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Researchers evaluate gynecology-specific laparoscopic simulator
Students have similar confidence levels during a simulated laparoscopic vaginal cuff suturing task whether they train with the current standard laparoscopic simulator or a newer gynecology-specific simulator, a randomized trial found.
Participants who trained on the gynecology-specific simulator, known as Essentials in Minimally Invasive Gynecology (EMIG), reported higher confidence scores, but differences between the groups were not statistically significant, a researcher reported at the annual meeting sponsored by AAGL, held virtually this year.
The study compared EMIG with Fundamentals of Laparoscopic Surgery (FLS), a laparoscopic simulator that general surgeons launched in 2004.
In 2018, the American Board of Obstetrics and Gynecology announced an FLS requirement for residents graduating after May 31, 2020. The same year, the AAGL began validating EMIG. AAGL developed the simulator in response to a growing trend for minimally invasive approaches and to provide a training tool geared toward gynecologists, said Emily G. Lin, MD, an obstetrics and gynecology resident at McGaw Medical Center at Northwestern University in Chicago.
A comparison of the two simulators
The simulators use different port placement and operator positioning. The operating fields within the box trainers also differ. In EMIG, laparoscopic tasks take place within a bowl that simulates a confined workspace similar to a pelvis, whereas FLS tasks take place in an open box trainer environment, Dr. Lin said.
To compare students’ self-reported confidence levels after performing a laparoscopic vaginal cuff suturing task after training with EMIG or FLS, Dr. Lin and colleagues conducted a randomized controlled trial.
The researchers recruited 45 participants who were preclinical medical students or premedical college students without prior training experience. Participants were randomized to EMIG or FLS training. After watching instructional videos about their simulator tasks and the vaginal cuff suturing task, they attempted the vaginal cuff suturing task as a pretest.
They then trained for about 2 hours on their assigned simulator. Training for both groups included practicing peg transfer and intracorporeal knot tying. In addition, the EMIG group trained on a running suture task, and the FLS group trained on a ligating loop task.
After training, participants retried the vaginal cuff suturing task. Participants subsequently rated their confidence during each simulation task on a 5-point Likert scale.
Confidence levels on the peg transfer (4.13 with EMIG vs. 4.10 with FLS), intracorporeal knot tying (3.0 with EMIG vs. 2.86 with FLS) and vaginal cuff suturing (2.46 with EMIG vs. 2.05 with FLS) were similar for both groups.
The study was small, included only one training session, and included only three of the five tasks for each simulator because of time and cost constraints, Dr. Lin noted.
Using simulation in residency training
The study was well designed and sheds light on inevitable comparisons between FLS and EMIG, Ido Sirota, MD, MHA, of New York-Presbyterian Queens, said in a discussion following the research presentation.
“The field of medical simulation has developed tremendously in the past decade,” Dr. Sirota said. “The paradigm that used to be common in our field – of see one, do one, teach one – belongs to the past. ... Current trainees need extensive practice on their surgical skills in a simulation setting before” entering the operating room.
A 2017 review found that simulation may be a useful adjunct to residency training.
And in a pilot study, EMIG’s laparoscopic and hysteroscopic simulation systems were considered to have good face validity, Dr. Sirota noted.
Using a gynecology-specific simulation may have advantages.
“In this day and age when we are trying to differentiate ourselves as a subspecialty, there is a great value to developing our own simulation-based curricula to validate our surgical skills during training, as well as for maintenance throughout our career,” Dr. Sirota said. “We as a subspecialty need specific tests tailored to our surgical procedures.”
Dr. Sirota disclosed consulting for Medtronic, Activ Surgical, Heracure, and HT, and he is on the speakers bureau for Medtronic. Dr. Lin had no relevant financial disclosures.
SOURCE: Lin E et al. J Minim Invasive Gynecol. 2020 Nov. doi: 10.1016/j.jmig.2020.08.593.
Students have similar confidence levels during a simulated laparoscopic vaginal cuff suturing task whether they train with the current standard laparoscopic simulator or a newer gynecology-specific simulator, a randomized trial found.
Participants who trained on the gynecology-specific simulator, known as Essentials in Minimally Invasive Gynecology (EMIG), reported higher confidence scores, but differences between the groups were not statistically significant, a researcher reported at the annual meeting sponsored by AAGL, held virtually this year.
The study compared EMIG with Fundamentals of Laparoscopic Surgery (FLS), a laparoscopic simulator that general surgeons launched in 2004.
In 2018, the American Board of Obstetrics and Gynecology announced an FLS requirement for residents graduating after May 31, 2020. The same year, the AAGL began validating EMIG. AAGL developed the simulator in response to a growing trend for minimally invasive approaches and to provide a training tool geared toward gynecologists, said Emily G. Lin, MD, an obstetrics and gynecology resident at McGaw Medical Center at Northwestern University in Chicago.
A comparison of the two simulators
The simulators use different port placement and operator positioning. The operating fields within the box trainers also differ. In EMIG, laparoscopic tasks take place within a bowl that simulates a confined workspace similar to a pelvis, whereas FLS tasks take place in an open box trainer environment, Dr. Lin said.
To compare students’ self-reported confidence levels after performing a laparoscopic vaginal cuff suturing task after training with EMIG or FLS, Dr. Lin and colleagues conducted a randomized controlled trial.
The researchers recruited 45 participants who were preclinical medical students or premedical college students without prior training experience. Participants were randomized to EMIG or FLS training. After watching instructional videos about their simulator tasks and the vaginal cuff suturing task, they attempted the vaginal cuff suturing task as a pretest.
They then trained for about 2 hours on their assigned simulator. Training for both groups included practicing peg transfer and intracorporeal knot tying. In addition, the EMIG group trained on a running suture task, and the FLS group trained on a ligating loop task.
After training, participants retried the vaginal cuff suturing task. Participants subsequently rated their confidence during each simulation task on a 5-point Likert scale.
Confidence levels on the peg transfer (4.13 with EMIG vs. 4.10 with FLS), intracorporeal knot tying (3.0 with EMIG vs. 2.86 with FLS) and vaginal cuff suturing (2.46 with EMIG vs. 2.05 with FLS) were similar for both groups.
The study was small, included only one training session, and included only three of the five tasks for each simulator because of time and cost constraints, Dr. Lin noted.
Using simulation in residency training
The study was well designed and sheds light on inevitable comparisons between FLS and EMIG, Ido Sirota, MD, MHA, of New York-Presbyterian Queens, said in a discussion following the research presentation.
“The field of medical simulation has developed tremendously in the past decade,” Dr. Sirota said. “The paradigm that used to be common in our field – of see one, do one, teach one – belongs to the past. ... Current trainees need extensive practice on their surgical skills in a simulation setting before” entering the operating room.
A 2017 review found that simulation may be a useful adjunct to residency training.
And in a pilot study, EMIG’s laparoscopic and hysteroscopic simulation systems were considered to have good face validity, Dr. Sirota noted.
Using a gynecology-specific simulation may have advantages.
“In this day and age when we are trying to differentiate ourselves as a subspecialty, there is a great value to developing our own simulation-based curricula to validate our surgical skills during training, as well as for maintenance throughout our career,” Dr. Sirota said. “We as a subspecialty need specific tests tailored to our surgical procedures.”
Dr. Sirota disclosed consulting for Medtronic, Activ Surgical, Heracure, and HT, and he is on the speakers bureau for Medtronic. Dr. Lin had no relevant financial disclosures.
SOURCE: Lin E et al. J Minim Invasive Gynecol. 2020 Nov. doi: 10.1016/j.jmig.2020.08.593.
Students have similar confidence levels during a simulated laparoscopic vaginal cuff suturing task whether they train with the current standard laparoscopic simulator or a newer gynecology-specific simulator, a randomized trial found.
Participants who trained on the gynecology-specific simulator, known as Essentials in Minimally Invasive Gynecology (EMIG), reported higher confidence scores, but differences between the groups were not statistically significant, a researcher reported at the annual meeting sponsored by AAGL, held virtually this year.
The study compared EMIG with Fundamentals of Laparoscopic Surgery (FLS), a laparoscopic simulator that general surgeons launched in 2004.
In 2018, the American Board of Obstetrics and Gynecology announced an FLS requirement for residents graduating after May 31, 2020. The same year, the AAGL began validating EMIG. AAGL developed the simulator in response to a growing trend for minimally invasive approaches and to provide a training tool geared toward gynecologists, said Emily G. Lin, MD, an obstetrics and gynecology resident at McGaw Medical Center at Northwestern University in Chicago.
A comparison of the two simulators
The simulators use different port placement and operator positioning. The operating fields within the box trainers also differ. In EMIG, laparoscopic tasks take place within a bowl that simulates a confined workspace similar to a pelvis, whereas FLS tasks take place in an open box trainer environment, Dr. Lin said.
To compare students’ self-reported confidence levels after performing a laparoscopic vaginal cuff suturing task after training with EMIG or FLS, Dr. Lin and colleagues conducted a randomized controlled trial.
The researchers recruited 45 participants who were preclinical medical students or premedical college students without prior training experience. Participants were randomized to EMIG or FLS training. After watching instructional videos about their simulator tasks and the vaginal cuff suturing task, they attempted the vaginal cuff suturing task as a pretest.
They then trained for about 2 hours on their assigned simulator. Training for both groups included practicing peg transfer and intracorporeal knot tying. In addition, the EMIG group trained on a running suture task, and the FLS group trained on a ligating loop task.
After training, participants retried the vaginal cuff suturing task. Participants subsequently rated their confidence during each simulation task on a 5-point Likert scale.
Confidence levels on the peg transfer (4.13 with EMIG vs. 4.10 with FLS), intracorporeal knot tying (3.0 with EMIG vs. 2.86 with FLS) and vaginal cuff suturing (2.46 with EMIG vs. 2.05 with FLS) were similar for both groups.
The study was small, included only one training session, and included only three of the five tasks for each simulator because of time and cost constraints, Dr. Lin noted.
Using simulation in residency training
The study was well designed and sheds light on inevitable comparisons between FLS and EMIG, Ido Sirota, MD, MHA, of New York-Presbyterian Queens, said in a discussion following the research presentation.
“The field of medical simulation has developed tremendously in the past decade,” Dr. Sirota said. “The paradigm that used to be common in our field – of see one, do one, teach one – belongs to the past. ... Current trainees need extensive practice on their surgical skills in a simulation setting before” entering the operating room.
A 2017 review found that simulation may be a useful adjunct to residency training.
And in a pilot study, EMIG’s laparoscopic and hysteroscopic simulation systems were considered to have good face validity, Dr. Sirota noted.
Using a gynecology-specific simulation may have advantages.
“In this day and age when we are trying to differentiate ourselves as a subspecialty, there is a great value to developing our own simulation-based curricula to validate our surgical skills during training, as well as for maintenance throughout our career,” Dr. Sirota said. “We as a subspecialty need specific tests tailored to our surgical procedures.”
Dr. Sirota disclosed consulting for Medtronic, Activ Surgical, Heracure, and HT, and he is on the speakers bureau for Medtronic. Dr. Lin had no relevant financial disclosures.
SOURCE: Lin E et al. J Minim Invasive Gynecol. 2020 Nov. doi: 10.1016/j.jmig.2020.08.593.
FROM AAGL GLOBAL CONGRESS
Neoadjuvant chemotherapy for advanced ovarian cancer
Historically the standard treatment approach for advanced ovarian cancer has been to perform up-front primary cytoreduction surgery or primary “debulking” surgery (PDS) followed by adjuvant chemotherapy. The goal of surgery was to establish cytoreduction of the tumor to optimal (<1 cm3 disease) or, ideally, complete (no gross residual disease). While PDS has long been considered the default treatment approach, neoadjuvant chemotherapy (NACT) followed by interval cytoreductive surgery, typically after three or four cycles of chemotherapy, was the alternative strategy if it was anticipated or known that an “optimal” cytoreduction was not possible, feasible, or associated with acceptable morbidity. However, NACT was, and to some degree still is, widely considered the inferior strategy, reserved for patients with the worst prognosis. While mounting data challenges the inherent superiority of PDS, it still largely remains the default.
Why was PDS considered superior?
Why was PDS for advanced ovarian cancer considered a superior sequencing when it is so rarely considered appropriate for other disseminated cancers? This was born from the observation among retrospective data showing that survival was best when surgery was performed first, and when surgery was able to remove most or all visible disease (“complete” or “optimal” cytoreduction), NACT was performed.1 Several theories were proposed to explain the observations. These included the theory that bulky tumors contained avascular regions that would be less well accessed by chemotherapy, as well as the notion that chemotherapy exerts a constant fraction of kill on tumor cells, and if there is a lower burden of tumor cells to begin with, fewer cycles of chemotherapy will be necessary to eliminate all cells. Coupled with this was the notion that, if fewer cycles of chemotherapy are necessary, there would be less opportunity for development of drug resistance. Other theories such as the inflammatory effects of surgery impacting immune-mediated kill of malignant cells also are reported. These theories were largely found in the pages of textbooks, only supported by heavily biased observational series and not in the results of elegant translational studies. Of course, the observed superiority of PDS in these cohort studies was not surprising given that the patients who were historically selected for NACT had their treatment course chosen specifically for their poor prognostic factors (large volume, unresectable disease, poor performance status, and comorbidities). These “studies” were self-fulfilling prophecies.
Anecdotally I can attest that most patients are enthusiastic about a primary surgical approach to their advanced cancer. There is something concretely satisfying for patient and surgeon alike in the physical act of removing disease. As surgeons, if we believe that our added surgical effort will be rewarded with better outcomes for the patients, we will “try harder” in the operating room in order for them to do better. However, mounting data challenges whether it is our aggressive surgical effort as much as it is primary tumor biology that is the driver of prognosis in this disease. And aggressive primary surgery may add little other than perioperative morbidity.
Why that perspective may be changing
A culmination of many years of sophisticated translational research led by Anil Sood, MD, from the University of Texas MD Anderson Cancer Center, Houston, established there are fundamental biologic differences in the tumors of patients with ovarian cancer whose disease is amenable or not to a complete cytoreduction with PDS.2 In their work, the researchers sampled tumors from patients with advanced ovarian cancer who had been triaged either to PDS or NACT based on a standardized, validated laparoscopic algorithm that predicted a high probability of complete surgical resection. They performed pretreatment biopsies in both groups of patients and conducted a range of “omics” analyses to stratify these two subsets of patients – those who had a disease burden amenable to complete surgical resection versus those whose presenting disease burden exceeded an acceptable surgical effort). They identified several key molecular differences in the pretreatment biopsies of these two groups of patients, including alterations which might explain better or worse responses to therapy. These results suggest that the tumors of patients who go on to have successful PDS to no gross residual disease have different tumor biology to begin with. Otherwise said, perhaps it is favorable tumor biology that is associated with both a disease burden that is more amenable to both primary complete cytoreduction and better oncologic outcomes, rather than the surgical effort in and of itself.
This finding is supported by a study in which ovarian cancer survival outcomes were stratified by disease burden, surgical complexity scores, and postoperative residual disease among patients who were enrolled in GOG-182.3 Investigators led by Neil Horowitz, MD, created scores for surgical complexity, disease burden, and residual disease. They observed that the radicality of surgery (complexity score) was not an independent determinant of survival, but rather, patients who presented with a lower disease burden that required a less radical surgery had the best oncologic outcomes.
If the complexity of surgery does not influence outcomes as much as the predetermined, unmodifiable tumor biology, how should surgeons make decisions about the sequencing of treatment? Over the past 10 years, four randomized trials have been completed including more than 1,600 patients randomized to either PDS or NACT.4-7 All four have found no difference in the oncologic outcomes (progression-free or overall survival) between patients when randomized to PDS or NACT. While the statistical designs vary slightly, some being designed to look for noninferiority and others for superiority, they all showed that the sequence in which surgery and chemotherapy was performed mattered less than whether optimal cytoreduction was achieved when surgery was performed. As stated above, this phenomenon seems to be best determined by unmodifiable tumor biology. Unsurprisingly, these studies also have consistently found that perioperative outcomes (e.g., surgical complications, length of stay, death) were worse with PDS because of the higher surgical complexity that it demands. In the most recent SCORPION trial, rates of major postoperative complications in the PDS group were 25.9%, compared with only 7.6% in the NACT group (P < .0001) and all of the deaths from postoperative complications occurred in the PDS group at a rate of 8.3% (7 of 84 patients).7
Therefore, the wealth of data supports that oncologic outcomes are equivalent, and perioperative outcomes are improved for patients who undergo NACT for advanced, bulky ovarian cancer.
Why physicians still are questioning
Unfortunately, because ofthe nature of the disease, these prospective trials include heterogeneous populations of disease presentation, surgeon skill, and hospital settings. They have been criticized for achieving “low” rates of complete or optimal cytoreduction in the PDS arm. They also identified subgroups of patients who may do better with PDS (such as those with lower-volume stage IIIC disease) and those who have better outcomes with NACT (patients with stage IV disease). Therefore, not satisfied that we have definitively answered the question, a fifth randomized study, the TRUST trial, is underway.8 This study includes surgeons at high-volume institutions, purported to have the highest degree of skill and quality in executing radical debulking procedures. Perhaps this fifth trial will show that, if performed in the most skilled hands and quality settings, PDS is preferable to NACT. Perhaps. However, the generalizability of these results will be poor for all patients with advanced ovarian cancer, most of whom will have limited access to these highest-volume surgeons.
What can be agreed upon is that an individualized and nuanced approach is best for advanced ovarian cancer. There will be some patients who benefit from PDS (e.g., healthy, young patients with low-volume disease). However, for most patients, the bulk of prospective and translational research supports NACT as the default treatment course, associated with noninferior survival and superior perioperative outcomes (including postoperative death). While it may not be a one-size-fits-all approach, one could argue that NACT should be the default strategy, and surgeons should look for reasons to “opt in” to PDS in special circumstances guided by biomarkers such as imaging, tumor markers, clinical factors, and surgical findings.
Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She has no relevant financial disclosures. Email her at [email protected].
References
1. Gynecol Oncol. 2006 Dec. doi: 10.1016/j.ygyno.2006.06.025.
2. Cell Rep. 2020 Apr 14. doi: 10.1016/j.celrep.2020.03.066.
3. J Clin Oncol. 2015 Mar 10. doi: 10.1200/JCO.2014.56.3106.
4. N Engl J Med. 2010 Sep 2. doi: 10.1056/NEJMoa0908806.
5. Lancet. 2015 Jul 18. doi: 10.1016/S0140-6736(14)62223-6.
6. Eur J Cancer. 2020. doi: 10.1016/j.ejca.2020.02.020.
7. Int J Gynecol Cancer. 2020. doi: 10.1136/ijgc-2020-001640.
8. Int J Gynecol Cancer. 2019. doi: 10.1136/ijgc-2019-000682.
Historically the standard treatment approach for advanced ovarian cancer has been to perform up-front primary cytoreduction surgery or primary “debulking” surgery (PDS) followed by adjuvant chemotherapy. The goal of surgery was to establish cytoreduction of the tumor to optimal (<1 cm3 disease) or, ideally, complete (no gross residual disease). While PDS has long been considered the default treatment approach, neoadjuvant chemotherapy (NACT) followed by interval cytoreductive surgery, typically after three or four cycles of chemotherapy, was the alternative strategy if it was anticipated or known that an “optimal” cytoreduction was not possible, feasible, or associated with acceptable morbidity. However, NACT was, and to some degree still is, widely considered the inferior strategy, reserved for patients with the worst prognosis. While mounting data challenges the inherent superiority of PDS, it still largely remains the default.
Why was PDS considered superior?
Why was PDS for advanced ovarian cancer considered a superior sequencing when it is so rarely considered appropriate for other disseminated cancers? This was born from the observation among retrospective data showing that survival was best when surgery was performed first, and when surgery was able to remove most or all visible disease (“complete” or “optimal” cytoreduction), NACT was performed.1 Several theories were proposed to explain the observations. These included the theory that bulky tumors contained avascular regions that would be less well accessed by chemotherapy, as well as the notion that chemotherapy exerts a constant fraction of kill on tumor cells, and if there is a lower burden of tumor cells to begin with, fewer cycles of chemotherapy will be necessary to eliminate all cells. Coupled with this was the notion that, if fewer cycles of chemotherapy are necessary, there would be less opportunity for development of drug resistance. Other theories such as the inflammatory effects of surgery impacting immune-mediated kill of malignant cells also are reported. These theories were largely found in the pages of textbooks, only supported by heavily biased observational series and not in the results of elegant translational studies. Of course, the observed superiority of PDS in these cohort studies was not surprising given that the patients who were historically selected for NACT had their treatment course chosen specifically for their poor prognostic factors (large volume, unresectable disease, poor performance status, and comorbidities). These “studies” were self-fulfilling prophecies.
Anecdotally I can attest that most patients are enthusiastic about a primary surgical approach to their advanced cancer. There is something concretely satisfying for patient and surgeon alike in the physical act of removing disease. As surgeons, if we believe that our added surgical effort will be rewarded with better outcomes for the patients, we will “try harder” in the operating room in order for them to do better. However, mounting data challenges whether it is our aggressive surgical effort as much as it is primary tumor biology that is the driver of prognosis in this disease. And aggressive primary surgery may add little other than perioperative morbidity.
Why that perspective may be changing
A culmination of many years of sophisticated translational research led by Anil Sood, MD, from the University of Texas MD Anderson Cancer Center, Houston, established there are fundamental biologic differences in the tumors of patients with ovarian cancer whose disease is amenable or not to a complete cytoreduction with PDS.2 In their work, the researchers sampled tumors from patients with advanced ovarian cancer who had been triaged either to PDS or NACT based on a standardized, validated laparoscopic algorithm that predicted a high probability of complete surgical resection. They performed pretreatment biopsies in both groups of patients and conducted a range of “omics” analyses to stratify these two subsets of patients – those who had a disease burden amenable to complete surgical resection versus those whose presenting disease burden exceeded an acceptable surgical effort). They identified several key molecular differences in the pretreatment biopsies of these two groups of patients, including alterations which might explain better or worse responses to therapy. These results suggest that the tumors of patients who go on to have successful PDS to no gross residual disease have different tumor biology to begin with. Otherwise said, perhaps it is favorable tumor biology that is associated with both a disease burden that is more amenable to both primary complete cytoreduction and better oncologic outcomes, rather than the surgical effort in and of itself.
This finding is supported by a study in which ovarian cancer survival outcomes were stratified by disease burden, surgical complexity scores, and postoperative residual disease among patients who were enrolled in GOG-182.3 Investigators led by Neil Horowitz, MD, created scores for surgical complexity, disease burden, and residual disease. They observed that the radicality of surgery (complexity score) was not an independent determinant of survival, but rather, patients who presented with a lower disease burden that required a less radical surgery had the best oncologic outcomes.
If the complexity of surgery does not influence outcomes as much as the predetermined, unmodifiable tumor biology, how should surgeons make decisions about the sequencing of treatment? Over the past 10 years, four randomized trials have been completed including more than 1,600 patients randomized to either PDS or NACT.4-7 All four have found no difference in the oncologic outcomes (progression-free or overall survival) between patients when randomized to PDS or NACT. While the statistical designs vary slightly, some being designed to look for noninferiority and others for superiority, they all showed that the sequence in which surgery and chemotherapy was performed mattered less than whether optimal cytoreduction was achieved when surgery was performed. As stated above, this phenomenon seems to be best determined by unmodifiable tumor biology. Unsurprisingly, these studies also have consistently found that perioperative outcomes (e.g., surgical complications, length of stay, death) were worse with PDS because of the higher surgical complexity that it demands. In the most recent SCORPION trial, rates of major postoperative complications in the PDS group were 25.9%, compared with only 7.6% in the NACT group (P < .0001) and all of the deaths from postoperative complications occurred in the PDS group at a rate of 8.3% (7 of 84 patients).7
Therefore, the wealth of data supports that oncologic outcomes are equivalent, and perioperative outcomes are improved for patients who undergo NACT for advanced, bulky ovarian cancer.
Why physicians still are questioning
Unfortunately, because ofthe nature of the disease, these prospective trials include heterogeneous populations of disease presentation, surgeon skill, and hospital settings. They have been criticized for achieving “low” rates of complete or optimal cytoreduction in the PDS arm. They also identified subgroups of patients who may do better with PDS (such as those with lower-volume stage IIIC disease) and those who have better outcomes with NACT (patients with stage IV disease). Therefore, not satisfied that we have definitively answered the question, a fifth randomized study, the TRUST trial, is underway.8 This study includes surgeons at high-volume institutions, purported to have the highest degree of skill and quality in executing radical debulking procedures. Perhaps this fifth trial will show that, if performed in the most skilled hands and quality settings, PDS is preferable to NACT. Perhaps. However, the generalizability of these results will be poor for all patients with advanced ovarian cancer, most of whom will have limited access to these highest-volume surgeons.
What can be agreed upon is that an individualized and nuanced approach is best for advanced ovarian cancer. There will be some patients who benefit from PDS (e.g., healthy, young patients with low-volume disease). However, for most patients, the bulk of prospective and translational research supports NACT as the default treatment course, associated with noninferior survival and superior perioperative outcomes (including postoperative death). While it may not be a one-size-fits-all approach, one could argue that NACT should be the default strategy, and surgeons should look for reasons to “opt in” to PDS in special circumstances guided by biomarkers such as imaging, tumor markers, clinical factors, and surgical findings.
Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She has no relevant financial disclosures. Email her at [email protected].
References
1. Gynecol Oncol. 2006 Dec. doi: 10.1016/j.ygyno.2006.06.025.
2. Cell Rep. 2020 Apr 14. doi: 10.1016/j.celrep.2020.03.066.
3. J Clin Oncol. 2015 Mar 10. doi: 10.1200/JCO.2014.56.3106.
4. N Engl J Med. 2010 Sep 2. doi: 10.1056/NEJMoa0908806.
5. Lancet. 2015 Jul 18. doi: 10.1016/S0140-6736(14)62223-6.
6. Eur J Cancer. 2020. doi: 10.1016/j.ejca.2020.02.020.
7. Int J Gynecol Cancer. 2020. doi: 10.1136/ijgc-2020-001640.
8. Int J Gynecol Cancer. 2019. doi: 10.1136/ijgc-2019-000682.
Historically the standard treatment approach for advanced ovarian cancer has been to perform up-front primary cytoreduction surgery or primary “debulking” surgery (PDS) followed by adjuvant chemotherapy. The goal of surgery was to establish cytoreduction of the tumor to optimal (<1 cm3 disease) or, ideally, complete (no gross residual disease). While PDS has long been considered the default treatment approach, neoadjuvant chemotherapy (NACT) followed by interval cytoreductive surgery, typically after three or four cycles of chemotherapy, was the alternative strategy if it was anticipated or known that an “optimal” cytoreduction was not possible, feasible, or associated with acceptable morbidity. However, NACT was, and to some degree still is, widely considered the inferior strategy, reserved for patients with the worst prognosis. While mounting data challenges the inherent superiority of PDS, it still largely remains the default.
Why was PDS considered superior?
Why was PDS for advanced ovarian cancer considered a superior sequencing when it is so rarely considered appropriate for other disseminated cancers? This was born from the observation among retrospective data showing that survival was best when surgery was performed first, and when surgery was able to remove most or all visible disease (“complete” or “optimal” cytoreduction), NACT was performed.1 Several theories were proposed to explain the observations. These included the theory that bulky tumors contained avascular regions that would be less well accessed by chemotherapy, as well as the notion that chemotherapy exerts a constant fraction of kill on tumor cells, and if there is a lower burden of tumor cells to begin with, fewer cycles of chemotherapy will be necessary to eliminate all cells. Coupled with this was the notion that, if fewer cycles of chemotherapy are necessary, there would be less opportunity for development of drug resistance. Other theories such as the inflammatory effects of surgery impacting immune-mediated kill of malignant cells also are reported. These theories were largely found in the pages of textbooks, only supported by heavily biased observational series and not in the results of elegant translational studies. Of course, the observed superiority of PDS in these cohort studies was not surprising given that the patients who were historically selected for NACT had their treatment course chosen specifically for their poor prognostic factors (large volume, unresectable disease, poor performance status, and comorbidities). These “studies” were self-fulfilling prophecies.
Anecdotally I can attest that most patients are enthusiastic about a primary surgical approach to their advanced cancer. There is something concretely satisfying for patient and surgeon alike in the physical act of removing disease. As surgeons, if we believe that our added surgical effort will be rewarded with better outcomes for the patients, we will “try harder” in the operating room in order for them to do better. However, mounting data challenges whether it is our aggressive surgical effort as much as it is primary tumor biology that is the driver of prognosis in this disease. And aggressive primary surgery may add little other than perioperative morbidity.
Why that perspective may be changing
A culmination of many years of sophisticated translational research led by Anil Sood, MD, from the University of Texas MD Anderson Cancer Center, Houston, established there are fundamental biologic differences in the tumors of patients with ovarian cancer whose disease is amenable or not to a complete cytoreduction with PDS.2 In their work, the researchers sampled tumors from patients with advanced ovarian cancer who had been triaged either to PDS or NACT based on a standardized, validated laparoscopic algorithm that predicted a high probability of complete surgical resection. They performed pretreatment biopsies in both groups of patients and conducted a range of “omics” analyses to stratify these two subsets of patients – those who had a disease burden amenable to complete surgical resection versus those whose presenting disease burden exceeded an acceptable surgical effort). They identified several key molecular differences in the pretreatment biopsies of these two groups of patients, including alterations which might explain better or worse responses to therapy. These results suggest that the tumors of patients who go on to have successful PDS to no gross residual disease have different tumor biology to begin with. Otherwise said, perhaps it is favorable tumor biology that is associated with both a disease burden that is more amenable to both primary complete cytoreduction and better oncologic outcomes, rather than the surgical effort in and of itself.
This finding is supported by a study in which ovarian cancer survival outcomes were stratified by disease burden, surgical complexity scores, and postoperative residual disease among patients who were enrolled in GOG-182.3 Investigators led by Neil Horowitz, MD, created scores for surgical complexity, disease burden, and residual disease. They observed that the radicality of surgery (complexity score) was not an independent determinant of survival, but rather, patients who presented with a lower disease burden that required a less radical surgery had the best oncologic outcomes.
If the complexity of surgery does not influence outcomes as much as the predetermined, unmodifiable tumor biology, how should surgeons make decisions about the sequencing of treatment? Over the past 10 years, four randomized trials have been completed including more than 1,600 patients randomized to either PDS or NACT.4-7 All four have found no difference in the oncologic outcomes (progression-free or overall survival) between patients when randomized to PDS or NACT. While the statistical designs vary slightly, some being designed to look for noninferiority and others for superiority, they all showed that the sequence in which surgery and chemotherapy was performed mattered less than whether optimal cytoreduction was achieved when surgery was performed. As stated above, this phenomenon seems to be best determined by unmodifiable tumor biology. Unsurprisingly, these studies also have consistently found that perioperative outcomes (e.g., surgical complications, length of stay, death) were worse with PDS because of the higher surgical complexity that it demands. In the most recent SCORPION trial, rates of major postoperative complications in the PDS group were 25.9%, compared with only 7.6% in the NACT group (P < .0001) and all of the deaths from postoperative complications occurred in the PDS group at a rate of 8.3% (7 of 84 patients).7
Therefore, the wealth of data supports that oncologic outcomes are equivalent, and perioperative outcomes are improved for patients who undergo NACT for advanced, bulky ovarian cancer.
Why physicians still are questioning
Unfortunately, because ofthe nature of the disease, these prospective trials include heterogeneous populations of disease presentation, surgeon skill, and hospital settings. They have been criticized for achieving “low” rates of complete or optimal cytoreduction in the PDS arm. They also identified subgroups of patients who may do better with PDS (such as those with lower-volume stage IIIC disease) and those who have better outcomes with NACT (patients with stage IV disease). Therefore, not satisfied that we have definitively answered the question, a fifth randomized study, the TRUST trial, is underway.8 This study includes surgeons at high-volume institutions, purported to have the highest degree of skill and quality in executing radical debulking procedures. Perhaps this fifth trial will show that, if performed in the most skilled hands and quality settings, PDS is preferable to NACT. Perhaps. However, the generalizability of these results will be poor for all patients with advanced ovarian cancer, most of whom will have limited access to these highest-volume surgeons.
What can be agreed upon is that an individualized and nuanced approach is best for advanced ovarian cancer. There will be some patients who benefit from PDS (e.g., healthy, young patients with low-volume disease). However, for most patients, the bulk of prospective and translational research supports NACT as the default treatment course, associated with noninferior survival and superior perioperative outcomes (including postoperative death). While it may not be a one-size-fits-all approach, one could argue that NACT should be the default strategy, and surgeons should look for reasons to “opt in” to PDS in special circumstances guided by biomarkers such as imaging, tumor markers, clinical factors, and surgical findings.
Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She has no relevant financial disclosures. Email her at [email protected].
References
1. Gynecol Oncol. 2006 Dec. doi: 10.1016/j.ygyno.2006.06.025.
2. Cell Rep. 2020 Apr 14. doi: 10.1016/j.celrep.2020.03.066.
3. J Clin Oncol. 2015 Mar 10. doi: 10.1200/JCO.2014.56.3106.
4. N Engl J Med. 2010 Sep 2. doi: 10.1056/NEJMoa0908806.
5. Lancet. 2015 Jul 18. doi: 10.1016/S0140-6736(14)62223-6.
6. Eur J Cancer. 2020. doi: 10.1016/j.ejca.2020.02.020.
7. Int J Gynecol Cancer. 2020. doi: 10.1136/ijgc-2020-001640.
8. Int J Gynecol Cancer. 2019. doi: 10.1136/ijgc-2019-000682.
Prophylactic HIV treatment in female STI patients is rare
reported Kirk D. Henny, PhD, and colleagues of the Centers for Disease Control and Prevention.
In an effort to quantify HIV testing rates as well as the rate of pre-exposure prophylaxis (PrEP) among women with gonorrhea or syphilis, Dr. Henny and his colleagues performed a multivariate logistic regression analysis of 13,074 female patients aged 15-64 diagnosed with a STI in the absence of HIV. Data was pulled in 2017 from the IBM MarketScan commercial and Medicaid insurance databases, and the research was published in Obstetrics & Gynecology.
Medicaid patients were more likely to be tested for HIV
A total of 3,709 patients with commercial insurance were diagnosed with gonorrhea and 1,696 with syphilis. Among those with Medicaid, 6,172 were diagnosed with gonorrhea and 1,497 with syphilis. Medicaid patients diagnosed with either STI were more likely to be tested for HIV than the commercially insured patients. With an adjusted prevalence ratio, patients commercially insured with had either STI were more likely to be tested for HIV than patients who had no STI. Prophylactic treatment rates were similar in both insurance groups: 0.15% in the commercial insurance group and 0.26% in the Medicaid group. No patient from either group who was diagnosed with gonorrhea or syphilis and subsequently tested for HIV received pre-exposure prophylactic (PrEP) treatment.
STI diagnosis is a significant indicator of future HIV
Female patients diagnosed with either STI are more likely to contract HIV, the researchers noted. They cautioned that their findings of low HIV testing rates and the absence of prophylactic treatment means that “these missed opportunities for health care professionals to intervene with female patients diagnosed with gonorrhea or syphilis might have contributed to HIV infections that could have been averted.”
The researchers also pointed out that, in a recent analysis of pharmacy data, prophylactic prescribing for female patients with clinical indications for PrEP was 6.6%, less than one-third the coverage provided to male patients.
Future research should target understanding “individual and contextual factors associated with low HIV testing” and PrEP treatment in female patients, especially those with STIs, Dr. Henny and his colleagues advised.
In a separate interview, Constance Bohon, MD FACOG, observed: “The authors present data to document the low incidence of pre-exposure prophylaxis in women who are at substantial risk of acquiring HIV and possible causes for the low utilization of this treatment.” It is important to identify barriers to diagnosis, counseling, and treatment, she advised.
“Multicenter studies to determine the best methodologies to improve the identification, management, and treatment of these at-risk women need to be done, and the conclusions disseminated to health care providers caring for women,” Dr. Bohon said.
PrEP is an important, simple strategy for reducing HIV transmission
“Pre-exposure prophylaxis has been demonstrated to decrease HIV acquisition in those at risk by up to 90% when taken appropriately,” and yet prescribing rates are extremely low (2%-6%) in at-risk women and especially women of color. These disparities have only grown over time, with prophylactic prescriptions for women at 5% between 2012 and 2017, compared with 68% for men, Catherine S. Eppes, MD, MPH, and Jennifer McKinney, MD, MPH, said in a related editorial commenting on the Research Letter by Dr. Henny and colleagues in Obstetrics & Gynecology (2020 Dec;136[6]:1080-2).
Given the abundant research demonstrating the importance and ease of prescribing PrEP, the question remains: “why does preexposure prophylaxis uptake remain so low, especially for women and women of color? There are three important issues about preexposure prophylaxis raised by this study: the research gap, the implementation gap, and the effect of systemic racism and bias,” noted Dr. Eppes and Dr. McKinney.
Women constitute a significant portion of the population that would benefit from HIV-prevention strategies, yet they continue to be excluded from research, they noted. “Much focus on research into barriers and implementation interventions for preexposure prophylaxis have focused on men who have sex with men and transgender women,” the authors of the editorial wrote.
Most women eligible for treatment would be willing to consider it if they were aware of the option, but numerous studies have cited a lack of awareness, especially among high-risk women of color in the United States, Dr. Eppes and Dr. McKinney noted.
Clinicians also need to add it to their growing checklist of mandatory appointment discussion topics, the editorialists said. “We propose standardized inclusion of preexposure prophylaxis counseling during reproductive healthcare visits. This could be aided through an electronic medical record-based best practice advisory alert. … Standardized order sets with the medication and laboratory studies necessary for safe monitoring could facilitate ease of incorporating into routine visits,” they suggested.
“Preexposure prophylaxis is extremely effective in preventing HIV, is safe, and is the only prevention method that leaves control entirely in the hands of the female partner. As a specialty, we have a responsibility to make sure our patients know about this option,” the editorialists concluded.
The authors had no financial disclosures to report. Dr. Bohon had no conflicts of interest to report.
SOURCE: Henny KD et al. Obstet Gynecol. 2020 Dec;136(6):1083-5.
reported Kirk D. Henny, PhD, and colleagues of the Centers for Disease Control and Prevention.
In an effort to quantify HIV testing rates as well as the rate of pre-exposure prophylaxis (PrEP) among women with gonorrhea or syphilis, Dr. Henny and his colleagues performed a multivariate logistic regression analysis of 13,074 female patients aged 15-64 diagnosed with a STI in the absence of HIV. Data was pulled in 2017 from the IBM MarketScan commercial and Medicaid insurance databases, and the research was published in Obstetrics & Gynecology.
Medicaid patients were more likely to be tested for HIV
A total of 3,709 patients with commercial insurance were diagnosed with gonorrhea and 1,696 with syphilis. Among those with Medicaid, 6,172 were diagnosed with gonorrhea and 1,497 with syphilis. Medicaid patients diagnosed with either STI were more likely to be tested for HIV than the commercially insured patients. With an adjusted prevalence ratio, patients commercially insured with had either STI were more likely to be tested for HIV than patients who had no STI. Prophylactic treatment rates were similar in both insurance groups: 0.15% in the commercial insurance group and 0.26% in the Medicaid group. No patient from either group who was diagnosed with gonorrhea or syphilis and subsequently tested for HIV received pre-exposure prophylactic (PrEP) treatment.
STI diagnosis is a significant indicator of future HIV
Female patients diagnosed with either STI are more likely to contract HIV, the researchers noted. They cautioned that their findings of low HIV testing rates and the absence of prophylactic treatment means that “these missed opportunities for health care professionals to intervene with female patients diagnosed with gonorrhea or syphilis might have contributed to HIV infections that could have been averted.”
The researchers also pointed out that, in a recent analysis of pharmacy data, prophylactic prescribing for female patients with clinical indications for PrEP was 6.6%, less than one-third the coverage provided to male patients.
Future research should target understanding “individual and contextual factors associated with low HIV testing” and PrEP treatment in female patients, especially those with STIs, Dr. Henny and his colleagues advised.
In a separate interview, Constance Bohon, MD FACOG, observed: “The authors present data to document the low incidence of pre-exposure prophylaxis in women who are at substantial risk of acquiring HIV and possible causes for the low utilization of this treatment.” It is important to identify barriers to diagnosis, counseling, and treatment, she advised.
“Multicenter studies to determine the best methodologies to improve the identification, management, and treatment of these at-risk women need to be done, and the conclusions disseminated to health care providers caring for women,” Dr. Bohon said.
PrEP is an important, simple strategy for reducing HIV transmission
“Pre-exposure prophylaxis has been demonstrated to decrease HIV acquisition in those at risk by up to 90% when taken appropriately,” and yet prescribing rates are extremely low (2%-6%) in at-risk women and especially women of color. These disparities have only grown over time, with prophylactic prescriptions for women at 5% between 2012 and 2017, compared with 68% for men, Catherine S. Eppes, MD, MPH, and Jennifer McKinney, MD, MPH, said in a related editorial commenting on the Research Letter by Dr. Henny and colleagues in Obstetrics & Gynecology (2020 Dec;136[6]:1080-2).
Given the abundant research demonstrating the importance and ease of prescribing PrEP, the question remains: “why does preexposure prophylaxis uptake remain so low, especially for women and women of color? There are three important issues about preexposure prophylaxis raised by this study: the research gap, the implementation gap, and the effect of systemic racism and bias,” noted Dr. Eppes and Dr. McKinney.
Women constitute a significant portion of the population that would benefit from HIV-prevention strategies, yet they continue to be excluded from research, they noted. “Much focus on research into barriers and implementation interventions for preexposure prophylaxis have focused on men who have sex with men and transgender women,” the authors of the editorial wrote.
Most women eligible for treatment would be willing to consider it if they were aware of the option, but numerous studies have cited a lack of awareness, especially among high-risk women of color in the United States, Dr. Eppes and Dr. McKinney noted.
Clinicians also need to add it to their growing checklist of mandatory appointment discussion topics, the editorialists said. “We propose standardized inclusion of preexposure prophylaxis counseling during reproductive healthcare visits. This could be aided through an electronic medical record-based best practice advisory alert. … Standardized order sets with the medication and laboratory studies necessary for safe monitoring could facilitate ease of incorporating into routine visits,” they suggested.
“Preexposure prophylaxis is extremely effective in preventing HIV, is safe, and is the only prevention method that leaves control entirely in the hands of the female partner. As a specialty, we have a responsibility to make sure our patients know about this option,” the editorialists concluded.
The authors had no financial disclosures to report. Dr. Bohon had no conflicts of interest to report.
SOURCE: Henny KD et al. Obstet Gynecol. 2020 Dec;136(6):1083-5.
reported Kirk D. Henny, PhD, and colleagues of the Centers for Disease Control and Prevention.
In an effort to quantify HIV testing rates as well as the rate of pre-exposure prophylaxis (PrEP) among women with gonorrhea or syphilis, Dr. Henny and his colleagues performed a multivariate logistic regression analysis of 13,074 female patients aged 15-64 diagnosed with a STI in the absence of HIV. Data was pulled in 2017 from the IBM MarketScan commercial and Medicaid insurance databases, and the research was published in Obstetrics & Gynecology.
Medicaid patients were more likely to be tested for HIV
A total of 3,709 patients with commercial insurance were diagnosed with gonorrhea and 1,696 with syphilis. Among those with Medicaid, 6,172 were diagnosed with gonorrhea and 1,497 with syphilis. Medicaid patients diagnosed with either STI were more likely to be tested for HIV than the commercially insured patients. With an adjusted prevalence ratio, patients commercially insured with had either STI were more likely to be tested for HIV than patients who had no STI. Prophylactic treatment rates were similar in both insurance groups: 0.15% in the commercial insurance group and 0.26% in the Medicaid group. No patient from either group who was diagnosed with gonorrhea or syphilis and subsequently tested for HIV received pre-exposure prophylactic (PrEP) treatment.
STI diagnosis is a significant indicator of future HIV
Female patients diagnosed with either STI are more likely to contract HIV, the researchers noted. They cautioned that their findings of low HIV testing rates and the absence of prophylactic treatment means that “these missed opportunities for health care professionals to intervene with female patients diagnosed with gonorrhea or syphilis might have contributed to HIV infections that could have been averted.”
The researchers also pointed out that, in a recent analysis of pharmacy data, prophylactic prescribing for female patients with clinical indications for PrEP was 6.6%, less than one-third the coverage provided to male patients.
Future research should target understanding “individual and contextual factors associated with low HIV testing” and PrEP treatment in female patients, especially those with STIs, Dr. Henny and his colleagues advised.
In a separate interview, Constance Bohon, MD FACOG, observed: “The authors present data to document the low incidence of pre-exposure prophylaxis in women who are at substantial risk of acquiring HIV and possible causes for the low utilization of this treatment.” It is important to identify barriers to diagnosis, counseling, and treatment, she advised.
“Multicenter studies to determine the best methodologies to improve the identification, management, and treatment of these at-risk women need to be done, and the conclusions disseminated to health care providers caring for women,” Dr. Bohon said.
PrEP is an important, simple strategy for reducing HIV transmission
“Pre-exposure prophylaxis has been demonstrated to decrease HIV acquisition in those at risk by up to 90% when taken appropriately,” and yet prescribing rates are extremely low (2%-6%) in at-risk women and especially women of color. These disparities have only grown over time, with prophylactic prescriptions for women at 5% between 2012 and 2017, compared with 68% for men, Catherine S. Eppes, MD, MPH, and Jennifer McKinney, MD, MPH, said in a related editorial commenting on the Research Letter by Dr. Henny and colleagues in Obstetrics & Gynecology (2020 Dec;136[6]:1080-2).
Given the abundant research demonstrating the importance and ease of prescribing PrEP, the question remains: “why does preexposure prophylaxis uptake remain so low, especially for women and women of color? There are three important issues about preexposure prophylaxis raised by this study: the research gap, the implementation gap, and the effect of systemic racism and bias,” noted Dr. Eppes and Dr. McKinney.
Women constitute a significant portion of the population that would benefit from HIV-prevention strategies, yet they continue to be excluded from research, they noted. “Much focus on research into barriers and implementation interventions for preexposure prophylaxis have focused on men who have sex with men and transgender women,” the authors of the editorial wrote.
Most women eligible for treatment would be willing to consider it if they were aware of the option, but numerous studies have cited a lack of awareness, especially among high-risk women of color in the United States, Dr. Eppes and Dr. McKinney noted.
Clinicians also need to add it to their growing checklist of mandatory appointment discussion topics, the editorialists said. “We propose standardized inclusion of preexposure prophylaxis counseling during reproductive healthcare visits. This could be aided through an electronic medical record-based best practice advisory alert. … Standardized order sets with the medication and laboratory studies necessary for safe monitoring could facilitate ease of incorporating into routine visits,” they suggested.
“Preexposure prophylaxis is extremely effective in preventing HIV, is safe, and is the only prevention method that leaves control entirely in the hands of the female partner. As a specialty, we have a responsibility to make sure our patients know about this option,” the editorialists concluded.
The authors had no financial disclosures to report. Dr. Bohon had no conflicts of interest to report.
SOURCE: Henny KD et al. Obstet Gynecol. 2020 Dec;136(6):1083-5.
FROM OBSTETRICS & GYNECOLOGY
Is a pelvic examination necessary 6 weeks after hysterectomy?
Doctors commonly perform pelvic examinations approximately 6 weeks following hysterectomy to assess the integrity of the vaginal cuff. But this practice may not be necessary if patients do not have symptoms, a study suggests.
“The 6-week posthysterectomy pelvic examination in asymptomatic women may not be necessary, as it neither detected cuff dehiscence nor negated future risk for dehiscence,” Ritchie Mae Delara, MD, said at the meeting sponsored by AAGL, held virtually this year.
Dr. Delara, of the Mayo Clinic in Phoenix, and colleagues conducted a retrospective cohort study of data from more than 2,000 patients to assess the utility of the 6-week posthysterectomy pelvic examination in detecting cuff dehiscence in asymptomatic women.
An unpredictable complication
Vaginal cuff dehiscence is a rare complication of hysterectomy that can occur days or decades after surgery, which makes “identifying an optimal time for cuff evaluation difficult,” Dr. Delara said. “Currently there is neither evidence demonstrating benefit of routine posthysterectomy examination in detecting vaginal cuff dehiscence, nor data demonstrating the best time to perform posthysterectomy examination.”
For their study, which was also published in the Journal of Minimally Invasive Gynecology, the researchers examined data from 2,051 women who underwent hysterectomy at a single institution during a 6-year period. Patients received at least one postoperative evaluation within 90 days of surgery. Examination of the vaginal cuff routinely was performed approximately 6 weeks after hysterectomy. Patients’ posthysterectomy symptoms and pelvic examination findings were recorded.
About 80% of patients were asymptomatic at the 6-week visit.
Asymptomatic patients were more likely to have normal pelvic examination findings, compared with patients with posthysterectomy symptoms (86.4% vs. 54.3%).
In all, 13 patients experienced complete cuff dehiscence. All of them had an intact vaginal cuff at their 6-week examination. Three had symptoms at that time, including vaginal bleeding in one patient and pelvic pain in two patients.
One patient experienced a complete cuff dehiscence that was provoked by intercourse prior to her examination. The patient subsequently developed two additional episodes of dehiscence provoked by intercourse.
Dehiscence may present differently after benign and oncologic hysterectomies, the study indicated.
Eight patients who experienced complete cuff dehiscence after benign hysterectomy had symptoms such as pelvic pain and vaginal bleeding at the time of presentation for dehiscence, which mainly occurred after intercourse.
Five patients who experienced dehiscence after oncologic hysterectomy were more likely to present without symptoms or provocation.
The median time to dehiscence after benign hysterectomy was about 19 weeks, whereas the median time to dehiscence after oncologic hysterectomy was about 81 weeks.
Surgeons should educate patients about symptoms of dehiscence and the potential for events such as coitus to provoke its occurrence, and patients should promptly seek evaluation if symptoms occur, Dr. Delara said.
Patients with risk factors such as malignancy may benefit from continued routine evaluation, she added.
Timely research
The findings may be especially relevant during the COVID-19 pandemic, when states have issued shelter-in-place orders and doctors have increased their use of telemedicine to reduce in-person visits, Dr. Delara noted.
In that sense, the study is “extremely timely” and may inform and support practice changes, commented Emad Mikhail, MD, in a discussion following the research presentation.
Whether the results generalize to other centers, including smaller centers that perform fewer surgeries, is unclear, said Dr. Mikhail, of the University of South Florida, Tampa.
“It takes vision and critical thinking to challenge these traditional practices,” he said. “I applaud Dr. Delara for challenging one of these.”
Dr. Delara and Dr. Mikhail had no relevant disclosures.
SOURCE: Delara RMM et al. J Minim Invasive Gynecol. 2020 Nov 1. doi: 10.1016/j.jmig.2020.08.306.
Doctors commonly perform pelvic examinations approximately 6 weeks following hysterectomy to assess the integrity of the vaginal cuff. But this practice may not be necessary if patients do not have symptoms, a study suggests.
“The 6-week posthysterectomy pelvic examination in asymptomatic women may not be necessary, as it neither detected cuff dehiscence nor negated future risk for dehiscence,” Ritchie Mae Delara, MD, said at the meeting sponsored by AAGL, held virtually this year.
Dr. Delara, of the Mayo Clinic in Phoenix, and colleagues conducted a retrospective cohort study of data from more than 2,000 patients to assess the utility of the 6-week posthysterectomy pelvic examination in detecting cuff dehiscence in asymptomatic women.
An unpredictable complication
Vaginal cuff dehiscence is a rare complication of hysterectomy that can occur days or decades after surgery, which makes “identifying an optimal time for cuff evaluation difficult,” Dr. Delara said. “Currently there is neither evidence demonstrating benefit of routine posthysterectomy examination in detecting vaginal cuff dehiscence, nor data demonstrating the best time to perform posthysterectomy examination.”
For their study, which was also published in the Journal of Minimally Invasive Gynecology, the researchers examined data from 2,051 women who underwent hysterectomy at a single institution during a 6-year period. Patients received at least one postoperative evaluation within 90 days of surgery. Examination of the vaginal cuff routinely was performed approximately 6 weeks after hysterectomy. Patients’ posthysterectomy symptoms and pelvic examination findings were recorded.
About 80% of patients were asymptomatic at the 6-week visit.
Asymptomatic patients were more likely to have normal pelvic examination findings, compared with patients with posthysterectomy symptoms (86.4% vs. 54.3%).
In all, 13 patients experienced complete cuff dehiscence. All of them had an intact vaginal cuff at their 6-week examination. Three had symptoms at that time, including vaginal bleeding in one patient and pelvic pain in two patients.
One patient experienced a complete cuff dehiscence that was provoked by intercourse prior to her examination. The patient subsequently developed two additional episodes of dehiscence provoked by intercourse.
Dehiscence may present differently after benign and oncologic hysterectomies, the study indicated.
Eight patients who experienced complete cuff dehiscence after benign hysterectomy had symptoms such as pelvic pain and vaginal bleeding at the time of presentation for dehiscence, which mainly occurred after intercourse.
Five patients who experienced dehiscence after oncologic hysterectomy were more likely to present without symptoms or provocation.
The median time to dehiscence after benign hysterectomy was about 19 weeks, whereas the median time to dehiscence after oncologic hysterectomy was about 81 weeks.
Surgeons should educate patients about symptoms of dehiscence and the potential for events such as coitus to provoke its occurrence, and patients should promptly seek evaluation if symptoms occur, Dr. Delara said.
Patients with risk factors such as malignancy may benefit from continued routine evaluation, she added.
Timely research
The findings may be especially relevant during the COVID-19 pandemic, when states have issued shelter-in-place orders and doctors have increased their use of telemedicine to reduce in-person visits, Dr. Delara noted.
In that sense, the study is “extremely timely” and may inform and support practice changes, commented Emad Mikhail, MD, in a discussion following the research presentation.
Whether the results generalize to other centers, including smaller centers that perform fewer surgeries, is unclear, said Dr. Mikhail, of the University of South Florida, Tampa.
“It takes vision and critical thinking to challenge these traditional practices,” he said. “I applaud Dr. Delara for challenging one of these.”
Dr. Delara and Dr. Mikhail had no relevant disclosures.
SOURCE: Delara RMM et al. J Minim Invasive Gynecol. 2020 Nov 1. doi: 10.1016/j.jmig.2020.08.306.
Doctors commonly perform pelvic examinations approximately 6 weeks following hysterectomy to assess the integrity of the vaginal cuff. But this practice may not be necessary if patients do not have symptoms, a study suggests.
“The 6-week posthysterectomy pelvic examination in asymptomatic women may not be necessary, as it neither detected cuff dehiscence nor negated future risk for dehiscence,” Ritchie Mae Delara, MD, said at the meeting sponsored by AAGL, held virtually this year.
Dr. Delara, of the Mayo Clinic in Phoenix, and colleagues conducted a retrospective cohort study of data from more than 2,000 patients to assess the utility of the 6-week posthysterectomy pelvic examination in detecting cuff dehiscence in asymptomatic women.
An unpredictable complication
Vaginal cuff dehiscence is a rare complication of hysterectomy that can occur days or decades after surgery, which makes “identifying an optimal time for cuff evaluation difficult,” Dr. Delara said. “Currently there is neither evidence demonstrating benefit of routine posthysterectomy examination in detecting vaginal cuff dehiscence, nor data demonstrating the best time to perform posthysterectomy examination.”
For their study, which was also published in the Journal of Minimally Invasive Gynecology, the researchers examined data from 2,051 women who underwent hysterectomy at a single institution during a 6-year period. Patients received at least one postoperative evaluation within 90 days of surgery. Examination of the vaginal cuff routinely was performed approximately 6 weeks after hysterectomy. Patients’ posthysterectomy symptoms and pelvic examination findings were recorded.
About 80% of patients were asymptomatic at the 6-week visit.
Asymptomatic patients were more likely to have normal pelvic examination findings, compared with patients with posthysterectomy symptoms (86.4% vs. 54.3%).
In all, 13 patients experienced complete cuff dehiscence. All of them had an intact vaginal cuff at their 6-week examination. Three had symptoms at that time, including vaginal bleeding in one patient and pelvic pain in two patients.
One patient experienced a complete cuff dehiscence that was provoked by intercourse prior to her examination. The patient subsequently developed two additional episodes of dehiscence provoked by intercourse.
Dehiscence may present differently after benign and oncologic hysterectomies, the study indicated.
Eight patients who experienced complete cuff dehiscence after benign hysterectomy had symptoms such as pelvic pain and vaginal bleeding at the time of presentation for dehiscence, which mainly occurred after intercourse.
Five patients who experienced dehiscence after oncologic hysterectomy were more likely to present without symptoms or provocation.
The median time to dehiscence after benign hysterectomy was about 19 weeks, whereas the median time to dehiscence after oncologic hysterectomy was about 81 weeks.
Surgeons should educate patients about symptoms of dehiscence and the potential for events such as coitus to provoke its occurrence, and patients should promptly seek evaluation if symptoms occur, Dr. Delara said.
Patients with risk factors such as malignancy may benefit from continued routine evaluation, she added.
Timely research
The findings may be especially relevant during the COVID-19 pandemic, when states have issued shelter-in-place orders and doctors have increased their use of telemedicine to reduce in-person visits, Dr. Delara noted.
In that sense, the study is “extremely timely” and may inform and support practice changes, commented Emad Mikhail, MD, in a discussion following the research presentation.
Whether the results generalize to other centers, including smaller centers that perform fewer surgeries, is unclear, said Dr. Mikhail, of the University of South Florida, Tampa.
“It takes vision and critical thinking to challenge these traditional practices,” he said. “I applaud Dr. Delara for challenging one of these.”
Dr. Delara and Dr. Mikhail had no relevant disclosures.
SOURCE: Delara RMM et al. J Minim Invasive Gynecol. 2020 Nov 1. doi: 10.1016/j.jmig.2020.08.306.
FROM AAGL GLOBAL CONGRESS
Can a gene expression signature help diagnose endometriosis?
A gene expression signature may help physicians diagnose endometriosis by analyzing samples from endometrial biopsies instead of relying on more invasive methods, research suggests.
Yana B. Aznaurova, MD, and colleagues identified and validated a genetic biomarker based on differences in the endometrium of women with and without endometriosis. The biomarker is based on five genes that were down-regulated in patients with the disease.
Endometriosis is an enigmatic gynecologic disease that is associated with chronic pelvic pain, dyspareunia, and dysmenorrhea, said Dr. Aznaurova, of the department of reproductive medicine and surgery at A.I. Evdokimov Moscow State Medical and Dental University. Laparoscopy with histological confirmation is the standard method of diagnosis.
“Development of minimally invasive or even noninvasive diagnostic tests is a research priority in endometriosis,” she said at the meeting sponsored by the American Association of Gynecologic Laparoscopists, held virtually this year.
Attempts to identify biomarkers have tended to focus on single genes or proteins, but “endometriosis is a ... multifactorial disease,” said Dr. Aznaurova. Researchers have found that signaling pathway activation profiles are a more stable and reliable marker of some diseases.
To validate a complex gene expression biomarker for the diagnosis of endometriosis, the researchers conducted an observational cohort study that included 50 women with endometriosis and 35 controls. The patients with endometriosis were 18-49 years old, had not received hormone therapy in the past year, and did not have other gynecologic diseases. Patients in the control group had uterine scar incompetence after cesarean section, but did not have endometriosis or other gynecologic disease.
Investigators performed RNA sequencing of endometrial samples, including 50 eutopic and 50 ectopic samples from patients with endometriosis, and 35 samples from patients in the control group.
They analyzed gene expression and intracellular pathway activation profiles to identify an endometrial gene expression signature that differentiated samples from patients with and without the disease, with an area under the receiver operating characteristic curve of approximately 0.99.
The researchers further studied the biomarker using preexisting datasets with 120 other tissue samples, including from the cervix, ovarian surface epithelium, stomach, and lung. The biomarker had a sensitivity of 94% and specificity of 97% for endometriosis in these analyses.
The results suggest that the genetic biomarker “could be potentially used as a basis for early diagnosis of endometriosis via utilization of endometrial biopsy only,” Dr. Aznaurova said.
Further studies are needed to validate these findings, she noted.
“If we had a noninvasive way to look for endometriosis, this would be very powerful – very important as potentially a diagnostic test, or a triage test, or a monitoring test of treatment,” Patrick P. Yeung Jr., MD, said in a discussion following Dr. Aznaurova’s presentation.
The test might even suggest a target for treatment, said Dr. Yeung, professor of obstetrics, gynecology, and women’s health at Saint Louis University.
Dr. Aznaurova and Dr. Yeung had no relevant financial disclosures.
SOURCE: Aznaurova YB et al. J Minim Invasive Gynecol. 2020 Nov. doi: 10.1016/j.jmig.2020.08.040.
A gene expression signature may help physicians diagnose endometriosis by analyzing samples from endometrial biopsies instead of relying on more invasive methods, research suggests.
Yana B. Aznaurova, MD, and colleagues identified and validated a genetic biomarker based on differences in the endometrium of women with and without endometriosis. The biomarker is based on five genes that were down-regulated in patients with the disease.
Endometriosis is an enigmatic gynecologic disease that is associated with chronic pelvic pain, dyspareunia, and dysmenorrhea, said Dr. Aznaurova, of the department of reproductive medicine and surgery at A.I. Evdokimov Moscow State Medical and Dental University. Laparoscopy with histological confirmation is the standard method of diagnosis.
“Development of minimally invasive or even noninvasive diagnostic tests is a research priority in endometriosis,” she said at the meeting sponsored by the American Association of Gynecologic Laparoscopists, held virtually this year.
Attempts to identify biomarkers have tended to focus on single genes or proteins, but “endometriosis is a ... multifactorial disease,” said Dr. Aznaurova. Researchers have found that signaling pathway activation profiles are a more stable and reliable marker of some diseases.
To validate a complex gene expression biomarker for the diagnosis of endometriosis, the researchers conducted an observational cohort study that included 50 women with endometriosis and 35 controls. The patients with endometriosis were 18-49 years old, had not received hormone therapy in the past year, and did not have other gynecologic diseases. Patients in the control group had uterine scar incompetence after cesarean section, but did not have endometriosis or other gynecologic disease.
Investigators performed RNA sequencing of endometrial samples, including 50 eutopic and 50 ectopic samples from patients with endometriosis, and 35 samples from patients in the control group.
They analyzed gene expression and intracellular pathway activation profiles to identify an endometrial gene expression signature that differentiated samples from patients with and without the disease, with an area under the receiver operating characteristic curve of approximately 0.99.
The researchers further studied the biomarker using preexisting datasets with 120 other tissue samples, including from the cervix, ovarian surface epithelium, stomach, and lung. The biomarker had a sensitivity of 94% and specificity of 97% for endometriosis in these analyses.
The results suggest that the genetic biomarker “could be potentially used as a basis for early diagnosis of endometriosis via utilization of endometrial biopsy only,” Dr. Aznaurova said.
Further studies are needed to validate these findings, she noted.
“If we had a noninvasive way to look for endometriosis, this would be very powerful – very important as potentially a diagnostic test, or a triage test, or a monitoring test of treatment,” Patrick P. Yeung Jr., MD, said in a discussion following Dr. Aznaurova’s presentation.
The test might even suggest a target for treatment, said Dr. Yeung, professor of obstetrics, gynecology, and women’s health at Saint Louis University.
Dr. Aznaurova and Dr. Yeung had no relevant financial disclosures.
SOURCE: Aznaurova YB et al. J Minim Invasive Gynecol. 2020 Nov. doi: 10.1016/j.jmig.2020.08.040.
A gene expression signature may help physicians diagnose endometriosis by analyzing samples from endometrial biopsies instead of relying on more invasive methods, research suggests.
Yana B. Aznaurova, MD, and colleagues identified and validated a genetic biomarker based on differences in the endometrium of women with and without endometriosis. The biomarker is based on five genes that were down-regulated in patients with the disease.
Endometriosis is an enigmatic gynecologic disease that is associated with chronic pelvic pain, dyspareunia, and dysmenorrhea, said Dr. Aznaurova, of the department of reproductive medicine and surgery at A.I. Evdokimov Moscow State Medical and Dental University. Laparoscopy with histological confirmation is the standard method of diagnosis.
“Development of minimally invasive or even noninvasive diagnostic tests is a research priority in endometriosis,” she said at the meeting sponsored by the American Association of Gynecologic Laparoscopists, held virtually this year.
Attempts to identify biomarkers have tended to focus on single genes or proteins, but “endometriosis is a ... multifactorial disease,” said Dr. Aznaurova. Researchers have found that signaling pathway activation profiles are a more stable and reliable marker of some diseases.
To validate a complex gene expression biomarker for the diagnosis of endometriosis, the researchers conducted an observational cohort study that included 50 women with endometriosis and 35 controls. The patients with endometriosis were 18-49 years old, had not received hormone therapy in the past year, and did not have other gynecologic diseases. Patients in the control group had uterine scar incompetence after cesarean section, but did not have endometriosis or other gynecologic disease.
Investigators performed RNA sequencing of endometrial samples, including 50 eutopic and 50 ectopic samples from patients with endometriosis, and 35 samples from patients in the control group.
They analyzed gene expression and intracellular pathway activation profiles to identify an endometrial gene expression signature that differentiated samples from patients with and without the disease, with an area under the receiver operating characteristic curve of approximately 0.99.
The researchers further studied the biomarker using preexisting datasets with 120 other tissue samples, including from the cervix, ovarian surface epithelium, stomach, and lung. The biomarker had a sensitivity of 94% and specificity of 97% for endometriosis in these analyses.
The results suggest that the genetic biomarker “could be potentially used as a basis for early diagnosis of endometriosis via utilization of endometrial biopsy only,” Dr. Aznaurova said.
Further studies are needed to validate these findings, she noted.
“If we had a noninvasive way to look for endometriosis, this would be very powerful – very important as potentially a diagnostic test, or a triage test, or a monitoring test of treatment,” Patrick P. Yeung Jr., MD, said in a discussion following Dr. Aznaurova’s presentation.
The test might even suggest a target for treatment, said Dr. Yeung, professor of obstetrics, gynecology, and women’s health at Saint Louis University.
Dr. Aznaurova and Dr. Yeung had no relevant financial disclosures.
SOURCE: Aznaurova YB et al. J Minim Invasive Gynecol. 2020 Nov. doi: 10.1016/j.jmig.2020.08.040.
FROM AAGL GLOBAL CONGRESS
Harnessing the HIV care continuum model to improve HCV treatment success
Better linkage to care with providers who are familiar with both the HCV and HIV treatment cascade may not only improve access to HCV treatment, but it may also support patient retention, treatment adherence, and achievement of sustained virologic response (SVR) and viral suppression, said Stephanie LaMoy, CAN Community Health, North Point, Florida. She presented the results of a pilot study at the virtual Association of Nurses in AIDS Care 2020 Annual Meeting.
In an effort to identify strategies most important for improving care access among their patients with HCV, LaMoy and her colleagues assessed 12-month patient data collected from three of their clinics. These data were evaluated for HCV treatment access, engagement, and outcomes.
The pilot study included 126 patients who were reactive and another 24 HCV-positive patients who were referred from other sources. Active HCV infections requiring treatment were reported in 144 patients.
A total of 59 patients were linked to care but did not initiate treatment for their active infection. LaMoy said there were multiple causes, including homelessness, substance abuse, and inability to maintain contact.
In contrast, 85 patients with HCV infection started treatment, but 35 of these patients did not complete their regimen. Out of the 50 patients who reported completing treatment, 30 did not return to the clinic to confirm sustained viral suppression.
According to LaMoy, this raised a red flag, causing the investigators to consider a different approach to care.
HIV care continuum model and its role in HCV
To improve the rate at which patients with HCV infection complete treatment within their clinics, the researchers formed a panel to determine necessary interventions that could reduce barriers to care.
The HIV care continuum came into play. They chose this model based on knowledge that HCV and HIV share the same care continuum with similar goals in diagnosis, linkage to care, retention, and suppression.
Based on the consensus of the panel and consideration of the HIV care continuum model, they identified a number of interventions needed to mitigate HCV treatment barriers. These included the incorporation of peer navigators or linkage-to-care (LCC) coordinators, use of the mobile medical unit, greater implementation of onsite lab visits, and medication-assisted treatment.
The LCC coordinators proved to be particularly important, as these team members helped assist patients with social and financial support to address challenges with access to treatment. These coordinators can also help patients gain access to specialized providers, ultimately improving the chance of successful HCV management.
Additionally, LCC coordinators may help identify and reduce barriers associated with housing, transportation, and nutrition. Frequent patient contact by the LCC coordinators can encourage adherence and promote risk reduction education, such as providing referrals to needle exchange services.
“Linking individuals to care with providers who are familiar with the treatment cascade could help improve retention and should be a top priority for those involved in HCV screening and treatment,” said LaMoy. “An environment with knowledge, lack of judgment, and a tenacious need to heal the community that welcomes those with barriers to care is exactly what is needed for the patients in our program.”
National, community challenges fuel barriers to HCV treatment access
Substance use, trauma histories, and mental health problems can negatively affect care engagement and must be addressed before the benefits of HCV therapy can be realized.
Addressing these issues isn’t always easy, said Kathleen Bernock, FNP-BC, AACRN, AAHIVS, of the Bedford-Stuyvesant Family Health Center in New York City, in an email to Medscape Medical News. She pointed out that several states have harsh restrictions on who is able to access HCV treatment, and some states will not approve certain medications for people who actively use drugs.
“Even for states without these restrictions, many health systems are difficult to navigate and may not be welcoming to persons actively using,” said Bernock. Trauma-informed care can also be difficult to translate into clinics, she added.
“Decentralizing care to the communities most affected would greatly help mitigate these barriers,” suggested Bernock. Decentralization, she explained, might include co-locating services such as syringe exchanges, utilizing community health workers and patient navigators, and expanding capacity-to-treat to community-based providers.
“[And] with the expansion of telehealth services in the US,” said Bernock, “we now have even more avenues to reach people that we never had before.”
LaMoy and Bernock have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Better linkage to care with providers who are familiar with both the HCV and HIV treatment cascade may not only improve access to HCV treatment, but it may also support patient retention, treatment adherence, and achievement of sustained virologic response (SVR) and viral suppression, said Stephanie LaMoy, CAN Community Health, North Point, Florida. She presented the results of a pilot study at the virtual Association of Nurses in AIDS Care 2020 Annual Meeting.
In an effort to identify strategies most important for improving care access among their patients with HCV, LaMoy and her colleagues assessed 12-month patient data collected from three of their clinics. These data were evaluated for HCV treatment access, engagement, and outcomes.
The pilot study included 126 patients who were reactive and another 24 HCV-positive patients who were referred from other sources. Active HCV infections requiring treatment were reported in 144 patients.
A total of 59 patients were linked to care but did not initiate treatment for their active infection. LaMoy said there were multiple causes, including homelessness, substance abuse, and inability to maintain contact.
In contrast, 85 patients with HCV infection started treatment, but 35 of these patients did not complete their regimen. Out of the 50 patients who reported completing treatment, 30 did not return to the clinic to confirm sustained viral suppression.
According to LaMoy, this raised a red flag, causing the investigators to consider a different approach to care.
HIV care continuum model and its role in HCV
To improve the rate at which patients with HCV infection complete treatment within their clinics, the researchers formed a panel to determine necessary interventions that could reduce barriers to care.
The HIV care continuum came into play. They chose this model based on knowledge that HCV and HIV share the same care continuum with similar goals in diagnosis, linkage to care, retention, and suppression.
Based on the consensus of the panel and consideration of the HIV care continuum model, they identified a number of interventions needed to mitigate HCV treatment barriers. These included the incorporation of peer navigators or linkage-to-care (LCC) coordinators, use of the mobile medical unit, greater implementation of onsite lab visits, and medication-assisted treatment.
The LCC coordinators proved to be particularly important, as these team members helped assist patients with social and financial support to address challenges with access to treatment. These coordinators can also help patients gain access to specialized providers, ultimately improving the chance of successful HCV management.
Additionally, LCC coordinators may help identify and reduce barriers associated with housing, transportation, and nutrition. Frequent patient contact by the LCC coordinators can encourage adherence and promote risk reduction education, such as providing referrals to needle exchange services.
“Linking individuals to care with providers who are familiar with the treatment cascade could help improve retention and should be a top priority for those involved in HCV screening and treatment,” said LaMoy. “An environment with knowledge, lack of judgment, and a tenacious need to heal the community that welcomes those with barriers to care is exactly what is needed for the patients in our program.”
National, community challenges fuel barriers to HCV treatment access
Substance use, trauma histories, and mental health problems can negatively affect care engagement and must be addressed before the benefits of HCV therapy can be realized.
Addressing these issues isn’t always easy, said Kathleen Bernock, FNP-BC, AACRN, AAHIVS, of the Bedford-Stuyvesant Family Health Center in New York City, in an email to Medscape Medical News. She pointed out that several states have harsh restrictions on who is able to access HCV treatment, and some states will not approve certain medications for people who actively use drugs.
“Even for states without these restrictions, many health systems are difficult to navigate and may not be welcoming to persons actively using,” said Bernock. Trauma-informed care can also be difficult to translate into clinics, she added.
“Decentralizing care to the communities most affected would greatly help mitigate these barriers,” suggested Bernock. Decentralization, she explained, might include co-locating services such as syringe exchanges, utilizing community health workers and patient navigators, and expanding capacity-to-treat to community-based providers.
“[And] with the expansion of telehealth services in the US,” said Bernock, “we now have even more avenues to reach people that we never had before.”
LaMoy and Bernock have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Better linkage to care with providers who are familiar with both the HCV and HIV treatment cascade may not only improve access to HCV treatment, but it may also support patient retention, treatment adherence, and achievement of sustained virologic response (SVR) and viral suppression, said Stephanie LaMoy, CAN Community Health, North Point, Florida. She presented the results of a pilot study at the virtual Association of Nurses in AIDS Care 2020 Annual Meeting.
In an effort to identify strategies most important for improving care access among their patients with HCV, LaMoy and her colleagues assessed 12-month patient data collected from three of their clinics. These data were evaluated for HCV treatment access, engagement, and outcomes.
The pilot study included 126 patients who were reactive and another 24 HCV-positive patients who were referred from other sources. Active HCV infections requiring treatment were reported in 144 patients.
A total of 59 patients were linked to care but did not initiate treatment for their active infection. LaMoy said there were multiple causes, including homelessness, substance abuse, and inability to maintain contact.
In contrast, 85 patients with HCV infection started treatment, but 35 of these patients did not complete their regimen. Out of the 50 patients who reported completing treatment, 30 did not return to the clinic to confirm sustained viral suppression.
According to LaMoy, this raised a red flag, causing the investigators to consider a different approach to care.
HIV care continuum model and its role in HCV
To improve the rate at which patients with HCV infection complete treatment within their clinics, the researchers formed a panel to determine necessary interventions that could reduce barriers to care.
The HIV care continuum came into play. They chose this model based on knowledge that HCV and HIV share the same care continuum with similar goals in diagnosis, linkage to care, retention, and suppression.
Based on the consensus of the panel and consideration of the HIV care continuum model, they identified a number of interventions needed to mitigate HCV treatment barriers. These included the incorporation of peer navigators or linkage-to-care (LCC) coordinators, use of the mobile medical unit, greater implementation of onsite lab visits, and medication-assisted treatment.
The LCC coordinators proved to be particularly important, as these team members helped assist patients with social and financial support to address challenges with access to treatment. These coordinators can also help patients gain access to specialized providers, ultimately improving the chance of successful HCV management.
Additionally, LCC coordinators may help identify and reduce barriers associated with housing, transportation, and nutrition. Frequent patient contact by the LCC coordinators can encourage adherence and promote risk reduction education, such as providing referrals to needle exchange services.
“Linking individuals to care with providers who are familiar with the treatment cascade could help improve retention and should be a top priority for those involved in HCV screening and treatment,” said LaMoy. “An environment with knowledge, lack of judgment, and a tenacious need to heal the community that welcomes those with barriers to care is exactly what is needed for the patients in our program.”
National, community challenges fuel barriers to HCV treatment access
Substance use, trauma histories, and mental health problems can negatively affect care engagement and must be addressed before the benefits of HCV therapy can be realized.
Addressing these issues isn’t always easy, said Kathleen Bernock, FNP-BC, AACRN, AAHIVS, of the Bedford-Stuyvesant Family Health Center in New York City, in an email to Medscape Medical News. She pointed out that several states have harsh restrictions on who is able to access HCV treatment, and some states will not approve certain medications for people who actively use drugs.
“Even for states without these restrictions, many health systems are difficult to navigate and may not be welcoming to persons actively using,” said Bernock. Trauma-informed care can also be difficult to translate into clinics, she added.
“Decentralizing care to the communities most affected would greatly help mitigate these barriers,” suggested Bernock. Decentralization, she explained, might include co-locating services such as syringe exchanges, utilizing community health workers and patient navigators, and expanding capacity-to-treat to community-based providers.
“[And] with the expansion of telehealth services in the US,” said Bernock, “we now have even more avenues to reach people that we never had before.”
LaMoy and Bernock have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
‘Uptake is only the first step’ for effective HIV PrEP protection
To Amanda Allmacher, DNP, RN, nurse practitioner at the Detroit Public Health STD Clinic, that means that same-day PrEP prescribing works and is acceptable. But there’s more work to do on the clinic and pharmacy side to make HIV protection a reality for most of her patients. Allmacher presented her data at the Association of Nurses in AIDS Care 2020 virtual annual meeting.
Dawn K. Smith, MD, epidemiologist and medical officer in the Division of HIV/AIDS Prevention at the Centers for Disease Control and Prevention’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, said this adds to other data to show that we’re now entering the next phase of PrEP implementation.
“Our original focus was on uptake — informing folks what PrEP is, why they might benefit from its use, and then prescribing it if accepted,” Smith told Medscape Medical News via email. “Whether standard or same-day [PrEP prescribing], it is clear that uptake is only the first step.”
Nurses help navigate
Patients who attended the Detroit Public Health STD Clinic are more likely to be younger, have no insurance, and otherwise “have little to no contact with the healthcare system,” Allmacher said in her presentation. They also tend to come from communities that bear the greatest burden of HIV in the US — in other words, they are often the people most missed in PrEP rollouts thus far.
In response, the clinic implemented a same-day PrEP protocol, in which registered nurses trained in HIV risk assessment identify clients who might most benefit from PrEP. Criteria often include the presence of other STIs. Once the nurse explains what PrEP is and how it works, if the patient is interested, clients meet with a nurse practitioner right then to get the prescription for PrEP. The clinic also does labs to rule out current HIV infection, hepatitis B, metabolic issues, and other STI screening.
But it doesn’t stop there. The clinic used grant funding to offer PrEP navigation and financial counseling services, which help clients navigate the sometimes-thorny process of paying for PrEP. Payment comes either through Medicaid, which in Michigan charges $3 a month for a PrEP prescription, through patient assistance programs, or through private insurance. With clients under age 18 who are interested in PrEP, the clinic works to find a way to access PrEP without having to inform their parents. These same navigators schedule follow-up appointments, offer appointment reminders, and contact clients when they miss an appointment.
“Our navigators and financial counselors are a huge support for our same-day PrEP starts, helping with financial assistance, prior authorization, navigating different plans, and helping patients apply for Medicaid when appropriate,” she said.
The clinic also offers community outreach and incentives, which can include gift cards, bus passes, and pill containers, among other things.
This was a key lesson in setting up the program, Allmacher told Medscape Medical News.
“Starting PrEP at that initial visit allows for clinicians to meet patients where they are and administer care in a more equitable manner,” Allmacher said via email. “Use all available resources and funding sources. We have a versatile team working together to increase access for patients and promote HIV prevention and risk reduction.”
Script vs. follow-up
This approach is common, used in places like New York City and San Francisco. So once it was set up Allmacher sat back and waited to see how the program helped clients protect themselves from HIV.
Of the 451 clients eligible for PrEP in 2019, 336 were gay and bisexual men, 6 were transgender women, 61 were heterosexual, cisgender men, and 48 were cisgender women. One transgender man also screened as eligible. Allmacher did not break down data by race.
Uptake was high: 70% of all eligible clients did receive a prescription for PrEP, either generic tenofovir disoproxil fumarate/emtricitabine (Truvada) or tenofovir alafenamide/emtricitabine (Descovy). And uptake was high among people most at risk: 80% of gay and bisexual men who were eligible got a prescription, 60% of eligible cisgender women, 50% of the small number of transgender women, and 32.7% of heterosexual cisgender men did as well. The 1 transgender man also received a prescription.
This is a higher rate than found in a recent PrEP demonstration project, which found that despite gay and bisexual men, transgender adults, and Black people having the highest risk for HIV in the US, state health departments were more likely to refer heterosexual adults for PrEP.
That high uptake rate is encouraging, but follow-up? Not so much. After initial intake, clients are meant to return in a month to double-check their labs, ask about side effects, and start their 90-day supply of the medication. But just 40% showed up for their 30-day appointment, Allmacher said. And only one third of those showed up for the follow-up in 90 days.
By the end of 2019, just 73 of the original 451 clients screened were still taking PrEP.
“It was surprising to see just how significant the follow-up dropped off after that first visit, when the patient initially accepted the prescription,” Allmacher said.
And while it’s possible that some clients get their follow-up care from their primary care providers, “our clinic serves individuals regardless of insurance status and many do not identify having access to primary care for any type of service, PrEP or otherwise,” she said.
5 HIV acquisitions
In addition, the program review identified five clients who had been offered PrEP or had taken PrEP briefly who later acquired HIV. Those clients were offered same-day antiretroviral treatment, Allmacher said.
“So we’re finding people who are at high risk for HIV and we can prevent them, but we’re still not quite doing enough,” Allmacher said of those acquisitions. “Clearly we have a lot of work to do to focus on HIV prevention, and we are looking to create a more formal follow-up process” from the clinic’s side.
For instance, clinic staff call clients 1 week after their initial visit to share lab results. “This was identified as a missed opportunity for us to ask about their status, whether they filled their prescription, or if they need further assistance,” she said. “This is an area where our registered nurses are going to be taking on a greater role moving forward.”
Allmacher and team also discovered that, despite PrEP navigators arranging insurance coverage for clients on the day they receive their prescription, sometimes there were still barriers when the client showed up at the pharmacy to pick up their meds. The clinic does not have an in-house pharmacy and does not currently have the funding that would allow them to hand patients a bottle of the appropriate medication when they leave the clinic.
“Navigating the copays and the insurance coverage and using financial assistance through the drug manufacturer — even though we have the support in the clinic, it seems like there’s a disconnect between our clinic and getting to the pharmacy. Not every pharmacy is super familiar with navigating those,” she said. “So we have started to identify some area pharmacies near our clinic that are great at navigating these, and we really try to get our patients to go to places we know can give them assistance.”
A version of this story originally appeared on Medscape.com.
To Amanda Allmacher, DNP, RN, nurse practitioner at the Detroit Public Health STD Clinic, that means that same-day PrEP prescribing works and is acceptable. But there’s more work to do on the clinic and pharmacy side to make HIV protection a reality for most of her patients. Allmacher presented her data at the Association of Nurses in AIDS Care 2020 virtual annual meeting.
Dawn K. Smith, MD, epidemiologist and medical officer in the Division of HIV/AIDS Prevention at the Centers for Disease Control and Prevention’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, said this adds to other data to show that we’re now entering the next phase of PrEP implementation.
“Our original focus was on uptake — informing folks what PrEP is, why they might benefit from its use, and then prescribing it if accepted,” Smith told Medscape Medical News via email. “Whether standard or same-day [PrEP prescribing], it is clear that uptake is only the first step.”
Nurses help navigate
Patients who attended the Detroit Public Health STD Clinic are more likely to be younger, have no insurance, and otherwise “have little to no contact with the healthcare system,” Allmacher said in her presentation. They also tend to come from communities that bear the greatest burden of HIV in the US — in other words, they are often the people most missed in PrEP rollouts thus far.
In response, the clinic implemented a same-day PrEP protocol, in which registered nurses trained in HIV risk assessment identify clients who might most benefit from PrEP. Criteria often include the presence of other STIs. Once the nurse explains what PrEP is and how it works, if the patient is interested, clients meet with a nurse practitioner right then to get the prescription for PrEP. The clinic also does labs to rule out current HIV infection, hepatitis B, metabolic issues, and other STI screening.
But it doesn’t stop there. The clinic used grant funding to offer PrEP navigation and financial counseling services, which help clients navigate the sometimes-thorny process of paying for PrEP. Payment comes either through Medicaid, which in Michigan charges $3 a month for a PrEP prescription, through patient assistance programs, or through private insurance. With clients under age 18 who are interested in PrEP, the clinic works to find a way to access PrEP without having to inform their parents. These same navigators schedule follow-up appointments, offer appointment reminders, and contact clients when they miss an appointment.
“Our navigators and financial counselors are a huge support for our same-day PrEP starts, helping with financial assistance, prior authorization, navigating different plans, and helping patients apply for Medicaid when appropriate,” she said.
The clinic also offers community outreach and incentives, which can include gift cards, bus passes, and pill containers, among other things.
This was a key lesson in setting up the program, Allmacher told Medscape Medical News.
“Starting PrEP at that initial visit allows for clinicians to meet patients where they are and administer care in a more equitable manner,” Allmacher said via email. “Use all available resources and funding sources. We have a versatile team working together to increase access for patients and promote HIV prevention and risk reduction.”
Script vs. follow-up
This approach is common, used in places like New York City and San Francisco. So once it was set up Allmacher sat back and waited to see how the program helped clients protect themselves from HIV.
Of the 451 clients eligible for PrEP in 2019, 336 were gay and bisexual men, 6 were transgender women, 61 were heterosexual, cisgender men, and 48 were cisgender women. One transgender man also screened as eligible. Allmacher did not break down data by race.
Uptake was high: 70% of all eligible clients did receive a prescription for PrEP, either generic tenofovir disoproxil fumarate/emtricitabine (Truvada) or tenofovir alafenamide/emtricitabine (Descovy). And uptake was high among people most at risk: 80% of gay and bisexual men who were eligible got a prescription, 60% of eligible cisgender women, 50% of the small number of transgender women, and 32.7% of heterosexual cisgender men did as well. The 1 transgender man also received a prescription.
This is a higher rate than found in a recent PrEP demonstration project, which found that despite gay and bisexual men, transgender adults, and Black people having the highest risk for HIV in the US, state health departments were more likely to refer heterosexual adults for PrEP.
That high uptake rate is encouraging, but follow-up? Not so much. After initial intake, clients are meant to return in a month to double-check their labs, ask about side effects, and start their 90-day supply of the medication. But just 40% showed up for their 30-day appointment, Allmacher said. And only one third of those showed up for the follow-up in 90 days.
By the end of 2019, just 73 of the original 451 clients screened were still taking PrEP.
“It was surprising to see just how significant the follow-up dropped off after that first visit, when the patient initially accepted the prescription,” Allmacher said.
And while it’s possible that some clients get their follow-up care from their primary care providers, “our clinic serves individuals regardless of insurance status and many do not identify having access to primary care for any type of service, PrEP or otherwise,” she said.
5 HIV acquisitions
In addition, the program review identified five clients who had been offered PrEP or had taken PrEP briefly who later acquired HIV. Those clients were offered same-day antiretroviral treatment, Allmacher said.
“So we’re finding people who are at high risk for HIV and we can prevent them, but we’re still not quite doing enough,” Allmacher said of those acquisitions. “Clearly we have a lot of work to do to focus on HIV prevention, and we are looking to create a more formal follow-up process” from the clinic’s side.
For instance, clinic staff call clients 1 week after their initial visit to share lab results. “This was identified as a missed opportunity for us to ask about their status, whether they filled their prescription, or if they need further assistance,” she said. “This is an area where our registered nurses are going to be taking on a greater role moving forward.”
Allmacher and team also discovered that, despite PrEP navigators arranging insurance coverage for clients on the day they receive their prescription, sometimes there were still barriers when the client showed up at the pharmacy to pick up their meds. The clinic does not have an in-house pharmacy and does not currently have the funding that would allow them to hand patients a bottle of the appropriate medication when they leave the clinic.
“Navigating the copays and the insurance coverage and using financial assistance through the drug manufacturer — even though we have the support in the clinic, it seems like there’s a disconnect between our clinic and getting to the pharmacy. Not every pharmacy is super familiar with navigating those,” she said. “So we have started to identify some area pharmacies near our clinic that are great at navigating these, and we really try to get our patients to go to places we know can give them assistance.”
A version of this story originally appeared on Medscape.com.
To Amanda Allmacher, DNP, RN, nurse practitioner at the Detroit Public Health STD Clinic, that means that same-day PrEP prescribing works and is acceptable. But there’s more work to do on the clinic and pharmacy side to make HIV protection a reality for most of her patients. Allmacher presented her data at the Association of Nurses in AIDS Care 2020 virtual annual meeting.
Dawn K. Smith, MD, epidemiologist and medical officer in the Division of HIV/AIDS Prevention at the Centers for Disease Control and Prevention’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, said this adds to other data to show that we’re now entering the next phase of PrEP implementation.
“Our original focus was on uptake — informing folks what PrEP is, why they might benefit from its use, and then prescribing it if accepted,” Smith told Medscape Medical News via email. “Whether standard or same-day [PrEP prescribing], it is clear that uptake is only the first step.”
Nurses help navigate
Patients who attended the Detroit Public Health STD Clinic are more likely to be younger, have no insurance, and otherwise “have little to no contact with the healthcare system,” Allmacher said in her presentation. They also tend to come from communities that bear the greatest burden of HIV in the US — in other words, they are often the people most missed in PrEP rollouts thus far.
In response, the clinic implemented a same-day PrEP protocol, in which registered nurses trained in HIV risk assessment identify clients who might most benefit from PrEP. Criteria often include the presence of other STIs. Once the nurse explains what PrEP is and how it works, if the patient is interested, clients meet with a nurse practitioner right then to get the prescription for PrEP. The clinic also does labs to rule out current HIV infection, hepatitis B, metabolic issues, and other STI screening.
But it doesn’t stop there. The clinic used grant funding to offer PrEP navigation and financial counseling services, which help clients navigate the sometimes-thorny process of paying for PrEP. Payment comes either through Medicaid, which in Michigan charges $3 a month for a PrEP prescription, through patient assistance programs, or through private insurance. With clients under age 18 who are interested in PrEP, the clinic works to find a way to access PrEP without having to inform their parents. These same navigators schedule follow-up appointments, offer appointment reminders, and contact clients when they miss an appointment.
“Our navigators and financial counselors are a huge support for our same-day PrEP starts, helping with financial assistance, prior authorization, navigating different plans, and helping patients apply for Medicaid when appropriate,” she said.
The clinic also offers community outreach and incentives, which can include gift cards, bus passes, and pill containers, among other things.
This was a key lesson in setting up the program, Allmacher told Medscape Medical News.
“Starting PrEP at that initial visit allows for clinicians to meet patients where they are and administer care in a more equitable manner,” Allmacher said via email. “Use all available resources and funding sources. We have a versatile team working together to increase access for patients and promote HIV prevention and risk reduction.”
Script vs. follow-up
This approach is common, used in places like New York City and San Francisco. So once it was set up Allmacher sat back and waited to see how the program helped clients protect themselves from HIV.
Of the 451 clients eligible for PrEP in 2019, 336 were gay and bisexual men, 6 were transgender women, 61 were heterosexual, cisgender men, and 48 were cisgender women. One transgender man also screened as eligible. Allmacher did not break down data by race.
Uptake was high: 70% of all eligible clients did receive a prescription for PrEP, either generic tenofovir disoproxil fumarate/emtricitabine (Truvada) or tenofovir alafenamide/emtricitabine (Descovy). And uptake was high among people most at risk: 80% of gay and bisexual men who were eligible got a prescription, 60% of eligible cisgender women, 50% of the small number of transgender women, and 32.7% of heterosexual cisgender men did as well. The 1 transgender man also received a prescription.
This is a higher rate than found in a recent PrEP demonstration project, which found that despite gay and bisexual men, transgender adults, and Black people having the highest risk for HIV in the US, state health departments were more likely to refer heterosexual adults for PrEP.
That high uptake rate is encouraging, but follow-up? Not so much. After initial intake, clients are meant to return in a month to double-check their labs, ask about side effects, and start their 90-day supply of the medication. But just 40% showed up for their 30-day appointment, Allmacher said. And only one third of those showed up for the follow-up in 90 days.
By the end of 2019, just 73 of the original 451 clients screened were still taking PrEP.
“It was surprising to see just how significant the follow-up dropped off after that first visit, when the patient initially accepted the prescription,” Allmacher said.
And while it’s possible that some clients get their follow-up care from their primary care providers, “our clinic serves individuals regardless of insurance status and many do not identify having access to primary care for any type of service, PrEP or otherwise,” she said.
5 HIV acquisitions
In addition, the program review identified five clients who had been offered PrEP or had taken PrEP briefly who later acquired HIV. Those clients were offered same-day antiretroviral treatment, Allmacher said.
“So we’re finding people who are at high risk for HIV and we can prevent them, but we’re still not quite doing enough,” Allmacher said of those acquisitions. “Clearly we have a lot of work to do to focus on HIV prevention, and we are looking to create a more formal follow-up process” from the clinic’s side.
For instance, clinic staff call clients 1 week after their initial visit to share lab results. “This was identified as a missed opportunity for us to ask about their status, whether they filled their prescription, or if they need further assistance,” she said. “This is an area where our registered nurses are going to be taking on a greater role moving forward.”
Allmacher and team also discovered that, despite PrEP navigators arranging insurance coverage for clients on the day they receive their prescription, sometimes there were still barriers when the client showed up at the pharmacy to pick up their meds. The clinic does not have an in-house pharmacy and does not currently have the funding that would allow them to hand patients a bottle of the appropriate medication when they leave the clinic.
“Navigating the copays and the insurance coverage and using financial assistance through the drug manufacturer — even though we have the support in the clinic, it seems like there’s a disconnect between our clinic and getting to the pharmacy. Not every pharmacy is super familiar with navigating those,” she said. “So we have started to identify some area pharmacies near our clinic that are great at navigating these, and we really try to get our patients to go to places we know can give them assistance.”
A version of this story originally appeared on Medscape.com.
Half of women treated for gynecologic cancers miss or skip doses of oral drugs
Oral agents are taking on an ever-greater role in the management of gynecologic cancers. However, women being treated for these cancers have less than ideal adherence to such medications, a new study has found – with just over half reporting taking them exactly as prescribed.
The findings reported in Obstetrics & Gynecology are consistent with reports from other populations taking oral anticancer agents, in which adherence is generally lower than with intravenous therapies.
For their research, Catherine Watson, MD, and colleagues at Duke University, Durham, N.C., recruited 100 women at their institution taking a variety of oral anticancer agents for uterine or ovarian cancer for 30 days or more (median time, 6 months). The women answered a questionnaire that measured adherence as well as health literacy, quality of life, and distress. The researchers also collected information on the subjects’ race, age, insurance type, medication burden, and medication costs.
Fourteen of the women in the study additionally underwent qualitative interviews about their experiences with oral anticancer drugs. The researchers also queried physicians and nurse practitioners about their thoughts on adherence.
Dr. Watson and colleagues reported that 54% of women self-reported perfect adherence to their medication in the previous week, while 21% had missed or skipped one dose, and 25% reported skipping or missing more than one dose.
The researchers saw no significant differences between the adherent and nonadherent groups corresponding with race, age, or other demographic or clinical characteristics, but they noted that their study was not powered to detect such associations. The small sample size and self-reported data were among this study’s limitations, Dr. Watson and colleagues acknowledged.
Interviews with patients revealed some surprising reasons for the less-than-optimal adherence, with 43% of women reporting feeling anxiety about the burden of administering medication at home. While patients acknowledged the convenience of oral regimens, some also expressed a wish for more physician contact and support. Some women who were nonadherent said they perceived the efficacy of oral agents to be less than intravenous therapies.
Physicians and nurse practitioners interviewed by the researchers “tended to assume that their patients were adherent to oral anticancer therapy because of the therapy’s importance, and many did not routinely ask their patients about adherence,” Dr. Watson and colleagues wrote.
Emma Rossi, MD, a gynecologic oncologist at the University of North Carolina at Chapel Hill, commented in an interview that the study highlighted “the importance of not generalizing our perception of patients. As providers we have to spend the time asking patients where they’re at and how they’re thinking about taking an oral medication, with special attention to their fears, their expectations, and their concerns. We should be touching base with them not just before starting drugs, but during the course of treatment.”
Dr. Rossi stressed that compliance in real-life settings is likely to be different from that seen in clinical trials of oral anticancer drugs. “It’s important to recognize that real-world efficacy of treatments may be different from trial efficacy. We see these differences a lot in medicine where studies show a large magnitude of effect that doesn’t play out in real life practice – because of factors like this.”
Some 57% of the women in the study were taking their medications as maintenance, while the rest were taking the medications as active treatment. This too might have an effect on adherence, she said, with the active-treatment group potentially more motivated to maintain perfect adherence.
“You see in the interviews that doctors assume patients would be compliant because of the seriousness of the disease,” Dr. Rossi said. “But some patients said they perceived oral drugs as less strong or effective. If a patient is cancer free on a scan and doesn’t have measurable disease, prescribing an oral medication may be sending the subliminal message that it’s not as important.”
Physicians “may need to take the extra steps to individualize our counseling of patients – especially with therapies that they’re responsible for administering,” Dr. Rossi continued. “As this study shows, every patient sees treatment through her own individual lens. We really need to meet them where they’re at to make them comfortable with their treatment and optimize compliance.”
Dr. Watson and colleagues’ study was supported by their institution. One coauthor reported financial ties with drug manufacturers in the form of grant and clinical trial support and honoraria. Another coauthor is the member of various boards and steering committees, which are uncompensated. Dr. Rossi reported no financial conflicts of interest.
SOURCE: Watson C et al. Obstet Gynecol. 2020. doi: 10.1097/AOG.0000000000004170.
Oral agents are taking on an ever-greater role in the management of gynecologic cancers. However, women being treated for these cancers have less than ideal adherence to such medications, a new study has found – with just over half reporting taking them exactly as prescribed.
The findings reported in Obstetrics & Gynecology are consistent with reports from other populations taking oral anticancer agents, in which adherence is generally lower than with intravenous therapies.
For their research, Catherine Watson, MD, and colleagues at Duke University, Durham, N.C., recruited 100 women at their institution taking a variety of oral anticancer agents for uterine or ovarian cancer for 30 days or more (median time, 6 months). The women answered a questionnaire that measured adherence as well as health literacy, quality of life, and distress. The researchers also collected information on the subjects’ race, age, insurance type, medication burden, and medication costs.
Fourteen of the women in the study additionally underwent qualitative interviews about their experiences with oral anticancer drugs. The researchers also queried physicians and nurse practitioners about their thoughts on adherence.
Dr. Watson and colleagues reported that 54% of women self-reported perfect adherence to their medication in the previous week, while 21% had missed or skipped one dose, and 25% reported skipping or missing more than one dose.
The researchers saw no significant differences between the adherent and nonadherent groups corresponding with race, age, or other demographic or clinical characteristics, but they noted that their study was not powered to detect such associations. The small sample size and self-reported data were among this study’s limitations, Dr. Watson and colleagues acknowledged.
Interviews with patients revealed some surprising reasons for the less-than-optimal adherence, with 43% of women reporting feeling anxiety about the burden of administering medication at home. While patients acknowledged the convenience of oral regimens, some also expressed a wish for more physician contact and support. Some women who were nonadherent said they perceived the efficacy of oral agents to be less than intravenous therapies.
Physicians and nurse practitioners interviewed by the researchers “tended to assume that their patients were adherent to oral anticancer therapy because of the therapy’s importance, and many did not routinely ask their patients about adherence,” Dr. Watson and colleagues wrote.
Emma Rossi, MD, a gynecologic oncologist at the University of North Carolina at Chapel Hill, commented in an interview that the study highlighted “the importance of not generalizing our perception of patients. As providers we have to spend the time asking patients where they’re at and how they’re thinking about taking an oral medication, with special attention to their fears, their expectations, and their concerns. We should be touching base with them not just before starting drugs, but during the course of treatment.”
Dr. Rossi stressed that compliance in real-life settings is likely to be different from that seen in clinical trials of oral anticancer drugs. “It’s important to recognize that real-world efficacy of treatments may be different from trial efficacy. We see these differences a lot in medicine where studies show a large magnitude of effect that doesn’t play out in real life practice – because of factors like this.”
Some 57% of the women in the study were taking their medications as maintenance, while the rest were taking the medications as active treatment. This too might have an effect on adherence, she said, with the active-treatment group potentially more motivated to maintain perfect adherence.
“You see in the interviews that doctors assume patients would be compliant because of the seriousness of the disease,” Dr. Rossi said. “But some patients said they perceived oral drugs as less strong or effective. If a patient is cancer free on a scan and doesn’t have measurable disease, prescribing an oral medication may be sending the subliminal message that it’s not as important.”
Physicians “may need to take the extra steps to individualize our counseling of patients – especially with therapies that they’re responsible for administering,” Dr. Rossi continued. “As this study shows, every patient sees treatment through her own individual lens. We really need to meet them where they’re at to make them comfortable with their treatment and optimize compliance.”
Dr. Watson and colleagues’ study was supported by their institution. One coauthor reported financial ties with drug manufacturers in the form of grant and clinical trial support and honoraria. Another coauthor is the member of various boards and steering committees, which are uncompensated. Dr. Rossi reported no financial conflicts of interest.
SOURCE: Watson C et al. Obstet Gynecol. 2020. doi: 10.1097/AOG.0000000000004170.
Oral agents are taking on an ever-greater role in the management of gynecologic cancers. However, women being treated for these cancers have less than ideal adherence to such medications, a new study has found – with just over half reporting taking them exactly as prescribed.
The findings reported in Obstetrics & Gynecology are consistent with reports from other populations taking oral anticancer agents, in which adherence is generally lower than with intravenous therapies.
For their research, Catherine Watson, MD, and colleagues at Duke University, Durham, N.C., recruited 100 women at their institution taking a variety of oral anticancer agents for uterine or ovarian cancer for 30 days or more (median time, 6 months). The women answered a questionnaire that measured adherence as well as health literacy, quality of life, and distress. The researchers also collected information on the subjects’ race, age, insurance type, medication burden, and medication costs.
Fourteen of the women in the study additionally underwent qualitative interviews about their experiences with oral anticancer drugs. The researchers also queried physicians and nurse practitioners about their thoughts on adherence.
Dr. Watson and colleagues reported that 54% of women self-reported perfect adherence to their medication in the previous week, while 21% had missed or skipped one dose, and 25% reported skipping or missing more than one dose.
The researchers saw no significant differences between the adherent and nonadherent groups corresponding with race, age, or other demographic or clinical characteristics, but they noted that their study was not powered to detect such associations. The small sample size and self-reported data were among this study’s limitations, Dr. Watson and colleagues acknowledged.
Interviews with patients revealed some surprising reasons for the less-than-optimal adherence, with 43% of women reporting feeling anxiety about the burden of administering medication at home. While patients acknowledged the convenience of oral regimens, some also expressed a wish for more physician contact and support. Some women who were nonadherent said they perceived the efficacy of oral agents to be less than intravenous therapies.
Physicians and nurse practitioners interviewed by the researchers “tended to assume that their patients were adherent to oral anticancer therapy because of the therapy’s importance, and many did not routinely ask their patients about adherence,” Dr. Watson and colleagues wrote.
Emma Rossi, MD, a gynecologic oncologist at the University of North Carolina at Chapel Hill, commented in an interview that the study highlighted “the importance of not generalizing our perception of patients. As providers we have to spend the time asking patients where they’re at and how they’re thinking about taking an oral medication, with special attention to their fears, their expectations, and their concerns. We should be touching base with them not just before starting drugs, but during the course of treatment.”
Dr. Rossi stressed that compliance in real-life settings is likely to be different from that seen in clinical trials of oral anticancer drugs. “It’s important to recognize that real-world efficacy of treatments may be different from trial efficacy. We see these differences a lot in medicine where studies show a large magnitude of effect that doesn’t play out in real life practice – because of factors like this.”
Some 57% of the women in the study were taking their medications as maintenance, while the rest were taking the medications as active treatment. This too might have an effect on adherence, she said, with the active-treatment group potentially more motivated to maintain perfect adherence.
“You see in the interviews that doctors assume patients would be compliant because of the seriousness of the disease,” Dr. Rossi said. “But some patients said they perceived oral drugs as less strong or effective. If a patient is cancer free on a scan and doesn’t have measurable disease, prescribing an oral medication may be sending the subliminal message that it’s not as important.”
Physicians “may need to take the extra steps to individualize our counseling of patients – especially with therapies that they’re responsible for administering,” Dr. Rossi continued. “As this study shows, every patient sees treatment through her own individual lens. We really need to meet them where they’re at to make them comfortable with their treatment and optimize compliance.”
Dr. Watson and colleagues’ study was supported by their institution. One coauthor reported financial ties with drug manufacturers in the form of grant and clinical trial support and honoraria. Another coauthor is the member of various boards and steering committees, which are uncompensated. Dr. Rossi reported no financial conflicts of interest.
SOURCE: Watson C et al. Obstet Gynecol. 2020. doi: 10.1097/AOG.0000000000004170.
FROM OBSTETRICS & GYNECOLOGY
Sleep apnea may correlate with anxiety, depression in patients with PCOS
a study suggests.
This finding could have implications for screening and treatment, Diana Xiaojie Zhou, MD, said at the American Society for Reproductive Medicine’s 2020 annual meeting, held virtually this year.
“Routine OSA screening in women with PCOS should be considered in the setting of existing depression and anxiety,” said Dr. Zhou, a reproductive endocrinology and infertility fellow at the University of California, San Francisco. “Referral for OSA diagnosis and treatment in those who screen positive may have added psychological benefits in this population, as has been seen in the general population.”
Patients with PCOS experience a range of comorbidities, including higher rates of psychological disorders and OSA, she said.
OSA has been associated with depression and anxiety in the general population, and research indicates that treatment, such as with continuous positive airway pressure (CPAP), may have psychological benefits, such as reduced depression symptoms.
PCOS guidelines recommend screening for OSA to identify and alleviate symptoms such as fatigue that may to contribute to mood disorders. “However, there is a lack of studies assessing the relationship between OSA and depression and anxiety specifically in women with PCOS,” Dr. Zhou said.
A cross-sectional study
To evaluate whether OSA is associated with depression and anxiety in women with PCOS, Dr. Zhou and colleagues conducted a cross-sectional study of all women seen at a multidisciplinary PCOS clinic at university between June 2017 and June 2020.
Participants had a diagnosis of PCOS clinically confirmed by the Rotterdam criteria. Researchers determined OSA risk using the Berlin questionnaire, which is divided into three domains. A positive score in two or more domains indicates a high risk of OSA.
The investigators used the Patient Health Questionnaire-9 (PHQ-9) to assess depression symptoms, and they used the Generalized Anxiety Disorder-7 (GAD-7) to assess anxiety symptoms.
Researchers used two-sided t-test, chi-square test, and Fisher’s exact test to evaluate for differences in patient characteristics. They performed multivariate logistic regression analyses to determine the odds of moderate to severe symptoms of depression (that is, a PHQ-9 score of 10 or greater) and anxiety (a GAD-7 score of 10 or greater) among patients with a high risk of OSA, compared with patients with a low risk of OSA. They adjusted for age, body mass index, free testosterone level, and insulin resistance using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).
The researchers examined data from 201 patients: 125 with a low risk of OSA and 76 with a high risk of OSA. The average age of the patients was 28 years.
On average, patients in the high-risk OSA group had a greater body mass index (37.9 vs. 26.5), a higher level of free testosterone (6.5 ng/dL vs. 4.5 ng/dL), and a higher HOMA-IR score (7 vs. 3.1), relative to those with a low risk of OSA. In addition, a greater percentage of patients with a high risk of OSA experienced oligomenorrhea (84.9% vs. 70.5%).
The average PHQ-9 score was significantly higher in the high-risk OSA group (12 vs. 8.3), as was the average GAD-7 score (8.9 vs. 6.1).
In univariate analyses, having a high risk of OSA increased the likelihood of moderate or severe depression or anxiety approximately threefold.
In multivariate analyses, a high risk of OSA remained significantly associated with moderate or severe depression or anxiety, with an odds ratio of about 2.5. “Of note, BMI was a statistically significant predictor in the univariate analyses, but not so in the multivariate analyses,” Dr. Zhou said.
Although the investigators assessed OSA, depression, and anxiety using validated questionnaires, a study with clinically confirmed diagnoses of those conditions would strengthen these findings, she said.
Various possible links
Investigators have proposed various links between PCOS, OSA, and depression and anxiety, Dr. Zhou noted. Features of PCOS such as insulin resistance, obesity, and hyperandrogenemia increase the risk of OSA. “The sleep loss and fragmentation and hypoxia that define OSA then serve to increase sympathetic tone and oxidative stress, which then potentially can lead to an increase in depression and anxiety,” Dr. Zhou said.
The results suggests that treating OSA “may have added psychological benefits for women with PCOS and highlights the broad health implications of this condition,” Marla Lujan, PhD, chair of the ASRM’s androgen excess special interest group, said in a society news release.
“The cause of PCOS is still not well understood, but we do know that 1 in 10 women in their childbearing years suffer from PCOS,” said Dr. Lujan, of Cornell University, Ithaca, N.Y. “In addition to infertility, PCOS is also associated with type 2 diabetes and cardiovascular complications such as hypertension and abnormal blood lipids.”
In a discussion following Dr. Zhou’s presentation, Alice D. Domar, PhD, said the study was eye opening.
Dr. Domar, director of integrative care at Boston IVF and associate professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston, said that she does not typically discuss sleep apnea with patients. “For those of us who routinely work with PCOS patients, we are always looking for more information.”
Although PCOS guidelines mention screening for OSA, Dr. Zhou expects that few generalists who see PCOS patients or even subspecialists actually do.
Nevertheless, the potential for intervention is fascinating, she said. And if treating OSA also reduced a patient’s need for psychiatric medications, there could be added benefit in PCOS due to the metabolic side effects that accompany some of the drugs.
Dr. Zhou and Dr. Lujan had no relevant disclosures. Dr. Domar is a co-owner of FertiCalm, FertiStrong, and Aliz Health Apps, and a speaker for Ferring, EMD Serono, Merck, and Abbott.
SOURCE: Zhou DX et al. ASRM 2020. Abstract O-146.
a study suggests.
This finding could have implications for screening and treatment, Diana Xiaojie Zhou, MD, said at the American Society for Reproductive Medicine’s 2020 annual meeting, held virtually this year.
“Routine OSA screening in women with PCOS should be considered in the setting of existing depression and anxiety,” said Dr. Zhou, a reproductive endocrinology and infertility fellow at the University of California, San Francisco. “Referral for OSA diagnosis and treatment in those who screen positive may have added psychological benefits in this population, as has been seen in the general population.”
Patients with PCOS experience a range of comorbidities, including higher rates of psychological disorders and OSA, she said.
OSA has been associated with depression and anxiety in the general population, and research indicates that treatment, such as with continuous positive airway pressure (CPAP), may have psychological benefits, such as reduced depression symptoms.
PCOS guidelines recommend screening for OSA to identify and alleviate symptoms such as fatigue that may to contribute to mood disorders. “However, there is a lack of studies assessing the relationship between OSA and depression and anxiety specifically in women with PCOS,” Dr. Zhou said.
A cross-sectional study
To evaluate whether OSA is associated with depression and anxiety in women with PCOS, Dr. Zhou and colleagues conducted a cross-sectional study of all women seen at a multidisciplinary PCOS clinic at university between June 2017 and June 2020.
Participants had a diagnosis of PCOS clinically confirmed by the Rotterdam criteria. Researchers determined OSA risk using the Berlin questionnaire, which is divided into three domains. A positive score in two or more domains indicates a high risk of OSA.
The investigators used the Patient Health Questionnaire-9 (PHQ-9) to assess depression symptoms, and they used the Generalized Anxiety Disorder-7 (GAD-7) to assess anxiety symptoms.
Researchers used two-sided t-test, chi-square test, and Fisher’s exact test to evaluate for differences in patient characteristics. They performed multivariate logistic regression analyses to determine the odds of moderate to severe symptoms of depression (that is, a PHQ-9 score of 10 or greater) and anxiety (a GAD-7 score of 10 or greater) among patients with a high risk of OSA, compared with patients with a low risk of OSA. They adjusted for age, body mass index, free testosterone level, and insulin resistance using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).
The researchers examined data from 201 patients: 125 with a low risk of OSA and 76 with a high risk of OSA. The average age of the patients was 28 years.
On average, patients in the high-risk OSA group had a greater body mass index (37.9 vs. 26.5), a higher level of free testosterone (6.5 ng/dL vs. 4.5 ng/dL), and a higher HOMA-IR score (7 vs. 3.1), relative to those with a low risk of OSA. In addition, a greater percentage of patients with a high risk of OSA experienced oligomenorrhea (84.9% vs. 70.5%).
The average PHQ-9 score was significantly higher in the high-risk OSA group (12 vs. 8.3), as was the average GAD-7 score (8.9 vs. 6.1).
In univariate analyses, having a high risk of OSA increased the likelihood of moderate or severe depression or anxiety approximately threefold.
In multivariate analyses, a high risk of OSA remained significantly associated with moderate or severe depression or anxiety, with an odds ratio of about 2.5. “Of note, BMI was a statistically significant predictor in the univariate analyses, but not so in the multivariate analyses,” Dr. Zhou said.
Although the investigators assessed OSA, depression, and anxiety using validated questionnaires, a study with clinically confirmed diagnoses of those conditions would strengthen these findings, she said.
Various possible links
Investigators have proposed various links between PCOS, OSA, and depression and anxiety, Dr. Zhou noted. Features of PCOS such as insulin resistance, obesity, and hyperandrogenemia increase the risk of OSA. “The sleep loss and fragmentation and hypoxia that define OSA then serve to increase sympathetic tone and oxidative stress, which then potentially can lead to an increase in depression and anxiety,” Dr. Zhou said.
The results suggests that treating OSA “may have added psychological benefits for women with PCOS and highlights the broad health implications of this condition,” Marla Lujan, PhD, chair of the ASRM’s androgen excess special interest group, said in a society news release.
“The cause of PCOS is still not well understood, but we do know that 1 in 10 women in their childbearing years suffer from PCOS,” said Dr. Lujan, of Cornell University, Ithaca, N.Y. “In addition to infertility, PCOS is also associated with type 2 diabetes and cardiovascular complications such as hypertension and abnormal blood lipids.”
In a discussion following Dr. Zhou’s presentation, Alice D. Domar, PhD, said the study was eye opening.
Dr. Domar, director of integrative care at Boston IVF and associate professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston, said that she does not typically discuss sleep apnea with patients. “For those of us who routinely work with PCOS patients, we are always looking for more information.”
Although PCOS guidelines mention screening for OSA, Dr. Zhou expects that few generalists who see PCOS patients or even subspecialists actually do.
Nevertheless, the potential for intervention is fascinating, she said. And if treating OSA also reduced a patient’s need for psychiatric medications, there could be added benefit in PCOS due to the metabolic side effects that accompany some of the drugs.
Dr. Zhou and Dr. Lujan had no relevant disclosures. Dr. Domar is a co-owner of FertiCalm, FertiStrong, and Aliz Health Apps, and a speaker for Ferring, EMD Serono, Merck, and Abbott.
SOURCE: Zhou DX et al. ASRM 2020. Abstract O-146.
a study suggests.
This finding could have implications for screening and treatment, Diana Xiaojie Zhou, MD, said at the American Society for Reproductive Medicine’s 2020 annual meeting, held virtually this year.
“Routine OSA screening in women with PCOS should be considered in the setting of existing depression and anxiety,” said Dr. Zhou, a reproductive endocrinology and infertility fellow at the University of California, San Francisco. “Referral for OSA diagnosis and treatment in those who screen positive may have added psychological benefits in this population, as has been seen in the general population.”
Patients with PCOS experience a range of comorbidities, including higher rates of psychological disorders and OSA, she said.
OSA has been associated with depression and anxiety in the general population, and research indicates that treatment, such as with continuous positive airway pressure (CPAP), may have psychological benefits, such as reduced depression symptoms.
PCOS guidelines recommend screening for OSA to identify and alleviate symptoms such as fatigue that may to contribute to mood disorders. “However, there is a lack of studies assessing the relationship between OSA and depression and anxiety specifically in women with PCOS,” Dr. Zhou said.
A cross-sectional study
To evaluate whether OSA is associated with depression and anxiety in women with PCOS, Dr. Zhou and colleagues conducted a cross-sectional study of all women seen at a multidisciplinary PCOS clinic at university between June 2017 and June 2020.
Participants had a diagnosis of PCOS clinically confirmed by the Rotterdam criteria. Researchers determined OSA risk using the Berlin questionnaire, which is divided into three domains. A positive score in two or more domains indicates a high risk of OSA.
The investigators used the Patient Health Questionnaire-9 (PHQ-9) to assess depression symptoms, and they used the Generalized Anxiety Disorder-7 (GAD-7) to assess anxiety symptoms.
Researchers used two-sided t-test, chi-square test, and Fisher’s exact test to evaluate for differences in patient characteristics. They performed multivariate logistic regression analyses to determine the odds of moderate to severe symptoms of depression (that is, a PHQ-9 score of 10 or greater) and anxiety (a GAD-7 score of 10 or greater) among patients with a high risk of OSA, compared with patients with a low risk of OSA. They adjusted for age, body mass index, free testosterone level, and insulin resistance using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).
The researchers examined data from 201 patients: 125 with a low risk of OSA and 76 with a high risk of OSA. The average age of the patients was 28 years.
On average, patients in the high-risk OSA group had a greater body mass index (37.9 vs. 26.5), a higher level of free testosterone (6.5 ng/dL vs. 4.5 ng/dL), and a higher HOMA-IR score (7 vs. 3.1), relative to those with a low risk of OSA. In addition, a greater percentage of patients with a high risk of OSA experienced oligomenorrhea (84.9% vs. 70.5%).
The average PHQ-9 score was significantly higher in the high-risk OSA group (12 vs. 8.3), as was the average GAD-7 score (8.9 vs. 6.1).
In univariate analyses, having a high risk of OSA increased the likelihood of moderate or severe depression or anxiety approximately threefold.
In multivariate analyses, a high risk of OSA remained significantly associated with moderate or severe depression or anxiety, with an odds ratio of about 2.5. “Of note, BMI was a statistically significant predictor in the univariate analyses, but not so in the multivariate analyses,” Dr. Zhou said.
Although the investigators assessed OSA, depression, and anxiety using validated questionnaires, a study with clinically confirmed diagnoses of those conditions would strengthen these findings, she said.
Various possible links
Investigators have proposed various links between PCOS, OSA, and depression and anxiety, Dr. Zhou noted. Features of PCOS such as insulin resistance, obesity, and hyperandrogenemia increase the risk of OSA. “The sleep loss and fragmentation and hypoxia that define OSA then serve to increase sympathetic tone and oxidative stress, which then potentially can lead to an increase in depression and anxiety,” Dr. Zhou said.
The results suggests that treating OSA “may have added psychological benefits for women with PCOS and highlights the broad health implications of this condition,” Marla Lujan, PhD, chair of the ASRM’s androgen excess special interest group, said in a society news release.
“The cause of PCOS is still not well understood, but we do know that 1 in 10 women in their childbearing years suffer from PCOS,” said Dr. Lujan, of Cornell University, Ithaca, N.Y. “In addition to infertility, PCOS is also associated with type 2 diabetes and cardiovascular complications such as hypertension and abnormal blood lipids.”
In a discussion following Dr. Zhou’s presentation, Alice D. Domar, PhD, said the study was eye opening.
Dr. Domar, director of integrative care at Boston IVF and associate professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston, said that she does not typically discuss sleep apnea with patients. “For those of us who routinely work with PCOS patients, we are always looking for more information.”
Although PCOS guidelines mention screening for OSA, Dr. Zhou expects that few generalists who see PCOS patients or even subspecialists actually do.
Nevertheless, the potential for intervention is fascinating, she said. And if treating OSA also reduced a patient’s need for psychiatric medications, there could be added benefit in PCOS due to the metabolic side effects that accompany some of the drugs.
Dr. Zhou and Dr. Lujan had no relevant disclosures. Dr. Domar is a co-owner of FertiCalm, FertiStrong, and Aliz Health Apps, and a speaker for Ferring, EMD Serono, Merck, and Abbott.
SOURCE: Zhou DX et al. ASRM 2020. Abstract O-146.
FROM ASRM 2020
Studies gauge toll of pausing fertility treatment during pandemic
More than 60% of patients at a center for reproductive medicine in Utah who had fertility treatments canceled because of the COVID-19 pandemic opted to resume treatment once the suspension was lifted about 7 weeks later.
At another fertility center in New York, a survey found that 96% of respondents who had a cycle canceled because of the pandemic found it upsetting, and 22% found it extremely upsetting, with extremely upsetting defined as equivalent to the loss of a child.
The indefinite time frame for resuming treatment when the New York survey was conducted may have been a major source of distress for patients, one of the researchers said at the American Society for Reproductive Medicine’s 2020 annual meeting, held virtually this year.
“They don’t know when they might have that chance again,” said Jenna M. Turocy, MD, of Columbia University Fertility Center, New York.
COVID-19 guidelines published by ASRM on March 17 recommended the suspension of new treatment cycles, including ovulation induction, intrauterine inseminations, and in vitro fertilization (IVF).
An ASRM COVID-19 task force has since supported “the measured resumption of fertility care following the easing of restrictions,” said Paul C. Lin, MD, president of the Society for Assisted Reproductive Technology and a member of the task force.
“Over the past several months, significant knowledge has been gained regarding the COVID-19 virus and its impact on patients and the medical system,” he said in a news release about the two studies that assessed the pandemic’s effects.
Certain precautions remain. “It has become clear that we will need to be practicing COVID-19 protocols at least until an effective and safe vaccine or broadly effective treatment becomes widely available,” Dr. Lin said.
Desire to proceed during a pandemic
The center continued to offer IVF cycles for oncofertility patients on an urgent basis.
In early May, patients whose cycles had been suspended had the option to receive treatment.
“Upon reopening, every patient received standardized counseling from their primary IVF physician,” Lauren Verrilli, MD, a reproductive endocrinology and infertility fellow at the University of Utah, Salt Lake City, said at the virtual meeting.
Doctors explained that much remained unknown about COVID-19 in pregnancy, and that it was unclear whether the clinic would need to shut down again. In addition, patients had to undergo COVID-19 testing.
To identify factors associated with proceeding with treatment after the suspension, the researchers compared patients who resumed treatment with patients who did not.
Their analysis included 278 patients who had planned an IVF cycle or frozen embryo transfer (FET) prior to the shutdown. The researchers examined factors such as age, parity, anti-Müllerian hormone, antral follicle count, history of prior IVF cycles or FET, number of frozen blastocysts, gamete source, and use of a gestational carrier.
In all, 62% of patients opted to receive treatment once restrictions were lifted, including 69 of the 133 (52%) patients with planned fresh cycles and 104 of the 145 (72%) patients with planned FET cycles.
Among those with planned fresh cycles, those who opted to resume treatment tended to be older than those who did not resume treatment, with a median age of 37 years versus 35 years, but the difference was not statistically significant.
Among patients with planned FET cycles, those who did not resume treatment were more likely to have a gestational carrier, compared with those who resumed treatment (7% vs. 1%). In some cases, gestational carriers lived in another state and the pandemic complicated travel arrangements, which contributed to delays, Dr. Verrilli said.
The analysis did not include information about income or socioeconomic status, which may play a role in patients’ decisions, Dr. Verrilli said.
Emotional impact of indefinite delay
Fertility treatment is often time sensitive, particularly for patients with advanced reproductive age or diminished ovarian reserve, and indefinite postponement of fertility treatment potentially could lead some patients to lose the ability to conceive with their own gametes, Dr. Turocy said.
In early April, Dr. Turocy and colleagues surveyed patients at their academic fertility center in New York City to assess patients’ reactions to the ASRM recommendations. They decided to conduct the study after they realized that treatment cancellations were having a significant emotional effect.
Investigators emailed an 18-item survey to more than 3,000 patients.
In all, 518 patients completed the survey, a response rate of 17%. Patients had an average age of 37 years (range, 23-52 years), and 92% were female. About 24% had children, and 66% had received at least one fertility treatment.
Half had a cycle canceled because of the COVID-19 pandemic, including timed intercourse cycles (5%), intrauterine insemination cycles (23%), IVF cycles with a planned fresh embryo transfer (10%), IVF with all frozen embryos (27%), egg freeze cycles (3%), and FET cycles (30%).
In response to survey questions about whether they agreed with ASRM recommendations, “the reactions were mixed,” Dr. Turocy said.
About 36% of patients agreed all fertility cycles should be canceled, 22% were unsure, and 43% disagreed with the recommendation. Patients who had a cycle canceled were slightly more likely to agree with the cancellations (40% agreed) than those who did not have a cycle canceled (30% agreed), Dr. Turocy said.
Most respondents would have preferred an option to start a treatment cycle in consultation with their doctor. Half “would have chosen to start a new cycle during the height of the pandemic in New York City,” Dr. Turocy said.
Patient opinions may vary by region and depend on the severity of COVID-19 outbreaks there, and they also might change over time, Dr. Turocy suggested. In addition, the opinions and characteristics of patients who responded to the anonymous survey may differ from those of patients who did not respond.
Dr. Verrilli, Dr. Turocy, and Dr. Lin had no relevant financial disclosures.
More than 60% of patients at a center for reproductive medicine in Utah who had fertility treatments canceled because of the COVID-19 pandemic opted to resume treatment once the suspension was lifted about 7 weeks later.
At another fertility center in New York, a survey found that 96% of respondents who had a cycle canceled because of the pandemic found it upsetting, and 22% found it extremely upsetting, with extremely upsetting defined as equivalent to the loss of a child.
The indefinite time frame for resuming treatment when the New York survey was conducted may have been a major source of distress for patients, one of the researchers said at the American Society for Reproductive Medicine’s 2020 annual meeting, held virtually this year.
“They don’t know when they might have that chance again,” said Jenna M. Turocy, MD, of Columbia University Fertility Center, New York.
COVID-19 guidelines published by ASRM on March 17 recommended the suspension of new treatment cycles, including ovulation induction, intrauterine inseminations, and in vitro fertilization (IVF).
An ASRM COVID-19 task force has since supported “the measured resumption of fertility care following the easing of restrictions,” said Paul C. Lin, MD, president of the Society for Assisted Reproductive Technology and a member of the task force.
“Over the past several months, significant knowledge has been gained regarding the COVID-19 virus and its impact on patients and the medical system,” he said in a news release about the two studies that assessed the pandemic’s effects.
Certain precautions remain. “It has become clear that we will need to be practicing COVID-19 protocols at least until an effective and safe vaccine or broadly effective treatment becomes widely available,” Dr. Lin said.
Desire to proceed during a pandemic
The center continued to offer IVF cycles for oncofertility patients on an urgent basis.
In early May, patients whose cycles had been suspended had the option to receive treatment.
“Upon reopening, every patient received standardized counseling from their primary IVF physician,” Lauren Verrilli, MD, a reproductive endocrinology and infertility fellow at the University of Utah, Salt Lake City, said at the virtual meeting.
Doctors explained that much remained unknown about COVID-19 in pregnancy, and that it was unclear whether the clinic would need to shut down again. In addition, patients had to undergo COVID-19 testing.
To identify factors associated with proceeding with treatment after the suspension, the researchers compared patients who resumed treatment with patients who did not.
Their analysis included 278 patients who had planned an IVF cycle or frozen embryo transfer (FET) prior to the shutdown. The researchers examined factors such as age, parity, anti-Müllerian hormone, antral follicle count, history of prior IVF cycles or FET, number of frozen blastocysts, gamete source, and use of a gestational carrier.
In all, 62% of patients opted to receive treatment once restrictions were lifted, including 69 of the 133 (52%) patients with planned fresh cycles and 104 of the 145 (72%) patients with planned FET cycles.
Among those with planned fresh cycles, those who opted to resume treatment tended to be older than those who did not resume treatment, with a median age of 37 years versus 35 years, but the difference was not statistically significant.
Among patients with planned FET cycles, those who did not resume treatment were more likely to have a gestational carrier, compared with those who resumed treatment (7% vs. 1%). In some cases, gestational carriers lived in another state and the pandemic complicated travel arrangements, which contributed to delays, Dr. Verrilli said.
The analysis did not include information about income or socioeconomic status, which may play a role in patients’ decisions, Dr. Verrilli said.
Emotional impact of indefinite delay
Fertility treatment is often time sensitive, particularly for patients with advanced reproductive age or diminished ovarian reserve, and indefinite postponement of fertility treatment potentially could lead some patients to lose the ability to conceive with their own gametes, Dr. Turocy said.
In early April, Dr. Turocy and colleagues surveyed patients at their academic fertility center in New York City to assess patients’ reactions to the ASRM recommendations. They decided to conduct the study after they realized that treatment cancellations were having a significant emotional effect.
Investigators emailed an 18-item survey to more than 3,000 patients.
In all, 518 patients completed the survey, a response rate of 17%. Patients had an average age of 37 years (range, 23-52 years), and 92% were female. About 24% had children, and 66% had received at least one fertility treatment.
Half had a cycle canceled because of the COVID-19 pandemic, including timed intercourse cycles (5%), intrauterine insemination cycles (23%), IVF cycles with a planned fresh embryo transfer (10%), IVF with all frozen embryos (27%), egg freeze cycles (3%), and FET cycles (30%).
In response to survey questions about whether they agreed with ASRM recommendations, “the reactions were mixed,” Dr. Turocy said.
About 36% of patients agreed all fertility cycles should be canceled, 22% were unsure, and 43% disagreed with the recommendation. Patients who had a cycle canceled were slightly more likely to agree with the cancellations (40% agreed) than those who did not have a cycle canceled (30% agreed), Dr. Turocy said.
Most respondents would have preferred an option to start a treatment cycle in consultation with their doctor. Half “would have chosen to start a new cycle during the height of the pandemic in New York City,” Dr. Turocy said.
Patient opinions may vary by region and depend on the severity of COVID-19 outbreaks there, and they also might change over time, Dr. Turocy suggested. In addition, the opinions and characteristics of patients who responded to the anonymous survey may differ from those of patients who did not respond.
Dr. Verrilli, Dr. Turocy, and Dr. Lin had no relevant financial disclosures.
More than 60% of patients at a center for reproductive medicine in Utah who had fertility treatments canceled because of the COVID-19 pandemic opted to resume treatment once the suspension was lifted about 7 weeks later.
At another fertility center in New York, a survey found that 96% of respondents who had a cycle canceled because of the pandemic found it upsetting, and 22% found it extremely upsetting, with extremely upsetting defined as equivalent to the loss of a child.
The indefinite time frame for resuming treatment when the New York survey was conducted may have been a major source of distress for patients, one of the researchers said at the American Society for Reproductive Medicine’s 2020 annual meeting, held virtually this year.
“They don’t know when they might have that chance again,” said Jenna M. Turocy, MD, of Columbia University Fertility Center, New York.
COVID-19 guidelines published by ASRM on March 17 recommended the suspension of new treatment cycles, including ovulation induction, intrauterine inseminations, and in vitro fertilization (IVF).
An ASRM COVID-19 task force has since supported “the measured resumption of fertility care following the easing of restrictions,” said Paul C. Lin, MD, president of the Society for Assisted Reproductive Technology and a member of the task force.
“Over the past several months, significant knowledge has been gained regarding the COVID-19 virus and its impact on patients and the medical system,” he said in a news release about the two studies that assessed the pandemic’s effects.
Certain precautions remain. “It has become clear that we will need to be practicing COVID-19 protocols at least until an effective and safe vaccine or broadly effective treatment becomes widely available,” Dr. Lin said.
Desire to proceed during a pandemic
The center continued to offer IVF cycles for oncofertility patients on an urgent basis.
In early May, patients whose cycles had been suspended had the option to receive treatment.
“Upon reopening, every patient received standardized counseling from their primary IVF physician,” Lauren Verrilli, MD, a reproductive endocrinology and infertility fellow at the University of Utah, Salt Lake City, said at the virtual meeting.
Doctors explained that much remained unknown about COVID-19 in pregnancy, and that it was unclear whether the clinic would need to shut down again. In addition, patients had to undergo COVID-19 testing.
To identify factors associated with proceeding with treatment after the suspension, the researchers compared patients who resumed treatment with patients who did not.
Their analysis included 278 patients who had planned an IVF cycle or frozen embryo transfer (FET) prior to the shutdown. The researchers examined factors such as age, parity, anti-Müllerian hormone, antral follicle count, history of prior IVF cycles or FET, number of frozen blastocysts, gamete source, and use of a gestational carrier.
In all, 62% of patients opted to receive treatment once restrictions were lifted, including 69 of the 133 (52%) patients with planned fresh cycles and 104 of the 145 (72%) patients with planned FET cycles.
Among those with planned fresh cycles, those who opted to resume treatment tended to be older than those who did not resume treatment, with a median age of 37 years versus 35 years, but the difference was not statistically significant.
Among patients with planned FET cycles, those who did not resume treatment were more likely to have a gestational carrier, compared with those who resumed treatment (7% vs. 1%). In some cases, gestational carriers lived in another state and the pandemic complicated travel arrangements, which contributed to delays, Dr. Verrilli said.
The analysis did not include information about income or socioeconomic status, which may play a role in patients’ decisions, Dr. Verrilli said.
Emotional impact of indefinite delay
Fertility treatment is often time sensitive, particularly for patients with advanced reproductive age or diminished ovarian reserve, and indefinite postponement of fertility treatment potentially could lead some patients to lose the ability to conceive with their own gametes, Dr. Turocy said.
In early April, Dr. Turocy and colleagues surveyed patients at their academic fertility center in New York City to assess patients’ reactions to the ASRM recommendations. They decided to conduct the study after they realized that treatment cancellations were having a significant emotional effect.
Investigators emailed an 18-item survey to more than 3,000 patients.
In all, 518 patients completed the survey, a response rate of 17%. Patients had an average age of 37 years (range, 23-52 years), and 92% were female. About 24% had children, and 66% had received at least one fertility treatment.
Half had a cycle canceled because of the COVID-19 pandemic, including timed intercourse cycles (5%), intrauterine insemination cycles (23%), IVF cycles with a planned fresh embryo transfer (10%), IVF with all frozen embryos (27%), egg freeze cycles (3%), and FET cycles (30%).
In response to survey questions about whether they agreed with ASRM recommendations, “the reactions were mixed,” Dr. Turocy said.
About 36% of patients agreed all fertility cycles should be canceled, 22% were unsure, and 43% disagreed with the recommendation. Patients who had a cycle canceled were slightly more likely to agree with the cancellations (40% agreed) than those who did not have a cycle canceled (30% agreed), Dr. Turocy said.
Most respondents would have preferred an option to start a treatment cycle in consultation with their doctor. Half “would have chosen to start a new cycle during the height of the pandemic in New York City,” Dr. Turocy said.
Patient opinions may vary by region and depend on the severity of COVID-19 outbreaks there, and they also might change over time, Dr. Turocy suggested. In addition, the opinions and characteristics of patients who responded to the anonymous survey may differ from those of patients who did not respond.
Dr. Verrilli, Dr. Turocy, and Dr. Lin had no relevant financial disclosures.
FROM ASRM 2020