A new online survey of inflammatory bowel disease (IBD) patients found that individuals seeking information on social media are generally satisfied with the care that they get from their health care providers. However, the online activity suggested a desire for more information, especially with respect to supportive needs like diet and complementary/alternative medicine (CAM).

SonerCdem/Thinkstock

The study was led by Idan Goren, MD, and Henit Yanai, MD, of Rabin Medical Center, Petah Tikva, Israel.

The researchers suspected that social media users with IBD were looking for information they weren’t getting from their provider, so the researchers set out to identify those specific unmet needs. In a pilot exploratory phase of their investigation, they conducted an initial survey followed by an analysis of social media posts, then they conducted a second phase with a survey based on the findings in the pilot exploration.

The initial survey was conducted within a social media platform in Israel called Camoni, where patients can interact with each other and with health care providers who have experience treating IBD, including gastroenterologists, dietitians, and psychologists. The survey included 10 items about disease characteristics, information needs, information search habits, and other factors. The subsequent analysis step included individual posts on the network between January 2014 and January 2019; the investigators categorized posts by the topics of interest brought up in the initial survey and determined the frequency of posts related to each category.

Out of the 255 respondents to this initial survey, 72% reported satisfaction with the information they received in person. In addition, 67% said that search engines like Google were their most important source of disease-related information, 58% reported relying heavily on websites, and 53% reported relying on health care providers. The most common topics of interest were diet (65%), medications and their potential adverse effects (58%), disease management (48%), and CAM (43%).

After this pilot exploratory phase, the researchers developed a structured survey that they used in IBD-based forums on Facebook and other social networks. Data were collected from this survey during a 4-week period in November 2019.

About half of the 534 respondents to the more widely distributed follow-up survey were in Israel. Overall, 83% reported using IBD-related medications, 45% of which were biologics. Out of the 534 respondents, 70% primarily received treatment from IBD referral centers. Interestingly, 77% said that they would prefer to rely on social media that is guided by health care providers, but only 22% reported that they actually used such a network. Responding along a visual analog scale, they reported general satisfaction with their routine IBD care (mean score, 79 ± 27 out of 100), their providers’ effectiveness of communication (82 ± 24), and the providers’ ability to understand patient concerns (73 ± 28). Those who were active in social media rated accessibility of IBD service as 68 ± 30. Exploration of topical interest found the most common to be diet (46%), lifestyle (45%), CAM (43%), diagnostic test interpretation (34%), and specialist referrals and reviews (31%).

The general satisfaction with information from health care providers contrasted with some previous studies that had shown that patients seeking information online often felt the opposite: For example, a 2019 Canadian survey found that only 10%-36% of IBD patients believed they received adequate information on IBD issues during clinical visits. The authors of the current study speculated that the incongruence might be explained by the fact that the current survey included patients with greater disease burden, who might get more attention during clinic visits than might patients with milder illness.

“In conclusion, our results indicate that patients’ activity on [social media] appears to be independent of their satisfaction with formal IBD care and rather reflects the contemporary need for ongoing information, particularly focused on supportive needs, such as diet and CAM,” the investigators wrote.
 

“Try not to Google everything”

The findings weren’t surprising, but the researchers found that patients seeking information online often have a high level of disease burden, as evidenced by biologics use and a majority being seen by specialists. That’s worrisome, said Jason Reich, MD, a gastroenterologist in Fall River, Mass., who has also studied social media use among IBD patients but was not involved in this study. “The last person you want getting poor-quality information is someone with pretty active disease,” said Dr. Reich in an interview.

Dr. Reich agreed with the authors that IBD specialists should consider having a dietitian in their clinic, or at least refer patients to dietitians early on. He also advocated for gastroenterologists (and all physicians, really) to have an online presence, if possible. “At least make themselves and their office accessible. I always tell my patients, if you have questions, try not to Google everything online and just shoot me a message through the portal instead,” said Dr. Reich. He added that nurses can handle such duties, especially those trained in IBD. “Personally, I don’t mind sending my short messages back and forth. Especially if it’s just a question. That’s easy enough to do when it takes maybe a minute or 2.”

The authors disclosed no funding sources. Dr. Reich has no relevant financial disclosures.
 

A new online survey of inflammatory bowel disease (IBD) patients found that individuals seeking information on social media are generally satisfied with the care that they get from their health care providers. However, the online activity suggested a desire for more information, especially with respect to supportive needs like diet and complementary/alternative medicine (CAM).

SonerCdem/Thinkstock

The study was led by Idan Goren, MD, and Henit Yanai, MD, of Rabin Medical Center, Petah Tikva, Israel.

The researchers suspected that social media users with IBD were looking for information they weren’t getting from their provider, so the researchers set out to identify those specific unmet needs. In a pilot exploratory phase of their investigation, they conducted an initial survey followed by an analysis of social media posts, then they conducted a second phase with a survey based on the findings in the pilot exploration.

The initial survey was conducted within a social media platform in Israel called Camoni, where patients can interact with each other and with health care providers who have experience treating IBD, including gastroenterologists, dietitians, and psychologists. The survey included 10 items about disease characteristics, information needs, information search habits, and other factors. The subsequent analysis step included individual posts on the network between January 2014 and January 2019; the investigators categorized posts by the topics of interest brought up in the initial survey and determined the frequency of posts related to each category.

Out of the 255 respondents to this initial survey, 72% reported satisfaction with the information they received in person. In addition, 67% said that search engines like Google were their most important source of disease-related information, 58% reported relying heavily on websites, and 53% reported relying on health care providers. The most common topics of interest were diet (65%), medications and their potential adverse effects (58%), disease management (48%), and CAM (43%).

After this pilot exploratory phase, the researchers developed a structured survey that they used in IBD-based forums on Facebook and other social networks. Data were collected from this survey during a 4-week period in November 2019.

About half of the 534 respondents to the more widely distributed follow-up survey were in Israel. Overall, 83% reported using IBD-related medications, 45% of which were biologics. Out of the 534 respondents, 70% primarily received treatment from IBD referral centers. Interestingly, 77% said that they would prefer to rely on social media that is guided by health care providers, but only 22% reported that they actually used such a network. Responding along a visual analog scale, they reported general satisfaction with their routine IBD care (mean score, 79 ± 27 out of 100), their providers’ effectiveness of communication (82 ± 24), and the providers’ ability to understand patient concerns (73 ± 28). Those who were active in social media rated accessibility of IBD service as 68 ± 30. Exploration of topical interest found the most common to be diet (46%), lifestyle (45%), CAM (43%), diagnostic test interpretation (34%), and specialist referrals and reviews (31%).

The general satisfaction with information from health care providers contrasted with some previous studies that had shown that patients seeking information online often felt the opposite: For example, a 2019 Canadian survey found that only 10%-36% of IBD patients believed they received adequate information on IBD issues during clinical visits. The authors of the current study speculated that the incongruence might be explained by the fact that the current survey included patients with greater disease burden, who might get more attention during clinic visits than might patients with milder illness.

“In conclusion, our results indicate that patients’ activity on [social media] appears to be independent of their satisfaction with formal IBD care and rather reflects the contemporary need for ongoing information, particularly focused on supportive needs, such as diet and CAM,” the investigators wrote.
 

“Try not to Google everything”

The findings weren’t surprising, but the researchers found that patients seeking information online often have a high level of disease burden, as evidenced by biologics use and a majority being seen by specialists. That’s worrisome, said Jason Reich, MD, a gastroenterologist in Fall River, Mass., who has also studied social media use among IBD patients but was not involved in this study. “The last person you want getting poor-quality information is someone with pretty active disease,” said Dr. Reich in an interview.

Dr. Reich agreed with the authors that IBD specialists should consider having a dietitian in their clinic, or at least refer patients to dietitians early on. He also advocated for gastroenterologists (and all physicians, really) to have an online presence, if possible. “At least make themselves and their office accessible. I always tell my patients, if you have questions, try not to Google everything online and just shoot me a message through the portal instead,” said Dr. Reich. He added that nurses can handle such duties, especially those trained in IBD. “Personally, I don’t mind sending my short messages back and forth. Especially if it’s just a question. That’s easy enough to do when it takes maybe a minute or 2.”

The authors disclosed no funding sources. Dr. Reich has no relevant financial disclosures.
 

A new online survey of inflammatory bowel disease (IBD) patients found that individuals seeking information on social media are generally satisfied with the care that they get from their health care providers. However, the online activity suggested a desire for more information, especially with respect to supportive needs like diet and complementary/alternative medicine (CAM).

SonerCdem/Thinkstock

The study was led by Idan Goren, MD, and Henit Yanai, MD, of Rabin Medical Center, Petah Tikva, Israel.

The researchers suspected that social media users with IBD were looking for information they weren’t getting from their provider, so the researchers set out to identify those specific unmet needs. In a pilot exploratory phase of their investigation, they conducted an initial survey followed by an analysis of social media posts, then they conducted a second phase with a survey based on the findings in the pilot exploration.

The initial survey was conducted within a social media platform in Israel called Camoni, where patients can interact with each other and with health care providers who have experience treating IBD, including gastroenterologists, dietitians, and psychologists. The survey included 10 items about disease characteristics, information needs, information search habits, and other factors. The subsequent analysis step included individual posts on the network between January 2014 and January 2019; the investigators categorized posts by the topics of interest brought up in the initial survey and determined the frequency of posts related to each category.

Out of the 255 respondents to this initial survey, 72% reported satisfaction with the information they received in person. In addition, 67% said that search engines like Google were their most important source of disease-related information, 58% reported relying heavily on websites, and 53% reported relying on health care providers. The most common topics of interest were diet (65%), medications and their potential adverse effects (58%), disease management (48%), and CAM (43%).

After this pilot exploratory phase, the researchers developed a structured survey that they used in IBD-based forums on Facebook and other social networks. Data were collected from this survey during a 4-week period in November 2019.

About half of the 534 respondents to the more widely distributed follow-up survey were in Israel. Overall, 83% reported using IBD-related medications, 45% of which were biologics. Out of the 534 respondents, 70% primarily received treatment from IBD referral centers. Interestingly, 77% said that they would prefer to rely on social media that is guided by health care providers, but only 22% reported that they actually used such a network. Responding along a visual analog scale, they reported general satisfaction with their routine IBD care (mean score, 79 ± 27 out of 100), their providers’ effectiveness of communication (82 ± 24), and the providers’ ability to understand patient concerns (73 ± 28). Those who were active in social media rated accessibility of IBD service as 68 ± 30. Exploration of topical interest found the most common to be diet (46%), lifestyle (45%), CAM (43%), diagnostic test interpretation (34%), and specialist referrals and reviews (31%).

The general satisfaction with information from health care providers contrasted with some previous studies that had shown that patients seeking information online often felt the opposite: For example, a 2019 Canadian survey found that only 10%-36% of IBD patients believed they received adequate information on IBD issues during clinical visits. The authors of the current study speculated that the incongruence might be explained by the fact that the current survey included patients with greater disease burden, who might get more attention during clinic visits than might patients with milder illness.

“In conclusion, our results indicate that patients’ activity on [social media] appears to be independent of their satisfaction with formal IBD care and rather reflects the contemporary need for ongoing information, particularly focused on supportive needs, such as diet and CAM,” the investigators wrote.
 

“Try not to Google everything”

The findings weren’t surprising, but the researchers found that patients seeking information online often have a high level of disease burden, as evidenced by biologics use and a majority being seen by specialists. That’s worrisome, said Jason Reich, MD, a gastroenterologist in Fall River, Mass., who has also studied social media use among IBD patients but was not involved in this study. “The last person you want getting poor-quality information is someone with pretty active disease,” said Dr. Reich in an interview.

Dr. Reich agreed with the authors that IBD specialists should consider having a dietitian in their clinic, or at least refer patients to dietitians early on. He also advocated for gastroenterologists (and all physicians, really) to have an online presence, if possible. “At least make themselves and their office accessible. I always tell my patients, if you have questions, try not to Google everything online and just shoot me a message through the portal instead,” said Dr. Reich. He added that nurses can handle such duties, especially those trained in IBD. “Personally, I don’t mind sending my short messages back and forth. Especially if it’s just a question. That’s easy enough to do when it takes maybe a minute or 2.”

The authors disclosed no funding sources. Dr. Reich has no relevant financial disclosures.
 

Improving maternal morbidity and mortality begins prior to conception. Numerous modifiable and nonmodifiable factors—lifestyle behaviors, chronic medical conditions, medications, immunizations, prior pregnancy events—have been shown to improve pregnancy outcomes if they are reviewed, identified, and optimized before conception.

Laying a solid foundation for a healthy pregnancy requires a comprehensive approach to patient counseling. However, the national Pregnancy Risk Assessment Monitoring System (PRAMS; a surveillance program of the Centers for Disease Control and Prevention) data from 2014 show that only about 20% of women receive counseling on at least 5 out of 11 healthy lifestyle behaviors and prevention strategies before pregnancy. The ability to leverage technology-enabled smart device applications can provide clinicians with immediate access to information necessary to address with patients at a preconception visit. Apps built specifically for physicians offer a convenient, thorough, and peer-vetted reference that can increase the efficiency and quality of consultation in a busy practice.

Prepregnancy care app considerations

When applying the ACOG-recommended rubric to evaluate the quality of an app targeted to address preconception counseling, the accuracy and objectivity of the content, as well as the app’s ease of use, are vital characteristics to consider, and these criteria should score 4 out of 4 on the rubric.

Several apps offer suggestions on how to address important components of health, including counseling and intervention strategies and evidence-based recommendations. The most efficacious apps offer embedded references to more detailed resources for use when complexities inevitably arise during consultation. Truly comprehensive prepregnancy care requires clinicians to take a step beyond the review of patients’ medications and comorbidities. It is therefore helpful to implement point-of-care apps that prompt evaluation of the often-overlooked aspects of prepregnancy counseling, including risk of interpersonal violence and infectious diseases, occupational exposures, and immunization status.

Physician-focused prepregnancy apps that provide reminders, prompts, and strategies for addressing a comprehensive set of health components prior to conception can be valuable tools to incorporate into both educational environments and busy practices to address maternal morbidity and mortality. ●

Improving maternal morbidity and mortality begins prior to conception. Numerous modifiable and nonmodifiable factors—lifestyle behaviors, chronic medical conditions, medications, immunizations, prior pregnancy events—have been shown to improve pregnancy outcomes if they are reviewed, identified, and optimized before conception.

Laying a solid foundation for a healthy pregnancy requires a comprehensive approach to patient counseling. However, the national Pregnancy Risk Assessment Monitoring System (PRAMS; a surveillance program of the Centers for Disease Control and Prevention) data from 2014 show that only about 20% of women receive counseling on at least 5 out of 11 healthy lifestyle behaviors and prevention strategies before pregnancy. The ability to leverage technology-enabled smart device applications can provide clinicians with immediate access to information necessary to address with patients at a preconception visit. Apps built specifically for physicians offer a convenient, thorough, and peer-vetted reference that can increase the efficiency and quality of consultation in a busy practice.

Prepregnancy care app considerations

When applying the ACOG-recommended rubric to evaluate the quality of an app targeted to address preconception counseling, the accuracy and objectivity of the content, as well as the app’s ease of use, are vital characteristics to consider, and these criteria should score 4 out of 4 on the rubric.

Several apps offer suggestions on how to address important components of health, including counseling and intervention strategies and evidence-based recommendations. The most efficacious apps offer embedded references to more detailed resources for use when complexities inevitably arise during consultation. Truly comprehensive prepregnancy care requires clinicians to take a step beyond the review of patients’ medications and comorbidities. It is therefore helpful to implement point-of-care apps that prompt evaluation of the often-overlooked aspects of prepregnancy counseling, including risk of interpersonal violence and infectious diseases, occupational exposures, and immunization status.

Physician-focused prepregnancy apps that provide reminders, prompts, and strategies for addressing a comprehensive set of health components prior to conception can be valuable tools to incorporate into both educational environments and busy practices to address maternal morbidity and mortality. ●

Improving maternal morbidity and mortality begins prior to conception. Numerous modifiable and nonmodifiable factors—lifestyle behaviors, chronic medical conditions, medications, immunizations, prior pregnancy events—have been shown to improve pregnancy outcomes if they are reviewed, identified, and optimized before conception.

Laying a solid foundation for a healthy pregnancy requires a comprehensive approach to patient counseling. However, the national Pregnancy Risk Assessment Monitoring System (PRAMS; a surveillance program of the Centers for Disease Control and Prevention) data from 2014 show that only about 20% of women receive counseling on at least 5 out of 11 healthy lifestyle behaviors and prevention strategies before pregnancy. The ability to leverage technology-enabled smart device applications can provide clinicians with immediate access to information necessary to address with patients at a preconception visit. Apps built specifically for physicians offer a convenient, thorough, and peer-vetted reference that can increase the efficiency and quality of consultation in a busy practice.

Prepregnancy care app considerations

When applying the ACOG-recommended rubric to evaluate the quality of an app targeted to address preconception counseling, the accuracy and objectivity of the content, as well as the app’s ease of use, are vital characteristics to consider, and these criteria should score 4 out of 4 on the rubric.

Several apps offer suggestions on how to address important components of health, including counseling and intervention strategies and evidence-based recommendations. The most efficacious apps offer embedded references to more detailed resources for use when complexities inevitably arise during consultation. Truly comprehensive prepregnancy care requires clinicians to take a step beyond the review of patients’ medications and comorbidities. It is therefore helpful to implement point-of-care apps that prompt evaluation of the often-overlooked aspects of prepregnancy counseling, including risk of interpersonal violence and infectious diseases, occupational exposures, and immunization status.

Physician-focused prepregnancy apps that provide reminders, prompts, and strategies for addressing a comprehensive set of health components prior to conception can be valuable tools to incorporate into both educational environments and busy practices to address maternal morbidity and mortality. ●

Personalizing care is at the heart of the American College of Obstetricians and Gynecologists (ACOG) 2020–2021 President Dr. Eva Chalas’ initiative to “Revisit the Visit.” As obstetrician-gynecologists, we care for patients across the entirety of their life. This role gives us the opportunity to form long-term partnerships with women to address important preventive health care measures.

Dr. Chalas established a Presidential Task Force that identified 5 areas of preventive health that significantly influence the long-term morbidity of women: obesity, cardiovascular disease, preconception counseling, diabetes, and cancer risk. The annual visit can serve as a particularly impactful point of care to achieve specific preventive care objectives and offer mitigation strategies based on patient-specific risk factors. We are uniquely positioned to identify and initiate the conversation and subsequently manage, treat, and address these critical health areas.

Harnessing modern technology

To adopt these health topics into practice, we need improved, more effective tools both to increase productivity during the office visit and to provide more personalized care. Notably, the widespread adoption of and proliferation of mobile devices—and the medical apps accessible on them—is creating new and innovative ways to improve health and health care delivery. More than 90% of physicians use a smartphone at work, and 62% of smartphone users have used their device to gather health data.¹

In addition, according to a US Food and Drug Administration (FDA) report, in 2017, 325,000 health care applications were available on smartphones; this equates to an expected 3.7 billion mobile health application downloads that year by 1.7 billion smartphone users worldwide.² As of October 2020, 48,000-plus health apps were available on the iOS mobile operating system alone.³

For patients and clinicians, picking the most suitable apps can be challenging in the face of evolving clinical evidence, emerging privacy risks, functionality concerns, and the fact that apps constantly update and change. Many have relied on star rating systems and user reviews in app stores to guide their selection process despite mounting evidence that suggests that such evaluation methods are misleading, not always addressing such important parameters as usability, validity, security, and privacy.^4,5

Approaches for evaluating medical apps

Many app evaluation frameworks have emerged, but none is universally accepted within the health care field.

The American Psychiatric Association’s (APA) App Evaluation Model represents a comprehensive resource to consider when evaluating medical apps. It stratifies numerous variables into 5 levels that form a pyramid. In this model, background information forms the base of this pyramid and includes factors such as business model, credibility, cost, and advertising of the app. The top of the pyramid is comprised of data integration that considers data ownership and therapeutic alliance.⁶ Although this model is beneficial in that it provides a framework, it is not practical for point-of-care purposes as it offers no objective way to rate or score an app for quick and easy comparison.

The privately owned and operated Health On the Net (HON) Foundation is well known for its HONcode, an ethical standard for quality medical information on the internet. It uses 8 principles to certify a health website. However, the HON website itself states that it cannot guarantee the accuracy or completeness of medical information presented by a site.⁷ Although HON certification by a website is a sign of good intention, it is not beneficial to the practicing clinician who is looking to use an app to directly assist in clinical care.

The Agency for Healthcare Research and Quality (AHRQ) is another well-respected body that has delineated essential details to consider when using a health website. The AHRQ identifies features (similar to those of the APA pyramid and HONcode) for users to consider, such as credibility, content, design, and disclosures.⁸ However, this model too lacks a concise user-friendly evaluating system.

Although the FDA plans to apply some regulatory authority to the evaluation of a certain subset of high-risk mobile medical apps, it is not planning to evaluate or regulate many of the medical apps that clinicians use in daily practice. This leaves us, and our patients, to be guided by the principle of caveat emptor, or “let the buyer beware.”

Thus, Dr. Chalas’ Presidential Task Force carefully considered various resources to provide a useful tool that would help obstetrician-gynecologists objectively vet a medical app in practice.

Continue to: The Task Force’s recommended rubric...

The Task Force’s recommended rubric

The rubric shown for evaluating mobile drug information apps was developed by the American Society of Health-System Pharmacists (ASHP). The ASHP rubric takes into account the criteria recognized by the APA pyramid, the HON Foundation, and the AHRQ and incorporates them into a user-friendly tool and scoring system that can be applied as an evaluation checklist.⁹ This tool is meant to aid clinicians in evaluating medical apps, but it ultimately is the user’s decision to determine if an app’s deficiencies should deter its use.

While all of the criteria are relevant and important, it is incumbent on us as medical experts to pay careful attention to the accuracy, authority, objectivity, timeliness, and security of any app we consider incorporating into clinical practice. A low score on these criteria would belie any perceived usefulness or value the app may have.

When applying the rubric to evaluate the quality of an app, we should be mindful of the primary user and which characteristics are more important than others to effect positive changes in health. For example, in addressing obesity, it is the patient who will be interacting with the app. Therefore, it’s important that the app should score, on a 1- to 4-point scale (1 point being major deficiencies, 4 points being no deficiencies), a 4 out of 4 on features like usefulness, functionality, and design. Coveted design features that enhance the user’s experience will appeal to patients and keep them engaged and motivated. However, when addressing a woman’s health with respect to cancer risk, the principal features on which the app should score 4 out of 4 would be authority, objectivity, timeliness, and accuracy.

In the upcoming articles in this series, a member of the Presidential Task Force will reference the ASHP rubric to guide clinicians in choosing apps to address one of the critical health areas with their patients. The author of the piece will highlight key features of an app to consider what would add the most value in incorporating its use in clinical practice.

It would be impossible to evaluate all health care apps even if we focused only on the medical apps relevant to obstetrics and gynecology. There is much value in having a framework for efficiently measuring an app’s benefit in clinical practice. The objective of this article series is to help clinicians Revisit the Visit by providing an effective tool to evaluate a medical app. ●

Personalizing care is at the heart of the American College of Obstetricians and Gynecologists (ACOG) 2020–2021 President Dr. Eva Chalas’ initiative to “Revisit the Visit.” As obstetrician-gynecologists, we care for patients across the entirety of their life. This role gives us the opportunity to form long-term partnerships with women to address important preventive health care measures.

Dr. Chalas established a Presidential Task Force that identified 5 areas of preventive health that significantly influence the long-term morbidity of women: obesity, cardiovascular disease, preconception counseling, diabetes, and cancer risk. The annual visit can serve as a particularly impactful point of care to achieve specific preventive care objectives and offer mitigation strategies based on patient-specific risk factors. We are uniquely positioned to identify and initiate the conversation and subsequently manage, treat, and address these critical health areas.

Harnessing modern technology

To adopt these health topics into practice, we need improved, more effective tools both to increase productivity during the office visit and to provide more personalized care. Notably, the widespread adoption of and proliferation of mobile devices—and the medical apps accessible on them—is creating new and innovative ways to improve health and health care delivery. More than 90% of physicians use a smartphone at work, and 62% of smartphone users have used their device to gather health data.¹

In addition, according to a US Food and Drug Administration (FDA) report, in 2017, 325,000 health care applications were available on smartphones; this equates to an expected 3.7 billion mobile health application downloads that year by 1.7 billion smartphone users worldwide.² As of October 2020, 48,000-plus health apps were available on the iOS mobile operating system alone.³

For patients and clinicians, picking the most suitable apps can be challenging in the face of evolving clinical evidence, emerging privacy risks, functionality concerns, and the fact that apps constantly update and change. Many have relied on star rating systems and user reviews in app stores to guide their selection process despite mounting evidence that suggests that such evaluation methods are misleading, not always addressing such important parameters as usability, validity, security, and privacy.^4,5

Approaches for evaluating medical apps

Many app evaluation frameworks have emerged, but none is universally accepted within the health care field.

The American Psychiatric Association’s (APA) App Evaluation Model represents a comprehensive resource to consider when evaluating medical apps. It stratifies numerous variables into 5 levels that form a pyramid. In this model, background information forms the base of this pyramid and includes factors such as business model, credibility, cost, and advertising of the app. The top of the pyramid is comprised of data integration that considers data ownership and therapeutic alliance.⁶ Although this model is beneficial in that it provides a framework, it is not practical for point-of-care purposes as it offers no objective way to rate or score an app for quick and easy comparison.

The privately owned and operated Health On the Net (HON) Foundation is well known for its HONcode, an ethical standard for quality medical information on the internet. It uses 8 principles to certify a health website. However, the HON website itself states that it cannot guarantee the accuracy or completeness of medical information presented by a site.⁷ Although HON certification by a website is a sign of good intention, it is not beneficial to the practicing clinician who is looking to use an app to directly assist in clinical care.

The Agency for Healthcare Research and Quality (AHRQ) is another well-respected body that has delineated essential details to consider when using a health website. The AHRQ identifies features (similar to those of the APA pyramid and HONcode) for users to consider, such as credibility, content, design, and disclosures.⁸ However, this model too lacks a concise user-friendly evaluating system.

Although the FDA plans to apply some regulatory authority to the evaluation of a certain subset of high-risk mobile medical apps, it is not planning to evaluate or regulate many of the medical apps that clinicians use in daily practice. This leaves us, and our patients, to be guided by the principle of caveat emptor, or “let the buyer beware.”

Thus, Dr. Chalas’ Presidential Task Force carefully considered various resources to provide a useful tool that would help obstetrician-gynecologists objectively vet a medical app in practice.

Continue to: The Task Force’s recommended rubric...

The Task Force’s recommended rubric

The rubric shown for evaluating mobile drug information apps was developed by the American Society of Health-System Pharmacists (ASHP). The ASHP rubric takes into account the criteria recognized by the APA pyramid, the HON Foundation, and the AHRQ and incorporates them into a user-friendly tool and scoring system that can be applied as an evaluation checklist.⁹ This tool is meant to aid clinicians in evaluating medical apps, but it ultimately is the user’s decision to determine if an app’s deficiencies should deter its use.

While all of the criteria are relevant and important, it is incumbent on us as medical experts to pay careful attention to the accuracy, authority, objectivity, timeliness, and security of any app we consider incorporating into clinical practice. A low score on these criteria would belie any perceived usefulness or value the app may have.

When applying the rubric to evaluate the quality of an app, we should be mindful of the primary user and which characteristics are more important than others to effect positive changes in health. For example, in addressing obesity, it is the patient who will be interacting with the app. Therefore, it’s important that the app should score, on a 1- to 4-point scale (1 point being major deficiencies, 4 points being no deficiencies), a 4 out of 4 on features like usefulness, functionality, and design. Coveted design features that enhance the user’s experience will appeal to patients and keep them engaged and motivated. However, when addressing a woman’s health with respect to cancer risk, the principal features on which the app should score 4 out of 4 would be authority, objectivity, timeliness, and accuracy.

In the upcoming articles in this series, a member of the Presidential Task Force will reference the ASHP rubric to guide clinicians in choosing apps to address one of the critical health areas with their patients. The author of the piece will highlight key features of an app to consider what would add the most value in incorporating its use in clinical practice.

It would be impossible to evaluate all health care apps even if we focused only on the medical apps relevant to obstetrics and gynecology. There is much value in having a framework for efficiently measuring an app’s benefit in clinical practice. The objective of this article series is to help clinicians Revisit the Visit by providing an effective tool to evaluate a medical app. ●

Personalizing care is at the heart of the American College of Obstetricians and Gynecologists (ACOG) 2020–2021 President Dr. Eva Chalas’ initiative to “Revisit the Visit.” As obstetrician-gynecologists, we care for patients across the entirety of their life. This role gives us the opportunity to form long-term partnerships with women to address important preventive health care measures.

Dr. Chalas established a Presidential Task Force that identified 5 areas of preventive health that significantly influence the long-term morbidity of women: obesity, cardiovascular disease, preconception counseling, diabetes, and cancer risk. The annual visit can serve as a particularly impactful point of care to achieve specific preventive care objectives and offer mitigation strategies based on patient-specific risk factors. We are uniquely positioned to identify and initiate the conversation and subsequently manage, treat, and address these critical health areas.

Harnessing modern technology

To adopt these health topics into practice, we need improved, more effective tools both to increase productivity during the office visit and to provide more personalized care. Notably, the widespread adoption of and proliferation of mobile devices—and the medical apps accessible on them—is creating new and innovative ways to improve health and health care delivery. More than 90% of physicians use a smartphone at work, and 62% of smartphone users have used their device to gather health data.¹

In addition, according to a US Food and Drug Administration (FDA) report, in 2017, 325,000 health care applications were available on smartphones; this equates to an expected 3.7 billion mobile health application downloads that year by 1.7 billion smartphone users worldwide.² As of October 2020, 48,000-plus health apps were available on the iOS mobile operating system alone.³

For patients and clinicians, picking the most suitable apps can be challenging in the face of evolving clinical evidence, emerging privacy risks, functionality concerns, and the fact that apps constantly update and change. Many have relied on star rating systems and user reviews in app stores to guide their selection process despite mounting evidence that suggests that such evaluation methods are misleading, not always addressing such important parameters as usability, validity, security, and privacy.^4,5

Approaches for evaluating medical apps

Many app evaluation frameworks have emerged, but none is universally accepted within the health care field.

The American Psychiatric Association’s (APA) App Evaluation Model represents a comprehensive resource to consider when evaluating medical apps. It stratifies numerous variables into 5 levels that form a pyramid. In this model, background information forms the base of this pyramid and includes factors such as business model, credibility, cost, and advertising of the app. The top of the pyramid is comprised of data integration that considers data ownership and therapeutic alliance.⁶ Although this model is beneficial in that it provides a framework, it is not practical for point-of-care purposes as it offers no objective way to rate or score an app for quick and easy comparison.

The privately owned and operated Health On the Net (HON) Foundation is well known for its HONcode, an ethical standard for quality medical information on the internet. It uses 8 principles to certify a health website. However, the HON website itself states that it cannot guarantee the accuracy or completeness of medical information presented by a site.⁷ Although HON certification by a website is a sign of good intention, it is not beneficial to the practicing clinician who is looking to use an app to directly assist in clinical care.

The Agency for Healthcare Research and Quality (AHRQ) is another well-respected body that has delineated essential details to consider when using a health website. The AHRQ identifies features (similar to those of the APA pyramid and HONcode) for users to consider, such as credibility, content, design, and disclosures.⁸ However, this model too lacks a concise user-friendly evaluating system.

Although the FDA plans to apply some regulatory authority to the evaluation of a certain subset of high-risk mobile medical apps, it is not planning to evaluate or regulate many of the medical apps that clinicians use in daily practice. This leaves us, and our patients, to be guided by the principle of caveat emptor, or “let the buyer beware.”

Thus, Dr. Chalas’ Presidential Task Force carefully considered various resources to provide a useful tool that would help obstetrician-gynecologists objectively vet a medical app in practice.

Continue to: The Task Force’s recommended rubric...

The Task Force’s recommended rubric

The rubric shown for evaluating mobile drug information apps was developed by the American Society of Health-System Pharmacists (ASHP). The ASHP rubric takes into account the criteria recognized by the APA pyramid, the HON Foundation, and the AHRQ and incorporates them into a user-friendly tool and scoring system that can be applied as an evaluation checklist.⁹ This tool is meant to aid clinicians in evaluating medical apps, but it ultimately is the user’s decision to determine if an app’s deficiencies should deter its use.

While all of the criteria are relevant and important, it is incumbent on us as medical experts to pay careful attention to the accuracy, authority, objectivity, timeliness, and security of any app we consider incorporating into clinical practice. A low score on these criteria would belie any perceived usefulness or value the app may have.

When applying the rubric to evaluate the quality of an app, we should be mindful of the primary user and which characteristics are more important than others to effect positive changes in health. For example, in addressing obesity, it is the patient who will be interacting with the app. Therefore, it’s important that the app should score, on a 1- to 4-point scale (1 point being major deficiencies, 4 points being no deficiencies), a 4 out of 4 on features like usefulness, functionality, and design. Coveted design features that enhance the user’s experience will appeal to patients and keep them engaged and motivated. However, when addressing a woman’s health with respect to cancer risk, the principal features on which the app should score 4 out of 4 would be authority, objectivity, timeliness, and accuracy.

In the upcoming articles in this series, a member of the Presidential Task Force will reference the ASHP rubric to guide clinicians in choosing apps to address one of the critical health areas with their patients. The author of the piece will highlight key features of an app to consider what would add the most value in incorporating its use in clinical practice.

It would be impossible to evaluate all health care apps even if we focused only on the medical apps relevant to obstetrics and gynecology. There is much value in having a framework for efficiently measuring an app’s benefit in clinical practice. The objective of this article series is to help clinicians Revisit the Visit by providing an effective tool to evaluate a medical app. ●

To help ObGyns evaluate mobile apps for use in clinical practice, the American College of Obstetricians and Gynecologists Presidential Task Force of Dr. Eva Chalas recommends a quantitative rubric that was developed by the American Society of Health-System Pharmacists (ASHP) for evaluating drug information apps (TABLE).¹ Criteria are graded on a point scale of 1 to 4, with 1 point indicating major deficiencies and 4 points indicating no deficiencies.

The ASHP used the following criteria in evaluating mobile apps:

• Usefulness: the app’s overall usefulness in a particular practice setting
• Accuracy: overall accuracy of the app should be thoroughly examined
• Authority: it is critical to assess authority or authorship to determine that the developers are reputable, qualified, and authoritative enough to create the medical content in question
• Objectivity: to determine if content is fair, balanced, and unbiased
• Timeliness: given that medical information is continually changing, an app must be evaluated based on the timeliness of its content
• Functionality: how the app downloads, deploys, and operates across devices and software platforms (that is, iOS, Android)
• Design: well-designed apps are generally more user friendly and, therefore, useful. They should require minimal or no training and have easily discernible buttons, a clean and uncluttered format, consistent graphics layout, terminology appropriate for the intended audience, streamlined navigation without extraneous steps/gestures, appropriate-sized text, and sufficient white space to improve readability.
• Security: Many apps collect a wide array of personal and device data. Collected data has the potential for being sold to third parties for marketing and advertising purposes. Apps should disclose their privacy policy and provide an explanation as to why personal data are being collected. If personal identifiable information (PII) is collected, then the app should be encrypted. If protected health information (PHI) is collected, the app must follow compliance with HIPAA/HITECH (Health Insurance Portability and Accountability Act/Health Information Technology for Economic and Clinical Health Act). Additionally, apps should not compromise the security or functionality of the mobile device being used.
• Value: appropriateness of an app's cost. ●

To help ObGyns evaluate mobile apps for use in clinical practice, the American College of Obstetricians and Gynecologists Presidential Task Force of Dr. Eva Chalas recommends a quantitative rubric that was developed by the American Society of Health-System Pharmacists (ASHP) for evaluating drug information apps (TABLE).¹ Criteria are graded on a point scale of 1 to 4, with 1 point indicating major deficiencies and 4 points indicating no deficiencies.

The ASHP used the following criteria in evaluating mobile apps:

• Usefulness: the app’s overall usefulness in a particular practice setting
• Accuracy: overall accuracy of the app should be thoroughly examined
• Authority: it is critical to assess authority or authorship to determine that the developers are reputable, qualified, and authoritative enough to create the medical content in question
• Objectivity: to determine if content is fair, balanced, and unbiased
• Timeliness: given that medical information is continually changing, an app must be evaluated based on the timeliness of its content
• Functionality: how the app downloads, deploys, and operates across devices and software platforms (that is, iOS, Android)
• Design: well-designed apps are generally more user friendly and, therefore, useful. They should require minimal or no training and have easily discernible buttons, a clean and uncluttered format, consistent graphics layout, terminology appropriate for the intended audience, streamlined navigation without extraneous steps/gestures, appropriate-sized text, and sufficient white space to improve readability.
• Security: Many apps collect a wide array of personal and device data. Collected data has the potential for being sold to third parties for marketing and advertising purposes. Apps should disclose their privacy policy and provide an explanation as to why personal data are being collected. If personal identifiable information (PII) is collected, then the app should be encrypted. If protected health information (PHI) is collected, the app must follow compliance with HIPAA/HITECH (Health Insurance Portability and Accountability Act/Health Information Technology for Economic and Clinical Health Act). Additionally, apps should not compromise the security or functionality of the mobile device being used.
• Value: appropriateness of an app's cost. ●

To help ObGyns evaluate mobile apps for use in clinical practice, the American College of Obstetricians and Gynecologists Presidential Task Force of Dr. Eva Chalas recommends a quantitative rubric that was developed by the American Society of Health-System Pharmacists (ASHP) for evaluating drug information apps (TABLE).¹ Criteria are graded on a point scale of 1 to 4, with 1 point indicating major deficiencies and 4 points indicating no deficiencies.

The ASHP used the following criteria in evaluating mobile apps:

• Usefulness: the app’s overall usefulness in a particular practice setting
• Accuracy: overall accuracy of the app should be thoroughly examined
• Authority: it is critical to assess authority or authorship to determine that the developers are reputable, qualified, and authoritative enough to create the medical content in question
• Objectivity: to determine if content is fair, balanced, and unbiased
• Timeliness: given that medical information is continually changing, an app must be evaluated based on the timeliness of its content
• Functionality: how the app downloads, deploys, and operates across devices and software platforms (that is, iOS, Android)
• Design: well-designed apps are generally more user friendly and, therefore, useful. They should require minimal or no training and have easily discernible buttons, a clean and uncluttered format, consistent graphics layout, terminology appropriate for the intended audience, streamlined navigation without extraneous steps/gestures, appropriate-sized text, and sufficient white space to improve readability.
• Security: Many apps collect a wide array of personal and device data. Collected data has the potential for being sold to third parties for marketing and advertising purposes. Apps should disclose their privacy policy and provide an explanation as to why personal data are being collected. If personal identifiable information (PII) is collected, then the app should be encrypted. If protected health information (PHI) is collected, the app must follow compliance with HIPAA/HITECH (Health Insurance Portability and Accountability Act/Health Information Technology for Economic and Clinical Health Act). Additionally, apps should not compromise the security or functionality of the mobile device being used.
• Value: appropriateness of an app's cost. ●

The Choosing Wisely^® Pediatric Hospital Medicine (PHM) recommendations were published in January 2021. The initial Choosing Wisely^® PHM recommendations were released in 2012 and the 2021 recommendations were the result of an extensive and years-long process. The Choosing Wisely^® campaign, an initiative led by the American Board of Internal Medicine, was developed to enhance clinician-patient conversations, promoting care that is evidenced based, free from harm, and truly necessary.

The campaign has been embraced by the entire medical community, with more than 70 professional medical societies releasing recommendations. With its emphasis on high value care and eliminating medical waste, it is no surprise that the Choosing Wisely^® campaign has found a home in a pediatric hospital medicine community that prides itself on those very traits. This article sheds light on the recommendation development process and identifies challenges and opportunities for implementation across the country.

The Choosing Wisely^® process started with the selection of a committee. This group comprised nine members, with equal representation from all three societies affiliated with PHM: the Society of Hospital Medicine (SHM), the American Academy of Pediatrics’ Section on Hospital Medicine (AAP SOHM), and the Academic Pediatric Association (APA). Members of the committee intentionally represented a wide spectrum of practice variability, geography, and clinical experience.

The SHM members of the group were: James O’Callaghan, MD, FAAP, SFHM, pediatric hospitalist at Seattle Children’s Hospital and clinical professor of pediatrics at the University of Washington School of Medicine; Vivian Lee, MD, clinical pediatric hospitalist at Children’s Hospital of Los Angeles and associate professor of pediatrics at USC Keck School of Medicine; and Francisco Alvarez, MD, pediatric hospitalist at Lucile Packard Children’s Hospital, Palo Alto, Calif., and clinical associate professor of pediatrics at Stanford (Calif.) University.

According to Dr. O’Callaghan, it was important that the Choosing Wisely^® recommendations come from the broader PHM community, reflecting the community’s priorities.

The committee started the process by asking the broader PHM community to submit ideas for consideration, via SHM’s HMX and the AAP SOHM listserv. The PHM community responded with more than 400 submissions.

Dr. Alvarez said the committee organized and trimmed the initial submissions, removing redundancy, into approximately 200 distinct recommendations. After initial literature review, the committee focused on approximately 70 recommendations. At that point, each member undertook an extensive literature review of the topics.

Once every potential recommendation had received a thorough review, Dr. Lee said, the committee underwent a modified Delphi process to evaluate the list. In this process, each member ranked the recommendations on validity – a measure of the quality of evidence supporting a topic – and feasibility – a measure of the PHM community’s ability to influence compliance.

Dr. Casey is a pediatric hospitalist at Joe DiMaggio Children’s Hospital in Hollywood, Fla., and a member of the Society of Hospital Medicine’s Pediatric Special Interest Group’s Executive Council.

The Choosing Wisely^® Pediatric Hospital Medicine (PHM) recommendations were published in January 2021. The initial Choosing Wisely^® PHM recommendations were released in 2012 and the 2021 recommendations were the result of an extensive and years-long process. The Choosing Wisely^® campaign, an initiative led by the American Board of Internal Medicine, was developed to enhance clinician-patient conversations, promoting care that is evidenced based, free from harm, and truly necessary.

The campaign has been embraced by the entire medical community, with more than 70 professional medical societies releasing recommendations. With its emphasis on high value care and eliminating medical waste, it is no surprise that the Choosing Wisely^® campaign has found a home in a pediatric hospital medicine community that prides itself on those very traits. This article sheds light on the recommendation development process and identifies challenges and opportunities for implementation across the country.

The Choosing Wisely^® process started with the selection of a committee. This group comprised nine members, with equal representation from all three societies affiliated with PHM: the Society of Hospital Medicine (SHM), the American Academy of Pediatrics’ Section on Hospital Medicine (AAP SOHM), and the Academic Pediatric Association (APA). Members of the committee intentionally represented a wide spectrum of practice variability, geography, and clinical experience.

The SHM members of the group were: James O’Callaghan, MD, FAAP, SFHM, pediatric hospitalist at Seattle Children’s Hospital and clinical professor of pediatrics at the University of Washington School of Medicine; Vivian Lee, MD, clinical pediatric hospitalist at Children’s Hospital of Los Angeles and associate professor of pediatrics at USC Keck School of Medicine; and Francisco Alvarez, MD, pediatric hospitalist at Lucile Packard Children’s Hospital, Palo Alto, Calif., and clinical associate professor of pediatrics at Stanford (Calif.) University.

According to Dr. O’Callaghan, it was important that the Choosing Wisely^® recommendations come from the broader PHM community, reflecting the community’s priorities.

The committee started the process by asking the broader PHM community to submit ideas for consideration, via SHM’s HMX and the AAP SOHM listserv. The PHM community responded with more than 400 submissions.

Dr. Alvarez said the committee organized and trimmed the initial submissions, removing redundancy, into approximately 200 distinct recommendations. After initial literature review, the committee focused on approximately 70 recommendations. At that point, each member undertook an extensive literature review of the topics.

Once every potential recommendation had received a thorough review, Dr. Lee said, the committee underwent a modified Delphi process to evaluate the list. In this process, each member ranked the recommendations on validity – a measure of the quality of evidence supporting a topic – and feasibility – a measure of the PHM community’s ability to influence compliance.

Dr. Casey is a pediatric hospitalist at Joe DiMaggio Children’s Hospital in Hollywood, Fla., and a member of the Society of Hospital Medicine’s Pediatric Special Interest Group’s Executive Council.

The Choosing Wisely^® Pediatric Hospital Medicine (PHM) recommendations were published in January 2021. The initial Choosing Wisely^® PHM recommendations were released in 2012 and the 2021 recommendations were the result of an extensive and years-long process. The Choosing Wisely^® campaign, an initiative led by the American Board of Internal Medicine, was developed to enhance clinician-patient conversations, promoting care that is evidenced based, free from harm, and truly necessary.

The campaign has been embraced by the entire medical community, with more than 70 professional medical societies releasing recommendations. With its emphasis on high value care and eliminating medical waste, it is no surprise that the Choosing Wisely^® campaign has found a home in a pediatric hospital medicine community that prides itself on those very traits. This article sheds light on the recommendation development process and identifies challenges and opportunities for implementation across the country.

The Choosing Wisely^® process started with the selection of a committee. This group comprised nine members, with equal representation from all three societies affiliated with PHM: the Society of Hospital Medicine (SHM), the American Academy of Pediatrics’ Section on Hospital Medicine (AAP SOHM), and the Academic Pediatric Association (APA). Members of the committee intentionally represented a wide spectrum of practice variability, geography, and clinical experience.

The SHM members of the group were: James O’Callaghan, MD, FAAP, SFHM, pediatric hospitalist at Seattle Children’s Hospital and clinical professor of pediatrics at the University of Washington School of Medicine; Vivian Lee, MD, clinical pediatric hospitalist at Children’s Hospital of Los Angeles and associate professor of pediatrics at USC Keck School of Medicine; and Francisco Alvarez, MD, pediatric hospitalist at Lucile Packard Children’s Hospital, Palo Alto, Calif., and clinical associate professor of pediatrics at Stanford (Calif.) University.

According to Dr. O’Callaghan, it was important that the Choosing Wisely^® recommendations come from the broader PHM community, reflecting the community’s priorities.

The committee started the process by asking the broader PHM community to submit ideas for consideration, via SHM’s HMX and the AAP SOHM listserv. The PHM community responded with more than 400 submissions.

Dr. Alvarez said the committee organized and trimmed the initial submissions, removing redundancy, into approximately 200 distinct recommendations. After initial literature review, the committee focused on approximately 70 recommendations. At that point, each member undertook an extensive literature review of the topics.

Once every potential recommendation had received a thorough review, Dr. Lee said, the committee underwent a modified Delphi process to evaluate the list. In this process, each member ranked the recommendations on validity – a measure of the quality of evidence supporting a topic – and feasibility – a measure of the PHM community’s ability to influence compliance.

Dr. Casey is a pediatric hospitalist at Joe DiMaggio Children’s Hospital in Hollywood, Fla., and a member of the Society of Hospital Medicine’s Pediatric Special Interest Group’s Executive Council.

Primary care physicians are more likely to write a prescription for statins for their patients at risk for cardiovascular adverse events in the morning than in the afternoon, new research suggests.

RogerAshford/Thinkstock

In an observational cohort study, researchers from the nudge unit, University of Pennsylvania, Philadelphia, found that patients who had the first appointments of the day were most likely to have statins prescribed for them, and that this likelihood decreased as the day went on.

The study was published online May 11, 2021, in JAMA Network Open.

“Physicians are faced with decision fatigue, where they are seeing 20 patients in a day and may not have the mental bandwidth or cognitive bandwidth to fully think through every decision for every patient and to make all the appropriate decisions all of the time,” lead author Allison J. Hare, medical student and clinical informatics fellow in the nudge unit, said in an interview.

The Penn Medicine nudge unit attempts to better align clinician decision-making with current standards in best practices for the provision of various therapies, Ms. Hare explained.

“As we see more and more best-practice guidelines come out, we also see that there is a gap in the intention to treat and actual provision of these therapies,” she said. “There are also increasing expectations for clinicians to provide all of these different evidence-backed therapies. It can be hard to keep up with all these guidelines, especially when you are expected to take care of more and more patients, more and more efficiently.”

Guideline-directed statin therapy has been demonstrated to reduce the risk for major adverse cardiovascular events, yet 50% of statin-eligible patients have not been prescribed one.

“In our prior work at the nudge unit, we observed that rates of preventive care, including flu vaccination and cancer screening, declined as the clinic day progressed. We wanted to see if this occurred with statin scripts,” Ms. Hare said.

The researchers obtained data from 28 Penn Medicine primary care practices that included 10,757 patients at risk for heart disease for the period from March 2019 to February 2020.

Their mean age was 66.0 years (standard deviation, 10.5 years), 5,072 (47.2%) were female, and 7,071 (65.7%) were White. Patient characteristics were similar between morning and afternoon appointments.

All patients had clinical atherosclerotic cardiovascular disease, familial hypercholesterolemia, or LDL cholesterol of at least 190 mg/dL, conditions which qualified them for statins based on the U.S. Preventive Services Task Force guidelines.

The appointment times for each patient were broken down into hour blocks, ranging from the 8:00 a.m. hour to the 4:00 p.m. hour, which bookend open times in most practices.

Overall, statins were prescribed in 36% (n = 3,864) of visits.

The data showed a clear decline in statin prescribing as the day went on. For example, compared with patients who came in at 8:00 a.m. (the reference group), patients who came in at 9:00 a.m. were 12% less likely to get a prescription.

Patients coming in for noon appointments were 37% less likely to get a statin prescription, which made them the least likely to get a script. After the noon visits, there was a slight increase, but the likelihood of a statin prescription remained 27% less likely or worse for the rest of the day.

“In the context of the myriad tasks that clinicians are faced with doing for a single patient, and then also within the context of seeing 20 patients in 15-minute increments, it is easy to see how certain things fall through the cracks,” Ms. Hare said. “It’s impossible for any clinician to remember every single little thing for their patient every single time, so if we can augment the clinician’s ability to make those appropriate decisions with electronic tools, we can narrow that gap a little bit.”
 

Why the variability?

“The nudge unit uses prompts to ask the physician about prescribing statins. The question is, what is causing the variability in statin prescriptions?” Nieca Goldberg, MD, medical director of the New York University women’s heart program, said in an interview.

“Is it fatigue, lack of familiarity of guidelines, or is this due to the volume of patients and lack of time to discuss the therapy and make a shared decision with their patient? The answer to these questions was not part of the study,” said Dr. Goldberg, who is also an American Heart Association volunteer expert. “It would be interesting to know the thoughts of the physicians who were studied after they were informed of the results. Also, having a nudge to write the prescription will increase the prescriptions of statins, but will patients take the medication?”

The study was funded in part by a grant from the National Institute on Aging. Ms. Hare and Dr. Goldberg reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Primary care physicians are more likely to write a prescription for statins for their patients at risk for cardiovascular adverse events in the morning than in the afternoon, new research suggests.

RogerAshford/Thinkstock

In an observational cohort study, researchers from the nudge unit, University of Pennsylvania, Philadelphia, found that patients who had the first appointments of the day were most likely to have statins prescribed for them, and that this likelihood decreased as the day went on.

The study was published online May 11, 2021, in JAMA Network Open.

“Physicians are faced with decision fatigue, where they are seeing 20 patients in a day and may not have the mental bandwidth or cognitive bandwidth to fully think through every decision for every patient and to make all the appropriate decisions all of the time,” lead author Allison J. Hare, medical student and clinical informatics fellow in the nudge unit, said in an interview.

The Penn Medicine nudge unit attempts to better align clinician decision-making with current standards in best practices for the provision of various therapies, Ms. Hare explained.

“As we see more and more best-practice guidelines come out, we also see that there is a gap in the intention to treat and actual provision of these therapies,” she said. “There are also increasing expectations for clinicians to provide all of these different evidence-backed therapies. It can be hard to keep up with all these guidelines, especially when you are expected to take care of more and more patients, more and more efficiently.”

Guideline-directed statin therapy has been demonstrated to reduce the risk for major adverse cardiovascular events, yet 50% of statin-eligible patients have not been prescribed one.

“In our prior work at the nudge unit, we observed that rates of preventive care, including flu vaccination and cancer screening, declined as the clinic day progressed. We wanted to see if this occurred with statin scripts,” Ms. Hare said.

The researchers obtained data from 28 Penn Medicine primary care practices that included 10,757 patients at risk for heart disease for the period from March 2019 to February 2020.

Their mean age was 66.0 years (standard deviation, 10.5 years), 5,072 (47.2%) were female, and 7,071 (65.7%) were White. Patient characteristics were similar between morning and afternoon appointments.

All patients had clinical atherosclerotic cardiovascular disease, familial hypercholesterolemia, or LDL cholesterol of at least 190 mg/dL, conditions which qualified them for statins based on the U.S. Preventive Services Task Force guidelines.

The appointment times for each patient were broken down into hour blocks, ranging from the 8:00 a.m. hour to the 4:00 p.m. hour, which bookend open times in most practices.

Overall, statins were prescribed in 36% (n = 3,864) of visits.

The data showed a clear decline in statin prescribing as the day went on. For example, compared with patients who came in at 8:00 a.m. (the reference group), patients who came in at 9:00 a.m. were 12% less likely to get a prescription.

Patients coming in for noon appointments were 37% less likely to get a statin prescription, which made them the least likely to get a script. After the noon visits, there was a slight increase, but the likelihood of a statin prescription remained 27% less likely or worse for the rest of the day.

“In the context of the myriad tasks that clinicians are faced with doing for a single patient, and then also within the context of seeing 20 patients in 15-minute increments, it is easy to see how certain things fall through the cracks,” Ms. Hare said. “It’s impossible for any clinician to remember every single little thing for their patient every single time, so if we can augment the clinician’s ability to make those appropriate decisions with electronic tools, we can narrow that gap a little bit.”
 

Why the variability?

“The nudge unit uses prompts to ask the physician about prescribing statins. The question is, what is causing the variability in statin prescriptions?” Nieca Goldberg, MD, medical director of the New York University women’s heart program, said in an interview.

“Is it fatigue, lack of familiarity of guidelines, or is this due to the volume of patients and lack of time to discuss the therapy and make a shared decision with their patient? The answer to these questions was not part of the study,” said Dr. Goldberg, who is also an American Heart Association volunteer expert. “It would be interesting to know the thoughts of the physicians who were studied after they were informed of the results. Also, having a nudge to write the prescription will increase the prescriptions of statins, but will patients take the medication?”

The study was funded in part by a grant from the National Institute on Aging. Ms. Hare and Dr. Goldberg reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Primary care physicians are more likely to write a prescription for statins for their patients at risk for cardiovascular adverse events in the morning than in the afternoon, new research suggests.

RogerAshford/Thinkstock

In an observational cohort study, researchers from the nudge unit, University of Pennsylvania, Philadelphia, found that patients who had the first appointments of the day were most likely to have statins prescribed for them, and that this likelihood decreased as the day went on.

The study was published online May 11, 2021, in JAMA Network Open.

“Physicians are faced with decision fatigue, where they are seeing 20 patients in a day and may not have the mental bandwidth or cognitive bandwidth to fully think through every decision for every patient and to make all the appropriate decisions all of the time,” lead author Allison J. Hare, medical student and clinical informatics fellow in the nudge unit, said in an interview.

The Penn Medicine nudge unit attempts to better align clinician decision-making with current standards in best practices for the provision of various therapies, Ms. Hare explained.

“As we see more and more best-practice guidelines come out, we also see that there is a gap in the intention to treat and actual provision of these therapies,” she said. “There are also increasing expectations for clinicians to provide all of these different evidence-backed therapies. It can be hard to keep up with all these guidelines, especially when you are expected to take care of more and more patients, more and more efficiently.”

Guideline-directed statin therapy has been demonstrated to reduce the risk for major adverse cardiovascular events, yet 50% of statin-eligible patients have not been prescribed one.

“In our prior work at the nudge unit, we observed that rates of preventive care, including flu vaccination and cancer screening, declined as the clinic day progressed. We wanted to see if this occurred with statin scripts,” Ms. Hare said.

The researchers obtained data from 28 Penn Medicine primary care practices that included 10,757 patients at risk for heart disease for the period from March 2019 to February 2020.

Their mean age was 66.0 years (standard deviation, 10.5 years), 5,072 (47.2%) were female, and 7,071 (65.7%) were White. Patient characteristics were similar between morning and afternoon appointments.

All patients had clinical atherosclerotic cardiovascular disease, familial hypercholesterolemia, or LDL cholesterol of at least 190 mg/dL, conditions which qualified them for statins based on the U.S. Preventive Services Task Force guidelines.

The appointment times for each patient were broken down into hour blocks, ranging from the 8:00 a.m. hour to the 4:00 p.m. hour, which bookend open times in most practices.

Overall, statins were prescribed in 36% (n = 3,864) of visits.

The data showed a clear decline in statin prescribing as the day went on. For example, compared with patients who came in at 8:00 a.m. (the reference group), patients who came in at 9:00 a.m. were 12% less likely to get a prescription.

Patients coming in for noon appointments were 37% less likely to get a statin prescription, which made them the least likely to get a script. After the noon visits, there was a slight increase, but the likelihood of a statin prescription remained 27% less likely or worse for the rest of the day.

“In the context of the myriad tasks that clinicians are faced with doing for a single patient, and then also within the context of seeing 20 patients in 15-minute increments, it is easy to see how certain things fall through the cracks,” Ms. Hare said. “It’s impossible for any clinician to remember every single little thing for their patient every single time, so if we can augment the clinician’s ability to make those appropriate decisions with electronic tools, we can narrow that gap a little bit.”
 

Why the variability?

“The nudge unit uses prompts to ask the physician about prescribing statins. The question is, what is causing the variability in statin prescriptions?” Nieca Goldberg, MD, medical director of the New York University women’s heart program, said in an interview.

“Is it fatigue, lack of familiarity of guidelines, or is this due to the volume of patients and lack of time to discuss the therapy and make a shared decision with their patient? The answer to these questions was not part of the study,” said Dr. Goldberg, who is also an American Heart Association volunteer expert. “It would be interesting to know the thoughts of the physicians who were studied after they were informed of the results. Also, having a nudge to write the prescription will increase the prescriptions of statins, but will patients take the medication?”

The study was funded in part by a grant from the National Institute on Aging. Ms. Hare and Dr. Goldberg reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Tumor necrosis factor α (TNF-α) inhibitor–induced psoriasis is a known paradoxical adverse effect of this family of medications, which includes infliximab, adalimumab, etanercept, golimumab, and certolizumab. In the pediatric population, these therapies recently gained approval for nondermatologic conditions—meaning that this phenomenon is encountered more frequently.¹ In a systematic review of TNF-α inhibitor–induced psoriasis, severe scalp involvement was associated with alopecia in 7.5% of cases.² Onset of scalp psoriasis with alopecia in patients being treated with a TNF-α inhibitor should lead to consideration of this condition.

Psoriatic alopecia is an uncommon presentation of psoriasis. Although well described, alopecia as a clinical manifestation of scalp psoriasis is not a well-known concept among clinicians and has never been widely accepted. Adding to the diagnostic challenge is that psoriatic alopecia secondary to TNF-α inhibitor–induced psoriasis rarely has been reported in adults or children.^3-5 Including our case, our review of the literature yielded 7 pediatric cases (≤18 years) of TNF-α inhibitor–induced psoriatic alopecia.^6,7 A primary literature search of PubMed articles indexed for MEDLINE was conducted using the terms psoriatic alopecia, psoriasiform alopecia, TNF-α inhibitors, infliximab, adalimumab, etanercept, golimumab, and certolizumab.

We present the case of a pediatric patient with psoriatic alopecia secondary to treatment with adalimumab for Crohn disease (CD). We also provide a review of reported cases of psoriatic alopecia induced by a TNF-α inhibitor in the literature.

Case Report

A 12-year-old girl presented to our dermatology clinic with erythematous scaly plaques on the trunk, scalp, arms, and legs of 2 months’ duration. The lesions involved approximately 15% of the body surface area. The patient’s medical history was remarkable for CD diagnosed 4 years prior to presentation of the skin lesions. She had been treated for the past 2 years with adalimumab 40 mg once every 2 weeks and azathioprine 100 mg once daily. Because her CD was poorly controlled, the dosage of adalimumab was increased to 40 mg once weekly 6 months prior to the current presentation.

Our diagnosis was TNF-α inhibitor-induced psoriasis secondary to treatment with adalimumab.

The patient was treated with mometasone lotion 0.1% for the scalp lesions and triamcinolone cream 0.1% for the body lesions. Because of the extent of the psoriasis, we recommended changing adalimumab to ustekinumab, which is approved for CD in adults but is off label in children.

At 1-month follow-up, after receiving the induction dose of ustekinumab, the patient presented with partial improvement of the skin lesions but had developed a large, alopecic, erythematous plaque with thick yellowish scales on the scalp (Figure 1). She also had a positive hair pull test. The presumptive initial diagnosis of the alopecic scalp lesion was tinea capitis, for which multiple potassium hydroxide preparations of scales were performed, all yielding negative results. In addition, histopathologic examination with hematoxylin and eosin staining was performed (Figures 2A and 2B). Sterile tissue cultures for bacteria, fungi, and acid-fast bacilli were obtained and showed no growth. Periodic acid–Schiff staining was negative for fungal structures.

Comment

Psoriatic alopecia induced by a TNF-α inhibitor was first reported in 2007 in a 30-year-old woman with ankylosing spondylitis who was being treated with adalimumab.⁸ She had erythematous, scaly, alopecic plaques on the scalp and palmoplantar pustulosis. Findings on skin biopsy were compatible with psoriasis. The patient’s severe scalp psoriasis failed to respond to topical steroid treatment and adalimumab cessation. The extensive hair loss responded to cyclosporine 3 mg/kg daily.⁸

After conducting an extensive literature review, we found 26 cases of TNF-α–induced psoriatic alopecia, including the current case (Table).^6-16 The mean age at diagnosis was 27.8 years (SD, 13.6 years; range, 7–60 years). The female-to-male ratio was 3.3:1. The most common underlying condition for which TNF-α inhibitors were prescribed was CD (77% [20/26]). Psoriatic alopecia most commonly was reported secondary to treatment with infliximab (54% [14/26]), followed by adalimumab (42% [11/26]). Golimumab was the causative drug in 1 (4%) case. We did not find reports of etanercept or certolizumab having induced this manifestation. The onset of the scalp lesions occurred 2 to 46 months after starting treatment with the causative medication.

Previously reported cases have demonstrated various treatment options that yielded improvement or resolution of TNF-α inhibitor–induced psoriatic alopecia. These include either continuation or discontinuation of the TNF-α inhibitor combined with topical or intralesional steroids, methotrexate, or cyclosporine. Another option is to switch the TNF-α inhibitor to another biologic. Outcomes vary from patient to patient, making the physician’s clinical judgment crucial in deciding which treatment route to take. Our patient showed notable improvement when she was switched from adalimumab to ustekinumab as well as the combination of ustekinumab and clobetasol lotion 0.05%.

Conclusion

We recommend an individualized approach that provides patients with the safest and least invasive treatment option for TNF-α inhibitor–induced psoriatic alopecia. In most reported cases, the problem resolved with treatment, thereby classifying this form of alopecia as noncicatricial alopecia.

Tumor necrosis factor α (TNF-α) inhibitor–induced psoriasis is a known paradoxical adverse effect of this family of medications, which includes infliximab, adalimumab, etanercept, golimumab, and certolizumab. In the pediatric population, these therapies recently gained approval for nondermatologic conditions—meaning that this phenomenon is encountered more frequently.¹ In a systematic review of TNF-α inhibitor–induced psoriasis, severe scalp involvement was associated with alopecia in 7.5% of cases.² Onset of scalp psoriasis with alopecia in patients being treated with a TNF-α inhibitor should lead to consideration of this condition.

Psoriatic alopecia is an uncommon presentation of psoriasis. Although well described, alopecia as a clinical manifestation of scalp psoriasis is not a well-known concept among clinicians and has never been widely accepted. Adding to the diagnostic challenge is that psoriatic alopecia secondary to TNF-α inhibitor–induced psoriasis rarely has been reported in adults or children.^3-5 Including our case, our review of the literature yielded 7 pediatric cases (≤18 years) of TNF-α inhibitor–induced psoriatic alopecia.^6,7 A primary literature search of PubMed articles indexed for MEDLINE was conducted using the terms psoriatic alopecia, psoriasiform alopecia, TNF-α inhibitors, infliximab, adalimumab, etanercept, golimumab, and certolizumab.

We present the case of a pediatric patient with psoriatic alopecia secondary to treatment with adalimumab for Crohn disease (CD). We also provide a review of reported cases of psoriatic alopecia induced by a TNF-α inhibitor in the literature.

Case Report

A 12-year-old girl presented to our dermatology clinic with erythematous scaly plaques on the trunk, scalp, arms, and legs of 2 months’ duration. The lesions involved approximately 15% of the body surface area. The patient’s medical history was remarkable for CD diagnosed 4 years prior to presentation of the skin lesions. She had been treated for the past 2 years with adalimumab 40 mg once every 2 weeks and azathioprine 100 mg once daily. Because her CD was poorly controlled, the dosage of adalimumab was increased to 40 mg once weekly 6 months prior to the current presentation.

Our diagnosis was TNF-α inhibitor-induced psoriasis secondary to treatment with adalimumab.

The patient was treated with mometasone lotion 0.1% for the scalp lesions and triamcinolone cream 0.1% for the body lesions. Because of the extent of the psoriasis, we recommended changing adalimumab to ustekinumab, which is approved for CD in adults but is off label in children.

At 1-month follow-up, after receiving the induction dose of ustekinumab, the patient presented with partial improvement of the skin lesions but had developed a large, alopecic, erythematous plaque with thick yellowish scales on the scalp (Figure 1). She also had a positive hair pull test. The presumptive initial diagnosis of the alopecic scalp lesion was tinea capitis, for which multiple potassium hydroxide preparations of scales were performed, all yielding negative results. In addition, histopathologic examination with hematoxylin and eosin staining was performed (Figures 2A and 2B). Sterile tissue cultures for bacteria, fungi, and acid-fast bacilli were obtained and showed no growth. Periodic acid–Schiff staining was negative for fungal structures.

Comment

Psoriatic alopecia induced by a TNF-α inhibitor was first reported in 2007 in a 30-year-old woman with ankylosing spondylitis who was being treated with adalimumab.⁸ She had erythematous, scaly, alopecic plaques on the scalp and palmoplantar pustulosis. Findings on skin biopsy were compatible with psoriasis. The patient’s severe scalp psoriasis failed to respond to topical steroid treatment and adalimumab cessation. The extensive hair loss responded to cyclosporine 3 mg/kg daily.⁸

After conducting an extensive literature review, we found 26 cases of TNF-α–induced psoriatic alopecia, including the current case (Table).^6-16 The mean age at diagnosis was 27.8 years (SD, 13.6 years; range, 7–60 years). The female-to-male ratio was 3.3:1. The most common underlying condition for which TNF-α inhibitors were prescribed was CD (77% [20/26]). Psoriatic alopecia most commonly was reported secondary to treatment with infliximab (54% [14/26]), followed by adalimumab (42% [11/26]). Golimumab was the causative drug in 1 (4%) case. We did not find reports of etanercept or certolizumab having induced this manifestation. The onset of the scalp lesions occurred 2 to 46 months after starting treatment with the causative medication.

Previously reported cases have demonstrated various treatment options that yielded improvement or resolution of TNF-α inhibitor–induced psoriatic alopecia. These include either continuation or discontinuation of the TNF-α inhibitor combined with topical or intralesional steroids, methotrexate, or cyclosporine. Another option is to switch the TNF-α inhibitor to another biologic. Outcomes vary from patient to patient, making the physician’s clinical judgment crucial in deciding which treatment route to take. Our patient showed notable improvement when she was switched from adalimumab to ustekinumab as well as the combination of ustekinumab and clobetasol lotion 0.05%.

Conclusion

We recommend an individualized approach that provides patients with the safest and least invasive treatment option for TNF-α inhibitor–induced psoriatic alopecia. In most reported cases, the problem resolved with treatment, thereby classifying this form of alopecia as noncicatricial alopecia.

Tumor necrosis factor α (TNF-α) inhibitor–induced psoriasis is a known paradoxical adverse effect of this family of medications, which includes infliximab, adalimumab, etanercept, golimumab, and certolizumab. In the pediatric population, these therapies recently gained approval for nondermatologic conditions—meaning that this phenomenon is encountered more frequently.¹ In a systematic review of TNF-α inhibitor–induced psoriasis, severe scalp involvement was associated with alopecia in 7.5% of cases.² Onset of scalp psoriasis with alopecia in patients being treated with a TNF-α inhibitor should lead to consideration of this condition.

Psoriatic alopecia is an uncommon presentation of psoriasis. Although well described, alopecia as a clinical manifestation of scalp psoriasis is not a well-known concept among clinicians and has never been widely accepted. Adding to the diagnostic challenge is that psoriatic alopecia secondary to TNF-α inhibitor–induced psoriasis rarely has been reported in adults or children.^3-5 Including our case, our review of the literature yielded 7 pediatric cases (≤18 years) of TNF-α inhibitor–induced psoriatic alopecia.^6,7 A primary literature search of PubMed articles indexed for MEDLINE was conducted using the terms psoriatic alopecia, psoriasiform alopecia, TNF-α inhibitors, infliximab, adalimumab, etanercept, golimumab, and certolizumab.

We present the case of a pediatric patient with psoriatic alopecia secondary to treatment with adalimumab for Crohn disease (CD). We also provide a review of reported cases of psoriatic alopecia induced by a TNF-α inhibitor in the literature.

Case Report

A 12-year-old girl presented to our dermatology clinic with erythematous scaly plaques on the trunk, scalp, arms, and legs of 2 months’ duration. The lesions involved approximately 15% of the body surface area. The patient’s medical history was remarkable for CD diagnosed 4 years prior to presentation of the skin lesions. She had been treated for the past 2 years with adalimumab 40 mg once every 2 weeks and azathioprine 100 mg once daily. Because her CD was poorly controlled, the dosage of adalimumab was increased to 40 mg once weekly 6 months prior to the current presentation.

Our diagnosis was TNF-α inhibitor-induced psoriasis secondary to treatment with adalimumab.

The patient was treated with mometasone lotion 0.1% for the scalp lesions and triamcinolone cream 0.1% for the body lesions. Because of the extent of the psoriasis, we recommended changing adalimumab to ustekinumab, which is approved for CD in adults but is off label in children.

At 1-month follow-up, after receiving the induction dose of ustekinumab, the patient presented with partial improvement of the skin lesions but had developed a large, alopecic, erythematous plaque with thick yellowish scales on the scalp (Figure 1). She also had a positive hair pull test. The presumptive initial diagnosis of the alopecic scalp lesion was tinea capitis, for which multiple potassium hydroxide preparations of scales were performed, all yielding negative results. In addition, histopathologic examination with hematoxylin and eosin staining was performed (Figures 2A and 2B). Sterile tissue cultures for bacteria, fungi, and acid-fast bacilli were obtained and showed no growth. Periodic acid–Schiff staining was negative for fungal structures.

Comment

Psoriatic alopecia induced by a TNF-α inhibitor was first reported in 2007 in a 30-year-old woman with ankylosing spondylitis who was being treated with adalimumab.⁸ She had erythematous, scaly, alopecic plaques on the scalp and palmoplantar pustulosis. Findings on skin biopsy were compatible with psoriasis. The patient’s severe scalp psoriasis failed to respond to topical steroid treatment and adalimumab cessation. The extensive hair loss responded to cyclosporine 3 mg/kg daily.⁸

After conducting an extensive literature review, we found 26 cases of TNF-α–induced psoriatic alopecia, including the current case (Table).^6-16 The mean age at diagnosis was 27.8 years (SD, 13.6 years; range, 7–60 years). The female-to-male ratio was 3.3:1. The most common underlying condition for which TNF-α inhibitors were prescribed was CD (77% [20/26]). Psoriatic alopecia most commonly was reported secondary to treatment with infliximab (54% [14/26]), followed by adalimumab (42% [11/26]). Golimumab was the causative drug in 1 (4%) case. We did not find reports of etanercept or certolizumab having induced this manifestation. The onset of the scalp lesions occurred 2 to 46 months after starting treatment with the causative medication.

Previously reported cases have demonstrated various treatment options that yielded improvement or resolution of TNF-α inhibitor–induced psoriatic alopecia. These include either continuation or discontinuation of the TNF-α inhibitor combined with topical or intralesional steroids, methotrexate, or cyclosporine. Another option is to switch the TNF-α inhibitor to another biologic. Outcomes vary from patient to patient, making the physician’s clinical judgment crucial in deciding which treatment route to take. Our patient showed notable improvement when she was switched from adalimumab to ustekinumab as well as the combination of ustekinumab and clobetasol lotion 0.05%.

Conclusion

We recommend an individualized approach that provides patients with the safest and least invasive treatment option for TNF-α inhibitor–induced psoriatic alopecia. In most reported cases, the problem resolved with treatment, thereby classifying this form of alopecia as noncicatricial alopecia.

About 2% of asymptomatic college students carried 90% of COVID-19 viral load levels on a Colorado campus last year, new research reveals. Furthermore, the viral loads in these students were as elevated as those seen in hospitalized patients.

“College campuses were one of the few places where people without any symptoms or suspicions of exposure were being screened for the virus. This allowed us to make some powerful comparisons between symptomatic vs healthy carriers of the virus,” senior study author Sara Sawyer, PhD, professor of virology at the University of Colorado, Boulder, said in an interview.

“It turns out, walking around a college campus can be as dangerous as walking through a COVID ward in the hospital, in that you will experience these viral ‘super carriers’ equally in both settings,” she said.

“This is an important study in advancing our understanding of how SARS-CoV-2 is distributed in the population,” Thomas Giordano, MD, MPH, professor and section chief of infectious diseases at Baylor College of Medicine, Houston, said in an interview.

The study “adds to the evidence that viral load is not too tightly correlated with symptoms.” In fact, Dr. Giordano added, “this study suggests viral load is not at all correlated with symptoms.”

Viral load may not be correlated with transmissibility either, said Raphael Viscidi, MD, when asked to comment. “This is not a transmissibility study. They did not show that viral load is the factor related to transmission.”

“It’s true that 2% of the population they studied carried 90% of the virus, but it does not establish any biological importance to that 2%,” added Dr. Viscidi, professor of pediatrics and oncology at Johns Hopkins University, Baltimore,.

The 2% could just be the upper tail end of a normal bell-shaped distribution curve, Dr. Viscidi said, or there could be something biologically unique about that group. But the study does not make that distinction, he said.

The study was published online May 10, 2021, in PNAS, the official journal of the National Academy of Sciences.
 

A similar picture in hospitalized patients

Out of more than 72,500 saliva samples taken during COVID-19 screening at the University of Colorado Boulder between Aug. 27 and Dec. 11, 2020, 1,405 were positive for SARS-CoV-2.

The investigators also compared viral loads from students with those of hospitalized patients based on published data. They found the distribution of viral loads between these groups “indistinguishable.”

“Strikingly, these datasets demonstrate dramatic differences in viral levels between individuals, with a very small minority of the infected individuals harboring the vast majority of the infectious virions,” the researchers wrote. The comparison “really represents two extremes: One group is mostly hospitalized, while the other group represents a mostly young and healthy (but infected) college population.”

“It would be interesting to adjust public health recommendations based on a person’s viral load,” Dr. Giordano said. “One could speculate that a person with a very high viral load could be isolated longer or more thoroughly, while someone with a very low viral load could be minimally isolated.

“This is speculation, and more data are needed to test this concept,” he added. Also, quantitative viral load testing would need to be standardized before it could be used to guide such decision-making
 

Preceding the COVID-19 vaccine era

It should be noted that the research was conducted in fall 2020, before access to COVID-19 immunization.

“The study was performed prior to vaccine availability in a cohort of young people. It adds further data to support prior observations that the majority of infections are spread by a much smaller group of individuals,” David Hirschwerk, MD, said in an interview.

“Now that vaccines are available, I think it is very likely that a repeat study of this type would show diminished transmission from vaccinated people who were infected yet asymptomatic,” added Dr. Hirschwerk, an infectious disease specialist at Northwell Health in New Hyde Park, N.Y., who was not affiliated with the research.
 

Mechanism still a mystery

“This finding has been in the literature in piecemeal fashion since the beginning of the pandemic,” Dr. Sawyer said. “I just think we were the first to realize the bigger implications of these plots of viral load that we have all been seeing over and over again.”

How a minority of people walk around asymptomatic with a majority of virus remains unanswered. Are there special people who can harbor these extremely high viral loads? Or do many infected individuals experience a short period of time when they carry such elevated levels?

The highest observed viral load in the current study was more than 6 trillion virions per mL. “It is remarkable to consider that this individual was on campus and reported no symptoms at our testing site,” the researchers wrote.

In contrast, the lowest viral load detected was 8 virions per mL.

Although more research is needed, the investigators noted that “a strong implication is that these individuals who are viral ‘super carriers’ may also be ‘superspreaders.’ ”

Some of the study authors have financial ties to companies that offer commercial SARS-CoV-2 testing, including Darwin Biosciences, TUMI Genomics, Faze Medicines, and Arpeggio Biosciences.

A version of this article first appeared on Medscape.com.

About 2% of asymptomatic college students carried 90% of COVID-19 viral load levels on a Colorado campus last year, new research reveals. Furthermore, the viral loads in these students were as elevated as those seen in hospitalized patients.

“College campuses were one of the few places where people without any symptoms or suspicions of exposure were being screened for the virus. This allowed us to make some powerful comparisons between symptomatic vs healthy carriers of the virus,” senior study author Sara Sawyer, PhD, professor of virology at the University of Colorado, Boulder, said in an interview.

“It turns out, walking around a college campus can be as dangerous as walking through a COVID ward in the hospital, in that you will experience these viral ‘super carriers’ equally in both settings,” she said.

“This is an important study in advancing our understanding of how SARS-CoV-2 is distributed in the population,” Thomas Giordano, MD, MPH, professor and section chief of infectious diseases at Baylor College of Medicine, Houston, said in an interview.

The study “adds to the evidence that viral load is not too tightly correlated with symptoms.” In fact, Dr. Giordano added, “this study suggests viral load is not at all correlated with symptoms.”

Viral load may not be correlated with transmissibility either, said Raphael Viscidi, MD, when asked to comment. “This is not a transmissibility study. They did not show that viral load is the factor related to transmission.”

“It’s true that 2% of the population they studied carried 90% of the virus, but it does not establish any biological importance to that 2%,” added Dr. Viscidi, professor of pediatrics and oncology at Johns Hopkins University, Baltimore,.

The 2% could just be the upper tail end of a normal bell-shaped distribution curve, Dr. Viscidi said, or there could be something biologically unique about that group. But the study does not make that distinction, he said.

The study was published online May 10, 2021, in PNAS, the official journal of the National Academy of Sciences.
 

A similar picture in hospitalized patients

Out of more than 72,500 saliva samples taken during COVID-19 screening at the University of Colorado Boulder between Aug. 27 and Dec. 11, 2020, 1,405 were positive for SARS-CoV-2.

The investigators also compared viral loads from students with those of hospitalized patients based on published data. They found the distribution of viral loads between these groups “indistinguishable.”

“Strikingly, these datasets demonstrate dramatic differences in viral levels between individuals, with a very small minority of the infected individuals harboring the vast majority of the infectious virions,” the researchers wrote. The comparison “really represents two extremes: One group is mostly hospitalized, while the other group represents a mostly young and healthy (but infected) college population.”

“It would be interesting to adjust public health recommendations based on a person’s viral load,” Dr. Giordano said. “One could speculate that a person with a very high viral load could be isolated longer or more thoroughly, while someone with a very low viral load could be minimally isolated.

“This is speculation, and more data are needed to test this concept,” he added. Also, quantitative viral load testing would need to be standardized before it could be used to guide such decision-making
 

Preceding the COVID-19 vaccine era

It should be noted that the research was conducted in fall 2020, before access to COVID-19 immunization.

“The study was performed prior to vaccine availability in a cohort of young people. It adds further data to support prior observations that the majority of infections are spread by a much smaller group of individuals,” David Hirschwerk, MD, said in an interview.

“Now that vaccines are available, I think it is very likely that a repeat study of this type would show diminished transmission from vaccinated people who were infected yet asymptomatic,” added Dr. Hirschwerk, an infectious disease specialist at Northwell Health in New Hyde Park, N.Y., who was not affiliated with the research.
 

Mechanism still a mystery

“This finding has been in the literature in piecemeal fashion since the beginning of the pandemic,” Dr. Sawyer said. “I just think we were the first to realize the bigger implications of these plots of viral load that we have all been seeing over and over again.”

How a minority of people walk around asymptomatic with a majority of virus remains unanswered. Are there special people who can harbor these extremely high viral loads? Or do many infected individuals experience a short period of time when they carry such elevated levels?

The highest observed viral load in the current study was more than 6 trillion virions per mL. “It is remarkable to consider that this individual was on campus and reported no symptoms at our testing site,” the researchers wrote.

In contrast, the lowest viral load detected was 8 virions per mL.

Although more research is needed, the investigators noted that “a strong implication is that these individuals who are viral ‘super carriers’ may also be ‘superspreaders.’ ”

Some of the study authors have financial ties to companies that offer commercial SARS-CoV-2 testing, including Darwin Biosciences, TUMI Genomics, Faze Medicines, and Arpeggio Biosciences.

A version of this article first appeared on Medscape.com.

About 2% of asymptomatic college students carried 90% of COVID-19 viral load levels on a Colorado campus last year, new research reveals. Furthermore, the viral loads in these students were as elevated as those seen in hospitalized patients.

“College campuses were one of the few places where people without any symptoms or suspicions of exposure were being screened for the virus. This allowed us to make some powerful comparisons between symptomatic vs healthy carriers of the virus,” senior study author Sara Sawyer, PhD, professor of virology at the University of Colorado, Boulder, said in an interview.

“It turns out, walking around a college campus can be as dangerous as walking through a COVID ward in the hospital, in that you will experience these viral ‘super carriers’ equally in both settings,” she said.

“This is an important study in advancing our understanding of how SARS-CoV-2 is distributed in the population,” Thomas Giordano, MD, MPH, professor and section chief of infectious diseases at Baylor College of Medicine, Houston, said in an interview.

The study “adds to the evidence that viral load is not too tightly correlated with symptoms.” In fact, Dr. Giordano added, “this study suggests viral load is not at all correlated with symptoms.”

Viral load may not be correlated with transmissibility either, said Raphael Viscidi, MD, when asked to comment. “This is not a transmissibility study. They did not show that viral load is the factor related to transmission.”

“It’s true that 2% of the population they studied carried 90% of the virus, but it does not establish any biological importance to that 2%,” added Dr. Viscidi, professor of pediatrics and oncology at Johns Hopkins University, Baltimore,.

The 2% could just be the upper tail end of a normal bell-shaped distribution curve, Dr. Viscidi said, or there could be something biologically unique about that group. But the study does not make that distinction, he said.

The study was published online May 10, 2021, in PNAS, the official journal of the National Academy of Sciences.
 

A similar picture in hospitalized patients

Out of more than 72,500 saliva samples taken during COVID-19 screening at the University of Colorado Boulder between Aug. 27 and Dec. 11, 2020, 1,405 were positive for SARS-CoV-2.

The investigators also compared viral loads from students with those of hospitalized patients based on published data. They found the distribution of viral loads between these groups “indistinguishable.”

“Strikingly, these datasets demonstrate dramatic differences in viral levels between individuals, with a very small minority of the infected individuals harboring the vast majority of the infectious virions,” the researchers wrote. The comparison “really represents two extremes: One group is mostly hospitalized, while the other group represents a mostly young and healthy (but infected) college population.”

“It would be interesting to adjust public health recommendations based on a person’s viral load,” Dr. Giordano said. “One could speculate that a person with a very high viral load could be isolated longer or more thoroughly, while someone with a very low viral load could be minimally isolated.

“This is speculation, and more data are needed to test this concept,” he added. Also, quantitative viral load testing would need to be standardized before it could be used to guide such decision-making
 

Preceding the COVID-19 vaccine era

It should be noted that the research was conducted in fall 2020, before access to COVID-19 immunization.

“The study was performed prior to vaccine availability in a cohort of young people. It adds further data to support prior observations that the majority of infections are spread by a much smaller group of individuals,” David Hirschwerk, MD, said in an interview.

“Now that vaccines are available, I think it is very likely that a repeat study of this type would show diminished transmission from vaccinated people who were infected yet asymptomatic,” added Dr. Hirschwerk, an infectious disease specialist at Northwell Health in New Hyde Park, N.Y., who was not affiliated with the research.
 

Mechanism still a mystery

“This finding has been in the literature in piecemeal fashion since the beginning of the pandemic,” Dr. Sawyer said. “I just think we were the first to realize the bigger implications of these plots of viral load that we have all been seeing over and over again.”

How a minority of people walk around asymptomatic with a majority of virus remains unanswered. Are there special people who can harbor these extremely high viral loads? Or do many infected individuals experience a short period of time when they carry such elevated levels?

The highest observed viral load in the current study was more than 6 trillion virions per mL. “It is remarkable to consider that this individual was on campus and reported no symptoms at our testing site,” the researchers wrote.

In contrast, the lowest viral load detected was 8 virions per mL.

Although more research is needed, the investigators noted that “a strong implication is that these individuals who are viral ‘super carriers’ may also be ‘superspreaders.’ ”

Some of the study authors have financial ties to companies that offer commercial SARS-CoV-2 testing, including Darwin Biosciences, TUMI Genomics, Faze Medicines, and Arpeggio Biosciences.

A version of this article first appeared on Medscape.com.

In 2013, a California hospital paid $275,000 to settle claims that it violated the HIPAA privacy rule when it disclosed a patient’s health information in response to a negative online review. More recently, a Texas dental practice paid a substantial fine to the Department of Health & Human Services, which enforces HIPAA, after it responded to unfavorable Yelp reviews with patient names and details of their health conditions, treatment plans, and cost information. In addition to the fine, the practice agreed to 2 years of monitoring by HHS for compliance with HIPAA rules.

Most physicians have had the unpleasant experience of finding a negative online review from a disgruntled patient or family member. Some are justified, many are not; either way, your first impulse will often be to post a response – but that is almost always a bad idea. “Social media is not the place for providers to discuss a patient’s care,” an HHS official said in a statement issued about the dental practice case in 2016. “Doctors and dentists must think carefully about patient privacy before responding to online reviews.”

Any information that could be used to identify a patient is a HIPAA breach. This is true even if the patient has already disclosed information, because doing so does not nullify their HIPAA rights, and HIPAA provides no exceptions for responses. Even acknowledging that the reviewer was in fact your patient could, in some cases, be considered a violation.

Responding to good reviews can get you in trouble too, for the same reasons. In 2016, a physical therapy practice paid a $25,000 fine after it posted patient testimonials, “including full names and full-face photographic images to its website without obtaining valid, HIPAA-compliant authorizations.”

And by the way, most malpractice policies specifically exclude disciplinary fines and settlements from coverage.

All of that said, there are legal and ethical ways to deal with negative reviews. Here are some options:
 

• Ignore them. This is your best choice most of the time. Most negative reviews have minimal impact and simply do not deserve a response; responding may pour fuel on the fire. Besides, an occasional negative review actually lends credibility to a reviewing site and to the positive reviews posted on that site. Polls show that readers are suspicious of sites that contain only rave reviews. They assume such reviews have been “whitewashed” – or just fabricated.
• Solicit more reviews to that site. The more you can obtain, the less impact any complaints will have, since you know the overwhelming majority of your patients are happy with your care and will post a positive review if asked. Solicit them on your website, on social media, or in your email reminders. To be clear, you must encourage reviews from all patients, whether they have had a positive experience or not. If you invite only the satisfied ones, you are “filtering,” which can be perceived as false or deceptive advertising. (Google calls it “review-gating,” and according to their guidelines, if they catch you doing it they will remove all of your reviews.)
• Respond politely. In those rare cases where you feel you must respond, do so without acknowledging that the individual was a patient, or disclosing any information that may be linked to the patient. For example, you can say that you provide excellent and appropriate care, or describe your general policies. Be polite, professional, and sensitive to the patient’s position. Readers tend to respect and sympathize with a doctor who responds in a professional, respectful manner and does not trash the complainant in retaliation.
• Take the discussion offline. Sometimes the person posting the review is just frustrated and wants to be heard. In those cases, consider contacting the patient and offering to discuss their concerns privately. If you cannot resolve your differences, try to get the patient’s written permission to post a response to their review. If they refuse, you can explain that, thereby capturing the moral high ground.

If the review contains false or defamatory content, that’s a different situation entirely; you will probably need to consult your attorney.

Regardless of how you handle negative reviews, be sure to learn from them. Your critics, as the song goes, are not always evil – and not always wrong. Complaints give you a chance to review your office policies and procedures and your own conduct, identify weaknesses, and make changes as necessary. At the very least, the exercise will help you to avoid similar complaints in the future. Don’t let valuable opportunities like that pass you by.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

In 2013, a California hospital paid $275,000 to settle claims that it violated the HIPAA privacy rule when it disclosed a patient’s health information in response to a negative online review. More recently, a Texas dental practice paid a substantial fine to the Department of Health & Human Services, which enforces HIPAA, after it responded to unfavorable Yelp reviews with patient names and details of their health conditions, treatment plans, and cost information. In addition to the fine, the practice agreed to 2 years of monitoring by HHS for compliance with HIPAA rules.

Most physicians have had the unpleasant experience of finding a negative online review from a disgruntled patient or family member. Some are justified, many are not; either way, your first impulse will often be to post a response – but that is almost always a bad idea. “Social media is not the place for providers to discuss a patient’s care,” an HHS official said in a statement issued about the dental practice case in 2016. “Doctors and dentists must think carefully about patient privacy before responding to online reviews.”

Any information that could be used to identify a patient is a HIPAA breach. This is true even if the patient has already disclosed information, because doing so does not nullify their HIPAA rights, and HIPAA provides no exceptions for responses. Even acknowledging that the reviewer was in fact your patient could, in some cases, be considered a violation.

Responding to good reviews can get you in trouble too, for the same reasons. In 2016, a physical therapy practice paid a $25,000 fine after it posted patient testimonials, “including full names and full-face photographic images to its website without obtaining valid, HIPAA-compliant authorizations.”

And by the way, most malpractice policies specifically exclude disciplinary fines and settlements from coverage.

All of that said, there are legal and ethical ways to deal with negative reviews. Here are some options:
 

• Ignore them. This is your best choice most of the time. Most negative reviews have minimal impact and simply do not deserve a response; responding may pour fuel on the fire. Besides, an occasional negative review actually lends credibility to a reviewing site and to the positive reviews posted on that site. Polls show that readers are suspicious of sites that contain only rave reviews. They assume such reviews have been “whitewashed” – or just fabricated.
• Solicit more reviews to that site. The more you can obtain, the less impact any complaints will have, since you know the overwhelming majority of your patients are happy with your care and will post a positive review if asked. Solicit them on your website, on social media, or in your email reminders. To be clear, you must encourage reviews from all patients, whether they have had a positive experience or not. If you invite only the satisfied ones, you are “filtering,” which can be perceived as false or deceptive advertising. (Google calls it “review-gating,” and according to their guidelines, if they catch you doing it they will remove all of your reviews.)
• Respond politely. In those rare cases where you feel you must respond, do so without acknowledging that the individual was a patient, or disclosing any information that may be linked to the patient. For example, you can say that you provide excellent and appropriate care, or describe your general policies. Be polite, professional, and sensitive to the patient’s position. Readers tend to respect and sympathize with a doctor who responds in a professional, respectful manner and does not trash the complainant in retaliation.
• Take the discussion offline. Sometimes the person posting the review is just frustrated and wants to be heard. In those cases, consider contacting the patient and offering to discuss their concerns privately. If you cannot resolve your differences, try to get the patient’s written permission to post a response to their review. If they refuse, you can explain that, thereby capturing the moral high ground.

If the review contains false or defamatory content, that’s a different situation entirely; you will probably need to consult your attorney.

Regardless of how you handle negative reviews, be sure to learn from them. Your critics, as the song goes, are not always evil – and not always wrong. Complaints give you a chance to review your office policies and procedures and your own conduct, identify weaknesses, and make changes as necessary. At the very least, the exercise will help you to avoid similar complaints in the future. Don’t let valuable opportunities like that pass you by.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

In 2013, a California hospital paid $275,000 to settle claims that it violated the HIPAA privacy rule when it disclosed a patient’s health information in response to a negative online review. More recently, a Texas dental practice paid a substantial fine to the Department of Health & Human Services, which enforces HIPAA, after it responded to unfavorable Yelp reviews with patient names and details of their health conditions, treatment plans, and cost information. In addition to the fine, the practice agreed to 2 years of monitoring by HHS for compliance with HIPAA rules.

Most physicians have had the unpleasant experience of finding a negative online review from a disgruntled patient or family member. Some are justified, many are not; either way, your first impulse will often be to post a response – but that is almost always a bad idea. “Social media is not the place for providers to discuss a patient’s care,” an HHS official said in a statement issued about the dental practice case in 2016. “Doctors and dentists must think carefully about patient privacy before responding to online reviews.”

Any information that could be used to identify a patient is a HIPAA breach. This is true even if the patient has already disclosed information, because doing so does not nullify their HIPAA rights, and HIPAA provides no exceptions for responses. Even acknowledging that the reviewer was in fact your patient could, in some cases, be considered a violation.

Responding to good reviews can get you in trouble too, for the same reasons. In 2016, a physical therapy practice paid a $25,000 fine after it posted patient testimonials, “including full names and full-face photographic images to its website without obtaining valid, HIPAA-compliant authorizations.”

And by the way, most malpractice policies specifically exclude disciplinary fines and settlements from coverage.

All of that said, there are legal and ethical ways to deal with negative reviews. Here are some options:
 

• Ignore them. This is your best choice most of the time. Most negative reviews have minimal impact and simply do not deserve a response; responding may pour fuel on the fire. Besides, an occasional negative review actually lends credibility to a reviewing site and to the positive reviews posted on that site. Polls show that readers are suspicious of sites that contain only rave reviews. They assume such reviews have been “whitewashed” – or just fabricated.
• Solicit more reviews to that site. The more you can obtain, the less impact any complaints will have, since you know the overwhelming majority of your patients are happy with your care and will post a positive review if asked. Solicit them on your website, on social media, or in your email reminders. To be clear, you must encourage reviews from all patients, whether they have had a positive experience or not. If you invite only the satisfied ones, you are “filtering,” which can be perceived as false or deceptive advertising. (Google calls it “review-gating,” and according to their guidelines, if they catch you doing it they will remove all of your reviews.)
• Respond politely. In those rare cases where you feel you must respond, do so without acknowledging that the individual was a patient, or disclosing any information that may be linked to the patient. For example, you can say that you provide excellent and appropriate care, or describe your general policies. Be polite, professional, and sensitive to the patient’s position. Readers tend to respect and sympathize with a doctor who responds in a professional, respectful manner and does not trash the complainant in retaliation.
• Take the discussion offline. Sometimes the person posting the review is just frustrated and wants to be heard. In those cases, consider contacting the patient and offering to discuss their concerns privately. If you cannot resolve your differences, try to get the patient’s written permission to post a response to their review. If they refuse, you can explain that, thereby capturing the moral high ground.

If the review contains false or defamatory content, that’s a different situation entirely; you will probably need to consult your attorney.

Regardless of how you handle negative reviews, be sure to learn from them. Your critics, as the song goes, are not always evil – and not always wrong. Complaints give you a chance to review your office policies and procedures and your own conduct, identify weaknesses, and make changes as necessary. At the very least, the exercise will help you to avoid similar complaints in the future. Don’t let valuable opportunities like that pass you by.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Key clinical point: Quarterly and monthly dose regimens of fremanezumab effectively reduced the average monthly migraine days (MMD) vs. placebo in patients with difficult-to-treat migraine irrespective of country and continents.

Major finding: Reduction in MMD over 12 weeks was significantly higher with fremanezumab dose regimens vs. placebo in 3 top-recruiting countries including Czech Republic (least squares mean difference [LSMD]: quarterly, −1.9; monthly, −3.0), the United States (LSMD: quarterly, −3.7; monthly, −4.2), and Finland (LSMD: quarterly, −3.0; monthly, −3.9; P less than or equal to .01 for all).

Study details: Data come from an exploratory analysis of phase 3b FOCUS study including 838 patients with episodic or chronic migraine who had an inadequate response to 2-4 migraine preventive medication classes and were randomly allocated to either quarterly fremanezumab, monthly fremanezumab, or matched placebo.

Disclosures: The study was funded by Teva Pharmaceuticals. Some of the authors reported receiving research grants and/or personal compensation from multiple sources, including Teva Pharmaceuticals. Some of the authors declared being current/former employees of Teva Pharmaceuticals.

Source: Spierings ELH et al. J Headache Pain. 2021 Apr 16. doi: 10.1186/s10194-021-01232-8.

Key clinical point: Quarterly and monthly dose regimens of fremanezumab effectively reduced the average monthly migraine days (MMD) vs. placebo in patients with difficult-to-treat migraine irrespective of country and continents.

Major finding: Reduction in MMD over 12 weeks was significantly higher with fremanezumab dose regimens vs. placebo in 3 top-recruiting countries including Czech Republic (least squares mean difference [LSMD]: quarterly, −1.9; monthly, −3.0), the United States (LSMD: quarterly, −3.7; monthly, −4.2), and Finland (LSMD: quarterly, −3.0; monthly, −3.9; P less than or equal to .01 for all).

Study details: Data come from an exploratory analysis of phase 3b FOCUS study including 838 patients with episodic or chronic migraine who had an inadequate response to 2-4 migraine preventive medication classes and were randomly allocated to either quarterly fremanezumab, monthly fremanezumab, or matched placebo.

Disclosures: The study was funded by Teva Pharmaceuticals. Some of the authors reported receiving research grants and/or personal compensation from multiple sources, including Teva Pharmaceuticals. Some of the authors declared being current/former employees of Teva Pharmaceuticals.

Source: Spierings ELH et al. J Headache Pain. 2021 Apr 16. doi: 10.1186/s10194-021-01232-8.

Key clinical point: Quarterly and monthly dose regimens of fremanezumab effectively reduced the average monthly migraine days (MMD) vs. placebo in patients with difficult-to-treat migraine irrespective of country and continents.

Major finding: Reduction in MMD over 12 weeks was significantly higher with fremanezumab dose regimens vs. placebo in 3 top-recruiting countries including Czech Republic (least squares mean difference [LSMD]: quarterly, −1.9; monthly, −3.0), the United States (LSMD: quarterly, −3.7; monthly, −4.2), and Finland (LSMD: quarterly, −3.0; monthly, −3.9; P less than or equal to .01 for all).

Study details: Data come from an exploratory analysis of phase 3b FOCUS study including 838 patients with episodic or chronic migraine who had an inadequate response to 2-4 migraine preventive medication classes and were randomly allocated to either quarterly fremanezumab, monthly fremanezumab, or matched placebo.

Disclosures: The study was funded by Teva Pharmaceuticals. Some of the authors reported receiving research grants and/or personal compensation from multiple sources, including Teva Pharmaceuticals. Some of the authors declared being current/former employees of Teva Pharmaceuticals.

Source: Spierings ELH et al. J Headache Pain. 2021 Apr 16. doi: 10.1186/s10194-021-01232-8.