Early meniscal surgery does not appear to be better than a program of exercise and education in improving knee outcomes in young adults with meniscal tears, according to the results of the randomized controlled DREAM trial presented at the OARSI 2022 World Congress.

Indeed, similar clinically relevant improvements in knee pain, function, and quality of life at 12 months were seen among participants in both study arms.

“Our results highlight that decisions on surgery or nonsurgical treatment must depend on preferences and values and needs of the individuals consulting their surgeon,” Søren T. Skou, PT, MSc, PhD, reported during one of the opening sessions at the meeting sponsored by the Osteoarthritis Research Society International.

The lack of superiority was contrary to the expectations of the researchers who hypothesized that early surgical intervention in adults aged between 18 and 40 years would be more beneficial than an active rehabilitation program with later surgery if needed.

Although the results do tie in with the results of other trials and systematic reviews in older adults the reason for looking at young adults specifically, aside from the obvious differences and the origin of meniscal tears, was that no study had previously looked at this population, Dr. Skou explained.
 

Assembling the DREAM team

The DREAM (Danish RCT on Exercise versus Arthroscopic Meniscal Surgery for Young Adults) trial “was a collaborative effort among many clinicians in Denmark – physical therapists, exercise physiologists, and surgeons,” Dr. Skou observed.

In total, 121 adults with MRI-verified meniscal tears who were eligible for surgery were recruited and randomized to either the early meniscal surgery group (n = 60) or to the exercise and education group (n = 61). The mean age was just below 30 years and 28% were female

Meniscal surgery, which was either an arthroscopic partial meniscectomy or meniscal repair, was performed at seven specialist centers. The exercise and education program was delivered by trained physical therapists working at 19 participating centers. The latter consisted of 24 sessions of group-based exercise therapy and education held over a period of 12 weeks.

Participants randomized to the exercise and education arm had the option of later meniscal surgery, with one in four eventually undergoing this procedure.
 

No gain in pain

The primary outcome measure was the difference in the mean of four of the subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS4) from baseline to 12-month assessment. The KOOS4 looks at knee pain, symptoms, function in sport and recreation, and quality of life.

“We considered a 10-point difference between groups as clinically relevant,” said Dr. Skou, but “adjusting for the baseline differences, we found no [statistical] differences or clinically relevant differences between groups.”

Improvement was seen in both groups. In an intention-to-treat analysis the KOOS4 scores improved by 19.2 points and 16.4 points respectively in the surgery and exercise and education groups, with a mean adjusted difference of 5.4 (95% confidence interval, –0.7 to 11.4). There was also no difference in a per protocol analysis, which considered only those participants who received the treatment strategy they were allocated (mean adjusted difference, 5.7; 95% CI, –0.9 to 12.4).

Secondary outcomes were also similarly improved in both groups with clinically relevant increases in all four KOOS subscale scores and in the Western Ontario Meniscal Evaluation Tool (WOMET).

While there were some statistical differences between the groups, such as better KOOS pain, symptoms, and WOMET scores in the surgery group, these were felt unlikely to be clinically relevant. Likewise, there was a statistically greater improvement in muscle strength in the exercise and education group than surgery group.

There was no statistical difference in the number of serious adverse events, including worsening of symptoms with or without acute onset during activity and lateral meniscal cysts, with four reported in the surgical group and seven in the exercise and education group.
 

Views on results

The results of the trial, published in NEJM Evidence, garnered attention on Twitter with several physiotherapists noting the data were positive for the nonsurgical management of meniscal tears in younger adults.

During discussion at the meeting, Nadine Foster, PhD, NIHR Professor of Musculoskeletal Health in Primary Care at Keele (England) University, asked if a larger cohort might not swing the results in favor of surgery.

She said: “Congratulations on this trial. The challenge: Your 95% CIs suggest a larger trial would have concluded superiority of surgery?”

Dr. Skou responded: “Most likely the true difference is outside the clinically relevant difference, but obviously, we cannot exclude that there is actually a clinically relevant difference between groups.”

Martin Englund, MD, Phd, of Lund (Sweden) University Hospital in Sweden, pointed out that 16 patients in the exercise and education group had “crossed over” and undergone surgery. “Were there any differences for those patients?” he asked.

“We looked at whether there was a difference between those – obviously only having 16 participants, we’re not able to do any statistical comparisons – but looking just visually at the data, they seem to improve to the same extent as those undergoing nonsurgical only,” Dr. Skou said.

The 2-year MRI data are currently being examined and will “obviously also be very interesting,” he added.

The DREAM trial was funded by the Danish Council for Independent Research, IMK Almene Fond, Lundbeck Foundation, Spar Nord Foundation, Danish Rheumatism Association, Association of Danish Physiotherapists Research Fund, Research Council at Næstved-Slagelse-Ringsted Hospitals, and Region Zealand. Dr. Skou had no financial or other conflicts of interest to disclose.

Early meniscal surgery does not appear to be better than a program of exercise and education in improving knee outcomes in young adults with meniscal tears, according to the results of the randomized controlled DREAM trial presented at the OARSI 2022 World Congress.

Indeed, similar clinically relevant improvements in knee pain, function, and quality of life at 12 months were seen among participants in both study arms.

“Our results highlight that decisions on surgery or nonsurgical treatment must depend on preferences and values and needs of the individuals consulting their surgeon,” Søren T. Skou, PT, MSc, PhD, reported during one of the opening sessions at the meeting sponsored by the Osteoarthritis Research Society International.

The lack of superiority was contrary to the expectations of the researchers who hypothesized that early surgical intervention in adults aged between 18 and 40 years would be more beneficial than an active rehabilitation program with later surgery if needed.

Although the results do tie in with the results of other trials and systematic reviews in older adults the reason for looking at young adults specifically, aside from the obvious differences and the origin of meniscal tears, was that no study had previously looked at this population, Dr. Skou explained.
 

Assembling the DREAM team

The DREAM (Danish RCT on Exercise versus Arthroscopic Meniscal Surgery for Young Adults) trial “was a collaborative effort among many clinicians in Denmark – physical therapists, exercise physiologists, and surgeons,” Dr. Skou observed.

In total, 121 adults with MRI-verified meniscal tears who were eligible for surgery were recruited and randomized to either the early meniscal surgery group (n = 60) or to the exercise and education group (n = 61). The mean age was just below 30 years and 28% were female

Meniscal surgery, which was either an arthroscopic partial meniscectomy or meniscal repair, was performed at seven specialist centers. The exercise and education program was delivered by trained physical therapists working at 19 participating centers. The latter consisted of 24 sessions of group-based exercise therapy and education held over a period of 12 weeks.

Participants randomized to the exercise and education arm had the option of later meniscal surgery, with one in four eventually undergoing this procedure.
 

No gain in pain

The primary outcome measure was the difference in the mean of four of the subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS4) from baseline to 12-month assessment. The KOOS4 looks at knee pain, symptoms, function in sport and recreation, and quality of life.

“We considered a 10-point difference between groups as clinically relevant,” said Dr. Skou, but “adjusting for the baseline differences, we found no [statistical] differences or clinically relevant differences between groups.”

Improvement was seen in both groups. In an intention-to-treat analysis the KOOS4 scores improved by 19.2 points and 16.4 points respectively in the surgery and exercise and education groups, with a mean adjusted difference of 5.4 (95% confidence interval, –0.7 to 11.4). There was also no difference in a per protocol analysis, which considered only those participants who received the treatment strategy they were allocated (mean adjusted difference, 5.7; 95% CI, –0.9 to 12.4).

Secondary outcomes were also similarly improved in both groups with clinically relevant increases in all four KOOS subscale scores and in the Western Ontario Meniscal Evaluation Tool (WOMET).

While there were some statistical differences between the groups, such as better KOOS pain, symptoms, and WOMET scores in the surgery group, these were felt unlikely to be clinically relevant. Likewise, there was a statistically greater improvement in muscle strength in the exercise and education group than surgery group.

There was no statistical difference in the number of serious adverse events, including worsening of symptoms with or without acute onset during activity and lateral meniscal cysts, with four reported in the surgical group and seven in the exercise and education group.
 

Views on results

The results of the trial, published in NEJM Evidence, garnered attention on Twitter with several physiotherapists noting the data were positive for the nonsurgical management of meniscal tears in younger adults.

During discussion at the meeting, Nadine Foster, PhD, NIHR Professor of Musculoskeletal Health in Primary Care at Keele (England) University, asked if a larger cohort might not swing the results in favor of surgery.

She said: “Congratulations on this trial. The challenge: Your 95% CIs suggest a larger trial would have concluded superiority of surgery?”

Dr. Skou responded: “Most likely the true difference is outside the clinically relevant difference, but obviously, we cannot exclude that there is actually a clinically relevant difference between groups.”

Martin Englund, MD, Phd, of Lund (Sweden) University Hospital in Sweden, pointed out that 16 patients in the exercise and education group had “crossed over” and undergone surgery. “Were there any differences for those patients?” he asked.

“We looked at whether there was a difference between those – obviously only having 16 participants, we’re not able to do any statistical comparisons – but looking just visually at the data, they seem to improve to the same extent as those undergoing nonsurgical only,” Dr. Skou said.

The 2-year MRI data are currently being examined and will “obviously also be very interesting,” he added.

The DREAM trial was funded by the Danish Council for Independent Research, IMK Almene Fond, Lundbeck Foundation, Spar Nord Foundation, Danish Rheumatism Association, Association of Danish Physiotherapists Research Fund, Research Council at Næstved-Slagelse-Ringsted Hospitals, and Region Zealand. Dr. Skou had no financial or other conflicts of interest to disclose.

Early meniscal surgery does not appear to be better than a program of exercise and education in improving knee outcomes in young adults with meniscal tears, according to the results of the randomized controlled DREAM trial presented at the OARSI 2022 World Congress.

Indeed, similar clinically relevant improvements in knee pain, function, and quality of life at 12 months were seen among participants in both study arms.

“Our results highlight that decisions on surgery or nonsurgical treatment must depend on preferences and values and needs of the individuals consulting their surgeon,” Søren T. Skou, PT, MSc, PhD, reported during one of the opening sessions at the meeting sponsored by the Osteoarthritis Research Society International.

The lack of superiority was contrary to the expectations of the researchers who hypothesized that early surgical intervention in adults aged between 18 and 40 years would be more beneficial than an active rehabilitation program with later surgery if needed.

Although the results do tie in with the results of other trials and systematic reviews in older adults the reason for looking at young adults specifically, aside from the obvious differences and the origin of meniscal tears, was that no study had previously looked at this population, Dr. Skou explained.
 

Assembling the DREAM team

The DREAM (Danish RCT on Exercise versus Arthroscopic Meniscal Surgery for Young Adults) trial “was a collaborative effort among many clinicians in Denmark – physical therapists, exercise physiologists, and surgeons,” Dr. Skou observed.

In total, 121 adults with MRI-verified meniscal tears who were eligible for surgery were recruited and randomized to either the early meniscal surgery group (n = 60) or to the exercise and education group (n = 61). The mean age was just below 30 years and 28% were female

Meniscal surgery, which was either an arthroscopic partial meniscectomy or meniscal repair, was performed at seven specialist centers. The exercise and education program was delivered by trained physical therapists working at 19 participating centers. The latter consisted of 24 sessions of group-based exercise therapy and education held over a period of 12 weeks.

Participants randomized to the exercise and education arm had the option of later meniscal surgery, with one in four eventually undergoing this procedure.
 

No gain in pain

The primary outcome measure was the difference in the mean of four of the subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS4) from baseline to 12-month assessment. The KOOS4 looks at knee pain, symptoms, function in sport and recreation, and quality of life.

“We considered a 10-point difference between groups as clinically relevant,” said Dr. Skou, but “adjusting for the baseline differences, we found no [statistical] differences or clinically relevant differences between groups.”

Improvement was seen in both groups. In an intention-to-treat analysis the KOOS4 scores improved by 19.2 points and 16.4 points respectively in the surgery and exercise and education groups, with a mean adjusted difference of 5.4 (95% confidence interval, –0.7 to 11.4). There was also no difference in a per protocol analysis, which considered only those participants who received the treatment strategy they were allocated (mean adjusted difference, 5.7; 95% CI, –0.9 to 12.4).

Secondary outcomes were also similarly improved in both groups with clinically relevant increases in all four KOOS subscale scores and in the Western Ontario Meniscal Evaluation Tool (WOMET).

While there were some statistical differences between the groups, such as better KOOS pain, symptoms, and WOMET scores in the surgery group, these were felt unlikely to be clinically relevant. Likewise, there was a statistically greater improvement in muscle strength in the exercise and education group than surgery group.

There was no statistical difference in the number of serious adverse events, including worsening of symptoms with or without acute onset during activity and lateral meniscal cysts, with four reported in the surgical group and seven in the exercise and education group.
 

Views on results

The results of the trial, published in NEJM Evidence, garnered attention on Twitter with several physiotherapists noting the data were positive for the nonsurgical management of meniscal tears in younger adults.

During discussion at the meeting, Nadine Foster, PhD, NIHR Professor of Musculoskeletal Health in Primary Care at Keele (England) University, asked if a larger cohort might not swing the results in favor of surgery.

She said: “Congratulations on this trial. The challenge: Your 95% CIs suggest a larger trial would have concluded superiority of surgery?”

Dr. Skou responded: “Most likely the true difference is outside the clinically relevant difference, but obviously, we cannot exclude that there is actually a clinically relevant difference between groups.”

Martin Englund, MD, Phd, of Lund (Sweden) University Hospital in Sweden, pointed out that 16 patients in the exercise and education group had “crossed over” and undergone surgery. “Were there any differences for those patients?” he asked.

“We looked at whether there was a difference between those – obviously only having 16 participants, we’re not able to do any statistical comparisons – but looking just visually at the data, they seem to improve to the same extent as those undergoing nonsurgical only,” Dr. Skou said.

The 2-year MRI data are currently being examined and will “obviously also be very interesting,” he added.

The DREAM trial was funded by the Danish Council for Independent Research, IMK Almene Fond, Lundbeck Foundation, Spar Nord Foundation, Danish Rheumatism Association, Association of Danish Physiotherapists Research Fund, Research Council at Næstved-Slagelse-Ringsted Hospitals, and Region Zealand. Dr. Skou had no financial or other conflicts of interest to disclose.

The American Academy of Pediatrics, with funding from the Centers for Disease Control and Prevention, studied the CDC’s “Learn the Signs. Act Early” developmental surveillance milestones for children 0-5 years to update the milestones based on published studies. The goal was to improve this tool for developmental surveillance and use by the public. Developmental surveillance is not just observing a child at a check-up but rather “is a longitudinal process that involves eliciting concerns, taking a developmental history based on milestone attainment, observing milestones and other behaviors, examining the child, and applying clinical judgment during health supervision visits (HSVs).”¹

While the milestones we were trained on were a good start and highlighted the developmental progression central to pediatrics, they were not based on norms or cut scores indicating significant developmental risk unless taught from a validated tool. The CDC was concerned that their public handouts and apps were based on median ages (middle number of the entire range) of attainment not the mode (most common) or even average ages. That means that about half of all typically developing children would “not have attained” that skill at the age noted, potentially evoking unnecessary concern for parents and a “wait-and-see” message from a knowledgeable provider who realized the statistical meaning and the broad range of normal. Another potential problem with using milestones set at the median age is that parents, especially those with several children or experienced friends, may see the provider as an alarmist when they have seen great variation in children who later were normal. This reaction can dampen provider willingness to discuss development or even to screen with validated tools. We have learned the hard way from COVID-19 that it is difficult to convey concepts of risk effectively both balancing fear and stimulating action.

The AAP experts reviewed the English literature for data-based milestones, finding 34 articles, 10 of which had an opinion for at least one milestone. If this sounds like a very small number, you are correct. You may not realize that almost all screening and diagnostic tools have been based on data collected by Gesell in 1928!² While most of health care has changed since then, which milestones are measured in infants has not.

The biggest change from this review was deciding to use as milestones skills reported for 75% of children at each age of typical HSVs, adding ones for 15 and 30 months. The implication is that children not attaining these milestones are all at risk and deserving of more careful history, examination, and administration of a validated screening tool; not true when based on median data. Of the 94 existing CDC milestones retained after the review, one-third were moved to a different age with 21 of 31 assigned to an older age. Domains of functioning for the milestones were consolidated into social emotional, cognitive, language/communication, and motor, to help parents learn to distinguish these areas, and, although many milestones reflect several domains, each was included only once to reduce confusion.

Psychosocial assessment is recommended by the AAP and Bright Futures at every HSV but the fewest milestones with normative data were identified for this domain, often self-help rather than social engagement or emotion regulation skills. The cross-cultural study cited for many of the new milestones was reassuring overall in that the median ages for 67%-88% of milestones in most domains were equivalent across the four countries sampled, but only 22% of self-help skills were equivalent.³ This should remind us that parenting has more influence over psychosocial skills than other domains. Psychosocial and behavioral functioning, especially emotional regulation, also deserve “surveillance” as they have enormous impact on life outcomes but need to be measured and supported differently. Routine use of validated tools such as the Early Childhood Screening Assessment or the Ages & Stages Questionnaires: Social-Emotional for these domains are also needed.

Normal variations in temperament and patterns of attachment can affect many milestones including courage for walking, exploration, social engagement, and prosocial behaviors or self-control for social situations, attention, range of affect, and cooperation. All of these skills are among the 42 total (14 new) social-emotional milestones for 0- to 5-year-olds. Variations in these functions are at the root of the most common “challenging behaviors” in our studies in primary care. They are also the most vulnerable to suboptimal parent-child relationships, adverse childhood experiences, and social determinants of health.

As primary care providers, we not only need to detect children at risk for developmental problems but also promote and celebrate developmental progress. I hope that changing the threshold for concern to 75% will allow for a more positive review with the family (as fewer will be flagged as at risk) and chance to congratulate parents on all that is going well. But I also hope the change will not make us overlook parenting challenges, often from the psychosocial milestones most amenable to our guidance and support.

Early identification is mainly important to obtain the early intervention shown to improve outcomes. However, less than 25% of children with delays or disabilities receive early intervention before age 3 and most with emotional, behavioral, and developmental conditions, other than autism spectrum disorder, not before age 5. Since early intervention services are freely available in all states, we also need to do better at getting children to this care.

Let’s reconsider the process of developmental surveillance in this light of delayed referral: “Eliciting concerns” is key as parents have been shown to be usually correct in their worries. Listening to how they express the concerns can help you connect their specific issues when discussing reasons for referral. While most parent “recall of past milestones” is not accurate, current milestones reported are; thus, the need to have the new more accurate norms for all ages for comparison. When we make observations of a child’s abilities and behaviors ourselves we may not only pick up on issues missed by the parent, but will be more convincing in conveying the need for referral when indicated. When we “examine” the child we can use our professional skills to determine the very important risk factor of the quality of how a skill is performed, not just that it is. The recommended “use of validated screening tools” when the new milestones are not met give us an objective tool to share with parents, more confidence in when referral is warranted, which we will convey to parents (and perhaps skeptical relatives), and baseline documentation from which we can “track” referrals, progress, and, hopefully, better outcomes.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. Email her at [email protected].

References

1. Zubler JM et al. Pediatrics. 2022;149(3):e2021052138.

2. Gessell A et al. Macmillan: New York, 1928.

3. Ertem IO et al. Lancet Glob Health. 2018 Mar;6(3):e279-91.

The American Academy of Pediatrics, with funding from the Centers for Disease Control and Prevention, studied the CDC’s “Learn the Signs. Act Early” developmental surveillance milestones for children 0-5 years to update the milestones based on published studies. The goal was to improve this tool for developmental surveillance and use by the public. Developmental surveillance is not just observing a child at a check-up but rather “is a longitudinal process that involves eliciting concerns, taking a developmental history based on milestone attainment, observing milestones and other behaviors, examining the child, and applying clinical judgment during health supervision visits (HSVs).”¹

While the milestones we were trained on were a good start and highlighted the developmental progression central to pediatrics, they were not based on norms or cut scores indicating significant developmental risk unless taught from a validated tool. The CDC was concerned that their public handouts and apps were based on median ages (middle number of the entire range) of attainment not the mode (most common) or even average ages. That means that about half of all typically developing children would “not have attained” that skill at the age noted, potentially evoking unnecessary concern for parents and a “wait-and-see” message from a knowledgeable provider who realized the statistical meaning and the broad range of normal. Another potential problem with using milestones set at the median age is that parents, especially those with several children or experienced friends, may see the provider as an alarmist when they have seen great variation in children who later were normal. This reaction can dampen provider willingness to discuss development or even to screen with validated tools. We have learned the hard way from COVID-19 that it is difficult to convey concepts of risk effectively both balancing fear and stimulating action.

The AAP experts reviewed the English literature for data-based milestones, finding 34 articles, 10 of which had an opinion for at least one milestone. If this sounds like a very small number, you are correct. You may not realize that almost all screening and diagnostic tools have been based on data collected by Gesell in 1928!² While most of health care has changed since then, which milestones are measured in infants has not.

The biggest change from this review was deciding to use as milestones skills reported for 75% of children at each age of typical HSVs, adding ones for 15 and 30 months. The implication is that children not attaining these milestones are all at risk and deserving of more careful history, examination, and administration of a validated screening tool; not true when based on median data. Of the 94 existing CDC milestones retained after the review, one-third were moved to a different age with 21 of 31 assigned to an older age. Domains of functioning for the milestones were consolidated into social emotional, cognitive, language/communication, and motor, to help parents learn to distinguish these areas, and, although many milestones reflect several domains, each was included only once to reduce confusion.

Psychosocial assessment is recommended by the AAP and Bright Futures at every HSV but the fewest milestones with normative data were identified for this domain, often self-help rather than social engagement or emotion regulation skills. The cross-cultural study cited for many of the new milestones was reassuring overall in that the median ages for 67%-88% of milestones in most domains were equivalent across the four countries sampled, but only 22% of self-help skills were equivalent.³ This should remind us that parenting has more influence over psychosocial skills than other domains. Psychosocial and behavioral functioning, especially emotional regulation, also deserve “surveillance” as they have enormous impact on life outcomes but need to be measured and supported differently. Routine use of validated tools such as the Early Childhood Screening Assessment or the Ages & Stages Questionnaires: Social-Emotional for these domains are also needed.

Normal variations in temperament and patterns of attachment can affect many milestones including courage for walking, exploration, social engagement, and prosocial behaviors or self-control for social situations, attention, range of affect, and cooperation. All of these skills are among the 42 total (14 new) social-emotional milestones for 0- to 5-year-olds. Variations in these functions are at the root of the most common “challenging behaviors” in our studies in primary care. They are also the most vulnerable to suboptimal parent-child relationships, adverse childhood experiences, and social determinants of health.

As primary care providers, we not only need to detect children at risk for developmental problems but also promote and celebrate developmental progress. I hope that changing the threshold for concern to 75% will allow for a more positive review with the family (as fewer will be flagged as at risk) and chance to congratulate parents on all that is going well. But I also hope the change will not make us overlook parenting challenges, often from the psychosocial milestones most amenable to our guidance and support.

Early identification is mainly important to obtain the early intervention shown to improve outcomes. However, less than 25% of children with delays or disabilities receive early intervention before age 3 and most with emotional, behavioral, and developmental conditions, other than autism spectrum disorder, not before age 5. Since early intervention services are freely available in all states, we also need to do better at getting children to this care.

Let’s reconsider the process of developmental surveillance in this light of delayed referral: “Eliciting concerns” is key as parents have been shown to be usually correct in their worries. Listening to how they express the concerns can help you connect their specific issues when discussing reasons for referral. While most parent “recall of past milestones” is not accurate, current milestones reported are; thus, the need to have the new more accurate norms for all ages for comparison. When we make observations of a child’s abilities and behaviors ourselves we may not only pick up on issues missed by the parent, but will be more convincing in conveying the need for referral when indicated. When we “examine” the child we can use our professional skills to determine the very important risk factor of the quality of how a skill is performed, not just that it is. The recommended “use of validated screening tools” when the new milestones are not met give us an objective tool to share with parents, more confidence in when referral is warranted, which we will convey to parents (and perhaps skeptical relatives), and baseline documentation from which we can “track” referrals, progress, and, hopefully, better outcomes.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. Email her at [email protected].

References

1. Zubler JM et al. Pediatrics. 2022;149(3):e2021052138.

2. Gessell A et al. Macmillan: New York, 1928.

3. Ertem IO et al. Lancet Glob Health. 2018 Mar;6(3):e279-91.

The American Academy of Pediatrics, with funding from the Centers for Disease Control and Prevention, studied the CDC’s “Learn the Signs. Act Early” developmental surveillance milestones for children 0-5 years to update the milestones based on published studies. The goal was to improve this tool for developmental surveillance and use by the public. Developmental surveillance is not just observing a child at a check-up but rather “is a longitudinal process that involves eliciting concerns, taking a developmental history based on milestone attainment, observing milestones and other behaviors, examining the child, and applying clinical judgment during health supervision visits (HSVs).”¹

While the milestones we were trained on were a good start and highlighted the developmental progression central to pediatrics, they were not based on norms or cut scores indicating significant developmental risk unless taught from a validated tool. The CDC was concerned that their public handouts and apps were based on median ages (middle number of the entire range) of attainment not the mode (most common) or even average ages. That means that about half of all typically developing children would “not have attained” that skill at the age noted, potentially evoking unnecessary concern for parents and a “wait-and-see” message from a knowledgeable provider who realized the statistical meaning and the broad range of normal. Another potential problem with using milestones set at the median age is that parents, especially those with several children or experienced friends, may see the provider as an alarmist when they have seen great variation in children who later were normal. This reaction can dampen provider willingness to discuss development or even to screen with validated tools. We have learned the hard way from COVID-19 that it is difficult to convey concepts of risk effectively both balancing fear and stimulating action.

The AAP experts reviewed the English literature for data-based milestones, finding 34 articles, 10 of which had an opinion for at least one milestone. If this sounds like a very small number, you are correct. You may not realize that almost all screening and diagnostic tools have been based on data collected by Gesell in 1928!² While most of health care has changed since then, which milestones are measured in infants has not.

The biggest change from this review was deciding to use as milestones skills reported for 75% of children at each age of typical HSVs, adding ones for 15 and 30 months. The implication is that children not attaining these milestones are all at risk and deserving of more careful history, examination, and administration of a validated screening tool; not true when based on median data. Of the 94 existing CDC milestones retained after the review, one-third were moved to a different age with 21 of 31 assigned to an older age. Domains of functioning for the milestones were consolidated into social emotional, cognitive, language/communication, and motor, to help parents learn to distinguish these areas, and, although many milestones reflect several domains, each was included only once to reduce confusion.

Psychosocial assessment is recommended by the AAP and Bright Futures at every HSV but the fewest milestones with normative data were identified for this domain, often self-help rather than social engagement or emotion regulation skills. The cross-cultural study cited for many of the new milestones was reassuring overall in that the median ages for 67%-88% of milestones in most domains were equivalent across the four countries sampled, but only 22% of self-help skills were equivalent.³ This should remind us that parenting has more influence over psychosocial skills than other domains. Psychosocial and behavioral functioning, especially emotional regulation, also deserve “surveillance” as they have enormous impact on life outcomes but need to be measured and supported differently. Routine use of validated tools such as the Early Childhood Screening Assessment or the Ages & Stages Questionnaires: Social-Emotional for these domains are also needed.

Normal variations in temperament and patterns of attachment can affect many milestones including courage for walking, exploration, social engagement, and prosocial behaviors or self-control for social situations, attention, range of affect, and cooperation. All of these skills are among the 42 total (14 new) social-emotional milestones for 0- to 5-year-olds. Variations in these functions are at the root of the most common “challenging behaviors” in our studies in primary care. They are also the most vulnerable to suboptimal parent-child relationships, adverse childhood experiences, and social determinants of health.

As primary care providers, we not only need to detect children at risk for developmental problems but also promote and celebrate developmental progress. I hope that changing the threshold for concern to 75% will allow for a more positive review with the family (as fewer will be flagged as at risk) and chance to congratulate parents on all that is going well. But I also hope the change will not make us overlook parenting challenges, often from the psychosocial milestones most amenable to our guidance and support.

Early identification is mainly important to obtain the early intervention shown to improve outcomes. However, less than 25% of children with delays or disabilities receive early intervention before age 3 and most with emotional, behavioral, and developmental conditions, other than autism spectrum disorder, not before age 5. Since early intervention services are freely available in all states, we also need to do better at getting children to this care.

Let’s reconsider the process of developmental surveillance in this light of delayed referral: “Eliciting concerns” is key as parents have been shown to be usually correct in their worries. Listening to how they express the concerns can help you connect their specific issues when discussing reasons for referral. While most parent “recall of past milestones” is not accurate, current milestones reported are; thus, the need to have the new more accurate norms for all ages for comparison. When we make observations of a child’s abilities and behaviors ourselves we may not only pick up on issues missed by the parent, but will be more convincing in conveying the need for referral when indicated. When we “examine” the child we can use our professional skills to determine the very important risk factor of the quality of how a skill is performed, not just that it is. The recommended “use of validated screening tools” when the new milestones are not met give us an objective tool to share with parents, more confidence in when referral is warranted, which we will convey to parents (and perhaps skeptical relatives), and baseline documentation from which we can “track” referrals, progress, and, hopefully, better outcomes.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. Email her at [email protected].

References

1. Zubler JM et al. Pediatrics. 2022;149(3):e2021052138.

2. Gessell A et al. Macmillan: New York, 1928.

3. Ertem IO et al. Lancet Glob Health. 2018 Mar;6(3):e279-91.

An analysis at a large academic health system suggests that universal screening might help to reduce problematic disparities in depression treatment.  

The study began soon after the U.S. Preventive Services Task Force recommended depression screening for all adults in 2016. The task force based this recommendation on evidence that people who are screened and treated experience fewer debilitating symptoms.

In the new research, the investigators analyzed electronic health record data following a rollout of a universal depression screening program at the University of California, San Francisco. The researchers found that the overall rate of depression screening doubled at six primary care practices over a little more than 2 years, reaching nearly 90%. The investigators presented the data April 9 at the Society of General Internal Medicine 2022 Annual Meeting in Orlando.

Meanwhile, screening disparities diminished for men, older individuals, racial and ethnic minorities, and people with language barriers – all groups that are undertreated for depression.

“It shows that if a health system is really invested, it can achieve really high depression screening,” primary investigator Maria Garcia, MD, MPH, co-director of UCSF’s Multiethnic Health Equity Research Center, told this news organization.
 

Methods for identifying depression

The health system assigned medical assistants to administer annual screening using a validated tool, the Patient Health Questionnaire-2 (PHQ-2). A “yes” response to either of its two questions triggered a longer questionnaire, the PHQ-9, used to diagnose and guide treatment.

Screening forms were available in multiple languages. Medical assistants received training on the importance of identifying depression in undertreated groups, and a banner was inserted in the electronic health record to indicate a screening was due, Dr. Garcia said.

During the rollout, a committee was assigned to monitor screening rates and adjust strategies to target disparities.

Dr. Garcia and fellow researchers calculated the likelihood of a patient being screened starting in September 2017 – when a field for depression screening status was added to the system’s electronic health record – until the rollout was completed on Dec. 31, 2019.
 

Screening disparities narrowed for all groups studied

The screening rate for patients who had a primary care visit increased from 40.5% to 88.8%. Early on, patients with language barriers were less likely to be screened than English-speaking White individuals (odds ratios, 0.55-0.59). Men were less likely to be screened than women (OR, 0.82; 95% confidence interval, 0.78-0.86), and the likelihood of being screened decreased as people got older. By 2019, screening disparities had narrowed for all groups and were only statistically significant for men (OR, 0.87; 95% CI, 0.81-0.93).

Ian Kronish, MD, MPH, a general internist and associate professor of medicine at Columbia University, New York, called the increases “impressive,” adding that the data show universal depression screening is possible in a system that serves a diverse population.

Dr. Kronish, who was not involved in this study, noted that other research indicates screening does not result in a significant reduction in depressive symptoms in the overall population. He found this to be the case in a trial he led, which focused on patients with recent cardiac events, for example.

“Given all the effort that is going into depression screening and the inclusion of depression screening as a quality metric, we need definitive randomized clinical trials testing whether depression screening leads to increased treatment uptake and, importantly, improved depressive symptoms and quality of life,” he said.

Dr. Garcia acknowledged that more work needs to be done to address treatment barriers, such as language and lack of insurance, and assess whether greater recognition of depressive symptoms in underserved groups can lead to effective treatment. “But this is an important step to know that universal depression screening narrowed disparities in screening over time,” she added.

Dr. Garcia and Dr. Kronish have disclosed no relevant financial relationships.

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

An analysis at a large academic health system suggests that universal screening might help to reduce problematic disparities in depression treatment.  

The study began soon after the U.S. Preventive Services Task Force recommended depression screening for all adults in 2016. The task force based this recommendation on evidence that people who are screened and treated experience fewer debilitating symptoms.

In the new research, the investigators analyzed electronic health record data following a rollout of a universal depression screening program at the University of California, San Francisco. The researchers found that the overall rate of depression screening doubled at six primary care practices over a little more than 2 years, reaching nearly 90%. The investigators presented the data April 9 at the Society of General Internal Medicine 2022 Annual Meeting in Orlando.

Meanwhile, screening disparities diminished for men, older individuals, racial and ethnic minorities, and people with language barriers – all groups that are undertreated for depression.

“It shows that if a health system is really invested, it can achieve really high depression screening,” primary investigator Maria Garcia, MD, MPH, co-director of UCSF’s Multiethnic Health Equity Research Center, told this news organization.
 

Methods for identifying depression

The health system assigned medical assistants to administer annual screening using a validated tool, the Patient Health Questionnaire-2 (PHQ-2). A “yes” response to either of its two questions triggered a longer questionnaire, the PHQ-9, used to diagnose and guide treatment.

Screening forms were available in multiple languages. Medical assistants received training on the importance of identifying depression in undertreated groups, and a banner was inserted in the electronic health record to indicate a screening was due, Dr. Garcia said.

During the rollout, a committee was assigned to monitor screening rates and adjust strategies to target disparities.

Dr. Garcia and fellow researchers calculated the likelihood of a patient being screened starting in September 2017 – when a field for depression screening status was added to the system’s electronic health record – until the rollout was completed on Dec. 31, 2019.
 

Screening disparities narrowed for all groups studied

The screening rate for patients who had a primary care visit increased from 40.5% to 88.8%. Early on, patients with language barriers were less likely to be screened than English-speaking White individuals (odds ratios, 0.55-0.59). Men were less likely to be screened than women (OR, 0.82; 95% confidence interval, 0.78-0.86), and the likelihood of being screened decreased as people got older. By 2019, screening disparities had narrowed for all groups and were only statistically significant for men (OR, 0.87; 95% CI, 0.81-0.93).

Ian Kronish, MD, MPH, a general internist and associate professor of medicine at Columbia University, New York, called the increases “impressive,” adding that the data show universal depression screening is possible in a system that serves a diverse population.

Dr. Kronish, who was not involved in this study, noted that other research indicates screening does not result in a significant reduction in depressive symptoms in the overall population. He found this to be the case in a trial he led, which focused on patients with recent cardiac events, for example.

“Given all the effort that is going into depression screening and the inclusion of depression screening as a quality metric, we need definitive randomized clinical trials testing whether depression screening leads to increased treatment uptake and, importantly, improved depressive symptoms and quality of life,” he said.

Dr. Garcia acknowledged that more work needs to be done to address treatment barriers, such as language and lack of insurance, and assess whether greater recognition of depressive symptoms in underserved groups can lead to effective treatment. “But this is an important step to know that universal depression screening narrowed disparities in screening over time,” she added.

Dr. Garcia and Dr. Kronish have disclosed no relevant financial relationships.

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

An analysis at a large academic health system suggests that universal screening might help to reduce problematic disparities in depression treatment.  

The study began soon after the U.S. Preventive Services Task Force recommended depression screening for all adults in 2016. The task force based this recommendation on evidence that people who are screened and treated experience fewer debilitating symptoms.

In the new research, the investigators analyzed electronic health record data following a rollout of a universal depression screening program at the University of California, San Francisco. The researchers found that the overall rate of depression screening doubled at six primary care practices over a little more than 2 years, reaching nearly 90%. The investigators presented the data April 9 at the Society of General Internal Medicine 2022 Annual Meeting in Orlando.

Meanwhile, screening disparities diminished for men, older individuals, racial and ethnic minorities, and people with language barriers – all groups that are undertreated for depression.

“It shows that if a health system is really invested, it can achieve really high depression screening,” primary investigator Maria Garcia, MD, MPH, co-director of UCSF’s Multiethnic Health Equity Research Center, told this news organization.
 

Methods for identifying depression

The health system assigned medical assistants to administer annual screening using a validated tool, the Patient Health Questionnaire-2 (PHQ-2). A “yes” response to either of its two questions triggered a longer questionnaire, the PHQ-9, used to diagnose and guide treatment.

Screening forms were available in multiple languages. Medical assistants received training on the importance of identifying depression in undertreated groups, and a banner was inserted in the electronic health record to indicate a screening was due, Dr. Garcia said.

During the rollout, a committee was assigned to monitor screening rates and adjust strategies to target disparities.

Dr. Garcia and fellow researchers calculated the likelihood of a patient being screened starting in September 2017 – when a field for depression screening status was added to the system’s electronic health record – until the rollout was completed on Dec. 31, 2019.
 

Screening disparities narrowed for all groups studied

The screening rate for patients who had a primary care visit increased from 40.5% to 88.8%. Early on, patients with language barriers were less likely to be screened than English-speaking White individuals (odds ratios, 0.55-0.59). Men were less likely to be screened than women (OR, 0.82; 95% confidence interval, 0.78-0.86), and the likelihood of being screened decreased as people got older. By 2019, screening disparities had narrowed for all groups and were only statistically significant for men (OR, 0.87; 95% CI, 0.81-0.93).

Ian Kronish, MD, MPH, a general internist and associate professor of medicine at Columbia University, New York, called the increases “impressive,” adding that the data show universal depression screening is possible in a system that serves a diverse population.

Dr. Kronish, who was not involved in this study, noted that other research indicates screening does not result in a significant reduction in depressive symptoms in the overall population. He found this to be the case in a trial he led, which focused on patients with recent cardiac events, for example.

“Given all the effort that is going into depression screening and the inclusion of depression screening as a quality metric, we need definitive randomized clinical trials testing whether depression screening leads to increased treatment uptake and, importantly, improved depressive symptoms and quality of life,” he said.

Dr. Garcia acknowledged that more work needs to be done to address treatment barriers, such as language and lack of insurance, and assess whether greater recognition of depressive symptoms in underserved groups can lead to effective treatment. “But this is an important step to know that universal depression screening narrowed disparities in screening over time,” she added.

Dr. Garcia and Dr. Kronish have disclosed no relevant financial relationships.

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

The medical news is full of articles about the coming epidemic of dementia. How many people will have it in 10 years, 20 years, etc. It’s a very legitimate concern, and I am not going to make light of it, or disagree with the predictions.

In my everyday practice, though, I find there’s an epidemic of overdiagnosed dementia, in those who aren’t even close.

This occurs in a few ways:

Aricept is pretty inexpensive these days. Long off patent, insurance companies don’t bother to question its use anymore. So anyone older than 60 who complains of losing their car keys gets put on it. Why? Because patients want their doctors to DO SOMETHING. Even if the doctor knows that there’s really nothing of alarm going on, sometimes it’s easier to go with the placebo effect than argue. I think we’ve all done that before.

There are also a lot of nonneurologists in practice who still, after almost 30 years on the market, think Aricept improves memory, when in fact that’s far from the truth. The best it can claim to do is slow down the rate at which patients get worse, but nobody wants to hear that.

I’ve also seen Aricept used for pseudodementia due to depression. Actually, I’ve seen it used for depression, too. Sometimes it’s used to counteract the side effects dof drugs that can impair cognition, such as Topamax, even in patients who aren’t even remotely demented.

None of the above are a major issue on their own. Where the trouble really happens, as with so many other things, is when they collide with an EMR, or someone too rushed to take a history, or both.

Let’s say Mrs. Jones is on Aricept because she went into a room, then forgot why she did.

Then she gets admitted to the hospital for pneumonia. Or she changes doctors and, like many practices these days, her medications are put in the computer by an MA or secretary.

A lot of times just the mention of Aricept will automatically bring the assumption that the person is demented, so that gets punched in as a diagnosis and the patient is now believed to be unable to provide a reliable history. Or the person entering the info looks up its indication and enters “Alzheimer’s disease.”

Even worse is that I’ve seen EMRs where, in an effort to save time, the computer automatically enters diagnoses as you type medications in, and it’s up to the doctor to review them for accuracy. How that saves time I have no idea. But, as above, in these cases it’s going to lead to an entry of dementia where there isn’t any.

That, in particular, is pretty scary. As I wrote here in January of this year, what happens in the EMR stays in the EMR (kind of like Las Vegas).

I’m not knocking off-label use of medications. I don’t know a doctor who doesn’t use some that way, including myself.

But when doing so leads to the wrong assumptions and diagnoses it creates a lot of problems.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

The medical news is full of articles about the coming epidemic of dementia. How many people will have it in 10 years, 20 years, etc. It’s a very legitimate concern, and I am not going to make light of it, or disagree with the predictions.

In my everyday practice, though, I find there’s an epidemic of overdiagnosed dementia, in those who aren’t even close.

This occurs in a few ways:

Aricept is pretty inexpensive these days. Long off patent, insurance companies don’t bother to question its use anymore. So anyone older than 60 who complains of losing their car keys gets put on it. Why? Because patients want their doctors to DO SOMETHING. Even if the doctor knows that there’s really nothing of alarm going on, sometimes it’s easier to go with the placebo effect than argue. I think we’ve all done that before.

There are also a lot of nonneurologists in practice who still, after almost 30 years on the market, think Aricept improves memory, when in fact that’s far from the truth. The best it can claim to do is slow down the rate at which patients get worse, but nobody wants to hear that.

I’ve also seen Aricept used for pseudodementia due to depression. Actually, I’ve seen it used for depression, too. Sometimes it’s used to counteract the side effects dof drugs that can impair cognition, such as Topamax, even in patients who aren’t even remotely demented.

None of the above are a major issue on their own. Where the trouble really happens, as with so many other things, is when they collide with an EMR, or someone too rushed to take a history, or both.

Let’s say Mrs. Jones is on Aricept because she went into a room, then forgot why she did.

Then she gets admitted to the hospital for pneumonia. Or she changes doctors and, like many practices these days, her medications are put in the computer by an MA or secretary.

A lot of times just the mention of Aricept will automatically bring the assumption that the person is demented, so that gets punched in as a diagnosis and the patient is now believed to be unable to provide a reliable history. Or the person entering the info looks up its indication and enters “Alzheimer’s disease.”

Even worse is that I’ve seen EMRs where, in an effort to save time, the computer automatically enters diagnoses as you type medications in, and it’s up to the doctor to review them for accuracy. How that saves time I have no idea. But, as above, in these cases it’s going to lead to an entry of dementia where there isn’t any.

That, in particular, is pretty scary. As I wrote here in January of this year, what happens in the EMR stays in the EMR (kind of like Las Vegas).

I’m not knocking off-label use of medications. I don’t know a doctor who doesn’t use some that way, including myself.

But when doing so leads to the wrong assumptions and diagnoses it creates a lot of problems.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

The medical news is full of articles about the coming epidemic of dementia. How many people will have it in 10 years, 20 years, etc. It’s a very legitimate concern, and I am not going to make light of it, or disagree with the predictions.

In my everyday practice, though, I find there’s an epidemic of overdiagnosed dementia, in those who aren’t even close.

This occurs in a few ways:

Aricept is pretty inexpensive these days. Long off patent, insurance companies don’t bother to question its use anymore. So anyone older than 60 who complains of losing their car keys gets put on it. Why? Because patients want their doctors to DO SOMETHING. Even if the doctor knows that there’s really nothing of alarm going on, sometimes it’s easier to go with the placebo effect than argue. I think we’ve all done that before.

There are also a lot of nonneurologists in practice who still, after almost 30 years on the market, think Aricept improves memory, when in fact that’s far from the truth. The best it can claim to do is slow down the rate at which patients get worse, but nobody wants to hear that.

I’ve also seen Aricept used for pseudodementia due to depression. Actually, I’ve seen it used for depression, too. Sometimes it’s used to counteract the side effects dof drugs that can impair cognition, such as Topamax, even in patients who aren’t even remotely demented.

None of the above are a major issue on their own. Where the trouble really happens, as with so many other things, is when they collide with an EMR, or someone too rushed to take a history, or both.

Let’s say Mrs. Jones is on Aricept because she went into a room, then forgot why she did.

Then she gets admitted to the hospital for pneumonia. Or she changes doctors and, like many practices these days, her medications are put in the computer by an MA or secretary.

A lot of times just the mention of Aricept will automatically bring the assumption that the person is demented, so that gets punched in as a diagnosis and the patient is now believed to be unable to provide a reliable history. Or the person entering the info looks up its indication and enters “Alzheimer’s disease.”

Even worse is that I’ve seen EMRs where, in an effort to save time, the computer automatically enters diagnoses as you type medications in, and it’s up to the doctor to review them for accuracy. How that saves time I have no idea. But, as above, in these cases it’s going to lead to an entry of dementia where there isn’t any.

That, in particular, is pretty scary. As I wrote here in January of this year, what happens in the EMR stays in the EMR (kind of like Las Vegas).

I’m not knocking off-label use of medications. I don’t know a doctor who doesn’t use some that way, including myself.

But when doing so leads to the wrong assumptions and diagnoses it creates a lot of problems.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Radiofrequency renal denervation provided progressive reductions in blood pressure at 3 years in patients on antihypertensive medication, but this did not translate into fewer antihypertensive drugs, new results from the SPYRAL HTN-ON MED trial show.

At 36 months, 24-hour ambulatory systolic and diastolic blood pressures were 10.0 mm Hg (P = .003) and 5.9 mm Hg (P = .005) lower, respectively, in patients who underwent renal denervation with Medtronic’s Symplicity Spyral radiofrequency catheter, compared with patients treated with a sham procedure.

The number of antihypertensive drugs, however, increased in both groups from an average of two at baseline and 6 months to three at 3 years (P = .76).

Based on the number of drugs, class, and dose, medication burden increased significantly in the sham group at 12 months (6.5 vs. 4.9; P = .04) and trended higher at 3 years (10.3 vs. 7.6; P = .26).

The procedure appeared safe, with no renal safety events in the denervation group and only three safety events overall at 36 months. One cardiovascular death occurred 693 days after a sham procedure and one patient had a hypertensive crisis and stroke 427 days after renal denervation and was discharged in stable condition, according to results published in The Lancet.

“Given the long-term safety and efficacy of renal denervation, it may provide an alternative adjunctive treatment modality in the management of hypertension,” Felix Mahfoud, MD, Saarland University Hospital, Homburg, Germany, said during a presentation of the study at the recent American College of Cardiology (ACC) 2022 Scientific Session.

Ted Bosworth/MDedge News

Sham-controlled evidence

As previously reported, significant BP reductions at 6 months in SPYRAL HTN-ON provided proof of concept and helped revive enthusiasm for the procedure after failing to meet the primary endpoint in the SYMPLICITY HTN-3 trial. Results from the Global SYMPLICITY Registry have shown benefits out to 3 years, but sham-controlled data have been lacking.

The trial enrolled 80 patients with an office systolic BP of 150-180 mm Hg and diastolic of 90 mm Hg or greater and 24-hour ambulatory systolic BP of 140-170 mm Hg, who were on up to three antihypertensive medications.

Medication changes were allowed beginning at 6 months; patients and physicians were unblinded at 12 months. Between 24 and 36 months, 13 patients assigned to the sham procedure crossed over to denervation treatment. Medication adherence at 3 years was 77% in the denervation group versus 93% in the sham group.

At 3 years, the renal denervation group had significantly greater reductions from baseline in several ambulatory BP measures, compared with the sham group, including: 24-hour systolic (10.0 mm Hg), morning systolic (11.0 mm Hg), daytime systolic (8.9 mm Hg), and night-time systolic (11.8 mm Hg).

Renal denervation led to an 8.2 mm Hg greater fall in office systolic BP, but this failed to reach statistical significance (P = .07).

Almost twice as many patients in the denervation group achieved a 24-hour systolic BP less than 140 mm Hg than in the sham group (83.3%, vs. 43.8%; P = .002), Dr. Mahfoud reported.

“Although renal denervation appears to effectively lower blood pressure, participants in the renal denervation group did not quite reach guideline-recommended blood pressure thresholds,” Harini Sarathy, MD, University of California, San Francisco, and Liann Abu Salman, MD, Perelman School of Medicine, University of Pennsylvania, Philadelphia, point out in an accompanying editorial. “This result could have been due to a degree of physician inertia or differential prescribing of blood pressure medications for the intervention group, compared with the sham control group, wherein physicians might have considered renal denervation to be the fourth antihypertensive medication.”

The editorialists also note that nearly a third of the sham group (13 of 42) underwent renal denervation. “The differentially missing BP readings at 24 months for the sham group are a cause for concern, although the absence of any meaningful differences in results after imputation is somewhat reassuring.”

A 10 mm Hg reduction in BP after 36 months would be expected to translate to a significant reduction in cardiovascular outcomes, they say. The sustained reductions in several systolic readings also speak to the “always-on distinctiveness” that renal denervation proponents claim.

“In the stark absence of novel antihypertensive drug development, renal denervation is seemingly poised to be an effective supplement, if not an alternative, to complex antihypertensive regimens with frequent dosing schedules,” they conclude. “We look forward to results of the Expansion trial in providing more definitive answers regarding whether this translates to meaningful protection from target organ damage.”

Dr. Mahfoud observed that BP control worsened during the COVID-19 pandemic, which may have impacted BP results, but that in-person follow-up visits were still performed. Other limitations are a lack of information on patients’ exercise, diet, and smoking habits and that blood and urine testing assessed medication adherence at discrete time points, but adherence over an extended period of time is uncertain.

Dr. Mahfoud reports research grants from Deutsche Forschungsgemeinschaft and Deutsche Gesellschaft für Kardiologie and scientific support and speaker honoraria from Bayer, Boehringer Ingelheim, Medtronic, Merck, and ReCor Medical. The study was funded by Medtronic. Dr. Sarathy and Dr. Salman report no relevant financial relationships.

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

Radiofrequency renal denervation provided progressive reductions in blood pressure at 3 years in patients on antihypertensive medication, but this did not translate into fewer antihypertensive drugs, new results from the SPYRAL HTN-ON MED trial show.

At 36 months, 24-hour ambulatory systolic and diastolic blood pressures were 10.0 mm Hg (P = .003) and 5.9 mm Hg (P = .005) lower, respectively, in patients who underwent renal denervation with Medtronic’s Symplicity Spyral radiofrequency catheter, compared with patients treated with a sham procedure.

The number of antihypertensive drugs, however, increased in both groups from an average of two at baseline and 6 months to three at 3 years (P = .76).

Based on the number of drugs, class, and dose, medication burden increased significantly in the sham group at 12 months (6.5 vs. 4.9; P = .04) and trended higher at 3 years (10.3 vs. 7.6; P = .26).

The procedure appeared safe, with no renal safety events in the denervation group and only three safety events overall at 36 months. One cardiovascular death occurred 693 days after a sham procedure and one patient had a hypertensive crisis and stroke 427 days after renal denervation and was discharged in stable condition, according to results published in The Lancet.

“Given the long-term safety and efficacy of renal denervation, it may provide an alternative adjunctive treatment modality in the management of hypertension,” Felix Mahfoud, MD, Saarland University Hospital, Homburg, Germany, said during a presentation of the study at the recent American College of Cardiology (ACC) 2022 Scientific Session.

Ted Bosworth/MDedge News

Sham-controlled evidence

As previously reported, significant BP reductions at 6 months in SPYRAL HTN-ON provided proof of concept and helped revive enthusiasm for the procedure after failing to meet the primary endpoint in the SYMPLICITY HTN-3 trial. Results from the Global SYMPLICITY Registry have shown benefits out to 3 years, but sham-controlled data have been lacking.

The trial enrolled 80 patients with an office systolic BP of 150-180 mm Hg and diastolic of 90 mm Hg or greater and 24-hour ambulatory systolic BP of 140-170 mm Hg, who were on up to three antihypertensive medications.

Medication changes were allowed beginning at 6 months; patients and physicians were unblinded at 12 months. Between 24 and 36 months, 13 patients assigned to the sham procedure crossed over to denervation treatment. Medication adherence at 3 years was 77% in the denervation group versus 93% in the sham group.

At 3 years, the renal denervation group had significantly greater reductions from baseline in several ambulatory BP measures, compared with the sham group, including: 24-hour systolic (10.0 mm Hg), morning systolic (11.0 mm Hg), daytime systolic (8.9 mm Hg), and night-time systolic (11.8 mm Hg).

Renal denervation led to an 8.2 mm Hg greater fall in office systolic BP, but this failed to reach statistical significance (P = .07).

Almost twice as many patients in the denervation group achieved a 24-hour systolic BP less than 140 mm Hg than in the sham group (83.3%, vs. 43.8%; P = .002), Dr. Mahfoud reported.

“Although renal denervation appears to effectively lower blood pressure, participants in the renal denervation group did not quite reach guideline-recommended blood pressure thresholds,” Harini Sarathy, MD, University of California, San Francisco, and Liann Abu Salman, MD, Perelman School of Medicine, University of Pennsylvania, Philadelphia, point out in an accompanying editorial. “This result could have been due to a degree of physician inertia or differential prescribing of blood pressure medications for the intervention group, compared with the sham control group, wherein physicians might have considered renal denervation to be the fourth antihypertensive medication.”

The editorialists also note that nearly a third of the sham group (13 of 42) underwent renal denervation. “The differentially missing BP readings at 24 months for the sham group are a cause for concern, although the absence of any meaningful differences in results after imputation is somewhat reassuring.”

A 10 mm Hg reduction in BP after 36 months would be expected to translate to a significant reduction in cardiovascular outcomes, they say. The sustained reductions in several systolic readings also speak to the “always-on distinctiveness” that renal denervation proponents claim.

“In the stark absence of novel antihypertensive drug development, renal denervation is seemingly poised to be an effective supplement, if not an alternative, to complex antihypertensive regimens with frequent dosing schedules,” they conclude. “We look forward to results of the Expansion trial in providing more definitive answers regarding whether this translates to meaningful protection from target organ damage.”

Dr. Mahfoud observed that BP control worsened during the COVID-19 pandemic, which may have impacted BP results, but that in-person follow-up visits were still performed. Other limitations are a lack of information on patients’ exercise, diet, and smoking habits and that blood and urine testing assessed medication adherence at discrete time points, but adherence over an extended period of time is uncertain.

Dr. Mahfoud reports research grants from Deutsche Forschungsgemeinschaft and Deutsche Gesellschaft für Kardiologie and scientific support and speaker honoraria from Bayer, Boehringer Ingelheim, Medtronic, Merck, and ReCor Medical. The study was funded by Medtronic. Dr. Sarathy and Dr. Salman report no relevant financial relationships.

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

Radiofrequency renal denervation provided progressive reductions in blood pressure at 3 years in patients on antihypertensive medication, but this did not translate into fewer antihypertensive drugs, new results from the SPYRAL HTN-ON MED trial show.

At 36 months, 24-hour ambulatory systolic and diastolic blood pressures were 10.0 mm Hg (P = .003) and 5.9 mm Hg (P = .005) lower, respectively, in patients who underwent renal denervation with Medtronic’s Symplicity Spyral radiofrequency catheter, compared with patients treated with a sham procedure.

The number of antihypertensive drugs, however, increased in both groups from an average of two at baseline and 6 months to three at 3 years (P = .76).

Based on the number of drugs, class, and dose, medication burden increased significantly in the sham group at 12 months (6.5 vs. 4.9; P = .04) and trended higher at 3 years (10.3 vs. 7.6; P = .26).

The procedure appeared safe, with no renal safety events in the denervation group and only three safety events overall at 36 months. One cardiovascular death occurred 693 days after a sham procedure and one patient had a hypertensive crisis and stroke 427 days after renal denervation and was discharged in stable condition, according to results published in The Lancet.

“Given the long-term safety and efficacy of renal denervation, it may provide an alternative adjunctive treatment modality in the management of hypertension,” Felix Mahfoud, MD, Saarland University Hospital, Homburg, Germany, said during a presentation of the study at the recent American College of Cardiology (ACC) 2022 Scientific Session.

Ted Bosworth/MDedge News

Sham-controlled evidence

As previously reported, significant BP reductions at 6 months in SPYRAL HTN-ON provided proof of concept and helped revive enthusiasm for the procedure after failing to meet the primary endpoint in the SYMPLICITY HTN-3 trial. Results from the Global SYMPLICITY Registry have shown benefits out to 3 years, but sham-controlled data have been lacking.

The trial enrolled 80 patients with an office systolic BP of 150-180 mm Hg and diastolic of 90 mm Hg or greater and 24-hour ambulatory systolic BP of 140-170 mm Hg, who were on up to three antihypertensive medications.

Medication changes were allowed beginning at 6 months; patients and physicians were unblinded at 12 months. Between 24 and 36 months, 13 patients assigned to the sham procedure crossed over to denervation treatment. Medication adherence at 3 years was 77% in the denervation group versus 93% in the sham group.

At 3 years, the renal denervation group had significantly greater reductions from baseline in several ambulatory BP measures, compared with the sham group, including: 24-hour systolic (10.0 mm Hg), morning systolic (11.0 mm Hg), daytime systolic (8.9 mm Hg), and night-time systolic (11.8 mm Hg).

Renal denervation led to an 8.2 mm Hg greater fall in office systolic BP, but this failed to reach statistical significance (P = .07).

Almost twice as many patients in the denervation group achieved a 24-hour systolic BP less than 140 mm Hg than in the sham group (83.3%, vs. 43.8%; P = .002), Dr. Mahfoud reported.

“Although renal denervation appears to effectively lower blood pressure, participants in the renal denervation group did not quite reach guideline-recommended blood pressure thresholds,” Harini Sarathy, MD, University of California, San Francisco, and Liann Abu Salman, MD, Perelman School of Medicine, University of Pennsylvania, Philadelphia, point out in an accompanying editorial. “This result could have been due to a degree of physician inertia or differential prescribing of blood pressure medications for the intervention group, compared with the sham control group, wherein physicians might have considered renal denervation to be the fourth antihypertensive medication.”

The editorialists also note that nearly a third of the sham group (13 of 42) underwent renal denervation. “The differentially missing BP readings at 24 months for the sham group are a cause for concern, although the absence of any meaningful differences in results after imputation is somewhat reassuring.”

A 10 mm Hg reduction in BP after 36 months would be expected to translate to a significant reduction in cardiovascular outcomes, they say. The sustained reductions in several systolic readings also speak to the “always-on distinctiveness” that renal denervation proponents claim.

“In the stark absence of novel antihypertensive drug development, renal denervation is seemingly poised to be an effective supplement, if not an alternative, to complex antihypertensive regimens with frequent dosing schedules,” they conclude. “We look forward to results of the Expansion trial in providing more definitive answers regarding whether this translates to meaningful protection from target organ damage.”

Dr. Mahfoud observed that BP control worsened during the COVID-19 pandemic, which may have impacted BP results, but that in-person follow-up visits were still performed. Other limitations are a lack of information on patients’ exercise, diet, and smoking habits and that blood and urine testing assessed medication adherence at discrete time points, but adherence over an extended period of time is uncertain.

Dr. Mahfoud reports research grants from Deutsche Forschungsgemeinschaft and Deutsche Gesellschaft für Kardiologie and scientific support and speaker honoraria from Bayer, Boehringer Ingelheim, Medtronic, Merck, and ReCor Medical. The study was funded by Medtronic. Dr. Sarathy and Dr. Salman report no relevant financial relationships.

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

None of us like being wrong, especially about a patient’s diagnosis. To help you avoid diagnostic errors for 4 difficult diagnoses, read and study the article in this issue of JFP by Rosen and colleagues.¹ They discuss misdiagnosis of polymyalgia rheumatica, fibromyalgia, ovarian cancer, and Lewy body dementia to illustrate how we can go astray if we do not take care to pause and think through things carefully. They point out that, for quick and mostly accurate diagnoses, pattern recognition or type 1 thinking serves us well in a busy office practice. However, we must frequently pause and reflect, using type 2 thinking—especially when the puzzle pieces don’t quite fit together.

I still recall vividly a diagnostic error I made many years ago. One of my patients, whom I had diagnosed and was treating for hyperlipidemia, returned for follow-up while I was on vacation. My partner conducted the follow-up visit. To my chagrin, he noticed her puffy face and weight gain and ordered thyroid studies. Sure enough, my patient was severely hypothyroid, and her lipid levels normalized with thyroid replacement therapy.

I recall vividly a diagnostic error I made years ago. I was treating a patient for hyperlipidemia but my partner recognized it as a case of severe hypothyroid.

A happier tale for me was making the correct diagnosis for a woman with chronic cough. She had been evaluated by multiple specialists during the prior year and treated with a nasal steroid for allergies, a proton pump inhibitor for reflux, and a steroid inhaler for possible asthma. None of these relieved her cough. After reviewing her medication list and noting that it included amitriptyline, which has anticholinergic adverse effects, I recommended she stop taking that medication and the cough resolved.

John Ely, MD, MPH, a family physician who has spent his academic career investigating causes of and solutions to diagnostic errors, has outlined important steps we can take. These include: (1) obtaining your own complete medical history, (2) performing a “focused and purposeful” physical exam, (3) generating initial hypotheses and differentiating them through additional history taking, exams, and diagnostic tests, (4) pausing to reflect [my emphasis], and (5) embarking on a plan (while acknowledging uncertainty) and ensuring there is a pathway for follow-up.²

To help avoid diagnostic errors, Dr. Ely developed and uses a set of checklists that cover the differential diagnosis for 72 presenting complaints/conditions, including syncope, back pain, insomnia, and headache.² When you are faced with diagnostic uncertainty, it takes just a few minutes to run through the checklist for the patient’s presenting complaint.

None of us like being wrong, especially about a patient’s diagnosis. To help you avoid diagnostic errors for 4 difficult diagnoses, read and study the article in this issue of JFP by Rosen and colleagues.¹ They discuss misdiagnosis of polymyalgia rheumatica, fibromyalgia, ovarian cancer, and Lewy body dementia to illustrate how we can go astray if we do not take care to pause and think through things carefully. They point out that, for quick and mostly accurate diagnoses, pattern recognition or type 1 thinking serves us well in a busy office practice. However, we must frequently pause and reflect, using type 2 thinking—especially when the puzzle pieces don’t quite fit together.

I still recall vividly a diagnostic error I made many years ago. One of my patients, whom I had diagnosed and was treating for hyperlipidemia, returned for follow-up while I was on vacation. My partner conducted the follow-up visit. To my chagrin, he noticed her puffy face and weight gain and ordered thyroid studies. Sure enough, my patient was severely hypothyroid, and her lipid levels normalized with thyroid replacement therapy.

I recall vividly a diagnostic error I made years ago. I was treating a patient for hyperlipidemia but my partner recognized it as a case of severe hypothyroid.

A happier tale for me was making the correct diagnosis for a woman with chronic cough. She had been evaluated by multiple specialists during the prior year and treated with a nasal steroid for allergies, a proton pump inhibitor for reflux, and a steroid inhaler for possible asthma. None of these relieved her cough. After reviewing her medication list and noting that it included amitriptyline, which has anticholinergic adverse effects, I recommended she stop taking that medication and the cough resolved.

John Ely, MD, MPH, a family physician who has spent his academic career investigating causes of and solutions to diagnostic errors, has outlined important steps we can take. These include: (1) obtaining your own complete medical history, (2) performing a “focused and purposeful” physical exam, (3) generating initial hypotheses and differentiating them through additional history taking, exams, and diagnostic tests, (4) pausing to reflect [my emphasis], and (5) embarking on a plan (while acknowledging uncertainty) and ensuring there is a pathway for follow-up.²

To help avoid diagnostic errors, Dr. Ely developed and uses a set of checklists that cover the differential diagnosis for 72 presenting complaints/conditions, including syncope, back pain, insomnia, and headache.² When you are faced with diagnostic uncertainty, it takes just a few minutes to run through the checklist for the patient’s presenting complaint.

None of us like being wrong, especially about a patient’s diagnosis. To help you avoid diagnostic errors for 4 difficult diagnoses, read and study the article in this issue of JFP by Rosen and colleagues.¹ They discuss misdiagnosis of polymyalgia rheumatica, fibromyalgia, ovarian cancer, and Lewy body dementia to illustrate how we can go astray if we do not take care to pause and think through things carefully. They point out that, for quick and mostly accurate diagnoses, pattern recognition or type 1 thinking serves us well in a busy office practice. However, we must frequently pause and reflect, using type 2 thinking—especially when the puzzle pieces don’t quite fit together.

I still recall vividly a diagnostic error I made many years ago. One of my patients, whom I had diagnosed and was treating for hyperlipidemia, returned for follow-up while I was on vacation. My partner conducted the follow-up visit. To my chagrin, he noticed her puffy face and weight gain and ordered thyroid studies. Sure enough, my patient was severely hypothyroid, and her lipid levels normalized with thyroid replacement therapy.

I recall vividly a diagnostic error I made years ago. I was treating a patient for hyperlipidemia but my partner recognized it as a case of severe hypothyroid.

A happier tale for me was making the correct diagnosis for a woman with chronic cough. She had been evaluated by multiple specialists during the prior year and treated with a nasal steroid for allergies, a proton pump inhibitor for reflux, and a steroid inhaler for possible asthma. None of these relieved her cough. After reviewing her medication list and noting that it included amitriptyline, which has anticholinergic adverse effects, I recommended she stop taking that medication and the cough resolved.

John Ely, MD, MPH, a family physician who has spent his academic career investigating causes of and solutions to diagnostic errors, has outlined important steps we can take. These include: (1) obtaining your own complete medical history, (2) performing a “focused and purposeful” physical exam, (3) generating initial hypotheses and differentiating them through additional history taking, exams, and diagnostic tests, (4) pausing to reflect [my emphasis], and (5) embarking on a plan (while acknowledging uncertainty) and ensuring there is a pathway for follow-up.²

To help avoid diagnostic errors, Dr. Ely developed and uses a set of checklists that cover the differential diagnosis for 72 presenting complaints/conditions, including syncope, back pain, insomnia, and headache.² When you are faced with diagnostic uncertainty, it takes just a few minutes to run through the checklist for the patient’s presenting complaint.

THE CASE 

An active 61-year-old woman (140 lbs) in good health became ill during a sailing holiday in the Virgin Islands. During the trip, she ate various fish in local restaurants; after one lunch, she developed nausea, diarrhea, dizziness, headache, and light-headedness. In the following days, she suffered “intense itching” in the ears, dizziness, malaise, a “fluttering feeling” throughout her body, genitourinary sensitivity, and a “rhythmic buzzing sensation near the rectum.”

She said that cold objects and beverages felt uncomfortably hot (cold allodynia). She noted heightened senses of smell and taste, as well as paresthesia down her spine, and described feeling “moody.” She reduced her workload, took many days off from work, and ceased consuming meat and alcohol because these items seemed to aggravate her symptoms.

The paresthesia persisted, and she consulted her family physician one month later. Laboratory tests—including a complete blood count, hematocrit, thyroid-stimulating hormone, antinuclear antibodies, and titers for Ehrlichia chaffeensis, Lyme disease, and Anaplasma phagocytophila—all yielded normal results. Her symptoms continued for 3 more months before referral to Medical Toxicology.

THE DIAGNOSIS

The patient’s symptoms and history were consistent with ciguatera poisoning. Features supporting this diagnosis included an acute gastrointestinal illness after eating fish caught in tropical waters and subsequent persistent paresthesia, including cold allodynia.¹ Laboratory testing excluded acute infection, anemia, thyroid dysfunction, vitamin B12 deficiency, lupus, rheumatoid arthritis, Lyme disease, ehrlichiosis, and anaplasmosis.

DISCUSSION

Ciguatera results from ciguatoxin, a class of heat-stable polycyclic toxins produced in warm tropical waters by microscopic dinoflagellates (most often Gambierdiscus toxicus).^2,3 Small variations exist in the Caribbean, Pacific, and Indian Ocean forms. Ciguatoxin bio-­accumulates in the food chain, and humans most often ingest it by eating larger fish (typically barracuda, snapper, grouper, or amberjack).⁴ Because ciguatoxin confers no characteristic taste or smell to the fish, people who prepare or eat contaminated seafood have no reliable means to detect and avoid it.

Ciguatoxin opens neuronal voltage-gated sodium channels and blocks delayed-­rectifier potassium channels.⁵ These cause repetitive, spontaneous action potentials that explain the paresthesia. Sodium influx triggers an increase in intracellular calcium concentrations. Increased intracellular sodium and calcium concentrations draw water into the intracellular space and cause neuronal edema.

Death is rarely associated with ciguatera (< 0.1% in the largest observational study).¹ Even without treatment (discussed shortly), symptoms of ciguatera will gradually resolve over several weeks to several months in most cases.^1,4,5 However, after recovery, patients often briefly experience milder symptoms after consuming fish, alcohol, or nuts.⁶

Continue to: Treatment of ciguatera

Treatment of ciguatera may include intravenous (IV) mannitol infusion. Other treatments, such as amitriptyline, gabapentin, pregabalin, and tocainide, have been used, but there is limited supporting evidence and they appear variably effective.⁷

Mannitol reverses the effects of ciguatoxin, with suppression of spontaneous action potentials and reversal of neuronal edema.^8,9 It is reasonable to offer mannitol for acute or persistent symptoms of ciguatera fish poisoning even after a delay of several weeks.

Ciguatoxin confers no characteristic taste or smell to the fish. Thus, people who prepare or eat contaminated seafood have no reliable means to detect and avoid it.

A recent systematic review found that mannitol has the largest body of evidence supporting its use, although that evidence is generally of low quality (case reports and large case series).⁷ While these reports^10-13 describe beneficial effects of mannitol, a single randomized trial suggested that mannitol is no more effective than normal saline.¹⁴ However, this study was underpowered and had inadequate treatment concealment; twice as many saline control patients as mannitol-treated patients requested a rescue dose of mannitol.¹⁴

Mannitol may be most effective when given early in the course of ciguatera but has shown some success when given later.^5,12,13 In 1 large case series, the longest interval from symptom onset to successful treatment was 70 days, although most patients with satisfactory results received mannitol in the first few days.⁵

Our patient was administered an IV infusion of 100 g of 20% mannitol over 1 hour. She received the infusion 140 days after the onset of her symptoms and experienced rapid symptom relief.

Continue to: At a follow-up visit...

At a follow-up visit 2 weeks later, she described increased energy and further improvement in her paresthesia. She returned to a full work schedule and resumed all of her daily activities. However, she continued to avoid alcohol and proteins, as she had experienced a mild recurrence that she temporally related to eating meat and drinking alcohol.

At the 2-month follow-up, the patient reported continued improvement in her paresthesia but continued to experience occasional gastrointestinal symptoms and fatigue associated with meat and alcohol consumption.

The Takeaway 

Ciguatera fish poisoning is largely a clinical diagnosis. It is based on early gastrointestinal symptoms followed by persistent paresthesia and cold allodynia after consumption of fish caught in tropical waters. Family physicians may see ciguatera in returning travelers or people who have consumed certain fish imported from endemic areas. Untreated symptoms may last for many weeks or months. IV mannitol may relieve symptoms of ciguatera poisoning even when administered several months after symptom onset.

Acknowledgement
We are grateful to our patient, who allowed us to share her story in the hope of helping other travelers.

CORRESPONDENCE
Michael E. Mullins, MD, Division of Medical Toxicology, Department of Emergency Medicine, Washington University School of Medicine, Campus Box 8072, 660 South Euclid Avenue, Saint Louis, MO 63110; [email protected]

THE CASE 

An active 61-year-old woman (140 lbs) in good health became ill during a sailing holiday in the Virgin Islands. During the trip, she ate various fish in local restaurants; after one lunch, she developed nausea, diarrhea, dizziness, headache, and light-headedness. In the following days, she suffered “intense itching” in the ears, dizziness, malaise, a “fluttering feeling” throughout her body, genitourinary sensitivity, and a “rhythmic buzzing sensation near the rectum.”

She said that cold objects and beverages felt uncomfortably hot (cold allodynia). She noted heightened senses of smell and taste, as well as paresthesia down her spine, and described feeling “moody.” She reduced her workload, took many days off from work, and ceased consuming meat and alcohol because these items seemed to aggravate her symptoms.

The paresthesia persisted, and she consulted her family physician one month later. Laboratory tests—including a complete blood count, hematocrit, thyroid-stimulating hormone, antinuclear antibodies, and titers for Ehrlichia chaffeensis, Lyme disease, and Anaplasma phagocytophila—all yielded normal results. Her symptoms continued for 3 more months before referral to Medical Toxicology.

THE DIAGNOSIS

The patient’s symptoms and history were consistent with ciguatera poisoning. Features supporting this diagnosis included an acute gastrointestinal illness after eating fish caught in tropical waters and subsequent persistent paresthesia, including cold allodynia.¹ Laboratory testing excluded acute infection, anemia, thyroid dysfunction, vitamin B12 deficiency, lupus, rheumatoid arthritis, Lyme disease, ehrlichiosis, and anaplasmosis.

DISCUSSION

Ciguatera results from ciguatoxin, a class of heat-stable polycyclic toxins produced in warm tropical waters by microscopic dinoflagellates (most often Gambierdiscus toxicus).^2,3 Small variations exist in the Caribbean, Pacific, and Indian Ocean forms. Ciguatoxin bio-­accumulates in the food chain, and humans most often ingest it by eating larger fish (typically barracuda, snapper, grouper, or amberjack).⁴ Because ciguatoxin confers no characteristic taste or smell to the fish, people who prepare or eat contaminated seafood have no reliable means to detect and avoid it.

Ciguatoxin opens neuronal voltage-gated sodium channels and blocks delayed-­rectifier potassium channels.⁵ These cause repetitive, spontaneous action potentials that explain the paresthesia. Sodium influx triggers an increase in intracellular calcium concentrations. Increased intracellular sodium and calcium concentrations draw water into the intracellular space and cause neuronal edema.

Death is rarely associated with ciguatera (< 0.1% in the largest observational study).¹ Even without treatment (discussed shortly), symptoms of ciguatera will gradually resolve over several weeks to several months in most cases.^1,4,5 However, after recovery, patients often briefly experience milder symptoms after consuming fish, alcohol, or nuts.⁶

Continue to: Treatment of ciguatera

Treatment of ciguatera may include intravenous (IV) mannitol infusion. Other treatments, such as amitriptyline, gabapentin, pregabalin, and tocainide, have been used, but there is limited supporting evidence and they appear variably effective.⁷

Mannitol reverses the effects of ciguatoxin, with suppression of spontaneous action potentials and reversal of neuronal edema.^8,9 It is reasonable to offer mannitol for acute or persistent symptoms of ciguatera fish poisoning even after a delay of several weeks.

Ciguatoxin confers no characteristic taste or smell to the fish. Thus, people who prepare or eat contaminated seafood have no reliable means to detect and avoid it.

A recent systematic review found that mannitol has the largest body of evidence supporting its use, although that evidence is generally of low quality (case reports and large case series).⁷ While these reports^10-13 describe beneficial effects of mannitol, a single randomized trial suggested that mannitol is no more effective than normal saline.¹⁴ However, this study was underpowered and had inadequate treatment concealment; twice as many saline control patients as mannitol-treated patients requested a rescue dose of mannitol.¹⁴

Mannitol may be most effective when given early in the course of ciguatera but has shown some success when given later.^5,12,13 In 1 large case series, the longest interval from symptom onset to successful treatment was 70 days, although most patients with satisfactory results received mannitol in the first few days.⁵

Our patient was administered an IV infusion of 100 g of 20% mannitol over 1 hour. She received the infusion 140 days after the onset of her symptoms and experienced rapid symptom relief.

Continue to: At a follow-up visit...

At a follow-up visit 2 weeks later, she described increased energy and further improvement in her paresthesia. She returned to a full work schedule and resumed all of her daily activities. However, she continued to avoid alcohol and proteins, as she had experienced a mild recurrence that she temporally related to eating meat and drinking alcohol.

At the 2-month follow-up, the patient reported continued improvement in her paresthesia but continued to experience occasional gastrointestinal symptoms and fatigue associated with meat and alcohol consumption.

The Takeaway 

Ciguatera fish poisoning is largely a clinical diagnosis. It is based on early gastrointestinal symptoms followed by persistent paresthesia and cold allodynia after consumption of fish caught in tropical waters. Family physicians may see ciguatera in returning travelers or people who have consumed certain fish imported from endemic areas. Untreated symptoms may last for many weeks or months. IV mannitol may relieve symptoms of ciguatera poisoning even when administered several months after symptom onset.

Acknowledgement
We are grateful to our patient, who allowed us to share her story in the hope of helping other travelers.

CORRESPONDENCE
Michael E. Mullins, MD, Division of Medical Toxicology, Department of Emergency Medicine, Washington University School of Medicine, Campus Box 8072, 660 South Euclid Avenue, Saint Louis, MO 63110; [email protected]

THE CASE 

An active 61-year-old woman (140 lbs) in good health became ill during a sailing holiday in the Virgin Islands. During the trip, she ate various fish in local restaurants; after one lunch, she developed nausea, diarrhea, dizziness, headache, and light-headedness. In the following days, she suffered “intense itching” in the ears, dizziness, malaise, a “fluttering feeling” throughout her body, genitourinary sensitivity, and a “rhythmic buzzing sensation near the rectum.”

She said that cold objects and beverages felt uncomfortably hot (cold allodynia). She noted heightened senses of smell and taste, as well as paresthesia down her spine, and described feeling “moody.” She reduced her workload, took many days off from work, and ceased consuming meat and alcohol because these items seemed to aggravate her symptoms.

The paresthesia persisted, and she consulted her family physician one month later. Laboratory tests—including a complete blood count, hematocrit, thyroid-stimulating hormone, antinuclear antibodies, and titers for Ehrlichia chaffeensis, Lyme disease, and Anaplasma phagocytophila—all yielded normal results. Her symptoms continued for 3 more months before referral to Medical Toxicology.

THE DIAGNOSIS

The patient’s symptoms and history were consistent with ciguatera poisoning. Features supporting this diagnosis included an acute gastrointestinal illness after eating fish caught in tropical waters and subsequent persistent paresthesia, including cold allodynia.¹ Laboratory testing excluded acute infection, anemia, thyroid dysfunction, vitamin B12 deficiency, lupus, rheumatoid arthritis, Lyme disease, ehrlichiosis, and anaplasmosis.

DISCUSSION

Ciguatera results from ciguatoxin, a class of heat-stable polycyclic toxins produced in warm tropical waters by microscopic dinoflagellates (most often Gambierdiscus toxicus).^2,3 Small variations exist in the Caribbean, Pacific, and Indian Ocean forms. Ciguatoxin bio-­accumulates in the food chain, and humans most often ingest it by eating larger fish (typically barracuda, snapper, grouper, or amberjack).⁴ Because ciguatoxin confers no characteristic taste or smell to the fish, people who prepare or eat contaminated seafood have no reliable means to detect and avoid it.

Ciguatoxin opens neuronal voltage-gated sodium channels and blocks delayed-­rectifier potassium channels.⁵ These cause repetitive, spontaneous action potentials that explain the paresthesia. Sodium influx triggers an increase in intracellular calcium concentrations. Increased intracellular sodium and calcium concentrations draw water into the intracellular space and cause neuronal edema.

Death is rarely associated with ciguatera (< 0.1% in the largest observational study).¹ Even without treatment (discussed shortly), symptoms of ciguatera will gradually resolve over several weeks to several months in most cases.^1,4,5 However, after recovery, patients often briefly experience milder symptoms after consuming fish, alcohol, or nuts.⁶

Continue to: Treatment of ciguatera

Treatment of ciguatera may include intravenous (IV) mannitol infusion. Other treatments, such as amitriptyline, gabapentin, pregabalin, and tocainide, have been used, but there is limited supporting evidence and they appear variably effective.⁷

Mannitol reverses the effects of ciguatoxin, with suppression of spontaneous action potentials and reversal of neuronal edema.^8,9 It is reasonable to offer mannitol for acute or persistent symptoms of ciguatera fish poisoning even after a delay of several weeks.

Ciguatoxin confers no characteristic taste or smell to the fish. Thus, people who prepare or eat contaminated seafood have no reliable means to detect and avoid it.

A recent systematic review found that mannitol has the largest body of evidence supporting its use, although that evidence is generally of low quality (case reports and large case series).⁷ While these reports^10-13 describe beneficial effects of mannitol, a single randomized trial suggested that mannitol is no more effective than normal saline.¹⁴ However, this study was underpowered and had inadequate treatment concealment; twice as many saline control patients as mannitol-treated patients requested a rescue dose of mannitol.¹⁴

Mannitol may be most effective when given early in the course of ciguatera but has shown some success when given later.^5,12,13 In 1 large case series, the longest interval from symptom onset to successful treatment was 70 days, although most patients with satisfactory results received mannitol in the first few days.⁵

Our patient was administered an IV infusion of 100 g of 20% mannitol over 1 hour. She received the infusion 140 days after the onset of her symptoms and experienced rapid symptom relief.

Continue to: At a follow-up visit...

At a follow-up visit 2 weeks later, she described increased energy and further improvement in her paresthesia. She returned to a full work schedule and resumed all of her daily activities. However, she continued to avoid alcohol and proteins, as she had experienced a mild recurrence that she temporally related to eating meat and drinking alcohol.

At the 2-month follow-up, the patient reported continued improvement in her paresthesia but continued to experience occasional gastrointestinal symptoms and fatigue associated with meat and alcohol consumption.

The Takeaway 

Ciguatera fish poisoning is largely a clinical diagnosis. It is based on early gastrointestinal symptoms followed by persistent paresthesia and cold allodynia after consumption of fish caught in tropical waters. Family physicians may see ciguatera in returning travelers or people who have consumed certain fish imported from endemic areas. Untreated symptoms may last for many weeks or months. IV mannitol may relieve symptoms of ciguatera poisoning even when administered several months after symptom onset.

Acknowledgement
We are grateful to our patient, who allowed us to share her story in the hope of helping other travelers.

CORRESPONDENCE
Michael E. Mullins, MD, Division of Medical Toxicology, Department of Emergency Medicine, Washington University School of Medicine, Campus Box 8072, 660 South Euclid Avenue, Saint Louis, MO 63110; [email protected]

A healthy woman in her 60s presented to the clinic with a 1-month history of red, itchy, and slightly painful nodules on the scalp and back. The patient had travelled to Belize for a vacation in the weeks prior to the onset of the lesions. She was initially given a course of cephalexin for presumed furunculosis at another clinic, without improvement.

Examination revealed inflamed nodules with a central open pore on the left upper back (FIGURE 1) and the occipital scalp. Notably, when the lesions were observed with a dermatoscope, intermittent air bubbles were seen through the skin opening.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

Given the patient’s clinical presentation and travel history, furuncular myiasis infestation was suspected and confirmed by punch biopsy. Pathologic exam revealed botfly larvae in both wounds, consistent with the human botfly, Dermatobia hominis (FIGURE 2). Myiasis is not common in the United States but should be suspected in patients who have recently traveled to tropical or subtropical areas. Furuncular myiasis describes the condition in which fly larvae penetrate healthy skin in a localized fashion, leading to the development of a ­furuncle-like nodule with 1 or more larvae within it.

Dermatobia hominis is the most common causative organism for furuncular myiasis in the regions of the Americas. Patients typically present with 1 lesion on an exposed part of the body (eg, scalp, face, extremities). The lesions typically contain a central pore with purulent or serosanguinous exudate.¹ Upon dermatoscopic inspection, one can often see the posterior part of the larva or the respiratory spiracles, which look like tiny black dots on the surface of the wound. The organism may also be indirectly viewed through respiratory bubble formation within the exudate.^1,2 Diagnosis is confirmed by extracting the larvae from the wound and having the species identified by an experienced pathologist or parasitologist.

Mode of transmission

Phoresis is the name of the process by which Dermatobia hominis invades the skin.³ The female fly lays her eggs onto captured mosquitos using a quick-drying adhesive. The eggs are then transferred to the host by a mosquito bite. The host’s body heat induces egg hatching, and the larvae burrow into follicular openings or skin perforations. This leads to the development of a small erythematous papule, which can further lead to a furuncle-like nodule with a central pore that allows the organism to respirate. When ready to pupate, the larvae work their way to the skin surface and drop to the soil, where they can further develop. After pupation, the fly hatches and develops into an adult, and the cycle repeats.

Common infectious and inflammatory lesions are in the differential Dx

The differential diagnosis includes bacterial abscess, exaggerated arthropod reaction, and ruptured epidermal cyst. With our patient, the travel history and unique exam findings led to the suspicion of myiasis.

Bacterial abscess is likely to have more notable purulence with response to appropriate oral antibiotics and no bubbling phenomenon on exam. It is also unlikely to be present for 1 month without progressive worsening.

Continue to: Exaggerated arthropod reaction

Exaggerated arthropod reaction usually manifests as a smooth, red, papular lesion without bubble formation from a central pore.

Ruptured epidermal cyst would be considered if there was a known preexisting cyst that recently changed. No bubble formation would be observed from the central pore.

Extraction is the treatment of choice

Treatment of furuncular myiasis involves removing the larvae or forcing them out of the lesion. Wounds can be covered with a substance, such as petrolatum, nail polish, beeswax, paraffin, or mineral oil, to block respiration.³ Occlusion may be needed for 24 hours to create adequate localized hypoxia to force the larvae to migrate from the wound and allow for easier manual extraction. Surgical removal of the larvae is also effective. A cruciate incision can be made adjacent to the central pore to avoid damaging the organisms.³ A topical, broad-based antiparasitic, such as a 10% ivermectin solution, has also been successfully used to treat furuncular myiasis. This approach works by either inducing larval migration outward or simply killing the larvae.³

Our patient recovered well after we performed a punch biopsy to make a larger wound opening and remove the intact larvae.

ACKNOWLEDGMENT
We thank Richard Pollack, PhD, at IdentifyUS, LLC, for providing the botfly larvae photo.

A healthy woman in her 60s presented to the clinic with a 1-month history of red, itchy, and slightly painful nodules on the scalp and back. The patient had travelled to Belize for a vacation in the weeks prior to the onset of the lesions. She was initially given a course of cephalexin for presumed furunculosis at another clinic, without improvement.

Examination revealed inflamed nodules with a central open pore on the left upper back (FIGURE 1) and the occipital scalp. Notably, when the lesions were observed with a dermatoscope, intermittent air bubbles were seen through the skin opening.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

Given the patient’s clinical presentation and travel history, furuncular myiasis infestation was suspected and confirmed by punch biopsy. Pathologic exam revealed botfly larvae in both wounds, consistent with the human botfly, Dermatobia hominis (FIGURE 2). Myiasis is not common in the United States but should be suspected in patients who have recently traveled to tropical or subtropical areas. Furuncular myiasis describes the condition in which fly larvae penetrate healthy skin in a localized fashion, leading to the development of a ­furuncle-like nodule with 1 or more larvae within it.

Dermatobia hominis is the most common causative organism for furuncular myiasis in the regions of the Americas. Patients typically present with 1 lesion on an exposed part of the body (eg, scalp, face, extremities). The lesions typically contain a central pore with purulent or serosanguinous exudate.¹ Upon dermatoscopic inspection, one can often see the posterior part of the larva or the respiratory spiracles, which look like tiny black dots on the surface of the wound. The organism may also be indirectly viewed through respiratory bubble formation within the exudate.^1,2 Diagnosis is confirmed by extracting the larvae from the wound and having the species identified by an experienced pathologist or parasitologist.

Mode of transmission

Phoresis is the name of the process by which Dermatobia hominis invades the skin.³ The female fly lays her eggs onto captured mosquitos using a quick-drying adhesive. The eggs are then transferred to the host by a mosquito bite. The host’s body heat induces egg hatching, and the larvae burrow into follicular openings or skin perforations. This leads to the development of a small erythematous papule, which can further lead to a furuncle-like nodule with a central pore that allows the organism to respirate. When ready to pupate, the larvae work their way to the skin surface and drop to the soil, where they can further develop. After pupation, the fly hatches and develops into an adult, and the cycle repeats.

Common infectious and inflammatory lesions are in the differential Dx

The differential diagnosis includes bacterial abscess, exaggerated arthropod reaction, and ruptured epidermal cyst. With our patient, the travel history and unique exam findings led to the suspicion of myiasis.

Bacterial abscess is likely to have more notable purulence with response to appropriate oral antibiotics and no bubbling phenomenon on exam. It is also unlikely to be present for 1 month without progressive worsening.

Continue to: Exaggerated arthropod reaction

Exaggerated arthropod reaction usually manifests as a smooth, red, papular lesion without bubble formation from a central pore.

Ruptured epidermal cyst would be considered if there was a known preexisting cyst that recently changed. No bubble formation would be observed from the central pore.

Extraction is the treatment of choice

Treatment of furuncular myiasis involves removing the larvae or forcing them out of the lesion. Wounds can be covered with a substance, such as petrolatum, nail polish, beeswax, paraffin, or mineral oil, to block respiration.³ Occlusion may be needed for 24 hours to create adequate localized hypoxia to force the larvae to migrate from the wound and allow for easier manual extraction. Surgical removal of the larvae is also effective. A cruciate incision can be made adjacent to the central pore to avoid damaging the organisms.³ A topical, broad-based antiparasitic, such as a 10% ivermectin solution, has also been successfully used to treat furuncular myiasis. This approach works by either inducing larval migration outward or simply killing the larvae.³

Our patient recovered well after we performed a punch biopsy to make a larger wound opening and remove the intact larvae.

ACKNOWLEDGMENT
We thank Richard Pollack, PhD, at IdentifyUS, LLC, for providing the botfly larvae photo.

A healthy woman in her 60s presented to the clinic with a 1-month history of red, itchy, and slightly painful nodules on the scalp and back. The patient had travelled to Belize for a vacation in the weeks prior to the onset of the lesions. She was initially given a course of cephalexin for presumed furunculosis at another clinic, without improvement.

Examination revealed inflamed nodules with a central open pore on the left upper back (FIGURE 1) and the occipital scalp. Notably, when the lesions were observed with a dermatoscope, intermittent air bubbles were seen through the skin opening.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

Given the patient’s clinical presentation and travel history, furuncular myiasis infestation was suspected and confirmed by punch biopsy. Pathologic exam revealed botfly larvae in both wounds, consistent with the human botfly, Dermatobia hominis (FIGURE 2). Myiasis is not common in the United States but should be suspected in patients who have recently traveled to tropical or subtropical areas. Furuncular myiasis describes the condition in which fly larvae penetrate healthy skin in a localized fashion, leading to the development of a ­furuncle-like nodule with 1 or more larvae within it.

Dermatobia hominis is the most common causative organism for furuncular myiasis in the regions of the Americas. Patients typically present with 1 lesion on an exposed part of the body (eg, scalp, face, extremities). The lesions typically contain a central pore with purulent or serosanguinous exudate.¹ Upon dermatoscopic inspection, one can often see the posterior part of the larva or the respiratory spiracles, which look like tiny black dots on the surface of the wound. The organism may also be indirectly viewed through respiratory bubble formation within the exudate.^1,2 Diagnosis is confirmed by extracting the larvae from the wound and having the species identified by an experienced pathologist or parasitologist.

Mode of transmission

Phoresis is the name of the process by which Dermatobia hominis invades the skin.³ The female fly lays her eggs onto captured mosquitos using a quick-drying adhesive. The eggs are then transferred to the host by a mosquito bite. The host’s body heat induces egg hatching, and the larvae burrow into follicular openings or skin perforations. This leads to the development of a small erythematous papule, which can further lead to a furuncle-like nodule with a central pore that allows the organism to respirate. When ready to pupate, the larvae work their way to the skin surface and drop to the soil, where they can further develop. After pupation, the fly hatches and develops into an adult, and the cycle repeats.

Common infectious and inflammatory lesions are in the differential Dx

The differential diagnosis includes bacterial abscess, exaggerated arthropod reaction, and ruptured epidermal cyst. With our patient, the travel history and unique exam findings led to the suspicion of myiasis.

Bacterial abscess is likely to have more notable purulence with response to appropriate oral antibiotics and no bubbling phenomenon on exam. It is also unlikely to be present for 1 month without progressive worsening.

Continue to: Exaggerated arthropod reaction

Exaggerated arthropod reaction usually manifests as a smooth, red, papular lesion without bubble formation from a central pore.

Ruptured epidermal cyst would be considered if there was a known preexisting cyst that recently changed. No bubble formation would be observed from the central pore.

Extraction is the treatment of choice

Treatment of furuncular myiasis involves removing the larvae or forcing them out of the lesion. Wounds can be covered with a substance, such as petrolatum, nail polish, beeswax, paraffin, or mineral oil, to block respiration.³ Occlusion may be needed for 24 hours to create adequate localized hypoxia to force the larvae to migrate from the wound and allow for easier manual extraction. Surgical removal of the larvae is also effective. A cruciate incision can be made adjacent to the central pore to avoid damaging the organisms.³ A topical, broad-based antiparasitic, such as a 10% ivermectin solution, has also been successfully used to treat furuncular myiasis. This approach works by either inducing larval migration outward or simply killing the larvae.³

Our patient recovered well after we performed a punch biopsy to make a larger wound opening and remove the intact larvae.

ACKNOWLEDGMENT
We thank Richard Pollack, PhD, at IdentifyUS, LLC, for providing the botfly larvae photo.

Bone strength and microarchitecture remained stronger at 24 months after treatment with denosumab compared to risedronate, in a study of 110 adults using glucocorticoids.

Patients using glucocorticoids are at increased risk for vertebral and nonvertebral fractures at both the start of treatment or as treatment continues, wrote Piet Geusens, MD, of Maastricht University, the Netherlands, and colleagues.

Imaging data collected via high-resolution peripheral quantitative computed tomography (HR-pQCT) allow for the assessment of bone microarchitecture and strength, but specific data comparing the impact of bone treatment in patients using glucocorticoids are lacking, they said.

In a study published in the Journal of Bone and Mineral Research, the researchers identified a subset of 56 patients randomized to denosumab and 54 to risedronate patients out of a total of 590 patients who were enrolled in a phase 3 randomized, controlled trial of denosumab vs. risedronate for bone mineral density. The main results of the larger trial – presented at EULAR 2018 – showed greater increases in bone strength with denosumab over risedronate in patients receiving glucocorticoids.

In the current study, the researchers reviewed HR-pQCT scans of the distal radius and tibia at baseline, 12 months, and 24 months. Bone strength and microarchitecture were defined in terms of failure load (FL) as a primary outcome. Patients also were divided into subpopulations of those initiating glucocorticoid treatment (GC-I) and continuing treatment (GC-C).

Baseline characteristics were mainly balanced among the treatment groups within the GC-I and GC-C categories.

Among the GC-I patients, in the denosumab group, FL increased significantly from baseline to 12 months at the radius at tibia (1.8% and 1.7%, respectively) but did not change significantly in the risedronate group, which translated to a significant treatment difference between the drugs of 3.3% for radius and 2.5% for tibia.

At 24 months, the radius measure of FL was unchanged from baseline in denosumab patients but significantly decreased in risedronate patients, with a difference of –4.1%, which translated to a significant between-treatment difference at the radius of 5.6% (P < .001). Changes at the tibia were not significantly different between the groups at 24 months.

Among the GC-C patients, FL was unchanged from baseline to 12 months for both the denosumab and risedronate groups. However, FL significantly increased with denosumab (4.3%) and remained unchanged in the risedronate group.

The researchers also found significant differences between denosumab and risedronate in percentage changes in cortical bone mineral density, and less prominent changes and differences in trabecular bone mineral density.

The study findings were limited by several factors including the use of the HR-pQCT scanner, which limits the measurement of trabecular microarchitecture, and the use of only standard HR-pQCT parameters, which do not allow insight into endosteal changes, and the inability to correct for multiplicity of data, the researchers noted.

However, the results support the superiority of denosumab over risedronate for preventing FL and total bone mineral density loss at the radius and tibia in new glucocorticoid users, and for increasing FL and total bone mineral density at the radius in long-term glucocorticoid users, they said.

Denosumab therefore could be a useful therapeutic option and could inform decision-making in patients initiating GC-therapy or on long-term GC-therapy, they concluded.

The study was supported by Amgen. Dr. Geusens disclosed grants from Amgen, Celgene, Lilly, Merck, Pfizer, Roche, UCB, Fresenius, Mylan, and Sandoz, and grants and other funding from AbbVie, outside the current study.

Bone strength and microarchitecture remained stronger at 24 months after treatment with denosumab compared to risedronate, in a study of 110 adults using glucocorticoids.

Patients using glucocorticoids are at increased risk for vertebral and nonvertebral fractures at both the start of treatment or as treatment continues, wrote Piet Geusens, MD, of Maastricht University, the Netherlands, and colleagues.

Imaging data collected via high-resolution peripheral quantitative computed tomography (HR-pQCT) allow for the assessment of bone microarchitecture and strength, but specific data comparing the impact of bone treatment in patients using glucocorticoids are lacking, they said.

In a study published in the Journal of Bone and Mineral Research, the researchers identified a subset of 56 patients randomized to denosumab and 54 to risedronate patients out of a total of 590 patients who were enrolled in a phase 3 randomized, controlled trial of denosumab vs. risedronate for bone mineral density. The main results of the larger trial – presented at EULAR 2018 – showed greater increases in bone strength with denosumab over risedronate in patients receiving glucocorticoids.

In the current study, the researchers reviewed HR-pQCT scans of the distal radius and tibia at baseline, 12 months, and 24 months. Bone strength and microarchitecture were defined in terms of failure load (FL) as a primary outcome. Patients also were divided into subpopulations of those initiating glucocorticoid treatment (GC-I) and continuing treatment (GC-C).

Baseline characteristics were mainly balanced among the treatment groups within the GC-I and GC-C categories.

Among the GC-I patients, in the denosumab group, FL increased significantly from baseline to 12 months at the radius at tibia (1.8% and 1.7%, respectively) but did not change significantly in the risedronate group, which translated to a significant treatment difference between the drugs of 3.3% for radius and 2.5% for tibia.

At 24 months, the radius measure of FL was unchanged from baseline in denosumab patients but significantly decreased in risedronate patients, with a difference of –4.1%, which translated to a significant between-treatment difference at the radius of 5.6% (P < .001). Changes at the tibia were not significantly different between the groups at 24 months.

Among the GC-C patients, FL was unchanged from baseline to 12 months for both the denosumab and risedronate groups. However, FL significantly increased with denosumab (4.3%) and remained unchanged in the risedronate group.

The researchers also found significant differences between denosumab and risedronate in percentage changes in cortical bone mineral density, and less prominent changes and differences in trabecular bone mineral density.

The study findings were limited by several factors including the use of the HR-pQCT scanner, which limits the measurement of trabecular microarchitecture, and the use of only standard HR-pQCT parameters, which do not allow insight into endosteal changes, and the inability to correct for multiplicity of data, the researchers noted.

However, the results support the superiority of denosumab over risedronate for preventing FL and total bone mineral density loss at the radius and tibia in new glucocorticoid users, and for increasing FL and total bone mineral density at the radius in long-term glucocorticoid users, they said.

Denosumab therefore could be a useful therapeutic option and could inform decision-making in patients initiating GC-therapy or on long-term GC-therapy, they concluded.

The study was supported by Amgen. Dr. Geusens disclosed grants from Amgen, Celgene, Lilly, Merck, Pfizer, Roche, UCB, Fresenius, Mylan, and Sandoz, and grants and other funding from AbbVie, outside the current study.

Bone strength and microarchitecture remained stronger at 24 months after treatment with denosumab compared to risedronate, in a study of 110 adults using glucocorticoids.

Patients using glucocorticoids are at increased risk for vertebral and nonvertebral fractures at both the start of treatment or as treatment continues, wrote Piet Geusens, MD, of Maastricht University, the Netherlands, and colleagues.

Imaging data collected via high-resolution peripheral quantitative computed tomography (HR-pQCT) allow for the assessment of bone microarchitecture and strength, but specific data comparing the impact of bone treatment in patients using glucocorticoids are lacking, they said.

In a study published in the Journal of Bone and Mineral Research, the researchers identified a subset of 56 patients randomized to denosumab and 54 to risedronate patients out of a total of 590 patients who were enrolled in a phase 3 randomized, controlled trial of denosumab vs. risedronate for bone mineral density. The main results of the larger trial – presented at EULAR 2018 – showed greater increases in bone strength with denosumab over risedronate in patients receiving glucocorticoids.

In the current study, the researchers reviewed HR-pQCT scans of the distal radius and tibia at baseline, 12 months, and 24 months. Bone strength and microarchitecture were defined in terms of failure load (FL) as a primary outcome. Patients also were divided into subpopulations of those initiating glucocorticoid treatment (GC-I) and continuing treatment (GC-C).

Baseline characteristics were mainly balanced among the treatment groups within the GC-I and GC-C categories.

Among the GC-I patients, in the denosumab group, FL increased significantly from baseline to 12 months at the radius at tibia (1.8% and 1.7%, respectively) but did not change significantly in the risedronate group, which translated to a significant treatment difference between the drugs of 3.3% for radius and 2.5% for tibia.

At 24 months, the radius measure of FL was unchanged from baseline in denosumab patients but significantly decreased in risedronate patients, with a difference of –4.1%, which translated to a significant between-treatment difference at the radius of 5.6% (P < .001). Changes at the tibia were not significantly different between the groups at 24 months.

Among the GC-C patients, FL was unchanged from baseline to 12 months for both the denosumab and risedronate groups. However, FL significantly increased with denosumab (4.3%) and remained unchanged in the risedronate group.

The researchers also found significant differences between denosumab and risedronate in percentage changes in cortical bone mineral density, and less prominent changes and differences in trabecular bone mineral density.

The study findings were limited by several factors including the use of the HR-pQCT scanner, which limits the measurement of trabecular microarchitecture, and the use of only standard HR-pQCT parameters, which do not allow insight into endosteal changes, and the inability to correct for multiplicity of data, the researchers noted.

However, the results support the superiority of denosumab over risedronate for preventing FL and total bone mineral density loss at the radius and tibia in new glucocorticoid users, and for increasing FL and total bone mineral density at the radius in long-term glucocorticoid users, they said.

Denosumab therefore could be a useful therapeutic option and could inform decision-making in patients initiating GC-therapy or on long-term GC-therapy, they concluded.

The study was supported by Amgen. Dr. Geusens disclosed grants from Amgen, Celgene, Lilly, Merck, Pfizer, Roche, UCB, Fresenius, Mylan, and Sandoz, and grants and other funding from AbbVie, outside the current study.

ABSTRACT

Background: Medical assistant (MA) roles have expanded rapidly as primary care has evolved and MAs take on new patient care duties. Research that looks at the MA experience and factors that enhance or reduce efficiency among MAs is limited.

Methods: We surveyed all MAs working in 6 clinics run by a large academic family medicine department in Ann Arbor, Michigan. MAs deemed by peers as “most efficient” were selected for follow-up interviews. We evaluated personal strategies for efficiency, barriers to efficient care, impact of physician actions on efficiency, and satisfaction.

Results: A total of 75/86 MAs (87%) responded to at least some survey questions and 61/86 (71%) completed the full survey. We interviewed 18 MAs face to face. Most saw their role as essential to clinic functioning and viewed health care as a personal calling. MAs identified common strategies to improve efficiency and described the MA role to orchestrate the flow of the clinic day. Staff recognized differing priorities of patients, staff, and physicians and articulated frustrations with hierarchy and competing priorities as well as behaviors that impeded clinic efficiency. Respondents emphasized the importance of feeling valued by others on their team.

Conclusions: With the evolving demands made on MAs’ time, it is critical to understand how the most effective staff members manage their role and highlight the strategies they employ to provide efficient clinical care. Understanding factors that increase or decrease MA job satisfaction can help identify high-efficiency practices and promote a clinic culture that values and supports all staff.

As primary care continues to evolve into more team-based practice, the role of the medical assistant (MA) has rapidly transformed.¹ Staff may assist with patient management, documentation in the electronic medical record, order entry, pre-visit planning, and fulfillment of quality metrics, particularly in a Primary Care Medical Home (PCMH).² From 2012 through 2014, MA job postings per graduate increased from 1.3 to 2.3, suggesting twice as many job postings as graduates.³ As the demand for experienced MAs increases, the ability to recruit and retain high-performing staff members will be critical.

MAs are referenced in medical literature as early as the 1800s.⁴ The American Association of Medical Assistants was founded in 1956, which led to educational standardization and certifications.⁵ Despite the important role that MAs have long played in the proper functioning of a medical clinic—and the knowledge that team configurations impact a clinic’s efficiency and quality^6,7—few investigations have sought out the MA’s perspective.^8,9 Given the increasing clinical demands placed on all members of the primary care team (and the burnout that often results), it seems that MA insights into clinic efficiency could be valuable.

METHODS

This cross-sectional study was conducted from February to April 2019 at a large academic institution with 6 regional ambulatory care family medicine clinics, each one with 11,000 to 18,000 patient visits annually. Faculty work at all 6 clinics and residents at 2 of them. All MAs are hired, paid, and managed by a central administrative department rather than by the family medicine department. The family medicine clinics are currently PCMH certified, with a mix of fee-for-service and capitated reimbursement.

Continue to: We developed and piloted...

We developed and piloted a voluntary, anonymous 39-question (29 closed-ended and 10 brief open-ended) online Qualtrics survey, which we distributed via an email link to all the MAs in the department. The survey included clinic site, years as an MA, perceptions of the clinic environment, perception of teamwork at their site, identification of efficient practices, and feedback for physicians to improve efficiency and flow. Most questions were Likert-style with 5 choices ranging from “strongly agree” to “strongly disagree” or short answer. Age and gender were omitted to protect confidentiality, as most MAs in the department are female. Participants could opt to enter in a drawing for three $25 gift cards. The survey was reviewed by the University of Michigan Institutional Review Board and deemed exempt.

Seventy-five percent of MAs reported preclinic huddles to plan for patient care were helpful, but only half said huddles took place “always” or “most of the time.”

We asked MAs to nominate peers in their clinic who were “especially efficient and do their jobs well—people that others can learn from.” The staff members who were nominated most frequently by their peers were invited to share additional perspectives via a 10- to 30-minute semi-structured interview with the first author. Interviews covered highly efficient practices, barriers and facilitators to efficient care, and physician behaviors that impaired efficiency. We interviewed a minimum of 2 MAs per clinic and increased the number of interviews through snowball sampling, as needed, to reach data saturation (eg, the point at which we were no longer hearing new content). MAs were assured that all comments would be anonymized. There was no monetary incentive for the interviews. The interviewer had previously met only 3 of the 18 MAs interviewed.

Analysis. Summary statistics were calculated for quantitative data. To compare subgroups (such as individual clinics), a chi-square test was used. In cases when there were small cell sizes (< 5 subjects), we used the Fisher’s Exact test. Qualitative data was collected with real-time typewritten notes during the interviews to capture ideas and verbatim quotes when possible. We also included open-ended comments shared on the Qualtrics survey. Data were organized by theme using a deductive coding approach. Both authors reviewed and discussed observations, and coding was conducted by the first author. Reporting followed the STROBE Statement checklist for cross-sectional studies.¹⁰ Results were shared with MAs, supervisory staff, and physicians, which allowed for feedback and comments and served as “member-checking.” MAs reported that the data reflected their lived experiences.

RESULTS

Surveys were distributed to all 86 MAs working in family medicine clinics. A total of 75 (87%) responded to at least some questions (typically just demographics). We used those who completed the full survey (n = 61; 71%) for data analysis. Eighteen MAs participated in face-to-face interviews. Among respondents, 35 (47%) had worked at least 10 years as an MA and 21 (28%) had worked at least a decade in the family medicine department.

Perception of role

All respondents (n = 61; 100%) somewhat or strongly agreed that the MA role was “very important to keep the clinic functioning” and 58 (95%) reported that working in health care was “a calling” for them. Only 7 (11%) agreed that family medicine was an easier environment for MAs compared to a specialty clinic; 30 (49%) disagreed with this. Among respondents, 32 (53%) strongly or somewhat agreed that their work was very stressful and just half (n = 28; 46%) agreed there were adequate MA staff at their clinic.

Continue to: Efficiency and competing priorities

Efficiency and competing priorities

MAs described important work values that increased their efficiency. These included clinic culture (good communication and strong teamwork), as well as individual strategies such as multitasking, limiting patient conversations, and doing tasks in a consistent way to improve accuracy. (See TABLE 1.) They identified ways physicians bolster or hurt efficiency and ways in which the relationship between the physician and the MA shapes the MA’s perception of their value in clinic.

When asked about “pet peeves,” a few MAs advised that physicians should not “talk down” to staff and should try to teach rather than criticize.

Communication was emphasized as critical for efficient care, and MAs encouraged the use of preclinic huddles and communication as priorities. Seventy-five percent of MAs reported preclinic huddles to plan for patient care were helpful, but only half said huddles took place “always” or “most of the time.” Many described reviewing the schedule and completing tasks ahead of patient arrival as critical to efficiency.

Participants described the tension between their identified role of orchestrating clinic flow and responding to directives by others that disrupted the flow. Several MAs found it challenging when physicians agreed to see very late patients and felt frustrated when decisions that changed the flow were made by the physician or front desk staff without including the MA. MAs were also able to articulate how they managed competing priorities within the clinic, such as when a patient- or physician-driven need to extend appointments was at odds with maintaining a timely schedule. They were eager to share personal tips for time management and prided themselves on careful and accurate performance and skills they had learned on the job. MAs also described how efficiency could be adversely affected by the behaviors or attitudes of physicians. (See TABLE 2.)

Clinic environment

Thirty-six MAs (59%) reported that other MAs on their team were willing to help them out in clinic “a great deal” or “a lot” of the time, by helping to room a patient, acting as a chaperone for an exam, or doing a point-of-care lab. This sense of support varied across clinics (38% to 91% reported good support), suggesting that cultures vary by site. Some MAs expressed frustration at peers they saw as resistant to helping, exemplified by this verbatim quote from an interview:

“ Some don’t want to help out. They may sigh. It’s how they react—you just know.” (Clinic #1, MA #2 interview)

Efficient MAs stressed the need for situational awareness to recognize when co-workers need help:

“ [Peers often] are not aware that another MA is drowning. There’s 5 people who could have done that, and here I am running around and nobody budged.” (Clinic #5, MA #2 interview)

Continue to: A minority of staff...

A minority of staff used the open-ended survey sections to describe clinic hierarchy. When asked about “pet peeves,” a few advised that physicians should not “talk down” to staff and should try to teach rather than criticize. Another asked that physicians not “bark orders” or have “low gratitude” for staff work. MAs found micromanaging stressful—particularly when the physician prompted the MA about patient arrivals:

“[I don’t like] when providers will make a comment about a patient arriving when you already know this information. You then rush to put [the] patient in [a] room, then [the] provider ends up making [the] patient wait an extensive amount of time. I’m perfectly capable of knowing when a patient arrives.” (Clinic #6, survey)

MAs did not like physicians “talking bad about us” or blaming the MA if the clinic is running behind.

Despite these concerns, most MAs reported feeling appreciated for the job they do. Only 10 (16%) reported that the people they work with rarely say “thank you,” and 2 (3%) stated they were not well supported by the physicians in clinic. Most (n = 38; 62%) strongly agreed or agreed that they felt part of the team and that their opinions matter. In the interviews, many expanded on this idea:

“I really feel like I’m valued, so I want to do everything I can to make [my doctor’s] day go better. If you want a good clinic, the best thing a doc can do is make the MA feel valued.” (Clinic #1, MA #1 interview)

DISCUSSION

Participants described their role much as an orchestra director, with MAs as the key to clinic flow and timeliness.⁹ Respondents articulated multiple common strategies used to increase their own efficiency and clinic flow; these may be considered best practices and incorporated as part of the basic training. Most MAs reported their day-to-day jobs were stressful and believed this was underrecognized, so efficiency strategies are critical. With staff completing multiple time-sensitive tasks during clinic, consistent co-worker support is crucial and may impact efficiency.⁸ Proper training of managers to provide that support and ensure equitable workloads may be one strategy to ensure that staff members feel the workplace is fair and collegial.

Several comments reflected the power differential within medical offices. One study reported that MAs and physicians “occupy roles at opposite ends of social and occupational hierarchies.”¹¹ It’s important for physicians to be cognizant of these patterns and clinic culture, as reducing a hierarchy-based environment will be appreciated by MAs.⁹ Prior research has found that MAs have higher perceptions of their own competence than do the physicians working with them.¹² If there is a fundamental lack of trust between the 2 groups, this will undoubtedly hinder team-building. Attention to this issue is key to a more favorable work environment.

Continue to: Almost all respondents...

Almost all respondents reported health care was a “calling,” which mirrors physician research that suggests seeing work as a “calling” is protective against burnout.^13,14 Open-ended comments indicated great pride in contributions, and most staff members felt appreciated by their teams. Many described the working relationships with physicians as critical to their satisfaction at work and indicated that strong partnerships motivated them to do their best to make the physician’s day easier. Staff job satisfaction is linked to improved quality of care, so treating staff well contributes to high-value care for patients.¹⁵ We also uncovered some MA “pet peeves” that hinder efficiency and could be shared with physicians to emphasize the importance of patience and civility.

One barrier to expansion of MA roles within PCMH practices is the limited pay and career ladder for MAs who adopt new job responsibilities that require advanced skills or training.^1,2 The mean MA salary at our institution ($37,372) is higher than in our state overall ($33,760), which may impact satisfaction.¹⁶ In addition, 93% of MAs are women; thus, they may continue to struggle more with lower pay than do workers in male-­dominated professions.^17,18 Expected job growth from 2018-2028 is predicted at 23%, which may help to boost salaries.¹⁹ Prior studies describe the lack of a job ladder or promotion opportunities as a challenge^1,20; this was not formally assessed in our study.

Prior research has found that MAs have higher perceptions of their own competence than do the physicians working with them.

MAs see work in family medicine as much harder than it is in other specialty clinics. Being trusted with more responsibility, greater autonomy,^21-23 and expanded patient care roles can boost MA self-efficacy, which can reduce burnout for both physicians and MAs.^8,24 However, new responsibilities should include appropriate training, support, and compensation, and match staff interests.⁷

Study limitations. The study was limited to 6 clinics in 1 department at a large academic medical center. Interviewed participants were selected by convenience and snowball sampling and thus, the results cannot be generalized to the population of MAs as a whole. As the initial interview goal was simply to gather efficiency tips, the project was not designed to be formal qualitative research. However, the discussions built on open-ended comments from the written survey helped contextualize our quantitative findings about efficiency. Notes were documented in real time by a single interviewer with rapid typing skills, which allowed capture of quotes verbatim. Subsequent studies would benefit from more formal qualitative research methods (recording and transcribing interviews, multiple coders to reduce risk of bias, and more complex thematic analysis).

Our research demonstrated how MAs perceive their roles in primary care and the facilitators and barriers to high efficiency in the workplace, which begins to fill an important knowledge gap in primary care. Disseminating practices that staff members themselves have identified as effective, and being attentive to how staff members are treated, may increase individual efficiency while improving staff retention and satisfaction.

CORRESPONDENCE
Katherine J. Gold, MD, MSW, MS, Department of Family Medicine and Department of Obstetrics and Gynecology, University of Michigan, 1018 Fuller Street, Ann Arbor, MI 48104-1213; [email protected]

ABSTRACT

Background: Medical assistant (MA) roles have expanded rapidly as primary care has evolved and MAs take on new patient care duties. Research that looks at the MA experience and factors that enhance or reduce efficiency among MAs is limited.

Methods: We surveyed all MAs working in 6 clinics run by a large academic family medicine department in Ann Arbor, Michigan. MAs deemed by peers as “most efficient” were selected for follow-up interviews. We evaluated personal strategies for efficiency, barriers to efficient care, impact of physician actions on efficiency, and satisfaction.

Results: A total of 75/86 MAs (87%) responded to at least some survey questions and 61/86 (71%) completed the full survey. We interviewed 18 MAs face to face. Most saw their role as essential to clinic functioning and viewed health care as a personal calling. MAs identified common strategies to improve efficiency and described the MA role to orchestrate the flow of the clinic day. Staff recognized differing priorities of patients, staff, and physicians and articulated frustrations with hierarchy and competing priorities as well as behaviors that impeded clinic efficiency. Respondents emphasized the importance of feeling valued by others on their team.

Conclusions: With the evolving demands made on MAs’ time, it is critical to understand how the most effective staff members manage their role and highlight the strategies they employ to provide efficient clinical care. Understanding factors that increase or decrease MA job satisfaction can help identify high-efficiency practices and promote a clinic culture that values and supports all staff.

As primary care continues to evolve into more team-based practice, the role of the medical assistant (MA) has rapidly transformed.¹ Staff may assist with patient management, documentation in the electronic medical record, order entry, pre-visit planning, and fulfillment of quality metrics, particularly in a Primary Care Medical Home (PCMH).² From 2012 through 2014, MA job postings per graduate increased from 1.3 to 2.3, suggesting twice as many job postings as graduates.³ As the demand for experienced MAs increases, the ability to recruit and retain high-performing staff members will be critical.

MAs are referenced in medical literature as early as the 1800s.⁴ The American Association of Medical Assistants was founded in 1956, which led to educational standardization and certifications.⁵ Despite the important role that MAs have long played in the proper functioning of a medical clinic—and the knowledge that team configurations impact a clinic’s efficiency and quality^6,7—few investigations have sought out the MA’s perspective.^8,9 Given the increasing clinical demands placed on all members of the primary care team (and the burnout that often results), it seems that MA insights into clinic efficiency could be valuable.

METHODS

This cross-sectional study was conducted from February to April 2019 at a large academic institution with 6 regional ambulatory care family medicine clinics, each one with 11,000 to 18,000 patient visits annually. Faculty work at all 6 clinics and residents at 2 of them. All MAs are hired, paid, and managed by a central administrative department rather than by the family medicine department. The family medicine clinics are currently PCMH certified, with a mix of fee-for-service and capitated reimbursement.

Continue to: We developed and piloted...

We developed and piloted a voluntary, anonymous 39-question (29 closed-ended and 10 brief open-ended) online Qualtrics survey, which we distributed via an email link to all the MAs in the department. The survey included clinic site, years as an MA, perceptions of the clinic environment, perception of teamwork at their site, identification of efficient practices, and feedback for physicians to improve efficiency and flow. Most questions were Likert-style with 5 choices ranging from “strongly agree” to “strongly disagree” or short answer. Age and gender were omitted to protect confidentiality, as most MAs in the department are female. Participants could opt to enter in a drawing for three $25 gift cards. The survey was reviewed by the University of Michigan Institutional Review Board and deemed exempt.

Seventy-five percent of MAs reported preclinic huddles to plan for patient care were helpful, but only half said huddles took place “always” or “most of the time.”

We asked MAs to nominate peers in their clinic who were “especially efficient and do their jobs well—people that others can learn from.” The staff members who were nominated most frequently by their peers were invited to share additional perspectives via a 10- to 30-minute semi-structured interview with the first author. Interviews covered highly efficient practices, barriers and facilitators to efficient care, and physician behaviors that impaired efficiency. We interviewed a minimum of 2 MAs per clinic and increased the number of interviews through snowball sampling, as needed, to reach data saturation (eg, the point at which we were no longer hearing new content). MAs were assured that all comments would be anonymized. There was no monetary incentive for the interviews. The interviewer had previously met only 3 of the 18 MAs interviewed.

Analysis. Summary statistics were calculated for quantitative data. To compare subgroups (such as individual clinics), a chi-square test was used. In cases when there were small cell sizes (< 5 subjects), we used the Fisher’s Exact test. Qualitative data was collected with real-time typewritten notes during the interviews to capture ideas and verbatim quotes when possible. We also included open-ended comments shared on the Qualtrics survey. Data were organized by theme using a deductive coding approach. Both authors reviewed and discussed observations, and coding was conducted by the first author. Reporting followed the STROBE Statement checklist for cross-sectional studies.¹⁰ Results were shared with MAs, supervisory staff, and physicians, which allowed for feedback and comments and served as “member-checking.” MAs reported that the data reflected their lived experiences.

RESULTS

Surveys were distributed to all 86 MAs working in family medicine clinics. A total of 75 (87%) responded to at least some questions (typically just demographics). We used those who completed the full survey (n = 61; 71%) for data analysis. Eighteen MAs participated in face-to-face interviews. Among respondents, 35 (47%) had worked at least 10 years as an MA and 21 (28%) had worked at least a decade in the family medicine department.

Perception of role

All respondents (n = 61; 100%) somewhat or strongly agreed that the MA role was “very important to keep the clinic functioning” and 58 (95%) reported that working in health care was “a calling” for them. Only 7 (11%) agreed that family medicine was an easier environment for MAs compared to a specialty clinic; 30 (49%) disagreed with this. Among respondents, 32 (53%) strongly or somewhat agreed that their work was very stressful and just half (n = 28; 46%) agreed there were adequate MA staff at their clinic.

Continue to: Efficiency and competing priorities

Efficiency and competing priorities

MAs described important work values that increased their efficiency. These included clinic culture (good communication and strong teamwork), as well as individual strategies such as multitasking, limiting patient conversations, and doing tasks in a consistent way to improve accuracy. (See TABLE 1.) They identified ways physicians bolster or hurt efficiency and ways in which the relationship between the physician and the MA shapes the MA’s perception of their value in clinic.

When asked about “pet peeves,” a few MAs advised that physicians should not “talk down” to staff and should try to teach rather than criticize.

Communication was emphasized as critical for efficient care, and MAs encouraged the use of preclinic huddles and communication as priorities. Seventy-five percent of MAs reported preclinic huddles to plan for patient care were helpful, but only half said huddles took place “always” or “most of the time.” Many described reviewing the schedule and completing tasks ahead of patient arrival as critical to efficiency.

Participants described the tension between their identified role of orchestrating clinic flow and responding to directives by others that disrupted the flow. Several MAs found it challenging when physicians agreed to see very late patients and felt frustrated when decisions that changed the flow were made by the physician or front desk staff without including the MA. MAs were also able to articulate how they managed competing priorities within the clinic, such as when a patient- or physician-driven need to extend appointments was at odds with maintaining a timely schedule. They were eager to share personal tips for time management and prided themselves on careful and accurate performance and skills they had learned on the job. MAs also described how efficiency could be adversely affected by the behaviors or attitudes of physicians. (See TABLE 2.)

Clinic environment

Thirty-six MAs (59%) reported that other MAs on their team were willing to help them out in clinic “a great deal” or “a lot” of the time, by helping to room a patient, acting as a chaperone for an exam, or doing a point-of-care lab. This sense of support varied across clinics (38% to 91% reported good support), suggesting that cultures vary by site. Some MAs expressed frustration at peers they saw as resistant to helping, exemplified by this verbatim quote from an interview:

“ Some don’t want to help out. They may sigh. It’s how they react—you just know.” (Clinic #1, MA #2 interview)

Efficient MAs stressed the need for situational awareness to recognize when co-workers need help:

“ [Peers often] are not aware that another MA is drowning. There’s 5 people who could have done that, and here I am running around and nobody budged.” (Clinic #5, MA #2 interview)

Continue to: A minority of staff...

A minority of staff used the open-ended survey sections to describe clinic hierarchy. When asked about “pet peeves,” a few advised that physicians should not “talk down” to staff and should try to teach rather than criticize. Another asked that physicians not “bark orders” or have “low gratitude” for staff work. MAs found micromanaging stressful—particularly when the physician prompted the MA about patient arrivals:

“[I don’t like] when providers will make a comment about a patient arriving when you already know this information. You then rush to put [the] patient in [a] room, then [the] provider ends up making [the] patient wait an extensive amount of time. I’m perfectly capable of knowing when a patient arrives.” (Clinic #6, survey)

MAs did not like physicians “talking bad about us” or blaming the MA if the clinic is running behind.

Despite these concerns, most MAs reported feeling appreciated for the job they do. Only 10 (16%) reported that the people they work with rarely say “thank you,” and 2 (3%) stated they were not well supported by the physicians in clinic. Most (n = 38; 62%) strongly agreed or agreed that they felt part of the team and that their opinions matter. In the interviews, many expanded on this idea:

“I really feel like I’m valued, so I want to do everything I can to make [my doctor’s] day go better. If you want a good clinic, the best thing a doc can do is make the MA feel valued.” (Clinic #1, MA #1 interview)

DISCUSSION

Participants described their role much as an orchestra director, with MAs as the key to clinic flow and timeliness.⁹ Respondents articulated multiple common strategies used to increase their own efficiency and clinic flow; these may be considered best practices and incorporated as part of the basic training. Most MAs reported their day-to-day jobs were stressful and believed this was underrecognized, so efficiency strategies are critical. With staff completing multiple time-sensitive tasks during clinic, consistent co-worker support is crucial and may impact efficiency.⁸ Proper training of managers to provide that support and ensure equitable workloads may be one strategy to ensure that staff members feel the workplace is fair and collegial.

Several comments reflected the power differential within medical offices. One study reported that MAs and physicians “occupy roles at opposite ends of social and occupational hierarchies.”¹¹ It’s important for physicians to be cognizant of these patterns and clinic culture, as reducing a hierarchy-based environment will be appreciated by MAs.⁹ Prior research has found that MAs have higher perceptions of their own competence than do the physicians working with them.¹² If there is a fundamental lack of trust between the 2 groups, this will undoubtedly hinder team-building. Attention to this issue is key to a more favorable work environment.

Continue to: Almost all respondents...

Almost all respondents reported health care was a “calling,” which mirrors physician research that suggests seeing work as a “calling” is protective against burnout.^13,14 Open-ended comments indicated great pride in contributions, and most staff members felt appreciated by their teams. Many described the working relationships with physicians as critical to their satisfaction at work and indicated that strong partnerships motivated them to do their best to make the physician’s day easier. Staff job satisfaction is linked to improved quality of care, so treating staff well contributes to high-value care for patients.¹⁵ We also uncovered some MA “pet peeves” that hinder efficiency and could be shared with physicians to emphasize the importance of patience and civility.

One barrier to expansion of MA roles within PCMH practices is the limited pay and career ladder for MAs who adopt new job responsibilities that require advanced skills or training.^1,2 The mean MA salary at our institution ($37,372) is higher than in our state overall ($33,760), which may impact satisfaction.¹⁶ In addition, 93% of MAs are women; thus, they may continue to struggle more with lower pay than do workers in male-­dominated professions.^17,18 Expected job growth from 2018-2028 is predicted at 23%, which may help to boost salaries.¹⁹ Prior studies describe the lack of a job ladder or promotion opportunities as a challenge^1,20; this was not formally assessed in our study.

Prior research has found that MAs have higher perceptions of their own competence than do the physicians working with them.

MAs see work in family medicine as much harder than it is in other specialty clinics. Being trusted with more responsibility, greater autonomy,^21-23 and expanded patient care roles can boost MA self-efficacy, which can reduce burnout for both physicians and MAs.^8,24 However, new responsibilities should include appropriate training, support, and compensation, and match staff interests.⁷

Study limitations. The study was limited to 6 clinics in 1 department at a large academic medical center. Interviewed participants were selected by convenience and snowball sampling and thus, the results cannot be generalized to the population of MAs as a whole. As the initial interview goal was simply to gather efficiency tips, the project was not designed to be formal qualitative research. However, the discussions built on open-ended comments from the written survey helped contextualize our quantitative findings about efficiency. Notes were documented in real time by a single interviewer with rapid typing skills, which allowed capture of quotes verbatim. Subsequent studies would benefit from more formal qualitative research methods (recording and transcribing interviews, multiple coders to reduce risk of bias, and more complex thematic analysis).

Our research demonstrated how MAs perceive their roles in primary care and the facilitators and barriers to high efficiency in the workplace, which begins to fill an important knowledge gap in primary care. Disseminating practices that staff members themselves have identified as effective, and being attentive to how staff members are treated, may increase individual efficiency while improving staff retention and satisfaction.

CORRESPONDENCE
Katherine J. Gold, MD, MSW, MS, Department of Family Medicine and Department of Obstetrics and Gynecology, University of Michigan, 1018 Fuller Street, Ann Arbor, MI 48104-1213; [email protected]

ABSTRACT

Background: Medical assistant (MA) roles have expanded rapidly as primary care has evolved and MAs take on new patient care duties. Research that looks at the MA experience and factors that enhance or reduce efficiency among MAs is limited.

Methods: We surveyed all MAs working in 6 clinics run by a large academic family medicine department in Ann Arbor, Michigan. MAs deemed by peers as “most efficient” were selected for follow-up interviews. We evaluated personal strategies for efficiency, barriers to efficient care, impact of physician actions on efficiency, and satisfaction.

Results: A total of 75/86 MAs (87%) responded to at least some survey questions and 61/86 (71%) completed the full survey. We interviewed 18 MAs face to face. Most saw their role as essential to clinic functioning and viewed health care as a personal calling. MAs identified common strategies to improve efficiency and described the MA role to orchestrate the flow of the clinic day. Staff recognized differing priorities of patients, staff, and physicians and articulated frustrations with hierarchy and competing priorities as well as behaviors that impeded clinic efficiency. Respondents emphasized the importance of feeling valued by others on their team.

Conclusions: With the evolving demands made on MAs’ time, it is critical to understand how the most effective staff members manage their role and highlight the strategies they employ to provide efficient clinical care. Understanding factors that increase or decrease MA job satisfaction can help identify high-efficiency practices and promote a clinic culture that values and supports all staff.

As primary care continues to evolve into more team-based practice, the role of the medical assistant (MA) has rapidly transformed.¹ Staff may assist with patient management, documentation in the electronic medical record, order entry, pre-visit planning, and fulfillment of quality metrics, particularly in a Primary Care Medical Home (PCMH).² From 2012 through 2014, MA job postings per graduate increased from 1.3 to 2.3, suggesting twice as many job postings as graduates.³ As the demand for experienced MAs increases, the ability to recruit and retain high-performing staff members will be critical.

MAs are referenced in medical literature as early as the 1800s.⁴ The American Association of Medical Assistants was founded in 1956, which led to educational standardization and certifications.⁵ Despite the important role that MAs have long played in the proper functioning of a medical clinic—and the knowledge that team configurations impact a clinic’s efficiency and quality^6,7—few investigations have sought out the MA’s perspective.^8,9 Given the increasing clinical demands placed on all members of the primary care team (and the burnout that often results), it seems that MA insights into clinic efficiency could be valuable.

METHODS

This cross-sectional study was conducted from February to April 2019 at a large academic institution with 6 regional ambulatory care family medicine clinics, each one with 11,000 to 18,000 patient visits annually. Faculty work at all 6 clinics and residents at 2 of them. All MAs are hired, paid, and managed by a central administrative department rather than by the family medicine department. The family medicine clinics are currently PCMH certified, with a mix of fee-for-service and capitated reimbursement.

Continue to: We developed and piloted...

We developed and piloted a voluntary, anonymous 39-question (29 closed-ended and 10 brief open-ended) online Qualtrics survey, which we distributed via an email link to all the MAs in the department. The survey included clinic site, years as an MA, perceptions of the clinic environment, perception of teamwork at their site, identification of efficient practices, and feedback for physicians to improve efficiency and flow. Most questions were Likert-style with 5 choices ranging from “strongly agree” to “strongly disagree” or short answer. Age and gender were omitted to protect confidentiality, as most MAs in the department are female. Participants could opt to enter in a drawing for three $25 gift cards. The survey was reviewed by the University of Michigan Institutional Review Board and deemed exempt.

Seventy-five percent of MAs reported preclinic huddles to plan for patient care were helpful, but only half said huddles took place “always” or “most of the time.”

We asked MAs to nominate peers in their clinic who were “especially efficient and do their jobs well—people that others can learn from.” The staff members who were nominated most frequently by their peers were invited to share additional perspectives via a 10- to 30-minute semi-structured interview with the first author. Interviews covered highly efficient practices, barriers and facilitators to efficient care, and physician behaviors that impaired efficiency. We interviewed a minimum of 2 MAs per clinic and increased the number of interviews through snowball sampling, as needed, to reach data saturation (eg, the point at which we were no longer hearing new content). MAs were assured that all comments would be anonymized. There was no monetary incentive for the interviews. The interviewer had previously met only 3 of the 18 MAs interviewed.

Analysis. Summary statistics were calculated for quantitative data. To compare subgroups (such as individual clinics), a chi-square test was used. In cases when there were small cell sizes (< 5 subjects), we used the Fisher’s Exact test. Qualitative data was collected with real-time typewritten notes during the interviews to capture ideas and verbatim quotes when possible. We also included open-ended comments shared on the Qualtrics survey. Data were organized by theme using a deductive coding approach. Both authors reviewed and discussed observations, and coding was conducted by the first author. Reporting followed the STROBE Statement checklist for cross-sectional studies.¹⁰ Results were shared with MAs, supervisory staff, and physicians, which allowed for feedback and comments and served as “member-checking.” MAs reported that the data reflected their lived experiences.

RESULTS

Surveys were distributed to all 86 MAs working in family medicine clinics. A total of 75 (87%) responded to at least some questions (typically just demographics). We used those who completed the full survey (n = 61; 71%) for data analysis. Eighteen MAs participated in face-to-face interviews. Among respondents, 35 (47%) had worked at least 10 years as an MA and 21 (28%) had worked at least a decade in the family medicine department.

Perception of role

All respondents (n = 61; 100%) somewhat or strongly agreed that the MA role was “very important to keep the clinic functioning” and 58 (95%) reported that working in health care was “a calling” for them. Only 7 (11%) agreed that family medicine was an easier environment for MAs compared to a specialty clinic; 30 (49%) disagreed with this. Among respondents, 32 (53%) strongly or somewhat agreed that their work was very stressful and just half (n = 28; 46%) agreed there were adequate MA staff at their clinic.

Continue to: Efficiency and competing priorities

Efficiency and competing priorities

MAs described important work values that increased their efficiency. These included clinic culture (good communication and strong teamwork), as well as individual strategies such as multitasking, limiting patient conversations, and doing tasks in a consistent way to improve accuracy. (See TABLE 1.) They identified ways physicians bolster or hurt efficiency and ways in which the relationship between the physician and the MA shapes the MA’s perception of their value in clinic.

When asked about “pet peeves,” a few MAs advised that physicians should not “talk down” to staff and should try to teach rather than criticize.

Communication was emphasized as critical for efficient care, and MAs encouraged the use of preclinic huddles and communication as priorities. Seventy-five percent of MAs reported preclinic huddles to plan for patient care were helpful, but only half said huddles took place “always” or “most of the time.” Many described reviewing the schedule and completing tasks ahead of patient arrival as critical to efficiency.

Participants described the tension between their identified role of orchestrating clinic flow and responding to directives by others that disrupted the flow. Several MAs found it challenging when physicians agreed to see very late patients and felt frustrated when decisions that changed the flow were made by the physician or front desk staff without including the MA. MAs were also able to articulate how they managed competing priorities within the clinic, such as when a patient- or physician-driven need to extend appointments was at odds with maintaining a timely schedule. They were eager to share personal tips for time management and prided themselves on careful and accurate performance and skills they had learned on the job. MAs also described how efficiency could be adversely affected by the behaviors or attitudes of physicians. (See TABLE 2.)

Clinic environment

Thirty-six MAs (59%) reported that other MAs on their team were willing to help them out in clinic “a great deal” or “a lot” of the time, by helping to room a patient, acting as a chaperone for an exam, or doing a point-of-care lab. This sense of support varied across clinics (38% to 91% reported good support), suggesting that cultures vary by site. Some MAs expressed frustration at peers they saw as resistant to helping, exemplified by this verbatim quote from an interview:

“ Some don’t want to help out. They may sigh. It’s how they react—you just know.” (Clinic #1, MA #2 interview)

Efficient MAs stressed the need for situational awareness to recognize when co-workers need help:

“ [Peers often] are not aware that another MA is drowning. There’s 5 people who could have done that, and here I am running around and nobody budged.” (Clinic #5, MA #2 interview)

Continue to: A minority of staff...

A minority of staff used the open-ended survey sections to describe clinic hierarchy. When asked about “pet peeves,” a few advised that physicians should not “talk down” to staff and should try to teach rather than criticize. Another asked that physicians not “bark orders” or have “low gratitude” for staff work. MAs found micromanaging stressful—particularly when the physician prompted the MA about patient arrivals:

“[I don’t like] when providers will make a comment about a patient arriving when you already know this information. You then rush to put [the] patient in [a] room, then [the] provider ends up making [the] patient wait an extensive amount of time. I’m perfectly capable of knowing when a patient arrives.” (Clinic #6, survey)

MAs did not like physicians “talking bad about us” or blaming the MA if the clinic is running behind.

Despite these concerns, most MAs reported feeling appreciated for the job they do. Only 10 (16%) reported that the people they work with rarely say “thank you,” and 2 (3%) stated they were not well supported by the physicians in clinic. Most (n = 38; 62%) strongly agreed or agreed that they felt part of the team and that their opinions matter. In the interviews, many expanded on this idea:

“I really feel like I’m valued, so I want to do everything I can to make [my doctor’s] day go better. If you want a good clinic, the best thing a doc can do is make the MA feel valued.” (Clinic #1, MA #1 interview)

DISCUSSION

Participants described their role much as an orchestra director, with MAs as the key to clinic flow and timeliness.⁹ Respondents articulated multiple common strategies used to increase their own efficiency and clinic flow; these may be considered best practices and incorporated as part of the basic training. Most MAs reported their day-to-day jobs were stressful and believed this was underrecognized, so efficiency strategies are critical. With staff completing multiple time-sensitive tasks during clinic, consistent co-worker support is crucial and may impact efficiency.⁸ Proper training of managers to provide that support and ensure equitable workloads may be one strategy to ensure that staff members feel the workplace is fair and collegial.

Several comments reflected the power differential within medical offices. One study reported that MAs and physicians “occupy roles at opposite ends of social and occupational hierarchies.”¹¹ It’s important for physicians to be cognizant of these patterns and clinic culture, as reducing a hierarchy-based environment will be appreciated by MAs.⁹ Prior research has found that MAs have higher perceptions of their own competence than do the physicians working with them.¹² If there is a fundamental lack of trust between the 2 groups, this will undoubtedly hinder team-building. Attention to this issue is key to a more favorable work environment.

Continue to: Almost all respondents...

Almost all respondents reported health care was a “calling,” which mirrors physician research that suggests seeing work as a “calling” is protective against burnout.^13,14 Open-ended comments indicated great pride in contributions, and most staff members felt appreciated by their teams. Many described the working relationships with physicians as critical to their satisfaction at work and indicated that strong partnerships motivated them to do their best to make the physician’s day easier. Staff job satisfaction is linked to improved quality of care, so treating staff well contributes to high-value care for patients.¹⁵ We also uncovered some MA “pet peeves” that hinder efficiency and could be shared with physicians to emphasize the importance of patience and civility.

One barrier to expansion of MA roles within PCMH practices is the limited pay and career ladder for MAs who adopt new job responsibilities that require advanced skills or training.^1,2 The mean MA salary at our institution ($37,372) is higher than in our state overall ($33,760), which may impact satisfaction.¹⁶ In addition, 93% of MAs are women; thus, they may continue to struggle more with lower pay than do workers in male-­dominated professions.^17,18 Expected job growth from 2018-2028 is predicted at 23%, which may help to boost salaries.¹⁹ Prior studies describe the lack of a job ladder or promotion opportunities as a challenge^1,20; this was not formally assessed in our study.

Prior research has found that MAs have higher perceptions of their own competence than do the physicians working with them.

MAs see work in family medicine as much harder than it is in other specialty clinics. Being trusted with more responsibility, greater autonomy,^21-23 and expanded patient care roles can boost MA self-efficacy, which can reduce burnout for both physicians and MAs.^8,24 However, new responsibilities should include appropriate training, support, and compensation, and match staff interests.⁷

Study limitations. The study was limited to 6 clinics in 1 department at a large academic medical center. Interviewed participants were selected by convenience and snowball sampling and thus, the results cannot be generalized to the population of MAs as a whole. As the initial interview goal was simply to gather efficiency tips, the project was not designed to be formal qualitative research. However, the discussions built on open-ended comments from the written survey helped contextualize our quantitative findings about efficiency. Notes were documented in real time by a single interviewer with rapid typing skills, which allowed capture of quotes verbatim. Subsequent studies would benefit from more formal qualitative research methods (recording and transcribing interviews, multiple coders to reduce risk of bias, and more complex thematic analysis).

Our research demonstrated how MAs perceive their roles in primary care and the facilitators and barriers to high efficiency in the workplace, which begins to fill an important knowledge gap in primary care. Disseminating practices that staff members themselves have identified as effective, and being attentive to how staff members are treated, may increase individual efficiency while improving staff retention and satisfaction.

CORRESPONDENCE
Katherine J. Gold, MD, MSW, MS, Department of Family Medicine and Department of Obstetrics and Gynecology, University of Michigan, 1018 Fuller Street, Ann Arbor, MI 48104-1213; [email protected]