The central role of informed consent in novel procedures

Mrs. Jones is a 44-year-old woman who has struggled with her weight. She has a body mass index (BMI) of 35 kg/m² and hypertension requiring daily medication. She has tried various diets over the years and has never been able to exercise consistently. She desperately wants to lose weight to improve her confidence and to avoid developing diabetes and dialysis that her parents required. She has considered weight loss surgery but is afraid after her best friend died following uterine fibroid surgery. She saw a billboard that advertised a new weight loss procedure without surgery. She looked up the procedure, found Dr. Indo on the university medical center’s website, and booked an appointment. Dr. Indo talked about performing an incisionless procedure done with an endoscope through her mouth. It would make her stomach into a tube to reduce the amount of food she could eat as well as prevent some absorption of food in her intestines. When Mrs. Jones asked how many of these the doctor had performed, Dr. Indo remarked she personally had done “several” in the past few years including training. Dr. Indo reassured Mrs. Jones that the procedure has been performed hundreds of times around the country and has been shown to be safe. Dr. Indo also explained that studies were still ongoing, including possibly at the university medical center, but that she had never personally seen any serious complications or death, and only one patient she knew of converted to a traditional bariatric surgery.

Obesity is a large international public health problem, with the World Health Organization estimating that there are 600 million obese adults worldwide.¹ Bariatric surgery has been an effective way to improve complications related to obesity and quality of life. Endoscopic approaches to bariatric surgery have appeared since at least the late 1980s and, similarly to their traditional surgical counterparts, work in two main categories: restrictive or malabsorptive.¹ Restrictive endoscopic bariatric therapies (EBTs) include intragastric balloons (IGB) that are filled with saline or gas to decrease intragastric luminal size, endoscopic sleeve gastroplasty that makes full-thickness plications of the gastric wall to tubularize the stomach like a sleeve gastrectomy, and AspireAssist where patients use a percutaneous gastrostomy to remove part of an ingested meal.¹ Malabsorptive procedures include bypass sleeves that use a stentlike device to bypass absorption of food in the duodenum and proximal jejunum, the incisionless magnetic anastomosis system (IMAS) that creates a gastrojejunal bypass for diverting absorption, and duodenal mucosal resurfacing (DMR) that ablates the duodenal mucosa.^1,2

The benefits of EBTs over traditional bariatric surgery are that they have a lower risk profile, there is limited anatomic alternation, and they are potentially reversible.¹ Although no formal guidelines exist in the United States for the use of EBTs, the American Society for Gastrointestinal Endoscopy (ASGE) preliminary recommendations describe EBTs as applicable for patients who have failed lifestyle interventions and have BMIs between 30 and 45.¹ While some of these techniques were first described in the 1980s, many individual companies and devices still do not have Food and Drug Administration approval and some have even had approval withdrawn. While traditional bariatric surgery may have complication rates up to 17%, EBTs are not without complications.¹ Endoscopic barriers can migrate and occlude, cause pancreatitis, cause liver abscesses from biliary occlusion, and more severely cause GI bleeding and perforations.¹ Many EBTs are also temporary treatments with IGBs and barrier bypasses placed only for 6-12 months.1 While there have been some studies looking at individual outcomes of the various EBTs, large prospective research trials looking at safety and efficacy, especially when comparing EBT to traditional bariatric surgery or in combination, are lacking.

Continued innovation in medicine and technology is critical to improving patient care. New innovations in medicine have allowed us to treat more disease, save lives, reduce complications, and better care for patients. But what exactly is innovation and when does it become research? The landmark Belmont Report in 1979 distinguishes research from innovative therapy, calling research “an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge.”³ Patients in research thus bear the risks while others stand to benefit. The report affirms then that routine medical practice involves interventions designed specifically to benefit the individual patient. The European Association for Endoscopic Surgery defines innovations as any “significant modification of a standard technique, a new application of or new indication for an established technique, or an alternative combination of an established technique with another therapeutic modality.”⁴ As such, innovations should eventually be formally studied with institutional review board (IRB) approval and protocols to establish safety and efficacy. Another complicating factor is that there is no FDA approval for surgical and procedural techniques as there is for medications and certain devices. Therefore, no robust regulatory mechanisms exist to ensure patient safety and benefit. Further complicating matters is that innovative procedures often start as modifications of techniques and are often done regularly to fit specific situations – for example, an additional stitch in a different location or in a different orientation to what is done in the standard fashion. However, true innovations should be distinguished from these modifications. Perhaps then another way to think about the two is to splinter them into three types of activity: research, routine accepted practice, and innovative medicine.⁵

 

Given this potential for blurred lines about novel approaches to medical conditions, how do we communicate this to patients? This is where the role of informed consent becomes essential. Informed consent is key to respecting patients’ autonomy – a central tenet of medical ethics. For patients to make autonomous choices they need basic facts to make informed decisions.⁶ These facts must be unbiased and free from conflicts, and they must not only be truthful but also be comprehensive and free from omission. It is in this informed consent process that we must explain that a technique or procedure is new, outline the risks and benefits, and share our actual experiences with said procedure especially if it is limited.⁷ We must also be aware of how certain biases and conflicts can affect our decisions to adapt and recommend innovative therapies. We may have incentives to offer innovative therapies to be on the “cutting edge” and attract patients. We may have explicit financial gain if working directly with device manufacturers or reimbursed by our institutions per procedure. Conflicts of interest are not only financial, but they can also be the prospects of promotion or career advancement.³ Institutions as well are incentivized to advertise the “latest” to bolster their prestige and reputations. Ultimately, we should act to the highest levels of professionalism, and ethics, by ignoring benefit to ourselves as physicians and always focusing on the benefits for our patients.⁷

What about when patients ask for specific innovative procedures as Mrs. Jones did above? What is our responsibility then? In situations where patients specifically push for a new procedure, it remains our duty to inform patients about the novelty of the procedure and the limited study of its safety and efficacy. When speaking about the “experience” with a novel procedure, it is tempting to speak globally and broadly. For example, Dr. Indo spoke about the procedure being done hundreds of times across the country and being safe in this context. It is our duty to be transparent, disclose our own experiences, and consider our own skills when recommending a novel procedure.⁷ It should be noted that patients are a vulnerable population and many times at the mercy of our recommendations. We’ve often heard patients say “Whatever you say doc; You’re the doctor;” or “I’ll do what you think is best” when presented with treatment options. This is an incredible amount of power, and we must protect this trust patients place in us by clearly acknowledging the uncertainties of new procedures and placing their benefit over our own potential gain.

Dr. Williams is a general surgery resident at the University of Chicago and a fellow at the MacLean Center for clinical medical ethics. Dr. Angelos is the Linda Kohler Anderson Professor of Surgery and Surgical Ethics, vice chairman for ethics, professional development, and wellness, and chief of endocrine surgery, department of surgery, and the associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago. The authors have no conflicts to disclose.

References

1. Goyal H et al. Ther Adv Gastrointest Endosc. 2021;14. doi: 10.1177/2631774520984627.

2. Machytka E et al. Gastrointestinal Endosc. 2017;86(5):904-12. doi: 10.1016/j.gie.2017.07.009.

3. Eastwood GL. J Gastroenterol Hepatol (Australia). 2015;30(S1):8-11. doi: 10.1111/jgh.12755.

4. Neugebauer EAM et al. Surg Endosc. 2010;24(7):1594-1615. doi: 10.1007/s00464-009-0818-3.

5. Eaton, ML and Kennedy, DL. Innovation in Medical Technology: Ethical Issues and Challenges. Baltimore: Johns Hopkins University Press, 2007.

6. Angelos P. Ann Thorac Surg. 2019;108(6):1611-2. doi: 10.1016/j.athoracsur.2019.08.010.

7. Angelos P. Virtual Mentor. 2011;13(1):6-9. doi: 10.1001/virtualmentor.2011.13.1.ccas1-1101.

Mrs. Jones is a 44-year-old woman who has struggled with her weight. She has a body mass index (BMI) of 35 kg/m² and hypertension requiring daily medication. She has tried various diets over the years and has never been able to exercise consistently. She desperately wants to lose weight to improve her confidence and to avoid developing diabetes and dialysis that her parents required. She has considered weight loss surgery but is afraid after her best friend died following uterine fibroid surgery. She saw a billboard that advertised a new weight loss procedure without surgery. She looked up the procedure, found Dr. Indo on the university medical center’s website, and booked an appointment. Dr. Indo talked about performing an incisionless procedure done with an endoscope through her mouth. It would make her stomach into a tube to reduce the amount of food she could eat as well as prevent some absorption of food in her intestines. When Mrs. Jones asked how many of these the doctor had performed, Dr. Indo remarked she personally had done “several” in the past few years including training. Dr. Indo reassured Mrs. Jones that the procedure has been performed hundreds of times around the country and has been shown to be safe. Dr. Indo also explained that studies were still ongoing, including possibly at the university medical center, but that she had never personally seen any serious complications or death, and only one patient she knew of converted to a traditional bariatric surgery.

Obesity is a large international public health problem, with the World Health Organization estimating that there are 600 million obese adults worldwide.¹ Bariatric surgery has been an effective way to improve complications related to obesity and quality of life. Endoscopic approaches to bariatric surgery have appeared since at least the late 1980s and, similarly to their traditional surgical counterparts, work in two main categories: restrictive or malabsorptive.¹ Restrictive endoscopic bariatric therapies (EBTs) include intragastric balloons (IGB) that are filled with saline or gas to decrease intragastric luminal size, endoscopic sleeve gastroplasty that makes full-thickness plications of the gastric wall to tubularize the stomach like a sleeve gastrectomy, and AspireAssist where patients use a percutaneous gastrostomy to remove part of an ingested meal.¹ Malabsorptive procedures include bypass sleeves that use a stentlike device to bypass absorption of food in the duodenum and proximal jejunum, the incisionless magnetic anastomosis system (IMAS) that creates a gastrojejunal bypass for diverting absorption, and duodenal mucosal resurfacing (DMR) that ablates the duodenal mucosa.^1,2

The benefits of EBTs over traditional bariatric surgery are that they have a lower risk profile, there is limited anatomic alternation, and they are potentially reversible.¹ Although no formal guidelines exist in the United States for the use of EBTs, the American Society for Gastrointestinal Endoscopy (ASGE) preliminary recommendations describe EBTs as applicable for patients who have failed lifestyle interventions and have BMIs between 30 and 45.¹ While some of these techniques were first described in the 1980s, many individual companies and devices still do not have Food and Drug Administration approval and some have even had approval withdrawn. While traditional bariatric surgery may have complication rates up to 17%, EBTs are not without complications.¹ Endoscopic barriers can migrate and occlude, cause pancreatitis, cause liver abscesses from biliary occlusion, and more severely cause GI bleeding and perforations.¹ Many EBTs are also temporary treatments with IGBs and barrier bypasses placed only for 6-12 months.1 While there have been some studies looking at individual outcomes of the various EBTs, large prospective research trials looking at safety and efficacy, especially when comparing EBT to traditional bariatric surgery or in combination, are lacking.

Continued innovation in medicine and technology is critical to improving patient care. New innovations in medicine have allowed us to treat more disease, save lives, reduce complications, and better care for patients. But what exactly is innovation and when does it become research? The landmark Belmont Report in 1979 distinguishes research from innovative therapy, calling research “an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge.”³ Patients in research thus bear the risks while others stand to benefit. The report affirms then that routine medical practice involves interventions designed specifically to benefit the individual patient. The European Association for Endoscopic Surgery defines innovations as any “significant modification of a standard technique, a new application of or new indication for an established technique, or an alternative combination of an established technique with another therapeutic modality.”⁴ As such, innovations should eventually be formally studied with institutional review board (IRB) approval and protocols to establish safety and efficacy. Another complicating factor is that there is no FDA approval for surgical and procedural techniques as there is for medications and certain devices. Therefore, no robust regulatory mechanisms exist to ensure patient safety and benefit. Further complicating matters is that innovative procedures often start as modifications of techniques and are often done regularly to fit specific situations – for example, an additional stitch in a different location or in a different orientation to what is done in the standard fashion. However, true innovations should be distinguished from these modifications. Perhaps then another way to think about the two is to splinter them into three types of activity: research, routine accepted practice, and innovative medicine.⁵

 

Given this potential for blurred lines about novel approaches to medical conditions, how do we communicate this to patients? This is where the role of informed consent becomes essential. Informed consent is key to respecting patients’ autonomy – a central tenet of medical ethics. For patients to make autonomous choices they need basic facts to make informed decisions.⁶ These facts must be unbiased and free from conflicts, and they must not only be truthful but also be comprehensive and free from omission. It is in this informed consent process that we must explain that a technique or procedure is new, outline the risks and benefits, and share our actual experiences with said procedure especially if it is limited.⁷ We must also be aware of how certain biases and conflicts can affect our decisions to adapt and recommend innovative therapies. We may have incentives to offer innovative therapies to be on the “cutting edge” and attract patients. We may have explicit financial gain if working directly with device manufacturers or reimbursed by our institutions per procedure. Conflicts of interest are not only financial, but they can also be the prospects of promotion or career advancement.³ Institutions as well are incentivized to advertise the “latest” to bolster their prestige and reputations. Ultimately, we should act to the highest levels of professionalism, and ethics, by ignoring benefit to ourselves as physicians and always focusing on the benefits for our patients.⁷

What about when patients ask for specific innovative procedures as Mrs. Jones did above? What is our responsibility then? In situations where patients specifically push for a new procedure, it remains our duty to inform patients about the novelty of the procedure and the limited study of its safety and efficacy. When speaking about the “experience” with a novel procedure, it is tempting to speak globally and broadly. For example, Dr. Indo spoke about the procedure being done hundreds of times across the country and being safe in this context. It is our duty to be transparent, disclose our own experiences, and consider our own skills when recommending a novel procedure.⁷ It should be noted that patients are a vulnerable population and many times at the mercy of our recommendations. We’ve often heard patients say “Whatever you say doc; You’re the doctor;” or “I’ll do what you think is best” when presented with treatment options. This is an incredible amount of power, and we must protect this trust patients place in us by clearly acknowledging the uncertainties of new procedures and placing their benefit over our own potential gain.

Dr. Williams is a general surgery resident at the University of Chicago and a fellow at the MacLean Center for clinical medical ethics. Dr. Angelos is the Linda Kohler Anderson Professor of Surgery and Surgical Ethics, vice chairman for ethics, professional development, and wellness, and chief of endocrine surgery, department of surgery, and the associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago. The authors have no conflicts to disclose.

References

1. Goyal H et al. Ther Adv Gastrointest Endosc. 2021;14. doi: 10.1177/2631774520984627.

2. Machytka E et al. Gastrointestinal Endosc. 2017;86(5):904-12. doi: 10.1016/j.gie.2017.07.009.

3. Eastwood GL. J Gastroenterol Hepatol (Australia). 2015;30(S1):8-11. doi: 10.1111/jgh.12755.

4. Neugebauer EAM et al. Surg Endosc. 2010;24(7):1594-1615. doi: 10.1007/s00464-009-0818-3.

5. Eaton, ML and Kennedy, DL. Innovation in Medical Technology: Ethical Issues and Challenges. Baltimore: Johns Hopkins University Press, 2007.

6. Angelos P. Ann Thorac Surg. 2019;108(6):1611-2. doi: 10.1016/j.athoracsur.2019.08.010.

7. Angelos P. Virtual Mentor. 2011;13(1):6-9. doi: 10.1001/virtualmentor.2011.13.1.ccas1-1101.

Mrs. Jones is a 44-year-old woman who has struggled with her weight. She has a body mass index (BMI) of 35 kg/m² and hypertension requiring daily medication. She has tried various diets over the years and has never been able to exercise consistently. She desperately wants to lose weight to improve her confidence and to avoid developing diabetes and dialysis that her parents required. She has considered weight loss surgery but is afraid after her best friend died following uterine fibroid surgery. She saw a billboard that advertised a new weight loss procedure without surgery. She looked up the procedure, found Dr. Indo on the university medical center’s website, and booked an appointment. Dr. Indo talked about performing an incisionless procedure done with an endoscope through her mouth. It would make her stomach into a tube to reduce the amount of food she could eat as well as prevent some absorption of food in her intestines. When Mrs. Jones asked how many of these the doctor had performed, Dr. Indo remarked she personally had done “several” in the past few years including training. Dr. Indo reassured Mrs. Jones that the procedure has been performed hundreds of times around the country and has been shown to be safe. Dr. Indo also explained that studies were still ongoing, including possibly at the university medical center, but that she had never personally seen any serious complications or death, and only one patient she knew of converted to a traditional bariatric surgery.

Obesity is a large international public health problem, with the World Health Organization estimating that there are 600 million obese adults worldwide.¹ Bariatric surgery has been an effective way to improve complications related to obesity and quality of life. Endoscopic approaches to bariatric surgery have appeared since at least the late 1980s and, similarly to their traditional surgical counterparts, work in two main categories: restrictive or malabsorptive.¹ Restrictive endoscopic bariatric therapies (EBTs) include intragastric balloons (IGB) that are filled with saline or gas to decrease intragastric luminal size, endoscopic sleeve gastroplasty that makes full-thickness plications of the gastric wall to tubularize the stomach like a sleeve gastrectomy, and AspireAssist where patients use a percutaneous gastrostomy to remove part of an ingested meal.¹ Malabsorptive procedures include bypass sleeves that use a stentlike device to bypass absorption of food in the duodenum and proximal jejunum, the incisionless magnetic anastomosis system (IMAS) that creates a gastrojejunal bypass for diverting absorption, and duodenal mucosal resurfacing (DMR) that ablates the duodenal mucosa.^1,2

The benefits of EBTs over traditional bariatric surgery are that they have a lower risk profile, there is limited anatomic alternation, and they are potentially reversible.¹ Although no formal guidelines exist in the United States for the use of EBTs, the American Society for Gastrointestinal Endoscopy (ASGE) preliminary recommendations describe EBTs as applicable for patients who have failed lifestyle interventions and have BMIs between 30 and 45.¹ While some of these techniques were first described in the 1980s, many individual companies and devices still do not have Food and Drug Administration approval and some have even had approval withdrawn. While traditional bariatric surgery may have complication rates up to 17%, EBTs are not without complications.¹ Endoscopic barriers can migrate and occlude, cause pancreatitis, cause liver abscesses from biliary occlusion, and more severely cause GI bleeding and perforations.¹ Many EBTs are also temporary treatments with IGBs and barrier bypasses placed only for 6-12 months.1 While there have been some studies looking at individual outcomes of the various EBTs, large prospective research trials looking at safety and efficacy, especially when comparing EBT to traditional bariatric surgery or in combination, are lacking.

Continued innovation in medicine and technology is critical to improving patient care. New innovations in medicine have allowed us to treat more disease, save lives, reduce complications, and better care for patients. But what exactly is innovation and when does it become research? The landmark Belmont Report in 1979 distinguishes research from innovative therapy, calling research “an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge.”³ Patients in research thus bear the risks while others stand to benefit. The report affirms then that routine medical practice involves interventions designed specifically to benefit the individual patient. The European Association for Endoscopic Surgery defines innovations as any “significant modification of a standard technique, a new application of or new indication for an established technique, or an alternative combination of an established technique with another therapeutic modality.”⁴ As such, innovations should eventually be formally studied with institutional review board (IRB) approval and protocols to establish safety and efficacy. Another complicating factor is that there is no FDA approval for surgical and procedural techniques as there is for medications and certain devices. Therefore, no robust regulatory mechanisms exist to ensure patient safety and benefit. Further complicating matters is that innovative procedures often start as modifications of techniques and are often done regularly to fit specific situations – for example, an additional stitch in a different location or in a different orientation to what is done in the standard fashion. However, true innovations should be distinguished from these modifications. Perhaps then another way to think about the two is to splinter them into three types of activity: research, routine accepted practice, and innovative medicine.⁵

 

Given this potential for blurred lines about novel approaches to medical conditions, how do we communicate this to patients? This is where the role of informed consent becomes essential. Informed consent is key to respecting patients’ autonomy – a central tenet of medical ethics. For patients to make autonomous choices they need basic facts to make informed decisions.⁶ These facts must be unbiased and free from conflicts, and they must not only be truthful but also be comprehensive and free from omission. It is in this informed consent process that we must explain that a technique or procedure is new, outline the risks and benefits, and share our actual experiences with said procedure especially if it is limited.⁷ We must also be aware of how certain biases and conflicts can affect our decisions to adapt and recommend innovative therapies. We may have incentives to offer innovative therapies to be on the “cutting edge” and attract patients. We may have explicit financial gain if working directly with device manufacturers or reimbursed by our institutions per procedure. Conflicts of interest are not only financial, but they can also be the prospects of promotion or career advancement.³ Institutions as well are incentivized to advertise the “latest” to bolster their prestige and reputations. Ultimately, we should act to the highest levels of professionalism, and ethics, by ignoring benefit to ourselves as physicians and always focusing on the benefits for our patients.⁷

What about when patients ask for specific innovative procedures as Mrs. Jones did above? What is our responsibility then? In situations where patients specifically push for a new procedure, it remains our duty to inform patients about the novelty of the procedure and the limited study of its safety and efficacy. When speaking about the “experience” with a novel procedure, it is tempting to speak globally and broadly. For example, Dr. Indo spoke about the procedure being done hundreds of times across the country and being safe in this context. It is our duty to be transparent, disclose our own experiences, and consider our own skills when recommending a novel procedure.⁷ It should be noted that patients are a vulnerable population and many times at the mercy of our recommendations. We’ve often heard patients say “Whatever you say doc; You’re the doctor;” or “I’ll do what you think is best” when presented with treatment options. This is an incredible amount of power, and we must protect this trust patients place in us by clearly acknowledging the uncertainties of new procedures and placing their benefit over our own potential gain.

Dr. Williams is a general surgery resident at the University of Chicago and a fellow at the MacLean Center for clinical medical ethics. Dr. Angelos is the Linda Kohler Anderson Professor of Surgery and Surgical Ethics, vice chairman for ethics, professional development, and wellness, and chief of endocrine surgery, department of surgery, and the associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago. The authors have no conflicts to disclose.

References

1. Goyal H et al. Ther Adv Gastrointest Endosc. 2021;14. doi: 10.1177/2631774520984627.

2. Machytka E et al. Gastrointestinal Endosc. 2017;86(5):904-12. doi: 10.1016/j.gie.2017.07.009.

3. Eastwood GL. J Gastroenterol Hepatol (Australia). 2015;30(S1):8-11. doi: 10.1111/jgh.12755.

4. Neugebauer EAM et al. Surg Endosc. 2010;24(7):1594-1615. doi: 10.1007/s00464-009-0818-3.

5. Eaton, ML and Kennedy, DL. Innovation in Medical Technology: Ethical Issues and Challenges. Baltimore: Johns Hopkins University Press, 2007.

6. Angelos P. Ann Thorac Surg. 2019;108(6):1611-2. doi: 10.1016/j.athoracsur.2019.08.010.

7. Angelos P. Virtual Mentor. 2011;13(1):6-9. doi: 10.1001/virtualmentor.2011.13.1.ccas1-1101.