User login
‘Praise Diabetes’: Support programs in Black churches yield lasting A1c changes
A church-based diabetes self-management support intervention that incorporated parish nurses and peer leaders is feasible and may help improve diabetes-related outcomes in participants.
Sustained reductions in hemoglobin A1c and diabetes distress were seen in the Praise Diabetes Project, a 33-month study that piloted several different approaches to parish nurse and peer leader support at 21 urban churches in Michigan and Ohio, said Gretchen Piatt, MPH, PhD, associate professor in the department of learning health sciences at the University of Michigan, Ann Arbor, reported at the annual scientific sessions of the American Diabetes Association.
“Of the participants who achieved glycemic control following diabetes self-management education, a really large proportion – upward of 77% of participants across all the groups– achieved sustained glycemic control at 33 months,” Dr. Piatt said.
Findings from this study has helped diabetes educators better understand how to design effective support approaches that may have a long-term impact on glycemic control and diabetes distress, Dr. Piatt said.
The Praise Diabetes Project represents a “very smart strategy” of leveraging institutions that already exist in the African American community that are trusted and provide emotional support, said Tracey D. Brown, CEO of the ADA.
“This is about behavior change, really, at its crux,” Ms. Brown said in an interview. “To get there, you’ve got to have trust, and you have to have an emotional connection. If you don’t get either one of those things, then you really are not going to do anything in terms of changing behavior.”
Long-term solutions needed
Many studies show that diabetes self-management education can improve clinical and psychosocial outcomes, and reduce health care utilization and cost, at least in the short term, Dr. Piatt said. However, it’s less clear how those improvements can be sustained over longer periods of time.
“This then presents a critical need to develop and evaluate diabetes self-management support models that are ongoing, patient driven, and embedded within existing community infrastructures,” Dr. Piatt said in her presentation.
Working with churches is one approach to working within existing community infrastructures: “Churches are embedded in the community, they have the personnel oftentimes to facilitate these types of health programs, and most importantly, they have the established relationships with the community that brings about sustained changes,” Dr. Piatt said in her presentation.
Addressing diabetes education needs in urban, low-resource communities
The Praise Diabetes Project was a randomized, 33-month clinical trial conducted in 21 predominantly Black churches in Detroit; Flint, Mich.; and Toledo, Ohio, which are all urban, low-resource communities where diabetes is a significant public health problem, according to Dr. Piatt.
The study was designed to evaluate the relative effectiveness of three different approaches to diabetes self-management support at improving A1c and levels of diabetes distress, according to the investigators.
The churches were randomized to one of the support arms, including parish nurse plus peer leader support, parish nurse support by itself, or peer leader support by itself.
A total of 47 individuals were trained, including 31 peer leaders and 16 parish nurses.
All three interventions included an initial 6-month period of “enhanced usual care” during which biweekly newsletters that were distributed, according to Dr. Piatt. That was followed by 12 months of diabetes self-management support, and an additional 12 months of ongoing support facilitated by parish nurses and peer leaders on their own, without input from the research team or health care providers.
Participants in the program had to be at least 21 years old and under the care of a physician for their diabetes, according to Dr. Piatt. The parish nurses had to be registered nurses in Michigan or Ohio. Peer leaders had to be at least 21 years old, had at least an eighth-grade education, and had to commit to a 30-hour training program.
Peer leaders also had to be individuals living with diabetes: “Prior studies have found that, when peer leaders are actively working on their own self-management goals, they tend to be much more successful in helping others,” Dr. Piatt explained.
In addition to facilitating diabetes self-management education, the parish nurses and peer leaders in these interventions were responsible for recruitment, church announcements, room reservations, follow-up calls to participants, according to Dr. Piatt. Parish nurses also provided clinical content knowledge and supervised the peer leaders in the combined model.
Sustained reductions in A1c and diabetes distress
These diabetes self-management support approaches led to significant changes over time in A1c and diabetes distress, the primary outcomes of the study, Dr. Piatt said.
The peer leader support approach resulted in a statistically significant decline in A1c, from a mean of 8.0% at baseline to 7.7% at 33 months (P = .04), while nonsignificant declines were observed in the parish nurse and combined parish nurse–peer leader approach, according to the researcher.
Reductions in A1c persisted despite the COVID-19 pandemic, which began roughly 21 months into the study, she said.
Glycemic control remained steady over the course of the study, as illustrated by similar proportions of participants with A1c below 7% from baseline to 33 months, she added.
Sustained glycemic control was seen in all three groups, according to Dr. Piatt. For example, 42.7% of individuals in the parish nurse and peer leader support group achieved glycemic control following the intervention, and 88.5% of them sustained it at 33 months.
“I think this is one of the longest diabetes self-management education and diabetes self-management support interventions that’s out there right now, so we were so happy to see that sustained by glycemic control that far into the future,” she said.
Diabetes distress levels decreased steadily over time in all three groups, with declines that were statistically significant from baseline to 33 months in the parish nurse–only and peer leader–only groups, the investigator said.
The proportion of participants reporting moderate levels of diabetes distress dropped over time, especially in the peer leader support group, where there was a 50% reduction, she added.
Despite these findings, the study had limitations, according to Dr. Piatt, including some “burnout” that impacted participants, parish nurses, and peer leaders, especially after the pandemic started.
In addition, this type of intervention may have limited impact in the community at large: “We probably didn’t reach people who did not have good connection to the church,” Dr. Piatt said.
Dr. Piatt reported no conflicts of interest related to the research.
A church-based diabetes self-management support intervention that incorporated parish nurses and peer leaders is feasible and may help improve diabetes-related outcomes in participants.
Sustained reductions in hemoglobin A1c and diabetes distress were seen in the Praise Diabetes Project, a 33-month study that piloted several different approaches to parish nurse and peer leader support at 21 urban churches in Michigan and Ohio, said Gretchen Piatt, MPH, PhD, associate professor in the department of learning health sciences at the University of Michigan, Ann Arbor, reported at the annual scientific sessions of the American Diabetes Association.
“Of the participants who achieved glycemic control following diabetes self-management education, a really large proportion – upward of 77% of participants across all the groups– achieved sustained glycemic control at 33 months,” Dr. Piatt said.
Findings from this study has helped diabetes educators better understand how to design effective support approaches that may have a long-term impact on glycemic control and diabetes distress, Dr. Piatt said.
The Praise Diabetes Project represents a “very smart strategy” of leveraging institutions that already exist in the African American community that are trusted and provide emotional support, said Tracey D. Brown, CEO of the ADA.
“This is about behavior change, really, at its crux,” Ms. Brown said in an interview. “To get there, you’ve got to have trust, and you have to have an emotional connection. If you don’t get either one of those things, then you really are not going to do anything in terms of changing behavior.”
Long-term solutions needed
Many studies show that diabetes self-management education can improve clinical and psychosocial outcomes, and reduce health care utilization and cost, at least in the short term, Dr. Piatt said. However, it’s less clear how those improvements can be sustained over longer periods of time.
“This then presents a critical need to develop and evaluate diabetes self-management support models that are ongoing, patient driven, and embedded within existing community infrastructures,” Dr. Piatt said in her presentation.
Working with churches is one approach to working within existing community infrastructures: “Churches are embedded in the community, they have the personnel oftentimes to facilitate these types of health programs, and most importantly, they have the established relationships with the community that brings about sustained changes,” Dr. Piatt said in her presentation.
Addressing diabetes education needs in urban, low-resource communities
The Praise Diabetes Project was a randomized, 33-month clinical trial conducted in 21 predominantly Black churches in Detroit; Flint, Mich.; and Toledo, Ohio, which are all urban, low-resource communities where diabetes is a significant public health problem, according to Dr. Piatt.
The study was designed to evaluate the relative effectiveness of three different approaches to diabetes self-management support at improving A1c and levels of diabetes distress, according to the investigators.
The churches were randomized to one of the support arms, including parish nurse plus peer leader support, parish nurse support by itself, or peer leader support by itself.
A total of 47 individuals were trained, including 31 peer leaders and 16 parish nurses.
All three interventions included an initial 6-month period of “enhanced usual care” during which biweekly newsletters that were distributed, according to Dr. Piatt. That was followed by 12 months of diabetes self-management support, and an additional 12 months of ongoing support facilitated by parish nurses and peer leaders on their own, without input from the research team or health care providers.
Participants in the program had to be at least 21 years old and under the care of a physician for their diabetes, according to Dr. Piatt. The parish nurses had to be registered nurses in Michigan or Ohio. Peer leaders had to be at least 21 years old, had at least an eighth-grade education, and had to commit to a 30-hour training program.
Peer leaders also had to be individuals living with diabetes: “Prior studies have found that, when peer leaders are actively working on their own self-management goals, they tend to be much more successful in helping others,” Dr. Piatt explained.
In addition to facilitating diabetes self-management education, the parish nurses and peer leaders in these interventions were responsible for recruitment, church announcements, room reservations, follow-up calls to participants, according to Dr. Piatt. Parish nurses also provided clinical content knowledge and supervised the peer leaders in the combined model.
Sustained reductions in A1c and diabetes distress
These diabetes self-management support approaches led to significant changes over time in A1c and diabetes distress, the primary outcomes of the study, Dr. Piatt said.
The peer leader support approach resulted in a statistically significant decline in A1c, from a mean of 8.0% at baseline to 7.7% at 33 months (P = .04), while nonsignificant declines were observed in the parish nurse and combined parish nurse–peer leader approach, according to the researcher.
Reductions in A1c persisted despite the COVID-19 pandemic, which began roughly 21 months into the study, she said.
Glycemic control remained steady over the course of the study, as illustrated by similar proportions of participants with A1c below 7% from baseline to 33 months, she added.
Sustained glycemic control was seen in all three groups, according to Dr. Piatt. For example, 42.7% of individuals in the parish nurse and peer leader support group achieved glycemic control following the intervention, and 88.5% of them sustained it at 33 months.
“I think this is one of the longest diabetes self-management education and diabetes self-management support interventions that’s out there right now, so we were so happy to see that sustained by glycemic control that far into the future,” she said.
Diabetes distress levels decreased steadily over time in all three groups, with declines that were statistically significant from baseline to 33 months in the parish nurse–only and peer leader–only groups, the investigator said.
The proportion of participants reporting moderate levels of diabetes distress dropped over time, especially in the peer leader support group, where there was a 50% reduction, she added.
Despite these findings, the study had limitations, according to Dr. Piatt, including some “burnout” that impacted participants, parish nurses, and peer leaders, especially after the pandemic started.
In addition, this type of intervention may have limited impact in the community at large: “We probably didn’t reach people who did not have good connection to the church,” Dr. Piatt said.
Dr. Piatt reported no conflicts of interest related to the research.
A church-based diabetes self-management support intervention that incorporated parish nurses and peer leaders is feasible and may help improve diabetes-related outcomes in participants.
Sustained reductions in hemoglobin A1c and diabetes distress were seen in the Praise Diabetes Project, a 33-month study that piloted several different approaches to parish nurse and peer leader support at 21 urban churches in Michigan and Ohio, said Gretchen Piatt, MPH, PhD, associate professor in the department of learning health sciences at the University of Michigan, Ann Arbor, reported at the annual scientific sessions of the American Diabetes Association.
“Of the participants who achieved glycemic control following diabetes self-management education, a really large proportion – upward of 77% of participants across all the groups– achieved sustained glycemic control at 33 months,” Dr. Piatt said.
Findings from this study has helped diabetes educators better understand how to design effective support approaches that may have a long-term impact on glycemic control and diabetes distress, Dr. Piatt said.
The Praise Diabetes Project represents a “very smart strategy” of leveraging institutions that already exist in the African American community that are trusted and provide emotional support, said Tracey D. Brown, CEO of the ADA.
“This is about behavior change, really, at its crux,” Ms. Brown said in an interview. “To get there, you’ve got to have trust, and you have to have an emotional connection. If you don’t get either one of those things, then you really are not going to do anything in terms of changing behavior.”
Long-term solutions needed
Many studies show that diabetes self-management education can improve clinical and psychosocial outcomes, and reduce health care utilization and cost, at least in the short term, Dr. Piatt said. However, it’s less clear how those improvements can be sustained over longer periods of time.
“This then presents a critical need to develop and evaluate diabetes self-management support models that are ongoing, patient driven, and embedded within existing community infrastructures,” Dr. Piatt said in her presentation.
Working with churches is one approach to working within existing community infrastructures: “Churches are embedded in the community, they have the personnel oftentimes to facilitate these types of health programs, and most importantly, they have the established relationships with the community that brings about sustained changes,” Dr. Piatt said in her presentation.
Addressing diabetes education needs in urban, low-resource communities
The Praise Diabetes Project was a randomized, 33-month clinical trial conducted in 21 predominantly Black churches in Detroit; Flint, Mich.; and Toledo, Ohio, which are all urban, low-resource communities where diabetes is a significant public health problem, according to Dr. Piatt.
The study was designed to evaluate the relative effectiveness of three different approaches to diabetes self-management support at improving A1c and levels of diabetes distress, according to the investigators.
The churches were randomized to one of the support arms, including parish nurse plus peer leader support, parish nurse support by itself, or peer leader support by itself.
A total of 47 individuals were trained, including 31 peer leaders and 16 parish nurses.
All three interventions included an initial 6-month period of “enhanced usual care” during which biweekly newsletters that were distributed, according to Dr. Piatt. That was followed by 12 months of diabetes self-management support, and an additional 12 months of ongoing support facilitated by parish nurses and peer leaders on their own, without input from the research team or health care providers.
Participants in the program had to be at least 21 years old and under the care of a physician for their diabetes, according to Dr. Piatt. The parish nurses had to be registered nurses in Michigan or Ohio. Peer leaders had to be at least 21 years old, had at least an eighth-grade education, and had to commit to a 30-hour training program.
Peer leaders also had to be individuals living with diabetes: “Prior studies have found that, when peer leaders are actively working on their own self-management goals, they tend to be much more successful in helping others,” Dr. Piatt explained.
In addition to facilitating diabetes self-management education, the parish nurses and peer leaders in these interventions were responsible for recruitment, church announcements, room reservations, follow-up calls to participants, according to Dr. Piatt. Parish nurses also provided clinical content knowledge and supervised the peer leaders in the combined model.
Sustained reductions in A1c and diabetes distress
These diabetes self-management support approaches led to significant changes over time in A1c and diabetes distress, the primary outcomes of the study, Dr. Piatt said.
The peer leader support approach resulted in a statistically significant decline in A1c, from a mean of 8.0% at baseline to 7.7% at 33 months (P = .04), while nonsignificant declines were observed in the parish nurse and combined parish nurse–peer leader approach, according to the researcher.
Reductions in A1c persisted despite the COVID-19 pandemic, which began roughly 21 months into the study, she said.
Glycemic control remained steady over the course of the study, as illustrated by similar proportions of participants with A1c below 7% from baseline to 33 months, she added.
Sustained glycemic control was seen in all three groups, according to Dr. Piatt. For example, 42.7% of individuals in the parish nurse and peer leader support group achieved glycemic control following the intervention, and 88.5% of them sustained it at 33 months.
“I think this is one of the longest diabetes self-management education and diabetes self-management support interventions that’s out there right now, so we were so happy to see that sustained by glycemic control that far into the future,” she said.
Diabetes distress levels decreased steadily over time in all three groups, with declines that were statistically significant from baseline to 33 months in the parish nurse–only and peer leader–only groups, the investigator said.
The proportion of participants reporting moderate levels of diabetes distress dropped over time, especially in the peer leader support group, where there was a 50% reduction, she added.
Despite these findings, the study had limitations, according to Dr. Piatt, including some “burnout” that impacted participants, parish nurses, and peer leaders, especially after the pandemic started.
In addition, this type of intervention may have limited impact in the community at large: “We probably didn’t reach people who did not have good connection to the church,” Dr. Piatt said.
Dr. Piatt reported no conflicts of interest related to the research.
FROM ADA 2020
Top 12 tips for research success in fellowship and early academic faculty years
Congratulations! You have matched in a competitive medical subspecialty or you have secured your first faculty position. But what do you do now? Success in your early career – as a new fellow or a new attending – requires both hard work and perseverance. We present our top 12 tips for how to be successful as you transition into your new position.
Tip #1: Be kind to yourself
As you transition from medical resident to GI fellow or from GI fellow to first-time attending, it is important to recognize that you are going through a major career transition (not as major as fourth year to intern, but probably a close second). First and foremost, remember to be kind to yourself and set reasonable expectations. You need to allow yourself time to transition to a new role which may also be in a new city or state. Take care of yourself – don’t forget to exercise, eat well, and sleep. You are in the long game now. Work to get yourself in a routine that is sustainable. Block out time to exercise, explore your new city, meal plan, and pursue your interests outside of medicine.
Tip #2: Set up for success
Since you are going through this major life/career transition, it is really helpful if you can set yourself up for success by having some projects that are easily completed during this challenging time so that you can demonstrate success. If you have projects in different stages of development, you will always have something you can work on when some projects are delayed for reasons outside of your control. In particular, it is great to have a few papers ready to go during late fellowship so they are published during your first year as an academic attending! This will allow you to continue your research trajectory as you learn the ropes of your new position.
Tip #3: Ask for help
It turns out you cannot do everything on your own! Make sure you are getting help professionally and personally so that you are set up for success. It’s okay to feel overwhelmed or confused; we all do at some point or another. Fellowship and early academic faculty years are stressful and nobody expects you to do it alone. Chances are your mentors or cofellows have had similar struggles, and in opening up, this dialogue may help you both.
Tip #4: Write out your 5-year plan
You need to know where you are going before you can figure out how to get there. Take some time for “soul searching”: Think about where you would like to be in 5 years and work backward (along with help from your mentors; see Tip #5) to determine how best to get there. If you think a career in academia might be for you, it’s never too soon to start networking and involving yourself in research. If a specific institution or clinical position draws your attention, check out the current faculty. You can use their CVs as a roadmap of types of experiences and honors that should be on your radar throughout these 5 years. Remember that your 5-year plan is not written in stone – this is something that you should re-evaluate as your interests and priorities change throughout your career.
Tip #5: Develop your personal ‘Board of Directors’
Instead of trying to find the perfect mentor, we suggest you seek out a personal “Board of Directors” who can serve as your mentoring team. There will never be a single perfect mentor for you and it is likely that you will need separate mentors to help guide you on different aspects of your career. I personally have separate individuals serving as my clinical mentor, my research content mentor, my research methods mentor, my career mentor, and my personal/life mentor. Having multiple mentors allows you to maximize the impact of your different mentors’ strengths across each component of your career. Further, your mentors themselves may have past histories of collaboration that you may then leverage to buoy your own fledgling career. When deciding on who to choose as a mentor, it is important to talk to prior mentees about their experiences with a mentor to help you decide if you may be a good match.
Tip #6: Master the art of “Menteering”
Now that you have identified mentors, you need to do your part in nurturing this mentee-mentor relationship. Be an excellent mentee: Show up, stick to a timeline, bring ideas and enthusiasm, and make it easy for your mentor. Your mentors want to see you succeed and sometimes this requires you to help them help you. If you know your own learning style and how you like to interact, have that conversation with your mentor upfront (for example, you may need strict deadlines or you may prefer having more time to develop ideas). Having these conversations before you start a project or a relationship will help set the expectations and ensure effective communication with your mentor. If you find that your mentor is doing something that hinders your progress, such as asking for updates too often or not checking in enough, have a constructive conversation with them about how you feel. Come prepared for meetings with your mentor with an agenda and timeline. Be specific if there is something you need from your mentor and be respectful of their other commitments. For example, if you would like your mentor to review your grant application, let them know the grant deadline and find out when you need to get them a draft so that they will have time to provide meaningful feedback.
Tip #7: Identify sponsors
Equally, if not more important than your mentoring team, are sponsors. These are people in positions of power who will promote you and help push your career forward. Sponsors can be people more senior to you, cofellows, or even acquaintances in industry or pharmaceuticals. Your mentor may also be your sponsor, but not always. As early academic faculty, it is important to get your name out there with speaking engagements related to your clinical and research niche, and that is one way a sponsor can help bolster your career.
Tip #8: Develop your personal brand – what is on your T-shirt?
As medicine becomes more and more subspecialized, finding your brand is becoming increasingly important. A brand could be anything from your academic niche to social justice, or even social media utilization. Your brand should encompass what you are naturally excited by within your field. Finding your brand will not only distinguish you from your peers but will also provide you with expertise which you can then offer to your colleagues, near and far. Practice the “elevator pitch” of your personal brand so that you can effectively (and efficiently) describe yourself and your interests when meeting new people and networking.
Tip #9: Meet thought leaders in your field
Think of the top five or six most prominent and influential people in your area of clinical or research interest and introduce yourself. This can be done at a national meeting or simply over email, though in person is always best if possible. Although thought leaders are busy, in my experience, if you are persistent, you can always find a few minutes to make an introduction. I’ve shared cab rides just to get a few minutes of someone’s time. In my first few years on faculty, I met with most of the thought leaders in my field; some of these meetings led to fruitful collaborations and important introductions (see tip #7). Meet others at your career level too. They can be great to bounce ideas off, and they will be future leaders in the field. Inviting thought leaders to come to your institution to give talks (in-person or virtually) is another great way to show your interest in their work and also find time to introduce yourself.
Tip #10: Apply, apply, apply
Remember that feedback is a gift and the best way to receive feedback is to apply to as many opportunities as you can. Any successful person in GI will have a ‘CV of failures’ far longer than their actual CV documenting their successes. I applied to 8 grants before landing my first one, but I received invaluable feedback and improved my writing skills in the process. Success in fellowship and early faculty takes immense grit – work on building a thick skin and finding the learning opportunity within any outcome.
Tip #11: Don’t get sucked into the email abyss
It is easy to fill your time completing low priority, but easy to complete, tasks such as responding to emails. Time management is key and you need to make sure that you dedicate time to more time-consuming tasks – such as writing and developing projects/grants – that have a high reward. Dedicate time on your calendar for high-priority tasks and make sure you don’t open your email during this time. Turn off the email pop-up window and do emails at the end of the day (or whenever you are done writing and thinking). Limiting distractions will help get your creative juices flowing.
Tip #12: Don’t always say yes
In fact, don’t ever say yes to a career or research opportunity within the first 24 hours to allow yourself time to weigh the pros and cons of the commitment, to assess the timeline feasibility, and to decide it fits into your 5-year plan. You can say you need to talk to your mentor about it first. If you decide you cannot accept an opportunity, a great way to mitigate that is to simply say “I’d love to, but my mentor says no.” Act as a sponsor to someone else by suggesting a potential colleague who might be interested in the opportunity. As you accept more responsibilities, think about what you might be able to give up to give yourself time to be successful in this new opportunity (and not distract from yourself or your 5-year plan).
Conclusion
Success in research and early academic faculty years takes planning and determination. We hope these tips provide a broad outline for what to think about and how to approach planning your future career. First and foremost, you must put in the time to think about what you really want and what will make you happy in the long run. Academic success is a broad term that each of us defines differently. What does it mean to you? Once you figure that out, make your 5-year plan and run with it!
Dr. Rebello and Dr. Long are with section of gastroenterology at Boston Medical Center and Boston University. They have no conflicts to report.
Congratulations! You have matched in a competitive medical subspecialty or you have secured your first faculty position. But what do you do now? Success in your early career – as a new fellow or a new attending – requires both hard work and perseverance. We present our top 12 tips for how to be successful as you transition into your new position.
Tip #1: Be kind to yourself
As you transition from medical resident to GI fellow or from GI fellow to first-time attending, it is important to recognize that you are going through a major career transition (not as major as fourth year to intern, but probably a close second). First and foremost, remember to be kind to yourself and set reasonable expectations. You need to allow yourself time to transition to a new role which may also be in a new city or state. Take care of yourself – don’t forget to exercise, eat well, and sleep. You are in the long game now. Work to get yourself in a routine that is sustainable. Block out time to exercise, explore your new city, meal plan, and pursue your interests outside of medicine.
Tip #2: Set up for success
Since you are going through this major life/career transition, it is really helpful if you can set yourself up for success by having some projects that are easily completed during this challenging time so that you can demonstrate success. If you have projects in different stages of development, you will always have something you can work on when some projects are delayed for reasons outside of your control. In particular, it is great to have a few papers ready to go during late fellowship so they are published during your first year as an academic attending! This will allow you to continue your research trajectory as you learn the ropes of your new position.
Tip #3: Ask for help
It turns out you cannot do everything on your own! Make sure you are getting help professionally and personally so that you are set up for success. It’s okay to feel overwhelmed or confused; we all do at some point or another. Fellowship and early academic faculty years are stressful and nobody expects you to do it alone. Chances are your mentors or cofellows have had similar struggles, and in opening up, this dialogue may help you both.
Tip #4: Write out your 5-year plan
You need to know where you are going before you can figure out how to get there. Take some time for “soul searching”: Think about where you would like to be in 5 years and work backward (along with help from your mentors; see Tip #5) to determine how best to get there. If you think a career in academia might be for you, it’s never too soon to start networking and involving yourself in research. If a specific institution or clinical position draws your attention, check out the current faculty. You can use their CVs as a roadmap of types of experiences and honors that should be on your radar throughout these 5 years. Remember that your 5-year plan is not written in stone – this is something that you should re-evaluate as your interests and priorities change throughout your career.
Tip #5: Develop your personal ‘Board of Directors’
Instead of trying to find the perfect mentor, we suggest you seek out a personal “Board of Directors” who can serve as your mentoring team. There will never be a single perfect mentor for you and it is likely that you will need separate mentors to help guide you on different aspects of your career. I personally have separate individuals serving as my clinical mentor, my research content mentor, my research methods mentor, my career mentor, and my personal/life mentor. Having multiple mentors allows you to maximize the impact of your different mentors’ strengths across each component of your career. Further, your mentors themselves may have past histories of collaboration that you may then leverage to buoy your own fledgling career. When deciding on who to choose as a mentor, it is important to talk to prior mentees about their experiences with a mentor to help you decide if you may be a good match.
Tip #6: Master the art of “Menteering”
Now that you have identified mentors, you need to do your part in nurturing this mentee-mentor relationship. Be an excellent mentee: Show up, stick to a timeline, bring ideas and enthusiasm, and make it easy for your mentor. Your mentors want to see you succeed and sometimes this requires you to help them help you. If you know your own learning style and how you like to interact, have that conversation with your mentor upfront (for example, you may need strict deadlines or you may prefer having more time to develop ideas). Having these conversations before you start a project or a relationship will help set the expectations and ensure effective communication with your mentor. If you find that your mentor is doing something that hinders your progress, such as asking for updates too often or not checking in enough, have a constructive conversation with them about how you feel. Come prepared for meetings with your mentor with an agenda and timeline. Be specific if there is something you need from your mentor and be respectful of their other commitments. For example, if you would like your mentor to review your grant application, let them know the grant deadline and find out when you need to get them a draft so that they will have time to provide meaningful feedback.
Tip #7: Identify sponsors
Equally, if not more important than your mentoring team, are sponsors. These are people in positions of power who will promote you and help push your career forward. Sponsors can be people more senior to you, cofellows, or even acquaintances in industry or pharmaceuticals. Your mentor may also be your sponsor, but not always. As early academic faculty, it is important to get your name out there with speaking engagements related to your clinical and research niche, and that is one way a sponsor can help bolster your career.
Tip #8: Develop your personal brand – what is on your T-shirt?
As medicine becomes more and more subspecialized, finding your brand is becoming increasingly important. A brand could be anything from your academic niche to social justice, or even social media utilization. Your brand should encompass what you are naturally excited by within your field. Finding your brand will not only distinguish you from your peers but will also provide you with expertise which you can then offer to your colleagues, near and far. Practice the “elevator pitch” of your personal brand so that you can effectively (and efficiently) describe yourself and your interests when meeting new people and networking.
Tip #9: Meet thought leaders in your field
Think of the top five or six most prominent and influential people in your area of clinical or research interest and introduce yourself. This can be done at a national meeting or simply over email, though in person is always best if possible. Although thought leaders are busy, in my experience, if you are persistent, you can always find a few minutes to make an introduction. I’ve shared cab rides just to get a few minutes of someone’s time. In my first few years on faculty, I met with most of the thought leaders in my field; some of these meetings led to fruitful collaborations and important introductions (see tip #7). Meet others at your career level too. They can be great to bounce ideas off, and they will be future leaders in the field. Inviting thought leaders to come to your institution to give talks (in-person or virtually) is another great way to show your interest in their work and also find time to introduce yourself.
Tip #10: Apply, apply, apply
Remember that feedback is a gift and the best way to receive feedback is to apply to as many opportunities as you can. Any successful person in GI will have a ‘CV of failures’ far longer than their actual CV documenting their successes. I applied to 8 grants before landing my first one, but I received invaluable feedback and improved my writing skills in the process. Success in fellowship and early faculty takes immense grit – work on building a thick skin and finding the learning opportunity within any outcome.
Tip #11: Don’t get sucked into the email abyss
It is easy to fill your time completing low priority, but easy to complete, tasks such as responding to emails. Time management is key and you need to make sure that you dedicate time to more time-consuming tasks – such as writing and developing projects/grants – that have a high reward. Dedicate time on your calendar for high-priority tasks and make sure you don’t open your email during this time. Turn off the email pop-up window and do emails at the end of the day (or whenever you are done writing and thinking). Limiting distractions will help get your creative juices flowing.
Tip #12: Don’t always say yes
In fact, don’t ever say yes to a career or research opportunity within the first 24 hours to allow yourself time to weigh the pros and cons of the commitment, to assess the timeline feasibility, and to decide it fits into your 5-year plan. You can say you need to talk to your mentor about it first. If you decide you cannot accept an opportunity, a great way to mitigate that is to simply say “I’d love to, but my mentor says no.” Act as a sponsor to someone else by suggesting a potential colleague who might be interested in the opportunity. As you accept more responsibilities, think about what you might be able to give up to give yourself time to be successful in this new opportunity (and not distract from yourself or your 5-year plan).
Conclusion
Success in research and early academic faculty years takes planning and determination. We hope these tips provide a broad outline for what to think about and how to approach planning your future career. First and foremost, you must put in the time to think about what you really want and what will make you happy in the long run. Academic success is a broad term that each of us defines differently. What does it mean to you? Once you figure that out, make your 5-year plan and run with it!
Dr. Rebello and Dr. Long are with section of gastroenterology at Boston Medical Center and Boston University. They have no conflicts to report.
Congratulations! You have matched in a competitive medical subspecialty or you have secured your first faculty position. But what do you do now? Success in your early career – as a new fellow or a new attending – requires both hard work and perseverance. We present our top 12 tips for how to be successful as you transition into your new position.
Tip #1: Be kind to yourself
As you transition from medical resident to GI fellow or from GI fellow to first-time attending, it is important to recognize that you are going through a major career transition (not as major as fourth year to intern, but probably a close second). First and foremost, remember to be kind to yourself and set reasonable expectations. You need to allow yourself time to transition to a new role which may also be in a new city or state. Take care of yourself – don’t forget to exercise, eat well, and sleep. You are in the long game now. Work to get yourself in a routine that is sustainable. Block out time to exercise, explore your new city, meal plan, and pursue your interests outside of medicine.
Tip #2: Set up for success
Since you are going through this major life/career transition, it is really helpful if you can set yourself up for success by having some projects that are easily completed during this challenging time so that you can demonstrate success. If you have projects in different stages of development, you will always have something you can work on when some projects are delayed for reasons outside of your control. In particular, it is great to have a few papers ready to go during late fellowship so they are published during your first year as an academic attending! This will allow you to continue your research trajectory as you learn the ropes of your new position.
Tip #3: Ask for help
It turns out you cannot do everything on your own! Make sure you are getting help professionally and personally so that you are set up for success. It’s okay to feel overwhelmed or confused; we all do at some point or another. Fellowship and early academic faculty years are stressful and nobody expects you to do it alone. Chances are your mentors or cofellows have had similar struggles, and in opening up, this dialogue may help you both.
Tip #4: Write out your 5-year plan
You need to know where you are going before you can figure out how to get there. Take some time for “soul searching”: Think about where you would like to be in 5 years and work backward (along with help from your mentors; see Tip #5) to determine how best to get there. If you think a career in academia might be for you, it’s never too soon to start networking and involving yourself in research. If a specific institution or clinical position draws your attention, check out the current faculty. You can use their CVs as a roadmap of types of experiences and honors that should be on your radar throughout these 5 years. Remember that your 5-year plan is not written in stone – this is something that you should re-evaluate as your interests and priorities change throughout your career.
Tip #5: Develop your personal ‘Board of Directors’
Instead of trying to find the perfect mentor, we suggest you seek out a personal “Board of Directors” who can serve as your mentoring team. There will never be a single perfect mentor for you and it is likely that you will need separate mentors to help guide you on different aspects of your career. I personally have separate individuals serving as my clinical mentor, my research content mentor, my research methods mentor, my career mentor, and my personal/life mentor. Having multiple mentors allows you to maximize the impact of your different mentors’ strengths across each component of your career. Further, your mentors themselves may have past histories of collaboration that you may then leverage to buoy your own fledgling career. When deciding on who to choose as a mentor, it is important to talk to prior mentees about their experiences with a mentor to help you decide if you may be a good match.
Tip #6: Master the art of “Menteering”
Now that you have identified mentors, you need to do your part in nurturing this mentee-mentor relationship. Be an excellent mentee: Show up, stick to a timeline, bring ideas and enthusiasm, and make it easy for your mentor. Your mentors want to see you succeed and sometimes this requires you to help them help you. If you know your own learning style and how you like to interact, have that conversation with your mentor upfront (for example, you may need strict deadlines or you may prefer having more time to develop ideas). Having these conversations before you start a project or a relationship will help set the expectations and ensure effective communication with your mentor. If you find that your mentor is doing something that hinders your progress, such as asking for updates too often or not checking in enough, have a constructive conversation with them about how you feel. Come prepared for meetings with your mentor with an agenda and timeline. Be specific if there is something you need from your mentor and be respectful of their other commitments. For example, if you would like your mentor to review your grant application, let them know the grant deadline and find out when you need to get them a draft so that they will have time to provide meaningful feedback.
Tip #7: Identify sponsors
Equally, if not more important than your mentoring team, are sponsors. These are people in positions of power who will promote you and help push your career forward. Sponsors can be people more senior to you, cofellows, or even acquaintances in industry or pharmaceuticals. Your mentor may also be your sponsor, but not always. As early academic faculty, it is important to get your name out there with speaking engagements related to your clinical and research niche, and that is one way a sponsor can help bolster your career.
Tip #8: Develop your personal brand – what is on your T-shirt?
As medicine becomes more and more subspecialized, finding your brand is becoming increasingly important. A brand could be anything from your academic niche to social justice, or even social media utilization. Your brand should encompass what you are naturally excited by within your field. Finding your brand will not only distinguish you from your peers but will also provide you with expertise which you can then offer to your colleagues, near and far. Practice the “elevator pitch” of your personal brand so that you can effectively (and efficiently) describe yourself and your interests when meeting new people and networking.
Tip #9: Meet thought leaders in your field
Think of the top five or six most prominent and influential people in your area of clinical or research interest and introduce yourself. This can be done at a national meeting or simply over email, though in person is always best if possible. Although thought leaders are busy, in my experience, if you are persistent, you can always find a few minutes to make an introduction. I’ve shared cab rides just to get a few minutes of someone’s time. In my first few years on faculty, I met with most of the thought leaders in my field; some of these meetings led to fruitful collaborations and important introductions (see tip #7). Meet others at your career level too. They can be great to bounce ideas off, and they will be future leaders in the field. Inviting thought leaders to come to your institution to give talks (in-person or virtually) is another great way to show your interest in their work and also find time to introduce yourself.
Tip #10: Apply, apply, apply
Remember that feedback is a gift and the best way to receive feedback is to apply to as many opportunities as you can. Any successful person in GI will have a ‘CV of failures’ far longer than their actual CV documenting their successes. I applied to 8 grants before landing my first one, but I received invaluable feedback and improved my writing skills in the process. Success in fellowship and early faculty takes immense grit – work on building a thick skin and finding the learning opportunity within any outcome.
Tip #11: Don’t get sucked into the email abyss
It is easy to fill your time completing low priority, but easy to complete, tasks such as responding to emails. Time management is key and you need to make sure that you dedicate time to more time-consuming tasks – such as writing and developing projects/grants – that have a high reward. Dedicate time on your calendar for high-priority tasks and make sure you don’t open your email during this time. Turn off the email pop-up window and do emails at the end of the day (or whenever you are done writing and thinking). Limiting distractions will help get your creative juices flowing.
Tip #12: Don’t always say yes
In fact, don’t ever say yes to a career or research opportunity within the first 24 hours to allow yourself time to weigh the pros and cons of the commitment, to assess the timeline feasibility, and to decide it fits into your 5-year plan. You can say you need to talk to your mentor about it first. If you decide you cannot accept an opportunity, a great way to mitigate that is to simply say “I’d love to, but my mentor says no.” Act as a sponsor to someone else by suggesting a potential colleague who might be interested in the opportunity. As you accept more responsibilities, think about what you might be able to give up to give yourself time to be successful in this new opportunity (and not distract from yourself or your 5-year plan).
Conclusion
Success in research and early academic faculty years takes planning and determination. We hope these tips provide a broad outline for what to think about and how to approach planning your future career. First and foremost, you must put in the time to think about what you really want and what will make you happy in the long run. Academic success is a broad term that each of us defines differently. What does it mean to you? Once you figure that out, make your 5-year plan and run with it!
Dr. Rebello and Dr. Long are with section of gastroenterology at Boston Medical Center and Boston University. They have no conflicts to report.
The challenge of poverty to health and success: What should pediatricians do?
Some days it feels like more than half of the journal articles I encounter report data suggesting that poverty is associated with some disease entity. I realize that young postgraduates are under some pressure to publish, but I’m ready for a break. I and most pediatricians already know, or at least have assumed, that in general and with few exceptions unwellness and poverty are closely linked. Whether that association is causal or not is a more interesting question. The answer, I suspect, depends on which health condition we are talking about. For the moment I think we should assume that poverty is more likely a major contributor and not merely a fellow traveler of poor health.
Some other questions: What are we as pediatricians expected to do about poverty? Is awareness sufficient? Should I be content with having an elevated awareness that a certain patient has a given disease because I know his family is economically challenged? Or, conversely, should I be satisfied that I have asked about a family’s economic distress when I have just diagnosed a child with asthma? The answer to those questions is a very personal one for each of us to ponder and may depend on where we feel we can best invest our time and skill set.
Like me, you may feel that the focus of your professional life is better spent diagnosing and treating the collateral damage of poverty and addressing economic inequities in your philanthropic activities and your choices at the polls. On the other hand, you may choose to use your public persona as a physician to more actively address poverty whether it is on a local, national, or global stage. There is no correct answer and a hybrid may work best for you.
On the other hand, while you agree that there is some link between poverty and unwellness, perhaps the issue is overblown and we should pay more attention to other factors such as the sad state of the family in both disadvantaged and advantaged populations. Maybe if we worked harder to foster and support two-parent families the drag of economic disadvantage would be reduced.
I recently encountered a study that explores this very question. Christina Cross, PhD, a postdoctoral fellow in the department of sociology at Harvard University, reports on her soon-to-be-published study of a nationally representative sample in which she found that, using a selection of academic metrics including earned grades, likelihood of grade repetition, and rates of suspension, in low-income families there was no difference in achievement between Black youth raised in single-parent households and Black youth raised in two-parent households. However, in well-off families, Black youth raised in two-parent households had better academic metrics. (“Why living in a two-parent home isn’t a cure-all for Black students.” Christina Cross. The Harvard Gazette. 2021 Jun 3).
I guess few of us are surprised that living in a two-parent household can provide a child with some advantages. However, it is disappointing and again not surprising that poverty can rob a child of these advantages. While it may make us feel like we are doing something when we offer counseling that promotes two-family households, this may be no more valuable than supporting apple pie and motherhood. Dr. Cross concludes that President Biden’s proposed American Families Plan is more likely to succeed than those focused on counseling because it will offer direct financial support with its tax credits and subsidies.*
Let’s hope she is correct.
* This story was updated on July 6, 2021.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
Some days it feels like more than half of the journal articles I encounter report data suggesting that poverty is associated with some disease entity. I realize that young postgraduates are under some pressure to publish, but I’m ready for a break. I and most pediatricians already know, or at least have assumed, that in general and with few exceptions unwellness and poverty are closely linked. Whether that association is causal or not is a more interesting question. The answer, I suspect, depends on which health condition we are talking about. For the moment I think we should assume that poverty is more likely a major contributor and not merely a fellow traveler of poor health.
Some other questions: What are we as pediatricians expected to do about poverty? Is awareness sufficient? Should I be content with having an elevated awareness that a certain patient has a given disease because I know his family is economically challenged? Or, conversely, should I be satisfied that I have asked about a family’s economic distress when I have just diagnosed a child with asthma? The answer to those questions is a very personal one for each of us to ponder and may depend on where we feel we can best invest our time and skill set.
Like me, you may feel that the focus of your professional life is better spent diagnosing and treating the collateral damage of poverty and addressing economic inequities in your philanthropic activities and your choices at the polls. On the other hand, you may choose to use your public persona as a physician to more actively address poverty whether it is on a local, national, or global stage. There is no correct answer and a hybrid may work best for you.
On the other hand, while you agree that there is some link between poverty and unwellness, perhaps the issue is overblown and we should pay more attention to other factors such as the sad state of the family in both disadvantaged and advantaged populations. Maybe if we worked harder to foster and support two-parent families the drag of economic disadvantage would be reduced.
I recently encountered a study that explores this very question. Christina Cross, PhD, a postdoctoral fellow in the department of sociology at Harvard University, reports on her soon-to-be-published study of a nationally representative sample in which she found that, using a selection of academic metrics including earned grades, likelihood of grade repetition, and rates of suspension, in low-income families there was no difference in achievement between Black youth raised in single-parent households and Black youth raised in two-parent households. However, in well-off families, Black youth raised in two-parent households had better academic metrics. (“Why living in a two-parent home isn’t a cure-all for Black students.” Christina Cross. The Harvard Gazette. 2021 Jun 3).
I guess few of us are surprised that living in a two-parent household can provide a child with some advantages. However, it is disappointing and again not surprising that poverty can rob a child of these advantages. While it may make us feel like we are doing something when we offer counseling that promotes two-family households, this may be no more valuable than supporting apple pie and motherhood. Dr. Cross concludes that President Biden’s proposed American Families Plan is more likely to succeed than those focused on counseling because it will offer direct financial support with its tax credits and subsidies.*
Let’s hope she is correct.
* This story was updated on July 6, 2021.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
Some days it feels like more than half of the journal articles I encounter report data suggesting that poverty is associated with some disease entity. I realize that young postgraduates are under some pressure to publish, but I’m ready for a break. I and most pediatricians already know, or at least have assumed, that in general and with few exceptions unwellness and poverty are closely linked. Whether that association is causal or not is a more interesting question. The answer, I suspect, depends on which health condition we are talking about. For the moment I think we should assume that poverty is more likely a major contributor and not merely a fellow traveler of poor health.
Some other questions: What are we as pediatricians expected to do about poverty? Is awareness sufficient? Should I be content with having an elevated awareness that a certain patient has a given disease because I know his family is economically challenged? Or, conversely, should I be satisfied that I have asked about a family’s economic distress when I have just diagnosed a child with asthma? The answer to those questions is a very personal one for each of us to ponder and may depend on where we feel we can best invest our time and skill set.
Like me, you may feel that the focus of your professional life is better spent diagnosing and treating the collateral damage of poverty and addressing economic inequities in your philanthropic activities and your choices at the polls. On the other hand, you may choose to use your public persona as a physician to more actively address poverty whether it is on a local, national, or global stage. There is no correct answer and a hybrid may work best for you.
On the other hand, while you agree that there is some link between poverty and unwellness, perhaps the issue is overblown and we should pay more attention to other factors such as the sad state of the family in both disadvantaged and advantaged populations. Maybe if we worked harder to foster and support two-parent families the drag of economic disadvantage would be reduced.
I recently encountered a study that explores this very question. Christina Cross, PhD, a postdoctoral fellow in the department of sociology at Harvard University, reports on her soon-to-be-published study of a nationally representative sample in which she found that, using a selection of academic metrics including earned grades, likelihood of grade repetition, and rates of suspension, in low-income families there was no difference in achievement between Black youth raised in single-parent households and Black youth raised in two-parent households. However, in well-off families, Black youth raised in two-parent households had better academic metrics. (“Why living in a two-parent home isn’t a cure-all for Black students.” Christina Cross. The Harvard Gazette. 2021 Jun 3).
I guess few of us are surprised that living in a two-parent household can provide a child with some advantages. However, it is disappointing and again not surprising that poverty can rob a child of these advantages. While it may make us feel like we are doing something when we offer counseling that promotes two-family households, this may be no more valuable than supporting apple pie and motherhood. Dr. Cross concludes that President Biden’s proposed American Families Plan is more likely to succeed than those focused on counseling because it will offer direct financial support with its tax credits and subsidies.*
Let’s hope she is correct.
* This story was updated on July 6, 2021.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
COVID-19: Guiding vaccinated patients through to the ‘new normal’
As COVID-related restrictions are lifting and the streets, restaurants, and events are filling back up, we must encourage our patients to take inventory. It is time to help them create posttraumatic growth.
As we help them navigate this part of the pandemic, encourage them to ask what they learned over the last year and how they plan to integrate what they’ve been through to successfully create the “new normal.”
The Biden administration had set a goal of getting at least one shot to 70% of American adults by July 4, and that goal will not be reached. That shortfall, combined with the increase of the highly transmissible Delta variant of SARS-CoV-2 means that we and our patients must not let our guards completely down. At the same time, we can encourage our vaccinated patients to get back to their prepandemic lives – to the extent that they feel comfortable doing so.
Ultimately, this is about respecting physical and emotional boundaries. How do we greet vaccinated people now? Is it okay to shake hands, hug, or kiss to greet a friend or family member – or should we continue to elbow bump – or perhaps wave? Should we confront family members who have opted not to get vaccinated for reasons not related to health? Is it safe to visit with older relatives who are vaccinated? What about children under 12 who are not?
Those who were on the front lines of the pandemic faced unfathomable pain and suffering – and mental and physical exhaustion. And we know that the nightmare is not over. Several areas of the country with large numbers of unvaccinated people could face “very dense outbreaks,” in large part because of the Delta variant.
As we sort through the remaining challenges, I urge us all to reflect. We have been in this together and will emerge together. We know that the closer we were to the trauma, the longer recovery will take.
Ask patients to consider what is most important to resume and what can still wait. Some are eager to jump back into the deep end of the pool; others prefer to continue to wait cautiously. Families need to be on the same page as they assess risks and opportunities going forward, because household spread continues to be at the highest risk. Remind patients that the health of one of us affects the health of all of us.
Urge patients to take time to explore the following questions as they process the pandemic. We can also ask ourselves these same questions and share them with colleagues who are also rebuilding.
- Did you prioritize your family more? How can you continue to spend quality time them as other opportunities emerge?
- Did you have to withdraw from friends/coworkers and family members because of the pandemic? If so, how can you reincorporate them in our lives?
- Did you send more time caring for yourself with exercise and meditation? Can those new habits remain in place as life presents more options? How can you continue to make time for self-care while adding back other responsibilities?
- Did you eat better or worse in quarantine? Can you maintain the positive habits you developed as you venture back to restaurants, parties, and gatherings?
- What habits did you break that you are now better off without?
- What new habits or hobbies did you create that you want to continue?
- What hobbies should you resume that you missed during the last year?
- What new coping skills have you gained?
- Has your alcohol consumption declined or increased during the pandemic?
- Did you neglect/decide to forgo your medical and dental care? How quickly can you safely resume that care?
- How did your value system shift this year?
- Did the people you feel closest to change?
- How can you use this trauma to appreciate life more?
Life might get very busy this summer, so encourage patients to find time to answer these questions. Journaling can be a great way to think through all that we have experienced. Our brains will need to change again to adapt. Many of us have felt sad or anxious for a quite a while, and we want to move toward more positive feelings of safety, happiness, optimism, and joy. This will take effort. After all, we have lost more than 600,000 people to COVID, and much of the world is still in the middle of the pandemic. But this will get much easier as the threat of COVID-19 continues to recede. We must now work toward creating better times ahead.
Dr. Ritvo has almost 30 years’ experience in psychiatry and is currently practicing telemedicine. She is the author of “Bekindr – The Transformative Power of Kindness” (Hellertown, Pa.: Momosa Publishing, 2018). She has no conflicts of interest.
As COVID-related restrictions are lifting and the streets, restaurants, and events are filling back up, we must encourage our patients to take inventory. It is time to help them create posttraumatic growth.
As we help them navigate this part of the pandemic, encourage them to ask what they learned over the last year and how they plan to integrate what they’ve been through to successfully create the “new normal.”
The Biden administration had set a goal of getting at least one shot to 70% of American adults by July 4, and that goal will not be reached. That shortfall, combined with the increase of the highly transmissible Delta variant of SARS-CoV-2 means that we and our patients must not let our guards completely down. At the same time, we can encourage our vaccinated patients to get back to their prepandemic lives – to the extent that they feel comfortable doing so.
Ultimately, this is about respecting physical and emotional boundaries. How do we greet vaccinated people now? Is it okay to shake hands, hug, or kiss to greet a friend or family member – or should we continue to elbow bump – or perhaps wave? Should we confront family members who have opted not to get vaccinated for reasons not related to health? Is it safe to visit with older relatives who are vaccinated? What about children under 12 who are not?
Those who were on the front lines of the pandemic faced unfathomable pain and suffering – and mental and physical exhaustion. And we know that the nightmare is not over. Several areas of the country with large numbers of unvaccinated people could face “very dense outbreaks,” in large part because of the Delta variant.
As we sort through the remaining challenges, I urge us all to reflect. We have been in this together and will emerge together. We know that the closer we were to the trauma, the longer recovery will take.
Ask patients to consider what is most important to resume and what can still wait. Some are eager to jump back into the deep end of the pool; others prefer to continue to wait cautiously. Families need to be on the same page as they assess risks and opportunities going forward, because household spread continues to be at the highest risk. Remind patients that the health of one of us affects the health of all of us.
Urge patients to take time to explore the following questions as they process the pandemic. We can also ask ourselves these same questions and share them with colleagues who are also rebuilding.
- Did you prioritize your family more? How can you continue to spend quality time them as other opportunities emerge?
- Did you have to withdraw from friends/coworkers and family members because of the pandemic? If so, how can you reincorporate them in our lives?
- Did you send more time caring for yourself with exercise and meditation? Can those new habits remain in place as life presents more options? How can you continue to make time for self-care while adding back other responsibilities?
- Did you eat better or worse in quarantine? Can you maintain the positive habits you developed as you venture back to restaurants, parties, and gatherings?
- What habits did you break that you are now better off without?
- What new habits or hobbies did you create that you want to continue?
- What hobbies should you resume that you missed during the last year?
- What new coping skills have you gained?
- Has your alcohol consumption declined or increased during the pandemic?
- Did you neglect/decide to forgo your medical and dental care? How quickly can you safely resume that care?
- How did your value system shift this year?
- Did the people you feel closest to change?
- How can you use this trauma to appreciate life more?
Life might get very busy this summer, so encourage patients to find time to answer these questions. Journaling can be a great way to think through all that we have experienced. Our brains will need to change again to adapt. Many of us have felt sad or anxious for a quite a while, and we want to move toward more positive feelings of safety, happiness, optimism, and joy. This will take effort. After all, we have lost more than 600,000 people to COVID, and much of the world is still in the middle of the pandemic. But this will get much easier as the threat of COVID-19 continues to recede. We must now work toward creating better times ahead.
Dr. Ritvo has almost 30 years’ experience in psychiatry and is currently practicing telemedicine. She is the author of “Bekindr – The Transformative Power of Kindness” (Hellertown, Pa.: Momosa Publishing, 2018). She has no conflicts of interest.
As COVID-related restrictions are lifting and the streets, restaurants, and events are filling back up, we must encourage our patients to take inventory. It is time to help them create posttraumatic growth.
As we help them navigate this part of the pandemic, encourage them to ask what they learned over the last year and how they plan to integrate what they’ve been through to successfully create the “new normal.”
The Biden administration had set a goal of getting at least one shot to 70% of American adults by July 4, and that goal will not be reached. That shortfall, combined with the increase of the highly transmissible Delta variant of SARS-CoV-2 means that we and our patients must not let our guards completely down. At the same time, we can encourage our vaccinated patients to get back to their prepandemic lives – to the extent that they feel comfortable doing so.
Ultimately, this is about respecting physical and emotional boundaries. How do we greet vaccinated people now? Is it okay to shake hands, hug, or kiss to greet a friend or family member – or should we continue to elbow bump – or perhaps wave? Should we confront family members who have opted not to get vaccinated for reasons not related to health? Is it safe to visit with older relatives who are vaccinated? What about children under 12 who are not?
Those who were on the front lines of the pandemic faced unfathomable pain and suffering – and mental and physical exhaustion. And we know that the nightmare is not over. Several areas of the country with large numbers of unvaccinated people could face “very dense outbreaks,” in large part because of the Delta variant.
As we sort through the remaining challenges, I urge us all to reflect. We have been in this together and will emerge together. We know that the closer we were to the trauma, the longer recovery will take.
Ask patients to consider what is most important to resume and what can still wait. Some are eager to jump back into the deep end of the pool; others prefer to continue to wait cautiously. Families need to be on the same page as they assess risks and opportunities going forward, because household spread continues to be at the highest risk. Remind patients that the health of one of us affects the health of all of us.
Urge patients to take time to explore the following questions as they process the pandemic. We can also ask ourselves these same questions and share them with colleagues who are also rebuilding.
- Did you prioritize your family more? How can you continue to spend quality time them as other opportunities emerge?
- Did you have to withdraw from friends/coworkers and family members because of the pandemic? If so, how can you reincorporate them in our lives?
- Did you send more time caring for yourself with exercise and meditation? Can those new habits remain in place as life presents more options? How can you continue to make time for self-care while adding back other responsibilities?
- Did you eat better or worse in quarantine? Can you maintain the positive habits you developed as you venture back to restaurants, parties, and gatherings?
- What habits did you break that you are now better off without?
- What new habits or hobbies did you create that you want to continue?
- What hobbies should you resume that you missed during the last year?
- What new coping skills have you gained?
- Has your alcohol consumption declined or increased during the pandemic?
- Did you neglect/decide to forgo your medical and dental care? How quickly can you safely resume that care?
- How did your value system shift this year?
- Did the people you feel closest to change?
- How can you use this trauma to appreciate life more?
Life might get very busy this summer, so encourage patients to find time to answer these questions. Journaling can be a great way to think through all that we have experienced. Our brains will need to change again to adapt. Many of us have felt sad or anxious for a quite a while, and we want to move toward more positive feelings of safety, happiness, optimism, and joy. This will take effort. After all, we have lost more than 600,000 people to COVID, and much of the world is still in the middle of the pandemic. But this will get much easier as the threat of COVID-19 continues to recede. We must now work toward creating better times ahead.
Dr. Ritvo has almost 30 years’ experience in psychiatry and is currently practicing telemedicine. She is the author of “Bekindr – The Transformative Power of Kindness” (Hellertown, Pa.: Momosa Publishing, 2018). She has no conflicts of interest.
Anti-VEGF injections for diabetic retinopathy linked to mortality risk
The use of anti–vascular endothelial growth factor injections has been linked to an increased risk of mortality in patients with diabetic retinopathy in a new study, sounding a note of caution regarding the cardiovascular safety of these agents in clinical practice, an investigator said.
There was no increased risk of MI or stroke risk associated with intravitreal anti-VEGF injections versus steroid injections or laser photocoagulation in the study, which was based on analysis of health records for more than 60,000 treated individuals.
However, a “signal” was observed for increased risk of death from any cause among patients receiving anti-VEGF injections, and especially so in those with a history of cardiovascular events, said investigator Miin Roh, MD, PhD, a retina surgeon and instructor in ophthalmology at Harvard Medical School, Boston.
“This study suggests that we would have to be very careful in giving anti-VEGF injections in patients for diabetic retinopathy, especially when you’re giving it for a long-term period,” Dr. Roh said in a virtual presentation at the annual scientific sessions of the American Diabetes Association.
Report of a mortality signal
The study by Dr. Roh and colleagues included patients with type 1 or 2 diabetes, identified in health claims databases who started intravitreal anti-VEGF injections, intravitreal steroid injections, or laser photocoagulation between 2009 and 2017.
Their analysis included 30,741 patients who received anti-VEGF injections and 30,741 matched controls who received laser or steroid treatment.
There were no differences in the primary composite outcome of MI or stroke, with 674 events in the anti-VEGF group and 708 events in the laser or steroid group over a 365-day treatment period, Dr. Roh reported.
By contrast, the investigator said she saw a signal for increased risk of all-cause mortality in analyses of secondary outcomes.
Over a 180-day treatment period, there was a “slight numerical increase” in all-cause mortality, with 144 deaths in the anti-VEGF group and 115 in the control group. That translated into a hazard ratio of 1.26 (95% confidence interval, 0.99-1.60).
Looking at a 365-day treatment period, there was an increase in all-cause mortality in the anti-VEGF group that this time was statistically significant, she said, with 311 and 236 events, respectively (HR, 1.32; 95% CI, 1.12-1.57).
The mortality signal was especially strong among individuals who had a prior history of a cardiovascular event, according to Dr. Roh.
In patients with cardiovascular disease history, there were 219 deaths from any cause in the anti-VEGF group and 153 in the laser or steroid group (HR, 1.44, 95% CI, 3.10-11.22) over a 365-day period, the investigator reported. By comparison, in patients with no cardiovascular disease history, there were 95 and 96 deaths (HR, 1.00; 95% CI, 0.75-1.33).
More research needed
Although these findings are “hypothesis generating,” exploration of other datasets would be warranted to measure mortality risk among patients receiving treatment for diabetic neuropathy, said Robert Gabbay, MD, PhD, chief scientific and medical officer of the ADA.
“It’s something that we need now to study more rigorously,” Dr. Gabbay said in an interview. “It doesn’t prove that there’s a connection, but it tells us that this is worth studying.”
The current study is not a randomized comparison, which means that the people chosen to receive anti-VEGF therapy, as opposed to steroid injections or laser treatment, may differ in other ways that are associated with mortality, he said.
“It’s always good to monitor these patients,” Dr. Gabbay added. “The good news is that these individuals typically are coming in, oftentimes monthly for repeated injections, and so there’s an opportunity to monitor any changes.”
Dr. Roh reported that she is a coinvestigator in a Boehringer Ingelheim–initiated study that is not directly related to the topic of this research.
The use of anti–vascular endothelial growth factor injections has been linked to an increased risk of mortality in patients with diabetic retinopathy in a new study, sounding a note of caution regarding the cardiovascular safety of these agents in clinical practice, an investigator said.
There was no increased risk of MI or stroke risk associated with intravitreal anti-VEGF injections versus steroid injections or laser photocoagulation in the study, which was based on analysis of health records for more than 60,000 treated individuals.
However, a “signal” was observed for increased risk of death from any cause among patients receiving anti-VEGF injections, and especially so in those with a history of cardiovascular events, said investigator Miin Roh, MD, PhD, a retina surgeon and instructor in ophthalmology at Harvard Medical School, Boston.
“This study suggests that we would have to be very careful in giving anti-VEGF injections in patients for diabetic retinopathy, especially when you’re giving it for a long-term period,” Dr. Roh said in a virtual presentation at the annual scientific sessions of the American Diabetes Association.
Report of a mortality signal
The study by Dr. Roh and colleagues included patients with type 1 or 2 diabetes, identified in health claims databases who started intravitreal anti-VEGF injections, intravitreal steroid injections, or laser photocoagulation between 2009 and 2017.
Their analysis included 30,741 patients who received anti-VEGF injections and 30,741 matched controls who received laser or steroid treatment.
There were no differences in the primary composite outcome of MI or stroke, with 674 events in the anti-VEGF group and 708 events in the laser or steroid group over a 365-day treatment period, Dr. Roh reported.
By contrast, the investigator said she saw a signal for increased risk of all-cause mortality in analyses of secondary outcomes.
Over a 180-day treatment period, there was a “slight numerical increase” in all-cause mortality, with 144 deaths in the anti-VEGF group and 115 in the control group. That translated into a hazard ratio of 1.26 (95% confidence interval, 0.99-1.60).
Looking at a 365-day treatment period, there was an increase in all-cause mortality in the anti-VEGF group that this time was statistically significant, she said, with 311 and 236 events, respectively (HR, 1.32; 95% CI, 1.12-1.57).
The mortality signal was especially strong among individuals who had a prior history of a cardiovascular event, according to Dr. Roh.
In patients with cardiovascular disease history, there were 219 deaths from any cause in the anti-VEGF group and 153 in the laser or steroid group (HR, 1.44, 95% CI, 3.10-11.22) over a 365-day period, the investigator reported. By comparison, in patients with no cardiovascular disease history, there were 95 and 96 deaths (HR, 1.00; 95% CI, 0.75-1.33).
More research needed
Although these findings are “hypothesis generating,” exploration of other datasets would be warranted to measure mortality risk among patients receiving treatment for diabetic neuropathy, said Robert Gabbay, MD, PhD, chief scientific and medical officer of the ADA.
“It’s something that we need now to study more rigorously,” Dr. Gabbay said in an interview. “It doesn’t prove that there’s a connection, but it tells us that this is worth studying.”
The current study is not a randomized comparison, which means that the people chosen to receive anti-VEGF therapy, as opposed to steroid injections or laser treatment, may differ in other ways that are associated with mortality, he said.
“It’s always good to monitor these patients,” Dr. Gabbay added. “The good news is that these individuals typically are coming in, oftentimes monthly for repeated injections, and so there’s an opportunity to monitor any changes.”
Dr. Roh reported that she is a coinvestigator in a Boehringer Ingelheim–initiated study that is not directly related to the topic of this research.
The use of anti–vascular endothelial growth factor injections has been linked to an increased risk of mortality in patients with diabetic retinopathy in a new study, sounding a note of caution regarding the cardiovascular safety of these agents in clinical practice, an investigator said.
There was no increased risk of MI or stroke risk associated with intravitreal anti-VEGF injections versus steroid injections or laser photocoagulation in the study, which was based on analysis of health records for more than 60,000 treated individuals.
However, a “signal” was observed for increased risk of death from any cause among patients receiving anti-VEGF injections, and especially so in those with a history of cardiovascular events, said investigator Miin Roh, MD, PhD, a retina surgeon and instructor in ophthalmology at Harvard Medical School, Boston.
“This study suggests that we would have to be very careful in giving anti-VEGF injections in patients for diabetic retinopathy, especially when you’re giving it for a long-term period,” Dr. Roh said in a virtual presentation at the annual scientific sessions of the American Diabetes Association.
Report of a mortality signal
The study by Dr. Roh and colleagues included patients with type 1 or 2 diabetes, identified in health claims databases who started intravitreal anti-VEGF injections, intravitreal steroid injections, or laser photocoagulation between 2009 and 2017.
Their analysis included 30,741 patients who received anti-VEGF injections and 30,741 matched controls who received laser or steroid treatment.
There were no differences in the primary composite outcome of MI or stroke, with 674 events in the anti-VEGF group and 708 events in the laser or steroid group over a 365-day treatment period, Dr. Roh reported.
By contrast, the investigator said she saw a signal for increased risk of all-cause mortality in analyses of secondary outcomes.
Over a 180-day treatment period, there was a “slight numerical increase” in all-cause mortality, with 144 deaths in the anti-VEGF group and 115 in the control group. That translated into a hazard ratio of 1.26 (95% confidence interval, 0.99-1.60).
Looking at a 365-day treatment period, there was an increase in all-cause mortality in the anti-VEGF group that this time was statistically significant, she said, with 311 and 236 events, respectively (HR, 1.32; 95% CI, 1.12-1.57).
The mortality signal was especially strong among individuals who had a prior history of a cardiovascular event, according to Dr. Roh.
In patients with cardiovascular disease history, there were 219 deaths from any cause in the anti-VEGF group and 153 in the laser or steroid group (HR, 1.44, 95% CI, 3.10-11.22) over a 365-day period, the investigator reported. By comparison, in patients with no cardiovascular disease history, there were 95 and 96 deaths (HR, 1.00; 95% CI, 0.75-1.33).
More research needed
Although these findings are “hypothesis generating,” exploration of other datasets would be warranted to measure mortality risk among patients receiving treatment for diabetic neuropathy, said Robert Gabbay, MD, PhD, chief scientific and medical officer of the ADA.
“It’s something that we need now to study more rigorously,” Dr. Gabbay said in an interview. “It doesn’t prove that there’s a connection, but it tells us that this is worth studying.”
The current study is not a randomized comparison, which means that the people chosen to receive anti-VEGF therapy, as opposed to steroid injections or laser treatment, may differ in other ways that are associated with mortality, he said.
“It’s always good to monitor these patients,” Dr. Gabbay added. “The good news is that these individuals typically are coming in, oftentimes monthly for repeated injections, and so there’s an opportunity to monitor any changes.”
Dr. Roh reported that she is a coinvestigator in a Boehringer Ingelheim–initiated study that is not directly related to the topic of this research.
FROM ADA 2021
Malignancy risk: Secukinumab shows long-term safety for psoriasis, PsA, ankylosing spondylitis
that included 49 clinical trials.
Secukinumab (Cosentyx), an interleukin-17A antagonist, is approved for several conditions: moderate to severe psoriasis in children and adults, PsA, ankylosing spondylitis (AS), and nonradiographic axial spondyloarthritis.
Although secukinumab has demonstrated safety and tolerability, data on long-term malignancy rates are limited, wrote Mark Lebwohl, MD, professor of dermatology at the Icahn School of Medicine at Mount Sinai, New York, and coauthors.
In a study published in the British Journal of Dermatology, they analyzed the combined safety data from clinical trials and postmarketing surveillance. The study population included 10,685 patients with psoriasis, 2,523 patients with PsA, and 1,311 patients with ankylosing spondylitis who received at least one approved dose of secukinumab (300 mg or 150 mg). The maximum follow-up was 5 years. The exposure-adjusted incidence rate was defined as the incidence rates per 100 patient treatment-years (PTY). The cumulative exposure for patients with psoriasis, PsA, and AS was 16,482, 4,944, and 2,668 PTY, respectively, with average follow-up times of 1.54, 1.96, and 2.03 years, respectively.
The observed and the expected number of malignancies were comparable, with a standardized incidence ratio (SIR) for malignancy of 0.99 across all treatment indications, the researchers said. In further analysis of malignancy by indication, the SIR was 0.87, 1.16, and 1.61 for psoriasis, PsA, and AS, respectively.
Data from postmarketing surveillance showed similar results: The estimated crude cumulative incidence reporting rate per 100 PTY was 0.27 for malignancy across all indications. The cumulative exposure was 285,811 PTY.
The study findings were limited by several factors including the post hoc design, differences in clinical trial methodologies, and lack of controlling for confounding variables, such as smoking status and previous exposure to systemic and biologic treatments, the researchers noted. In addition, the analysis did not include postexposure follow-up data, or data on patients who discontinued clinical trials, they said.
Overall, the analysis is the largest to date and supports the low risk of malignancy in patients with psoriasis, PsA, and AS treated with secukinumab, the researchers noted.
However, “while this assessment provides a broader understanding of the safety of secukinumab and supports its long-term use in these chronic systemic inflammatory conditions, registry data are further warranted to fully understand the real-world effect of biologics on malignancy risk,” they concluded.
“Secukinumab is a relatively newer biologic, approved in 2015, and there is currently a lack of longer-term data on the incidence of malignancy in secukinumab-treated patients, so it’s important to look at the data we have so far on this topic so we can better understand the long-term risks and counsel our psoriasis and psoriatic arthritis patients,” Flavia Fedeles, MD, of the department of dermatology at Massachusetts General Hospital, Boston, said in an interview.
Dr. Fedeles, who was not involved with the study, said that she was not surprised by the study results. “Data reported in the past from phase 3 clinical trials of secukinumab compared with placebo did not show an increase in risk of malignancy, though at that time no long-term safety data or data from patients with history of malignancy was available,” she said. “This study is reassuring in that there wasn’t a signal of increased malignancy events up to 5 years of secukinumab treatment,” said Dr. Fedeles.
However, she noted that the study has a number of limitations, including the use of clinical trials data, which have stringent inclusion/exclusion criteria that can lead to selection bias, the use of postmarketing surveillance data, the post hoc nature of the analysis, and the fact that the sponsor of the trial was the manufacturer of secukinumab, which “potentially can lead to bias to this study.”
She added that “registry data are needed to fully understand the real-world long-term effect of secukinumab on malignancy risk.”
The study was funded by Novartis. Lead author Dr. Lebwohl disclosed participating in advisory boards and/or as an investigator and/or speaker and receiving grants and/or honoraria from multiple companies including Novartis. Several study coauthors are employees of Novartis.
Dr. Fedeles had no financial conflicts to disclose.
that included 49 clinical trials.
Secukinumab (Cosentyx), an interleukin-17A antagonist, is approved for several conditions: moderate to severe psoriasis in children and adults, PsA, ankylosing spondylitis (AS), and nonradiographic axial spondyloarthritis.
Although secukinumab has demonstrated safety and tolerability, data on long-term malignancy rates are limited, wrote Mark Lebwohl, MD, professor of dermatology at the Icahn School of Medicine at Mount Sinai, New York, and coauthors.
In a study published in the British Journal of Dermatology, they analyzed the combined safety data from clinical trials and postmarketing surveillance. The study population included 10,685 patients with psoriasis, 2,523 patients with PsA, and 1,311 patients with ankylosing spondylitis who received at least one approved dose of secukinumab (300 mg or 150 mg). The maximum follow-up was 5 years. The exposure-adjusted incidence rate was defined as the incidence rates per 100 patient treatment-years (PTY). The cumulative exposure for patients with psoriasis, PsA, and AS was 16,482, 4,944, and 2,668 PTY, respectively, with average follow-up times of 1.54, 1.96, and 2.03 years, respectively.
The observed and the expected number of malignancies were comparable, with a standardized incidence ratio (SIR) for malignancy of 0.99 across all treatment indications, the researchers said. In further analysis of malignancy by indication, the SIR was 0.87, 1.16, and 1.61 for psoriasis, PsA, and AS, respectively.
Data from postmarketing surveillance showed similar results: The estimated crude cumulative incidence reporting rate per 100 PTY was 0.27 for malignancy across all indications. The cumulative exposure was 285,811 PTY.
The study findings were limited by several factors including the post hoc design, differences in clinical trial methodologies, and lack of controlling for confounding variables, such as smoking status and previous exposure to systemic and biologic treatments, the researchers noted. In addition, the analysis did not include postexposure follow-up data, or data on patients who discontinued clinical trials, they said.
Overall, the analysis is the largest to date and supports the low risk of malignancy in patients with psoriasis, PsA, and AS treated with secukinumab, the researchers noted.
However, “while this assessment provides a broader understanding of the safety of secukinumab and supports its long-term use in these chronic systemic inflammatory conditions, registry data are further warranted to fully understand the real-world effect of biologics on malignancy risk,” they concluded.
“Secukinumab is a relatively newer biologic, approved in 2015, and there is currently a lack of longer-term data on the incidence of malignancy in secukinumab-treated patients, so it’s important to look at the data we have so far on this topic so we can better understand the long-term risks and counsel our psoriasis and psoriatic arthritis patients,” Flavia Fedeles, MD, of the department of dermatology at Massachusetts General Hospital, Boston, said in an interview.
Dr. Fedeles, who was not involved with the study, said that she was not surprised by the study results. “Data reported in the past from phase 3 clinical trials of secukinumab compared with placebo did not show an increase in risk of malignancy, though at that time no long-term safety data or data from patients with history of malignancy was available,” she said. “This study is reassuring in that there wasn’t a signal of increased malignancy events up to 5 years of secukinumab treatment,” said Dr. Fedeles.
However, she noted that the study has a number of limitations, including the use of clinical trials data, which have stringent inclusion/exclusion criteria that can lead to selection bias, the use of postmarketing surveillance data, the post hoc nature of the analysis, and the fact that the sponsor of the trial was the manufacturer of secukinumab, which “potentially can lead to bias to this study.”
She added that “registry data are needed to fully understand the real-world long-term effect of secukinumab on malignancy risk.”
The study was funded by Novartis. Lead author Dr. Lebwohl disclosed participating in advisory boards and/or as an investigator and/or speaker and receiving grants and/or honoraria from multiple companies including Novartis. Several study coauthors are employees of Novartis.
Dr. Fedeles had no financial conflicts to disclose.
that included 49 clinical trials.
Secukinumab (Cosentyx), an interleukin-17A antagonist, is approved for several conditions: moderate to severe psoriasis in children and adults, PsA, ankylosing spondylitis (AS), and nonradiographic axial spondyloarthritis.
Although secukinumab has demonstrated safety and tolerability, data on long-term malignancy rates are limited, wrote Mark Lebwohl, MD, professor of dermatology at the Icahn School of Medicine at Mount Sinai, New York, and coauthors.
In a study published in the British Journal of Dermatology, they analyzed the combined safety data from clinical trials and postmarketing surveillance. The study population included 10,685 patients with psoriasis, 2,523 patients with PsA, and 1,311 patients with ankylosing spondylitis who received at least one approved dose of secukinumab (300 mg or 150 mg). The maximum follow-up was 5 years. The exposure-adjusted incidence rate was defined as the incidence rates per 100 patient treatment-years (PTY). The cumulative exposure for patients with psoriasis, PsA, and AS was 16,482, 4,944, and 2,668 PTY, respectively, with average follow-up times of 1.54, 1.96, and 2.03 years, respectively.
The observed and the expected number of malignancies were comparable, with a standardized incidence ratio (SIR) for malignancy of 0.99 across all treatment indications, the researchers said. In further analysis of malignancy by indication, the SIR was 0.87, 1.16, and 1.61 for psoriasis, PsA, and AS, respectively.
Data from postmarketing surveillance showed similar results: The estimated crude cumulative incidence reporting rate per 100 PTY was 0.27 for malignancy across all indications. The cumulative exposure was 285,811 PTY.
The study findings were limited by several factors including the post hoc design, differences in clinical trial methodologies, and lack of controlling for confounding variables, such as smoking status and previous exposure to systemic and biologic treatments, the researchers noted. In addition, the analysis did not include postexposure follow-up data, or data on patients who discontinued clinical trials, they said.
Overall, the analysis is the largest to date and supports the low risk of malignancy in patients with psoriasis, PsA, and AS treated with secukinumab, the researchers noted.
However, “while this assessment provides a broader understanding of the safety of secukinumab and supports its long-term use in these chronic systemic inflammatory conditions, registry data are further warranted to fully understand the real-world effect of biologics on malignancy risk,” they concluded.
“Secukinumab is a relatively newer biologic, approved in 2015, and there is currently a lack of longer-term data on the incidence of malignancy in secukinumab-treated patients, so it’s important to look at the data we have so far on this topic so we can better understand the long-term risks and counsel our psoriasis and psoriatic arthritis patients,” Flavia Fedeles, MD, of the department of dermatology at Massachusetts General Hospital, Boston, said in an interview.
Dr. Fedeles, who was not involved with the study, said that she was not surprised by the study results. “Data reported in the past from phase 3 clinical trials of secukinumab compared with placebo did not show an increase in risk of malignancy, though at that time no long-term safety data or data from patients with history of malignancy was available,” she said. “This study is reassuring in that there wasn’t a signal of increased malignancy events up to 5 years of secukinumab treatment,” said Dr. Fedeles.
However, she noted that the study has a number of limitations, including the use of clinical trials data, which have stringent inclusion/exclusion criteria that can lead to selection bias, the use of postmarketing surveillance data, the post hoc nature of the analysis, and the fact that the sponsor of the trial was the manufacturer of secukinumab, which “potentially can lead to bias to this study.”
She added that “registry data are needed to fully understand the real-world long-term effect of secukinumab on malignancy risk.”
The study was funded by Novartis. Lead author Dr. Lebwohl disclosed participating in advisory boards and/or as an investigator and/or speaker and receiving grants and/or honoraria from multiple companies including Novartis. Several study coauthors are employees of Novartis.
Dr. Fedeles had no financial conflicts to disclose.
FROM THE BRITISH JOURNAL OF DERMATOLOGY
Prostate Cancer – Diagnosis and Staging
Atopic Dermatitis – Presentation and Diagnosis
Type -2 Inflammation in Severe Asthma
Stimulant reduces ‘sluggish cognitive tempo’ in adults with ADHD
A stimulant used in patients with attention-deficit/hyperactivity disorder might prove useful for other comorbid symptoms, results of a randomized, crossover trial suggest.
In the trial, the investigators reported that lisdexamfetamine (Vyvanse) reduced self-reported symptoms of sluggish cognitive tempo (SCT) by 30%, in addition to lowering ADHD symptoms by more than 40%.
The drug also corrected deficits in executive brain function. Patients had fewer episodes of procrastination, were better able to prioritize, and showed improvements in keeping things in mind.
“These findings highlight the importance of assessing symptoms of sluggish cognitive tempo and executive brain function in patients when they are initially diagnosed with ADHD,” Lenard A. Adler, MD, the lead author, said in a press release. The results were published June 29, 2021, in the Journal of Clinical Psychiatry.
The trial is groundbreaking because it is the first treatment study for ADHD with SCT in adults, Dr. Adler, director of the adult ADHD program at New York University Langone Health, said in an interview. He said that Russell A. Barkley, PhD, a clinical professor of psychiatry at Virginia Commonwealth University, Richmond, defines SCT as having nine cardinal symptoms: prone to daydreaming, easy boredom, trouble staying awake, feeling foggy, spaciness, lethargy, underachieving, less energy, and not processing information quickly or accurately.
Dr. Barkley, who studied more than 1,200 individuals with SCT, discovered that nearly half also had ADHD, Dr. Adler said. Those with the comorbid symptoms also had more impairment.
Whether or not the symptom set of SCT is a distinct disorder or a cotraveling symptom set that goes along with ADHD has been an area of investigation, said Dr. Adler, also a professor in the departments of psychiatry and child and adolescent psychiatry at New York University. Other known comorbid symptoms include executive function deficits and trouble with emotional control.
Stimulants to date have only shown success in children, as far as improving SCT. The goal of this study was to determine the efficacy of lisdexamfetamine on the nature and severity of ADHD symptoms and SCT behavioral indicators in adults with ADHD and SCT.
Two cohorts, alternating regimens
The investigators enrolled 38 adults with DSM-5 ADHD and SCT. Patients were recruited from two academic centers, New York University and the Icahn School of Medicine at Mount Sinai. The randomized 10-week crossover trial included two double-blind treatment periods, each 4 weeks long, with an intervening 2-week, single-blind placebo washout period.
“In crossover design, patients act as their own control, because they receive both treatments,” Dr. Adler said. Recruiting a smaller number of subjects helps to achieve significance in results.
For the first 4 weeks, participants received daily doses of either lisdexamfetamine (30-70 mg/day; mean, 59.1 mg/day) or a placebo sugar pill (mean, 66.6 mg/day). Researchers used standardized tests for SCT signs and symptoms, ADHD, and other measures of brain function to track psychiatric health on a weekly basis. After a month, the two cohorts switched regimens – those taking the placebo started the daily doses of lisdexamfetamine, and the other half stopped the drug and started taking the placebo.
Primary outcomes included the ADHD Rating Scale and Barkley Adult ADHD Rating Scale-IV SCT subscale.
Compared with placebo, adults with ADHD and comorbid SCT showed significant improvement after taking lisdexamfetamine in ratings of SCT and total ADHD symptoms. This was also true of other comorbid symptoms, such as executive function deficits.
In the crossover design, patients who received the drug first hadn’t gone fully back to baseline by the time the investigators crossed them over into the placebo group. “So, we couldn’t combine the two treatment epochs,” Dr. Adler said. However, the effect of the drug versus placebo was comparable in both study arms.
SCT alone was not studied
The trial had some limitations, mainly that it was an initial study with a modest sample size, Dr. Adler said. It also did not examine SCT alone, “so we can’t really say whether the stimulant medicine would improve SCT in patients who don’t have ADHD. What’s notable is when you look at how much of the improvement in SCT was due to improvement in ADHD, it was just 25%.” This means the effects occurring on SCT symptoms were not solely caused by effects on ADHD.
Dr. Adler would like to see treatment studies of adults with ADHD and SCT in a larger sample, potentially with other stimulants. In addition, future trials could examine the effects of stimulants on adults with SCT that do not have ADHD.
The results of this trial underscore the importance of evaluating adults with ADHD for comorbid symptoms, such as executive function and emotional control, he continued. “Impairing SCT symptoms may very well fall under that umbrella,” Dr. Adler said. “If you don’t identify them, you can’t track them in terms of treatment.”
SCT as a ‘flavor’ of ADHD
The outcome of this study demonstrates that lisdexamfetamine significantly improves both ADHD symptoms and SCT symptoms, said David W. Goodman MD, LFAPA, an assistant professor in the department of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore.
Dr. Goodman, who was not involved in the study, agreed that clinicians should be aware of SCT when assessing adults with ADHD and conceptualize SCT as a “flavor” of ADHD. “SCT is not widely recognized by clinicians outside of the research arena but will likely become an important characteristic of ADHD presentation,” he said in an interview.
“Future studies in adult ADHD should further clarify the prevalence of SCT in the ADHD population and address more specific effective treatment options,” he said.
James M. Swanson, PhD, who also was not involved with the study, agreed in an interview that it documents the clear short-term benefit of stimulants on symptoms of SCT. The study “may be very timely, since adults who were affected by COVID-19 often have residual sequelae manifested as ‘brain fog,’ which resemble SCT,” said Dr. Swanson, professor of pediatrics at the University of California, Irvine.
The study was funded by Takeda Pharmaceutical, manufacturer of lisdexamfetamine. Dr. Adler has received grant/research support and has served as a consultant from Shire/Takeda and other companies. Dr. Goodman is a scientific consultant to Takeda and other pharmaceutical companies in the ADHD arena. Dr. Swanson had no disclosures.
A stimulant used in patients with attention-deficit/hyperactivity disorder might prove useful for other comorbid symptoms, results of a randomized, crossover trial suggest.
In the trial, the investigators reported that lisdexamfetamine (Vyvanse) reduced self-reported symptoms of sluggish cognitive tempo (SCT) by 30%, in addition to lowering ADHD symptoms by more than 40%.
The drug also corrected deficits in executive brain function. Patients had fewer episodes of procrastination, were better able to prioritize, and showed improvements in keeping things in mind.
“These findings highlight the importance of assessing symptoms of sluggish cognitive tempo and executive brain function in patients when they are initially diagnosed with ADHD,” Lenard A. Adler, MD, the lead author, said in a press release. The results were published June 29, 2021, in the Journal of Clinical Psychiatry.
The trial is groundbreaking because it is the first treatment study for ADHD with SCT in adults, Dr. Adler, director of the adult ADHD program at New York University Langone Health, said in an interview. He said that Russell A. Barkley, PhD, a clinical professor of psychiatry at Virginia Commonwealth University, Richmond, defines SCT as having nine cardinal symptoms: prone to daydreaming, easy boredom, trouble staying awake, feeling foggy, spaciness, lethargy, underachieving, less energy, and not processing information quickly or accurately.
Dr. Barkley, who studied more than 1,200 individuals with SCT, discovered that nearly half also had ADHD, Dr. Adler said. Those with the comorbid symptoms also had more impairment.
Whether or not the symptom set of SCT is a distinct disorder or a cotraveling symptom set that goes along with ADHD has been an area of investigation, said Dr. Adler, also a professor in the departments of psychiatry and child and adolescent psychiatry at New York University. Other known comorbid symptoms include executive function deficits and trouble with emotional control.
Stimulants to date have only shown success in children, as far as improving SCT. The goal of this study was to determine the efficacy of lisdexamfetamine on the nature and severity of ADHD symptoms and SCT behavioral indicators in adults with ADHD and SCT.
Two cohorts, alternating regimens
The investigators enrolled 38 adults with DSM-5 ADHD and SCT. Patients were recruited from two academic centers, New York University and the Icahn School of Medicine at Mount Sinai. The randomized 10-week crossover trial included two double-blind treatment periods, each 4 weeks long, with an intervening 2-week, single-blind placebo washout period.
“In crossover design, patients act as their own control, because they receive both treatments,” Dr. Adler said. Recruiting a smaller number of subjects helps to achieve significance in results.
For the first 4 weeks, participants received daily doses of either lisdexamfetamine (30-70 mg/day; mean, 59.1 mg/day) or a placebo sugar pill (mean, 66.6 mg/day). Researchers used standardized tests for SCT signs and symptoms, ADHD, and other measures of brain function to track psychiatric health on a weekly basis. After a month, the two cohorts switched regimens – those taking the placebo started the daily doses of lisdexamfetamine, and the other half stopped the drug and started taking the placebo.
Primary outcomes included the ADHD Rating Scale and Barkley Adult ADHD Rating Scale-IV SCT subscale.
Compared with placebo, adults with ADHD and comorbid SCT showed significant improvement after taking lisdexamfetamine in ratings of SCT and total ADHD symptoms. This was also true of other comorbid symptoms, such as executive function deficits.
In the crossover design, patients who received the drug first hadn’t gone fully back to baseline by the time the investigators crossed them over into the placebo group. “So, we couldn’t combine the two treatment epochs,” Dr. Adler said. However, the effect of the drug versus placebo was comparable in both study arms.
SCT alone was not studied
The trial had some limitations, mainly that it was an initial study with a modest sample size, Dr. Adler said. It also did not examine SCT alone, “so we can’t really say whether the stimulant medicine would improve SCT in patients who don’t have ADHD. What’s notable is when you look at how much of the improvement in SCT was due to improvement in ADHD, it was just 25%.” This means the effects occurring on SCT symptoms were not solely caused by effects on ADHD.
Dr. Adler would like to see treatment studies of adults with ADHD and SCT in a larger sample, potentially with other stimulants. In addition, future trials could examine the effects of stimulants on adults with SCT that do not have ADHD.
The results of this trial underscore the importance of evaluating adults with ADHD for comorbid symptoms, such as executive function and emotional control, he continued. “Impairing SCT symptoms may very well fall under that umbrella,” Dr. Adler said. “If you don’t identify them, you can’t track them in terms of treatment.”
SCT as a ‘flavor’ of ADHD
The outcome of this study demonstrates that lisdexamfetamine significantly improves both ADHD symptoms and SCT symptoms, said David W. Goodman MD, LFAPA, an assistant professor in the department of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore.
Dr. Goodman, who was not involved in the study, agreed that clinicians should be aware of SCT when assessing adults with ADHD and conceptualize SCT as a “flavor” of ADHD. “SCT is not widely recognized by clinicians outside of the research arena but will likely become an important characteristic of ADHD presentation,” he said in an interview.
“Future studies in adult ADHD should further clarify the prevalence of SCT in the ADHD population and address more specific effective treatment options,” he said.
James M. Swanson, PhD, who also was not involved with the study, agreed in an interview that it documents the clear short-term benefit of stimulants on symptoms of SCT. The study “may be very timely, since adults who were affected by COVID-19 often have residual sequelae manifested as ‘brain fog,’ which resemble SCT,” said Dr. Swanson, professor of pediatrics at the University of California, Irvine.
The study was funded by Takeda Pharmaceutical, manufacturer of lisdexamfetamine. Dr. Adler has received grant/research support and has served as a consultant from Shire/Takeda and other companies. Dr. Goodman is a scientific consultant to Takeda and other pharmaceutical companies in the ADHD arena. Dr. Swanson had no disclosures.
A stimulant used in patients with attention-deficit/hyperactivity disorder might prove useful for other comorbid symptoms, results of a randomized, crossover trial suggest.
In the trial, the investigators reported that lisdexamfetamine (Vyvanse) reduced self-reported symptoms of sluggish cognitive tempo (SCT) by 30%, in addition to lowering ADHD symptoms by more than 40%.
The drug also corrected deficits in executive brain function. Patients had fewer episodes of procrastination, were better able to prioritize, and showed improvements in keeping things in mind.
“These findings highlight the importance of assessing symptoms of sluggish cognitive tempo and executive brain function in patients when they are initially diagnosed with ADHD,” Lenard A. Adler, MD, the lead author, said in a press release. The results were published June 29, 2021, in the Journal of Clinical Psychiatry.
The trial is groundbreaking because it is the first treatment study for ADHD with SCT in adults, Dr. Adler, director of the adult ADHD program at New York University Langone Health, said in an interview. He said that Russell A. Barkley, PhD, a clinical professor of psychiatry at Virginia Commonwealth University, Richmond, defines SCT as having nine cardinal symptoms: prone to daydreaming, easy boredom, trouble staying awake, feeling foggy, spaciness, lethargy, underachieving, less energy, and not processing information quickly or accurately.
Dr. Barkley, who studied more than 1,200 individuals with SCT, discovered that nearly half also had ADHD, Dr. Adler said. Those with the comorbid symptoms also had more impairment.
Whether or not the symptom set of SCT is a distinct disorder or a cotraveling symptom set that goes along with ADHD has been an area of investigation, said Dr. Adler, also a professor in the departments of psychiatry and child and adolescent psychiatry at New York University. Other known comorbid symptoms include executive function deficits and trouble with emotional control.
Stimulants to date have only shown success in children, as far as improving SCT. The goal of this study was to determine the efficacy of lisdexamfetamine on the nature and severity of ADHD symptoms and SCT behavioral indicators in adults with ADHD and SCT.
Two cohorts, alternating regimens
The investigators enrolled 38 adults with DSM-5 ADHD and SCT. Patients were recruited from two academic centers, New York University and the Icahn School of Medicine at Mount Sinai. The randomized 10-week crossover trial included two double-blind treatment periods, each 4 weeks long, with an intervening 2-week, single-blind placebo washout period.
“In crossover design, patients act as their own control, because they receive both treatments,” Dr. Adler said. Recruiting a smaller number of subjects helps to achieve significance in results.
For the first 4 weeks, participants received daily doses of either lisdexamfetamine (30-70 mg/day; mean, 59.1 mg/day) or a placebo sugar pill (mean, 66.6 mg/day). Researchers used standardized tests for SCT signs and symptoms, ADHD, and other measures of brain function to track psychiatric health on a weekly basis. After a month, the two cohorts switched regimens – those taking the placebo started the daily doses of lisdexamfetamine, and the other half stopped the drug and started taking the placebo.
Primary outcomes included the ADHD Rating Scale and Barkley Adult ADHD Rating Scale-IV SCT subscale.
Compared with placebo, adults with ADHD and comorbid SCT showed significant improvement after taking lisdexamfetamine in ratings of SCT and total ADHD symptoms. This was also true of other comorbid symptoms, such as executive function deficits.
In the crossover design, patients who received the drug first hadn’t gone fully back to baseline by the time the investigators crossed them over into the placebo group. “So, we couldn’t combine the two treatment epochs,” Dr. Adler said. However, the effect of the drug versus placebo was comparable in both study arms.
SCT alone was not studied
The trial had some limitations, mainly that it was an initial study with a modest sample size, Dr. Adler said. It also did not examine SCT alone, “so we can’t really say whether the stimulant medicine would improve SCT in patients who don’t have ADHD. What’s notable is when you look at how much of the improvement in SCT was due to improvement in ADHD, it was just 25%.” This means the effects occurring on SCT symptoms were not solely caused by effects on ADHD.
Dr. Adler would like to see treatment studies of adults with ADHD and SCT in a larger sample, potentially with other stimulants. In addition, future trials could examine the effects of stimulants on adults with SCT that do not have ADHD.
The results of this trial underscore the importance of evaluating adults with ADHD for comorbid symptoms, such as executive function and emotional control, he continued. “Impairing SCT symptoms may very well fall under that umbrella,” Dr. Adler said. “If you don’t identify them, you can’t track them in terms of treatment.”
SCT as a ‘flavor’ of ADHD
The outcome of this study demonstrates that lisdexamfetamine significantly improves both ADHD symptoms and SCT symptoms, said David W. Goodman MD, LFAPA, an assistant professor in the department of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore.
Dr. Goodman, who was not involved in the study, agreed that clinicians should be aware of SCT when assessing adults with ADHD and conceptualize SCT as a “flavor” of ADHD. “SCT is not widely recognized by clinicians outside of the research arena but will likely become an important characteristic of ADHD presentation,” he said in an interview.
“Future studies in adult ADHD should further clarify the prevalence of SCT in the ADHD population and address more specific effective treatment options,” he said.
James M. Swanson, PhD, who also was not involved with the study, agreed in an interview that it documents the clear short-term benefit of stimulants on symptoms of SCT. The study “may be very timely, since adults who were affected by COVID-19 often have residual sequelae manifested as ‘brain fog,’ which resemble SCT,” said Dr. Swanson, professor of pediatrics at the University of California, Irvine.
The study was funded by Takeda Pharmaceutical, manufacturer of lisdexamfetamine. Dr. Adler has received grant/research support and has served as a consultant from Shire/Takeda and other companies. Dr. Goodman is a scientific consultant to Takeda and other pharmaceutical companies in the ADHD arena. Dr. Swanson had no disclosures.
FROM THE JOURNAL OF CLINICAL PSYCHIATRY