User login
For MD-IQ use only
Artifactual hypoglycemia: When there’s a problem in the tube
If you are looking for zebras you might consider adrenal insufficiency, which could cause both hyperkalemia and hypoglycemia, but this would make no sense in someone asymptomatic.
This pattern is one I have seen commonly when I am on call, and I am contacted about abnormal labs. The lab reported no hemolysis seen, but this is the typical pattern seen with hemolytic specimens and/or specimens that have been held a long time before they are analyzed.
Lippi and colleagues reported on the clinically significant increase in potassium in samples that visually appeared not to be hemolyzed.1 Hemolyzed specimens can also drop glucose values, but not as profoundly as raising potassium values. When left unprocessed, glycolysis occurs in the white blood cells of a blood sample and may consume 5%-7% of the sample’s glucose content per hour.2
Khaled and colleagues looked at the drop in glucose levels in samples over time based on what anticoagulants were used.3 They found that, at 3 hours, glucose measurements were decreased by 28.4 mg/dL when sodium citrate is used, 58 mg/dL when EDTA was used, 15.4 mg/dL when fluoride oxalate was used, and 60.2 mg/dL when no anticoagulant is used.
Low blood sugars caused by elevated WBCs in blood samples has been well described.4 It has been described with moderate and very high WBC counts, as well as with the leukocytosis seen with polycythemia vera.5 The term “leukocyte larceny” has been used to describe high WBC counts that can not only utilize glucose, but also oxygen.
Saccheti and colleagues described a patient with a WBC greater than 500,000 who had repeatedly low oxygen levels on blood gases, that did not correlate with the normal oxygen saturations measured by pulse oximetry.6 This same issue has been seen in patients with extreme thrombocytosis.7Pearl: When labs don’t make sense clinically, always look at the possibility that there may be a problem in the tube and not in the person. Especially think of this when blood samples may have been held for a long time before they are run, such as with visiting nurse visits and blood draws at shelters and nursing homes.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at imnews@mdedge.com.
References
1. Lippi G et al. Clin Chem Lab Med. 2006;44(3):311-6.
2. Mikesh LM and Bruns DE. Clin Chem. 2008 May;54(5):930-2.
3. Khaled S et al. Al-Mukhtar Journal of Sciences. 2018;33(2):100-6.
4. Goodenow TJ and Malarkey WB. JAMA. 1977;237(18):1961-2.
5. R Arem et al. Arch Intern Med. 1982 Nov;142(12):2199-201.
6. Sacchetti A et al. J Emerg Med. 1990;8:567–569.
7. A Mehta et al. Eur Respir J. 2008 Feb;31(2):469-72.
If you are looking for zebras you might consider adrenal insufficiency, which could cause both hyperkalemia and hypoglycemia, but this would make no sense in someone asymptomatic.
This pattern is one I have seen commonly when I am on call, and I am contacted about abnormal labs. The lab reported no hemolysis seen, but this is the typical pattern seen with hemolytic specimens and/or specimens that have been held a long time before they are analyzed.
Lippi and colleagues reported on the clinically significant increase in potassium in samples that visually appeared not to be hemolyzed.1 Hemolyzed specimens can also drop glucose values, but not as profoundly as raising potassium values. When left unprocessed, glycolysis occurs in the white blood cells of a blood sample and may consume 5%-7% of the sample’s glucose content per hour.2
Khaled and colleagues looked at the drop in glucose levels in samples over time based on what anticoagulants were used.3 They found that, at 3 hours, glucose measurements were decreased by 28.4 mg/dL when sodium citrate is used, 58 mg/dL when EDTA was used, 15.4 mg/dL when fluoride oxalate was used, and 60.2 mg/dL when no anticoagulant is used.
Low blood sugars caused by elevated WBCs in blood samples has been well described.4 It has been described with moderate and very high WBC counts, as well as with the leukocytosis seen with polycythemia vera.5 The term “leukocyte larceny” has been used to describe high WBC counts that can not only utilize glucose, but also oxygen.
Saccheti and colleagues described a patient with a WBC greater than 500,000 who had repeatedly low oxygen levels on blood gases, that did not correlate with the normal oxygen saturations measured by pulse oximetry.6 This same issue has been seen in patients with extreme thrombocytosis.7Pearl: When labs don’t make sense clinically, always look at the possibility that there may be a problem in the tube and not in the person. Especially think of this when blood samples may have been held for a long time before they are run, such as with visiting nurse visits and blood draws at shelters and nursing homes.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at imnews@mdedge.com.
References
1. Lippi G et al. Clin Chem Lab Med. 2006;44(3):311-6.
2. Mikesh LM and Bruns DE. Clin Chem. 2008 May;54(5):930-2.
3. Khaled S et al. Al-Mukhtar Journal of Sciences. 2018;33(2):100-6.
4. Goodenow TJ and Malarkey WB. JAMA. 1977;237(18):1961-2.
5. R Arem et al. Arch Intern Med. 1982 Nov;142(12):2199-201.
6. Sacchetti A et al. J Emerg Med. 1990;8:567–569.
7. A Mehta et al. Eur Respir J. 2008 Feb;31(2):469-72.
If you are looking for zebras you might consider adrenal insufficiency, which could cause both hyperkalemia and hypoglycemia, but this would make no sense in someone asymptomatic.
This pattern is one I have seen commonly when I am on call, and I am contacted about abnormal labs. The lab reported no hemolysis seen, but this is the typical pattern seen with hemolytic specimens and/or specimens that have been held a long time before they are analyzed.
Lippi and colleagues reported on the clinically significant increase in potassium in samples that visually appeared not to be hemolyzed.1 Hemolyzed specimens can also drop glucose values, but not as profoundly as raising potassium values. When left unprocessed, glycolysis occurs in the white blood cells of a blood sample and may consume 5%-7% of the sample’s glucose content per hour.2
Khaled and colleagues looked at the drop in glucose levels in samples over time based on what anticoagulants were used.3 They found that, at 3 hours, glucose measurements were decreased by 28.4 mg/dL when sodium citrate is used, 58 mg/dL when EDTA was used, 15.4 mg/dL when fluoride oxalate was used, and 60.2 mg/dL when no anticoagulant is used.
Low blood sugars caused by elevated WBCs in blood samples has been well described.4 It has been described with moderate and very high WBC counts, as well as with the leukocytosis seen with polycythemia vera.5 The term “leukocyte larceny” has been used to describe high WBC counts that can not only utilize glucose, but also oxygen.
Saccheti and colleagues described a patient with a WBC greater than 500,000 who had repeatedly low oxygen levels on blood gases, that did not correlate with the normal oxygen saturations measured by pulse oximetry.6 This same issue has been seen in patients with extreme thrombocytosis.7Pearl: When labs don’t make sense clinically, always look at the possibility that there may be a problem in the tube and not in the person. Especially think of this when blood samples may have been held for a long time before they are run, such as with visiting nurse visits and blood draws at shelters and nursing homes.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at imnews@mdedge.com.
References
1. Lippi G et al. Clin Chem Lab Med. 2006;44(3):311-6.
2. Mikesh LM and Bruns DE. Clin Chem. 2008 May;54(5):930-2.
3. Khaled S et al. Al-Mukhtar Journal of Sciences. 2018;33(2):100-6.
4. Goodenow TJ and Malarkey WB. JAMA. 1977;237(18):1961-2.
5. R Arem et al. Arch Intern Med. 1982 Nov;142(12):2199-201.
6. Sacchetti A et al. J Emerg Med. 1990;8:567–569.
7. A Mehta et al. Eur Respir J. 2008 Feb;31(2):469-72.
Combo thyroid hormones as good as levothyroxine for hypothyroidism
Patients with hypothyroidism treated with the three most common pharmacologic strategies of levothyroxine (LT4) alone, LT4 in combination with triiodothyronine (T3), or desiccated thyroid extract showed no differences in thyroid symptoms or secondary outcomes in a double-blind, randomized study.
“There are now proven good treatment options for the more than 1 in 10 patients with hypothyroidism who continue to experience symptoms of fatigue, mental fogginess, weight gain, and other symptoms despite taking levothyroxine,” first author Thanh Duc Hoang, DO, an endocrinologist at the Walter Reed National Military Medical Center, in Bethesda, Md., said in a press statement.
The findings were presented at the annual meeting of the Endocrine Society.
Commenting on the study, Alan P. Farwell, MD, said these new results are a valuable contribution to the understanding of treatment effects. “I think this is an interesting and important study and further studies are needed to clarify the optimal way to treat hypothyroidism,” said Dr. Farwell, who is director of endocrine clinics at Boston University.
Importantly, “the findings are different than studies where the patients are aware of what medication they are receiving,” he stressed in an interview, underscoring the importance of the double-blind design of the trial.
But Anne Cappola, MD, of the University of Pennsylvania, Philadelphia, pointed out that “the study was small and unlikely to have the statistical power to detect differences that could have been clinically important.”
Nevertheless, she too agreed that the double-blind study design is key: “My experience with patients is [the effects] are affected by patients’ perceptions about their thyroid medication. That is why studies designed so that patients do not know which treatment they are receiving are so important in this area.”
Randomized, double-blind comparison
Prior to the widespread availability of the current gold standard hypothyroidism treatment of LT4, the condition was typically treated with desiccated (animal) thyroid extract. And with many patients continuing to have a preference for this therapeutic approach, it is still commonly used.
Additionally, some patients treated with LT4 alone report greater improvements in symptoms with the addition of T3 – despite studies showing no benefits from the two together – leading to many clinicians commonly trying the combination approach.
To compare the efficacy of the three approaches in a prospective, double-blind, cross-over fashion, 75 patients received three therapeutic approaches each for 3 months: desiccated thyroid extract, an LT4/T3 combination, or LT4 alone.
After each 3-month treatment, patients completed a 36-point thyroid symptom questionnaire.
There was no significant differences in symptom relief, the primary outcome, between the three treatments (P = .32).
Overall, 45% of patients indicated they preferred desiccated thyroid as their first choice of treatment, 32% preferred LT4/T3 as their first choice, and 23% preferred LT4 alone.
For the secondary endpoints of weight, general health, depression (assessed using the Beck Depression Inventory), memory (Wechsler Memory Scale), lipids, and thyroid function, again, there were no significant differences between groups in any of the measures.
When switched to desiccated thyroid, many felt ‘much better’
A further exploratory analysis revealed that those who experienced symptoms while taking LT4 alone reported greater alleviation of symptoms with the other two treatments.
“As a whole group, there was no significant difference between the three treatment arms,” Dr. Hoang explained in an interview.
“However, with the subgroup analysis based on the scores of symptom questionnaires, we found that symptomatic patients on LT4 improved while being treated with LT4/T3 or desiccated thyroid,” he said.
Reports of improvements in switching to desiccated thyroid were notable, Dr. Hoang added. “Many patients when switched from LT4 to desiccated thyroid extract said they felt much better, [with] more energy, less mental fogginess, a better outlook, less flair of lupus symptoms, easier to lose weight, etc.”
The study also showed more patients with Hashimoto’s disease preferred desiccated thyroid extract and LT4/T3, compared with LT4 alone, however, the differences were not significant.
Treatment adjustments a helpful first step
Dr. Farwell noted that his approach when patients are still reporting symptoms despite LT4 treatment is to first try tweaking the dose.
“In my own practice, I prefer to adjust LT4 dosing first, and on occasion add T3, with a goal of getting both hormone levels in the upper half of the normal range,” he said. “I find that to be a better approach than desiccated thyroid extract. T3 should be taken twice a day due to its half-life.”
The approach is generally successful, he added. “Even those that come in asking for desiccated thyroid extract whom I am able to convince to try LT4/T3 end up being happy with their treatment in the end.
“The key is that you need to spend time discussing the options with patients and come to a consensus as to the therapy that will best resolve their symptoms and that they are most comfortable with,” he concluded.
In response to mounting evidence of different hypothyroidism treatment responses according to various subgroups of patients, experts recently called for the initiation of more thorough clinical trials on the issue of combination therapy, as recently reported by this news organization.
Dr. Hoang reported being a speaker for Acella Pharmaceuticals. Dr. Farwell and Dr. Cappola reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Patients with hypothyroidism treated with the three most common pharmacologic strategies of levothyroxine (LT4) alone, LT4 in combination with triiodothyronine (T3), or desiccated thyroid extract showed no differences in thyroid symptoms or secondary outcomes in a double-blind, randomized study.
“There are now proven good treatment options for the more than 1 in 10 patients with hypothyroidism who continue to experience symptoms of fatigue, mental fogginess, weight gain, and other symptoms despite taking levothyroxine,” first author Thanh Duc Hoang, DO, an endocrinologist at the Walter Reed National Military Medical Center, in Bethesda, Md., said in a press statement.
The findings were presented at the annual meeting of the Endocrine Society.
Commenting on the study, Alan P. Farwell, MD, said these new results are a valuable contribution to the understanding of treatment effects. “I think this is an interesting and important study and further studies are needed to clarify the optimal way to treat hypothyroidism,” said Dr. Farwell, who is director of endocrine clinics at Boston University.
Importantly, “the findings are different than studies where the patients are aware of what medication they are receiving,” he stressed in an interview, underscoring the importance of the double-blind design of the trial.
But Anne Cappola, MD, of the University of Pennsylvania, Philadelphia, pointed out that “the study was small and unlikely to have the statistical power to detect differences that could have been clinically important.”
Nevertheless, she too agreed that the double-blind study design is key: “My experience with patients is [the effects] are affected by patients’ perceptions about their thyroid medication. That is why studies designed so that patients do not know which treatment they are receiving are so important in this area.”
Randomized, double-blind comparison
Prior to the widespread availability of the current gold standard hypothyroidism treatment of LT4, the condition was typically treated with desiccated (animal) thyroid extract. And with many patients continuing to have a preference for this therapeutic approach, it is still commonly used.
Additionally, some patients treated with LT4 alone report greater improvements in symptoms with the addition of T3 – despite studies showing no benefits from the two together – leading to many clinicians commonly trying the combination approach.
To compare the efficacy of the three approaches in a prospective, double-blind, cross-over fashion, 75 patients received three therapeutic approaches each for 3 months: desiccated thyroid extract, an LT4/T3 combination, or LT4 alone.
After each 3-month treatment, patients completed a 36-point thyroid symptom questionnaire.
There was no significant differences in symptom relief, the primary outcome, between the three treatments (P = .32).
Overall, 45% of patients indicated they preferred desiccated thyroid as their first choice of treatment, 32% preferred LT4/T3 as their first choice, and 23% preferred LT4 alone.
For the secondary endpoints of weight, general health, depression (assessed using the Beck Depression Inventory), memory (Wechsler Memory Scale), lipids, and thyroid function, again, there were no significant differences between groups in any of the measures.
When switched to desiccated thyroid, many felt ‘much better’
A further exploratory analysis revealed that those who experienced symptoms while taking LT4 alone reported greater alleviation of symptoms with the other two treatments.
“As a whole group, there was no significant difference between the three treatment arms,” Dr. Hoang explained in an interview.
“However, with the subgroup analysis based on the scores of symptom questionnaires, we found that symptomatic patients on LT4 improved while being treated with LT4/T3 or desiccated thyroid,” he said.
Reports of improvements in switching to desiccated thyroid were notable, Dr. Hoang added. “Many patients when switched from LT4 to desiccated thyroid extract said they felt much better, [with] more energy, less mental fogginess, a better outlook, less flair of lupus symptoms, easier to lose weight, etc.”
The study also showed more patients with Hashimoto’s disease preferred desiccated thyroid extract and LT4/T3, compared with LT4 alone, however, the differences were not significant.
Treatment adjustments a helpful first step
Dr. Farwell noted that his approach when patients are still reporting symptoms despite LT4 treatment is to first try tweaking the dose.
“In my own practice, I prefer to adjust LT4 dosing first, and on occasion add T3, with a goal of getting both hormone levels in the upper half of the normal range,” he said. “I find that to be a better approach than desiccated thyroid extract. T3 should be taken twice a day due to its half-life.”
The approach is generally successful, he added. “Even those that come in asking for desiccated thyroid extract whom I am able to convince to try LT4/T3 end up being happy with their treatment in the end.
“The key is that you need to spend time discussing the options with patients and come to a consensus as to the therapy that will best resolve their symptoms and that they are most comfortable with,” he concluded.
In response to mounting evidence of different hypothyroidism treatment responses according to various subgroups of patients, experts recently called for the initiation of more thorough clinical trials on the issue of combination therapy, as recently reported by this news organization.
Dr. Hoang reported being a speaker for Acella Pharmaceuticals. Dr. Farwell and Dr. Cappola reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Patients with hypothyroidism treated with the three most common pharmacologic strategies of levothyroxine (LT4) alone, LT4 in combination with triiodothyronine (T3), or desiccated thyroid extract showed no differences in thyroid symptoms or secondary outcomes in a double-blind, randomized study.
“There are now proven good treatment options for the more than 1 in 10 patients with hypothyroidism who continue to experience symptoms of fatigue, mental fogginess, weight gain, and other symptoms despite taking levothyroxine,” first author Thanh Duc Hoang, DO, an endocrinologist at the Walter Reed National Military Medical Center, in Bethesda, Md., said in a press statement.
The findings were presented at the annual meeting of the Endocrine Society.
Commenting on the study, Alan P. Farwell, MD, said these new results are a valuable contribution to the understanding of treatment effects. “I think this is an interesting and important study and further studies are needed to clarify the optimal way to treat hypothyroidism,” said Dr. Farwell, who is director of endocrine clinics at Boston University.
Importantly, “the findings are different than studies where the patients are aware of what medication they are receiving,” he stressed in an interview, underscoring the importance of the double-blind design of the trial.
But Anne Cappola, MD, of the University of Pennsylvania, Philadelphia, pointed out that “the study was small and unlikely to have the statistical power to detect differences that could have been clinically important.”
Nevertheless, she too agreed that the double-blind study design is key: “My experience with patients is [the effects] are affected by patients’ perceptions about their thyroid medication. That is why studies designed so that patients do not know which treatment they are receiving are so important in this area.”
Randomized, double-blind comparison
Prior to the widespread availability of the current gold standard hypothyroidism treatment of LT4, the condition was typically treated with desiccated (animal) thyroid extract. And with many patients continuing to have a preference for this therapeutic approach, it is still commonly used.
Additionally, some patients treated with LT4 alone report greater improvements in symptoms with the addition of T3 – despite studies showing no benefits from the two together – leading to many clinicians commonly trying the combination approach.
To compare the efficacy of the three approaches in a prospective, double-blind, cross-over fashion, 75 patients received three therapeutic approaches each for 3 months: desiccated thyroid extract, an LT4/T3 combination, or LT4 alone.
After each 3-month treatment, patients completed a 36-point thyroid symptom questionnaire.
There was no significant differences in symptom relief, the primary outcome, between the three treatments (P = .32).
Overall, 45% of patients indicated they preferred desiccated thyroid as their first choice of treatment, 32% preferred LT4/T3 as their first choice, and 23% preferred LT4 alone.
For the secondary endpoints of weight, general health, depression (assessed using the Beck Depression Inventory), memory (Wechsler Memory Scale), lipids, and thyroid function, again, there were no significant differences between groups in any of the measures.
When switched to desiccated thyroid, many felt ‘much better’
A further exploratory analysis revealed that those who experienced symptoms while taking LT4 alone reported greater alleviation of symptoms with the other two treatments.
“As a whole group, there was no significant difference between the three treatment arms,” Dr. Hoang explained in an interview.
“However, with the subgroup analysis based on the scores of symptom questionnaires, we found that symptomatic patients on LT4 improved while being treated with LT4/T3 or desiccated thyroid,” he said.
Reports of improvements in switching to desiccated thyroid were notable, Dr. Hoang added. “Many patients when switched from LT4 to desiccated thyroid extract said they felt much better, [with] more energy, less mental fogginess, a better outlook, less flair of lupus symptoms, easier to lose weight, etc.”
The study also showed more patients with Hashimoto’s disease preferred desiccated thyroid extract and LT4/T3, compared with LT4 alone, however, the differences were not significant.
Treatment adjustments a helpful first step
Dr. Farwell noted that his approach when patients are still reporting symptoms despite LT4 treatment is to first try tweaking the dose.
“In my own practice, I prefer to adjust LT4 dosing first, and on occasion add T3, with a goal of getting both hormone levels in the upper half of the normal range,” he said. “I find that to be a better approach than desiccated thyroid extract. T3 should be taken twice a day due to its half-life.”
The approach is generally successful, he added. “Even those that come in asking for desiccated thyroid extract whom I am able to convince to try LT4/T3 end up being happy with their treatment in the end.
“The key is that you need to spend time discussing the options with patients and come to a consensus as to the therapy that will best resolve their symptoms and that they are most comfortable with,” he concluded.
In response to mounting evidence of different hypothyroidism treatment responses according to various subgroups of patients, experts recently called for the initiation of more thorough clinical trials on the issue of combination therapy, as recently reported by this news organization.
Dr. Hoang reported being a speaker for Acella Pharmaceuticals. Dr. Farwell and Dr. Cappola reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Metyrapone for Cushing’s syndrome: Safe, effective in first test
Metyrapone, an inhibitor of endogenous adrenal corticosteroid synthesis currently used in U.S. practice to test adrenocorticotropic hormone (ACTH) function, was safe and effective for treating endogenous Cushing’s syndrome in a multicenter, open-label, single-arm study of 50 patients, the first prospective test of metyrapone (Metopirone) as a therapeutic agent.
Treatment with metyrapone for 12 weeks normalized mean levels of urinary free cortisol (UFC) in 23 of the 49 patients (47%) in the efficacy analysis, and cut pretreatment mean UFC levels by at least 50% in another 16 patients (33%). Treatment also improved clinical signs of hypercortisolism, associated comorbidities, and quality of life, and was well tolerated, Lynnette K. Nieman, MD, said at the annual meeting of the Endocrine Society.
“This prospective study confirms that metyrapone is effective, has a rapid onset of action, and is a safe medical treatment for endogenous Cushing’s syndrome,” declared Dr. Nieman, chief of the endocrinology consultation service of the National Institutes of Health Clinical Center in Bethesda, Md.
The study included a 24-week extension phase of continued metyrapone treatment in patients whose mean UFC level fell to less than two times the upper limit of normal (ULN), but Dr. Nieman did not report results from this extension.
Confirmation of off-label and European experience
“This was the first prospective study of metyrapone, albeit a small study and with only short-term data presented. It confirms what we have known from its off label use in the U.S. and retrospective studies in the U.K. and Europe: Metyrapone normalizes mean UFC in approximately half of patients. Probably with more aggressive up titration efficacy will have been even higher, but of course with the trade-off of adrenal insufficiency,” said Maria Fleseriu, MD, professor and director of the pituitary center at Oregon Health & Science University in Portland, who was not involved with the study.
“Longer-term data from this prospective study is clearly needed to evaluate for possible loss of response, as well as adverse events related to precursors accumulation. We also need data on tumor size with long-term use in patients with Cushing’s disease, “Dr. Fleseriu added in an interview.
“Metyrapone, an 11-hydroxylase inhibitor, is not [Food and Drug Administration–approved for therapy] and thus it will be hard for it to become a first-line medical therapy,” she continued. “Furthermore, multiple times a day administration is not ideal for most patients; however if metyrapone is readily available and cheaper than other drugs, its use might increase over time. Hirsutism in women (though not all women develop this) and hypertension could be issues with long-term use,” she cautioned.
“We have used metyrapone off label for many years. It has a rapid onset of action, and we also have experience using it in combination therapy with ketoconazole, especially in patients with severe Cushing’s, although ketoconazole is not [FDA] approved for Cushing’s syndrome, and all combination therapies are off-label, too,” Dr. Fleseriu noted.
Metyrapone is approved by the European Medicines Agency for treating Cushing’s syndrome based “on observational, retrospective studies published over more than 50 years,” according to Dr. Nieman. The drug has FDA approval only for diagnostic purposes.
The PROMPT (Effects of Metyrapone in Patients With Endogenous Cushing’s Syndrome) study enrolled patients in eight European countries who were newly diagnosed with endogenous Cushing’s syndrome of any etiology. The study excluded patients with an advanced adrenal carcinoma, as well as patients with recurrent or persistent Cushing’s disease following transsphenoidal surgery. Patients also needed three 24-hour measures of UFC that were at least 50% above the ULN (165 nmol/24 hours).
The average age of the patients was 46 years; 69% were women, 90% had Cushing’s disease, and 8% had ectopic ACTH secretion. The average time from initial symptom onset was 4 years. Sixty-one percent had a history of pituitary surgery, 69% were hypertensive, 43% had diabetes or glucose intolerance, and 41% had osteoporosis. The median mean UFC at entry was 570 nmol/24 hours, which is 3.5 times the ULN, and ranged from 291 to 8,476 nmol/24 hours.
Patients began on a metyrapone dosage of 750 mg/day unless their mean UFC exceeded 5 times the ULN, in which case the dosage doubled to 1,500 mg/day. During the 12-week period, clinicians up- or down-titrated the dosage to ideally achieve a UFC less than the ULN while maintaining serum cortisol levels of 7-12 mcg/dL to preclude adrenal insufficiency effects. The median dosage at the end of 12 weeks was 1,500 mg/day, and ranged from 250 to 5,500 mg/day. One of the 50 patients dropped out because of an unrelated acute medical condition, and two patients underwent pituitary surgery despite a response to metyrapone and were included in the efficacy analysis.
After the first week on treatment, patients had a median 49% cut from their baseline UFC level, and after 12 weeks this rose to a median 74% cut from baseline. The study’s primary endpoint was normalization of UFC after 12 weeks, which occurred in 47% of patients, while 22% had a normal level in a late-night salivary cortisol measurement.
Two-thirds of patients had an improvement or resolution of their signs and symptoms, on average quality of life scores improved, median systolic and diastolic blood pressures decreased by 4-5 mm Hg, and average A1c levels were stable, but the mean cholesterol level decreased significantly, and testosterone levels rose significantly in women.
Proper dose titration makes a difference
Adverse events occurred in 26 of the 50 patients (52%) who received any treatment; 1 patient had a serious adverse event, 7 patients required a dosage adjustment because of adverse events, and 6 patients stopped treatment. The most common adverse events were gastrointestinal – nausea in 24% and decreased appetite in 18% – as well as mild symptoms consistent with adrenal insufficiency such as fatigue and headache. Six patients (12%) were identified with reversible adrenal insufficiency, and no patients complained of worsening acne or hirsutism.
“I think the adverse events are a function of [less than optimal] dose titration and variability in UFC levels,” said Dr. Nieman.
This test of metyrapone’s efficacy comes a year after the FDA approved osilodrostat (Isturisa) for treating Cushing’s disease (but not Cushing’s syndrome). Like metyrapone, osilodrostat controls cortisol overproduction by blocking the enzyme 11-beta-hydroxylase and preventing cortisol synthesis, and osilodrostat was the first agent with these properties to receive an FDA label for therapy.
Osilodrostat “is the only adrenal steroidogenesis inhibitor assessed in randomized controlled long-term trials – over 200 patients with Cushing’s disease – and it has been shown to be highly effective at maintaining normal urinary free cortisol in large majority of patients with Cushing’s disease, as well as Cushing’s syndrome in a study in Japan. Adrenal insufficiency was high [with osilodrostat], especially with the high dose in the trial with forced uptitration. In my clinical practice I have noticed less adrenal insufficiency, but I use much slower drug titration,” said Dr. Fleseriu.
“I think these drugs [metyrapone and osilodrostat] are relatively equivalent,” Dr. Nieman said during discussion of her report. “One nonmedical judgment will be cost,” she added. “Everyone is looking forward to what the pricing structure will be for the new drugs.”
Dr. Fleseriu noted that “for most patients, surgery is first-line therapy, and rarely medication is an alternative first option, especially for Cushing’s disease. However, medical therapy is essential in the management of patients with Cushing’s syndrome when curative surgery fails, surgery is not feasible, when a patient is awaiting radiation’s effect, and for recurrent cases of Cushing’s syndrome.”
PROMPT was sponsored by HRA Pharma, the company that markets metyrapone. Dr. Nieman had no disclosures, but several of her associates on the study are HRA employees. Dr. Fleseriu has been a consultant to Novartis, Recordati, Sparrow, and Strongbridge.
Metyrapone, an inhibitor of endogenous adrenal corticosteroid synthesis currently used in U.S. practice to test adrenocorticotropic hormone (ACTH) function, was safe and effective for treating endogenous Cushing’s syndrome in a multicenter, open-label, single-arm study of 50 patients, the first prospective test of metyrapone (Metopirone) as a therapeutic agent.
Treatment with metyrapone for 12 weeks normalized mean levels of urinary free cortisol (UFC) in 23 of the 49 patients (47%) in the efficacy analysis, and cut pretreatment mean UFC levels by at least 50% in another 16 patients (33%). Treatment also improved clinical signs of hypercortisolism, associated comorbidities, and quality of life, and was well tolerated, Lynnette K. Nieman, MD, said at the annual meeting of the Endocrine Society.
“This prospective study confirms that metyrapone is effective, has a rapid onset of action, and is a safe medical treatment for endogenous Cushing’s syndrome,” declared Dr. Nieman, chief of the endocrinology consultation service of the National Institutes of Health Clinical Center in Bethesda, Md.
The study included a 24-week extension phase of continued metyrapone treatment in patients whose mean UFC level fell to less than two times the upper limit of normal (ULN), but Dr. Nieman did not report results from this extension.
Confirmation of off-label and European experience
“This was the first prospective study of metyrapone, albeit a small study and with only short-term data presented. It confirms what we have known from its off label use in the U.S. and retrospective studies in the U.K. and Europe: Metyrapone normalizes mean UFC in approximately half of patients. Probably with more aggressive up titration efficacy will have been even higher, but of course with the trade-off of adrenal insufficiency,” said Maria Fleseriu, MD, professor and director of the pituitary center at Oregon Health & Science University in Portland, who was not involved with the study.
“Longer-term data from this prospective study is clearly needed to evaluate for possible loss of response, as well as adverse events related to precursors accumulation. We also need data on tumor size with long-term use in patients with Cushing’s disease, “Dr. Fleseriu added in an interview.
“Metyrapone, an 11-hydroxylase inhibitor, is not [Food and Drug Administration–approved for therapy] and thus it will be hard for it to become a first-line medical therapy,” she continued. “Furthermore, multiple times a day administration is not ideal for most patients; however if metyrapone is readily available and cheaper than other drugs, its use might increase over time. Hirsutism in women (though not all women develop this) and hypertension could be issues with long-term use,” she cautioned.
“We have used metyrapone off label for many years. It has a rapid onset of action, and we also have experience using it in combination therapy with ketoconazole, especially in patients with severe Cushing’s, although ketoconazole is not [FDA] approved for Cushing’s syndrome, and all combination therapies are off-label, too,” Dr. Fleseriu noted.
Metyrapone is approved by the European Medicines Agency for treating Cushing’s syndrome based “on observational, retrospective studies published over more than 50 years,” according to Dr. Nieman. The drug has FDA approval only for diagnostic purposes.
The PROMPT (Effects of Metyrapone in Patients With Endogenous Cushing’s Syndrome) study enrolled patients in eight European countries who were newly diagnosed with endogenous Cushing’s syndrome of any etiology. The study excluded patients with an advanced adrenal carcinoma, as well as patients with recurrent or persistent Cushing’s disease following transsphenoidal surgery. Patients also needed three 24-hour measures of UFC that were at least 50% above the ULN (165 nmol/24 hours).
The average age of the patients was 46 years; 69% were women, 90% had Cushing’s disease, and 8% had ectopic ACTH secretion. The average time from initial symptom onset was 4 years. Sixty-one percent had a history of pituitary surgery, 69% were hypertensive, 43% had diabetes or glucose intolerance, and 41% had osteoporosis. The median mean UFC at entry was 570 nmol/24 hours, which is 3.5 times the ULN, and ranged from 291 to 8,476 nmol/24 hours.
Patients began on a metyrapone dosage of 750 mg/day unless their mean UFC exceeded 5 times the ULN, in which case the dosage doubled to 1,500 mg/day. During the 12-week period, clinicians up- or down-titrated the dosage to ideally achieve a UFC less than the ULN while maintaining serum cortisol levels of 7-12 mcg/dL to preclude adrenal insufficiency effects. The median dosage at the end of 12 weeks was 1,500 mg/day, and ranged from 250 to 5,500 mg/day. One of the 50 patients dropped out because of an unrelated acute medical condition, and two patients underwent pituitary surgery despite a response to metyrapone and were included in the efficacy analysis.
After the first week on treatment, patients had a median 49% cut from their baseline UFC level, and after 12 weeks this rose to a median 74% cut from baseline. The study’s primary endpoint was normalization of UFC after 12 weeks, which occurred in 47% of patients, while 22% had a normal level in a late-night salivary cortisol measurement.
Two-thirds of patients had an improvement or resolution of their signs and symptoms, on average quality of life scores improved, median systolic and diastolic blood pressures decreased by 4-5 mm Hg, and average A1c levels were stable, but the mean cholesterol level decreased significantly, and testosterone levels rose significantly in women.
Proper dose titration makes a difference
Adverse events occurred in 26 of the 50 patients (52%) who received any treatment; 1 patient had a serious adverse event, 7 patients required a dosage adjustment because of adverse events, and 6 patients stopped treatment. The most common adverse events were gastrointestinal – nausea in 24% and decreased appetite in 18% – as well as mild symptoms consistent with adrenal insufficiency such as fatigue and headache. Six patients (12%) were identified with reversible adrenal insufficiency, and no patients complained of worsening acne or hirsutism.
“I think the adverse events are a function of [less than optimal] dose titration and variability in UFC levels,” said Dr. Nieman.
This test of metyrapone’s efficacy comes a year after the FDA approved osilodrostat (Isturisa) for treating Cushing’s disease (but not Cushing’s syndrome). Like metyrapone, osilodrostat controls cortisol overproduction by blocking the enzyme 11-beta-hydroxylase and preventing cortisol synthesis, and osilodrostat was the first agent with these properties to receive an FDA label for therapy.
Osilodrostat “is the only adrenal steroidogenesis inhibitor assessed in randomized controlled long-term trials – over 200 patients with Cushing’s disease – and it has been shown to be highly effective at maintaining normal urinary free cortisol in large majority of patients with Cushing’s disease, as well as Cushing’s syndrome in a study in Japan. Adrenal insufficiency was high [with osilodrostat], especially with the high dose in the trial with forced uptitration. In my clinical practice I have noticed less adrenal insufficiency, but I use much slower drug titration,” said Dr. Fleseriu.
“I think these drugs [metyrapone and osilodrostat] are relatively equivalent,” Dr. Nieman said during discussion of her report. “One nonmedical judgment will be cost,” she added. “Everyone is looking forward to what the pricing structure will be for the new drugs.”
Dr. Fleseriu noted that “for most patients, surgery is first-line therapy, and rarely medication is an alternative first option, especially for Cushing’s disease. However, medical therapy is essential in the management of patients with Cushing’s syndrome when curative surgery fails, surgery is not feasible, when a patient is awaiting radiation’s effect, and for recurrent cases of Cushing’s syndrome.”
PROMPT was sponsored by HRA Pharma, the company that markets metyrapone. Dr. Nieman had no disclosures, but several of her associates on the study are HRA employees. Dr. Fleseriu has been a consultant to Novartis, Recordati, Sparrow, and Strongbridge.
Metyrapone, an inhibitor of endogenous adrenal corticosteroid synthesis currently used in U.S. practice to test adrenocorticotropic hormone (ACTH) function, was safe and effective for treating endogenous Cushing’s syndrome in a multicenter, open-label, single-arm study of 50 patients, the first prospective test of metyrapone (Metopirone) as a therapeutic agent.
Treatment with metyrapone for 12 weeks normalized mean levels of urinary free cortisol (UFC) in 23 of the 49 patients (47%) in the efficacy analysis, and cut pretreatment mean UFC levels by at least 50% in another 16 patients (33%). Treatment also improved clinical signs of hypercortisolism, associated comorbidities, and quality of life, and was well tolerated, Lynnette K. Nieman, MD, said at the annual meeting of the Endocrine Society.
“This prospective study confirms that metyrapone is effective, has a rapid onset of action, and is a safe medical treatment for endogenous Cushing’s syndrome,” declared Dr. Nieman, chief of the endocrinology consultation service of the National Institutes of Health Clinical Center in Bethesda, Md.
The study included a 24-week extension phase of continued metyrapone treatment in patients whose mean UFC level fell to less than two times the upper limit of normal (ULN), but Dr. Nieman did not report results from this extension.
Confirmation of off-label and European experience
“This was the first prospective study of metyrapone, albeit a small study and with only short-term data presented. It confirms what we have known from its off label use in the U.S. and retrospective studies in the U.K. and Europe: Metyrapone normalizes mean UFC in approximately half of patients. Probably with more aggressive up titration efficacy will have been even higher, but of course with the trade-off of adrenal insufficiency,” said Maria Fleseriu, MD, professor and director of the pituitary center at Oregon Health & Science University in Portland, who was not involved with the study.
“Longer-term data from this prospective study is clearly needed to evaluate for possible loss of response, as well as adverse events related to precursors accumulation. We also need data on tumor size with long-term use in patients with Cushing’s disease, “Dr. Fleseriu added in an interview.
“Metyrapone, an 11-hydroxylase inhibitor, is not [Food and Drug Administration–approved for therapy] and thus it will be hard for it to become a first-line medical therapy,” she continued. “Furthermore, multiple times a day administration is not ideal for most patients; however if metyrapone is readily available and cheaper than other drugs, its use might increase over time. Hirsutism in women (though not all women develop this) and hypertension could be issues with long-term use,” she cautioned.
“We have used metyrapone off label for many years. It has a rapid onset of action, and we also have experience using it in combination therapy with ketoconazole, especially in patients with severe Cushing’s, although ketoconazole is not [FDA] approved for Cushing’s syndrome, and all combination therapies are off-label, too,” Dr. Fleseriu noted.
Metyrapone is approved by the European Medicines Agency for treating Cushing’s syndrome based “on observational, retrospective studies published over more than 50 years,” according to Dr. Nieman. The drug has FDA approval only for diagnostic purposes.
The PROMPT (Effects of Metyrapone in Patients With Endogenous Cushing’s Syndrome) study enrolled patients in eight European countries who were newly diagnosed with endogenous Cushing’s syndrome of any etiology. The study excluded patients with an advanced adrenal carcinoma, as well as patients with recurrent or persistent Cushing’s disease following transsphenoidal surgery. Patients also needed three 24-hour measures of UFC that were at least 50% above the ULN (165 nmol/24 hours).
The average age of the patients was 46 years; 69% were women, 90% had Cushing’s disease, and 8% had ectopic ACTH secretion. The average time from initial symptom onset was 4 years. Sixty-one percent had a history of pituitary surgery, 69% were hypertensive, 43% had diabetes or glucose intolerance, and 41% had osteoporosis. The median mean UFC at entry was 570 nmol/24 hours, which is 3.5 times the ULN, and ranged from 291 to 8,476 nmol/24 hours.
Patients began on a metyrapone dosage of 750 mg/day unless their mean UFC exceeded 5 times the ULN, in which case the dosage doubled to 1,500 mg/day. During the 12-week period, clinicians up- or down-titrated the dosage to ideally achieve a UFC less than the ULN while maintaining serum cortisol levels of 7-12 mcg/dL to preclude adrenal insufficiency effects. The median dosage at the end of 12 weeks was 1,500 mg/day, and ranged from 250 to 5,500 mg/day. One of the 50 patients dropped out because of an unrelated acute medical condition, and two patients underwent pituitary surgery despite a response to metyrapone and were included in the efficacy analysis.
After the first week on treatment, patients had a median 49% cut from their baseline UFC level, and after 12 weeks this rose to a median 74% cut from baseline. The study’s primary endpoint was normalization of UFC after 12 weeks, which occurred in 47% of patients, while 22% had a normal level in a late-night salivary cortisol measurement.
Two-thirds of patients had an improvement or resolution of their signs and symptoms, on average quality of life scores improved, median systolic and diastolic blood pressures decreased by 4-5 mm Hg, and average A1c levels were stable, but the mean cholesterol level decreased significantly, and testosterone levels rose significantly in women.
Proper dose titration makes a difference
Adverse events occurred in 26 of the 50 patients (52%) who received any treatment; 1 patient had a serious adverse event, 7 patients required a dosage adjustment because of adverse events, and 6 patients stopped treatment. The most common adverse events were gastrointestinal – nausea in 24% and decreased appetite in 18% – as well as mild symptoms consistent with adrenal insufficiency such as fatigue and headache. Six patients (12%) were identified with reversible adrenal insufficiency, and no patients complained of worsening acne or hirsutism.
“I think the adverse events are a function of [less than optimal] dose titration and variability in UFC levels,” said Dr. Nieman.
This test of metyrapone’s efficacy comes a year after the FDA approved osilodrostat (Isturisa) for treating Cushing’s disease (but not Cushing’s syndrome). Like metyrapone, osilodrostat controls cortisol overproduction by blocking the enzyme 11-beta-hydroxylase and preventing cortisol synthesis, and osilodrostat was the first agent with these properties to receive an FDA label for therapy.
Osilodrostat “is the only adrenal steroidogenesis inhibitor assessed in randomized controlled long-term trials – over 200 patients with Cushing’s disease – and it has been shown to be highly effective at maintaining normal urinary free cortisol in large majority of patients with Cushing’s disease, as well as Cushing’s syndrome in a study in Japan. Adrenal insufficiency was high [with osilodrostat], especially with the high dose in the trial with forced uptitration. In my clinical practice I have noticed less adrenal insufficiency, but I use much slower drug titration,” said Dr. Fleseriu.
“I think these drugs [metyrapone and osilodrostat] are relatively equivalent,” Dr. Nieman said during discussion of her report. “One nonmedical judgment will be cost,” she added. “Everyone is looking forward to what the pricing structure will be for the new drugs.”
Dr. Fleseriu noted that “for most patients, surgery is first-line therapy, and rarely medication is an alternative first option, especially for Cushing’s disease. However, medical therapy is essential in the management of patients with Cushing’s syndrome when curative surgery fails, surgery is not feasible, when a patient is awaiting radiation’s effect, and for recurrent cases of Cushing’s syndrome.”
PROMPT was sponsored by HRA Pharma, the company that markets metyrapone. Dr. Nieman had no disclosures, but several of her associates on the study are HRA employees. Dr. Fleseriu has been a consultant to Novartis, Recordati, Sparrow, and Strongbridge.
FROM ENDO 2021
Our role in colorectal cancer prevention education
Each year in the month of March, advocates, physicians, and health care educators come together to promote the importance of colorectal cancer screening during Colorectal Cancer Awareness Month. As independent GI physicians, we work within our communities to promote colorectal screening year-round.
We also understand that our education efforts do not end with the people in our community who need to be screened. Independent GI practices also engage with primary care physicians who often initiate conversations about available screening tests and when people should be screened.
Colorectal cancer (CRC) is the second leading cause of cancer death in the United States.1 It is expected to kill more than 50,000 Americans this year alone.2 This is why screening for colorectal cancer is so important. The American Cancer Society recommends screening for all average-risk patients aged 45-75 years.3
The good news? If caught early, the survival rate is very high. In fact, when caught early, the five-year survival rate is 90 percent. Unfortunately, one in three Americans who are eligible for screenings do not get screened. For certain groups, there are larger numbers of people who are not getting screened. And there are groups for whom the death rates from colorectal cancer are much higher.
Disparities in colorectal cancer screenings
According to the American Cancer Society, Blacks and Hispanics are less likely to receive prompt follow up after an abnormal CRC screening result and are more likely to be diagnosed with late-stage cancer.4 African Americans have the highest death rate when compared with all other racial groups in the United States. American Indians and Alaska Natives are the only groups for which CRC death rates are not declining.
There are many factors that drive disparities, but the main factors seem to be socioeconomic status and differences in access to early detection and treatment. While some of these issues are complex and difficult to change, increasing awareness and providing education can be easier than you might think.
Working with your community as a private GI practitioner
To address economic factors, Atlanta Gastroenterology Associates has a program that provides resources on a sliding fee scale to people in our community who do not have insurance and are concerned about having to pay for CRC screening out of pocket. This includes the costs for anesthesia, colonoscopy, and pathology services.
We also have a Direct Access Program, which allows people to self-schedule a screening and fill out a survey that assesses their candidacy for screening colonoscopy. This allows our patients to bypass an initial prescreening office visit and associated copays. Patients are provided instructions for colonoscopy prep and show up for the colonoscopy on the day of their procedure. When the colonoscopy is completed, we give them a patient education card on CRC screening to share with friends and family members who need to be screened.
Atlanta is a very diverse city, and representation is important. But, fortunately, the size of Atlanta Gastroenterology Associates allows us to have representation within many communities. We attend a significant number of health fairs and community events, many of which are sourced internally. Our physicians and staff are members of churches and social groups that we work with to provide screening materials and conduct informational events.
Word of mouth is the best advertising, and it works the same way with health education. There are a lot of myths that we must debunk. And in many of our communities, people are worrying about paying the bills to keep the lights on – they are not thinking about getting screened. But, if they hear from a friend or family member that their screening colonoscopy was a good experience and that resources were provided to help pay for the procedure, it really does make a difference.
You do not need to join a large practice to have an impact. All over the country, there are community groups working to increase screening rates, and engaging with those groups is a good start. During the COVID-19 pandemic, we are all using social media and other platforms to connect. You do not need a lot of resources to set up a Zoom meeting with people in your community to discuss CRC screening.
Engaging with referring physicians
As a private practice practitioner, part of growing your practice is engaging with the primary care physicians in your area to ensure that they are up to date on the latest research in CRC screening and that they are discussing available screening options with their patients.
Preventing cancer should always be our first goal. Most CRCs begin as a polyp. Finding, quantifying, localizing, and removing polyps through screening colonoscopy is the most effective strategy for preventing this cancer. That is why colonoscopy remains the preferred method for colon cancer screening.
The Multi-Society Task Force on Colorectal Cancer recommends that, in sequential approaches, physicians should offer colonoscopy first.5 For patients who decline to have a colonoscopy, the FIT test should be offered next, followed by second-tier tests such as Cologuard and CT colonography for patients who decline both first-tier options.
Beyond the science of colorectal screening, we want to make sure that our primary care partners are aware of the disparities that exist – and which patients are at higher risk – so that they can engage with their patients to encourage screening.
For example, in our practice, we work with local Asian American community groups to help make sure that the “model minority” myth – that Asian Americans are healthier, wealthier, and better educated than the average American – does not become a barrier to screening. While Asian Americans may have lower overall rates of some types of cancer, there are some cancers that disproportionately affect certain Asian American groups. Rates of CRC in Japanese men, for instance, are 23% higher than in non-Hispanic Whites.
Additionally, we work with our primary care colleagues to help them understand that patients may have insurance considerations when choosing a test. While insurance typically covers 100% of a preventive screening test, a follow-up colonoscopy for a positive stool test is considered a diagnostic or therapeutic service and may not be fully covered. Medicare patients may face a coinsurance bill after their follow-up colonoscopy for a positive stool test. Legislation was passed last year to remove this barrier, but Medicare beneficiaries may have some out-of-pocket costs until it is completely removed in 2030.
Are you joining a practice that supports CRC education? Just ask!
We all want to work for an organization that aligns with our core values, and for GI physicians like us, CRC screening is a core component of our everyday work.
If you are considering joining a private practice, ask how the practice is doing with their CRC awareness programs and if it leads to increases in screenings. Inquire about the groups that are being engaged with and why. Is the practice focused on communities that have disparities in screening and treatment, and is it able to complete the entire screening process for individuals in communities that are more adversely affected by colorectal cancer?
We have found that candidates who have the most success in our practice are people who want to work at Atlanta Gastroenterology Associates but are also active in their communities and have a sense of how they want to be of service in their community. It is a sign of leadership in people – the idea that they are really going to get out and network and build a practice that serves everyone in their community. These actions make a difference in getting more people screened and in decreasing the disparities that exist.
Dr. Aja McCutchen is the chair of the quality committee at Atlanta Gastroenterology Associates and serves as chair of the Digestive Health Physicians Association’s Diversity, Equity and Inclusion Committee. She reports having nothing to disclose.
References
1. Siegel RL et al. CA Cancer J Clin. 2018 Jan;68(1):7-30.
2. Key Statistics for Colorectal Cancer. Cancer.org.
3. Wolf AMD et al. CA Cancer J Clin. 2018 Jul;68(4):250-281.
4. American Cancer Society. Colorectal Cancer Facts & Figures 2020-2022.
5. Rex DK et al. Am J Gastroenterol. 2017;112(7):1016-30.
Each year in the month of March, advocates, physicians, and health care educators come together to promote the importance of colorectal cancer screening during Colorectal Cancer Awareness Month. As independent GI physicians, we work within our communities to promote colorectal screening year-round.
We also understand that our education efforts do not end with the people in our community who need to be screened. Independent GI practices also engage with primary care physicians who often initiate conversations about available screening tests and when people should be screened.
Colorectal cancer (CRC) is the second leading cause of cancer death in the United States.1 It is expected to kill more than 50,000 Americans this year alone.2 This is why screening for colorectal cancer is so important. The American Cancer Society recommends screening for all average-risk patients aged 45-75 years.3
The good news? If caught early, the survival rate is very high. In fact, when caught early, the five-year survival rate is 90 percent. Unfortunately, one in three Americans who are eligible for screenings do not get screened. For certain groups, there are larger numbers of people who are not getting screened. And there are groups for whom the death rates from colorectal cancer are much higher.
Disparities in colorectal cancer screenings
According to the American Cancer Society, Blacks and Hispanics are less likely to receive prompt follow up after an abnormal CRC screening result and are more likely to be diagnosed with late-stage cancer.4 African Americans have the highest death rate when compared with all other racial groups in the United States. American Indians and Alaska Natives are the only groups for which CRC death rates are not declining.
There are many factors that drive disparities, but the main factors seem to be socioeconomic status and differences in access to early detection and treatment. While some of these issues are complex and difficult to change, increasing awareness and providing education can be easier than you might think.
Working with your community as a private GI practitioner
To address economic factors, Atlanta Gastroenterology Associates has a program that provides resources on a sliding fee scale to people in our community who do not have insurance and are concerned about having to pay for CRC screening out of pocket. This includes the costs for anesthesia, colonoscopy, and pathology services.
We also have a Direct Access Program, which allows people to self-schedule a screening and fill out a survey that assesses their candidacy for screening colonoscopy. This allows our patients to bypass an initial prescreening office visit and associated copays. Patients are provided instructions for colonoscopy prep and show up for the colonoscopy on the day of their procedure. When the colonoscopy is completed, we give them a patient education card on CRC screening to share with friends and family members who need to be screened.
Atlanta is a very diverse city, and representation is important. But, fortunately, the size of Atlanta Gastroenterology Associates allows us to have representation within many communities. We attend a significant number of health fairs and community events, many of which are sourced internally. Our physicians and staff are members of churches and social groups that we work with to provide screening materials and conduct informational events.
Word of mouth is the best advertising, and it works the same way with health education. There are a lot of myths that we must debunk. And in many of our communities, people are worrying about paying the bills to keep the lights on – they are not thinking about getting screened. But, if they hear from a friend or family member that their screening colonoscopy was a good experience and that resources were provided to help pay for the procedure, it really does make a difference.
You do not need to join a large practice to have an impact. All over the country, there are community groups working to increase screening rates, and engaging with those groups is a good start. During the COVID-19 pandemic, we are all using social media and other platforms to connect. You do not need a lot of resources to set up a Zoom meeting with people in your community to discuss CRC screening.
Engaging with referring physicians
As a private practice practitioner, part of growing your practice is engaging with the primary care physicians in your area to ensure that they are up to date on the latest research in CRC screening and that they are discussing available screening options with their patients.
Preventing cancer should always be our first goal. Most CRCs begin as a polyp. Finding, quantifying, localizing, and removing polyps through screening colonoscopy is the most effective strategy for preventing this cancer. That is why colonoscopy remains the preferred method for colon cancer screening.
The Multi-Society Task Force on Colorectal Cancer recommends that, in sequential approaches, physicians should offer colonoscopy first.5 For patients who decline to have a colonoscopy, the FIT test should be offered next, followed by second-tier tests such as Cologuard and CT colonography for patients who decline both first-tier options.
Beyond the science of colorectal screening, we want to make sure that our primary care partners are aware of the disparities that exist – and which patients are at higher risk – so that they can engage with their patients to encourage screening.
For example, in our practice, we work with local Asian American community groups to help make sure that the “model minority” myth – that Asian Americans are healthier, wealthier, and better educated than the average American – does not become a barrier to screening. While Asian Americans may have lower overall rates of some types of cancer, there are some cancers that disproportionately affect certain Asian American groups. Rates of CRC in Japanese men, for instance, are 23% higher than in non-Hispanic Whites.
Additionally, we work with our primary care colleagues to help them understand that patients may have insurance considerations when choosing a test. While insurance typically covers 100% of a preventive screening test, a follow-up colonoscopy for a positive stool test is considered a diagnostic or therapeutic service and may not be fully covered. Medicare patients may face a coinsurance bill after their follow-up colonoscopy for a positive stool test. Legislation was passed last year to remove this barrier, but Medicare beneficiaries may have some out-of-pocket costs until it is completely removed in 2030.
Are you joining a practice that supports CRC education? Just ask!
We all want to work for an organization that aligns with our core values, and for GI physicians like us, CRC screening is a core component of our everyday work.
If you are considering joining a private practice, ask how the practice is doing with their CRC awareness programs and if it leads to increases in screenings. Inquire about the groups that are being engaged with and why. Is the practice focused on communities that have disparities in screening and treatment, and is it able to complete the entire screening process for individuals in communities that are more adversely affected by colorectal cancer?
We have found that candidates who have the most success in our practice are people who want to work at Atlanta Gastroenterology Associates but are also active in their communities and have a sense of how they want to be of service in their community. It is a sign of leadership in people – the idea that they are really going to get out and network and build a practice that serves everyone in their community. These actions make a difference in getting more people screened and in decreasing the disparities that exist.
Dr. Aja McCutchen is the chair of the quality committee at Atlanta Gastroenterology Associates and serves as chair of the Digestive Health Physicians Association’s Diversity, Equity and Inclusion Committee. She reports having nothing to disclose.
References
1. Siegel RL et al. CA Cancer J Clin. 2018 Jan;68(1):7-30.
2. Key Statistics for Colorectal Cancer. Cancer.org.
3. Wolf AMD et al. CA Cancer J Clin. 2018 Jul;68(4):250-281.
4. American Cancer Society. Colorectal Cancer Facts & Figures 2020-2022.
5. Rex DK et al. Am J Gastroenterol. 2017;112(7):1016-30.
Each year in the month of March, advocates, physicians, and health care educators come together to promote the importance of colorectal cancer screening during Colorectal Cancer Awareness Month. As independent GI physicians, we work within our communities to promote colorectal screening year-round.
We also understand that our education efforts do not end with the people in our community who need to be screened. Independent GI practices also engage with primary care physicians who often initiate conversations about available screening tests and when people should be screened.
Colorectal cancer (CRC) is the second leading cause of cancer death in the United States.1 It is expected to kill more than 50,000 Americans this year alone.2 This is why screening for colorectal cancer is so important. The American Cancer Society recommends screening for all average-risk patients aged 45-75 years.3
The good news? If caught early, the survival rate is very high. In fact, when caught early, the five-year survival rate is 90 percent. Unfortunately, one in three Americans who are eligible for screenings do not get screened. For certain groups, there are larger numbers of people who are not getting screened. And there are groups for whom the death rates from colorectal cancer are much higher.
Disparities in colorectal cancer screenings
According to the American Cancer Society, Blacks and Hispanics are less likely to receive prompt follow up after an abnormal CRC screening result and are more likely to be diagnosed with late-stage cancer.4 African Americans have the highest death rate when compared with all other racial groups in the United States. American Indians and Alaska Natives are the only groups for which CRC death rates are not declining.
There are many factors that drive disparities, but the main factors seem to be socioeconomic status and differences in access to early detection and treatment. While some of these issues are complex and difficult to change, increasing awareness and providing education can be easier than you might think.
Working with your community as a private GI practitioner
To address economic factors, Atlanta Gastroenterology Associates has a program that provides resources on a sliding fee scale to people in our community who do not have insurance and are concerned about having to pay for CRC screening out of pocket. This includes the costs for anesthesia, colonoscopy, and pathology services.
We also have a Direct Access Program, which allows people to self-schedule a screening and fill out a survey that assesses their candidacy for screening colonoscopy. This allows our patients to bypass an initial prescreening office visit and associated copays. Patients are provided instructions for colonoscopy prep and show up for the colonoscopy on the day of their procedure. When the colonoscopy is completed, we give them a patient education card on CRC screening to share with friends and family members who need to be screened.
Atlanta is a very diverse city, and representation is important. But, fortunately, the size of Atlanta Gastroenterology Associates allows us to have representation within many communities. We attend a significant number of health fairs and community events, many of which are sourced internally. Our physicians and staff are members of churches and social groups that we work with to provide screening materials and conduct informational events.
Word of mouth is the best advertising, and it works the same way with health education. There are a lot of myths that we must debunk. And in many of our communities, people are worrying about paying the bills to keep the lights on – they are not thinking about getting screened. But, if they hear from a friend or family member that their screening colonoscopy was a good experience and that resources were provided to help pay for the procedure, it really does make a difference.
You do not need to join a large practice to have an impact. All over the country, there are community groups working to increase screening rates, and engaging with those groups is a good start. During the COVID-19 pandemic, we are all using social media and other platforms to connect. You do not need a lot of resources to set up a Zoom meeting with people in your community to discuss CRC screening.
Engaging with referring physicians
As a private practice practitioner, part of growing your practice is engaging with the primary care physicians in your area to ensure that they are up to date on the latest research in CRC screening and that they are discussing available screening options with their patients.
Preventing cancer should always be our first goal. Most CRCs begin as a polyp. Finding, quantifying, localizing, and removing polyps through screening colonoscopy is the most effective strategy for preventing this cancer. That is why colonoscopy remains the preferred method for colon cancer screening.
The Multi-Society Task Force on Colorectal Cancer recommends that, in sequential approaches, physicians should offer colonoscopy first.5 For patients who decline to have a colonoscopy, the FIT test should be offered next, followed by second-tier tests such as Cologuard and CT colonography for patients who decline both first-tier options.
Beyond the science of colorectal screening, we want to make sure that our primary care partners are aware of the disparities that exist – and which patients are at higher risk – so that they can engage with their patients to encourage screening.
For example, in our practice, we work with local Asian American community groups to help make sure that the “model minority” myth – that Asian Americans are healthier, wealthier, and better educated than the average American – does not become a barrier to screening. While Asian Americans may have lower overall rates of some types of cancer, there are some cancers that disproportionately affect certain Asian American groups. Rates of CRC in Japanese men, for instance, are 23% higher than in non-Hispanic Whites.
Additionally, we work with our primary care colleagues to help them understand that patients may have insurance considerations when choosing a test. While insurance typically covers 100% of a preventive screening test, a follow-up colonoscopy for a positive stool test is considered a diagnostic or therapeutic service and may not be fully covered. Medicare patients may face a coinsurance bill after their follow-up colonoscopy for a positive stool test. Legislation was passed last year to remove this barrier, but Medicare beneficiaries may have some out-of-pocket costs until it is completely removed in 2030.
Are you joining a practice that supports CRC education? Just ask!
We all want to work for an organization that aligns with our core values, and for GI physicians like us, CRC screening is a core component of our everyday work.
If you are considering joining a private practice, ask how the practice is doing with their CRC awareness programs and if it leads to increases in screenings. Inquire about the groups that are being engaged with and why. Is the practice focused on communities that have disparities in screening and treatment, and is it able to complete the entire screening process for individuals in communities that are more adversely affected by colorectal cancer?
We have found that candidates who have the most success in our practice are people who want to work at Atlanta Gastroenterology Associates but are also active in their communities and have a sense of how they want to be of service in their community. It is a sign of leadership in people – the idea that they are really going to get out and network and build a practice that serves everyone in their community. These actions make a difference in getting more people screened and in decreasing the disparities that exist.
Dr. Aja McCutchen is the chair of the quality committee at Atlanta Gastroenterology Associates and serves as chair of the Digestive Health Physicians Association’s Diversity, Equity and Inclusion Committee. She reports having nothing to disclose.
References
1. Siegel RL et al. CA Cancer J Clin. 2018 Jan;68(1):7-30.
2. Key Statistics for Colorectal Cancer. Cancer.org.
3. Wolf AMD et al. CA Cancer J Clin. 2018 Jul;68(4):250-281.
4. American Cancer Society. Colorectal Cancer Facts & Figures 2020-2022.
5. Rex DK et al. Am J Gastroenterol. 2017;112(7):1016-30.
New analysis eyes the surgical landscape for hidradenitis suppurativa
yet these options should be balanced against potentially higher morbidity of extensive procedures.
Those are among the key findings of a systematic review and meta-analysis published online in Dermatologic Surgery.
“There is a major need to better understand the best surgical approaches to HS,” one of the study authors, Christopher Sayed, MD, associate professor of dermatology at the University of North Carolina at Chapel Hill, said in an interview. Previous studies have mostly reviewed outcomes for procedure types in individual cohorts, “but no recent reports have combined and analyzed data from recent studies.”
When Dr. Sayed and colleagues set out to summarize the literature on HS surgery regarding patient characteristics, surgical approaches, and study quality, as well as compare postsurgical recurrence rates, the most recent meta-analysis on postoperative recurrence rates of HS included studies published between 1990 and 2015. “In the past few years, surgical management of HS has become an increasingly popular area of study,” corresponding author Ashley Riddle, MD, MPH, who is currently an internal medicine resident at the Carolinas Medical Center, Charlotte, said in an interview. “We sought to provide an updated picture of the HS surgical landscape by analyzing studies published between 2004 to 2019. We also limited our analysis to studies with follow-up periods of greater than 1 year and included information on disease severity, adverse events, and patient satisfaction when available.”
Of 715 relevant studies identified in the medical literature, the researchers included 59 in the review and 33 in the meta-analysis. Of these 59 studies, 56 were case series, 2 were randomized, controlled trials, and one was a retrospective cohort study.
Of the 50 studies reporting gender and age at time of surgery, 61% of patients were female and their average age was 37 years. Of the 25 studies that reported Hurley scores, 73% had Hurley stage 3 HS. Of the 38 studies reporting the number of procedures per anatomic region, the most commonly operated on regions were the axilla (59%) and the inguinal region (20%).
The researchers found that 22 studies of wide excision had the lowest pooled recurrence rate at 8%, while local excision had the highest pooled recurrence rate at 34%. Meanwhile, among studies of wide/radical excision, flap repair had a pooled recurrence rate of 0%, while delayed primary closure had the highest pooled recurrence rate at 38%.
“Extensive excisions of HS seem to portend a lower risk of postoperative recurrence, but there are many approaches available that may be more appropriate for certain patients,” Dr. Riddle said. “The influence of patient factors such as comorbidities and disease severity on surgical outcomes is unclear and is a potential area of future study.”
Dr. Sayed, an author of the 2019 North American guidelines for the clinical management of HS, pointed out that most studies in the review and meta-analysis included patients who had diabetes, were on biologics or other therapy, were actively smoking, or had other comorbidities that sometimes influence surgeons to delay surgical treatment because they consider it elective. “Most studies indicated minimal or no risk of significant complications relating to these factors, so they should ideally not become obstacles for patients interested in surgical care,” he said.
Dr. Riddle said that she was surprised by how relatively few studies had been published on more conservative surgical approaches such as skin tissue–sparing excision with electrosurgical peeling, deroofing, local excision, and CO2 laser–based evaporation.
The researchers acknowledged certain limitations of their work, including the high risk of bias for most included studies. “Almost all studies were retrospective with substantial methodological limitations, and there were no head-to-head comparisons of different surgical approaches,” Dr. Riddle said. “Patient comorbidities and postoperative complications were variably reported.”
Dr. Sayed disclosed that he is a speaker for AbbVie and Novartis; an investigator for AbbVie, Novartis, InflaRx, and UCB; and on the advisory board of AbbVie and InflaRx. The remaining authors reported having no financial disclosures.
yet these options should be balanced against potentially higher morbidity of extensive procedures.
Those are among the key findings of a systematic review and meta-analysis published online in Dermatologic Surgery.
“There is a major need to better understand the best surgical approaches to HS,” one of the study authors, Christopher Sayed, MD, associate professor of dermatology at the University of North Carolina at Chapel Hill, said in an interview. Previous studies have mostly reviewed outcomes for procedure types in individual cohorts, “but no recent reports have combined and analyzed data from recent studies.”
When Dr. Sayed and colleagues set out to summarize the literature on HS surgery regarding patient characteristics, surgical approaches, and study quality, as well as compare postsurgical recurrence rates, the most recent meta-analysis on postoperative recurrence rates of HS included studies published between 1990 and 2015. “In the past few years, surgical management of HS has become an increasingly popular area of study,” corresponding author Ashley Riddle, MD, MPH, who is currently an internal medicine resident at the Carolinas Medical Center, Charlotte, said in an interview. “We sought to provide an updated picture of the HS surgical landscape by analyzing studies published between 2004 to 2019. We also limited our analysis to studies with follow-up periods of greater than 1 year and included information on disease severity, adverse events, and patient satisfaction when available.”
Of 715 relevant studies identified in the medical literature, the researchers included 59 in the review and 33 in the meta-analysis. Of these 59 studies, 56 were case series, 2 were randomized, controlled trials, and one was a retrospective cohort study.
Of the 50 studies reporting gender and age at time of surgery, 61% of patients were female and their average age was 37 years. Of the 25 studies that reported Hurley scores, 73% had Hurley stage 3 HS. Of the 38 studies reporting the number of procedures per anatomic region, the most commonly operated on regions were the axilla (59%) and the inguinal region (20%).
The researchers found that 22 studies of wide excision had the lowest pooled recurrence rate at 8%, while local excision had the highest pooled recurrence rate at 34%. Meanwhile, among studies of wide/radical excision, flap repair had a pooled recurrence rate of 0%, while delayed primary closure had the highest pooled recurrence rate at 38%.
“Extensive excisions of HS seem to portend a lower risk of postoperative recurrence, but there are many approaches available that may be more appropriate for certain patients,” Dr. Riddle said. “The influence of patient factors such as comorbidities and disease severity on surgical outcomes is unclear and is a potential area of future study.”
Dr. Sayed, an author of the 2019 North American guidelines for the clinical management of HS, pointed out that most studies in the review and meta-analysis included patients who had diabetes, were on biologics or other therapy, were actively smoking, or had other comorbidities that sometimes influence surgeons to delay surgical treatment because they consider it elective. “Most studies indicated minimal or no risk of significant complications relating to these factors, so they should ideally not become obstacles for patients interested in surgical care,” he said.
Dr. Riddle said that she was surprised by how relatively few studies had been published on more conservative surgical approaches such as skin tissue–sparing excision with electrosurgical peeling, deroofing, local excision, and CO2 laser–based evaporation.
The researchers acknowledged certain limitations of their work, including the high risk of bias for most included studies. “Almost all studies were retrospective with substantial methodological limitations, and there were no head-to-head comparisons of different surgical approaches,” Dr. Riddle said. “Patient comorbidities and postoperative complications were variably reported.”
Dr. Sayed disclosed that he is a speaker for AbbVie and Novartis; an investigator for AbbVie, Novartis, InflaRx, and UCB; and on the advisory board of AbbVie and InflaRx. The remaining authors reported having no financial disclosures.
yet these options should be balanced against potentially higher morbidity of extensive procedures.
Those are among the key findings of a systematic review and meta-analysis published online in Dermatologic Surgery.
“There is a major need to better understand the best surgical approaches to HS,” one of the study authors, Christopher Sayed, MD, associate professor of dermatology at the University of North Carolina at Chapel Hill, said in an interview. Previous studies have mostly reviewed outcomes for procedure types in individual cohorts, “but no recent reports have combined and analyzed data from recent studies.”
When Dr. Sayed and colleagues set out to summarize the literature on HS surgery regarding patient characteristics, surgical approaches, and study quality, as well as compare postsurgical recurrence rates, the most recent meta-analysis on postoperative recurrence rates of HS included studies published between 1990 and 2015. “In the past few years, surgical management of HS has become an increasingly popular area of study,” corresponding author Ashley Riddle, MD, MPH, who is currently an internal medicine resident at the Carolinas Medical Center, Charlotte, said in an interview. “We sought to provide an updated picture of the HS surgical landscape by analyzing studies published between 2004 to 2019. We also limited our analysis to studies with follow-up periods of greater than 1 year and included information on disease severity, adverse events, and patient satisfaction when available.”
Of 715 relevant studies identified in the medical literature, the researchers included 59 in the review and 33 in the meta-analysis. Of these 59 studies, 56 were case series, 2 were randomized, controlled trials, and one was a retrospective cohort study.
Of the 50 studies reporting gender and age at time of surgery, 61% of patients were female and their average age was 37 years. Of the 25 studies that reported Hurley scores, 73% had Hurley stage 3 HS. Of the 38 studies reporting the number of procedures per anatomic region, the most commonly operated on regions were the axilla (59%) and the inguinal region (20%).
The researchers found that 22 studies of wide excision had the lowest pooled recurrence rate at 8%, while local excision had the highest pooled recurrence rate at 34%. Meanwhile, among studies of wide/radical excision, flap repair had a pooled recurrence rate of 0%, while delayed primary closure had the highest pooled recurrence rate at 38%.
“Extensive excisions of HS seem to portend a lower risk of postoperative recurrence, but there are many approaches available that may be more appropriate for certain patients,” Dr. Riddle said. “The influence of patient factors such as comorbidities and disease severity on surgical outcomes is unclear and is a potential area of future study.”
Dr. Sayed, an author of the 2019 North American guidelines for the clinical management of HS, pointed out that most studies in the review and meta-analysis included patients who had diabetes, were on biologics or other therapy, were actively smoking, or had other comorbidities that sometimes influence surgeons to delay surgical treatment because they consider it elective. “Most studies indicated minimal or no risk of significant complications relating to these factors, so they should ideally not become obstacles for patients interested in surgical care,” he said.
Dr. Riddle said that she was surprised by how relatively few studies had been published on more conservative surgical approaches such as skin tissue–sparing excision with electrosurgical peeling, deroofing, local excision, and CO2 laser–based evaporation.
The researchers acknowledged certain limitations of their work, including the high risk of bias for most included studies. “Almost all studies were retrospective with substantial methodological limitations, and there were no head-to-head comparisons of different surgical approaches,” Dr. Riddle said. “Patient comorbidities and postoperative complications were variably reported.”
Dr. Sayed disclosed that he is a speaker for AbbVie and Novartis; an investigator for AbbVie, Novartis, InflaRx, and UCB; and on the advisory board of AbbVie and InflaRx. The remaining authors reported having no financial disclosures.
FROM DERMATOLOGIC SURGERY
How family medicine has changed over the past half century
From my residency training graduation date, June 1978, many changes to the family medicine specialty have occurred. These are not due to certification requirements but to the dilution of physician control in health care.
The need to provide more affordable health care by insurance companies while maintaining quality prompted more changes. Additionally, employer-based decisions to change insurance plans, since they were the payer for employer-based health insurance, sometimes yearly, prompted mandatory changes in health insurance.
To achieve hospital-based goals and cost containment the advent and use of hospitalists and the expanded use of physician extenders emerged. While I have some support for these changes, they have redefined elements of the Folsom report, which concluded that every American should have a personal physician to care for them and help integrate them into the health care system.
Changes in the health care delivery system and insurance companies’ need to contain costs, while expanding preventative medicine, coupled with a decreasing number of trained family medicine physicians, represents the background of some of the changes in family medicine over the past 50 years. Managed health care, I believe, was certainly part of the answer to implementing the following recommendation of the Folsom report: every American should have a physician-manager for their health care.
Despite the continual output of new family physicians, a shortage of physicians trained in this specialty remained. Advances in health care, which lengthened life expectancy and the fact that most health insurance companies required its members to name a primary care physician expanded the population requiring primary health care services. This only exacerbated the shortage of family physicians and lowered earning power for doctors practicing family medicine, and it created greater professional demands on family physicians, compared with those in other, more limited-scope specialties. The primary care physician shortage needed to be addressed, prompting a redefinition in the traditional nurse practitioner role.
The expansion of nurse practitioners and physician assistants’ roles
The nursing profession began training advanced-placement nurses and instituted a Doctor of Nurse Practitioner degree. At the same time physician assistants, a program that began while I was a resident, had a further role expansion, including training confined to a single specialty area of medicine. These roles were expanded by state legislators who added them to the list of primary care providers, in some locations, permitting independent practice and placing the physician assistant under the state medical boards and the nurse practitioner and Doctor of Nurse Practitioners under the nursing boards, for expanded regulations and the implementation of the new provider requirements for licensure.
The effects of insurance companies on primary care physicians and patients
When I started practicing medicine the physician was truly the manager of a person’s health care. With the advent of managed health care, that has changed. Physicians are no longer the managers; an uninvited marriage between physician, physician extender, insurance company, employer, and patient jointly controls health care.
Patients are opting for less care at the cheapest price based on incentives driven by cost and abetted by insurance companies and employers. The cost of medications has increased and provider services, coupled with medication and specialty costs have nearly priced many beyond their economic limits to pay. As a result, the patient is not always as committed as their provider to meeting the metrics of their insurance company, especially if that is increasing their out-of-pocket cost.
In addition to usual services, the primary care physician is required to demonstrate the adequacy of services provided through meeting certain practice quality metrics for nearly all insurance carriers, including Medicare and Medicaid. Because meeting these metrics carries a significant economic incentive many practices are retaining fewer noncompliant patients and have opted to bolster their bottom line with the more complaint. This adversely impacts the delivery of primary care to a significant portion of the population.
Patients that reside in poorer neighborhoods, rural areas, as well the marginalized compose a significant portion of many primary care provider’s practices and make up a significant percentage of noncompliant patients. Recognizing that the primary care physician’s overhead is high, coupled with the amount of financial and personal resources put into place to meet metrics, it costs much more to care for the marginalized, poor, and rural populations than easier-to-care for patient groups. This creates a disparity in health care.
A study that revisited the Folsom report concluded that “the 21st century primary care physician must be a true public health professional, forming partnerships and assisting data sharing with community organizations to facilitate healthy changes.” These observations have redefined primary care. This type of medicine is no longer tied to a physician; it is tied to a fairly expensive team of providers, which includes a nurse manager, physician, physician extender, social worker, and in some cases, a pharmacist. The days of mostly solo practitioners are waning and the days of the traditional family medicine residency training requires continuous nuancing, to accommodate the expanded list of practice-related responsibilities assigned to the family doctor.
Low reimbursements rates and high office overhead
The last change I have observed in the practice of family medicine over the past 50 years is a decline in the ratio of reimbursement rate for services to practice expenses. Many practitioners opt out of Medicaid or have certainly curtailed the number of Medicaid recipients on their panel because of its unacceptably low reimbursement rates combined with their high office overhead. The requirements for organizing community resources, including nursing agencies and church and community groups, carry no reimbursement for time invested. The primary care provider is responsible and evaluated on patient outcomes despite the noncompliant behavior of the patient.
What is the future of the primary care physician or provider?
The factors that determine this answer lie in what will be required of the provider and the role of the insurance company in assisting the provider of services. Insurance companies have a responsibility because they receive money to pay for metrics while remaining profitable. They must be brought into the success formula and assist the provider in order for the latter to survive. Currently the primary care provider, in an abundance of caution, is required to seek more specialty services, which drives up the cost of health care. Instead, the insurance company should allow the primary care provider to direct the health care and stop being the manager, approving or disapproving services. In summary, much has happened in family medicine over the past 50 years. The ongoing personal doctor-patient relationship has turned into a doctor-patient-insurance company relationship. The introduction of the third party has created an economic incentive for the physician to meet practice metrics, which sometimes, from the patient’s economic perspective, creates economic hardship.
Some patients enlist a primary care physician in name only but continue to drive their health care by the older model, thanks to the advent of the urgent care centers. These patients see participating in the crisis-care model as resulting in lower out-of-pocket costs. Insurance companies should enlist patient support by expanding their patient education to include the benefits of health, the benefits of meeting quality metrics by their physician, and the necessity of maintaining a compliant doctor-patient relationship. Just as they offer incentives to the primary care practitioner for meeting quality metrics incentives should be offered to those patients that meet quality metrics as well.
In the 21st century, a new model of health care emerged, which includes a primary care practitioner, nurse manager-educator, social worker, and a pharmacist. To deliver quality health care one person can’t be responsible for this burden and do it effectively. Many family practice residencies already use this model and most likely advise their graduates to seek employment where this model exists. Additionally, I am sure that family practice residencies are continually nuanced to achieve the teaching mantra required for successful postgraduate employment and good patient outcomes.
What is the future of family medicine?
The family medicine specialty is represented by a practice that looks at outcome metrics primarily without an incentive for helping the marginalized, poor, homeless, and displaced members of our society.
Urban family medicine, much like what I have practiced in this my 43rd year, is different. My practice community includes every segment of society and my approach lies in the improvement of outcomes from all that I serve. It is my impression that the future of family medicine education must include all members of our society and train residents to effectively care for all, irrespective of economic status, and evolve ways to improve the health outcomes for all.
The federal government, through reimbursement and incentive programs, needs to include such efforts in the model of care for these individuals to reduce the expense burden on the practitioner achieving better practice success and less burnout.
Dr. Betton practices family medicine in Little Rock, Ark. He also serves on the editorial advisory board of Family Practice News.
From my residency training graduation date, June 1978, many changes to the family medicine specialty have occurred. These are not due to certification requirements but to the dilution of physician control in health care.
The need to provide more affordable health care by insurance companies while maintaining quality prompted more changes. Additionally, employer-based decisions to change insurance plans, since they were the payer for employer-based health insurance, sometimes yearly, prompted mandatory changes in health insurance.
To achieve hospital-based goals and cost containment the advent and use of hospitalists and the expanded use of physician extenders emerged. While I have some support for these changes, they have redefined elements of the Folsom report, which concluded that every American should have a personal physician to care for them and help integrate them into the health care system.
Changes in the health care delivery system and insurance companies’ need to contain costs, while expanding preventative medicine, coupled with a decreasing number of trained family medicine physicians, represents the background of some of the changes in family medicine over the past 50 years. Managed health care, I believe, was certainly part of the answer to implementing the following recommendation of the Folsom report: every American should have a physician-manager for their health care.
Despite the continual output of new family physicians, a shortage of physicians trained in this specialty remained. Advances in health care, which lengthened life expectancy and the fact that most health insurance companies required its members to name a primary care physician expanded the population requiring primary health care services. This only exacerbated the shortage of family physicians and lowered earning power for doctors practicing family medicine, and it created greater professional demands on family physicians, compared with those in other, more limited-scope specialties. The primary care physician shortage needed to be addressed, prompting a redefinition in the traditional nurse practitioner role.
The expansion of nurse practitioners and physician assistants’ roles
The nursing profession began training advanced-placement nurses and instituted a Doctor of Nurse Practitioner degree. At the same time physician assistants, a program that began while I was a resident, had a further role expansion, including training confined to a single specialty area of medicine. These roles were expanded by state legislators who added them to the list of primary care providers, in some locations, permitting independent practice and placing the physician assistant under the state medical boards and the nurse practitioner and Doctor of Nurse Practitioners under the nursing boards, for expanded regulations and the implementation of the new provider requirements for licensure.
The effects of insurance companies on primary care physicians and patients
When I started practicing medicine the physician was truly the manager of a person’s health care. With the advent of managed health care, that has changed. Physicians are no longer the managers; an uninvited marriage between physician, physician extender, insurance company, employer, and patient jointly controls health care.
Patients are opting for less care at the cheapest price based on incentives driven by cost and abetted by insurance companies and employers. The cost of medications has increased and provider services, coupled with medication and specialty costs have nearly priced many beyond their economic limits to pay. As a result, the patient is not always as committed as their provider to meeting the metrics of their insurance company, especially if that is increasing their out-of-pocket cost.
In addition to usual services, the primary care physician is required to demonstrate the adequacy of services provided through meeting certain practice quality metrics for nearly all insurance carriers, including Medicare and Medicaid. Because meeting these metrics carries a significant economic incentive many practices are retaining fewer noncompliant patients and have opted to bolster their bottom line with the more complaint. This adversely impacts the delivery of primary care to a significant portion of the population.
Patients that reside in poorer neighborhoods, rural areas, as well the marginalized compose a significant portion of many primary care provider’s practices and make up a significant percentage of noncompliant patients. Recognizing that the primary care physician’s overhead is high, coupled with the amount of financial and personal resources put into place to meet metrics, it costs much more to care for the marginalized, poor, and rural populations than easier-to-care for patient groups. This creates a disparity in health care.
A study that revisited the Folsom report concluded that “the 21st century primary care physician must be a true public health professional, forming partnerships and assisting data sharing with community organizations to facilitate healthy changes.” These observations have redefined primary care. This type of medicine is no longer tied to a physician; it is tied to a fairly expensive team of providers, which includes a nurse manager, physician, physician extender, social worker, and in some cases, a pharmacist. The days of mostly solo practitioners are waning and the days of the traditional family medicine residency training requires continuous nuancing, to accommodate the expanded list of practice-related responsibilities assigned to the family doctor.
Low reimbursements rates and high office overhead
The last change I have observed in the practice of family medicine over the past 50 years is a decline in the ratio of reimbursement rate for services to practice expenses. Many practitioners opt out of Medicaid or have certainly curtailed the number of Medicaid recipients on their panel because of its unacceptably low reimbursement rates combined with their high office overhead. The requirements for organizing community resources, including nursing agencies and church and community groups, carry no reimbursement for time invested. The primary care provider is responsible and evaluated on patient outcomes despite the noncompliant behavior of the patient.
What is the future of the primary care physician or provider?
The factors that determine this answer lie in what will be required of the provider and the role of the insurance company in assisting the provider of services. Insurance companies have a responsibility because they receive money to pay for metrics while remaining profitable. They must be brought into the success formula and assist the provider in order for the latter to survive. Currently the primary care provider, in an abundance of caution, is required to seek more specialty services, which drives up the cost of health care. Instead, the insurance company should allow the primary care provider to direct the health care and stop being the manager, approving or disapproving services. In summary, much has happened in family medicine over the past 50 years. The ongoing personal doctor-patient relationship has turned into a doctor-patient-insurance company relationship. The introduction of the third party has created an economic incentive for the physician to meet practice metrics, which sometimes, from the patient’s economic perspective, creates economic hardship.
Some patients enlist a primary care physician in name only but continue to drive their health care by the older model, thanks to the advent of the urgent care centers. These patients see participating in the crisis-care model as resulting in lower out-of-pocket costs. Insurance companies should enlist patient support by expanding their patient education to include the benefits of health, the benefits of meeting quality metrics by their physician, and the necessity of maintaining a compliant doctor-patient relationship. Just as they offer incentives to the primary care practitioner for meeting quality metrics incentives should be offered to those patients that meet quality metrics as well.
In the 21st century, a new model of health care emerged, which includes a primary care practitioner, nurse manager-educator, social worker, and a pharmacist. To deliver quality health care one person can’t be responsible for this burden and do it effectively. Many family practice residencies already use this model and most likely advise their graduates to seek employment where this model exists. Additionally, I am sure that family practice residencies are continually nuanced to achieve the teaching mantra required for successful postgraduate employment and good patient outcomes.
What is the future of family medicine?
The family medicine specialty is represented by a practice that looks at outcome metrics primarily without an incentive for helping the marginalized, poor, homeless, and displaced members of our society.
Urban family medicine, much like what I have practiced in this my 43rd year, is different. My practice community includes every segment of society and my approach lies in the improvement of outcomes from all that I serve. It is my impression that the future of family medicine education must include all members of our society and train residents to effectively care for all, irrespective of economic status, and evolve ways to improve the health outcomes for all.
The federal government, through reimbursement and incentive programs, needs to include such efforts in the model of care for these individuals to reduce the expense burden on the practitioner achieving better practice success and less burnout.
Dr. Betton practices family medicine in Little Rock, Ark. He also serves on the editorial advisory board of Family Practice News.
From my residency training graduation date, June 1978, many changes to the family medicine specialty have occurred. These are not due to certification requirements but to the dilution of physician control in health care.
The need to provide more affordable health care by insurance companies while maintaining quality prompted more changes. Additionally, employer-based decisions to change insurance plans, since they were the payer for employer-based health insurance, sometimes yearly, prompted mandatory changes in health insurance.
To achieve hospital-based goals and cost containment the advent and use of hospitalists and the expanded use of physician extenders emerged. While I have some support for these changes, they have redefined elements of the Folsom report, which concluded that every American should have a personal physician to care for them and help integrate them into the health care system.
Changes in the health care delivery system and insurance companies’ need to contain costs, while expanding preventative medicine, coupled with a decreasing number of trained family medicine physicians, represents the background of some of the changes in family medicine over the past 50 years. Managed health care, I believe, was certainly part of the answer to implementing the following recommendation of the Folsom report: every American should have a physician-manager for their health care.
Despite the continual output of new family physicians, a shortage of physicians trained in this specialty remained. Advances in health care, which lengthened life expectancy and the fact that most health insurance companies required its members to name a primary care physician expanded the population requiring primary health care services. This only exacerbated the shortage of family physicians and lowered earning power for doctors practicing family medicine, and it created greater professional demands on family physicians, compared with those in other, more limited-scope specialties. The primary care physician shortage needed to be addressed, prompting a redefinition in the traditional nurse practitioner role.
The expansion of nurse practitioners and physician assistants’ roles
The nursing profession began training advanced-placement nurses and instituted a Doctor of Nurse Practitioner degree. At the same time physician assistants, a program that began while I was a resident, had a further role expansion, including training confined to a single specialty area of medicine. These roles were expanded by state legislators who added them to the list of primary care providers, in some locations, permitting independent practice and placing the physician assistant under the state medical boards and the nurse practitioner and Doctor of Nurse Practitioners under the nursing boards, for expanded regulations and the implementation of the new provider requirements for licensure.
The effects of insurance companies on primary care physicians and patients
When I started practicing medicine the physician was truly the manager of a person’s health care. With the advent of managed health care, that has changed. Physicians are no longer the managers; an uninvited marriage between physician, physician extender, insurance company, employer, and patient jointly controls health care.
Patients are opting for less care at the cheapest price based on incentives driven by cost and abetted by insurance companies and employers. The cost of medications has increased and provider services, coupled with medication and specialty costs have nearly priced many beyond their economic limits to pay. As a result, the patient is not always as committed as their provider to meeting the metrics of their insurance company, especially if that is increasing their out-of-pocket cost.
In addition to usual services, the primary care physician is required to demonstrate the adequacy of services provided through meeting certain practice quality metrics for nearly all insurance carriers, including Medicare and Medicaid. Because meeting these metrics carries a significant economic incentive many practices are retaining fewer noncompliant patients and have opted to bolster their bottom line with the more complaint. This adversely impacts the delivery of primary care to a significant portion of the population.
Patients that reside in poorer neighborhoods, rural areas, as well the marginalized compose a significant portion of many primary care provider’s practices and make up a significant percentage of noncompliant patients. Recognizing that the primary care physician’s overhead is high, coupled with the amount of financial and personal resources put into place to meet metrics, it costs much more to care for the marginalized, poor, and rural populations than easier-to-care for patient groups. This creates a disparity in health care.
A study that revisited the Folsom report concluded that “the 21st century primary care physician must be a true public health professional, forming partnerships and assisting data sharing with community organizations to facilitate healthy changes.” These observations have redefined primary care. This type of medicine is no longer tied to a physician; it is tied to a fairly expensive team of providers, which includes a nurse manager, physician, physician extender, social worker, and in some cases, a pharmacist. The days of mostly solo practitioners are waning and the days of the traditional family medicine residency training requires continuous nuancing, to accommodate the expanded list of practice-related responsibilities assigned to the family doctor.
Low reimbursements rates and high office overhead
The last change I have observed in the practice of family medicine over the past 50 years is a decline in the ratio of reimbursement rate for services to practice expenses. Many practitioners opt out of Medicaid or have certainly curtailed the number of Medicaid recipients on their panel because of its unacceptably low reimbursement rates combined with their high office overhead. The requirements for organizing community resources, including nursing agencies and church and community groups, carry no reimbursement for time invested. The primary care provider is responsible and evaluated on patient outcomes despite the noncompliant behavior of the patient.
What is the future of the primary care physician or provider?
The factors that determine this answer lie in what will be required of the provider and the role of the insurance company in assisting the provider of services. Insurance companies have a responsibility because they receive money to pay for metrics while remaining profitable. They must be brought into the success formula and assist the provider in order for the latter to survive. Currently the primary care provider, in an abundance of caution, is required to seek more specialty services, which drives up the cost of health care. Instead, the insurance company should allow the primary care provider to direct the health care and stop being the manager, approving or disapproving services. In summary, much has happened in family medicine over the past 50 years. The ongoing personal doctor-patient relationship has turned into a doctor-patient-insurance company relationship. The introduction of the third party has created an economic incentive for the physician to meet practice metrics, which sometimes, from the patient’s economic perspective, creates economic hardship.
Some patients enlist a primary care physician in name only but continue to drive their health care by the older model, thanks to the advent of the urgent care centers. These patients see participating in the crisis-care model as resulting in lower out-of-pocket costs. Insurance companies should enlist patient support by expanding their patient education to include the benefits of health, the benefits of meeting quality metrics by their physician, and the necessity of maintaining a compliant doctor-patient relationship. Just as they offer incentives to the primary care practitioner for meeting quality metrics incentives should be offered to those patients that meet quality metrics as well.
In the 21st century, a new model of health care emerged, which includes a primary care practitioner, nurse manager-educator, social worker, and a pharmacist. To deliver quality health care one person can’t be responsible for this burden and do it effectively. Many family practice residencies already use this model and most likely advise their graduates to seek employment where this model exists. Additionally, I am sure that family practice residencies are continually nuanced to achieve the teaching mantra required for successful postgraduate employment and good patient outcomes.
What is the future of family medicine?
The family medicine specialty is represented by a practice that looks at outcome metrics primarily without an incentive for helping the marginalized, poor, homeless, and displaced members of our society.
Urban family medicine, much like what I have practiced in this my 43rd year, is different. My practice community includes every segment of society and my approach lies in the improvement of outcomes from all that I serve. It is my impression that the future of family medicine education must include all members of our society and train residents to effectively care for all, irrespective of economic status, and evolve ways to improve the health outcomes for all.
The federal government, through reimbursement and incentive programs, needs to include such efforts in the model of care for these individuals to reduce the expense burden on the practitioner achieving better practice success and less burnout.
Dr. Betton practices family medicine in Little Rock, Ark. He also serves on the editorial advisory board of Family Practice News.
1 in 3 on levothyroxine take meds that interfere with thyroid tests
, potentially compromising treatment decisions, new research shows.
“We know from previous studies that thyroid hormone use is common in older adults and that there are a multitude of medications that can interfere with thyroid function tests in different ways,” senior author Maria Papaleontiou, MD, told Medscape Medical News.
“However, to our knowledge, the extent of concurrent use of thyroid hormone and interfering medications in older adults, age 65 years and older, has not been previously explored,” added Dr. Papaleontiou, of the Division of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor.
The findings were presented as a poster during virtual ENDO 2021, the Endocrine Society’s annual meeting.
Commenting on the study, Thanh Duc Hoang, DO, an endocrinologist with the Walter Reed National Military Medical Center, in Bethesda, Md., said: “It is important for clinicians to be aware of various interactions and interferences of medications affecting the accuracy of thyroid function tests.”
“If patients are not able to discontinue the medications shortly before the bloodwork, the clinicians may consider ordering different thyroid tests or assays that avoid the interferences,” he told Medscape Medical News.
32% of patients taking meds that could interfere with tests
In evaluating data on 538,137 patients treated with thyroid hormones from the Corporate Data Warehouse of the Veterans Health Administration, spanning 2004-2017, first author Rachel Beeson, MD, and colleagues with the University of Michigan found most patients in the study were men (96.5%), White (77.1%), and had two or more comorbidities (62.6%).
Of this total, 170,261 (31.6%) patients treated with thyroid hormones, over a median follow-up of 56 months, were taking at least one drug that could potentially interfere with thyroid function tests.
Among the drugs with potential thyroid test interference, about 28% of patients were taking prednisone or prednisolone, 8% were taking amiodarone, and 1.42% were taking phenytoin. Other reported drugs that could potentially interfere included carbamazepine (0.91%), phenobarbital (0.15%), lithium (0.40%), and tamoxifen (0.11%).
Multivariate analysis showed that characteristics associated with those most likely to have concurrent medication use included non-Whites (OR, 1.18 vs Whites), Hispanic ethnicity (OR 1.11 vs non-Hispanic), female sex (OR 1.12 vs males), and presence of comorbidities (eg, Charlson-Deyo comorbidity score ≥ 2, OR, 2.47 vs score of 0).
Meanwhile, older patients age 85 years and over had a lower likelihood of concurrent medications interfering with thyroid tests (OR, 0.47 vs age 65-74 years).
The findings are concerning given the wide use of levothyroxine to treat hypothyroidism, which is the most widely prescribed drug in the United States.
“Our findings not only highlight the complexity of thyroid hormone management in older adults in the context of polypharmacy and multimorbidity, but they also draw attention to vulnerable groups for this practice, which included female patients, non-Whites, patients of Hispanic ethnicity, and patients with comorbidities,” Dr. Papaleontiou said.
Nature of interference possibilities varies
Medications or supplements can interfere with thyroid function tests in a variety of ways, she explained. “Some medications could lead to a decrease in the absorption of levothyroxine, others may affect how well the pill dissolves.”
In addition, certain medications can affect the circulation of thyroid hormone in the blood and how it binds with proteins, or they can lead to decreasing thyroid hormone levels due to a variety of interactions.
And in contrast, “What is even more challenging is that some medications or supplements may appear to affect thyroid function based on lab tests when in reality they don’t actually affect thyroid function and may lead to dose adjustments unnecessarily,” Dr. Papaleontiou noted.
Recommendations to counter interference
Current recommendations to try to counter the effects of polypharmacy on thyroid treatment include advising patients to take thyroid hormones on an empty stomach at least 30-60 minutes prior to eating for optimal absorption.
If the patient is taking medications known to interfere with absorption of thyroid hormones, the recommendation is to space those out by at least 4 hours.
“The big challenge in older adults is that many of them do experience polypharmacy, being at risk for multiple drug-drug interactions,” Dr. Papaleontiou said.
“Physicians and patients should be vigilant and communicate closely every time there is initiation of a new medication or supplement to consider whether there may be interference.”
The authors have reported no relevant financial relationships. Dr. Hoang has reported being a speaker for Acella Pharmaceuticals.
A version of this article first appeared on Medscape.com.
, potentially compromising treatment decisions, new research shows.
“We know from previous studies that thyroid hormone use is common in older adults and that there are a multitude of medications that can interfere with thyroid function tests in different ways,” senior author Maria Papaleontiou, MD, told Medscape Medical News.
“However, to our knowledge, the extent of concurrent use of thyroid hormone and interfering medications in older adults, age 65 years and older, has not been previously explored,” added Dr. Papaleontiou, of the Division of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor.
The findings were presented as a poster during virtual ENDO 2021, the Endocrine Society’s annual meeting.
Commenting on the study, Thanh Duc Hoang, DO, an endocrinologist with the Walter Reed National Military Medical Center, in Bethesda, Md., said: “It is important for clinicians to be aware of various interactions and interferences of medications affecting the accuracy of thyroid function tests.”
“If patients are not able to discontinue the medications shortly before the bloodwork, the clinicians may consider ordering different thyroid tests or assays that avoid the interferences,” he told Medscape Medical News.
32% of patients taking meds that could interfere with tests
In evaluating data on 538,137 patients treated with thyroid hormones from the Corporate Data Warehouse of the Veterans Health Administration, spanning 2004-2017, first author Rachel Beeson, MD, and colleagues with the University of Michigan found most patients in the study were men (96.5%), White (77.1%), and had two or more comorbidities (62.6%).
Of this total, 170,261 (31.6%) patients treated with thyroid hormones, over a median follow-up of 56 months, were taking at least one drug that could potentially interfere with thyroid function tests.
Among the drugs with potential thyroid test interference, about 28% of patients were taking prednisone or prednisolone, 8% were taking amiodarone, and 1.42% were taking phenytoin. Other reported drugs that could potentially interfere included carbamazepine (0.91%), phenobarbital (0.15%), lithium (0.40%), and tamoxifen (0.11%).
Multivariate analysis showed that characteristics associated with those most likely to have concurrent medication use included non-Whites (OR, 1.18 vs Whites), Hispanic ethnicity (OR 1.11 vs non-Hispanic), female sex (OR 1.12 vs males), and presence of comorbidities (eg, Charlson-Deyo comorbidity score ≥ 2, OR, 2.47 vs score of 0).
Meanwhile, older patients age 85 years and over had a lower likelihood of concurrent medications interfering with thyroid tests (OR, 0.47 vs age 65-74 years).
The findings are concerning given the wide use of levothyroxine to treat hypothyroidism, which is the most widely prescribed drug in the United States.
“Our findings not only highlight the complexity of thyroid hormone management in older adults in the context of polypharmacy and multimorbidity, but they also draw attention to vulnerable groups for this practice, which included female patients, non-Whites, patients of Hispanic ethnicity, and patients with comorbidities,” Dr. Papaleontiou said.
Nature of interference possibilities varies
Medications or supplements can interfere with thyroid function tests in a variety of ways, she explained. “Some medications could lead to a decrease in the absorption of levothyroxine, others may affect how well the pill dissolves.”
In addition, certain medications can affect the circulation of thyroid hormone in the blood and how it binds with proteins, or they can lead to decreasing thyroid hormone levels due to a variety of interactions.
And in contrast, “What is even more challenging is that some medications or supplements may appear to affect thyroid function based on lab tests when in reality they don’t actually affect thyroid function and may lead to dose adjustments unnecessarily,” Dr. Papaleontiou noted.
Recommendations to counter interference
Current recommendations to try to counter the effects of polypharmacy on thyroid treatment include advising patients to take thyroid hormones on an empty stomach at least 30-60 minutes prior to eating for optimal absorption.
If the patient is taking medications known to interfere with absorption of thyroid hormones, the recommendation is to space those out by at least 4 hours.
“The big challenge in older adults is that many of them do experience polypharmacy, being at risk for multiple drug-drug interactions,” Dr. Papaleontiou said.
“Physicians and patients should be vigilant and communicate closely every time there is initiation of a new medication or supplement to consider whether there may be interference.”
The authors have reported no relevant financial relationships. Dr. Hoang has reported being a speaker for Acella Pharmaceuticals.
A version of this article first appeared on Medscape.com.
, potentially compromising treatment decisions, new research shows.
“We know from previous studies that thyroid hormone use is common in older adults and that there are a multitude of medications that can interfere with thyroid function tests in different ways,” senior author Maria Papaleontiou, MD, told Medscape Medical News.
“However, to our knowledge, the extent of concurrent use of thyroid hormone and interfering medications in older adults, age 65 years and older, has not been previously explored,” added Dr. Papaleontiou, of the Division of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor.
The findings were presented as a poster during virtual ENDO 2021, the Endocrine Society’s annual meeting.
Commenting on the study, Thanh Duc Hoang, DO, an endocrinologist with the Walter Reed National Military Medical Center, in Bethesda, Md., said: “It is important for clinicians to be aware of various interactions and interferences of medications affecting the accuracy of thyroid function tests.”
“If patients are not able to discontinue the medications shortly before the bloodwork, the clinicians may consider ordering different thyroid tests or assays that avoid the interferences,” he told Medscape Medical News.
32% of patients taking meds that could interfere with tests
In evaluating data on 538,137 patients treated with thyroid hormones from the Corporate Data Warehouse of the Veterans Health Administration, spanning 2004-2017, first author Rachel Beeson, MD, and colleagues with the University of Michigan found most patients in the study were men (96.5%), White (77.1%), and had two or more comorbidities (62.6%).
Of this total, 170,261 (31.6%) patients treated with thyroid hormones, over a median follow-up of 56 months, were taking at least one drug that could potentially interfere with thyroid function tests.
Among the drugs with potential thyroid test interference, about 28% of patients were taking prednisone or prednisolone, 8% were taking amiodarone, and 1.42% were taking phenytoin. Other reported drugs that could potentially interfere included carbamazepine (0.91%), phenobarbital (0.15%), lithium (0.40%), and tamoxifen (0.11%).
Multivariate analysis showed that characteristics associated with those most likely to have concurrent medication use included non-Whites (OR, 1.18 vs Whites), Hispanic ethnicity (OR 1.11 vs non-Hispanic), female sex (OR 1.12 vs males), and presence of comorbidities (eg, Charlson-Deyo comorbidity score ≥ 2, OR, 2.47 vs score of 0).
Meanwhile, older patients age 85 years and over had a lower likelihood of concurrent medications interfering with thyroid tests (OR, 0.47 vs age 65-74 years).
The findings are concerning given the wide use of levothyroxine to treat hypothyroidism, which is the most widely prescribed drug in the United States.
“Our findings not only highlight the complexity of thyroid hormone management in older adults in the context of polypharmacy and multimorbidity, but they also draw attention to vulnerable groups for this practice, which included female patients, non-Whites, patients of Hispanic ethnicity, and patients with comorbidities,” Dr. Papaleontiou said.
Nature of interference possibilities varies
Medications or supplements can interfere with thyroid function tests in a variety of ways, she explained. “Some medications could lead to a decrease in the absorption of levothyroxine, others may affect how well the pill dissolves.”
In addition, certain medications can affect the circulation of thyroid hormone in the blood and how it binds with proteins, or they can lead to decreasing thyroid hormone levels due to a variety of interactions.
And in contrast, “What is even more challenging is that some medications or supplements may appear to affect thyroid function based on lab tests when in reality they don’t actually affect thyroid function and may lead to dose adjustments unnecessarily,” Dr. Papaleontiou noted.
Recommendations to counter interference
Current recommendations to try to counter the effects of polypharmacy on thyroid treatment include advising patients to take thyroid hormones on an empty stomach at least 30-60 minutes prior to eating for optimal absorption.
If the patient is taking medications known to interfere with absorption of thyroid hormones, the recommendation is to space those out by at least 4 hours.
“The big challenge in older adults is that many of them do experience polypharmacy, being at risk for multiple drug-drug interactions,” Dr. Papaleontiou said.
“Physicians and patients should be vigilant and communicate closely every time there is initiation of a new medication or supplement to consider whether there may be interference.”
The authors have reported no relevant financial relationships. Dr. Hoang has reported being a speaker for Acella Pharmaceuticals.
A version of this article first appeared on Medscape.com.
Imaging alternative to AVS could boost detection of primary aldosteronism
A noninvasive imaging method for identifying whether the source of a patient’s primary aldosteronism is from unilateral or bilateral adrenal adenomas worked as well as the standard method, invasive adrenal vein sampling, in a head-to-head comparison with 143 patients.
This noninvasive alternative, which also does not require the substantial technical expertise that AVS demands, should make assessment of adenoma laterality in patients with primary aldosteronism (PA) much more widely available and accessible, predicted Dr. Wu, a researcher at Queen Mary University of London.
“It will allow more places to do this, and I think it will definitely allow more patients to be diagnosed” with PA from a unilateral source. AVS “is a real bottleneck,” she said. “We hope metomidate, or molecular imaging using other selective radiotracers, will enable many more patients to be diagnosed and appropriately managed.” Creating new diagnostic options for patients with PA and potentially increasing the number of these patients who are surgical candidates “is the aim of this study.”
Patients with PA develop a curable form of hypertension if their excess aldosterone can be neutralized with a mineralocorticoid receptor antagonist (MRA), or even more definitively by surgical removal of the adrenal aldosteronoma generating the hormonal excess as long as the adenoma is unilateral. Conventional imaging of the adrenals with CT or MRI has proven unreliable for identifying adrenal nodules noninvasively, which has made the invasive and technically challenging standard option of AVS the only game in town.
But some endocrinologists caution that the results from this one study do not suffice to make 11C-metomidate-based PET-CT imaging a widely used alternative.
‘This is a first step.’
“This study is a first step. It will take lots more data for endocrinologists to buy into a scan over AVS,” commented David A. D’Alessio, MD, professor and chief of the division of endocrinology and metabolism at Duke University in Durham, N.C.
But Dr. D’Alessio also acknowledged the clear benefits from a safe and effective alternative to AVS.
“A reliable, less invasive, and less technical means of lateralizing excess aldosterone production would increase the number of people [with a unilateral PA source] going to surgery. The reality is that, if you are not a patient at the Mayo Clinic . . .or the National Institutes of Health, then AVS is a bit of crap shoot” that is very operator and institution dependent for its accuracy, Dr. D’Alessio said in an interview.
Metomidate specifically binds to key enzymes of the adrenal corticosteroid biosynthetic pathway, making it a precise targeting agent for a radioactive tag as documented almost a decade ago. One limitation is that this radiotracer labeling of metomidate has a 20-minute half life, which means it must be produced on site, thereby making the technology out of reach for locations that can’t set up this capability.
MATCHing imaging against AVS
To test the clinical utility of metomidate-based PET-CT directly against AVS, Dr. Wu and her associates enrolled 143 adults with confirmed PA and hypertension at two centers in London and one in Cambridge, England. The MATCH study cohort averaged 53 years of age; two-thirds were men, 58% were White, and 30% were Black. Their median blood pressure was 147/91 mm Hg, and they were maintained on a median of two antihypertensive drugs.
The researchers assessed every patient with both the imaging method and AVS, performed in random order and blindly scored. They then began each patient on a 1-month regimen with an MRA (usually spironolactone but eplerenone [Inspra] was also an option) to test the responsiveness of each patient’s hypertension to this drug class and to gauge their likely response to adrenalectomy. After the MRA test, the researchers assessed the lateralization tests and determined that 78 patients were appropriate candidates for unilateral adrenalectomy while the remaining 65 patients were not and continued on the MRA regimen. They recommended surgery if patients were clear positives by AVS, by PET-CT imaging, or both.
The study had four primary outcomes to assess the ability of the two diagnostic methods to predict the success of surgery based on four increasingly stringent postsurgical criteria calculated in hierarchical sequence: Partial or complete biochemical success, complete biochemical success, partial or complete clinical success (partial meaning any significant reduction in blood pressure), or complete clinical success (systolic pressure reduced to less than 135 mm Hg). Only one of the 78 patients treated with surgery failed to achieve at least a partial biochemical response.
For each of the four metrics, 11C-metomidate PET-CT produced point estimates of diagnostic accuracy that consistently edged out AVS. While these advantages were not large enough to meet the prespecified threshold for proving superiority, they comfortably showed the noninferiority of this imaging method compared with AVS.
For example, the PET-CT method had 43.6% accuracy for predicting a clinical cure, compared with 39.7% accuracy for AVS. For complete biochemical cure, imaging had 68.8% accuracy, compared with 62.3% for AVS, Dr. Wu reported.
Another notable finding from the study was how strongly a robust blood pressure response to spironolactone predicted the clinical outcome from surgery. Patients whose systolic blood pressure fell below 135 mm Hg on MRA treatment had a nearly 18-fold higher rate of achieving a complete clinical cure following surgery compared with patients who did not have as dramatic a blood pressure response to MRA treatment.
Woefully low rates of PA assessment
But regardless of the success that PET-CT imaging has for identifying surgical candidates, the first step is to identify patients with PA, a diagnosis that’s woefully underperformed worldwide. One example: A separate report at ENDO 2021 retrospectively reviewed nearly 12,000 patients with hypertension and an indication of PA, such as treatment-resistant hypertension or early-onset hypertension, and managed at either of two university outpatient clinics in Michigan during 2010-2019. The report documented that 3% underwent PA assessment.
Diagnosis of patients with PA “is a major problem,” noted Dr. D’Alessio. “I think of PA as an underdiagnosed and undertreated condition, with a huge impact on morbidity and mortality. Any advance in this area is likely to be useful.” But, he added, “I’m dubious whether this [new imaging approach] will increase diagnosis of PA.” What’s needed is “getting more primary care physicians to do more screening” for PA among their patients with hypertension and a suggestion of a PA cause.
“Surgical cures are glamorous, but medical management is also very effective, and we have good, inexpensive drugs to do this,” the MRAs, Dr. D’Alessio said.
The study received no commercial funding. Dr. Wu and her coauthors had no disclosures. Dr. D’Alessio has been a speaker on behalf of Novo Nordisk, a consultant to Intarcia and Lilly, and has received research funding from Lilly and Merck.
A noninvasive imaging method for identifying whether the source of a patient’s primary aldosteronism is from unilateral or bilateral adrenal adenomas worked as well as the standard method, invasive adrenal vein sampling, in a head-to-head comparison with 143 patients.
This noninvasive alternative, which also does not require the substantial technical expertise that AVS demands, should make assessment of adenoma laterality in patients with primary aldosteronism (PA) much more widely available and accessible, predicted Dr. Wu, a researcher at Queen Mary University of London.
“It will allow more places to do this, and I think it will definitely allow more patients to be diagnosed” with PA from a unilateral source. AVS “is a real bottleneck,” she said. “We hope metomidate, or molecular imaging using other selective radiotracers, will enable many more patients to be diagnosed and appropriately managed.” Creating new diagnostic options for patients with PA and potentially increasing the number of these patients who are surgical candidates “is the aim of this study.”
Patients with PA develop a curable form of hypertension if their excess aldosterone can be neutralized with a mineralocorticoid receptor antagonist (MRA), or even more definitively by surgical removal of the adrenal aldosteronoma generating the hormonal excess as long as the adenoma is unilateral. Conventional imaging of the adrenals with CT or MRI has proven unreliable for identifying adrenal nodules noninvasively, which has made the invasive and technically challenging standard option of AVS the only game in town.
But some endocrinologists caution that the results from this one study do not suffice to make 11C-metomidate-based PET-CT imaging a widely used alternative.
‘This is a first step.’
“This study is a first step. It will take lots more data for endocrinologists to buy into a scan over AVS,” commented David A. D’Alessio, MD, professor and chief of the division of endocrinology and metabolism at Duke University in Durham, N.C.
But Dr. D’Alessio also acknowledged the clear benefits from a safe and effective alternative to AVS.
“A reliable, less invasive, and less technical means of lateralizing excess aldosterone production would increase the number of people [with a unilateral PA source] going to surgery. The reality is that, if you are not a patient at the Mayo Clinic . . .or the National Institutes of Health, then AVS is a bit of crap shoot” that is very operator and institution dependent for its accuracy, Dr. D’Alessio said in an interview.
Metomidate specifically binds to key enzymes of the adrenal corticosteroid biosynthetic pathway, making it a precise targeting agent for a radioactive tag as documented almost a decade ago. One limitation is that this radiotracer labeling of metomidate has a 20-minute half life, which means it must be produced on site, thereby making the technology out of reach for locations that can’t set up this capability.
MATCHing imaging against AVS
To test the clinical utility of metomidate-based PET-CT directly against AVS, Dr. Wu and her associates enrolled 143 adults with confirmed PA and hypertension at two centers in London and one in Cambridge, England. The MATCH study cohort averaged 53 years of age; two-thirds were men, 58% were White, and 30% were Black. Their median blood pressure was 147/91 mm Hg, and they were maintained on a median of two antihypertensive drugs.
The researchers assessed every patient with both the imaging method and AVS, performed in random order and blindly scored. They then began each patient on a 1-month regimen with an MRA (usually spironolactone but eplerenone [Inspra] was also an option) to test the responsiveness of each patient’s hypertension to this drug class and to gauge their likely response to adrenalectomy. After the MRA test, the researchers assessed the lateralization tests and determined that 78 patients were appropriate candidates for unilateral adrenalectomy while the remaining 65 patients were not and continued on the MRA regimen. They recommended surgery if patients were clear positives by AVS, by PET-CT imaging, or both.
The study had four primary outcomes to assess the ability of the two diagnostic methods to predict the success of surgery based on four increasingly stringent postsurgical criteria calculated in hierarchical sequence: Partial or complete biochemical success, complete biochemical success, partial or complete clinical success (partial meaning any significant reduction in blood pressure), or complete clinical success (systolic pressure reduced to less than 135 mm Hg). Only one of the 78 patients treated with surgery failed to achieve at least a partial biochemical response.
For each of the four metrics, 11C-metomidate PET-CT produced point estimates of diagnostic accuracy that consistently edged out AVS. While these advantages were not large enough to meet the prespecified threshold for proving superiority, they comfortably showed the noninferiority of this imaging method compared with AVS.
For example, the PET-CT method had 43.6% accuracy for predicting a clinical cure, compared with 39.7% accuracy for AVS. For complete biochemical cure, imaging had 68.8% accuracy, compared with 62.3% for AVS, Dr. Wu reported.
Another notable finding from the study was how strongly a robust blood pressure response to spironolactone predicted the clinical outcome from surgery. Patients whose systolic blood pressure fell below 135 mm Hg on MRA treatment had a nearly 18-fold higher rate of achieving a complete clinical cure following surgery compared with patients who did not have as dramatic a blood pressure response to MRA treatment.
Woefully low rates of PA assessment
But regardless of the success that PET-CT imaging has for identifying surgical candidates, the first step is to identify patients with PA, a diagnosis that’s woefully underperformed worldwide. One example: A separate report at ENDO 2021 retrospectively reviewed nearly 12,000 patients with hypertension and an indication of PA, such as treatment-resistant hypertension or early-onset hypertension, and managed at either of two university outpatient clinics in Michigan during 2010-2019. The report documented that 3% underwent PA assessment.
Diagnosis of patients with PA “is a major problem,” noted Dr. D’Alessio. “I think of PA as an underdiagnosed and undertreated condition, with a huge impact on morbidity and mortality. Any advance in this area is likely to be useful.” But, he added, “I’m dubious whether this [new imaging approach] will increase diagnosis of PA.” What’s needed is “getting more primary care physicians to do more screening” for PA among their patients with hypertension and a suggestion of a PA cause.
“Surgical cures are glamorous, but medical management is also very effective, and we have good, inexpensive drugs to do this,” the MRAs, Dr. D’Alessio said.
The study received no commercial funding. Dr. Wu and her coauthors had no disclosures. Dr. D’Alessio has been a speaker on behalf of Novo Nordisk, a consultant to Intarcia and Lilly, and has received research funding from Lilly and Merck.
A noninvasive imaging method for identifying whether the source of a patient’s primary aldosteronism is from unilateral or bilateral adrenal adenomas worked as well as the standard method, invasive adrenal vein sampling, in a head-to-head comparison with 143 patients.
This noninvasive alternative, which also does not require the substantial technical expertise that AVS demands, should make assessment of adenoma laterality in patients with primary aldosteronism (PA) much more widely available and accessible, predicted Dr. Wu, a researcher at Queen Mary University of London.
“It will allow more places to do this, and I think it will definitely allow more patients to be diagnosed” with PA from a unilateral source. AVS “is a real bottleneck,” she said. “We hope metomidate, or molecular imaging using other selective radiotracers, will enable many more patients to be diagnosed and appropriately managed.” Creating new diagnostic options for patients with PA and potentially increasing the number of these patients who are surgical candidates “is the aim of this study.”
Patients with PA develop a curable form of hypertension if their excess aldosterone can be neutralized with a mineralocorticoid receptor antagonist (MRA), or even more definitively by surgical removal of the adrenal aldosteronoma generating the hormonal excess as long as the adenoma is unilateral. Conventional imaging of the adrenals with CT or MRI has proven unreliable for identifying adrenal nodules noninvasively, which has made the invasive and technically challenging standard option of AVS the only game in town.
But some endocrinologists caution that the results from this one study do not suffice to make 11C-metomidate-based PET-CT imaging a widely used alternative.
‘This is a first step.’
“This study is a first step. It will take lots more data for endocrinologists to buy into a scan over AVS,” commented David A. D’Alessio, MD, professor and chief of the division of endocrinology and metabolism at Duke University in Durham, N.C.
But Dr. D’Alessio also acknowledged the clear benefits from a safe and effective alternative to AVS.
“A reliable, less invasive, and less technical means of lateralizing excess aldosterone production would increase the number of people [with a unilateral PA source] going to surgery. The reality is that, if you are not a patient at the Mayo Clinic . . .or the National Institutes of Health, then AVS is a bit of crap shoot” that is very operator and institution dependent for its accuracy, Dr. D’Alessio said in an interview.
Metomidate specifically binds to key enzymes of the adrenal corticosteroid biosynthetic pathway, making it a precise targeting agent for a radioactive tag as documented almost a decade ago. One limitation is that this radiotracer labeling of metomidate has a 20-minute half life, which means it must be produced on site, thereby making the technology out of reach for locations that can’t set up this capability.
MATCHing imaging against AVS
To test the clinical utility of metomidate-based PET-CT directly against AVS, Dr. Wu and her associates enrolled 143 adults with confirmed PA and hypertension at two centers in London and one in Cambridge, England. The MATCH study cohort averaged 53 years of age; two-thirds were men, 58% were White, and 30% were Black. Their median blood pressure was 147/91 mm Hg, and they were maintained on a median of two antihypertensive drugs.
The researchers assessed every patient with both the imaging method and AVS, performed in random order and blindly scored. They then began each patient on a 1-month regimen with an MRA (usually spironolactone but eplerenone [Inspra] was also an option) to test the responsiveness of each patient’s hypertension to this drug class and to gauge their likely response to adrenalectomy. After the MRA test, the researchers assessed the lateralization tests and determined that 78 patients were appropriate candidates for unilateral adrenalectomy while the remaining 65 patients were not and continued on the MRA regimen. They recommended surgery if patients were clear positives by AVS, by PET-CT imaging, or both.
The study had four primary outcomes to assess the ability of the two diagnostic methods to predict the success of surgery based on four increasingly stringent postsurgical criteria calculated in hierarchical sequence: Partial or complete biochemical success, complete biochemical success, partial or complete clinical success (partial meaning any significant reduction in blood pressure), or complete clinical success (systolic pressure reduced to less than 135 mm Hg). Only one of the 78 patients treated with surgery failed to achieve at least a partial biochemical response.
For each of the four metrics, 11C-metomidate PET-CT produced point estimates of diagnostic accuracy that consistently edged out AVS. While these advantages were not large enough to meet the prespecified threshold for proving superiority, they comfortably showed the noninferiority of this imaging method compared with AVS.
For example, the PET-CT method had 43.6% accuracy for predicting a clinical cure, compared with 39.7% accuracy for AVS. For complete biochemical cure, imaging had 68.8% accuracy, compared with 62.3% for AVS, Dr. Wu reported.
Another notable finding from the study was how strongly a robust blood pressure response to spironolactone predicted the clinical outcome from surgery. Patients whose systolic blood pressure fell below 135 mm Hg on MRA treatment had a nearly 18-fold higher rate of achieving a complete clinical cure following surgery compared with patients who did not have as dramatic a blood pressure response to MRA treatment.
Woefully low rates of PA assessment
But regardless of the success that PET-CT imaging has for identifying surgical candidates, the first step is to identify patients with PA, a diagnosis that’s woefully underperformed worldwide. One example: A separate report at ENDO 2021 retrospectively reviewed nearly 12,000 patients with hypertension and an indication of PA, such as treatment-resistant hypertension or early-onset hypertension, and managed at either of two university outpatient clinics in Michigan during 2010-2019. The report documented that 3% underwent PA assessment.
Diagnosis of patients with PA “is a major problem,” noted Dr. D’Alessio. “I think of PA as an underdiagnosed and undertreated condition, with a huge impact on morbidity and mortality. Any advance in this area is likely to be useful.” But, he added, “I’m dubious whether this [new imaging approach] will increase diagnosis of PA.” What’s needed is “getting more primary care physicians to do more screening” for PA among their patients with hypertension and a suggestion of a PA cause.
“Surgical cures are glamorous, but medical management is also very effective, and we have good, inexpensive drugs to do this,” the MRAs, Dr. D’Alessio said.
The study received no commercial funding. Dr. Wu and her coauthors had no disclosures. Dr. D’Alessio has been a speaker on behalf of Novo Nordisk, a consultant to Intarcia and Lilly, and has received research funding from Lilly and Merck.
FROM ENDO 2021
When to not go with your gut: Modern approaches to abdominal wall pain
Abdominal pain is a commonly seen presenting concern in gastroenterology clinics. Establishing a diagnosis effectively and efficiently can be challenging given the broad differential. Abdominal wall pain is an often-overlooked diagnosis but accounts for up to 30% of cases of chronic abdominal pain1 and up to 10% of patients with chronic idiopathic abdominal pain seen in gastroenterology practices.2 Trigger point injection in the office can be both diagnostic and therapeutic.
The prevalence of chronic abdominal wall pain is highest in the fifth and sixth decades, and it is four times more likely to occur in women than in men. Common comorbid conditions include obesity, gastroesophageal reflux disease, irritable bowel syndrome, and fibromyalgia.3 Abdominal wall pain is often sharp or burning due to somatic innervation of the abdominal wall supplied by the anterior branches of thoracic intercostal nerves (T7 to T11). Abdominal wall pain may originate from entrapment of these nerves.2 Potential causes of entrapment include disruption of insulating fat, localized edema and distension, and scar tissue or fibrosis from prior surgical procedures.3 Symptoms are typically exacerbated with any actions or activities that engage the abdominal wall such as twisting or turning, and pain often improves with rest.
The classic physical exam finding for abdominal wall pain is a positive Carnett sign. This is determined via palpation of the point of maximal tenderness. First, this is done with a single finger while the patient’s abdominal wall is relaxed. The same point is then palpated again while the patient engages their abdominal muscles, most commonly while the patient to performs a “sit up” or lifts their legs off the exam table. Exacerbation of pain with these maneuvers indicates a positive test and suggests the abdominal wall as the underlying etiology.
While performing the maneuver for determining Carnett sign is a simple test in the traditional office visit, the COVID-19 pandemic has led to a burgeoning proportion of telehealth visits, limiting the physician’s ability to perform a direct physical exam. Fortunately, the maneuvers required when testing for Carnett sign are simple enough that a clinician can guide a patient step-by-step on how to perform the test. Ideally, if a family member or friend is available to serve as the clinician’s hands, the test can be performed with ease while directly visualizing proper technique. Sample videos of how the test is performed are readily available on the Internet for patients to view (the authors suggest screening the video yourself before providing a link to patients). The sensitivity and specificity of Carnett sign are very high (>70%) and even better when there is no apparent hernia.1
Management
Trigger point injections with local anesthetic can be both diagnostic and therapeutic in patients with abdominal wall pain. An immediate reduction of pain by at least 50% with injection at the site of maximal tenderness strongly supports the diagnosis of abdominal wall pain.1 Patients should first be thoroughly counseled on potential side effects of local corticosteroid injection to include risk of infection, bleeding, pain, skin hypopigmentation, or thinning and fat atrophy. Repeat injections are rarely needed, and any additional injection should be performed after at least 3 months. Additional adjunct therapies include nonsteroidal anti-inflammatory medications, topical therapies such as lidocaine, and neuroleptic agents such as gabapentin.4 One previously described trigger point injection technique, involves a mix of triamcinolone and lidocaine injected at the point of maximal tenderness.5 This technique is easy to perform in clinic and has minimal risks.
Conclusion
Abdominal wall pain is a common, yet often-overlooked, condition that can be diagnosed with a good clinical history and physical exam. A simple in-office trigger point injection can confirm the diagnosis and offer durable relief for most patients. A shift to virtual medicine does not need to a barrier to diagnosis, particularly in the attentive patient.
Dr. Park is a fellow in the gastroenterology service in the Department of Internal Medicine at Naval Medical Center San Diego and an assistant professor in the department of medicine of the Uniformed Services University in Bethesda, Md. Dr. Singla is a gastroenterologist at Capital Digestive Care in Silver Spring, Md., and an associate professor in the department of medicine at the Uniformed Services University. The authors have no conflicts of interest.
References
1. Glissen Brown JR et al. J Clin Gastroenterol. 2016;50(10):828-35.
2. Srinivasan R, Greenbaum DS. Am J Gastroenterol. 2002;97(4):824-30.
3. Kambox AK et al. Mayo Clin Proc. 2019;94(1):139-44.
4. Scheltinga MR, Roumen RM. Hernia. 2018;22(3):507-16.
5. Singla M, Laczek JT. Am J Gastroenterol. 2020 May;115(5):645-7.
Abdominal pain is a commonly seen presenting concern in gastroenterology clinics. Establishing a diagnosis effectively and efficiently can be challenging given the broad differential. Abdominal wall pain is an often-overlooked diagnosis but accounts for up to 30% of cases of chronic abdominal pain1 and up to 10% of patients with chronic idiopathic abdominal pain seen in gastroenterology practices.2 Trigger point injection in the office can be both diagnostic and therapeutic.
The prevalence of chronic abdominal wall pain is highest in the fifth and sixth decades, and it is four times more likely to occur in women than in men. Common comorbid conditions include obesity, gastroesophageal reflux disease, irritable bowel syndrome, and fibromyalgia.3 Abdominal wall pain is often sharp or burning due to somatic innervation of the abdominal wall supplied by the anterior branches of thoracic intercostal nerves (T7 to T11). Abdominal wall pain may originate from entrapment of these nerves.2 Potential causes of entrapment include disruption of insulating fat, localized edema and distension, and scar tissue or fibrosis from prior surgical procedures.3 Symptoms are typically exacerbated with any actions or activities that engage the abdominal wall such as twisting or turning, and pain often improves with rest.
The classic physical exam finding for abdominal wall pain is a positive Carnett sign. This is determined via palpation of the point of maximal tenderness. First, this is done with a single finger while the patient’s abdominal wall is relaxed. The same point is then palpated again while the patient engages their abdominal muscles, most commonly while the patient to performs a “sit up” or lifts their legs off the exam table. Exacerbation of pain with these maneuvers indicates a positive test and suggests the abdominal wall as the underlying etiology.
While performing the maneuver for determining Carnett sign is a simple test in the traditional office visit, the COVID-19 pandemic has led to a burgeoning proportion of telehealth visits, limiting the physician’s ability to perform a direct physical exam. Fortunately, the maneuvers required when testing for Carnett sign are simple enough that a clinician can guide a patient step-by-step on how to perform the test. Ideally, if a family member or friend is available to serve as the clinician’s hands, the test can be performed with ease while directly visualizing proper technique. Sample videos of how the test is performed are readily available on the Internet for patients to view (the authors suggest screening the video yourself before providing a link to patients). The sensitivity and specificity of Carnett sign are very high (>70%) and even better when there is no apparent hernia.1
Management
Trigger point injections with local anesthetic can be both diagnostic and therapeutic in patients with abdominal wall pain. An immediate reduction of pain by at least 50% with injection at the site of maximal tenderness strongly supports the diagnosis of abdominal wall pain.1 Patients should first be thoroughly counseled on potential side effects of local corticosteroid injection to include risk of infection, bleeding, pain, skin hypopigmentation, or thinning and fat atrophy. Repeat injections are rarely needed, and any additional injection should be performed after at least 3 months. Additional adjunct therapies include nonsteroidal anti-inflammatory medications, topical therapies such as lidocaine, and neuroleptic agents such as gabapentin.4 One previously described trigger point injection technique, involves a mix of triamcinolone and lidocaine injected at the point of maximal tenderness.5 This technique is easy to perform in clinic and has minimal risks.
Conclusion
Abdominal wall pain is a common, yet often-overlooked, condition that can be diagnosed with a good clinical history and physical exam. A simple in-office trigger point injection can confirm the diagnosis and offer durable relief for most patients. A shift to virtual medicine does not need to a barrier to diagnosis, particularly in the attentive patient.
Dr. Park is a fellow in the gastroenterology service in the Department of Internal Medicine at Naval Medical Center San Diego and an assistant professor in the department of medicine of the Uniformed Services University in Bethesda, Md. Dr. Singla is a gastroenterologist at Capital Digestive Care in Silver Spring, Md., and an associate professor in the department of medicine at the Uniformed Services University. The authors have no conflicts of interest.
References
1. Glissen Brown JR et al. J Clin Gastroenterol. 2016;50(10):828-35.
2. Srinivasan R, Greenbaum DS. Am J Gastroenterol. 2002;97(4):824-30.
3. Kambox AK et al. Mayo Clin Proc. 2019;94(1):139-44.
4. Scheltinga MR, Roumen RM. Hernia. 2018;22(3):507-16.
5. Singla M, Laczek JT. Am J Gastroenterol. 2020 May;115(5):645-7.
Abdominal pain is a commonly seen presenting concern in gastroenterology clinics. Establishing a diagnosis effectively and efficiently can be challenging given the broad differential. Abdominal wall pain is an often-overlooked diagnosis but accounts for up to 30% of cases of chronic abdominal pain1 and up to 10% of patients with chronic idiopathic abdominal pain seen in gastroenterology practices.2 Trigger point injection in the office can be both diagnostic and therapeutic.
The prevalence of chronic abdominal wall pain is highest in the fifth and sixth decades, and it is four times more likely to occur in women than in men. Common comorbid conditions include obesity, gastroesophageal reflux disease, irritable bowel syndrome, and fibromyalgia.3 Abdominal wall pain is often sharp or burning due to somatic innervation of the abdominal wall supplied by the anterior branches of thoracic intercostal nerves (T7 to T11). Abdominal wall pain may originate from entrapment of these nerves.2 Potential causes of entrapment include disruption of insulating fat, localized edema and distension, and scar tissue or fibrosis from prior surgical procedures.3 Symptoms are typically exacerbated with any actions or activities that engage the abdominal wall such as twisting or turning, and pain often improves with rest.
The classic physical exam finding for abdominal wall pain is a positive Carnett sign. This is determined via palpation of the point of maximal tenderness. First, this is done with a single finger while the patient’s abdominal wall is relaxed. The same point is then palpated again while the patient engages their abdominal muscles, most commonly while the patient to performs a “sit up” or lifts their legs off the exam table. Exacerbation of pain with these maneuvers indicates a positive test and suggests the abdominal wall as the underlying etiology.
While performing the maneuver for determining Carnett sign is a simple test in the traditional office visit, the COVID-19 pandemic has led to a burgeoning proportion of telehealth visits, limiting the physician’s ability to perform a direct physical exam. Fortunately, the maneuvers required when testing for Carnett sign are simple enough that a clinician can guide a patient step-by-step on how to perform the test. Ideally, if a family member or friend is available to serve as the clinician’s hands, the test can be performed with ease while directly visualizing proper technique. Sample videos of how the test is performed are readily available on the Internet for patients to view (the authors suggest screening the video yourself before providing a link to patients). The sensitivity and specificity of Carnett sign are very high (>70%) and even better when there is no apparent hernia.1
Management
Trigger point injections with local anesthetic can be both diagnostic and therapeutic in patients with abdominal wall pain. An immediate reduction of pain by at least 50% with injection at the site of maximal tenderness strongly supports the diagnosis of abdominal wall pain.1 Patients should first be thoroughly counseled on potential side effects of local corticosteroid injection to include risk of infection, bleeding, pain, skin hypopigmentation, or thinning and fat atrophy. Repeat injections are rarely needed, and any additional injection should be performed after at least 3 months. Additional adjunct therapies include nonsteroidal anti-inflammatory medications, topical therapies such as lidocaine, and neuroleptic agents such as gabapentin.4 One previously described trigger point injection technique, involves a mix of triamcinolone and lidocaine injected at the point of maximal tenderness.5 This technique is easy to perform in clinic and has minimal risks.
Conclusion
Abdominal wall pain is a common, yet often-overlooked, condition that can be diagnosed with a good clinical history and physical exam. A simple in-office trigger point injection can confirm the diagnosis and offer durable relief for most patients. A shift to virtual medicine does not need to a barrier to diagnosis, particularly in the attentive patient.
Dr. Park is a fellow in the gastroenterology service in the Department of Internal Medicine at Naval Medical Center San Diego and an assistant professor in the department of medicine of the Uniformed Services University in Bethesda, Md. Dr. Singla is a gastroenterologist at Capital Digestive Care in Silver Spring, Md., and an associate professor in the department of medicine at the Uniformed Services University. The authors have no conflicts of interest.
References
1. Glissen Brown JR et al. J Clin Gastroenterol. 2016;50(10):828-35.
2. Srinivasan R, Greenbaum DS. Am J Gastroenterol. 2002;97(4):824-30.
3. Kambox AK et al. Mayo Clin Proc. 2019;94(1):139-44.
4. Scheltinga MR, Roumen RM. Hernia. 2018;22(3):507-16.
5. Singla M, Laczek JT. Am J Gastroenterol. 2020 May;115(5):645-7.
Advocating in a pandemic: A fellow’s perspective on AGA Advocacy Day
Gastroenterology fellowship is an exercise in balance. You are learning your way around different parts of the gastrointestinal tract, both cerebrally and anatomically. You are continuously taking care of patients, in the hospital and in the clinic. You attend all kinds of conferences, didactics, and webinars. And though the hours are long, the work is worth seeing a smile from even one patient for whom you have made a tangible difference in health care. Though these moments are priceless, how often they happen is often limited by access to care, health care disparities, and systemic injustice. Fighting for each one of our patients and their health is difficult for even the most seasoned physician. Training during the middle of a pandemic has brought health care disparities to the forefront; delays in colorectal cancer screening and postponements of nonurgent procedures will have downstream impacts. It was with these thoughts in mind that I decided to participate in AGA (American Gastroenterological Association) Advocacy Day in September 2020 as a gastroenterology fellow.
After close to 20 years of in-person Advocacy Days, the AGA decided to take its advocacy efforts to a virtual platform in the fall of 2020. The country remained in the throes of the worst pandemic it had seen in over a century, and social distancing efforts necessitated a different venue than previous years. This year’s online platform was designed to let individuals involved in gastroenterology health care join each other and discuss policies germane to our patients and our profession.
I have to confess that I did not have significant legislative experience, and I signed up for the virtual Advocacy Day with a sense of slight trepidation. Would I be prepared to talk to experts in the field? What did I know about health care policy on the granular level? How could I get across my message cogently and successfully? All I really knew was that I wanted to get engaged with a group of gastroenterologists early on in my career who were not only vociferous advocates for their patients at the bedside, but who were also able to actively support policy changes that would bring about systemic change.
As it turned out, I had nothing to worry about. This advocacy experience was designed for gastroenterology clinical providers to be able to talk intelligently about topics they knew well – research funding, colonoscopy costs, and different levels of therapy for patients with inflammatory bowel disease, among others. To provide an overview of public policy issues, the AGA prepared a legislative briefing book that allowed us to take a deep dive into these topics. I remember reviewing the issue briefs in detail, understanding that I did not need to be an expert but that familiarity with the issues would be a key component of having a successful meeting. I also completed an online advocacy training module that gave me insight into how and why I could advocate for my profession as a future gastroenterologist. Based on our congressional district and state, we were divided into groups of congressional advocates who would speak to specific congressional staff members. During our meetings, we had legislative staff available to help us navigate the finer points of public policy. Each member of my group chose a topic that was personally relevant to them. Throughout our sessions, we shared personal stories, dove in and out of virtual meeting rooms, and made sure we were clear in what we were advocating for.
As a second-year gastroenterology fellow working at the National Institutes of Health, I chose to focus on digestive diseases research funding for the research community. I talked to the congressional staff members about a patient I had seen earlier that year. He was a man in his mid-30s who was diagnosed with hepatitis C more than 10 years ago and was told, at the time of his diagnosis, that there were no good treatments for him. He had resigned himself to that fact until I saw him in my office and spoke to him about the remarkable advances in liver disease treatment that were made over the past few years. I talked to him about how Hepatitis C was a disease that could now be cured – the relief on his face was clear and only reaffirmed in me the understanding that research in digestive diseases has improved the health of our nation’s population through sustained research efforts in gastrointestinal cancers and other life-altering illnesses.
So what did I take away from this adventure in advocacy? Our role as gastroenterologists can go beyond treating one patient in one office in one hospital system at a time. We can effect change by addressing policies that we know are hurting our patients and their health. The learning curve is made much easier under the excellence of the AGA advocacy staff, who takes the time to gather resources and educate us on the specifics of relevant legislative policies, as well as of the congressional members with whom we are speaking. Our advice was sought after because, after years of training, we were the experts in this field. I was proud to have joined this grassroots network of engaged members to speak to our lawmakers. I can only imagine, in the years to come, how wonderful it would be to do this in person in our nation’s capital.
Dr. Asif is a gastroenterology fellow working with the University of Maryland and National Institutes of Health. He has no conflicts of interest to disclose.
Gastroenterology fellowship is an exercise in balance. You are learning your way around different parts of the gastrointestinal tract, both cerebrally and anatomically. You are continuously taking care of patients, in the hospital and in the clinic. You attend all kinds of conferences, didactics, and webinars. And though the hours are long, the work is worth seeing a smile from even one patient for whom you have made a tangible difference in health care. Though these moments are priceless, how often they happen is often limited by access to care, health care disparities, and systemic injustice. Fighting for each one of our patients and their health is difficult for even the most seasoned physician. Training during the middle of a pandemic has brought health care disparities to the forefront; delays in colorectal cancer screening and postponements of nonurgent procedures will have downstream impacts. It was with these thoughts in mind that I decided to participate in AGA (American Gastroenterological Association) Advocacy Day in September 2020 as a gastroenterology fellow.
After close to 20 years of in-person Advocacy Days, the AGA decided to take its advocacy efforts to a virtual platform in the fall of 2020. The country remained in the throes of the worst pandemic it had seen in over a century, and social distancing efforts necessitated a different venue than previous years. This year’s online platform was designed to let individuals involved in gastroenterology health care join each other and discuss policies germane to our patients and our profession.
I have to confess that I did not have significant legislative experience, and I signed up for the virtual Advocacy Day with a sense of slight trepidation. Would I be prepared to talk to experts in the field? What did I know about health care policy on the granular level? How could I get across my message cogently and successfully? All I really knew was that I wanted to get engaged with a group of gastroenterologists early on in my career who were not only vociferous advocates for their patients at the bedside, but who were also able to actively support policy changes that would bring about systemic change.
As it turned out, I had nothing to worry about. This advocacy experience was designed for gastroenterology clinical providers to be able to talk intelligently about topics they knew well – research funding, colonoscopy costs, and different levels of therapy for patients with inflammatory bowel disease, among others. To provide an overview of public policy issues, the AGA prepared a legislative briefing book that allowed us to take a deep dive into these topics. I remember reviewing the issue briefs in detail, understanding that I did not need to be an expert but that familiarity with the issues would be a key component of having a successful meeting. I also completed an online advocacy training module that gave me insight into how and why I could advocate for my profession as a future gastroenterologist. Based on our congressional district and state, we were divided into groups of congressional advocates who would speak to specific congressional staff members. During our meetings, we had legislative staff available to help us navigate the finer points of public policy. Each member of my group chose a topic that was personally relevant to them. Throughout our sessions, we shared personal stories, dove in and out of virtual meeting rooms, and made sure we were clear in what we were advocating for.
As a second-year gastroenterology fellow working at the National Institutes of Health, I chose to focus on digestive diseases research funding for the research community. I talked to the congressional staff members about a patient I had seen earlier that year. He was a man in his mid-30s who was diagnosed with hepatitis C more than 10 years ago and was told, at the time of his diagnosis, that there were no good treatments for him. He had resigned himself to that fact until I saw him in my office and spoke to him about the remarkable advances in liver disease treatment that were made over the past few years. I talked to him about how Hepatitis C was a disease that could now be cured – the relief on his face was clear and only reaffirmed in me the understanding that research in digestive diseases has improved the health of our nation’s population through sustained research efforts in gastrointestinal cancers and other life-altering illnesses.
So what did I take away from this adventure in advocacy? Our role as gastroenterologists can go beyond treating one patient in one office in one hospital system at a time. We can effect change by addressing policies that we know are hurting our patients and their health. The learning curve is made much easier under the excellence of the AGA advocacy staff, who takes the time to gather resources and educate us on the specifics of relevant legislative policies, as well as of the congressional members with whom we are speaking. Our advice was sought after because, after years of training, we were the experts in this field. I was proud to have joined this grassroots network of engaged members to speak to our lawmakers. I can only imagine, in the years to come, how wonderful it would be to do this in person in our nation’s capital.
Dr. Asif is a gastroenterology fellow working with the University of Maryland and National Institutes of Health. He has no conflicts of interest to disclose.
Gastroenterology fellowship is an exercise in balance. You are learning your way around different parts of the gastrointestinal tract, both cerebrally and anatomically. You are continuously taking care of patients, in the hospital and in the clinic. You attend all kinds of conferences, didactics, and webinars. And though the hours are long, the work is worth seeing a smile from even one patient for whom you have made a tangible difference in health care. Though these moments are priceless, how often they happen is often limited by access to care, health care disparities, and systemic injustice. Fighting for each one of our patients and their health is difficult for even the most seasoned physician. Training during the middle of a pandemic has brought health care disparities to the forefront; delays in colorectal cancer screening and postponements of nonurgent procedures will have downstream impacts. It was with these thoughts in mind that I decided to participate in AGA (American Gastroenterological Association) Advocacy Day in September 2020 as a gastroenterology fellow.
After close to 20 years of in-person Advocacy Days, the AGA decided to take its advocacy efforts to a virtual platform in the fall of 2020. The country remained in the throes of the worst pandemic it had seen in over a century, and social distancing efforts necessitated a different venue than previous years. This year’s online platform was designed to let individuals involved in gastroenterology health care join each other and discuss policies germane to our patients and our profession.
I have to confess that I did not have significant legislative experience, and I signed up for the virtual Advocacy Day with a sense of slight trepidation. Would I be prepared to talk to experts in the field? What did I know about health care policy on the granular level? How could I get across my message cogently and successfully? All I really knew was that I wanted to get engaged with a group of gastroenterologists early on in my career who were not only vociferous advocates for their patients at the bedside, but who were also able to actively support policy changes that would bring about systemic change.
As it turned out, I had nothing to worry about. This advocacy experience was designed for gastroenterology clinical providers to be able to talk intelligently about topics they knew well – research funding, colonoscopy costs, and different levels of therapy for patients with inflammatory bowel disease, among others. To provide an overview of public policy issues, the AGA prepared a legislative briefing book that allowed us to take a deep dive into these topics. I remember reviewing the issue briefs in detail, understanding that I did not need to be an expert but that familiarity with the issues would be a key component of having a successful meeting. I also completed an online advocacy training module that gave me insight into how and why I could advocate for my profession as a future gastroenterologist. Based on our congressional district and state, we were divided into groups of congressional advocates who would speak to specific congressional staff members. During our meetings, we had legislative staff available to help us navigate the finer points of public policy. Each member of my group chose a topic that was personally relevant to them. Throughout our sessions, we shared personal stories, dove in and out of virtual meeting rooms, and made sure we were clear in what we were advocating for.
As a second-year gastroenterology fellow working at the National Institutes of Health, I chose to focus on digestive diseases research funding for the research community. I talked to the congressional staff members about a patient I had seen earlier that year. He was a man in his mid-30s who was diagnosed with hepatitis C more than 10 years ago and was told, at the time of his diagnosis, that there were no good treatments for him. He had resigned himself to that fact until I saw him in my office and spoke to him about the remarkable advances in liver disease treatment that were made over the past few years. I talked to him about how Hepatitis C was a disease that could now be cured – the relief on his face was clear and only reaffirmed in me the understanding that research in digestive diseases has improved the health of our nation’s population through sustained research efforts in gastrointestinal cancers and other life-altering illnesses.
So what did I take away from this adventure in advocacy? Our role as gastroenterologists can go beyond treating one patient in one office in one hospital system at a time. We can effect change by addressing policies that we know are hurting our patients and their health. The learning curve is made much easier under the excellence of the AGA advocacy staff, who takes the time to gather resources and educate us on the specifics of relevant legislative policies, as well as of the congressional members with whom we are speaking. Our advice was sought after because, after years of training, we were the experts in this field. I was proud to have joined this grassroots network of engaged members to speak to our lawmakers. I can only imagine, in the years to come, how wonderful it would be to do this in person in our nation’s capital.
Dr. Asif is a gastroenterology fellow working with the University of Maryland and National Institutes of Health. He has no conflicts of interest to disclose.