersome and time-consuming it can be to create Powerpoint presentations. Once again, AI can save you time and trouble. Presentation designers such as Presentations.AI, Deck Robot, iA Presenter, and Beautiful.AI can assemble very acceptable presentations from your primary inputs. You typically choose a template, input your basic data, and AI will format the slides and offer you visuals, animations, voice-overs, and other fancy features. You will also have flexibility in changing segments or images or sizes you don’t like.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
Proposed TNM update could shift staging for lung cancers
The updates for the 9th edition of the TNM Classification of Malignant Tumors: Lung Cancer were presented at the annual World Conference on Lung Cancer. The final version will be published Jan. 1, 2024.
The core proposed change, according to Hisao Asamura, MD, chair of the IASLC Staging and Prognostic Factors Committee, is to divide N2 and M1c disease into two subcategories, while leaving the T descriptors unchanged.
This update is based on large survival differences among patients with these tumor characteristics, following an analysis of outcomes in more than 87,000 individuals diagnosed with lung cancer.
Session cochair Ramón Rami-Porta, MD, PhD, explained that previous editions of the classification were based on “pathologic stage, not clinical stage” but ultimately “we could not validate those findings” clinically.
“This is the first time that some sort of very simple quantification” of lung tumors “could be validated at the clinical stage as well,” which means that clinical staging can improve all over the world, said Dr. Rami-Porta, medical oncologist at Hospital Universitari Mútua Terrassa (Spain).
Session cochair Paul Van Schil, MD, PhD, of Antwerp (the Netherlands) University Hospital explained that the proposed changes reflect what clinicians already see in their daily practice.
The latest TNM classification included data submitted on 124,581 patients diagnosed with lung cancer between 2011 and 2019, 56% of whom were from Asia/Australia, 25% from Europe, and 16% from North America.
Overall, 87,339 patients were included in the analysis – 83% with non–small cell lung cancer (NSCLC) and 7% with small cell lung cancer (SCLC). Most (62%) underwent surgery, either alone (47%), alongside chemotherapy (13%), or plus radiotherapy (2%). A minority (13%) received chemotherapy alone, and 13% received all three modalities.
The committee working on the update to the TNM classification had 112 members and comprised 14 subcommittees, which focused on different aspects of diagnosing and assessing the disease.
The committee agreed there should be no changes to the T category in the upcoming 9th Edition.
Evaluating the T category, some members expressed concern that patients with T3 disease embedded in the chest wall have worse survival outcomes than those with other forms of T3 disease. But, Dr. Asamura explained, the pathological versus clinical findings were inconsistent.
On pathological assessment, patients with T3 disease in the chest wall had a worse prognosis but clinical assessment indicated no survival difference. Given the lack of consensus, “we do not recommend any changes” to the current criteria, said Dr. Asamura.
Turning to the N category, Dr. Asamura explained that N2 disease will be divided into two subcategories: N2a, categorized by single N2 station involvement, and N2b, defined as multiple N2 station involvement.
Further analysis indicated that the estimated 5-year survival was significantly worse for patients with N2b disease on clinical assessment (31% vs. 42% with N2a disease; hazard ratio for death, 1.27; P < .0001) and on pathological assessment (HR, 1.46; P < .0001).
The committee also proposed a change to the M category, dividing M1c disease into two subcategories:
- M1c1 – defined as multiple extrathoracic metastases in a single organ system
- M1c2 – defined as multiple extrathoracic metastases in multiple organ systems
This change was driven by estimates of 5-year survival among patients with M1c1 (27%) versus M1c2 disease (19%). Compared with M1b disease, M1c1 was associated with a lower risk for death than M1c2 disease (HR, 1.27 vs. 1.39).
These changes, particularly those for the N category, will have a notable impact on how patients are staged, Dr. Asamura said.
Dividing the N2 category into N2a and N2b disease will push patients with T1, N1 disease from the IIB category (8th edition) to the IIA category (9th edition). The 8th edition categorized all T1, N2 patients as IIIA but the new edition would categorize patients with T1, N2a disease as IIB overall and those with N2b disease as IIIA. And patients with T2, N2a disease will be staged as IIIA — the same category as T2, N2 disease in the 8th edition – while those with N2b disease will be staged as IIIB.
By contrast, the division of M1c into M1c1 and M1c2 disease will not affect a patient’s overall stage, which will be IVB in all cases.
Upal Basu Roy, PhD, MPH, who was not part of the committee, said the TNM classification stage of cancers is “incredibly important in cataloguing the extent of disease” and to “decide the optimal treatment option.”
TNM classification is also “used to describe the burden of disease to be eligible for a clinical trial,” said Dr. Roy, executive director of research, LUNGevity Foundation, Chicago.
The changes in N staging may require sampling more lymph nodes than the current sampling frame of six, Dr. Roy said, adding that “surgeons and pathologists may need to be educated about the need for additional sampling.”
The subcategories for M1c disease will also need to be aligned with definitions of oligometastatic disease. “This is critical,” Dr. Roy said, as this staging may affect treatment choices.
No funding was declared. Dr. Asamura declares relationships with Medtronic, Taiho Pharmaceutical, Johnson & Johnson, Lily, Astellas, and Ono Pharmaceutical. Dr. Roy declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The updates for the 9th edition of the TNM Classification of Malignant Tumors: Lung Cancer were presented at the annual World Conference on Lung Cancer. The final version will be published Jan. 1, 2024.
The core proposed change, according to Hisao Asamura, MD, chair of the IASLC Staging and Prognostic Factors Committee, is to divide N2 and M1c disease into two subcategories, while leaving the T descriptors unchanged.
This update is based on large survival differences among patients with these tumor characteristics, following an analysis of outcomes in more than 87,000 individuals diagnosed with lung cancer.
Session cochair Ramón Rami-Porta, MD, PhD, explained that previous editions of the classification were based on “pathologic stage, not clinical stage” but ultimately “we could not validate those findings” clinically.
“This is the first time that some sort of very simple quantification” of lung tumors “could be validated at the clinical stage as well,” which means that clinical staging can improve all over the world, said Dr. Rami-Porta, medical oncologist at Hospital Universitari Mútua Terrassa (Spain).
Session cochair Paul Van Schil, MD, PhD, of Antwerp (the Netherlands) University Hospital explained that the proposed changes reflect what clinicians already see in their daily practice.
The latest TNM classification included data submitted on 124,581 patients diagnosed with lung cancer between 2011 and 2019, 56% of whom were from Asia/Australia, 25% from Europe, and 16% from North America.
Overall, 87,339 patients were included in the analysis – 83% with non–small cell lung cancer (NSCLC) and 7% with small cell lung cancer (SCLC). Most (62%) underwent surgery, either alone (47%), alongside chemotherapy (13%), or plus radiotherapy (2%). A minority (13%) received chemotherapy alone, and 13% received all three modalities.
The committee working on the update to the TNM classification had 112 members and comprised 14 subcommittees, which focused on different aspects of diagnosing and assessing the disease.
The committee agreed there should be no changes to the T category in the upcoming 9th Edition.
Evaluating the T category, some members expressed concern that patients with T3 disease embedded in the chest wall have worse survival outcomes than those with other forms of T3 disease. But, Dr. Asamura explained, the pathological versus clinical findings were inconsistent.
On pathological assessment, patients with T3 disease in the chest wall had a worse prognosis but clinical assessment indicated no survival difference. Given the lack of consensus, “we do not recommend any changes” to the current criteria, said Dr. Asamura.
Turning to the N category, Dr. Asamura explained that N2 disease will be divided into two subcategories: N2a, categorized by single N2 station involvement, and N2b, defined as multiple N2 station involvement.
Further analysis indicated that the estimated 5-year survival was significantly worse for patients with N2b disease on clinical assessment (31% vs. 42% with N2a disease; hazard ratio for death, 1.27; P < .0001) and on pathological assessment (HR, 1.46; P < .0001).
The committee also proposed a change to the M category, dividing M1c disease into two subcategories:
- M1c1 – defined as multiple extrathoracic metastases in a single organ system
- M1c2 – defined as multiple extrathoracic metastases in multiple organ systems
This change was driven by estimates of 5-year survival among patients with M1c1 (27%) versus M1c2 disease (19%). Compared with M1b disease, M1c1 was associated with a lower risk for death than M1c2 disease (HR, 1.27 vs. 1.39).
These changes, particularly those for the N category, will have a notable impact on how patients are staged, Dr. Asamura said.
Dividing the N2 category into N2a and N2b disease will push patients with T1, N1 disease from the IIB category (8th edition) to the IIA category (9th edition). The 8th edition categorized all T1, N2 patients as IIIA but the new edition would categorize patients with T1, N2a disease as IIB overall and those with N2b disease as IIIA. And patients with T2, N2a disease will be staged as IIIA — the same category as T2, N2 disease in the 8th edition – while those with N2b disease will be staged as IIIB.
By contrast, the division of M1c into M1c1 and M1c2 disease will not affect a patient’s overall stage, which will be IVB in all cases.
Upal Basu Roy, PhD, MPH, who was not part of the committee, said the TNM classification stage of cancers is “incredibly important in cataloguing the extent of disease” and to “decide the optimal treatment option.”
TNM classification is also “used to describe the burden of disease to be eligible for a clinical trial,” said Dr. Roy, executive director of research, LUNGevity Foundation, Chicago.
The changes in N staging may require sampling more lymph nodes than the current sampling frame of six, Dr. Roy said, adding that “surgeons and pathologists may need to be educated about the need for additional sampling.”
The subcategories for M1c disease will also need to be aligned with definitions of oligometastatic disease. “This is critical,” Dr. Roy said, as this staging may affect treatment choices.
No funding was declared. Dr. Asamura declares relationships with Medtronic, Taiho Pharmaceutical, Johnson & Johnson, Lily, Astellas, and Ono Pharmaceutical. Dr. Roy declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The updates for the 9th edition of the TNM Classification of Malignant Tumors: Lung Cancer were presented at the annual World Conference on Lung Cancer. The final version will be published Jan. 1, 2024.
The core proposed change, according to Hisao Asamura, MD, chair of the IASLC Staging and Prognostic Factors Committee, is to divide N2 and M1c disease into two subcategories, while leaving the T descriptors unchanged.
This update is based on large survival differences among patients with these tumor characteristics, following an analysis of outcomes in more than 87,000 individuals diagnosed with lung cancer.
Session cochair Ramón Rami-Porta, MD, PhD, explained that previous editions of the classification were based on “pathologic stage, not clinical stage” but ultimately “we could not validate those findings” clinically.
“This is the first time that some sort of very simple quantification” of lung tumors “could be validated at the clinical stage as well,” which means that clinical staging can improve all over the world, said Dr. Rami-Porta, medical oncologist at Hospital Universitari Mútua Terrassa (Spain).
Session cochair Paul Van Schil, MD, PhD, of Antwerp (the Netherlands) University Hospital explained that the proposed changes reflect what clinicians already see in their daily practice.
The latest TNM classification included data submitted on 124,581 patients diagnosed with lung cancer between 2011 and 2019, 56% of whom were from Asia/Australia, 25% from Europe, and 16% from North America.
Overall, 87,339 patients were included in the analysis – 83% with non–small cell lung cancer (NSCLC) and 7% with small cell lung cancer (SCLC). Most (62%) underwent surgery, either alone (47%), alongside chemotherapy (13%), or plus radiotherapy (2%). A minority (13%) received chemotherapy alone, and 13% received all three modalities.
The committee working on the update to the TNM classification had 112 members and comprised 14 subcommittees, which focused on different aspects of diagnosing and assessing the disease.
The committee agreed there should be no changes to the T category in the upcoming 9th Edition.
Evaluating the T category, some members expressed concern that patients with T3 disease embedded in the chest wall have worse survival outcomes than those with other forms of T3 disease. But, Dr. Asamura explained, the pathological versus clinical findings were inconsistent.
On pathological assessment, patients with T3 disease in the chest wall had a worse prognosis but clinical assessment indicated no survival difference. Given the lack of consensus, “we do not recommend any changes” to the current criteria, said Dr. Asamura.
Turning to the N category, Dr. Asamura explained that N2 disease will be divided into two subcategories: N2a, categorized by single N2 station involvement, and N2b, defined as multiple N2 station involvement.
Further analysis indicated that the estimated 5-year survival was significantly worse for patients with N2b disease on clinical assessment (31% vs. 42% with N2a disease; hazard ratio for death, 1.27; P < .0001) and on pathological assessment (HR, 1.46; P < .0001).
The committee also proposed a change to the M category, dividing M1c disease into two subcategories:
- M1c1 – defined as multiple extrathoracic metastases in a single organ system
- M1c2 – defined as multiple extrathoracic metastases in multiple organ systems
This change was driven by estimates of 5-year survival among patients with M1c1 (27%) versus M1c2 disease (19%). Compared with M1b disease, M1c1 was associated with a lower risk for death than M1c2 disease (HR, 1.27 vs. 1.39).
These changes, particularly those for the N category, will have a notable impact on how patients are staged, Dr. Asamura said.
Dividing the N2 category into N2a and N2b disease will push patients with T1, N1 disease from the IIB category (8th edition) to the IIA category (9th edition). The 8th edition categorized all T1, N2 patients as IIIA but the new edition would categorize patients with T1, N2a disease as IIB overall and those with N2b disease as IIIA. And patients with T2, N2a disease will be staged as IIIA — the same category as T2, N2 disease in the 8th edition – while those with N2b disease will be staged as IIIB.
By contrast, the division of M1c into M1c1 and M1c2 disease will not affect a patient’s overall stage, which will be IVB in all cases.
Upal Basu Roy, PhD, MPH, who was not part of the committee, said the TNM classification stage of cancers is “incredibly important in cataloguing the extent of disease” and to “decide the optimal treatment option.”
TNM classification is also “used to describe the burden of disease to be eligible for a clinical trial,” said Dr. Roy, executive director of research, LUNGevity Foundation, Chicago.
The changes in N staging may require sampling more lymph nodes than the current sampling frame of six, Dr. Roy said, adding that “surgeons and pathologists may need to be educated about the need for additional sampling.”
The subcategories for M1c disease will also need to be aligned with definitions of oligometastatic disease. “This is critical,” Dr. Roy said, as this staging may affect treatment choices.
No funding was declared. Dr. Asamura declares relationships with Medtronic, Taiho Pharmaceutical, Johnson & Johnson, Lily, Astellas, and Ono Pharmaceutical. Dr. Roy declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM WCLC 2023
Neoadjuvant durvalumab does not affect surgical outcomes in NSCLC: Study
, according to the most recent analysis of data from the phase 3 AEGEAN study.
“In terms of cancellation of surgery, surgical delay, surgically related adverse events, complications, operation time, and operation procedure, there was no difference between the durvalumab group and the placebo group. In addition, the R0 resection rate was numerically higher in the durvalumab group. These [results] indicate that adding perioperative durvalumab did not adversely affect surgical outcomes,” wrote Tetsuya Mitsudomi, MD, PhD, who presented the new results at the annual World Conference on Lung Cancer, in an email. The topline results of AEGEAN were presented earlier this year at AACR 2023, which showed that the regimen combined with adjuvant durvalumab improved event-free survival (EFS) and pathologic complete response (pCR), compared with chemotherapy plus placebo.
Dr. Mitsudomi also pointed out that AEGEAN is one of the first studies looking at immune checkpoint inhibitors (ICI) in the perioperative settings that demonstrated improved EFS and pCR with no effect on surgical outcomes. Previously, the CheckMate 816 study demonstrated efficacy of neoadjuvant ICI alone.
“The AEGEAN study showed that neoadjuvant plus adjuvant ICI is another option for these patients. However, no one knows who should receive the postoperative ICI in addition to neoadjuvant ICI, because there are no trials including ongoing ones that ask this question,” wrote Dr. Mitsudomi.
The phase 3 AEGEAN study included 740 patients who were randomized to durvalumab or placebo. The median age was 65.0 years in both groups, and 33.3% and 33.4% of patients in each group respectively had fewer than 1% of tumor cells that expressed PD-L1. Expression in 1-49% of tumor cells occurred in 36.9% and 38.0% respectively, and expression ≥ 50% occurred in 29.8% and 28.6%.
Prior to surgery, 84.7% of the durvalumab arm completed four cycles of chemotherapy, as did 87.2% in the placebo arm. The proportion of patients undergoing surgery was 80.6% and 80.7% in the two arms, respectively, and surgical completion was achieved in 77.6% and 76.7%. The durvalumab arm and placebo arm had similar median times from last neoadjuvant treatment to surgery (34.0 days for both) and median time from surgery to first adjuvant dose (50.0 versus 52.0 days).
Among patients with stage II NSCLC, 84.3% in the durvalumab arm underwent surgery, versus 88.9% in the placebo arm. Among patients with stage III disease, the numbers were 79.2% and 77.4%, respectively. There was no surgical delay in 82.7% of patients in the durvalumab arm, compared with 77.8% in the placebo arm. The most common reason for surgical delay was logistical reasons. Mediastinal lymph node dissection was completed in 86.6% of the durvalumab arm and 84.7% of the placebo arm. In both groups where surgery was completed, R0 resection rates were over 90% overall as well as in both stage I and stage II patients. Following surgery, adverse events possibly related to surgery occurred in 40.2% of the durvalumab group and 39.2% of the placebo group. The most common surgical adverse events occurred at similar frequency between groups.
After the presentation, Solange Peters, MD, PhD, served as a discussant. She pointed out other studies that have examined ICI therapy for NSCLC in both the neoadjuvant and adjuvant setting, including Keynote-671 (pembrolizumab), Neotorch (toripalimab), CheckMate 77T (nivolumab), and Impower030 (atezolizumab). She pointed out that AEGEAN, Keynote-671, CheckMate 816, and NeoTorch all had similar trial designs and showed similar magnitude of benefit. “We have a growing paradigm [for combining neoadjuvant and adjuvant ICI therapy]. We are quite all convinced in the community that there is a biological rationale to use neoadjuvant immunotherapy because of the fit immune system, because of the presence of the neoantigens within the tumor at the time of the start of neoadjuvant treatment, [leading to] better priming of immune cells,” said Dr. Peters, who is a professor of medical oncology at University Hospital of Lausanne, Switzerland.
About one in five patients across the trials who would be eligible for surgery never undergo it, but there is promising data from CheckMate 816 that neoadjuvant ICB may improve the odds of surgery, according to Dr. Solange. The AEGEAN data produced some “quite interesting” data about the reasons that patients don’t make it to surgery, as it showed that 8%-10% of patients don’t reach surgery because of progression, but 10%-15% may fall out because they turned out not to be a good candidate for surgery. “I think we probably have to blame the enthusiasm we have to add all these patients into the trial, hoping for the best for the patient but maybe making a wrong selection,” said Dr. Peters.
The study was funded by AstraZeneca. Dr. Mitsudomi has received speaker fees, honoraria, or research funding from AstraZeneca, Chugai, Ono, Bristol Myers Squibb, and MSD. Dr. Peters has financial relationships with AstraZeneca as well as a wide range of other pharmaceutical companies.
, according to the most recent analysis of data from the phase 3 AEGEAN study.
“In terms of cancellation of surgery, surgical delay, surgically related adverse events, complications, operation time, and operation procedure, there was no difference between the durvalumab group and the placebo group. In addition, the R0 resection rate was numerically higher in the durvalumab group. These [results] indicate that adding perioperative durvalumab did not adversely affect surgical outcomes,” wrote Tetsuya Mitsudomi, MD, PhD, who presented the new results at the annual World Conference on Lung Cancer, in an email. The topline results of AEGEAN were presented earlier this year at AACR 2023, which showed that the regimen combined with adjuvant durvalumab improved event-free survival (EFS) and pathologic complete response (pCR), compared with chemotherapy plus placebo.
Dr. Mitsudomi also pointed out that AEGEAN is one of the first studies looking at immune checkpoint inhibitors (ICI) in the perioperative settings that demonstrated improved EFS and pCR with no effect on surgical outcomes. Previously, the CheckMate 816 study demonstrated efficacy of neoadjuvant ICI alone.
“The AEGEAN study showed that neoadjuvant plus adjuvant ICI is another option for these patients. However, no one knows who should receive the postoperative ICI in addition to neoadjuvant ICI, because there are no trials including ongoing ones that ask this question,” wrote Dr. Mitsudomi.
The phase 3 AEGEAN study included 740 patients who were randomized to durvalumab or placebo. The median age was 65.0 years in both groups, and 33.3% and 33.4% of patients in each group respectively had fewer than 1% of tumor cells that expressed PD-L1. Expression in 1-49% of tumor cells occurred in 36.9% and 38.0% respectively, and expression ≥ 50% occurred in 29.8% and 28.6%.
Prior to surgery, 84.7% of the durvalumab arm completed four cycles of chemotherapy, as did 87.2% in the placebo arm. The proportion of patients undergoing surgery was 80.6% and 80.7% in the two arms, respectively, and surgical completion was achieved in 77.6% and 76.7%. The durvalumab arm and placebo arm had similar median times from last neoadjuvant treatment to surgery (34.0 days for both) and median time from surgery to first adjuvant dose (50.0 versus 52.0 days).
Among patients with stage II NSCLC, 84.3% in the durvalumab arm underwent surgery, versus 88.9% in the placebo arm. Among patients with stage III disease, the numbers were 79.2% and 77.4%, respectively. There was no surgical delay in 82.7% of patients in the durvalumab arm, compared with 77.8% in the placebo arm. The most common reason for surgical delay was logistical reasons. Mediastinal lymph node dissection was completed in 86.6% of the durvalumab arm and 84.7% of the placebo arm. In both groups where surgery was completed, R0 resection rates were over 90% overall as well as in both stage I and stage II patients. Following surgery, adverse events possibly related to surgery occurred in 40.2% of the durvalumab group and 39.2% of the placebo group. The most common surgical adverse events occurred at similar frequency between groups.
After the presentation, Solange Peters, MD, PhD, served as a discussant. She pointed out other studies that have examined ICI therapy for NSCLC in both the neoadjuvant and adjuvant setting, including Keynote-671 (pembrolizumab), Neotorch (toripalimab), CheckMate 77T (nivolumab), and Impower030 (atezolizumab). She pointed out that AEGEAN, Keynote-671, CheckMate 816, and NeoTorch all had similar trial designs and showed similar magnitude of benefit. “We have a growing paradigm [for combining neoadjuvant and adjuvant ICI therapy]. We are quite all convinced in the community that there is a biological rationale to use neoadjuvant immunotherapy because of the fit immune system, because of the presence of the neoantigens within the tumor at the time of the start of neoadjuvant treatment, [leading to] better priming of immune cells,” said Dr. Peters, who is a professor of medical oncology at University Hospital of Lausanne, Switzerland.
About one in five patients across the trials who would be eligible for surgery never undergo it, but there is promising data from CheckMate 816 that neoadjuvant ICB may improve the odds of surgery, according to Dr. Solange. The AEGEAN data produced some “quite interesting” data about the reasons that patients don’t make it to surgery, as it showed that 8%-10% of patients don’t reach surgery because of progression, but 10%-15% may fall out because they turned out not to be a good candidate for surgery. “I think we probably have to blame the enthusiasm we have to add all these patients into the trial, hoping for the best for the patient but maybe making a wrong selection,” said Dr. Peters.
The study was funded by AstraZeneca. Dr. Mitsudomi has received speaker fees, honoraria, or research funding from AstraZeneca, Chugai, Ono, Bristol Myers Squibb, and MSD. Dr. Peters has financial relationships with AstraZeneca as well as a wide range of other pharmaceutical companies.
, according to the most recent analysis of data from the phase 3 AEGEAN study.
“In terms of cancellation of surgery, surgical delay, surgically related adverse events, complications, operation time, and operation procedure, there was no difference between the durvalumab group and the placebo group. In addition, the R0 resection rate was numerically higher in the durvalumab group. These [results] indicate that adding perioperative durvalumab did not adversely affect surgical outcomes,” wrote Tetsuya Mitsudomi, MD, PhD, who presented the new results at the annual World Conference on Lung Cancer, in an email. The topline results of AEGEAN were presented earlier this year at AACR 2023, which showed that the regimen combined with adjuvant durvalumab improved event-free survival (EFS) and pathologic complete response (pCR), compared with chemotherapy plus placebo.
Dr. Mitsudomi also pointed out that AEGEAN is one of the first studies looking at immune checkpoint inhibitors (ICI) in the perioperative settings that demonstrated improved EFS and pCR with no effect on surgical outcomes. Previously, the CheckMate 816 study demonstrated efficacy of neoadjuvant ICI alone.
“The AEGEAN study showed that neoadjuvant plus adjuvant ICI is another option for these patients. However, no one knows who should receive the postoperative ICI in addition to neoadjuvant ICI, because there are no trials including ongoing ones that ask this question,” wrote Dr. Mitsudomi.
The phase 3 AEGEAN study included 740 patients who were randomized to durvalumab or placebo. The median age was 65.0 years in both groups, and 33.3% and 33.4% of patients in each group respectively had fewer than 1% of tumor cells that expressed PD-L1. Expression in 1-49% of tumor cells occurred in 36.9% and 38.0% respectively, and expression ≥ 50% occurred in 29.8% and 28.6%.
Prior to surgery, 84.7% of the durvalumab arm completed four cycles of chemotherapy, as did 87.2% in the placebo arm. The proportion of patients undergoing surgery was 80.6% and 80.7% in the two arms, respectively, and surgical completion was achieved in 77.6% and 76.7%. The durvalumab arm and placebo arm had similar median times from last neoadjuvant treatment to surgery (34.0 days for both) and median time from surgery to first adjuvant dose (50.0 versus 52.0 days).
Among patients with stage II NSCLC, 84.3% in the durvalumab arm underwent surgery, versus 88.9% in the placebo arm. Among patients with stage III disease, the numbers were 79.2% and 77.4%, respectively. There was no surgical delay in 82.7% of patients in the durvalumab arm, compared with 77.8% in the placebo arm. The most common reason for surgical delay was logistical reasons. Mediastinal lymph node dissection was completed in 86.6% of the durvalumab arm and 84.7% of the placebo arm. In both groups where surgery was completed, R0 resection rates were over 90% overall as well as in both stage I and stage II patients. Following surgery, adverse events possibly related to surgery occurred in 40.2% of the durvalumab group and 39.2% of the placebo group. The most common surgical adverse events occurred at similar frequency between groups.
After the presentation, Solange Peters, MD, PhD, served as a discussant. She pointed out other studies that have examined ICI therapy for NSCLC in both the neoadjuvant and adjuvant setting, including Keynote-671 (pembrolizumab), Neotorch (toripalimab), CheckMate 77T (nivolumab), and Impower030 (atezolizumab). She pointed out that AEGEAN, Keynote-671, CheckMate 816, and NeoTorch all had similar trial designs and showed similar magnitude of benefit. “We have a growing paradigm [for combining neoadjuvant and adjuvant ICI therapy]. We are quite all convinced in the community that there is a biological rationale to use neoadjuvant immunotherapy because of the fit immune system, because of the presence of the neoantigens within the tumor at the time of the start of neoadjuvant treatment, [leading to] better priming of immune cells,” said Dr. Peters, who is a professor of medical oncology at University Hospital of Lausanne, Switzerland.
About one in five patients across the trials who would be eligible for surgery never undergo it, but there is promising data from CheckMate 816 that neoadjuvant ICB may improve the odds of surgery, according to Dr. Solange. The AEGEAN data produced some “quite interesting” data about the reasons that patients don’t make it to surgery, as it showed that 8%-10% of patients don’t reach surgery because of progression, but 10%-15% may fall out because they turned out not to be a good candidate for surgery. “I think we probably have to blame the enthusiasm we have to add all these patients into the trial, hoping for the best for the patient but maybe making a wrong selection,” said Dr. Peters.
The study was funded by AstraZeneca. Dr. Mitsudomi has received speaker fees, honoraria, or research funding from AstraZeneca, Chugai, Ono, Bristol Myers Squibb, and MSD. Dr. Peters has financial relationships with AstraZeneca as well as a wide range of other pharmaceutical companies.
FROM WCLC 2023
Atypical antipsychotics no safer than haloperidol for postoperative delirium: Study
Dae Hyun Kim, MD, ScD, associate professor of medicine at Harvard Medical School, in Boston, who is the lead author of the study, said the findings were especially relevant, as the use of atypical antipsychotics, such as quetiapine, olanzapine, and risperidone, has increased while use of haloperidol has fallen.
A separate but related study led by Dr. Kim, which was recently published in the Journal of the American Geriatrics Society, showed that between 2008 and 2018, use of haloperidol and benzodiazepines in community hospitals and academic medical centers decreased while use of atypical antipsychotics, antidepressants, antiepileptics, and dexmedetomidine rose (P < .01).
“Clinicians should not think atypical antipsychotics are the safer option to haloperidol,” Dr. Kim said. “We should focus on reducing prescriptions.”
Postoperative delirium
Postoperative delirium is the among the most common complications of surgery in older adults, affecting between 15% and 50% of those patients who undergo major operations. Postoperative delirium is associated with longer hospital stays, poor functional recovery, institutionalization, dementia, and death.
According to research from Harvard Medical School, postoperative delirium is linked to a 40% faster rate of cognitive decline among patients who develop the condition, compared with those who do not experience the complication.
While older patients often feel tired or a bit off after surgery, marked changes in mental function, such as confusion, disorientation, agitation, aggression, hallucinations, or persistent sleepiness, could indicate postoperative delirium.
“Antipsychotic medications are most commonly used off label for managing those symptoms of delirium,” Dr. Kim said. “What we’ve done is look at the comparative safety of two other drugs.”
Results
In the retrospective cohort study, researchers analyzed data from 17,115 patients aged 65 years and older who were without psychiatric disorders and who received oral antipsychotics after major surgery requiring general anesthesia.
“These results don’t apply to people in emergent situations where there is severe behavior that threatens their safety and others,” Dr. Kim noted.
There was no statistically significant difference in the risk for in-hospital death among patients treated with haloperidol (3.7%), olanzapine (2.8%; relative risk, 0.74; 95% confidence interval, 0.42-1.27), quetiapine (2.6%; RR, 0.70; 95% CI, 0.47-1.04), or risperidone (3.3%; RR, 0.90; CI, 0.53-1.41).
The study also found statistically insignificant differences in the risk for nonfatal clinical events. Those risks ranged from 2% to 2.6% for a cardiac arrhythmia, from 4.2% to 4.6% for pneumonia, and from 0.6% to 1.2% for strokes or transient ischemic attacks.
Esther Oh, MD, PhD, an associate professor at Johns Hopkins University, Baltimore, said that caring for patients who experience acute changes in mental status or behaviors during hospitalization can be difficult.
“Although there is a lot of evidence in the literature that nonpharmacological methods to address these problems are effective, staff shortages of recent years have made it even more difficult for the care team to institute these methods,” Dr. Oh said in an interview.
Prevention
Dr. Oh and Dr. Kim agreed that nonpharmacologic strategies, such as ensuring good nutrition and hydration, daily walking, cognitive-stimulating activities, and good sleep hygiene, are effective and safe in preventing postoperative delirium.
“These are common sense interventions, but they require a lot of staffing and training,” Dr. Kim said. “It’s a resource-intensive intervention that requires really changing the way hospital staff interacts with older patients in the hospital.”
Second-generation antipsychotic medications often are thought to be safer than haloperidol in terms of side effects, Dr. Oh said, but the new findings challenge that assumption.
“Based on the findings from this study and on prior studies of antipsychotic use for older adults, use of all antipsychotics, both first and second generation, should be reviewed carefully to ensure they are being administered at the lowest effective dose for the shortest duration possible,” she said.
The study was supported by the National Institute on Aging of the National Institutes of Health. Dr. Kim and Dr. Oh disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Dae Hyun Kim, MD, ScD, associate professor of medicine at Harvard Medical School, in Boston, who is the lead author of the study, said the findings were especially relevant, as the use of atypical antipsychotics, such as quetiapine, olanzapine, and risperidone, has increased while use of haloperidol has fallen.
A separate but related study led by Dr. Kim, which was recently published in the Journal of the American Geriatrics Society, showed that between 2008 and 2018, use of haloperidol and benzodiazepines in community hospitals and academic medical centers decreased while use of atypical antipsychotics, antidepressants, antiepileptics, and dexmedetomidine rose (P < .01).
“Clinicians should not think atypical antipsychotics are the safer option to haloperidol,” Dr. Kim said. “We should focus on reducing prescriptions.”
Postoperative delirium
Postoperative delirium is the among the most common complications of surgery in older adults, affecting between 15% and 50% of those patients who undergo major operations. Postoperative delirium is associated with longer hospital stays, poor functional recovery, institutionalization, dementia, and death.
According to research from Harvard Medical School, postoperative delirium is linked to a 40% faster rate of cognitive decline among patients who develop the condition, compared with those who do not experience the complication.
While older patients often feel tired or a bit off after surgery, marked changes in mental function, such as confusion, disorientation, agitation, aggression, hallucinations, or persistent sleepiness, could indicate postoperative delirium.
“Antipsychotic medications are most commonly used off label for managing those symptoms of delirium,” Dr. Kim said. “What we’ve done is look at the comparative safety of two other drugs.”
Results
In the retrospective cohort study, researchers analyzed data from 17,115 patients aged 65 years and older who were without psychiatric disorders and who received oral antipsychotics after major surgery requiring general anesthesia.
“These results don’t apply to people in emergent situations where there is severe behavior that threatens their safety and others,” Dr. Kim noted.
There was no statistically significant difference in the risk for in-hospital death among patients treated with haloperidol (3.7%), olanzapine (2.8%; relative risk, 0.74; 95% confidence interval, 0.42-1.27), quetiapine (2.6%; RR, 0.70; 95% CI, 0.47-1.04), or risperidone (3.3%; RR, 0.90; CI, 0.53-1.41).
The study also found statistically insignificant differences in the risk for nonfatal clinical events. Those risks ranged from 2% to 2.6% for a cardiac arrhythmia, from 4.2% to 4.6% for pneumonia, and from 0.6% to 1.2% for strokes or transient ischemic attacks.
Esther Oh, MD, PhD, an associate professor at Johns Hopkins University, Baltimore, said that caring for patients who experience acute changes in mental status or behaviors during hospitalization can be difficult.
“Although there is a lot of evidence in the literature that nonpharmacological methods to address these problems are effective, staff shortages of recent years have made it even more difficult for the care team to institute these methods,” Dr. Oh said in an interview.
Prevention
Dr. Oh and Dr. Kim agreed that nonpharmacologic strategies, such as ensuring good nutrition and hydration, daily walking, cognitive-stimulating activities, and good sleep hygiene, are effective and safe in preventing postoperative delirium.
“These are common sense interventions, but they require a lot of staffing and training,” Dr. Kim said. “It’s a resource-intensive intervention that requires really changing the way hospital staff interacts with older patients in the hospital.”
Second-generation antipsychotic medications often are thought to be safer than haloperidol in terms of side effects, Dr. Oh said, but the new findings challenge that assumption.
“Based on the findings from this study and on prior studies of antipsychotic use for older adults, use of all antipsychotics, both first and second generation, should be reviewed carefully to ensure they are being administered at the lowest effective dose for the shortest duration possible,” she said.
The study was supported by the National Institute on Aging of the National Institutes of Health. Dr. Kim and Dr. Oh disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Dae Hyun Kim, MD, ScD, associate professor of medicine at Harvard Medical School, in Boston, who is the lead author of the study, said the findings were especially relevant, as the use of atypical antipsychotics, such as quetiapine, olanzapine, and risperidone, has increased while use of haloperidol has fallen.
A separate but related study led by Dr. Kim, which was recently published in the Journal of the American Geriatrics Society, showed that between 2008 and 2018, use of haloperidol and benzodiazepines in community hospitals and academic medical centers decreased while use of atypical antipsychotics, antidepressants, antiepileptics, and dexmedetomidine rose (P < .01).
“Clinicians should not think atypical antipsychotics are the safer option to haloperidol,” Dr. Kim said. “We should focus on reducing prescriptions.”
Postoperative delirium
Postoperative delirium is the among the most common complications of surgery in older adults, affecting between 15% and 50% of those patients who undergo major operations. Postoperative delirium is associated with longer hospital stays, poor functional recovery, institutionalization, dementia, and death.
According to research from Harvard Medical School, postoperative delirium is linked to a 40% faster rate of cognitive decline among patients who develop the condition, compared with those who do not experience the complication.
While older patients often feel tired or a bit off after surgery, marked changes in mental function, such as confusion, disorientation, agitation, aggression, hallucinations, or persistent sleepiness, could indicate postoperative delirium.
“Antipsychotic medications are most commonly used off label for managing those symptoms of delirium,” Dr. Kim said. “What we’ve done is look at the comparative safety of two other drugs.”
Results
In the retrospective cohort study, researchers analyzed data from 17,115 patients aged 65 years and older who were without psychiatric disorders and who received oral antipsychotics after major surgery requiring general anesthesia.
“These results don’t apply to people in emergent situations where there is severe behavior that threatens their safety and others,” Dr. Kim noted.
There was no statistically significant difference in the risk for in-hospital death among patients treated with haloperidol (3.7%), olanzapine (2.8%; relative risk, 0.74; 95% confidence interval, 0.42-1.27), quetiapine (2.6%; RR, 0.70; 95% CI, 0.47-1.04), or risperidone (3.3%; RR, 0.90; CI, 0.53-1.41).
The study also found statistically insignificant differences in the risk for nonfatal clinical events. Those risks ranged from 2% to 2.6% for a cardiac arrhythmia, from 4.2% to 4.6% for pneumonia, and from 0.6% to 1.2% for strokes or transient ischemic attacks.
Esther Oh, MD, PhD, an associate professor at Johns Hopkins University, Baltimore, said that caring for patients who experience acute changes in mental status or behaviors during hospitalization can be difficult.
“Although there is a lot of evidence in the literature that nonpharmacological methods to address these problems are effective, staff shortages of recent years have made it even more difficult for the care team to institute these methods,” Dr. Oh said in an interview.
Prevention
Dr. Oh and Dr. Kim agreed that nonpharmacologic strategies, such as ensuring good nutrition and hydration, daily walking, cognitive-stimulating activities, and good sleep hygiene, are effective and safe in preventing postoperative delirium.
“These are common sense interventions, but they require a lot of staffing and training,” Dr. Kim said. “It’s a resource-intensive intervention that requires really changing the way hospital staff interacts with older patients in the hospital.”
Second-generation antipsychotic medications often are thought to be safer than haloperidol in terms of side effects, Dr. Oh said, but the new findings challenge that assumption.
“Based on the findings from this study and on prior studies of antipsychotic use for older adults, use of all antipsychotics, both first and second generation, should be reviewed carefully to ensure they are being administered at the lowest effective dose for the shortest duration possible,” she said.
The study was supported by the National Institute on Aging of the National Institutes of Health. Dr. Kim and Dr. Oh disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ANNALS OF INTERNAL MEDICINE
Your workplace is toxic: Can you make it better?
A physician in your office is hot-tempered, critical, and upsets both the physicians and staff. Two of your partners are arguing over a software vendor and refuse to compromise. One doctor’s spouse is the office manager and snipes at everyone; the lead partner micromanages and second-guesses other doctors’ treatment plans, and no one will stand up to her.
If your practice has similar scenarios, you’re likely dealing with your own anger, irritation, and dread at work. You’re struggling with a toxic practice atmosphere, and you must make changes – fast.
However, this isn’t easy, given that what goes on in a doctor’s office is “high consequence,” says Leonard J. Marcus, PhD, founding director of the program for health care negotiation and conflict resolution at the Harvard School of Public Health in Boston.
The two things that tend to plague medical practices most: A culture of fear and someone who is letting ego run the day-to-day, he says.
“Fear overwhelms any chance for good morale among colleagues,” says Dr. Marcus, who is also the coauthor of “Renegotiating Health Care: Resolving Conflict to Build Collaboration.” “In a work environment where the fear is overwhelming, the ego can take over, and someone at the practice becomes overly concerned about getting credit, taking control, ordering other people around, and deciding who is on top and who is on the bottom.”
Tension, stress, back-biting, and rudeness are also symptoms of a more significant problem, says Jes Montgomery, MD, a psychiatrist and medical director of APN Dallas, a mental health–focused practice.
“If you don’t get toxicity under control, it will blow the office apart,” Dr. Montgomery says.
1. Recognize the signs
Part of the problem with a toxic medical practice is that, culturally, we don’t treat mental health and burnout as real illnesses. “A physician who is depressed is not going to be melancholy or bursting into tears with patients,” Dr. Montgomery says. “They’ll get behind on paperwork, skip meals, or find that it’s difficult to sleep at night. Next, they’ll yell at the partners and staff, always be in a foul mood, and gripe about inconsequential things. Their behavior affects everyone.”
Dr. Montgomery says that physicians aren’t taught to ask for help, making it difficult to see what’s really going on when someone displays toxic behavior in the practice. If it’s a partner, take time to ask what’s going on. If it’s yourself, step back and see if you can ask someone for the help you need.
2. Have difficult conversations
This is tough for most of us, says Jeremy Pollack, PhD, CEO and founder of Pollack Peacebuilding Systems, a conflict resolution consulting firm. If a team member is hot-tempered, disrespectful, or talking to patients in an unproductive manner, see if you can have an effective conversation with that person. The tricky part is critiquing in a way that doesn’t make them feel defensive – and wanting to push back.
For a micromanaging office manager, for example, you could say something like,”You’re doing a great job with the inventory, but I need you to let the staff have some autonomy and not hover over every supply they use in the break room, so that people won’t feel resentful toward us.” Make it clear you’re a team, and this is a team challenge. “However, if a doctor feels like they’ve tried to communicate to that colleague and are still walking on eggshells, it’s time to try to get help from someone – perhaps a practice management organization,” says Dr. Pollack.
3. Open lines of communication
It’s critical to create a comfortable space to speak with your colleagues, says Marisa Garshick, MD, a dermatologist in private practice in New York. “Creating an environment where there is an open line of communication, whether it’s directly to somebody in charge or having a system where you can give feedback more privately or anonymously, is important so that tension doesn’t build.”
“Being a doctor is a social enterprise,” Dr. Marcus says. “The science of medicine is critically important, but patients and the other health care workers on your team are also critically important. In the long run, the most successful physicians pay attention to both. It’s a full package.”
4. Emphasize the positive
Instead of discussing things only when they go wrong, try optimism, Dr. Garshick said. When positive things happen, whether it’s an excellent patient encounter or the office did something really well together, highlight it so everyone has a sense of accomplishment. If a patient compliments a medical assistant or raves about a nurse, share those compliments with the employees so that not every encounter you have calls out problems and staff missteps.
Suppose partners have a conflict with one another or are arguing over something. In that case, you may need to mediate or invest in a meaningful intervention so people can reflect on the narrative they’re contributing to the culture.
5. Practice self-care
Finally, the work of a physician is exhausting, so it’s crucial to practice personal TLC. That may mean taking micro breaks, getting adequate sleep, maintaining a healthy diet, and exercising well and managing stress to maintain energy levels and patience.
“Sometimes, when I’m fed up with the office, I need to get away,” Dr. Montgomery says. “I’ll take a day to go fishing, golfing, and not think about the office.” Just a small break can shift the lens that you see through when you return to the office and put problems in perspective.
A version of this article first appeared on Medscape.com.
A physician in your office is hot-tempered, critical, and upsets both the physicians and staff. Two of your partners are arguing over a software vendor and refuse to compromise. One doctor’s spouse is the office manager and snipes at everyone; the lead partner micromanages and second-guesses other doctors’ treatment plans, and no one will stand up to her.
If your practice has similar scenarios, you’re likely dealing with your own anger, irritation, and dread at work. You’re struggling with a toxic practice atmosphere, and you must make changes – fast.
However, this isn’t easy, given that what goes on in a doctor’s office is “high consequence,” says Leonard J. Marcus, PhD, founding director of the program for health care negotiation and conflict resolution at the Harvard School of Public Health in Boston.
The two things that tend to plague medical practices most: A culture of fear and someone who is letting ego run the day-to-day, he says.
“Fear overwhelms any chance for good morale among colleagues,” says Dr. Marcus, who is also the coauthor of “Renegotiating Health Care: Resolving Conflict to Build Collaboration.” “In a work environment where the fear is overwhelming, the ego can take over, and someone at the practice becomes overly concerned about getting credit, taking control, ordering other people around, and deciding who is on top and who is on the bottom.”
Tension, stress, back-biting, and rudeness are also symptoms of a more significant problem, says Jes Montgomery, MD, a psychiatrist and medical director of APN Dallas, a mental health–focused practice.
“If you don’t get toxicity under control, it will blow the office apart,” Dr. Montgomery says.
1. Recognize the signs
Part of the problem with a toxic medical practice is that, culturally, we don’t treat mental health and burnout as real illnesses. “A physician who is depressed is not going to be melancholy or bursting into tears with patients,” Dr. Montgomery says. “They’ll get behind on paperwork, skip meals, or find that it’s difficult to sleep at night. Next, they’ll yell at the partners and staff, always be in a foul mood, and gripe about inconsequential things. Their behavior affects everyone.”
Dr. Montgomery says that physicians aren’t taught to ask for help, making it difficult to see what’s really going on when someone displays toxic behavior in the practice. If it’s a partner, take time to ask what’s going on. If it’s yourself, step back and see if you can ask someone for the help you need.
2. Have difficult conversations
This is tough for most of us, says Jeremy Pollack, PhD, CEO and founder of Pollack Peacebuilding Systems, a conflict resolution consulting firm. If a team member is hot-tempered, disrespectful, or talking to patients in an unproductive manner, see if you can have an effective conversation with that person. The tricky part is critiquing in a way that doesn’t make them feel defensive – and wanting to push back.
For a micromanaging office manager, for example, you could say something like,”You’re doing a great job with the inventory, but I need you to let the staff have some autonomy and not hover over every supply they use in the break room, so that people won’t feel resentful toward us.” Make it clear you’re a team, and this is a team challenge. “However, if a doctor feels like they’ve tried to communicate to that colleague and are still walking on eggshells, it’s time to try to get help from someone – perhaps a practice management organization,” says Dr. Pollack.
3. Open lines of communication
It’s critical to create a comfortable space to speak with your colleagues, says Marisa Garshick, MD, a dermatologist in private practice in New York. “Creating an environment where there is an open line of communication, whether it’s directly to somebody in charge or having a system where you can give feedback more privately or anonymously, is important so that tension doesn’t build.”
“Being a doctor is a social enterprise,” Dr. Marcus says. “The science of medicine is critically important, but patients and the other health care workers on your team are also critically important. In the long run, the most successful physicians pay attention to both. It’s a full package.”
4. Emphasize the positive
Instead of discussing things only when they go wrong, try optimism, Dr. Garshick said. When positive things happen, whether it’s an excellent patient encounter or the office did something really well together, highlight it so everyone has a sense of accomplishment. If a patient compliments a medical assistant or raves about a nurse, share those compliments with the employees so that not every encounter you have calls out problems and staff missteps.
Suppose partners have a conflict with one another or are arguing over something. In that case, you may need to mediate or invest in a meaningful intervention so people can reflect on the narrative they’re contributing to the culture.
5. Practice self-care
Finally, the work of a physician is exhausting, so it’s crucial to practice personal TLC. That may mean taking micro breaks, getting adequate sleep, maintaining a healthy diet, and exercising well and managing stress to maintain energy levels and patience.
“Sometimes, when I’m fed up with the office, I need to get away,” Dr. Montgomery says. “I’ll take a day to go fishing, golfing, and not think about the office.” Just a small break can shift the lens that you see through when you return to the office and put problems in perspective.
A version of this article first appeared on Medscape.com.
A physician in your office is hot-tempered, critical, and upsets both the physicians and staff. Two of your partners are arguing over a software vendor and refuse to compromise. One doctor’s spouse is the office manager and snipes at everyone; the lead partner micromanages and second-guesses other doctors’ treatment plans, and no one will stand up to her.
If your practice has similar scenarios, you’re likely dealing with your own anger, irritation, and dread at work. You’re struggling with a toxic practice atmosphere, and you must make changes – fast.
However, this isn’t easy, given that what goes on in a doctor’s office is “high consequence,” says Leonard J. Marcus, PhD, founding director of the program for health care negotiation and conflict resolution at the Harvard School of Public Health in Boston.
The two things that tend to plague medical practices most: A culture of fear and someone who is letting ego run the day-to-day, he says.
“Fear overwhelms any chance for good morale among colleagues,” says Dr. Marcus, who is also the coauthor of “Renegotiating Health Care: Resolving Conflict to Build Collaboration.” “In a work environment where the fear is overwhelming, the ego can take over, and someone at the practice becomes overly concerned about getting credit, taking control, ordering other people around, and deciding who is on top and who is on the bottom.”
Tension, stress, back-biting, and rudeness are also symptoms of a more significant problem, says Jes Montgomery, MD, a psychiatrist and medical director of APN Dallas, a mental health–focused practice.
“If you don’t get toxicity under control, it will blow the office apart,” Dr. Montgomery says.
1. Recognize the signs
Part of the problem with a toxic medical practice is that, culturally, we don’t treat mental health and burnout as real illnesses. “A physician who is depressed is not going to be melancholy or bursting into tears with patients,” Dr. Montgomery says. “They’ll get behind on paperwork, skip meals, or find that it’s difficult to sleep at night. Next, they’ll yell at the partners and staff, always be in a foul mood, and gripe about inconsequential things. Their behavior affects everyone.”
Dr. Montgomery says that physicians aren’t taught to ask for help, making it difficult to see what’s really going on when someone displays toxic behavior in the practice. If it’s a partner, take time to ask what’s going on. If it’s yourself, step back and see if you can ask someone for the help you need.
2. Have difficult conversations
This is tough for most of us, says Jeremy Pollack, PhD, CEO and founder of Pollack Peacebuilding Systems, a conflict resolution consulting firm. If a team member is hot-tempered, disrespectful, or talking to patients in an unproductive manner, see if you can have an effective conversation with that person. The tricky part is critiquing in a way that doesn’t make them feel defensive – and wanting to push back.
For a micromanaging office manager, for example, you could say something like,”You’re doing a great job with the inventory, but I need you to let the staff have some autonomy and not hover over every supply they use in the break room, so that people won’t feel resentful toward us.” Make it clear you’re a team, and this is a team challenge. “However, if a doctor feels like they’ve tried to communicate to that colleague and are still walking on eggshells, it’s time to try to get help from someone – perhaps a practice management organization,” says Dr. Pollack.
3. Open lines of communication
It’s critical to create a comfortable space to speak with your colleagues, says Marisa Garshick, MD, a dermatologist in private practice in New York. “Creating an environment where there is an open line of communication, whether it’s directly to somebody in charge or having a system where you can give feedback more privately or anonymously, is important so that tension doesn’t build.”
“Being a doctor is a social enterprise,” Dr. Marcus says. “The science of medicine is critically important, but patients and the other health care workers on your team are also critically important. In the long run, the most successful physicians pay attention to both. It’s a full package.”
4. Emphasize the positive
Instead of discussing things only when they go wrong, try optimism, Dr. Garshick said. When positive things happen, whether it’s an excellent patient encounter or the office did something really well together, highlight it so everyone has a sense of accomplishment. If a patient compliments a medical assistant or raves about a nurse, share those compliments with the employees so that not every encounter you have calls out problems and staff missteps.
Suppose partners have a conflict with one another or are arguing over something. In that case, you may need to mediate or invest in a meaningful intervention so people can reflect on the narrative they’re contributing to the culture.
5. Practice self-care
Finally, the work of a physician is exhausting, so it’s crucial to practice personal TLC. That may mean taking micro breaks, getting adequate sleep, maintaining a healthy diet, and exercising well and managing stress to maintain energy levels and patience.
“Sometimes, when I’m fed up with the office, I need to get away,” Dr. Montgomery says. “I’ll take a day to go fishing, golfing, and not think about the office.” Just a small break can shift the lens that you see through when you return to the office and put problems in perspective.
A version of this article first appeared on Medscape.com.
Surgery may worsen pleural mesothelioma survival outcomes
Pleural mesothelioma is generally treated by extended pleurectomy decortication, and there has been little improvement in systemic treatment of early-stage, resectable mesothelioma, which has led to the recommendations of maximum cytoreduction. U.S. and European guidelines, as well as an international consensus statement, support this approach, but it has never been tested in a randomized, controlled trial.
Now it has, and the result is surprising: MARS2 trial at the annual World Conference on Lung Cancer. “Ladies and gentlemen, as a surgeon standing here, you have no idea how much it pains me to conclude that extended pleurectomy decortication, an operation that we have been offering for over 70 years, has been associated with a higher risk of death, more serious complications, poorer quality of life, and higher costs, compared to mesothelioma patients who were randomized to chemotherapy alone,” said Dr. Lim of the Royal Brompton Hospital, London, during his presentation.
Although the line drew laughter and applause from the audience, Paula Ugalde Figueroa, MD, who served as a discussant, raised some concerns about the study. Disease presence in one hemithorax was assessed only by chest CT scan, which is notorious for underestimating the volume of disease during surgery. There was also no information on pleural effusion or how many patients received it prior to intervention. Existing guidelines suggest staging of mesothelioma should also use PET scans, and invasive mediastinal staging should be assessed with endobronchial ultrasound. “None of these were performed during the trial,” said Dr. Figueroa, who is an associate thoracic surgeon at Brigham and Women’s Hospital, Boston. “At this point, my question is, are the arms of this study well balanced in regard to tumor volume? We don’t know,” she added.
Dr. Figueroa noted that the 90-day mortality seemed higher than that seen in other studies. “So, does the surgeon’s experience and center volume affect the outcome of this study?” she asked. Dr. Figueroa personally made phone calls to the participating centers and found that 45% of the patients in the trial were treated at low-volume centers, defined by her as two to three patients per year. “Should we assume that their surgical outcomes are similar between those centers? In this trial, with approximately half of patients from low-volume centers, extended pleurectomy decortication for mesothelioma had no significant difference when compared to those patients that underwent chemotherapy alone. Would the outcome be different in exclusively high-volume centers?” she concluded.
The study randomized 335 patients to receive surgery and chemotherapy, or chemotherapy alone. They received two cycles of platinum-based chemotherapy and pemetrexed prior to surgery and up to four cycles after surgery. The average age was 69 years; 86.9% were male, and 85.7% of tumors were epithelioid only. Among those in the surgery group, 88.5% underwent extended pleurectomy/decortication, 8.3% underwent pleurectomy decortication, 1.9% underwent partial pleurectomy, 0.6% exploration with no pleurodesis, and 0.6% were classified as “other” surgery. Completeness of resection was R0 in 3.2% of surgeries, R1 in 80.9%, and R2 in 15.9%. In-hospital mortality occurred in 3.8% of patients, and postsurgical 90-day mortality was 8.9%.
Over the first 42 months of follow-up, the hazard ratio for overall survival was 1.28 in the no-surgery group (P = .03). “The survival was so good in this early-stage cohort that we had to extend the trial by 6 months to get the prerequisite number of deaths, underscoring the phenomenal importance of having a randomized comparative cohort for all future studies on surgery for mesothelioma,” said Dr. Lim.
After 42 months, there was no survival difference between the two groups (hazard ratio, 0.48; P = .15). Dr. Lim attributed the change at 42 months to the fact that only 15 patients remained in each arm at that stage. There was no significant difference between the two groups with respect to progression-free survival.
The survival benefit of the no-surgery group was sustained after additional analyses, including adjustment of the number of first-line chemotherapy cycles and immunotherapy received after completion of the trial protocol.
Adverse events were more common in the surgery group (incidence rate ratio, 3.6; P < .001), including any cardiac disorder (IRR, 2.73; 95% confidence interval, 1.11-6.67); any infection or infestation (IRR, 1.99; 95% CI, 1.33-2.99); any respiratory, thoracic, or mediastinal disorder (IRR, 2.40; 95% CI, 1.52-3.80); and any surgical or medical procedure (IRR, 2.23; 95% CI, 1.04-4.78). The EORTC quality of life score favored the nonsurgery group at 6 weeks, but there was no significant difference at other time points.
Dr. Lim and Dr. Figueroa have no relevant financial disclosures.
Pleural mesothelioma is generally treated by extended pleurectomy decortication, and there has been little improvement in systemic treatment of early-stage, resectable mesothelioma, which has led to the recommendations of maximum cytoreduction. U.S. and European guidelines, as well as an international consensus statement, support this approach, but it has never been tested in a randomized, controlled trial.
Now it has, and the result is surprising: MARS2 trial at the annual World Conference on Lung Cancer. “Ladies and gentlemen, as a surgeon standing here, you have no idea how much it pains me to conclude that extended pleurectomy decortication, an operation that we have been offering for over 70 years, has been associated with a higher risk of death, more serious complications, poorer quality of life, and higher costs, compared to mesothelioma patients who were randomized to chemotherapy alone,” said Dr. Lim of the Royal Brompton Hospital, London, during his presentation.
Although the line drew laughter and applause from the audience, Paula Ugalde Figueroa, MD, who served as a discussant, raised some concerns about the study. Disease presence in one hemithorax was assessed only by chest CT scan, which is notorious for underestimating the volume of disease during surgery. There was also no information on pleural effusion or how many patients received it prior to intervention. Existing guidelines suggest staging of mesothelioma should also use PET scans, and invasive mediastinal staging should be assessed with endobronchial ultrasound. “None of these were performed during the trial,” said Dr. Figueroa, who is an associate thoracic surgeon at Brigham and Women’s Hospital, Boston. “At this point, my question is, are the arms of this study well balanced in regard to tumor volume? We don’t know,” she added.
Dr. Figueroa noted that the 90-day mortality seemed higher than that seen in other studies. “So, does the surgeon’s experience and center volume affect the outcome of this study?” she asked. Dr. Figueroa personally made phone calls to the participating centers and found that 45% of the patients in the trial were treated at low-volume centers, defined by her as two to three patients per year. “Should we assume that their surgical outcomes are similar between those centers? In this trial, with approximately half of patients from low-volume centers, extended pleurectomy decortication for mesothelioma had no significant difference when compared to those patients that underwent chemotherapy alone. Would the outcome be different in exclusively high-volume centers?” she concluded.
The study randomized 335 patients to receive surgery and chemotherapy, or chemotherapy alone. They received two cycles of platinum-based chemotherapy and pemetrexed prior to surgery and up to four cycles after surgery. The average age was 69 years; 86.9% were male, and 85.7% of tumors were epithelioid only. Among those in the surgery group, 88.5% underwent extended pleurectomy/decortication, 8.3% underwent pleurectomy decortication, 1.9% underwent partial pleurectomy, 0.6% exploration with no pleurodesis, and 0.6% were classified as “other” surgery. Completeness of resection was R0 in 3.2% of surgeries, R1 in 80.9%, and R2 in 15.9%. In-hospital mortality occurred in 3.8% of patients, and postsurgical 90-day mortality was 8.9%.
Over the first 42 months of follow-up, the hazard ratio for overall survival was 1.28 in the no-surgery group (P = .03). “The survival was so good in this early-stage cohort that we had to extend the trial by 6 months to get the prerequisite number of deaths, underscoring the phenomenal importance of having a randomized comparative cohort for all future studies on surgery for mesothelioma,” said Dr. Lim.
After 42 months, there was no survival difference between the two groups (hazard ratio, 0.48; P = .15). Dr. Lim attributed the change at 42 months to the fact that only 15 patients remained in each arm at that stage. There was no significant difference between the two groups with respect to progression-free survival.
The survival benefit of the no-surgery group was sustained after additional analyses, including adjustment of the number of first-line chemotherapy cycles and immunotherapy received after completion of the trial protocol.
Adverse events were more common in the surgery group (incidence rate ratio, 3.6; P < .001), including any cardiac disorder (IRR, 2.73; 95% confidence interval, 1.11-6.67); any infection or infestation (IRR, 1.99; 95% CI, 1.33-2.99); any respiratory, thoracic, or mediastinal disorder (IRR, 2.40; 95% CI, 1.52-3.80); and any surgical or medical procedure (IRR, 2.23; 95% CI, 1.04-4.78). The EORTC quality of life score favored the nonsurgery group at 6 weeks, but there was no significant difference at other time points.
Dr. Lim and Dr. Figueroa have no relevant financial disclosures.
Pleural mesothelioma is generally treated by extended pleurectomy decortication, and there has been little improvement in systemic treatment of early-stage, resectable mesothelioma, which has led to the recommendations of maximum cytoreduction. U.S. and European guidelines, as well as an international consensus statement, support this approach, but it has never been tested in a randomized, controlled trial.
Now it has, and the result is surprising: MARS2 trial at the annual World Conference on Lung Cancer. “Ladies and gentlemen, as a surgeon standing here, you have no idea how much it pains me to conclude that extended pleurectomy decortication, an operation that we have been offering for over 70 years, has been associated with a higher risk of death, more serious complications, poorer quality of life, and higher costs, compared to mesothelioma patients who were randomized to chemotherapy alone,” said Dr. Lim of the Royal Brompton Hospital, London, during his presentation.
Although the line drew laughter and applause from the audience, Paula Ugalde Figueroa, MD, who served as a discussant, raised some concerns about the study. Disease presence in one hemithorax was assessed only by chest CT scan, which is notorious for underestimating the volume of disease during surgery. There was also no information on pleural effusion or how many patients received it prior to intervention. Existing guidelines suggest staging of mesothelioma should also use PET scans, and invasive mediastinal staging should be assessed with endobronchial ultrasound. “None of these were performed during the trial,” said Dr. Figueroa, who is an associate thoracic surgeon at Brigham and Women’s Hospital, Boston. “At this point, my question is, are the arms of this study well balanced in regard to tumor volume? We don’t know,” she added.
Dr. Figueroa noted that the 90-day mortality seemed higher than that seen in other studies. “So, does the surgeon’s experience and center volume affect the outcome of this study?” she asked. Dr. Figueroa personally made phone calls to the participating centers and found that 45% of the patients in the trial were treated at low-volume centers, defined by her as two to three patients per year. “Should we assume that their surgical outcomes are similar between those centers? In this trial, with approximately half of patients from low-volume centers, extended pleurectomy decortication for mesothelioma had no significant difference when compared to those patients that underwent chemotherapy alone. Would the outcome be different in exclusively high-volume centers?” she concluded.
The study randomized 335 patients to receive surgery and chemotherapy, or chemotherapy alone. They received two cycles of platinum-based chemotherapy and pemetrexed prior to surgery and up to four cycles after surgery. The average age was 69 years; 86.9% were male, and 85.7% of tumors were epithelioid only. Among those in the surgery group, 88.5% underwent extended pleurectomy/decortication, 8.3% underwent pleurectomy decortication, 1.9% underwent partial pleurectomy, 0.6% exploration with no pleurodesis, and 0.6% were classified as “other” surgery. Completeness of resection was R0 in 3.2% of surgeries, R1 in 80.9%, and R2 in 15.9%. In-hospital mortality occurred in 3.8% of patients, and postsurgical 90-day mortality was 8.9%.
Over the first 42 months of follow-up, the hazard ratio for overall survival was 1.28 in the no-surgery group (P = .03). “The survival was so good in this early-stage cohort that we had to extend the trial by 6 months to get the prerequisite number of deaths, underscoring the phenomenal importance of having a randomized comparative cohort for all future studies on surgery for mesothelioma,” said Dr. Lim.
After 42 months, there was no survival difference between the two groups (hazard ratio, 0.48; P = .15). Dr. Lim attributed the change at 42 months to the fact that only 15 patients remained in each arm at that stage. There was no significant difference between the two groups with respect to progression-free survival.
The survival benefit of the no-surgery group was sustained after additional analyses, including adjustment of the number of first-line chemotherapy cycles and immunotherapy received after completion of the trial protocol.
Adverse events were more common in the surgery group (incidence rate ratio, 3.6; P < .001), including any cardiac disorder (IRR, 2.73; 95% confidence interval, 1.11-6.67); any infection or infestation (IRR, 1.99; 95% CI, 1.33-2.99); any respiratory, thoracic, or mediastinal disorder (IRR, 2.40; 95% CI, 1.52-3.80); and any surgical or medical procedure (IRR, 2.23; 95% CI, 1.04-4.78). The EORTC quality of life score favored the nonsurgery group at 6 weeks, but there was no significant difference at other time points.
Dr. Lim and Dr. Figueroa have no relevant financial disclosures.
FROM WCLC 2023
12 steps to closing your practice without problems
Whether you’ve decided to retire, relocate, or work for your local hospital, unwinding your practice will take time.
“Doctors shouldn’t assume everything takes care of itself. Many don’t think about compliance issues, patient abandonment, or accounts receivable that they need to keep open to collect from billing, which can occur months after the dates of service,” said David Zetter, president of Zetter HealthCare management consultants in Pennsylvania.
Debra Phairas, president of Practice and Liability Consultants, LLC, in California, suggests doctors start planning for the closing of their practice at least 90-120 days from their closing date.
“Many people and entities need to be notified,” said Ms. Phairas. The list includes patients, payers, vendors, employees, licensing boards, and federal and state agencies.
Medical societies may have specific bylaws that apply; malpractice carriers have rules about how long you should retain medical records; and some state laws require that you communicate that you’re closing in a newspaper, Mr. Zetter added.
Ms. Phairas recommends that physicians decide first whether they will sell their practice or if they’ll just shut it down. If they sell and the buyer is a doctor, they may want to provide transition assistance such as introducing patients and staff, she said. Otherwise, doctors may need to terminate their staff.
After doctors make that decision, Mr. Zetter and Ms. Phairas recommend taking these 12 steps to ensure that the process goes smoothly.
What to do 60-90 days out
1. Check your insurance contracts. The Centers for Medicare & Medicaid Services requires physicians to notify them 90 days after deciding to retire or withdraw from Medicare or Medicaid. Other payers may also require 90 days’ notice to terminate their contracts.
You’ll also need to provide payers with a forwarding address for sending payments after the office closes, and notify your malpractice insurance carrier and any other contracted insurance carriers such as workers’ compensation or employee benefit plans.
2. Buy “tail” coverage. Doctors can be sued for malpractice years after they close their practice so this provides coverage against claims reported after the liability policy expires.
3. Check your hospital contracts. Most hospitals where you have privileges require 90 days’ notice that you are closing the practice.
4. Arrange for safe storage of medical records. If you are selling your practice to another physician, that doctor can take charge of them, as long as you obtain a patient’s consent to transfer the medical records, said Ms. Phairas. Otherwise, the practice is required to make someone the guardian of the records after the practice closes, said Mr. Zetter. This allows patients at a later date to obtain copies of their records at a cost.
“This usually means printing all the records to PDF to be retained; otherwise, doctors have to continue to pay the license fee for the EMR software to access the records, and no practice is going to continue to pay this indefinitely,” said Mr. Zetter.
Check with your malpractice insurance carrier for how long they require medical records to be retained, which may vary for adult and pediatric records.
Ms. Phairas also advises doctors to keep their original records. “The biggest mistake doctors can make is to give patients all their records. Your chart is your best defense weapon in a liability claim.”
What to do 30-60 days out
5. Tell your staff. They should not hear that you’re retiring or leaving the practice from other people, said Ms. Phairas. But timing is important. “If you notify them too soon, they may look for another job. I recommend telling them about 45 days out and just before you notify patients, although you may want to tell the office manager sooner.”
Doctors may need help closing the practice and should consider offering the employees a severance bonus to stay until the end, said Ms. Phairas. If they do leave sooner, then you can hire temporary staff.
6. Notify patients to avoid any claims of abandonment. You should notify all active patients, which, depending on your state, can be any patient the physician has treated sometime in the past 12-36 months.
Some state laws require the notice to be published as an advertisement in the local newspaper and will say how far in advance it needs to be published and how long the ad needs to run. Notification also should be posted throughout the practice, and patients who call or visit should be given oral reminders.
“Your biggest expense will be mailing a letter to all patients,” said Mr. Zetter. The letter should include:
- The date of closing.
- The name(s) of the physicians taking over the practice (if applicable).
- Local physicians who would be willing to accept new patients.
- Instructions for how patients can obtain or transfer medical records (with a deadline for submitting record requests).
- How to contact the practice if patients and families have any concerns about the closing.
7. Notify your professional associations. These include your state medical board, credentialing organizations, and professional memberships. It’s critical to renew your license even if you plan to practice in other states. He recalled that one doctor let his license lapse and the medical board notified Medicaid that he was no longer licensed. “CMS went after him because he didn’t notify them that he was no longer operating in Washington. CMS shut him down in every state/territory. This interventional radiologist spent 3 years with two attorneys to get it resolved,” said Mr. Zetter.
8. Terminate any leases with landlords or try to negotiate renting the office space on a month-to-month basis until you close or sell, suggests Ms. Phairas. If the practice owns the space, the partners will need to decide if the space will be sold or leased to a new business.
What to do 30 days out
9. Notify referring physicians of when you plan to close your practice so they don’t send new patients after that date.
10. Send a letter to the Drug Enforcement Agency to deactivate your license if you plan not to write another prescription and after you have safely disposed of prescription drugs following the federal guidelines. Destroy all prescription pads and contact drug representatives to determine what to do with unused samples, if needed.
11. Notify all vendors. Inform medical suppliers, office suppliers, collection agencies, laundry services, housekeeping services, hazardous waste disposal services, and any other vendors. Make sure to request a final statement from them so you can close out your accounts.
12. Process your accounts receivable to collect money owed to you. Consider employing a collection agency or staff member to reconcile accounts after the practice has closed.
Mr. Zetter also suggested retaining a certified accountant to handle the expenses for shutting down the business and to handle your future tax returns. “If you shut down the practice in 2023, you will still have to file a tax return for that year in 2024,” he said.
A version of this article first appeared on Medscape.com.
Whether you’ve decided to retire, relocate, or work for your local hospital, unwinding your practice will take time.
“Doctors shouldn’t assume everything takes care of itself. Many don’t think about compliance issues, patient abandonment, or accounts receivable that they need to keep open to collect from billing, which can occur months after the dates of service,” said David Zetter, president of Zetter HealthCare management consultants in Pennsylvania.
Debra Phairas, president of Practice and Liability Consultants, LLC, in California, suggests doctors start planning for the closing of their practice at least 90-120 days from their closing date.
“Many people and entities need to be notified,” said Ms. Phairas. The list includes patients, payers, vendors, employees, licensing boards, and federal and state agencies.
Medical societies may have specific bylaws that apply; malpractice carriers have rules about how long you should retain medical records; and some state laws require that you communicate that you’re closing in a newspaper, Mr. Zetter added.
Ms. Phairas recommends that physicians decide first whether they will sell their practice or if they’ll just shut it down. If they sell and the buyer is a doctor, they may want to provide transition assistance such as introducing patients and staff, she said. Otherwise, doctors may need to terminate their staff.
After doctors make that decision, Mr. Zetter and Ms. Phairas recommend taking these 12 steps to ensure that the process goes smoothly.
What to do 60-90 days out
1. Check your insurance contracts. The Centers for Medicare & Medicaid Services requires physicians to notify them 90 days after deciding to retire or withdraw from Medicare or Medicaid. Other payers may also require 90 days’ notice to terminate their contracts.
You’ll also need to provide payers with a forwarding address for sending payments after the office closes, and notify your malpractice insurance carrier and any other contracted insurance carriers such as workers’ compensation or employee benefit plans.
2. Buy “tail” coverage. Doctors can be sued for malpractice years after they close their practice so this provides coverage against claims reported after the liability policy expires.
3. Check your hospital contracts. Most hospitals where you have privileges require 90 days’ notice that you are closing the practice.
4. Arrange for safe storage of medical records. If you are selling your practice to another physician, that doctor can take charge of them, as long as you obtain a patient’s consent to transfer the medical records, said Ms. Phairas. Otherwise, the practice is required to make someone the guardian of the records after the practice closes, said Mr. Zetter. This allows patients at a later date to obtain copies of their records at a cost.
“This usually means printing all the records to PDF to be retained; otherwise, doctors have to continue to pay the license fee for the EMR software to access the records, and no practice is going to continue to pay this indefinitely,” said Mr. Zetter.
Check with your malpractice insurance carrier for how long they require medical records to be retained, which may vary for adult and pediatric records.
Ms. Phairas also advises doctors to keep their original records. “The biggest mistake doctors can make is to give patients all their records. Your chart is your best defense weapon in a liability claim.”
What to do 30-60 days out
5. Tell your staff. They should not hear that you’re retiring or leaving the practice from other people, said Ms. Phairas. But timing is important. “If you notify them too soon, they may look for another job. I recommend telling them about 45 days out and just before you notify patients, although you may want to tell the office manager sooner.”
Doctors may need help closing the practice and should consider offering the employees a severance bonus to stay until the end, said Ms. Phairas. If they do leave sooner, then you can hire temporary staff.
6. Notify patients to avoid any claims of abandonment. You should notify all active patients, which, depending on your state, can be any patient the physician has treated sometime in the past 12-36 months.
Some state laws require the notice to be published as an advertisement in the local newspaper and will say how far in advance it needs to be published and how long the ad needs to run. Notification also should be posted throughout the practice, and patients who call or visit should be given oral reminders.
“Your biggest expense will be mailing a letter to all patients,” said Mr. Zetter. The letter should include:
- The date of closing.
- The name(s) of the physicians taking over the practice (if applicable).
- Local physicians who would be willing to accept new patients.
- Instructions for how patients can obtain or transfer medical records (with a deadline for submitting record requests).
- How to contact the practice if patients and families have any concerns about the closing.
7. Notify your professional associations. These include your state medical board, credentialing organizations, and professional memberships. It’s critical to renew your license even if you plan to practice in other states. He recalled that one doctor let his license lapse and the medical board notified Medicaid that he was no longer licensed. “CMS went after him because he didn’t notify them that he was no longer operating in Washington. CMS shut him down in every state/territory. This interventional radiologist spent 3 years with two attorneys to get it resolved,” said Mr. Zetter.
8. Terminate any leases with landlords or try to negotiate renting the office space on a month-to-month basis until you close or sell, suggests Ms. Phairas. If the practice owns the space, the partners will need to decide if the space will be sold or leased to a new business.
What to do 30 days out
9. Notify referring physicians of when you plan to close your practice so they don’t send new patients after that date.
10. Send a letter to the Drug Enforcement Agency to deactivate your license if you plan not to write another prescription and after you have safely disposed of prescription drugs following the federal guidelines. Destroy all prescription pads and contact drug representatives to determine what to do with unused samples, if needed.
11. Notify all vendors. Inform medical suppliers, office suppliers, collection agencies, laundry services, housekeeping services, hazardous waste disposal services, and any other vendors. Make sure to request a final statement from them so you can close out your accounts.
12. Process your accounts receivable to collect money owed to you. Consider employing a collection agency or staff member to reconcile accounts after the practice has closed.
Mr. Zetter also suggested retaining a certified accountant to handle the expenses for shutting down the business and to handle your future tax returns. “If you shut down the practice in 2023, you will still have to file a tax return for that year in 2024,” he said.
A version of this article first appeared on Medscape.com.
Whether you’ve decided to retire, relocate, or work for your local hospital, unwinding your practice will take time.
“Doctors shouldn’t assume everything takes care of itself. Many don’t think about compliance issues, patient abandonment, or accounts receivable that they need to keep open to collect from billing, which can occur months after the dates of service,” said David Zetter, president of Zetter HealthCare management consultants in Pennsylvania.
Debra Phairas, president of Practice and Liability Consultants, LLC, in California, suggests doctors start planning for the closing of their practice at least 90-120 days from their closing date.
“Many people and entities need to be notified,” said Ms. Phairas. The list includes patients, payers, vendors, employees, licensing boards, and federal and state agencies.
Medical societies may have specific bylaws that apply; malpractice carriers have rules about how long you should retain medical records; and some state laws require that you communicate that you’re closing in a newspaper, Mr. Zetter added.
Ms. Phairas recommends that physicians decide first whether they will sell their practice or if they’ll just shut it down. If they sell and the buyer is a doctor, they may want to provide transition assistance such as introducing patients and staff, she said. Otherwise, doctors may need to terminate their staff.
After doctors make that decision, Mr. Zetter and Ms. Phairas recommend taking these 12 steps to ensure that the process goes smoothly.
What to do 60-90 days out
1. Check your insurance contracts. The Centers for Medicare & Medicaid Services requires physicians to notify them 90 days after deciding to retire or withdraw from Medicare or Medicaid. Other payers may also require 90 days’ notice to terminate their contracts.
You’ll also need to provide payers with a forwarding address for sending payments after the office closes, and notify your malpractice insurance carrier and any other contracted insurance carriers such as workers’ compensation or employee benefit plans.
2. Buy “tail” coverage. Doctors can be sued for malpractice years after they close their practice so this provides coverage against claims reported after the liability policy expires.
3. Check your hospital contracts. Most hospitals where you have privileges require 90 days’ notice that you are closing the practice.
4. Arrange for safe storage of medical records. If you are selling your practice to another physician, that doctor can take charge of them, as long as you obtain a patient’s consent to transfer the medical records, said Ms. Phairas. Otherwise, the practice is required to make someone the guardian of the records after the practice closes, said Mr. Zetter. This allows patients at a later date to obtain copies of their records at a cost.
“This usually means printing all the records to PDF to be retained; otherwise, doctors have to continue to pay the license fee for the EMR software to access the records, and no practice is going to continue to pay this indefinitely,” said Mr. Zetter.
Check with your malpractice insurance carrier for how long they require medical records to be retained, which may vary for adult and pediatric records.
Ms. Phairas also advises doctors to keep their original records. “The biggest mistake doctors can make is to give patients all their records. Your chart is your best defense weapon in a liability claim.”
What to do 30-60 days out
5. Tell your staff. They should not hear that you’re retiring or leaving the practice from other people, said Ms. Phairas. But timing is important. “If you notify them too soon, they may look for another job. I recommend telling them about 45 days out and just before you notify patients, although you may want to tell the office manager sooner.”
Doctors may need help closing the practice and should consider offering the employees a severance bonus to stay until the end, said Ms. Phairas. If they do leave sooner, then you can hire temporary staff.
6. Notify patients to avoid any claims of abandonment. You should notify all active patients, which, depending on your state, can be any patient the physician has treated sometime in the past 12-36 months.
Some state laws require the notice to be published as an advertisement in the local newspaper and will say how far in advance it needs to be published and how long the ad needs to run. Notification also should be posted throughout the practice, and patients who call or visit should be given oral reminders.
“Your biggest expense will be mailing a letter to all patients,” said Mr. Zetter. The letter should include:
- The date of closing.
- The name(s) of the physicians taking over the practice (if applicable).
- Local physicians who would be willing to accept new patients.
- Instructions for how patients can obtain or transfer medical records (with a deadline for submitting record requests).
- How to contact the practice if patients and families have any concerns about the closing.
7. Notify your professional associations. These include your state medical board, credentialing organizations, and professional memberships. It’s critical to renew your license even if you plan to practice in other states. He recalled that one doctor let his license lapse and the medical board notified Medicaid that he was no longer licensed. “CMS went after him because he didn’t notify them that he was no longer operating in Washington. CMS shut him down in every state/territory. This interventional radiologist spent 3 years with two attorneys to get it resolved,” said Mr. Zetter.
8. Terminate any leases with landlords or try to negotiate renting the office space on a month-to-month basis until you close or sell, suggests Ms. Phairas. If the practice owns the space, the partners will need to decide if the space will be sold or leased to a new business.
What to do 30 days out
9. Notify referring physicians of when you plan to close your practice so they don’t send new patients after that date.
10. Send a letter to the Drug Enforcement Agency to deactivate your license if you plan not to write another prescription and after you have safely disposed of prescription drugs following the federal guidelines. Destroy all prescription pads and contact drug representatives to determine what to do with unused samples, if needed.
11. Notify all vendors. Inform medical suppliers, office suppliers, collection agencies, laundry services, housekeeping services, hazardous waste disposal services, and any other vendors. Make sure to request a final statement from them so you can close out your accounts.
12. Process your accounts receivable to collect money owed to you. Consider employing a collection agency or staff member to reconcile accounts after the practice has closed.
Mr. Zetter also suggested retaining a certified accountant to handle the expenses for shutting down the business and to handle your future tax returns. “If you shut down the practice in 2023, you will still have to file a tax return for that year in 2024,” he said.
A version of this article first appeared on Medscape.com.
Disenfranchised grief: What it looks like, where it goes
What happens to grief when those around you don’t understand it? Where does it go? How do you process it?
Disenfranchised grief, when someone or society more generally doesn’t see a loss as worthy of mourning, can deprive people of experiencing or processing their sadness. This grief, which may be triggered by the death of an ex-spouse, a pet, a failed adoption, can be painful and long-lasting.
Suzanne Cole, MD: ‘I didn’t feel the right to grieve’
During the COVID-19 pandemic, my little sister unexpectedly died. Though she was not one of the nearly 7 million people who died of the virus, in 2021 she became another type of statistic: one of the 109,699 people in the United State who died from a drug overdose. Hers was from fentanyl laced with methamphetamines.
Her death unraveled me. I felt deep guilt that I could not pull her from the sweeping current that had wrenched her from mainstream society into the underbelly of sex work and toward the solace of mind-altering drugs.
But I did not feel the right to grieve for her as I have grieved for other loved ones who were not blamed for their exit from this world. My sister was living a sordid life on the fringes of society. My grief felt invalid, undeserved. Yet, in the eyes of other “upstanding citizens,” her life was not as worth grieving – or so I thought. I tucked my sorrow into a small corner of my soul so no one would see, and I carried on.
To this day, the shame I feel robbed me of the ability to freely talk about her or share the searing pain I feel. Tears still prick my eyes when I think of her, but I have become adept at swallowing them, shaking off the waves of grief as though nothing happened. Even now, I cannot shake the pervasive feeling that my silent tears don’t deserve to be wept.
Don S. Dizon, MD: Working through tragedy
As a medical student, I worked with an outpatient physician as part of a third-year rotation. When we met, the first thing that struck me was how disheveled he looked. His clothes were wrinkled, and his pants were baggy. He took cigarette breaks, which I found disturbing.
But I quickly came to admire him. Despite my first impression, he was the type of doctor I aspired to be. He didn’t need to look at a patient’s chart to recall who they were. He just knew them. He greeted patients warmly, asked about their family. He even remembered the special occasions his patients had mentioned since their past visit. He epitomized empathy and connectedness.
Spending one day in clinic brought to light the challenges of forming such bonds with patients. A man came into the cancer clinic reporting chest pain and was triaged to an exam room. Soon after, the patient was found unresponsive on the floor. Nurses were yelling for help, and the doctor ran in and started CPR while minutes ticked by waiting for an ambulance that could take him to the ED.
By the time help arrived, the patient was blue.
He had died in the clinic in the middle of the day, as the waiting room filled. After the body was taken away, the doctor went into the bathroom. About 20 minutes later, he came out, eyes bloodshot, and continued with the rest of his day, ensuring each patient was seen and cared for.
As a medical student, it hit me how hard it must be to see something so tragic like the end of a life and then continue with your day as if nothing had happened. This is an experience of grief I later came to know well after nearly 30 years treating patients with advanced cancers: compartmentalizing it and carrying on.
A space for grieving: The Schwartz Center Rounds
Disenfranchised grief, the grief that is hard to share and often seems wrong to feel in the first place, can be triggered in many situations. Losing a person others don’t believe deserve to be grieved, such as an abusive partner or someone who committed a crime; losing someone you cared for in a professional role; a loss experienced in a breakup or same-sex partnership, if that relationship was not accepted by one’s family; loss from infertility, miscarriage, stillbirth, or failed adoption; loss that may be taboo or stigmatized, such as deaths via suicide or abortion; and loss of a job, home, or possession that you treasure.
Many of us have had similar situations or will, and the feeling that no one understands the need to mourn can be paralyzing and alienating. In the early days, intense, crushing feelings can cause intrusive, distracting thoughts, and over time, that grief can linger and find a permanent place in our minds.
More and more, though, we are being given opportunities to reflect on these sad moments.
The Schwartz Rounds are an example of such an opportunity. In these rounds, we gather to talk about the experience of caring for people, not the science of medicine.
During one particularly powerful rounds, I spoke to my colleagues about my initial meeting with a patient who was very sick. I detailed the experience of telling her children and her at that initial consult how I thought she was dying and that I did not recommend therapy. I remember how they cried. And I remembered how powerless I felt.
As I recalled that memory during Schwartz Rounds, I could not stop from crying. The unfairness of being a physician meeting someone for the first time and having to tell them such bad news overwhelmed me.
Even more poignant, I had the chance to reconnect with this woman’s children, who were present that day, not as audience members but as participants. Their presence may have brought my emotions to the surface more strongly. In that moment, I could show them the feelings I had bottled up for the sake of professionalism. Ultimately, I felt relieved, freer somehow, as if this burden my soul was carrying had been lifted.
Although we are both grateful for forums like this, these opportunities to share and express the grief we may have hidden away are not as common as they should be.
As physicians, we may express grief by shedding tears at the bedside of a patient nearing the end of life or through the anxiety we feel when our patient suffers a severe reaction to treatment. But we tend to put it away, to go on with our day, because there are others to be seen and cared for and more work to be done. Somehow, we move forward, shedding tears in one room and celebrating victories in another.
We need to create more spaces to express and feel grief, so we don’t get lost in it. Because understanding how grief impacts us, as people and as providers, is one of the most important realizations we can make as we go about our time-honored profession as healers.
Dr. Dizon is the director of women’s cancers at Lifespan Cancer Institute, director of medical oncology at Rhode Island Hospital, and a professor of medicine at Brown University, all in Providence. He reported conflicts of interest with Regeneron, AstraZeneca, Clovis, Bristol-Myers Squibb, and Kazia.
A version of this article first appeared on Medscape.com.
What happens to grief when those around you don’t understand it? Where does it go? How do you process it?
Disenfranchised grief, when someone or society more generally doesn’t see a loss as worthy of mourning, can deprive people of experiencing or processing their sadness. This grief, which may be triggered by the death of an ex-spouse, a pet, a failed adoption, can be painful and long-lasting.
Suzanne Cole, MD: ‘I didn’t feel the right to grieve’
During the COVID-19 pandemic, my little sister unexpectedly died. Though she was not one of the nearly 7 million people who died of the virus, in 2021 she became another type of statistic: one of the 109,699 people in the United State who died from a drug overdose. Hers was from fentanyl laced with methamphetamines.
Her death unraveled me. I felt deep guilt that I could not pull her from the sweeping current that had wrenched her from mainstream society into the underbelly of sex work and toward the solace of mind-altering drugs.
But I did not feel the right to grieve for her as I have grieved for other loved ones who were not blamed for their exit from this world. My sister was living a sordid life on the fringes of society. My grief felt invalid, undeserved. Yet, in the eyes of other “upstanding citizens,” her life was not as worth grieving – or so I thought. I tucked my sorrow into a small corner of my soul so no one would see, and I carried on.
To this day, the shame I feel robbed me of the ability to freely talk about her or share the searing pain I feel. Tears still prick my eyes when I think of her, but I have become adept at swallowing them, shaking off the waves of grief as though nothing happened. Even now, I cannot shake the pervasive feeling that my silent tears don’t deserve to be wept.
Don S. Dizon, MD: Working through tragedy
As a medical student, I worked with an outpatient physician as part of a third-year rotation. When we met, the first thing that struck me was how disheveled he looked. His clothes were wrinkled, and his pants were baggy. He took cigarette breaks, which I found disturbing.
But I quickly came to admire him. Despite my first impression, he was the type of doctor I aspired to be. He didn’t need to look at a patient’s chart to recall who they were. He just knew them. He greeted patients warmly, asked about their family. He even remembered the special occasions his patients had mentioned since their past visit. He epitomized empathy and connectedness.
Spending one day in clinic brought to light the challenges of forming such bonds with patients. A man came into the cancer clinic reporting chest pain and was triaged to an exam room. Soon after, the patient was found unresponsive on the floor. Nurses were yelling for help, and the doctor ran in and started CPR while minutes ticked by waiting for an ambulance that could take him to the ED.
By the time help arrived, the patient was blue.
He had died in the clinic in the middle of the day, as the waiting room filled. After the body was taken away, the doctor went into the bathroom. About 20 minutes later, he came out, eyes bloodshot, and continued with the rest of his day, ensuring each patient was seen and cared for.
As a medical student, it hit me how hard it must be to see something so tragic like the end of a life and then continue with your day as if nothing had happened. This is an experience of grief I later came to know well after nearly 30 years treating patients with advanced cancers: compartmentalizing it and carrying on.
A space for grieving: The Schwartz Center Rounds
Disenfranchised grief, the grief that is hard to share and often seems wrong to feel in the first place, can be triggered in many situations. Losing a person others don’t believe deserve to be grieved, such as an abusive partner or someone who committed a crime; losing someone you cared for in a professional role; a loss experienced in a breakup or same-sex partnership, if that relationship was not accepted by one’s family; loss from infertility, miscarriage, stillbirth, or failed adoption; loss that may be taboo or stigmatized, such as deaths via suicide or abortion; and loss of a job, home, or possession that you treasure.
Many of us have had similar situations or will, and the feeling that no one understands the need to mourn can be paralyzing and alienating. In the early days, intense, crushing feelings can cause intrusive, distracting thoughts, and over time, that grief can linger and find a permanent place in our minds.
More and more, though, we are being given opportunities to reflect on these sad moments.
The Schwartz Rounds are an example of such an opportunity. In these rounds, we gather to talk about the experience of caring for people, not the science of medicine.
During one particularly powerful rounds, I spoke to my colleagues about my initial meeting with a patient who was very sick. I detailed the experience of telling her children and her at that initial consult how I thought she was dying and that I did not recommend therapy. I remember how they cried. And I remembered how powerless I felt.
As I recalled that memory during Schwartz Rounds, I could not stop from crying. The unfairness of being a physician meeting someone for the first time and having to tell them such bad news overwhelmed me.
Even more poignant, I had the chance to reconnect with this woman’s children, who were present that day, not as audience members but as participants. Their presence may have brought my emotions to the surface more strongly. In that moment, I could show them the feelings I had bottled up for the sake of professionalism. Ultimately, I felt relieved, freer somehow, as if this burden my soul was carrying had been lifted.
Although we are both grateful for forums like this, these opportunities to share and express the grief we may have hidden away are not as common as they should be.
As physicians, we may express grief by shedding tears at the bedside of a patient nearing the end of life or through the anxiety we feel when our patient suffers a severe reaction to treatment. But we tend to put it away, to go on with our day, because there are others to be seen and cared for and more work to be done. Somehow, we move forward, shedding tears in one room and celebrating victories in another.
We need to create more spaces to express and feel grief, so we don’t get lost in it. Because understanding how grief impacts us, as people and as providers, is one of the most important realizations we can make as we go about our time-honored profession as healers.
Dr. Dizon is the director of women’s cancers at Lifespan Cancer Institute, director of medical oncology at Rhode Island Hospital, and a professor of medicine at Brown University, all in Providence. He reported conflicts of interest with Regeneron, AstraZeneca, Clovis, Bristol-Myers Squibb, and Kazia.
A version of this article first appeared on Medscape.com.
What happens to grief when those around you don’t understand it? Where does it go? How do you process it?
Disenfranchised grief, when someone or society more generally doesn’t see a loss as worthy of mourning, can deprive people of experiencing or processing their sadness. This grief, which may be triggered by the death of an ex-spouse, a pet, a failed adoption, can be painful and long-lasting.
Suzanne Cole, MD: ‘I didn’t feel the right to grieve’
During the COVID-19 pandemic, my little sister unexpectedly died. Though she was not one of the nearly 7 million people who died of the virus, in 2021 she became another type of statistic: one of the 109,699 people in the United State who died from a drug overdose. Hers was from fentanyl laced with methamphetamines.
Her death unraveled me. I felt deep guilt that I could not pull her from the sweeping current that had wrenched her from mainstream society into the underbelly of sex work and toward the solace of mind-altering drugs.
But I did not feel the right to grieve for her as I have grieved for other loved ones who were not blamed for their exit from this world. My sister was living a sordid life on the fringes of society. My grief felt invalid, undeserved. Yet, in the eyes of other “upstanding citizens,” her life was not as worth grieving – or so I thought. I tucked my sorrow into a small corner of my soul so no one would see, and I carried on.
To this day, the shame I feel robbed me of the ability to freely talk about her or share the searing pain I feel. Tears still prick my eyes when I think of her, but I have become adept at swallowing them, shaking off the waves of grief as though nothing happened. Even now, I cannot shake the pervasive feeling that my silent tears don’t deserve to be wept.
Don S. Dizon, MD: Working through tragedy
As a medical student, I worked with an outpatient physician as part of a third-year rotation. When we met, the first thing that struck me was how disheveled he looked. His clothes were wrinkled, and his pants were baggy. He took cigarette breaks, which I found disturbing.
But I quickly came to admire him. Despite my first impression, he was the type of doctor I aspired to be. He didn’t need to look at a patient’s chart to recall who they were. He just knew them. He greeted patients warmly, asked about their family. He even remembered the special occasions his patients had mentioned since their past visit. He epitomized empathy and connectedness.
Spending one day in clinic brought to light the challenges of forming such bonds with patients. A man came into the cancer clinic reporting chest pain and was triaged to an exam room. Soon after, the patient was found unresponsive on the floor. Nurses were yelling for help, and the doctor ran in and started CPR while minutes ticked by waiting for an ambulance that could take him to the ED.
By the time help arrived, the patient was blue.
He had died in the clinic in the middle of the day, as the waiting room filled. After the body was taken away, the doctor went into the bathroom. About 20 minutes later, he came out, eyes bloodshot, and continued with the rest of his day, ensuring each patient was seen and cared for.
As a medical student, it hit me how hard it must be to see something so tragic like the end of a life and then continue with your day as if nothing had happened. This is an experience of grief I later came to know well after nearly 30 years treating patients with advanced cancers: compartmentalizing it and carrying on.
A space for grieving: The Schwartz Center Rounds
Disenfranchised grief, the grief that is hard to share and often seems wrong to feel in the first place, can be triggered in many situations. Losing a person others don’t believe deserve to be grieved, such as an abusive partner or someone who committed a crime; losing someone you cared for in a professional role; a loss experienced in a breakup or same-sex partnership, if that relationship was not accepted by one’s family; loss from infertility, miscarriage, stillbirth, or failed adoption; loss that may be taboo or stigmatized, such as deaths via suicide or abortion; and loss of a job, home, or possession that you treasure.
Many of us have had similar situations or will, and the feeling that no one understands the need to mourn can be paralyzing and alienating. In the early days, intense, crushing feelings can cause intrusive, distracting thoughts, and over time, that grief can linger and find a permanent place in our minds.
More and more, though, we are being given opportunities to reflect on these sad moments.
The Schwartz Rounds are an example of such an opportunity. In these rounds, we gather to talk about the experience of caring for people, not the science of medicine.
During one particularly powerful rounds, I spoke to my colleagues about my initial meeting with a patient who was very sick. I detailed the experience of telling her children and her at that initial consult how I thought she was dying and that I did not recommend therapy. I remember how they cried. And I remembered how powerless I felt.
As I recalled that memory during Schwartz Rounds, I could not stop from crying. The unfairness of being a physician meeting someone for the first time and having to tell them such bad news overwhelmed me.
Even more poignant, I had the chance to reconnect with this woman’s children, who were present that day, not as audience members but as participants. Their presence may have brought my emotions to the surface more strongly. In that moment, I could show them the feelings I had bottled up for the sake of professionalism. Ultimately, I felt relieved, freer somehow, as if this burden my soul was carrying had been lifted.
Although we are both grateful for forums like this, these opportunities to share and express the grief we may have hidden away are not as common as they should be.
As physicians, we may express grief by shedding tears at the bedside of a patient nearing the end of life or through the anxiety we feel when our patient suffers a severe reaction to treatment. But we tend to put it away, to go on with our day, because there are others to be seen and cared for and more work to be done. Somehow, we move forward, shedding tears in one room and celebrating victories in another.
We need to create more spaces to express and feel grief, so we don’t get lost in it. Because understanding how grief impacts us, as people and as providers, is one of the most important realizations we can make as we go about our time-honored profession as healers.
Dr. Dizon is the director of women’s cancers at Lifespan Cancer Institute, director of medical oncology at Rhode Island Hospital, and a professor of medicine at Brown University, all in Providence. He reported conflicts of interest with Regeneron, AstraZeneca, Clovis, Bristol-Myers Squibb, and Kazia.
A version of this article first appeared on Medscape.com.
Blueprint to curb postop opioids after pancreatic resection
TOPLINE:
Implementing a post-surgery protocol that has undergone incremental changes over time significantly reduced inpatient and discharge opioid volumes while maintaining pain control after pancreatic cancer surgery.
METHODOLOGY:
- To reduce opioid dependence, misuse, and diversion, Centers for Disease Control and Prevention guidelines emphasize strategies to minimize opioid prescribing for managing pain. Still, opioid prescribing following surgery remains common practice.
- In the current study,
- The study evaluated three sequential protocols implemented over a period of about 6 years, from 2016 to 2022.
- In the final version, a standardized three-drug nonopioid bundle (acetaminophen, celecoxib, and methocarbamol) was initiated intravenously in the recovery room, after which the patient was given oral agents on postoperative day 1.
- The primary outcome measure was inpatient and discharge opioid volume in oral morphine equivalents (OMEs) across the three pathways.
TAKEAWAY:
- Opioid use significantly decreased with each sequential pathway refinement.
- For inpatients, total OME decreased by more than 55% across the pathways from a median of 290 mg to 184 mg and finally to 129 mg (P < .001).
- Median discharge OME dropped from 150 mg to 25 mg and then to 0 mg across the pathways (P < .001).
- With the final version of the pathway, more than half of patients (52.5%) had opioid-free discharges, compared with only 7.2% in the first pathway. Pain scores remained stable at 3 or less; the number of postdischarge refill requests was unchanged.
IN PRACTICE:
“Our findings suggest that reduction of postoperative opioid dissemination through opioid-free discharge after pancreatectomy and other major cancer operations may be realistic and feasible by following this no-cost blueprint,” the authors concluded. In an accompanying editorial, Melissa Hogg, MD, from NorthShore University Health System in Evanston, Ill., said the “study inspired me to update our institution’s [early recovery after surgery] protocol to reduce and eliminate opioid prescriptions.”
SOURCE:
The study was led by Ching-Wei D. Tzeng, MD, of the University of Texas MD Anderson Cancer Center, Houston. It was published online in JAMA Surgery.
LIMITATIONS:
The study evaluated the opioid protocol at a single center, which may limit the generalizability of the findings. The researchers did not receive patient feedback on pain control expectations or postoperative quality of life.
DISCLOSURES:
Dr. Tzeng reported receiving consultant fees and a sponsored research agreement from PanTher outside the submitted work. Dr. Hogg reported receiving training and travel funds from Intuitive Money. No other disclosures or outside funding were reported.
A version of this article appeared on Medscape.com.
TOPLINE:
Implementing a post-surgery protocol that has undergone incremental changes over time significantly reduced inpatient and discharge opioid volumes while maintaining pain control after pancreatic cancer surgery.
METHODOLOGY:
- To reduce opioid dependence, misuse, and diversion, Centers for Disease Control and Prevention guidelines emphasize strategies to minimize opioid prescribing for managing pain. Still, opioid prescribing following surgery remains common practice.
- In the current study,
- The study evaluated three sequential protocols implemented over a period of about 6 years, from 2016 to 2022.
- In the final version, a standardized three-drug nonopioid bundle (acetaminophen, celecoxib, and methocarbamol) was initiated intravenously in the recovery room, after which the patient was given oral agents on postoperative day 1.
- The primary outcome measure was inpatient and discharge opioid volume in oral morphine equivalents (OMEs) across the three pathways.
TAKEAWAY:
- Opioid use significantly decreased with each sequential pathway refinement.
- For inpatients, total OME decreased by more than 55% across the pathways from a median of 290 mg to 184 mg and finally to 129 mg (P < .001).
- Median discharge OME dropped from 150 mg to 25 mg and then to 0 mg across the pathways (P < .001).
- With the final version of the pathway, more than half of patients (52.5%) had opioid-free discharges, compared with only 7.2% in the first pathway. Pain scores remained stable at 3 or less; the number of postdischarge refill requests was unchanged.
IN PRACTICE:
“Our findings suggest that reduction of postoperative opioid dissemination through opioid-free discharge after pancreatectomy and other major cancer operations may be realistic and feasible by following this no-cost blueprint,” the authors concluded. In an accompanying editorial, Melissa Hogg, MD, from NorthShore University Health System in Evanston, Ill., said the “study inspired me to update our institution’s [early recovery after surgery] protocol to reduce and eliminate opioid prescriptions.”
SOURCE:
The study was led by Ching-Wei D. Tzeng, MD, of the University of Texas MD Anderson Cancer Center, Houston. It was published online in JAMA Surgery.
LIMITATIONS:
The study evaluated the opioid protocol at a single center, which may limit the generalizability of the findings. The researchers did not receive patient feedback on pain control expectations or postoperative quality of life.
DISCLOSURES:
Dr. Tzeng reported receiving consultant fees and a sponsored research agreement from PanTher outside the submitted work. Dr. Hogg reported receiving training and travel funds from Intuitive Money. No other disclosures or outside funding were reported.
A version of this article appeared on Medscape.com.
TOPLINE:
Implementing a post-surgery protocol that has undergone incremental changes over time significantly reduced inpatient and discharge opioid volumes while maintaining pain control after pancreatic cancer surgery.
METHODOLOGY:
- To reduce opioid dependence, misuse, and diversion, Centers for Disease Control and Prevention guidelines emphasize strategies to minimize opioid prescribing for managing pain. Still, opioid prescribing following surgery remains common practice.
- In the current study,
- The study evaluated three sequential protocols implemented over a period of about 6 years, from 2016 to 2022.
- In the final version, a standardized three-drug nonopioid bundle (acetaminophen, celecoxib, and methocarbamol) was initiated intravenously in the recovery room, after which the patient was given oral agents on postoperative day 1.
- The primary outcome measure was inpatient and discharge opioid volume in oral morphine equivalents (OMEs) across the three pathways.
TAKEAWAY:
- Opioid use significantly decreased with each sequential pathway refinement.
- For inpatients, total OME decreased by more than 55% across the pathways from a median of 290 mg to 184 mg and finally to 129 mg (P < .001).
- Median discharge OME dropped from 150 mg to 25 mg and then to 0 mg across the pathways (P < .001).
- With the final version of the pathway, more than half of patients (52.5%) had opioid-free discharges, compared with only 7.2% in the first pathway. Pain scores remained stable at 3 or less; the number of postdischarge refill requests was unchanged.
IN PRACTICE:
“Our findings suggest that reduction of postoperative opioid dissemination through opioid-free discharge after pancreatectomy and other major cancer operations may be realistic and feasible by following this no-cost blueprint,” the authors concluded. In an accompanying editorial, Melissa Hogg, MD, from NorthShore University Health System in Evanston, Ill., said the “study inspired me to update our institution’s [early recovery after surgery] protocol to reduce and eliminate opioid prescriptions.”
SOURCE:
The study was led by Ching-Wei D. Tzeng, MD, of the University of Texas MD Anderson Cancer Center, Houston. It was published online in JAMA Surgery.
LIMITATIONS:
The study evaluated the opioid protocol at a single center, which may limit the generalizability of the findings. The researchers did not receive patient feedback on pain control expectations or postoperative quality of life.
DISCLOSURES:
Dr. Tzeng reported receiving consultant fees and a sponsored research agreement from PanTher outside the submitted work. Dr. Hogg reported receiving training and travel funds from Intuitive Money. No other disclosures or outside funding were reported.
A version of this article appeared on Medscape.com.
FROM JAMA SURGERY