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Eruptive Melanocytic Nevi During Azathioprine Therapy for Antisynthetase Syndrome
Case Report
A 50-year-old man with a history of antisynthetase syndrome (positive for anti–Jo-1 polymyositis with interstitial lung disease) and sarcoidosis presented for evaluation of numerous new moles. The lesions had developed on the trunk, arms, legs, hands, and feet approximately 3 weeks after starting azathioprine 100 mg once daily for pulmonary and muscular involvement of antisynthetase syndrome. He denied any preceding cutaneous inflammation or sunburns. He had no personal or family history of skin cancer, and no family members had multiple nevi. Physical examination revealed 30 to 40 benign-appearing, 2- to 5-mm, hyperpigmented macules scattered on the medial aspect of the right foot (Figure 1A), left palm (Figure 1B), back, abdomen, chest, arms, and legs. A larger, somewhat asymmetric, irregularly bordered, and irregularly pigmented macule was noted on the left side of the upper back. A punch biopsy of the lesion revealed a benign, mildly atypical lentiginous compound nevus (Figure 2). Pathology confirmed that the lesions represented eruptive melanocytic nevi (EMN). The patient continued azathioprine therapy and was followed with regular full-body skin examinations. Mycophenolate mofetil was suggested as an alternative therapy, if clinically appropriate, though this change has not been made by the patient’s rheumatologists.
Comment
A PubMed search of articles indexed for MEDLINE using the search terms eruptive melanocytic nevi and azathioprine revealed 14 cases of EMN in the setting of azathioprine therapy, either during azathioprine monotherapy or in combination with other immunosuppressants, including systemic corticosteroids, biologics, and cyclosporine (Table).1-5 The majority of these cases occurred in renal transplant patients,1 with 3 additional cases reported in the setting of Crohn disease,2,3,5 and another in a patient with myasthenia gravis.4 Patients ranged in age from 8 to 42 years (mean age, 22 years), with lesions developing a few months to up to 7 years after starting therapy. When specified, the reported lesions typically were small, ranging from 1 to 3 mm in size, and developed rapidly over a couple of months with a predilection for the palms, soles, and trunk. Although dysplastic nevi were described in only 2 patients, melanomas were not detected.
Various hypotheses have sought to explain the largely unknown etiology of EMN. Bovenschen et al3 suggested that immunocompromised patients have diminished immune surveillance in the skin, which allows for unchecked proliferation of melanocytes. Specifically, immune suppression may induce melanocyte-stimulating hormone or melanoma growth stimulatory activity, with composition-specific growth in skin at the palms and soles.3,4 The preferential growth on the palms and soles suggests that those regions may have special sensitivity to melanocyte-stimulating hormone.4 Woodhouse and Maytin6 postulated that the increased density of eccrine sweat glands in the palms and soles as well as the absence of pilosebaceous units and apocrine glands and plentiful Pacinian and Meissner corpuscles may allow for a unique response to circulating melanocytic growth factors. Another hypothesis suggests the presence of genetic factors that allow subclinical nests of nevus cells to form, which become clinical eruptions following chemotherapy or immunosuppressive therapy.3 Azathioprine also has been suggested to induce various transcription factors that play a critical role in differentiation and proliferation of melanocytic stem cells, which leads to the formation of nevi.4 Our case and others similar to it implore that further studies be done to determine the molecular mechanism driving this phenomenon and whether a specific genetic predisposition exists that lowers the threshold for rapid proliferation of melanocytes given an immunosuppressed status.2
The risk for melanoma development in cases of EMN is unknown. Although our review of the literature did not reveal any melanomas reported in cases attributed to azathioprine, a theoretical risk exists given the established associations between melanoma and immunosuppression as well as increased numbers of nevi.6 Accordingly, these patients should be followed with regular skin examinations and biopsies of atypical-appearing lesions as indicated.2,3,5 Braun et al4 also suggested the discontinuance of azathioprine and switch to mycophenolic acid, which has not been noted to cause such eruptions; this drug was recommended in our case.
- Alaibac M, Piaserico S, Rossi CR, et al. Eruptive melanocytic nevi in patients with renal allografts: report of 10 cases with dermoscopic findings. J Am Acad Dermatol. 2003;49:1020-1022.
- Belloni FA, Piaserico S, Zattra E, et al. Dermoscopic features of eruptive melanocytic naevi in an adult patient receiving immunosuppressive therapy for Crohn’s disease. Melanoma Res. 2005;15:223-224.
- Bovenschen HJ, Tjioe M, Vermaat H, et al. Induction of eruptive benign melanocytic naevi by immune suppressive agents, including biologicals. Br J Dermatol. 2006;154:880-884.
- Braun SA, Helbig D, Frank J, et al. Eruptive melanocytic nevi during azathioprine therapy in myasthenia gravis [in German]. Hautarzt. 2012;63:756-759.
- Wonders J, De Boer N, Van Weyenberg S. Spot diagnosis: eruptive melanocytic naevi during azathioprine therapy in Crohn’s disease [published online March 6, 2012]. J Crohns Colitis. 2012;6:636.
- Woodhouse J, Maytin EV. Eruptive nevi of the palms and soles. J Am Acad Dermatol. 2005;52(5 suppl 1):S96-S100.
Case Report
A 50-year-old man with a history of antisynthetase syndrome (positive for anti–Jo-1 polymyositis with interstitial lung disease) and sarcoidosis presented for evaluation of numerous new moles. The lesions had developed on the trunk, arms, legs, hands, and feet approximately 3 weeks after starting azathioprine 100 mg once daily for pulmonary and muscular involvement of antisynthetase syndrome. He denied any preceding cutaneous inflammation or sunburns. He had no personal or family history of skin cancer, and no family members had multiple nevi. Physical examination revealed 30 to 40 benign-appearing, 2- to 5-mm, hyperpigmented macules scattered on the medial aspect of the right foot (Figure 1A), left palm (Figure 1B), back, abdomen, chest, arms, and legs. A larger, somewhat asymmetric, irregularly bordered, and irregularly pigmented macule was noted on the left side of the upper back. A punch biopsy of the lesion revealed a benign, mildly atypical lentiginous compound nevus (Figure 2). Pathology confirmed that the lesions represented eruptive melanocytic nevi (EMN). The patient continued azathioprine therapy and was followed with regular full-body skin examinations. Mycophenolate mofetil was suggested as an alternative therapy, if clinically appropriate, though this change has not been made by the patient’s rheumatologists.
Comment
A PubMed search of articles indexed for MEDLINE using the search terms eruptive melanocytic nevi and azathioprine revealed 14 cases of EMN in the setting of azathioprine therapy, either during azathioprine monotherapy or in combination with other immunosuppressants, including systemic corticosteroids, biologics, and cyclosporine (Table).1-5 The majority of these cases occurred in renal transplant patients,1 with 3 additional cases reported in the setting of Crohn disease,2,3,5 and another in a patient with myasthenia gravis.4 Patients ranged in age from 8 to 42 years (mean age, 22 years), with lesions developing a few months to up to 7 years after starting therapy. When specified, the reported lesions typically were small, ranging from 1 to 3 mm in size, and developed rapidly over a couple of months with a predilection for the palms, soles, and trunk. Although dysplastic nevi were described in only 2 patients, melanomas were not detected.
Various hypotheses have sought to explain the largely unknown etiology of EMN. Bovenschen et al3 suggested that immunocompromised patients have diminished immune surveillance in the skin, which allows for unchecked proliferation of melanocytes. Specifically, immune suppression may induce melanocyte-stimulating hormone or melanoma growth stimulatory activity, with composition-specific growth in skin at the palms and soles.3,4 The preferential growth on the palms and soles suggests that those regions may have special sensitivity to melanocyte-stimulating hormone.4 Woodhouse and Maytin6 postulated that the increased density of eccrine sweat glands in the palms and soles as well as the absence of pilosebaceous units and apocrine glands and plentiful Pacinian and Meissner corpuscles may allow for a unique response to circulating melanocytic growth factors. Another hypothesis suggests the presence of genetic factors that allow subclinical nests of nevus cells to form, which become clinical eruptions following chemotherapy or immunosuppressive therapy.3 Azathioprine also has been suggested to induce various transcription factors that play a critical role in differentiation and proliferation of melanocytic stem cells, which leads to the formation of nevi.4 Our case and others similar to it implore that further studies be done to determine the molecular mechanism driving this phenomenon and whether a specific genetic predisposition exists that lowers the threshold for rapid proliferation of melanocytes given an immunosuppressed status.2
The risk for melanoma development in cases of EMN is unknown. Although our review of the literature did not reveal any melanomas reported in cases attributed to azathioprine, a theoretical risk exists given the established associations between melanoma and immunosuppression as well as increased numbers of nevi.6 Accordingly, these patients should be followed with regular skin examinations and biopsies of atypical-appearing lesions as indicated.2,3,5 Braun et al4 also suggested the discontinuance of azathioprine and switch to mycophenolic acid, which has not been noted to cause such eruptions; this drug was recommended in our case.
Case Report
A 50-year-old man with a history of antisynthetase syndrome (positive for anti–Jo-1 polymyositis with interstitial lung disease) and sarcoidosis presented for evaluation of numerous new moles. The lesions had developed on the trunk, arms, legs, hands, and feet approximately 3 weeks after starting azathioprine 100 mg once daily for pulmonary and muscular involvement of antisynthetase syndrome. He denied any preceding cutaneous inflammation or sunburns. He had no personal or family history of skin cancer, and no family members had multiple nevi. Physical examination revealed 30 to 40 benign-appearing, 2- to 5-mm, hyperpigmented macules scattered on the medial aspect of the right foot (Figure 1A), left palm (Figure 1B), back, abdomen, chest, arms, and legs. A larger, somewhat asymmetric, irregularly bordered, and irregularly pigmented macule was noted on the left side of the upper back. A punch biopsy of the lesion revealed a benign, mildly atypical lentiginous compound nevus (Figure 2). Pathology confirmed that the lesions represented eruptive melanocytic nevi (EMN). The patient continued azathioprine therapy and was followed with regular full-body skin examinations. Mycophenolate mofetil was suggested as an alternative therapy, if clinically appropriate, though this change has not been made by the patient’s rheumatologists.
Comment
A PubMed search of articles indexed for MEDLINE using the search terms eruptive melanocytic nevi and azathioprine revealed 14 cases of EMN in the setting of azathioprine therapy, either during azathioprine monotherapy or in combination with other immunosuppressants, including systemic corticosteroids, biologics, and cyclosporine (Table).1-5 The majority of these cases occurred in renal transplant patients,1 with 3 additional cases reported in the setting of Crohn disease,2,3,5 and another in a patient with myasthenia gravis.4 Patients ranged in age from 8 to 42 years (mean age, 22 years), with lesions developing a few months to up to 7 years after starting therapy. When specified, the reported lesions typically were small, ranging from 1 to 3 mm in size, and developed rapidly over a couple of months with a predilection for the palms, soles, and trunk. Although dysplastic nevi were described in only 2 patients, melanomas were not detected.
Various hypotheses have sought to explain the largely unknown etiology of EMN. Bovenschen et al3 suggested that immunocompromised patients have diminished immune surveillance in the skin, which allows for unchecked proliferation of melanocytes. Specifically, immune suppression may induce melanocyte-stimulating hormone or melanoma growth stimulatory activity, with composition-specific growth in skin at the palms and soles.3,4 The preferential growth on the palms and soles suggests that those regions may have special sensitivity to melanocyte-stimulating hormone.4 Woodhouse and Maytin6 postulated that the increased density of eccrine sweat glands in the palms and soles as well as the absence of pilosebaceous units and apocrine glands and plentiful Pacinian and Meissner corpuscles may allow for a unique response to circulating melanocytic growth factors. Another hypothesis suggests the presence of genetic factors that allow subclinical nests of nevus cells to form, which become clinical eruptions following chemotherapy or immunosuppressive therapy.3 Azathioprine also has been suggested to induce various transcription factors that play a critical role in differentiation and proliferation of melanocytic stem cells, which leads to the formation of nevi.4 Our case and others similar to it implore that further studies be done to determine the molecular mechanism driving this phenomenon and whether a specific genetic predisposition exists that lowers the threshold for rapid proliferation of melanocytes given an immunosuppressed status.2
The risk for melanoma development in cases of EMN is unknown. Although our review of the literature did not reveal any melanomas reported in cases attributed to azathioprine, a theoretical risk exists given the established associations between melanoma and immunosuppression as well as increased numbers of nevi.6 Accordingly, these patients should be followed with regular skin examinations and biopsies of atypical-appearing lesions as indicated.2,3,5 Braun et al4 also suggested the discontinuance of azathioprine and switch to mycophenolic acid, which has not been noted to cause such eruptions; this drug was recommended in our case.
- Alaibac M, Piaserico S, Rossi CR, et al. Eruptive melanocytic nevi in patients with renal allografts: report of 10 cases with dermoscopic findings. J Am Acad Dermatol. 2003;49:1020-1022.
- Belloni FA, Piaserico S, Zattra E, et al. Dermoscopic features of eruptive melanocytic naevi in an adult patient receiving immunosuppressive therapy for Crohn’s disease. Melanoma Res. 2005;15:223-224.
- Bovenschen HJ, Tjioe M, Vermaat H, et al. Induction of eruptive benign melanocytic naevi by immune suppressive agents, including biologicals. Br J Dermatol. 2006;154:880-884.
- Braun SA, Helbig D, Frank J, et al. Eruptive melanocytic nevi during azathioprine therapy in myasthenia gravis [in German]. Hautarzt. 2012;63:756-759.
- Wonders J, De Boer N, Van Weyenberg S. Spot diagnosis: eruptive melanocytic naevi during azathioprine therapy in Crohn’s disease [published online March 6, 2012]. J Crohns Colitis. 2012;6:636.
- Woodhouse J, Maytin EV. Eruptive nevi of the palms and soles. J Am Acad Dermatol. 2005;52(5 suppl 1):S96-S100.
- Alaibac M, Piaserico S, Rossi CR, et al. Eruptive melanocytic nevi in patients with renal allografts: report of 10 cases with dermoscopic findings. J Am Acad Dermatol. 2003;49:1020-1022.
- Belloni FA, Piaserico S, Zattra E, et al. Dermoscopic features of eruptive melanocytic naevi in an adult patient receiving immunosuppressive therapy for Crohn’s disease. Melanoma Res. 2005;15:223-224.
- Bovenschen HJ, Tjioe M, Vermaat H, et al. Induction of eruptive benign melanocytic naevi by immune suppressive agents, including biologicals. Br J Dermatol. 2006;154:880-884.
- Braun SA, Helbig D, Frank J, et al. Eruptive melanocytic nevi during azathioprine therapy in myasthenia gravis [in German]. Hautarzt. 2012;63:756-759.
- Wonders J, De Boer N, Van Weyenberg S. Spot diagnosis: eruptive melanocytic naevi during azathioprine therapy in Crohn’s disease [published online March 6, 2012]. J Crohns Colitis. 2012;6:636.
- Woodhouse J, Maytin EV. Eruptive nevi of the palms and soles. J Am Acad Dermatol. 2005;52(5 suppl 1):S96-S100.
Practice Points
- A theoretical risk exists in the setting of eruptive melanocytic nevi (EMN) given the established associations between melanoma and immunosuppression as well as increased numbers of nevi.
- Follow patients with EMN with regular skin examinations and biopsies of atypical-appearing lesions given the increased risk for melanoma in this population.
Gliflozins’ heart failure protection in type 2 diabetes confirmed
WASHINGTON – The remarkable and unexpected findings first reported from the EMPA-REG OUTCOME trial in late 2015 – that treatment of type 2 diabetes patients with the SGLT-2 inhibitor empagliflozin led to significantly reduced rates of heart failure hospitalization and all-cause death – received its first major confirmation in an analysis of observational data collected from more than 300,000 patients with type 2 diabetes treated in six countries including the United States.
The new findings also, for the first time, extended the EMPA-REG OUTCOME results (N Engl J Med. 2015 Nov 26;373[22]:2117-28) beyond empagliflozin with evidence that the heart failure and mortality benefit also occurred with other drugs from the sodium glucose cotransporter–2 (SGLT-2) inhibitor class, specifically canagliflozin and dapagliflozin, Mikhail Kosiborod, MD, said at the annual meeting of the American College of Cardiology.
The analysis showed that type 2 diabetes patients who were newly started on treatment with one of these SGLT-2 inhibitors had during follow-up a 39% reduced rate of heart failure hospitalizations, a 51% reduced mortality rate, and a 46% reduced rate of the combined endpoint of heart failure hospitalization or death, compared with patients treated with any other type of oral glucose-lowering drug, reported Dr. Kosiborod. The risk reductions were “remarkably similar to those seen in EMPA-REG OUTCOME,” he noted.
The findings address three “key questions” raised by the EMPA-REG OUTCOME results, Dr. Kosiborod, a cardiologist and professor of medicine at Saint Luke’s Mid America Heart Institute in Kansas City, Mo., said in an interview:
• Is this a class effect? The data “seem to suggest that the benefits seen in the EMPA-REG OUTCOME study are likely a class effect.” The study population of 154,523 patients in the heart failure hospitalization analysis who began treatment with an SGLT-2 inhibitor included 53% who received canagliflozin (Invokana), 42% who received dapagliflozin (Farxiga), and 6% who received empagliflozin (Jardiance) (percentages total 101% because of rounding). Dr. Kosiborod also highlighted that within several of the six countries that contributed data to this analysis – the United States, Denmark, Germany, Norway, Sweden, and the United Kingdom – the percentages of patients on each of these three drugs varied substantially, but despite that the relative reduced risks for heart failure hospitalization and mortality were roughly the same within each country, giving further credence to the notion that a class effect exists.
• Do lower-risk patients benefit? “The benefits of SGLT-2 inhibitor treatment appeared to extend to lower risk patients” than those enrolled in EMPA-REG OUTCOME. In the randomized trial, which enrolled 7,028 patients, more than 99% had established cardiovascular disease. In the new analysis patients had a 13% prevalence of any cardiovascular disease at baseline, and the prevalence of heart failure was 3%.
• Is this relevant to clinical practice? Unlike the highly selected patients entered in the EMPA-REG OUTCOME trial, the patients started on an SGLT-2 inhibitor in the observational study were unselected and came from routine practice situations, “suggesting that the benefits seen in EMPA-REG OUTCOME translate into real-world clinical practice,” Dr. Kosiborod said. “With these data we see for the first time in a large number of patients from multiple countries important evidence suggesting that the SGLT-2 inhibitors may provide in the real world a similar benefit to what was observed in EMPA-REG OUTCOME.”
“The lesson from Dr. Kosiborod’s study is that among patients with type 2 diabetes, treatment with an SGLT-2 inhibitor seems to result in lowered rates of heart failure hospitalizations and mortality, and it’s a safe class of drugs. In the past, we worried about worsening heart failure in patients at risk for developing heart failure” such as patients with type 2 diabetes, said Adrian F. Hernandez, MD, professor of medicine and a cardiologist at Duke University in Durham, N.C. The new data make it seem like using an SGLT-2 inhibitor to treat patients with type 2 diabetes “is an appropriate strategy.” But Dr. Hernandez added that in his opinion metformin remains the top drug for type 2 diabetes, while SGLT-2 inhibitors are now “the next drug class to add,” he said in an interview.
Dr. Kosiborod had a somewhat different take. “If a patient with type 2 diabetes did not want to enter a trial or couldn’t get into a trial and fit the profile of a patient who could benefit, I would absolutely treat that patient with an SGLT-2 inhibitor. I’m using these medications clinically as a cardiologist,” he said. “Treatments that have significant benefits for important outcomes should be prioritized over treatments that may reduce hemoglobin A1c but do not have similar benefits.”
The CVD-REAL (Comparative Effectiveness of Cardiovascular Outcomes in New Users of SGLT-2 Inhibitors) study used data from adult, previously untreated patients with type 2 diabetes in national registries from the five included European countries. U.S. data were from the Truven Health MarketScan database and from Medicare. This produced a total pool of 160,010 patients who began treatment on an SGLT-2 inhibitor and 1,139,905 patients who began treatment with another oral antidiabetes drug.
Dr. Kosiborod and his associates then performed propensity-score matching to identify 154,523 patients started on an SGLT-2 inhibitor who each closely matched a patient from the other subgroup for baseline demographic and clinical features, producing an analysis dataset of just over 309,000 matched patients. The average age of the included patients was 57 years; 45% were women. During follow-up, 961 patients had a heart failure hospitalization and 1,334 patients died.
Dr. Kosiborod noted that while a potential limitation to his findings is residual confounding not eliminated by the propensity score matching, he was confident about the results because the incidence of other outcomes not expected to be influenced by treatment with SGLT-2 inhibitors were similar in the two study subgroups, suggesting that the linkages between the kind of drug used and differences in heart failure hospitalization rates and in mortality weren’t spurious.
“If there was residual confounding, you’d expect to see similar associations for other endpoints, which we didn’t see,” he said. In addition, the heart failure hospitalization rate differences seen between the SGLT-2 inhibitor recipients and the other patients were consistent in a trio of sensitivity analyses, further buttressing the findings’ plausibility.
CVD-REAL was sponsored by AstraZeneca, the company that markets dapagliflozin (Farxiga). Dr. Kosiborod has been a consultant to and/or received research funding from AstraZeneca, Boehringer Ingelheim, Sanofi-Aventis and Gilead. Dr. Hernandez has received honoraria and/or research support from AstraZeneca, Amgen, Janssen, Merck, Novartis, and Portola. Several of the coauthors on the CVD-REAL study were AstraZeneca employees.
[email protected]
On Twitter @mitchelzoler
WASHINGTON – The remarkable and unexpected findings first reported from the EMPA-REG OUTCOME trial in late 2015 – that treatment of type 2 diabetes patients with the SGLT-2 inhibitor empagliflozin led to significantly reduced rates of heart failure hospitalization and all-cause death – received its first major confirmation in an analysis of observational data collected from more than 300,000 patients with type 2 diabetes treated in six countries including the United States.
The new findings also, for the first time, extended the EMPA-REG OUTCOME results (N Engl J Med. 2015 Nov 26;373[22]:2117-28) beyond empagliflozin with evidence that the heart failure and mortality benefit also occurred with other drugs from the sodium glucose cotransporter–2 (SGLT-2) inhibitor class, specifically canagliflozin and dapagliflozin, Mikhail Kosiborod, MD, said at the annual meeting of the American College of Cardiology.
The analysis showed that type 2 diabetes patients who were newly started on treatment with one of these SGLT-2 inhibitors had during follow-up a 39% reduced rate of heart failure hospitalizations, a 51% reduced mortality rate, and a 46% reduced rate of the combined endpoint of heart failure hospitalization or death, compared with patients treated with any other type of oral glucose-lowering drug, reported Dr. Kosiborod. The risk reductions were “remarkably similar to those seen in EMPA-REG OUTCOME,” he noted.
The findings address three “key questions” raised by the EMPA-REG OUTCOME results, Dr. Kosiborod, a cardiologist and professor of medicine at Saint Luke’s Mid America Heart Institute in Kansas City, Mo., said in an interview:
• Is this a class effect? The data “seem to suggest that the benefits seen in the EMPA-REG OUTCOME study are likely a class effect.” The study population of 154,523 patients in the heart failure hospitalization analysis who began treatment with an SGLT-2 inhibitor included 53% who received canagliflozin (Invokana), 42% who received dapagliflozin (Farxiga), and 6% who received empagliflozin (Jardiance) (percentages total 101% because of rounding). Dr. Kosiborod also highlighted that within several of the six countries that contributed data to this analysis – the United States, Denmark, Germany, Norway, Sweden, and the United Kingdom – the percentages of patients on each of these three drugs varied substantially, but despite that the relative reduced risks for heart failure hospitalization and mortality were roughly the same within each country, giving further credence to the notion that a class effect exists.
• Do lower-risk patients benefit? “The benefits of SGLT-2 inhibitor treatment appeared to extend to lower risk patients” than those enrolled in EMPA-REG OUTCOME. In the randomized trial, which enrolled 7,028 patients, more than 99% had established cardiovascular disease. In the new analysis patients had a 13% prevalence of any cardiovascular disease at baseline, and the prevalence of heart failure was 3%.
• Is this relevant to clinical practice? Unlike the highly selected patients entered in the EMPA-REG OUTCOME trial, the patients started on an SGLT-2 inhibitor in the observational study were unselected and came from routine practice situations, “suggesting that the benefits seen in EMPA-REG OUTCOME translate into real-world clinical practice,” Dr. Kosiborod said. “With these data we see for the first time in a large number of patients from multiple countries important evidence suggesting that the SGLT-2 inhibitors may provide in the real world a similar benefit to what was observed in EMPA-REG OUTCOME.”
“The lesson from Dr. Kosiborod’s study is that among patients with type 2 diabetes, treatment with an SGLT-2 inhibitor seems to result in lowered rates of heart failure hospitalizations and mortality, and it’s a safe class of drugs. In the past, we worried about worsening heart failure in patients at risk for developing heart failure” such as patients with type 2 diabetes, said Adrian F. Hernandez, MD, professor of medicine and a cardiologist at Duke University in Durham, N.C. The new data make it seem like using an SGLT-2 inhibitor to treat patients with type 2 diabetes “is an appropriate strategy.” But Dr. Hernandez added that in his opinion metformin remains the top drug for type 2 diabetes, while SGLT-2 inhibitors are now “the next drug class to add,” he said in an interview.
Dr. Kosiborod had a somewhat different take. “If a patient with type 2 diabetes did not want to enter a trial or couldn’t get into a trial and fit the profile of a patient who could benefit, I would absolutely treat that patient with an SGLT-2 inhibitor. I’m using these medications clinically as a cardiologist,” he said. “Treatments that have significant benefits for important outcomes should be prioritized over treatments that may reduce hemoglobin A1c but do not have similar benefits.”
The CVD-REAL (Comparative Effectiveness of Cardiovascular Outcomes in New Users of SGLT-2 Inhibitors) study used data from adult, previously untreated patients with type 2 diabetes in national registries from the five included European countries. U.S. data were from the Truven Health MarketScan database and from Medicare. This produced a total pool of 160,010 patients who began treatment on an SGLT-2 inhibitor and 1,139,905 patients who began treatment with another oral antidiabetes drug.
Dr. Kosiborod and his associates then performed propensity-score matching to identify 154,523 patients started on an SGLT-2 inhibitor who each closely matched a patient from the other subgroup for baseline demographic and clinical features, producing an analysis dataset of just over 309,000 matched patients. The average age of the included patients was 57 years; 45% were women. During follow-up, 961 patients had a heart failure hospitalization and 1,334 patients died.
Dr. Kosiborod noted that while a potential limitation to his findings is residual confounding not eliminated by the propensity score matching, he was confident about the results because the incidence of other outcomes not expected to be influenced by treatment with SGLT-2 inhibitors were similar in the two study subgroups, suggesting that the linkages between the kind of drug used and differences in heart failure hospitalization rates and in mortality weren’t spurious.
“If there was residual confounding, you’d expect to see similar associations for other endpoints, which we didn’t see,” he said. In addition, the heart failure hospitalization rate differences seen between the SGLT-2 inhibitor recipients and the other patients were consistent in a trio of sensitivity analyses, further buttressing the findings’ plausibility.
CVD-REAL was sponsored by AstraZeneca, the company that markets dapagliflozin (Farxiga). Dr. Kosiborod has been a consultant to and/or received research funding from AstraZeneca, Boehringer Ingelheim, Sanofi-Aventis and Gilead. Dr. Hernandez has received honoraria and/or research support from AstraZeneca, Amgen, Janssen, Merck, Novartis, and Portola. Several of the coauthors on the CVD-REAL study were AstraZeneca employees.
[email protected]
On Twitter @mitchelzoler
WASHINGTON – The remarkable and unexpected findings first reported from the EMPA-REG OUTCOME trial in late 2015 – that treatment of type 2 diabetes patients with the SGLT-2 inhibitor empagliflozin led to significantly reduced rates of heart failure hospitalization and all-cause death – received its first major confirmation in an analysis of observational data collected from more than 300,000 patients with type 2 diabetes treated in six countries including the United States.
The new findings also, for the first time, extended the EMPA-REG OUTCOME results (N Engl J Med. 2015 Nov 26;373[22]:2117-28) beyond empagliflozin with evidence that the heart failure and mortality benefit also occurred with other drugs from the sodium glucose cotransporter–2 (SGLT-2) inhibitor class, specifically canagliflozin and dapagliflozin, Mikhail Kosiborod, MD, said at the annual meeting of the American College of Cardiology.
The analysis showed that type 2 diabetes patients who were newly started on treatment with one of these SGLT-2 inhibitors had during follow-up a 39% reduced rate of heart failure hospitalizations, a 51% reduced mortality rate, and a 46% reduced rate of the combined endpoint of heart failure hospitalization or death, compared with patients treated with any other type of oral glucose-lowering drug, reported Dr. Kosiborod. The risk reductions were “remarkably similar to those seen in EMPA-REG OUTCOME,” he noted.
The findings address three “key questions” raised by the EMPA-REG OUTCOME results, Dr. Kosiborod, a cardiologist and professor of medicine at Saint Luke’s Mid America Heart Institute in Kansas City, Mo., said in an interview:
• Is this a class effect? The data “seem to suggest that the benefits seen in the EMPA-REG OUTCOME study are likely a class effect.” The study population of 154,523 patients in the heart failure hospitalization analysis who began treatment with an SGLT-2 inhibitor included 53% who received canagliflozin (Invokana), 42% who received dapagliflozin (Farxiga), and 6% who received empagliflozin (Jardiance) (percentages total 101% because of rounding). Dr. Kosiborod also highlighted that within several of the six countries that contributed data to this analysis – the United States, Denmark, Germany, Norway, Sweden, and the United Kingdom – the percentages of patients on each of these three drugs varied substantially, but despite that the relative reduced risks for heart failure hospitalization and mortality were roughly the same within each country, giving further credence to the notion that a class effect exists.
• Do lower-risk patients benefit? “The benefits of SGLT-2 inhibitor treatment appeared to extend to lower risk patients” than those enrolled in EMPA-REG OUTCOME. In the randomized trial, which enrolled 7,028 patients, more than 99% had established cardiovascular disease. In the new analysis patients had a 13% prevalence of any cardiovascular disease at baseline, and the prevalence of heart failure was 3%.
• Is this relevant to clinical practice? Unlike the highly selected patients entered in the EMPA-REG OUTCOME trial, the patients started on an SGLT-2 inhibitor in the observational study were unselected and came from routine practice situations, “suggesting that the benefits seen in EMPA-REG OUTCOME translate into real-world clinical practice,” Dr. Kosiborod said. “With these data we see for the first time in a large number of patients from multiple countries important evidence suggesting that the SGLT-2 inhibitors may provide in the real world a similar benefit to what was observed in EMPA-REG OUTCOME.”
“The lesson from Dr. Kosiborod’s study is that among patients with type 2 diabetes, treatment with an SGLT-2 inhibitor seems to result in lowered rates of heart failure hospitalizations and mortality, and it’s a safe class of drugs. In the past, we worried about worsening heart failure in patients at risk for developing heart failure” such as patients with type 2 diabetes, said Adrian F. Hernandez, MD, professor of medicine and a cardiologist at Duke University in Durham, N.C. The new data make it seem like using an SGLT-2 inhibitor to treat patients with type 2 diabetes “is an appropriate strategy.” But Dr. Hernandez added that in his opinion metformin remains the top drug for type 2 diabetes, while SGLT-2 inhibitors are now “the next drug class to add,” he said in an interview.
Dr. Kosiborod had a somewhat different take. “If a patient with type 2 diabetes did not want to enter a trial or couldn’t get into a trial and fit the profile of a patient who could benefit, I would absolutely treat that patient with an SGLT-2 inhibitor. I’m using these medications clinically as a cardiologist,” he said. “Treatments that have significant benefits for important outcomes should be prioritized over treatments that may reduce hemoglobin A1c but do not have similar benefits.”
The CVD-REAL (Comparative Effectiveness of Cardiovascular Outcomes in New Users of SGLT-2 Inhibitors) study used data from adult, previously untreated patients with type 2 diabetes in national registries from the five included European countries. U.S. data were from the Truven Health MarketScan database and from Medicare. This produced a total pool of 160,010 patients who began treatment on an SGLT-2 inhibitor and 1,139,905 patients who began treatment with another oral antidiabetes drug.
Dr. Kosiborod and his associates then performed propensity-score matching to identify 154,523 patients started on an SGLT-2 inhibitor who each closely matched a patient from the other subgroup for baseline demographic and clinical features, producing an analysis dataset of just over 309,000 matched patients. The average age of the included patients was 57 years; 45% were women. During follow-up, 961 patients had a heart failure hospitalization and 1,334 patients died.
Dr. Kosiborod noted that while a potential limitation to his findings is residual confounding not eliminated by the propensity score matching, he was confident about the results because the incidence of other outcomes not expected to be influenced by treatment with SGLT-2 inhibitors were similar in the two study subgroups, suggesting that the linkages between the kind of drug used and differences in heart failure hospitalization rates and in mortality weren’t spurious.
“If there was residual confounding, you’d expect to see similar associations for other endpoints, which we didn’t see,” he said. In addition, the heart failure hospitalization rate differences seen between the SGLT-2 inhibitor recipients and the other patients were consistent in a trio of sensitivity analyses, further buttressing the findings’ plausibility.
CVD-REAL was sponsored by AstraZeneca, the company that markets dapagliflozin (Farxiga). Dr. Kosiborod has been a consultant to and/or received research funding from AstraZeneca, Boehringer Ingelheim, Sanofi-Aventis and Gilead. Dr. Hernandez has received honoraria and/or research support from AstraZeneca, Amgen, Janssen, Merck, Novartis, and Portola. Several of the coauthors on the CVD-REAL study were AstraZeneca employees.
[email protected]
On Twitter @mitchelzoler
AT ACC 17
Key clinical point:
Major finding: Treatment with an SGLT-2 inhibitor was associated with a significant 39% reduction in heart failure hospitalizations compared with other antidiabetes drugs.
Data source: CVD-REAL, which used observational data collected from 309,046 patients with type 2 diabetes in six countries.
Disclosures: CVD-REAL was sponsored by AstraZeneca, the company that markets dapagliflozin (Farxiga). Dr. Kosiborod has been a consultant to AstraZeneca and to several other drug companies, and he has received research funding from AstraZeneca, Boehringer Ingelheim, Sanofi-Aventis and Gilead. Dr. Hernandez has received honoraria and research support from AstraZeneca and has also received honoraria from Amgen, Janssen, Merck, and Novartis, and has also received research support from Amgen, Bayer, Merck, and Portola. Several of the coauthors on the CVD-REAL study were AstraZeneca employees.
Electronic Collaboration in Dermatology Resident Training Through Social Networking
More than 1.8 billion individuals utilize social media, a number that continues to grow as the social media market expands.1 Social media enables individuals, groups, and organizations to efficiently disperse and access information2-4 and also provides a structure that encourages collaboration between patients, staff, and physicians that cannot be achieved by other communication modalities.4-6 Expert opinions and related educational materials can be shared globally, improving collaboration between dermatologists.6 A structured social networking site for sharing training materials, research, and ideas can help bring the national dermatology community together in a new way.
Other professions have employed social networking tools to accomplish similar goals of organizing training resources; radiology has an electronic database that allows sharing of training materials and incorporates social networking capabilities.7 Their Web software provides functionality for individual file uploading and supports collaboration and sharing, all while maintaining the security of uploaded information. General surgery has already addressed similar concerns via a task force that incorporates all the essential organizations in surgical education.8 Increased satisfaction and academic abilities have been demonstrated with their collaborative curriculum.9 Gastroenterologists also utilize electronic resources; one study showed that using videos to educate patients prior to colonoscopies was superior to face-to-face education.10 In addition, video education may free up time for office staff to accomplish other tasks.
As a specialty, dermatology has not been a leader in the implementation of social networking for collaboration and training purposes. Every dermatologist is an educator. To maintain a successful practice, dermatologists must keep up-to-date on their own clinical knowledge, provide training to their staff, and educate their patients. Although there are numerous educational resources available to dermatologists, an informal survey of 30 dermatology faculty members revealed a practice gap in awareness and utilization of these expanding electronic resources.11
To better understand the needs of the specialty as a whole, we chose to focus on one aspect of dermatology education: resident training. The goal of our study was to survey dermatology residents and faculty to gain a better understanding of how they currently provide education and what online resources and social networking sites they currently use or would be willing to use. The study included 3 central hypotheses: First, residents would be less satisfied with their current curriculum and residents would report greater contributions to the curriculum relative to faculty. Second, both residents and faculty of smaller programs would be more interested in collaborative educational resources relative to larger programs. Lastly, residents would be more willing than faculty to participate in social networking for educational purposes.
Methods
This study was granted institutional review board exemption. Two surveys were developed by the authors to assess the current structure and satisfaction of dermatology residency curriculum and the willingness to participate in social networking to use and share educational materials. The surveys were evaluated for relevance by the survey evaluation team of the Association of Professors of Dermatology (APD). The instrument was not pilot tested.
The surveys were electronically distributed using an online service to dermatology faculty via the APD listserve, which comprised the entirety of the APD membership in 2014. The resident survey was distributed to the dermatology residents via the American Society for Dermatologic Surgery listserve, which included all residents in training (2013-2014 academic year). Second and third invitations to complete the surveys were distributed 3 and 5 weeks later, respectively.
Resident and faculty responses were compared. Additionally, responses were stratified for large (>9 residents) and small programs (≤9 residents) for comparison. Descriptive statistics including means and medians for continuous variables and frequency tables for categorical variables were generated using research and spreadsheet software.
Results
There were 137 survey respondents; 52 of 426 (12.2%) dermatology faculty and 85 of 1539 (5.5%) dermatology residents responded to the survey. Small programs accounted for 24% of total survey responses and 76% were from large programs.
Current Curriculum
The majority of dermatology faculty (44%) and residents (35%) identified 1 to 2 faculty members as contributing to the creation and organization of their respective curricula; however, a notable percentage of residents (9%) reported that no faculty contributed to the organization of the curriculum. Residents noted that senior residents carry twice the responsibility for structuring the curriculum compared to faculty (61% vs 32% of the workload), but faculty described an even split between senior residents and faculty (47% vs 49% of the workload). Faculty believed their residents spend a similar amount of time in resident- and faculty-led instruction (38% vs 35% of their time); however, the majority of residents reported spending too little time in faculty-led instruction (53%). When residents ranked their preference for learning modes, faculty-led and self-study learning were ranked first and second by 48% and 45% of residents, respectively. Resident-led instruction was ranked last by 66% of residents. Likewise, a majority of residents (53%) described their amount of time in faculty-led instruction as too little.
When asked what subjects in dermatology were lacking at their programs, residents reported clinical trials (47%), skin of color (46%), cosmetic dermatology (34%), and aggressive skin cancer/multidisciplinary tumor board (32%). Although 11% of residents reported lacking inpatient dermatology in their curriculum, 0% of faculty reported the same. A notable percentage of faculty reported nothing was lacking compared to residents (25% vs 7%). Despite these different views between residents and faculty on their contributions to and structure of their curriculums, both faculty and residents claimed overall satisfaction (satisfied or very satisfied) with their program’s ability to optimally cover the field of dermatology in 3 years (100% and 91%, respectively).
Large Versus Small Residency Programs
When stratifying the resident responses for small versus large programs, both program sizes reported more time in resident-led instruction than faculty-led instruction. Likewise, residents in both program sizes equally preferred self-study or faculty-led instruction to resident-led instruction. Residents at small programs more often reported lacking instruction in rheumatology, immunobullous diseases, and basic science/skin biology compared to large-program residents. Compared to large-program faculty, small-program faculty reported lacking instruction in cosmetic dermatology.
Faculty at small programs reported spending too little time preparing for their faculty-led instruction compared to faculty at large programs (44% vs 12%). All (100%) of the faculty at small programs were likely to seek out study materials shared by top educators, while 77% of faculty at large programs were likely to do the same. When asked if faculty would translate what their program does well into an electronic format for sharing, 30% of large-program faculty were likely to do so compared to 11% of small-program faculty (Figure 1).
Use of Online Educational Materials and Interest in Collaboration
A majority of faculty and residents stated that they use online educational materials as supplements to traditional classroom lecture and print materials (81% vs 86%); however, almost twice as many residents stated that online educational materials were essential to their current study routines compared to faculty (39% vs 21%).
The majority of faculty (92%) and residents (84%) were either interested or very interested in a collaborative online curriculum. Both residents (85%) and faculty (81%) stated they would be likely to seek out online educational materials shared by top educators. Although both residents and faculty reported many aspects of their curriculums they thought could be beneficial to other dermatology programs (Table 1), only 27% of faculty and 19% of residents were likely to translate those strengths into a shareable electronic format. Several reasons were reported for not contributing to an online curriculum, with lack of time being the most common reason (Table 2).
Eighty percent of residents and 88% of faculty reported they were either interested or very interested in being more connected/interactive with their dermatology peers nationally (Figure 2). Likewise, 94% of residents and 87% of faculty agreed that the dermatology community could benefit from a social networking site for educational collaboration. Four times as many residents versus faculty currently use social networking sites (eg, Facebook, LinkedIn, Google Groups) as a primary mode of communication with distant professional peers. The majority of residents (52%) reported they would be likely to participate in a professional social networking site, while the majority of faculty (50%) stated they were neutral on their likelihood of participating. Both residents and faculty reported lack of time as a common reason for being unlikely to utilize a professional social networking site. Other barriers to participation are listed in Table 3.
Comment
This study showed how dermatology faculty and residents currently provide training and what online resources and social networking sites they currently use or would be willing to use. The generalizability of the conclusions is limited by the low response rate for the surveys. The results demonstrated the different views between faculty and residents and between large and small residency programs on various topics. This microcosm of dermatology training can likely be applied to other training scenarios in dermatology, including patient education; training of nurses, physician extenders, and office staff; continuing medical education for physicians; and peer-to-peer collaboration.
Hypothesis 1: Partially Proven
We hypothesized that residents would report less satisfaction with their current curriculum and would report greater resident contributions to the curriculum relative to faculty. Overall, residents and faculty reported satisfaction with their curriculums to provide up-to-date information and breadth in the field of dermatology. Despite their overall satisfaction, more residents reported lacking instruction in several dermatology subtopics compared to faculty. Additionally, residents believed they spend twice as much time structuring their curriculum compared to faculty, with some residents reporting no faculty involvement. Although residents preferred faculty-led instruction, a majority of residents reported they do not have enough faculty-led didactics. The preference for faculty-led training is likely due to the expertise of faculty compared to residents.
Hypothesis 2: Partially Proven
We also hypothesized that both residents and faculty of smaller programs would be more interested in collaborative educational resources relative to larger programs. Although there was no difference in interest between residents at small versus large programs, there was a difference between faculty at small versus large programs. Small-program faculty were more interested in using shared materials than larger programs, while large-program faculty were more likely to share their educational materials. Small-program faculty reported spending too little time preparing their lectures, which is possibly due to a lack of time for preparation. Additionally, residents and faculty at smaller programs report their curriculum was lacking specific dermatology topics compared to large programs. These disparities between program sizes indicate a need for a social networking site for training collaboration in dermatology. Large programs have the ability to share what they do well, which small programs are eager to utilize.
Hypothesis 3: Not Proven
We hypothesized that residents would be more willing than faculty to participate in social networking for educational purposes. The majority of faculty and residents were interested in participating in a collaborative online curriculum and using the shared materials from top educators; however, even though such large majorities favored collaboration and sharing, only 27% of faculty and 19% of residents were likely to translate their own materials into a shareable format. Although lack of time was the most common reason for not sharing materials, electronic methods may have the potential to ultimately save time and remove the burden of content creation. The time it would take to translate selected personal training materials into a shareable form would be made up for by the time saved using another educators’ materials. Updating and customizing shared online educational materials can be much quicker and easier than educators creating materials on their own. Dermatologists would be more efficient facilitators of training via high-quality shared materials while decreasing the time burden associated with resident education.5 Another concern for not sharing or participating in a social networking site was skepticism of information security on such a network. The poor organization and information overload of online resources can compound the already existing time constraints on dermatologists, which may limit their ability to utilize such valuable resources. In addition, quality of online resources is not always guaranteed, and determining the sources that are high quality is sometimes a difficult task.6 For online materials to remain useful, there should be a peer-review process to evaluate quality and assess satisfaction.5
Solution: Create a Dermatology Task Force
A dermatology task force could facilitate the resolution of these challenges of online materials. In addition, a task force could cover the administrative support needed to ensure security and provide maintenance on social networks.
The main limitation to implementing a social network is the presence of the administrative infrastructure to jumpstart its creation. A task force incorporating the essential stakeholders in dermatology training is the first step. With inclusive representation from all of the smaller professional dermatology societies, the American Academy of Dermatology is optimally positioned to create this task force. With existing information technologies, a task force could address the concerns revealed in our survey as well as any future concerns that may arise.
The goal is a single social network for dermatologists that has the capability of improving communication and collaboration between professional peers regardless of their practice setting. Such a network is ideal for the practicing dermatologist for the purposes of staff training, patient education, and obtaining continuing medical education credit. Additionally, peer group collaboration would facilitate the understanding and completion of the evolving requirements for Maintenance of Certification from the American Board of Dermatology. The availability of quality shared materials would save time and increase efficiency of an entire dermatology practice. Materials that aid in patient education would allow office staff to dedicate their time to other tasks, thereby increasing productivity. Shared training materials would decrease the burden of staff education, providing more time for advanced hands-on training. This method of collaborative effort is capable of advancing the field of dermatology as a whole. It can overcome geographical and institutional barriers to connect dermatologists with similar interests worldwide; disseminate advances in diagnosis and treatment; and improve the quality of dermatology training of dermatologists, staff, and patients.
- Statistics and facts about social networks. Statista website. http://www.statista.com/topics/1164/social-networks/. Accessed March 22, 2017.
- Baker RC, Klein M, Samaan Z, et al. Effectiveness of an online pediatric primary care curriculum. Acad Pediatr. 2010;10:131-137.
- Dolev JC, O’Sullivan P, Berger T. The eDerm online curriculum: a randomized study of effective skin cancer teaching to medical students. J Am Acad Dermatol. 2011;65:e165-e171.
- Amir M, Sampson BP, Endly D, et al. Social networking sites: emerging and essential tools for communication in dermatology. JAMA Dermatol. 2014;150:56-60.
- Ruiz JG, Mintzer MJ, Leipzig RM. The impact of e-learning in medical education. Acad Med. 2006;81:207-212.
- Hanson AH, Krause LK, Simmons RN, et al. Dermatology education and the internet: traditional and cutting-edge resources. J Am Acad Dermatol. 2011;65:836-842.
- Rowe SP, Siddiqui A, Bonekamp D. The key image and case log application: new radiology software for teaching file creation and case logging that incorporates elements of a social network. Acad Radiol. 2014;21:916-930.
- Bell RH. Surgical council on resident education: a new organization devoted to graduate surgical education. J Am Coll Surg. 2007;204:341-346.
- Kirton OC, Reilly P, Staff I, et al. Development and implementation of an interactive, objective, and simulation-based curriculum for general surgery residents. J Surg Educ. 2012;69:718-723.
- Prakash S, Verma S, McGowan J, et al. Improving the quality of colonoscopy bowel preparation using an educational video. Can J Gastroenterol. 2013;27:696-700.
- Carroll BT. eTools for teaching dermatologic surgery. Paper presented at the Association of Professors of Dermatology 2014 Annual Meeting; September 12-13, 2014; Chicago, IL.
More than 1.8 billion individuals utilize social media, a number that continues to grow as the social media market expands.1 Social media enables individuals, groups, and organizations to efficiently disperse and access information2-4 and also provides a structure that encourages collaboration between patients, staff, and physicians that cannot be achieved by other communication modalities.4-6 Expert opinions and related educational materials can be shared globally, improving collaboration between dermatologists.6 A structured social networking site for sharing training materials, research, and ideas can help bring the national dermatology community together in a new way.
Other professions have employed social networking tools to accomplish similar goals of organizing training resources; radiology has an electronic database that allows sharing of training materials and incorporates social networking capabilities.7 Their Web software provides functionality for individual file uploading and supports collaboration and sharing, all while maintaining the security of uploaded information. General surgery has already addressed similar concerns via a task force that incorporates all the essential organizations in surgical education.8 Increased satisfaction and academic abilities have been demonstrated with their collaborative curriculum.9 Gastroenterologists also utilize electronic resources; one study showed that using videos to educate patients prior to colonoscopies was superior to face-to-face education.10 In addition, video education may free up time for office staff to accomplish other tasks.
As a specialty, dermatology has not been a leader in the implementation of social networking for collaboration and training purposes. Every dermatologist is an educator. To maintain a successful practice, dermatologists must keep up-to-date on their own clinical knowledge, provide training to their staff, and educate their patients. Although there are numerous educational resources available to dermatologists, an informal survey of 30 dermatology faculty members revealed a practice gap in awareness and utilization of these expanding electronic resources.11
To better understand the needs of the specialty as a whole, we chose to focus on one aspect of dermatology education: resident training. The goal of our study was to survey dermatology residents and faculty to gain a better understanding of how they currently provide education and what online resources and social networking sites they currently use or would be willing to use. The study included 3 central hypotheses: First, residents would be less satisfied with their current curriculum and residents would report greater contributions to the curriculum relative to faculty. Second, both residents and faculty of smaller programs would be more interested in collaborative educational resources relative to larger programs. Lastly, residents would be more willing than faculty to participate in social networking for educational purposes.
Methods
This study was granted institutional review board exemption. Two surveys were developed by the authors to assess the current structure and satisfaction of dermatology residency curriculum and the willingness to participate in social networking to use and share educational materials. The surveys were evaluated for relevance by the survey evaluation team of the Association of Professors of Dermatology (APD). The instrument was not pilot tested.
The surveys were electronically distributed using an online service to dermatology faculty via the APD listserve, which comprised the entirety of the APD membership in 2014. The resident survey was distributed to the dermatology residents via the American Society for Dermatologic Surgery listserve, which included all residents in training (2013-2014 academic year). Second and third invitations to complete the surveys were distributed 3 and 5 weeks later, respectively.
Resident and faculty responses were compared. Additionally, responses were stratified for large (>9 residents) and small programs (≤9 residents) for comparison. Descriptive statistics including means and medians for continuous variables and frequency tables for categorical variables were generated using research and spreadsheet software.
Results
There were 137 survey respondents; 52 of 426 (12.2%) dermatology faculty and 85 of 1539 (5.5%) dermatology residents responded to the survey. Small programs accounted for 24% of total survey responses and 76% were from large programs.
Current Curriculum
The majority of dermatology faculty (44%) and residents (35%) identified 1 to 2 faculty members as contributing to the creation and organization of their respective curricula; however, a notable percentage of residents (9%) reported that no faculty contributed to the organization of the curriculum. Residents noted that senior residents carry twice the responsibility for structuring the curriculum compared to faculty (61% vs 32% of the workload), but faculty described an even split between senior residents and faculty (47% vs 49% of the workload). Faculty believed their residents spend a similar amount of time in resident- and faculty-led instruction (38% vs 35% of their time); however, the majority of residents reported spending too little time in faculty-led instruction (53%). When residents ranked their preference for learning modes, faculty-led and self-study learning were ranked first and second by 48% and 45% of residents, respectively. Resident-led instruction was ranked last by 66% of residents. Likewise, a majority of residents (53%) described their amount of time in faculty-led instruction as too little.
When asked what subjects in dermatology were lacking at their programs, residents reported clinical trials (47%), skin of color (46%), cosmetic dermatology (34%), and aggressive skin cancer/multidisciplinary tumor board (32%). Although 11% of residents reported lacking inpatient dermatology in their curriculum, 0% of faculty reported the same. A notable percentage of faculty reported nothing was lacking compared to residents (25% vs 7%). Despite these different views between residents and faculty on their contributions to and structure of their curriculums, both faculty and residents claimed overall satisfaction (satisfied or very satisfied) with their program’s ability to optimally cover the field of dermatology in 3 years (100% and 91%, respectively).
Large Versus Small Residency Programs
When stratifying the resident responses for small versus large programs, both program sizes reported more time in resident-led instruction than faculty-led instruction. Likewise, residents in both program sizes equally preferred self-study or faculty-led instruction to resident-led instruction. Residents at small programs more often reported lacking instruction in rheumatology, immunobullous diseases, and basic science/skin biology compared to large-program residents. Compared to large-program faculty, small-program faculty reported lacking instruction in cosmetic dermatology.
Faculty at small programs reported spending too little time preparing for their faculty-led instruction compared to faculty at large programs (44% vs 12%). All (100%) of the faculty at small programs were likely to seek out study materials shared by top educators, while 77% of faculty at large programs were likely to do the same. When asked if faculty would translate what their program does well into an electronic format for sharing, 30% of large-program faculty were likely to do so compared to 11% of small-program faculty (Figure 1).
Use of Online Educational Materials and Interest in Collaboration
A majority of faculty and residents stated that they use online educational materials as supplements to traditional classroom lecture and print materials (81% vs 86%); however, almost twice as many residents stated that online educational materials were essential to their current study routines compared to faculty (39% vs 21%).
The majority of faculty (92%) and residents (84%) were either interested or very interested in a collaborative online curriculum. Both residents (85%) and faculty (81%) stated they would be likely to seek out online educational materials shared by top educators. Although both residents and faculty reported many aspects of their curriculums they thought could be beneficial to other dermatology programs (Table 1), only 27% of faculty and 19% of residents were likely to translate those strengths into a shareable electronic format. Several reasons were reported for not contributing to an online curriculum, with lack of time being the most common reason (Table 2).
Eighty percent of residents and 88% of faculty reported they were either interested or very interested in being more connected/interactive with their dermatology peers nationally (Figure 2). Likewise, 94% of residents and 87% of faculty agreed that the dermatology community could benefit from a social networking site for educational collaboration. Four times as many residents versus faculty currently use social networking sites (eg, Facebook, LinkedIn, Google Groups) as a primary mode of communication with distant professional peers. The majority of residents (52%) reported they would be likely to participate in a professional social networking site, while the majority of faculty (50%) stated they were neutral on their likelihood of participating. Both residents and faculty reported lack of time as a common reason for being unlikely to utilize a professional social networking site. Other barriers to participation are listed in Table 3.
Comment
This study showed how dermatology faculty and residents currently provide training and what online resources and social networking sites they currently use or would be willing to use. The generalizability of the conclusions is limited by the low response rate for the surveys. The results demonstrated the different views between faculty and residents and between large and small residency programs on various topics. This microcosm of dermatology training can likely be applied to other training scenarios in dermatology, including patient education; training of nurses, physician extenders, and office staff; continuing medical education for physicians; and peer-to-peer collaboration.
Hypothesis 1: Partially Proven
We hypothesized that residents would report less satisfaction with their current curriculum and would report greater resident contributions to the curriculum relative to faculty. Overall, residents and faculty reported satisfaction with their curriculums to provide up-to-date information and breadth in the field of dermatology. Despite their overall satisfaction, more residents reported lacking instruction in several dermatology subtopics compared to faculty. Additionally, residents believed they spend twice as much time structuring their curriculum compared to faculty, with some residents reporting no faculty involvement. Although residents preferred faculty-led instruction, a majority of residents reported they do not have enough faculty-led didactics. The preference for faculty-led training is likely due to the expertise of faculty compared to residents.
Hypothesis 2: Partially Proven
We also hypothesized that both residents and faculty of smaller programs would be more interested in collaborative educational resources relative to larger programs. Although there was no difference in interest between residents at small versus large programs, there was a difference between faculty at small versus large programs. Small-program faculty were more interested in using shared materials than larger programs, while large-program faculty were more likely to share their educational materials. Small-program faculty reported spending too little time preparing their lectures, which is possibly due to a lack of time for preparation. Additionally, residents and faculty at smaller programs report their curriculum was lacking specific dermatology topics compared to large programs. These disparities between program sizes indicate a need for a social networking site for training collaboration in dermatology. Large programs have the ability to share what they do well, which small programs are eager to utilize.
Hypothesis 3: Not Proven
We hypothesized that residents would be more willing than faculty to participate in social networking for educational purposes. The majority of faculty and residents were interested in participating in a collaborative online curriculum and using the shared materials from top educators; however, even though such large majorities favored collaboration and sharing, only 27% of faculty and 19% of residents were likely to translate their own materials into a shareable format. Although lack of time was the most common reason for not sharing materials, electronic methods may have the potential to ultimately save time and remove the burden of content creation. The time it would take to translate selected personal training materials into a shareable form would be made up for by the time saved using another educators’ materials. Updating and customizing shared online educational materials can be much quicker and easier than educators creating materials on their own. Dermatologists would be more efficient facilitators of training via high-quality shared materials while decreasing the time burden associated with resident education.5 Another concern for not sharing or participating in a social networking site was skepticism of information security on such a network. The poor organization and information overload of online resources can compound the already existing time constraints on dermatologists, which may limit their ability to utilize such valuable resources. In addition, quality of online resources is not always guaranteed, and determining the sources that are high quality is sometimes a difficult task.6 For online materials to remain useful, there should be a peer-review process to evaluate quality and assess satisfaction.5
Solution: Create a Dermatology Task Force
A dermatology task force could facilitate the resolution of these challenges of online materials. In addition, a task force could cover the administrative support needed to ensure security and provide maintenance on social networks.
The main limitation to implementing a social network is the presence of the administrative infrastructure to jumpstart its creation. A task force incorporating the essential stakeholders in dermatology training is the first step. With inclusive representation from all of the smaller professional dermatology societies, the American Academy of Dermatology is optimally positioned to create this task force. With existing information technologies, a task force could address the concerns revealed in our survey as well as any future concerns that may arise.
The goal is a single social network for dermatologists that has the capability of improving communication and collaboration between professional peers regardless of their practice setting. Such a network is ideal for the practicing dermatologist for the purposes of staff training, patient education, and obtaining continuing medical education credit. Additionally, peer group collaboration would facilitate the understanding and completion of the evolving requirements for Maintenance of Certification from the American Board of Dermatology. The availability of quality shared materials would save time and increase efficiency of an entire dermatology practice. Materials that aid in patient education would allow office staff to dedicate their time to other tasks, thereby increasing productivity. Shared training materials would decrease the burden of staff education, providing more time for advanced hands-on training. This method of collaborative effort is capable of advancing the field of dermatology as a whole. It can overcome geographical and institutional barriers to connect dermatologists with similar interests worldwide; disseminate advances in diagnosis and treatment; and improve the quality of dermatology training of dermatologists, staff, and patients.
More than 1.8 billion individuals utilize social media, a number that continues to grow as the social media market expands.1 Social media enables individuals, groups, and organizations to efficiently disperse and access information2-4 and also provides a structure that encourages collaboration between patients, staff, and physicians that cannot be achieved by other communication modalities.4-6 Expert opinions and related educational materials can be shared globally, improving collaboration between dermatologists.6 A structured social networking site for sharing training materials, research, and ideas can help bring the national dermatology community together in a new way.
Other professions have employed social networking tools to accomplish similar goals of organizing training resources; radiology has an electronic database that allows sharing of training materials and incorporates social networking capabilities.7 Their Web software provides functionality for individual file uploading and supports collaboration and sharing, all while maintaining the security of uploaded information. General surgery has already addressed similar concerns via a task force that incorporates all the essential organizations in surgical education.8 Increased satisfaction and academic abilities have been demonstrated with their collaborative curriculum.9 Gastroenterologists also utilize electronic resources; one study showed that using videos to educate patients prior to colonoscopies was superior to face-to-face education.10 In addition, video education may free up time for office staff to accomplish other tasks.
As a specialty, dermatology has not been a leader in the implementation of social networking for collaboration and training purposes. Every dermatologist is an educator. To maintain a successful practice, dermatologists must keep up-to-date on their own clinical knowledge, provide training to their staff, and educate their patients. Although there are numerous educational resources available to dermatologists, an informal survey of 30 dermatology faculty members revealed a practice gap in awareness and utilization of these expanding electronic resources.11
To better understand the needs of the specialty as a whole, we chose to focus on one aspect of dermatology education: resident training. The goal of our study was to survey dermatology residents and faculty to gain a better understanding of how they currently provide education and what online resources and social networking sites they currently use or would be willing to use. The study included 3 central hypotheses: First, residents would be less satisfied with their current curriculum and residents would report greater contributions to the curriculum relative to faculty. Second, both residents and faculty of smaller programs would be more interested in collaborative educational resources relative to larger programs. Lastly, residents would be more willing than faculty to participate in social networking for educational purposes.
Methods
This study was granted institutional review board exemption. Two surveys were developed by the authors to assess the current structure and satisfaction of dermatology residency curriculum and the willingness to participate in social networking to use and share educational materials. The surveys were evaluated for relevance by the survey evaluation team of the Association of Professors of Dermatology (APD). The instrument was not pilot tested.
The surveys were electronically distributed using an online service to dermatology faculty via the APD listserve, which comprised the entirety of the APD membership in 2014. The resident survey was distributed to the dermatology residents via the American Society for Dermatologic Surgery listserve, which included all residents in training (2013-2014 academic year). Second and third invitations to complete the surveys were distributed 3 and 5 weeks later, respectively.
Resident and faculty responses were compared. Additionally, responses were stratified for large (>9 residents) and small programs (≤9 residents) for comparison. Descriptive statistics including means and medians for continuous variables and frequency tables for categorical variables were generated using research and spreadsheet software.
Results
There were 137 survey respondents; 52 of 426 (12.2%) dermatology faculty and 85 of 1539 (5.5%) dermatology residents responded to the survey. Small programs accounted for 24% of total survey responses and 76% were from large programs.
Current Curriculum
The majority of dermatology faculty (44%) and residents (35%) identified 1 to 2 faculty members as contributing to the creation and organization of their respective curricula; however, a notable percentage of residents (9%) reported that no faculty contributed to the organization of the curriculum. Residents noted that senior residents carry twice the responsibility for structuring the curriculum compared to faculty (61% vs 32% of the workload), but faculty described an even split between senior residents and faculty (47% vs 49% of the workload). Faculty believed their residents spend a similar amount of time in resident- and faculty-led instruction (38% vs 35% of their time); however, the majority of residents reported spending too little time in faculty-led instruction (53%). When residents ranked their preference for learning modes, faculty-led and self-study learning were ranked first and second by 48% and 45% of residents, respectively. Resident-led instruction was ranked last by 66% of residents. Likewise, a majority of residents (53%) described their amount of time in faculty-led instruction as too little.
When asked what subjects in dermatology were lacking at their programs, residents reported clinical trials (47%), skin of color (46%), cosmetic dermatology (34%), and aggressive skin cancer/multidisciplinary tumor board (32%). Although 11% of residents reported lacking inpatient dermatology in their curriculum, 0% of faculty reported the same. A notable percentage of faculty reported nothing was lacking compared to residents (25% vs 7%). Despite these different views between residents and faculty on their contributions to and structure of their curriculums, both faculty and residents claimed overall satisfaction (satisfied or very satisfied) with their program’s ability to optimally cover the field of dermatology in 3 years (100% and 91%, respectively).
Large Versus Small Residency Programs
When stratifying the resident responses for small versus large programs, both program sizes reported more time in resident-led instruction than faculty-led instruction. Likewise, residents in both program sizes equally preferred self-study or faculty-led instruction to resident-led instruction. Residents at small programs more often reported lacking instruction in rheumatology, immunobullous diseases, and basic science/skin biology compared to large-program residents. Compared to large-program faculty, small-program faculty reported lacking instruction in cosmetic dermatology.
Faculty at small programs reported spending too little time preparing for their faculty-led instruction compared to faculty at large programs (44% vs 12%). All (100%) of the faculty at small programs were likely to seek out study materials shared by top educators, while 77% of faculty at large programs were likely to do the same. When asked if faculty would translate what their program does well into an electronic format for sharing, 30% of large-program faculty were likely to do so compared to 11% of small-program faculty (Figure 1).
Use of Online Educational Materials and Interest in Collaboration
A majority of faculty and residents stated that they use online educational materials as supplements to traditional classroom lecture and print materials (81% vs 86%); however, almost twice as many residents stated that online educational materials were essential to their current study routines compared to faculty (39% vs 21%).
The majority of faculty (92%) and residents (84%) were either interested or very interested in a collaborative online curriculum. Both residents (85%) and faculty (81%) stated they would be likely to seek out online educational materials shared by top educators. Although both residents and faculty reported many aspects of their curriculums they thought could be beneficial to other dermatology programs (Table 1), only 27% of faculty and 19% of residents were likely to translate those strengths into a shareable electronic format. Several reasons were reported for not contributing to an online curriculum, with lack of time being the most common reason (Table 2).
Eighty percent of residents and 88% of faculty reported they were either interested or very interested in being more connected/interactive with their dermatology peers nationally (Figure 2). Likewise, 94% of residents and 87% of faculty agreed that the dermatology community could benefit from a social networking site for educational collaboration. Four times as many residents versus faculty currently use social networking sites (eg, Facebook, LinkedIn, Google Groups) as a primary mode of communication with distant professional peers. The majority of residents (52%) reported they would be likely to participate in a professional social networking site, while the majority of faculty (50%) stated they were neutral on their likelihood of participating. Both residents and faculty reported lack of time as a common reason for being unlikely to utilize a professional social networking site. Other barriers to participation are listed in Table 3.
Comment
This study showed how dermatology faculty and residents currently provide training and what online resources and social networking sites they currently use or would be willing to use. The generalizability of the conclusions is limited by the low response rate for the surveys. The results demonstrated the different views between faculty and residents and between large and small residency programs on various topics. This microcosm of dermatology training can likely be applied to other training scenarios in dermatology, including patient education; training of nurses, physician extenders, and office staff; continuing medical education for physicians; and peer-to-peer collaboration.
Hypothesis 1: Partially Proven
We hypothesized that residents would report less satisfaction with their current curriculum and would report greater resident contributions to the curriculum relative to faculty. Overall, residents and faculty reported satisfaction with their curriculums to provide up-to-date information and breadth in the field of dermatology. Despite their overall satisfaction, more residents reported lacking instruction in several dermatology subtopics compared to faculty. Additionally, residents believed they spend twice as much time structuring their curriculum compared to faculty, with some residents reporting no faculty involvement. Although residents preferred faculty-led instruction, a majority of residents reported they do not have enough faculty-led didactics. The preference for faculty-led training is likely due to the expertise of faculty compared to residents.
Hypothesis 2: Partially Proven
We also hypothesized that both residents and faculty of smaller programs would be more interested in collaborative educational resources relative to larger programs. Although there was no difference in interest between residents at small versus large programs, there was a difference between faculty at small versus large programs. Small-program faculty were more interested in using shared materials than larger programs, while large-program faculty were more likely to share their educational materials. Small-program faculty reported spending too little time preparing their lectures, which is possibly due to a lack of time for preparation. Additionally, residents and faculty at smaller programs report their curriculum was lacking specific dermatology topics compared to large programs. These disparities between program sizes indicate a need for a social networking site for training collaboration in dermatology. Large programs have the ability to share what they do well, which small programs are eager to utilize.
Hypothesis 3: Not Proven
We hypothesized that residents would be more willing than faculty to participate in social networking for educational purposes. The majority of faculty and residents were interested in participating in a collaborative online curriculum and using the shared materials from top educators; however, even though such large majorities favored collaboration and sharing, only 27% of faculty and 19% of residents were likely to translate their own materials into a shareable format. Although lack of time was the most common reason for not sharing materials, electronic methods may have the potential to ultimately save time and remove the burden of content creation. The time it would take to translate selected personal training materials into a shareable form would be made up for by the time saved using another educators’ materials. Updating and customizing shared online educational materials can be much quicker and easier than educators creating materials on their own. Dermatologists would be more efficient facilitators of training via high-quality shared materials while decreasing the time burden associated with resident education.5 Another concern for not sharing or participating in a social networking site was skepticism of information security on such a network. The poor organization and information overload of online resources can compound the already existing time constraints on dermatologists, which may limit their ability to utilize such valuable resources. In addition, quality of online resources is not always guaranteed, and determining the sources that are high quality is sometimes a difficult task.6 For online materials to remain useful, there should be a peer-review process to evaluate quality and assess satisfaction.5
Solution: Create a Dermatology Task Force
A dermatology task force could facilitate the resolution of these challenges of online materials. In addition, a task force could cover the administrative support needed to ensure security and provide maintenance on social networks.
The main limitation to implementing a social network is the presence of the administrative infrastructure to jumpstart its creation. A task force incorporating the essential stakeholders in dermatology training is the first step. With inclusive representation from all of the smaller professional dermatology societies, the American Academy of Dermatology is optimally positioned to create this task force. With existing information technologies, a task force could address the concerns revealed in our survey as well as any future concerns that may arise.
The goal is a single social network for dermatologists that has the capability of improving communication and collaboration between professional peers regardless of their practice setting. Such a network is ideal for the practicing dermatologist for the purposes of staff training, patient education, and obtaining continuing medical education credit. Additionally, peer group collaboration would facilitate the understanding and completion of the evolving requirements for Maintenance of Certification from the American Board of Dermatology. The availability of quality shared materials would save time and increase efficiency of an entire dermatology practice. Materials that aid in patient education would allow office staff to dedicate their time to other tasks, thereby increasing productivity. Shared training materials would decrease the burden of staff education, providing more time for advanced hands-on training. This method of collaborative effort is capable of advancing the field of dermatology as a whole. It can overcome geographical and institutional barriers to connect dermatologists with similar interests worldwide; disseminate advances in diagnosis and treatment; and improve the quality of dermatology training of dermatologists, staff, and patients.
- Statistics and facts about social networks. Statista website. http://www.statista.com/topics/1164/social-networks/. Accessed March 22, 2017.
- Baker RC, Klein M, Samaan Z, et al. Effectiveness of an online pediatric primary care curriculum. Acad Pediatr. 2010;10:131-137.
- Dolev JC, O’Sullivan P, Berger T. The eDerm online curriculum: a randomized study of effective skin cancer teaching to medical students. J Am Acad Dermatol. 2011;65:e165-e171.
- Amir M, Sampson BP, Endly D, et al. Social networking sites: emerging and essential tools for communication in dermatology. JAMA Dermatol. 2014;150:56-60.
- Ruiz JG, Mintzer MJ, Leipzig RM. The impact of e-learning in medical education. Acad Med. 2006;81:207-212.
- Hanson AH, Krause LK, Simmons RN, et al. Dermatology education and the internet: traditional and cutting-edge resources. J Am Acad Dermatol. 2011;65:836-842.
- Rowe SP, Siddiqui A, Bonekamp D. The key image and case log application: new radiology software for teaching file creation and case logging that incorporates elements of a social network. Acad Radiol. 2014;21:916-930.
- Bell RH. Surgical council on resident education: a new organization devoted to graduate surgical education. J Am Coll Surg. 2007;204:341-346.
- Kirton OC, Reilly P, Staff I, et al. Development and implementation of an interactive, objective, and simulation-based curriculum for general surgery residents. J Surg Educ. 2012;69:718-723.
- Prakash S, Verma S, McGowan J, et al. Improving the quality of colonoscopy bowel preparation using an educational video. Can J Gastroenterol. 2013;27:696-700.
- Carroll BT. eTools for teaching dermatologic surgery. Paper presented at the Association of Professors of Dermatology 2014 Annual Meeting; September 12-13, 2014; Chicago, IL.
- Statistics and facts about social networks. Statista website. http://www.statista.com/topics/1164/social-networks/. Accessed March 22, 2017.
- Baker RC, Klein M, Samaan Z, et al. Effectiveness of an online pediatric primary care curriculum. Acad Pediatr. 2010;10:131-137.
- Dolev JC, O’Sullivan P, Berger T. The eDerm online curriculum: a randomized study of effective skin cancer teaching to medical students. J Am Acad Dermatol. 2011;65:e165-e171.
- Amir M, Sampson BP, Endly D, et al. Social networking sites: emerging and essential tools for communication in dermatology. JAMA Dermatol. 2014;150:56-60.
- Ruiz JG, Mintzer MJ, Leipzig RM. The impact of e-learning in medical education. Acad Med. 2006;81:207-212.
- Hanson AH, Krause LK, Simmons RN, et al. Dermatology education and the internet: traditional and cutting-edge resources. J Am Acad Dermatol. 2011;65:836-842.
- Rowe SP, Siddiqui A, Bonekamp D. The key image and case log application: new radiology software for teaching file creation and case logging that incorporates elements of a social network. Acad Radiol. 2014;21:916-930.
- Bell RH. Surgical council on resident education: a new organization devoted to graduate surgical education. J Am Coll Surg. 2007;204:341-346.
- Kirton OC, Reilly P, Staff I, et al. Development and implementation of an interactive, objective, and simulation-based curriculum for general surgery residents. J Surg Educ. 2012;69:718-723.
- Prakash S, Verma S, McGowan J, et al. Improving the quality of colonoscopy bowel preparation using an educational video. Can J Gastroenterol. 2013;27:696-700.
- Carroll BT. eTools for teaching dermatologic surgery. Paper presented at the Association of Professors of Dermatology 2014 Annual Meeting; September 12-13, 2014; Chicago, IL.
Practice Points
- Educational collaboration between residency programs via social media can result in more well-rounded dermatologists, which will enhance patient care.
- Social media can connect dermatologists nationwide to improve patient care via collaboration.
Osilodrostat maintained cortisol control in Cushing’s syndrome
ORLANDO – Osilodrostat, a drug that normalized cortisol in 89% of patients with Cushing’s syndrome who took it during a phase II study, continued to exert a sustained benefit during a 31-month extension phase.
In an intent-to-treat analysis, all of the 16 patients who entered the LINC-2 extension study responded well to the medication, with no lapse in cortisol control, Rosario Pivonello, MD, said at the annual meeting of the Endocrine Society.
Osilodrostat, made by Novartis, is an oral inhibitor of 11 beta–hydroxylase. The enzyme catalyzes the last step of cortisol synthesis in the adrenal cortex. The drug was granted orphan status in 2014 by the European Medicines Agency.
In the LINC-2 study, 19 patients took osilodrostat at an initial dose of either 4 mg/day or 10 mg/day, if baseline urinary-free cortisol exceeded three times the upper normal limit. The dose was escalated every 2 weeks to up to 60 mg/day, until cortisol levels were at or below the upper limit of normal. In this study, the main efficacy endpoint was normalization of cortisol, or at least a 50% decrease from baseline at weeks 10 and 22.
Overall response was 89%. Osilodrostat treatment reduced urinary-free cortisol in all patients, and 79% had normal cortisol levels at week 22. The most common adverse events were nausea, diarrhea, asthenia, and adrenal insufficiency. New or worsening hirsutism and/or acne were reported among four female patients, all of whom had increased testosterone levels.
The LINC-2 extension study enrolled 16 patients from the phase II cohort, all of whom had responded to the medication. They were allowed to continue on their existing effective dose through the 31-month period.
Dr. Pivonello presented response curves that tracked cortisol levels from treatment initiation in the LINC-2 study. The median baseline cortisol level was about 1,500 nmol per 24 hours. By the fourth week of treatment, this had normalized in all of the patients who entered the extension phase. The response curve showed continued, stable cortisol suppression throughout the entire 31-month period.
Four patients dropped out during the course of the study. Dr. Pivonello didn’t discuss the reasons for these dropouts. He did break down the results by response, imputing the missing data from these four patients. In this analysis, the majority (87.5%) were fully controlled, with urinary-free cortisol in the normal range. The remainder were partially controlled, experiencing at least a 50% decrease in cortisol from their baseline levels. These responses were stable, with no patient experiencing loss of control over the follow-up period.
The 12 remaining patients are still taking the medication, and they experienced other clinical improvements as well. Systolic blood pressure decreased by a mean of 2.2% (from 130 mm Hg to 127 mm Hg). Diastolic blood pressure also improved, by 6% (from 85 mm Hg to 80 mm Hg).
Fasting plasma glucose dropped from a mean of 89 mg/dL to 82 mg/dL. Weight decreased from a mean of 84 kg to 74 kg, with a corresponding decrease in body mass index, from 29.6 kg/m2 to 26.2 kg/m2.
Serum aldosterone decreased along with cortisol, dropping from a mean of 168 pmol/L to just 19 pmol/L. Adrenocorticotropic hormone increased, as did 11-deoxycortisol, 11-deoxycorticosterone, and testosterone.
Pituitary tumor size was measured in six patients. It increased in three and decreased in three. Dr. Pivonello didn’t discuss why this might have occurred.
The most common adverse events were asthenia, adrenal insufficiency, diarrhea, fatigue, headache, nausea, and acne. These moderated over time in both number and severity.
However, there were eight serious adverse events among three patients, including prolonged Q-T interval on electrocardiogram, food poisoning, gastroenteritis, headache, noncardiac chest pain, symptoms related to pituitary tumor (two patients), and uncontrolled Cushing’s syndrome.
Two patients experienced hypokalemia. Six experienced mild events related to hypocortisolism.
Novartis is pursuing the drug with two placebo-controlled phase III studies (LINC-3 and LINC-4), Dr. Pivonello said. An additional phase II study is being conducted in Japan.
Dr. Pivonello has received consulting fees and honoraria from Novartis, which sponsored the study.
[email protected]
On Twitter @alz_gal
ORLANDO – Osilodrostat, a drug that normalized cortisol in 89% of patients with Cushing’s syndrome who took it during a phase II study, continued to exert a sustained benefit during a 31-month extension phase.
In an intent-to-treat analysis, all of the 16 patients who entered the LINC-2 extension study responded well to the medication, with no lapse in cortisol control, Rosario Pivonello, MD, said at the annual meeting of the Endocrine Society.
Osilodrostat, made by Novartis, is an oral inhibitor of 11 beta–hydroxylase. The enzyme catalyzes the last step of cortisol synthesis in the adrenal cortex. The drug was granted orphan status in 2014 by the European Medicines Agency.
In the LINC-2 study, 19 patients took osilodrostat at an initial dose of either 4 mg/day or 10 mg/day, if baseline urinary-free cortisol exceeded three times the upper normal limit. The dose was escalated every 2 weeks to up to 60 mg/day, until cortisol levels were at or below the upper limit of normal. In this study, the main efficacy endpoint was normalization of cortisol, or at least a 50% decrease from baseline at weeks 10 and 22.
Overall response was 89%. Osilodrostat treatment reduced urinary-free cortisol in all patients, and 79% had normal cortisol levels at week 22. The most common adverse events were nausea, diarrhea, asthenia, and adrenal insufficiency. New or worsening hirsutism and/or acne were reported among four female patients, all of whom had increased testosterone levels.
The LINC-2 extension study enrolled 16 patients from the phase II cohort, all of whom had responded to the medication. They were allowed to continue on their existing effective dose through the 31-month period.
Dr. Pivonello presented response curves that tracked cortisol levels from treatment initiation in the LINC-2 study. The median baseline cortisol level was about 1,500 nmol per 24 hours. By the fourth week of treatment, this had normalized in all of the patients who entered the extension phase. The response curve showed continued, stable cortisol suppression throughout the entire 31-month period.
Four patients dropped out during the course of the study. Dr. Pivonello didn’t discuss the reasons for these dropouts. He did break down the results by response, imputing the missing data from these four patients. In this analysis, the majority (87.5%) were fully controlled, with urinary-free cortisol in the normal range. The remainder were partially controlled, experiencing at least a 50% decrease in cortisol from their baseline levels. These responses were stable, with no patient experiencing loss of control over the follow-up period.
The 12 remaining patients are still taking the medication, and they experienced other clinical improvements as well. Systolic blood pressure decreased by a mean of 2.2% (from 130 mm Hg to 127 mm Hg). Diastolic blood pressure also improved, by 6% (from 85 mm Hg to 80 mm Hg).
Fasting plasma glucose dropped from a mean of 89 mg/dL to 82 mg/dL. Weight decreased from a mean of 84 kg to 74 kg, with a corresponding decrease in body mass index, from 29.6 kg/m2 to 26.2 kg/m2.
Serum aldosterone decreased along with cortisol, dropping from a mean of 168 pmol/L to just 19 pmol/L. Adrenocorticotropic hormone increased, as did 11-deoxycortisol, 11-deoxycorticosterone, and testosterone.
Pituitary tumor size was measured in six patients. It increased in three and decreased in three. Dr. Pivonello didn’t discuss why this might have occurred.
The most common adverse events were asthenia, adrenal insufficiency, diarrhea, fatigue, headache, nausea, and acne. These moderated over time in both number and severity.
However, there were eight serious adverse events among three patients, including prolonged Q-T interval on electrocardiogram, food poisoning, gastroenteritis, headache, noncardiac chest pain, symptoms related to pituitary tumor (two patients), and uncontrolled Cushing’s syndrome.
Two patients experienced hypokalemia. Six experienced mild events related to hypocortisolism.
Novartis is pursuing the drug with two placebo-controlled phase III studies (LINC-3 and LINC-4), Dr. Pivonello said. An additional phase II study is being conducted in Japan.
Dr. Pivonello has received consulting fees and honoraria from Novartis, which sponsored the study.
[email protected]
On Twitter @alz_gal
ORLANDO – Osilodrostat, a drug that normalized cortisol in 89% of patients with Cushing’s syndrome who took it during a phase II study, continued to exert a sustained benefit during a 31-month extension phase.
In an intent-to-treat analysis, all of the 16 patients who entered the LINC-2 extension study responded well to the medication, with no lapse in cortisol control, Rosario Pivonello, MD, said at the annual meeting of the Endocrine Society.
Osilodrostat, made by Novartis, is an oral inhibitor of 11 beta–hydroxylase. The enzyme catalyzes the last step of cortisol synthesis in the adrenal cortex. The drug was granted orphan status in 2014 by the European Medicines Agency.
In the LINC-2 study, 19 patients took osilodrostat at an initial dose of either 4 mg/day or 10 mg/day, if baseline urinary-free cortisol exceeded three times the upper normal limit. The dose was escalated every 2 weeks to up to 60 mg/day, until cortisol levels were at or below the upper limit of normal. In this study, the main efficacy endpoint was normalization of cortisol, or at least a 50% decrease from baseline at weeks 10 and 22.
Overall response was 89%. Osilodrostat treatment reduced urinary-free cortisol in all patients, and 79% had normal cortisol levels at week 22. The most common adverse events were nausea, diarrhea, asthenia, and adrenal insufficiency. New or worsening hirsutism and/or acne were reported among four female patients, all of whom had increased testosterone levels.
The LINC-2 extension study enrolled 16 patients from the phase II cohort, all of whom had responded to the medication. They were allowed to continue on their existing effective dose through the 31-month period.
Dr. Pivonello presented response curves that tracked cortisol levels from treatment initiation in the LINC-2 study. The median baseline cortisol level was about 1,500 nmol per 24 hours. By the fourth week of treatment, this had normalized in all of the patients who entered the extension phase. The response curve showed continued, stable cortisol suppression throughout the entire 31-month period.
Four patients dropped out during the course of the study. Dr. Pivonello didn’t discuss the reasons for these dropouts. He did break down the results by response, imputing the missing data from these four patients. In this analysis, the majority (87.5%) were fully controlled, with urinary-free cortisol in the normal range. The remainder were partially controlled, experiencing at least a 50% decrease in cortisol from their baseline levels. These responses were stable, with no patient experiencing loss of control over the follow-up period.
The 12 remaining patients are still taking the medication, and they experienced other clinical improvements as well. Systolic blood pressure decreased by a mean of 2.2% (from 130 mm Hg to 127 mm Hg). Diastolic blood pressure also improved, by 6% (from 85 mm Hg to 80 mm Hg).
Fasting plasma glucose dropped from a mean of 89 mg/dL to 82 mg/dL. Weight decreased from a mean of 84 kg to 74 kg, with a corresponding decrease in body mass index, from 29.6 kg/m2 to 26.2 kg/m2.
Serum aldosterone decreased along with cortisol, dropping from a mean of 168 pmol/L to just 19 pmol/L. Adrenocorticotropic hormone increased, as did 11-deoxycortisol, 11-deoxycorticosterone, and testosterone.
Pituitary tumor size was measured in six patients. It increased in three and decreased in three. Dr. Pivonello didn’t discuss why this might have occurred.
The most common adverse events were asthenia, adrenal insufficiency, diarrhea, fatigue, headache, nausea, and acne. These moderated over time in both number and severity.
However, there were eight serious adverse events among three patients, including prolonged Q-T interval on electrocardiogram, food poisoning, gastroenteritis, headache, noncardiac chest pain, symptoms related to pituitary tumor (two patients), and uncontrolled Cushing’s syndrome.
Two patients experienced hypokalemia. Six experienced mild events related to hypocortisolism.
Novartis is pursuing the drug with two placebo-controlled phase III studies (LINC-3 and LINC-4), Dr. Pivonello said. An additional phase II study is being conducted in Japan.
Dr. Pivonello has received consulting fees and honoraria from Novartis, which sponsored the study.
[email protected]
On Twitter @alz_gal
AT ENDO 2017
Key clinical point:
Major finding: Every patient in the study responded either fully (87.5%) or partially, with a decrease of at least 50% in cortisol from baseline (12.5%), with no loss of control.
Data source: The 31-month extension study comprised 16 patients who had responded well to the drug in a phase II trial.
Disclosures: Dr. Pivonello has received consulting fees and honoraria from Novartis, which sponsored the study.
AATS Centennial Highlights
AATS Week 2017 is fast approaching, and we hope you are planning to participate in the wide variety of educational opportunities available across all areas of thoracic surgery.
The week opens with the two-day AATS Mitral Conclave, which will be held on Thursday, April 27, and Friday, April 28, in New York. You will have the chance to attend an exceptional program created by Director David H. Adams, MD, and the program com ntations, expert technique/video sessions and breakout sessions.
As we look back on the last 100 years and enter our second century as an Association for Thoracic Surgery, the 2017 meeting will provide again, as it always does, an extraordinary variety of educational opportunities across all areas of our specialty. The meeting’s theme of “Always Learning” is a testament to the drive for lifelong learning among attendees, and we commit to making certain that your time is well spent.
The meeting will include many of the most popular program components, including Saturday’s skills courses and Sunday’s Postgraduate Symposia. Saturday will also include hands-on sessions, the well-received Member for a Day Program as well as Survival Guide: Your First Night on Call. The abstract presentations were selected to provide you with new insights that are applicable to your practice and that benefit your patients as well as encourage rich discussions inside and outside of the sessions.
In addition to the programs with which you have become familiar, a number of sessions will be of interest to all members of the surgical team. The Association has long recognized the essential nature of a multidisciplinary approach to care of the cardiothoracic surgical patient as is reflected in the organization’s original membership roster, and the more recent addition of a postgraduate symposium for the Interprofessional Cardiothoracic Team. As always, we look forward to participation from nurses, perfusionists, anesthesiologists, and others in the program and as faculty. This year, we have taken another step forward by holding our meeting in conjunction with the American Society for ExtraCorporeal Technology (AmSECT) 55th International Conference.
It is fitting that we are holding such a historic meeting in a city like Boston, where you will be able to experience the city’s rich culture and history. We have planned a variety of special events and features in honor of the Centennial anniversary of the founding of the Association for Thoracic Surgery. I would like to thank meeting Co-Chairs, Robert D. Jaquiss. MD, and Bryan F. Meyers, MD, for their work to make this meeting represent the highest caliber in promoting leadership, scholarship, mentoring, excellence in patient care, integrity, and professionalism. Please visit the AATS website, watch your email for updates, and download the AATS Week Mobile App for all the information you need to make the most of the experience.
AATS Week 2017 is fast approaching, and we hope you are planning to participate in the wide variety of educational opportunities available across all areas of thoracic surgery.
The week opens with the two-day AATS Mitral Conclave, which will be held on Thursday, April 27, and Friday, April 28, in New York. You will have the chance to attend an exceptional program created by Director David H. Adams, MD, and the program com ntations, expert technique/video sessions and breakout sessions.
As we look back on the last 100 years and enter our second century as an Association for Thoracic Surgery, the 2017 meeting will provide again, as it always does, an extraordinary variety of educational opportunities across all areas of our specialty. The meeting’s theme of “Always Learning” is a testament to the drive for lifelong learning among attendees, and we commit to making certain that your time is well spent.
The meeting will include many of the most popular program components, including Saturday’s skills courses and Sunday’s Postgraduate Symposia. Saturday will also include hands-on sessions, the well-received Member for a Day Program as well as Survival Guide: Your First Night on Call. The abstract presentations were selected to provide you with new insights that are applicable to your practice and that benefit your patients as well as encourage rich discussions inside and outside of the sessions.
In addition to the programs with which you have become familiar, a number of sessions will be of interest to all members of the surgical team. The Association has long recognized the essential nature of a multidisciplinary approach to care of the cardiothoracic surgical patient as is reflected in the organization’s original membership roster, and the more recent addition of a postgraduate symposium for the Interprofessional Cardiothoracic Team. As always, we look forward to participation from nurses, perfusionists, anesthesiologists, and others in the program and as faculty. This year, we have taken another step forward by holding our meeting in conjunction with the American Society for ExtraCorporeal Technology (AmSECT) 55th International Conference.
It is fitting that we are holding such a historic meeting in a city like Boston, where you will be able to experience the city’s rich culture and history. We have planned a variety of special events and features in honor of the Centennial anniversary of the founding of the Association for Thoracic Surgery. I would like to thank meeting Co-Chairs, Robert D. Jaquiss. MD, and Bryan F. Meyers, MD, for their work to make this meeting represent the highest caliber in promoting leadership, scholarship, mentoring, excellence in patient care, integrity, and professionalism. Please visit the AATS website, watch your email for updates, and download the AATS Week Mobile App for all the information you need to make the most of the experience.
AATS Week 2017 is fast approaching, and we hope you are planning to participate in the wide variety of educational opportunities available across all areas of thoracic surgery.
The week opens with the two-day AATS Mitral Conclave, which will be held on Thursday, April 27, and Friday, April 28, in New York. You will have the chance to attend an exceptional program created by Director David H. Adams, MD, and the program com ntations, expert technique/video sessions and breakout sessions.
As we look back on the last 100 years and enter our second century as an Association for Thoracic Surgery, the 2017 meeting will provide again, as it always does, an extraordinary variety of educational opportunities across all areas of our specialty. The meeting’s theme of “Always Learning” is a testament to the drive for lifelong learning among attendees, and we commit to making certain that your time is well spent.
The meeting will include many of the most popular program components, including Saturday’s skills courses and Sunday’s Postgraduate Symposia. Saturday will also include hands-on sessions, the well-received Member for a Day Program as well as Survival Guide: Your First Night on Call. The abstract presentations were selected to provide you with new insights that are applicable to your practice and that benefit your patients as well as encourage rich discussions inside and outside of the sessions.
In addition to the programs with which you have become familiar, a number of sessions will be of interest to all members of the surgical team. The Association has long recognized the essential nature of a multidisciplinary approach to care of the cardiothoracic surgical patient as is reflected in the organization’s original membership roster, and the more recent addition of a postgraduate symposium for the Interprofessional Cardiothoracic Team. As always, we look forward to participation from nurses, perfusionists, anesthesiologists, and others in the program and as faculty. This year, we have taken another step forward by holding our meeting in conjunction with the American Society for ExtraCorporeal Technology (AmSECT) 55th International Conference.
It is fitting that we are holding such a historic meeting in a city like Boston, where you will be able to experience the city’s rich culture and history. We have planned a variety of special events and features in honor of the Centennial anniversary of the founding of the Association for Thoracic Surgery. I would like to thank meeting Co-Chairs, Robert D. Jaquiss. MD, and Bryan F. Meyers, MD, for their work to make this meeting represent the highest caliber in promoting leadership, scholarship, mentoring, excellence in patient care, integrity, and professionalism. Please visit the AATS website, watch your email for updates, and download the AATS Week Mobile App for all the information you need to make the most of the experience.
FDA approves deutetrabenazine for Huntington’s-associated chorea
The Food and Drug Administration has approved deutetrabenazine (Austedo) for the treatment of chorea associated with Huntington’s disease, according to an announcement by the drug’s manufacturer, Teva Pharmaceutical.
The random, sudden, involuntary twisting and writhing movements of chorea constitute perhaps the most striking symptom of Huntington’s disease and affect about 90% of the roughly 35,000 Americans with the fatal neurodegenerative disorder. Deutetrabenazine is only the second product approved to treat Huntington’s in any capacity, and it is the first in nearly a decade.
The most common side effects of deutetrabenazine were somnolence, diarrhea, dry mouth, and fatigue. Deutetrabenazine is contraindicated in patients with hepatic impairment; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; patients taking reserpine or within 20 days of discontinuing reserpine; and patients taking tetrabenazine. Deutetrabenazine can cause worsening of mood and is not recommended for suicidal patients or patients with improperly treated depression.
“Chorea associated with Huntington’s disease has a significant impact on those living with the disease and their families. The FDA’s approval of Austedo represents an important new treatment option for people with HD and highlights the need for more therapeutic resources for this underserved patient community,” Louise Vetter, CEO of the Huntington’s Disease Society of America, said in the company’s announcement.
The Food and Drug Administration has approved deutetrabenazine (Austedo) for the treatment of chorea associated with Huntington’s disease, according to an announcement by the drug’s manufacturer, Teva Pharmaceutical.
The random, sudden, involuntary twisting and writhing movements of chorea constitute perhaps the most striking symptom of Huntington’s disease and affect about 90% of the roughly 35,000 Americans with the fatal neurodegenerative disorder. Deutetrabenazine is only the second product approved to treat Huntington’s in any capacity, and it is the first in nearly a decade.
The most common side effects of deutetrabenazine were somnolence, diarrhea, dry mouth, and fatigue. Deutetrabenazine is contraindicated in patients with hepatic impairment; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; patients taking reserpine or within 20 days of discontinuing reserpine; and patients taking tetrabenazine. Deutetrabenazine can cause worsening of mood and is not recommended for suicidal patients or patients with improperly treated depression.
“Chorea associated with Huntington’s disease has a significant impact on those living with the disease and their families. The FDA’s approval of Austedo represents an important new treatment option for people with HD and highlights the need for more therapeutic resources for this underserved patient community,” Louise Vetter, CEO of the Huntington’s Disease Society of America, said in the company’s announcement.
The Food and Drug Administration has approved deutetrabenazine (Austedo) for the treatment of chorea associated with Huntington’s disease, according to an announcement by the drug’s manufacturer, Teva Pharmaceutical.
The random, sudden, involuntary twisting and writhing movements of chorea constitute perhaps the most striking symptom of Huntington’s disease and affect about 90% of the roughly 35,000 Americans with the fatal neurodegenerative disorder. Deutetrabenazine is only the second product approved to treat Huntington’s in any capacity, and it is the first in nearly a decade.
The most common side effects of deutetrabenazine were somnolence, diarrhea, dry mouth, and fatigue. Deutetrabenazine is contraindicated in patients with hepatic impairment; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; patients taking reserpine or within 20 days of discontinuing reserpine; and patients taking tetrabenazine. Deutetrabenazine can cause worsening of mood and is not recommended for suicidal patients or patients with improperly treated depression.
“Chorea associated with Huntington’s disease has a significant impact on those living with the disease and their families. The FDA’s approval of Austedo represents an important new treatment option for people with HD and highlights the need for more therapeutic resources for this underserved patient community,” Louise Vetter, CEO of the Huntington’s Disease Society of America, said in the company’s announcement.
Incorporate steroid dose into lupus disease activity score, expert says
MELBOURNE – Adding a patient’s current dose of glucocorticoids as a new metric in the systemic lupus erythematosus disease activity index score could make it a better predictor of damage accrual, Dafna Gladman, MD, told an international congress on systemic lupus erythematosus.
Dr. Gladman and her colleagues from the University of Toronto Lupus Clinic at Toronto Western Hospital conducted a three-part study that aimed to incorporate glucocorticoid dose into the existing systemic lupus erythematosus disease activity index (SLEDAI)-2K score.
“In clinical trials, the use of standard of care, which includes the use of corticosteroids, often confounds the results, and we see that in a number of trials, so there has been an unmet need to develop an index that incorporates the glucocorticoid dose into a disease activity measure.”
The first part of the study involved identification of 131 patient scenarios from a longitudinal cohort followed at the clinic for 20 years that included eight categories based on glucocorticoid dose, ranging from 5 to 60 mg/day.
In the second phase, three rheumatologists ranked the disease activity for each patient scenario using the Physician Global Assessment, and the study team used these rankings to derive a formula to explain the association between SLEDAI and glucocorticoid category.
The third phase used data from an inception cohort of patients from the clinic with 10 years of follow-up to validate the new score – called SLEDAI-2KG – by predicting the accrual of damage over the course of follow-up.
Researchers found that the modified score was significantly better at predicting damage accrual than was the original score.
“If somebody may have a very low disease activity measurable by the instrument, SLEDAI, but they’re still taking 10-15 mg prednisone, we need to somehow take it into account,” Dr. Gladman said in an interview. “It tells you that thinking that the patient is doing well but still taking 15 mg of prednisone is not appropriate.”
Session cochair Mandana Nikpour, MBBS, PhD, of St. Vincent’s Hospital and the University of Melbourne, questioned whether incorporating a treatment into a score for disease activity was too circular.
However, Dr. Gladman stressed that the glucocorticoid score was not based on what the physician planned to do, but what the patient was taking at the time of the consultation.
“If a patient has a rash and is currently taking 40 mg of prednisone, the value of the SLEDAI would be increased because of that dose,” she said. “On the other hand, somebody might come in with pleurisy, and some people might treat that with 60 mg, but they are only taking 20 mg; that suggests that the value would be lower in that particular patient.”
The study was supported by GlaxoSmithKline. Dr. Gladman and two coauthors declared receiving funding from GlaxoSmithKline.
MELBOURNE – Adding a patient’s current dose of glucocorticoids as a new metric in the systemic lupus erythematosus disease activity index score could make it a better predictor of damage accrual, Dafna Gladman, MD, told an international congress on systemic lupus erythematosus.
Dr. Gladman and her colleagues from the University of Toronto Lupus Clinic at Toronto Western Hospital conducted a three-part study that aimed to incorporate glucocorticoid dose into the existing systemic lupus erythematosus disease activity index (SLEDAI)-2K score.
“In clinical trials, the use of standard of care, which includes the use of corticosteroids, often confounds the results, and we see that in a number of trials, so there has been an unmet need to develop an index that incorporates the glucocorticoid dose into a disease activity measure.”
The first part of the study involved identification of 131 patient scenarios from a longitudinal cohort followed at the clinic for 20 years that included eight categories based on glucocorticoid dose, ranging from 5 to 60 mg/day.
In the second phase, three rheumatologists ranked the disease activity for each patient scenario using the Physician Global Assessment, and the study team used these rankings to derive a formula to explain the association between SLEDAI and glucocorticoid category.
The third phase used data from an inception cohort of patients from the clinic with 10 years of follow-up to validate the new score – called SLEDAI-2KG – by predicting the accrual of damage over the course of follow-up.
Researchers found that the modified score was significantly better at predicting damage accrual than was the original score.
“If somebody may have a very low disease activity measurable by the instrument, SLEDAI, but they’re still taking 10-15 mg prednisone, we need to somehow take it into account,” Dr. Gladman said in an interview. “It tells you that thinking that the patient is doing well but still taking 15 mg of prednisone is not appropriate.”
Session cochair Mandana Nikpour, MBBS, PhD, of St. Vincent’s Hospital and the University of Melbourne, questioned whether incorporating a treatment into a score for disease activity was too circular.
However, Dr. Gladman stressed that the glucocorticoid score was not based on what the physician planned to do, but what the patient was taking at the time of the consultation.
“If a patient has a rash and is currently taking 40 mg of prednisone, the value of the SLEDAI would be increased because of that dose,” she said. “On the other hand, somebody might come in with pleurisy, and some people might treat that with 60 mg, but they are only taking 20 mg; that suggests that the value would be lower in that particular patient.”
The study was supported by GlaxoSmithKline. Dr. Gladman and two coauthors declared receiving funding from GlaxoSmithKline.
MELBOURNE – Adding a patient’s current dose of glucocorticoids as a new metric in the systemic lupus erythematosus disease activity index score could make it a better predictor of damage accrual, Dafna Gladman, MD, told an international congress on systemic lupus erythematosus.
Dr. Gladman and her colleagues from the University of Toronto Lupus Clinic at Toronto Western Hospital conducted a three-part study that aimed to incorporate glucocorticoid dose into the existing systemic lupus erythematosus disease activity index (SLEDAI)-2K score.
“In clinical trials, the use of standard of care, which includes the use of corticosteroids, often confounds the results, and we see that in a number of trials, so there has been an unmet need to develop an index that incorporates the glucocorticoid dose into a disease activity measure.”
The first part of the study involved identification of 131 patient scenarios from a longitudinal cohort followed at the clinic for 20 years that included eight categories based on glucocorticoid dose, ranging from 5 to 60 mg/day.
In the second phase, three rheumatologists ranked the disease activity for each patient scenario using the Physician Global Assessment, and the study team used these rankings to derive a formula to explain the association between SLEDAI and glucocorticoid category.
The third phase used data from an inception cohort of patients from the clinic with 10 years of follow-up to validate the new score – called SLEDAI-2KG – by predicting the accrual of damage over the course of follow-up.
Researchers found that the modified score was significantly better at predicting damage accrual than was the original score.
“If somebody may have a very low disease activity measurable by the instrument, SLEDAI, but they’re still taking 10-15 mg prednisone, we need to somehow take it into account,” Dr. Gladman said in an interview. “It tells you that thinking that the patient is doing well but still taking 15 mg of prednisone is not appropriate.”
Session cochair Mandana Nikpour, MBBS, PhD, of St. Vincent’s Hospital and the University of Melbourne, questioned whether incorporating a treatment into a score for disease activity was too circular.
However, Dr. Gladman stressed that the glucocorticoid score was not based on what the physician planned to do, but what the patient was taking at the time of the consultation.
“If a patient has a rash and is currently taking 40 mg of prednisone, the value of the SLEDAI would be increased because of that dose,” she said. “On the other hand, somebody might come in with pleurisy, and some people might treat that with 60 mg, but they are only taking 20 mg; that suggests that the value would be lower in that particular patient.”
The study was supported by GlaxoSmithKline. Dr. Gladman and two coauthors declared receiving funding from GlaxoSmithKline.
AT LUPUS 2017
Key clinical point:
Major finding: A revised SLEDAI incorporating glucocorticoid dose was significantly better at predicting damage accrual.
Data source: Development of a new disease activity index from 131 patient scenarios derived from a longitudinal cohort and validated in a separate inception cohort.
Disclosures: The study was supported by GlaxoSmithKline. Dr. Gladman and two coauthors declared receiving funding from GlaxoSmithKline.
Lupus nephritis expert offers management tips
MELBOURNE – Multidisciplinary management of comorbidities is one of the most important aspects of the care of patients with lupus nephritis, Frédéric Houssiau, MD, PhD, said at an international congress on systemic lupus erythematosus.
In his presentation describing his top 10 tips for the management of lupus nephritis, Dr. Houssiau said traditional risk factors do not explain the two- to threefold higher risk of cardiovascular disease in patients with lupus, making it important to address known cardiovascular disease risk factors.
Dr. Houssiau also stressed the importance of paying attention to clotting disorders, preventing glucocorticoid-related intraocular pressure, ensuring patients are immunized against influenza, and enabling patient access to an intensive care unit in the event of severe sepsis.
He also called for physicians to “unmask” nonadherence to therapy, saying it was the most common cause of treatment failure.
“We don’t look enough to nonadherence to therapy, and we have no good clue to sort that out,” he said in an interview. “We can identify nonadherent patients, but it’s very difficult to change their mind, to make them adherent, and we have nurses, nurse-practitioners, questionnaires for adherence, but none of them, I think, so far have changed practice.”
Dr. Houssiau argued for the importance of having a good connection with a nephrologist and always performing a renal biopsy in patients with lupus nephritis.
“The reason for that is first to identify the immune deposits, either mesangial or subendothelial or subepithelial, and another reason is clearly not to miss the antiphospholipid syndrome,” he told the audience. “The third very good reason to perform the renal biopsy is clearly to classify the patient.”
Echoing other presentations at the conference, Dr. Houssiau said there was a need to define treatment targets in lupus nephritis.
“In diabetes, in hypertension, in rheumatoid arthritis, the target is well known by all of us,” he said. “What is the target that we should achieve in the lupus nephritis patient? That is much more difficult.”
He cited data from the recent MAINTAIN trial, which suggested that proteinuria levels at 12 months after initiation of treatment were highly predictive of patients who were likely to have a good renal prognosis. Patients with a 24-hour proteinuria level of around 0.7-0.8 g/day had a significantly greater likelihood of normal serum creatinine 7 years later, he said.
“Yet, we need more, we need better markers, because the negative predictive value is very bad, which means that a lot of patients who do not reach that target still, fortunately, will end up without renal failure.”
Dr. Houssiau also emphasized the need to minimize the use of steroids where possible, as data from an inception cohort run by him and his colleagues have shown that patients who failed to taper down to 4 mg of prednisone or less, after 1 year, had significantly more damage accrual.
He also advocated using either mycophenolate mofetil or intravenous cyclophosphamide as induction therapy based on data suggesting the two are equally efficacious at 6 months. Dr. Houssiau suggested favoring intravenous cyclophosphamide if fertility was a concern because it has been shown to not affect ovarian reserve and has the added advantage of better compliance.
Maintaining immunosuppression is also vital, Dr. Houssiau told the conference, and patients should be treated with immunosuppressants for at least 5, and possibly even up to 10, years.
“There is a small study showing an inverse correlation between the length of therapy and remission on the one hand, and risk of relapse, so the more you treat, the more the period of remission is long, the lower risk of relapse,” he said. However, there are little trial data on withdrawing immunosuppression or trials of immunosuppressant withdrawal, he noted.
Commenting on the future prospects for new treatments for lupus nephritis, Dr. Houssiau advised keeping faith in targeted therapies and precision medicine despite a slew of failed phase III clinical trials, and watching the development of calcineurin inhibitors, such as voclosporin.
Dr. Houssiau declared receiving research grants and honoraria from AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Lilly, Roche, Serono, and UCB.
MELBOURNE – Multidisciplinary management of comorbidities is one of the most important aspects of the care of patients with lupus nephritis, Frédéric Houssiau, MD, PhD, said at an international congress on systemic lupus erythematosus.
In his presentation describing his top 10 tips for the management of lupus nephritis, Dr. Houssiau said traditional risk factors do not explain the two- to threefold higher risk of cardiovascular disease in patients with lupus, making it important to address known cardiovascular disease risk factors.
Dr. Houssiau also stressed the importance of paying attention to clotting disorders, preventing glucocorticoid-related intraocular pressure, ensuring patients are immunized against influenza, and enabling patient access to an intensive care unit in the event of severe sepsis.
He also called for physicians to “unmask” nonadherence to therapy, saying it was the most common cause of treatment failure.
“We don’t look enough to nonadherence to therapy, and we have no good clue to sort that out,” he said in an interview. “We can identify nonadherent patients, but it’s very difficult to change their mind, to make them adherent, and we have nurses, nurse-practitioners, questionnaires for adherence, but none of them, I think, so far have changed practice.”
Dr. Houssiau argued for the importance of having a good connection with a nephrologist and always performing a renal biopsy in patients with lupus nephritis.
“The reason for that is first to identify the immune deposits, either mesangial or subendothelial or subepithelial, and another reason is clearly not to miss the antiphospholipid syndrome,” he told the audience. “The third very good reason to perform the renal biopsy is clearly to classify the patient.”
Echoing other presentations at the conference, Dr. Houssiau said there was a need to define treatment targets in lupus nephritis.
“In diabetes, in hypertension, in rheumatoid arthritis, the target is well known by all of us,” he said. “What is the target that we should achieve in the lupus nephritis patient? That is much more difficult.”
He cited data from the recent MAINTAIN trial, which suggested that proteinuria levels at 12 months after initiation of treatment were highly predictive of patients who were likely to have a good renal prognosis. Patients with a 24-hour proteinuria level of around 0.7-0.8 g/day had a significantly greater likelihood of normal serum creatinine 7 years later, he said.
“Yet, we need more, we need better markers, because the negative predictive value is very bad, which means that a lot of patients who do not reach that target still, fortunately, will end up without renal failure.”
Dr. Houssiau also emphasized the need to minimize the use of steroids where possible, as data from an inception cohort run by him and his colleagues have shown that patients who failed to taper down to 4 mg of prednisone or less, after 1 year, had significantly more damage accrual.
He also advocated using either mycophenolate mofetil or intravenous cyclophosphamide as induction therapy based on data suggesting the two are equally efficacious at 6 months. Dr. Houssiau suggested favoring intravenous cyclophosphamide if fertility was a concern because it has been shown to not affect ovarian reserve and has the added advantage of better compliance.
Maintaining immunosuppression is also vital, Dr. Houssiau told the conference, and patients should be treated with immunosuppressants for at least 5, and possibly even up to 10, years.
“There is a small study showing an inverse correlation between the length of therapy and remission on the one hand, and risk of relapse, so the more you treat, the more the period of remission is long, the lower risk of relapse,” he said. However, there are little trial data on withdrawing immunosuppression or trials of immunosuppressant withdrawal, he noted.
Commenting on the future prospects for new treatments for lupus nephritis, Dr. Houssiau advised keeping faith in targeted therapies and precision medicine despite a slew of failed phase III clinical trials, and watching the development of calcineurin inhibitors, such as voclosporin.
Dr. Houssiau declared receiving research grants and honoraria from AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Lilly, Roche, Serono, and UCB.
MELBOURNE – Multidisciplinary management of comorbidities is one of the most important aspects of the care of patients with lupus nephritis, Frédéric Houssiau, MD, PhD, said at an international congress on systemic lupus erythematosus.
In his presentation describing his top 10 tips for the management of lupus nephritis, Dr. Houssiau said traditional risk factors do not explain the two- to threefold higher risk of cardiovascular disease in patients with lupus, making it important to address known cardiovascular disease risk factors.
Dr. Houssiau also stressed the importance of paying attention to clotting disorders, preventing glucocorticoid-related intraocular pressure, ensuring patients are immunized against influenza, and enabling patient access to an intensive care unit in the event of severe sepsis.
He also called for physicians to “unmask” nonadherence to therapy, saying it was the most common cause of treatment failure.
“We don’t look enough to nonadherence to therapy, and we have no good clue to sort that out,” he said in an interview. “We can identify nonadherent patients, but it’s very difficult to change their mind, to make them adherent, and we have nurses, nurse-practitioners, questionnaires for adherence, but none of them, I think, so far have changed practice.”
Dr. Houssiau argued for the importance of having a good connection with a nephrologist and always performing a renal biopsy in patients with lupus nephritis.
“The reason for that is first to identify the immune deposits, either mesangial or subendothelial or subepithelial, and another reason is clearly not to miss the antiphospholipid syndrome,” he told the audience. “The third very good reason to perform the renal biopsy is clearly to classify the patient.”
Echoing other presentations at the conference, Dr. Houssiau said there was a need to define treatment targets in lupus nephritis.
“In diabetes, in hypertension, in rheumatoid arthritis, the target is well known by all of us,” he said. “What is the target that we should achieve in the lupus nephritis patient? That is much more difficult.”
He cited data from the recent MAINTAIN trial, which suggested that proteinuria levels at 12 months after initiation of treatment were highly predictive of patients who were likely to have a good renal prognosis. Patients with a 24-hour proteinuria level of around 0.7-0.8 g/day had a significantly greater likelihood of normal serum creatinine 7 years later, he said.
“Yet, we need more, we need better markers, because the negative predictive value is very bad, which means that a lot of patients who do not reach that target still, fortunately, will end up without renal failure.”
Dr. Houssiau also emphasized the need to minimize the use of steroids where possible, as data from an inception cohort run by him and his colleagues have shown that patients who failed to taper down to 4 mg of prednisone or less, after 1 year, had significantly more damage accrual.
He also advocated using either mycophenolate mofetil or intravenous cyclophosphamide as induction therapy based on data suggesting the two are equally efficacious at 6 months. Dr. Houssiau suggested favoring intravenous cyclophosphamide if fertility was a concern because it has been shown to not affect ovarian reserve and has the added advantage of better compliance.
Maintaining immunosuppression is also vital, Dr. Houssiau told the conference, and patients should be treated with immunosuppressants for at least 5, and possibly even up to 10, years.
“There is a small study showing an inverse correlation between the length of therapy and remission on the one hand, and risk of relapse, so the more you treat, the more the period of remission is long, the lower risk of relapse,” he said. However, there are little trial data on withdrawing immunosuppression or trials of immunosuppressant withdrawal, he noted.
Commenting on the future prospects for new treatments for lupus nephritis, Dr. Houssiau advised keeping faith in targeted therapies and precision medicine despite a slew of failed phase III clinical trials, and watching the development of calcineurin inhibitors, such as voclosporin.
Dr. Houssiau declared receiving research grants and honoraria from AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Lilly, Roche, Serono, and UCB.
EXPERT ANALYSIS FROM LUPUS 2017
Approach to covert recording by patients of encounters with gastroenterology providers
Last year, while sedated for colonoscopy, a patient covertly recorded conversations between endoscopy staff and providers. Comments about the patient were egregious and resulted in loss of employment for those involved and a large financial settlement. The reality of today’s world is that we all are subject to constant (real or potential) surveillance. Nothing is private and nothing recorded is temporary, yet physicians value private conversations with our patients. When a patient records a visit, either covertly or overtly, most physicians pause and have some emotional reaction (either positive or negative). Some welcome the ability to communicate accurately to a wider audience, while others believe the act of recording violates an interpersonal bond. In this month’s issue, Dr. Adams discusses the legal and ethical ramifications when a patient records our clinical interactions. She offers an excellent analysis and practical risk management strategies. Personally, I follow my wife’s dictum to act as if I am always on camera.
John I. Allen, MD, MBA, AGAF
Editor in Chief
Patients and physicians were collectively horrified last year when news broke of a Virginia man who recorded conversations between his gastroenterologist, his anesthesiologist, and other endoscopy unit staff, including a number of disparaging remarks about the patient, while sedated for his colonoscopy. Among other objectionable comments, providers mocked the patient for being demanding in the preprocedure area and for the amount of sedation he required, made comments implying that he had syphilis or tuberculosis, and discussed avoiding the patient following the procedure via an urgent “fake page.”1 The patient sued, resulting in a $500,000 judgment against the anesthesiologist for defamation and malpractice, including punitive damages. Although this case clearly represents an extreme example of unprofessional behavior, it also raises thought-provoking questions regarding the evolving relationship between patients and their physicians, as well as the legal and ethical implications of covert recording that deserve further discussion.
This article reviews the current state of knowledge regarding the frequency of and motivation for covert patient recording of medical encounters, and the legal and ethical principles informing this area. It concludes by proposing several strategies gastroenterologists can use to mitigate risk of liability while also preserving the patient-physician relationship and upholding professional autonomy.
Weighing the benefits and harms of patient electronic recording
Patient recording of medical encounters, whether covert or overt, presents both benefits and risks of harm. Theoretically, recording medical encounters could assist patients in remembering and/or better understanding recommendations provided by their physicians. It may also secondarily improve patient compliance and overall engagement in medical care and help patients accurately communicate recommendations to family members and other caregivers who are not immediately available during the clinical encounter. Patients may also view these recordings as a mechanism for empowerment, allowing them to shift the power dynamic between patient and provider.2,3 However, there is also the potential for recorded comments to be taken out of context or misinterpreted, leading to confusion on the part of the patient or family. Overt recording of medical encounters also may alter physician decision-making, leading to more aggressive testing and expense for the patient and the healthcare system. Even worse, covert recording of medical encounters (if discovered) may irreparably harm the physician-patient relationship by introducing distrust and causing the physician to take a more defensive posture in subsequent dealings with a given patient.
Recent research has shed new light on the potential frequency of patient covert recording of medical encounters, suggesting that it is alarmingly common. In a mixed-methods study of 130 patients in the United Kingdom who were recruited via radio and social media, 15% of respondents indicated that they had secretly recorded a clinical encounter, and an additional 11% personally knew someone who had covertly recorded.4 Those who reported having covertly recorded were significantly more likely to be less educated and male than those who had not. An additional 35% of respondents indicated that they would consider covertly recording a clinical encounter in the future. Although the generalizability of these results may be challenged based on the potential for sampling bias, the results suggest a shifting paradigm in the way in which patients view the physician-patient relationship and a fundamental breakdown in communication and erosion of trust.
The underlying motivations for patient recording of medical encounters are complex and multifaceted. These recordings seem to be a relatively new phenomenon and one that elicits strong reactions, positive and negative, on the part of patients, physicians, and society.2 Qualitative studies reveal that, whether covertly or overtly recording, most patients are driven by a common desire to replay, relisten, and/or share the recording with family, friends, and other caregivers.4 Indeed, the patient involved in the previously mentioned litigation purportedly intended to record the postcolonoscopy discharge instructions from his gastroenterologist, only to later discover much more. Patients who record covertly report being motivated by a fear of being denied permission to record or by prior experiences of poor quality care and the prospect of gathering verifiable evidence to support their experience. In contrast, patients who ask permission to record seem to be motivated primarily by a desire to preserve or enhance the physician-patient relationship.4 These insights are valuable in that they allow clinicians to view medical encounters from the perspective of patients, understand the power-dynamics at play, and ultimately, use this information to enlighten future care.
Legal guidance: “One-party” versus “all-party” consent
Although the prospect of covert patient recording may be unsettling to physicians, is it illegal? Because of a paucity of legal precedent in this area, the legal landscape is rather murky. Through the provisions of the Electronic Communications Privacy Act, federal law prohibits the interception and disclosure of wire, oral, or electronic communications without specific consent of at least one party to the conversation.5 This so-called “one-party” consent standard affords a baseline level of legal protection. A handful of states offer additional protection under state law by requiring all parties to the conversation to consent to the recording (so-called “all-party” consent). Virginia, where the audio recording of the previously mentioned colonoscopy took place, is a “one-party” consent state.6 In contrast, states such as California and Florida have adopted an “all-party” consent rule.7,8
However, uncertainty remains. For instance, if medical providers have a conversation in the same room as a sedated patient during a medical procedure on that patient, is the patient a “party” to the conversation? Furthermore, can such a conversation be considered private when held in front of a patient during a medical procedure? Is the patient in such a scenario “eavesdropping”? Given a lack of legal precedent in the form of case law and given the unique features of each clinical scenario, this is likely to remain an area of significant legal ambiguity. Although the possibility of covert patient recording may be unnerving for providers, the reality is that, in most cases, it is likely legally permissible.
Ethical principles: Navigating an evolving physician-patient relationship
The relationship between physician and patient, a core aspect of medical ethics, has evolved markedly over time. This relationship was historically paternalistic: The patient was seen to be dependent on the physician’s professional authority in determining the appropriateness of care, and patient’s preferences were seen as secondary to physician judgment. In recent years, however, the physician-patient relationship has evolved toward one privileging patient-centered care and shared decision-making based on a patient’s unique values, beliefs, and preferences.9,10
Concomitantly, the public’s view of doctoring has transitioned from “unquestioning acceptance of physician authority to a more ‘consumerist’ view accompanied by a questioning and bargaining approach to medicine, physicians and the medical encounter,” according to a 2001 study published in the Journal of Health and Social Behavior.11 In this context, many patients, attorneys, bioethicists, and patient advocates see patient recording of medical encounters as a legitimate check on the health care system, ensuring transparency and honesty and empowering patients to become more active participants in their medical care.2
Policy responses
Although recognition of patient recording of medical encounters has been growing, there have been few direct policy responses to date. One notable example was an effort by Wisconsin legislators in 2015 to mandate that any place where surgery is performed (including hospitals, ambulatory surgical centers, and other sites) offer patients the option to have their procedure videotaped and audiotaped.12 The proposed legislation was written broadly enough to include locations where gastroenterologists perform routine endoscopic procedures under sedation. Recordings would have been treated as part of the patient’s health care record and been admissible as evidence in subsequent legal proceedings relating to the medical care provided. Although this bill ultimately failed to pass pursuant to a Joint Resolution in the Wisconsin Senate in April 2016, it is a poignant example of the possible policy actions that may govern this area in the future.
In 2012, the National Institute for Health and Clinical Excellence, England, issued a guidance document focused on improving the patient care experience, which recommends that clinicians routinely ask patients if they would like to take notes and/or record the clinical encounter.13 Although not explicitly referencing covert recording, this guidance effectively aims to promote increased transparency by openly encouraging recording as a component of optimal medical practice. Although the American Medical Association Code of Ethics offers guidance regarding physicians recording patient encounters, it does not comment on patient-initiated recordings.14
Risk management strategies for gastroenterology providers
So, how can gastroenterologists and other providers protect themselves in a world of covert recording, while also preserving their relationships with patients and optimizing medical care? First, despite their harried days and varied responsibilities, gastroenterologists must recognize the possibility of covert recording and seek to maintain professionalism in all clinical environments, whether in an examination room or in an endoscopy suite with a sedated patient. Physicians set the tone for the entire team and also have an obligation to intervene if other members of the medical team are not adhering to professional standards. Although physicians and other medical providers often use cynical and derogatory humor as a coping mechanism given the heavy workload and amplified stressors of the clinical environment, it is important to be mindful of how such comments are perceived by patient bystanders.15,16 Although achieving a robust therapeutic alliance with a patient can take months, this trust can be easily broken by a single flippant remark by the physician.
Second, rather than assuming a defensive posture driven by fear of medical liability, it is vital for gastroenterologists to directly confront situations in which covert recording is suspected while also preserving the physician-patient relationship. In fact, by openly encouraging patient recording as a matter of routine practice, gastroenterologists can promote an environment of trust and transparency and bolster the therapeutic alliance between patient and provider.15 This approach also encourages providers to hone their communication skills and ensure they are communicating essential medical information clearly and succinctly and conveying medical nuance where appropriate. For example, in a clinic setting, a patient with inflammatory bowel disease who records might better remember or understand the risks and benefits of various treatment strategies and the common side effects of medications such as azathioprine and biologics. Patients recording medical encounters in the endoscopy suite might better recall postprocedure instructions, including recommended follow-up intervals and risks of postendoscopy complications. In this era of shared decision-making and patient-centered care, optimizing both physician delivery and patient understanding and recall of essential medical information is of critical importance.
Finally, although adoption of the above practices would serve the dual goals of enhancing patient-provider communication and mitigating legal risk, certain system interventions may further minimize the risk of covert recording. For instance, endoscopy units can store patients’ personal effects, including electronic devices, in a locker outside the endoscopy room rather than on the gurney. Retrieving patient belongings before postprocedure instructions are delivered would protect the patient’s ability to record this advice for future recall.
Conclusions
Recording by patients of clinical encounters, whether covert or overt, has become increasingly common as a result of the digital revolution. These recordings most often represent an attempt by the patient to gain more information relevant to their medical care. Rather than being threatened by this new reality, gastroenterologists should consider embracing this practice as an opportunity to enhance effective communication with patients, encourage shared decision making, and deliver truly patient-centered care.
Acknowledgments
This article is intended as general commentary and should not be interpreted as legal advice applicable to individual circumstances. Do not act or rely on information contained in this article without first seeking the advice of a personal attorney.
References
1. Washington Post. (2015 June 24). Audio: Anesthesiologist trashes sedated patient. Available at: https://youtu.be/Kar52idHgho. Accessed May 15, 2016.
2. Tsulukidze, M., Grande, S.W., Thompson, R., et al. Patients covertly recording clinical encounters: threat or opportunity? A qualitative analysis of online texts. PLoS One. 2015;10:e0125824.
3. Rodriguez, M., Morrow, J., Selfi, A. Ethical implications of patients and families secretly recording conversations with physicians. JAMA. 2015;313(16):1615-6.
4. Elwyn, G., Barr, P.J., Grande, S.W. Patients recording clinical encounters: a path to empowerment? Assessment by mixed methods. BMJ Open. 2015;5(8):e008566.
5. 18 U.S.C. §2511(2)(d).
6. VA Code §19.2-62.
7. Cal. Penal Code §632.
8. Fla. Stat. Ann. §934.03(3)(d).
9. Truog, R.D. Patients and doctors: the evolution of a relationship. N Engl J Med. 2012;366:581-5.
10. Barry, M.J., Edgman-Levitan, S. Shared decision making: the pinnacle of patient-centered care. N Engl J Med. 2012;366:780-1.
11. Pescosolido, B.A., Tuch, S.A., Martin, J.K. The profession of medicine and the public: examining Americans’ changing confidence in physician authority from the beginning of the ‘health care crisis’ to the era of health care reform. J Health Social Behavior. 2001;42(1):1-16.
12. Wisconsin Assembly Bill 255. (2015). Available at: https://docs.legis.wisconsin.gov/2015/proposals/ab255. Accessed June 29, 2016.
13. National Institute for Health and Clinical Excellence. (2012 Feb). Patient experience in adult NHS services: improving the experience of care for people using adult NHS service. Available at: https://www.nice.org.uk/guidance/cg138/chapter/1-guidance. Accessed June 29, 2016.
14. American Medical Association Code of Medical Ethics, Opinion 5.045 - Filming Patients in Health Care Settings. Updated June 2006. Available at: http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion5045.page? Accessed June 29, 2016.
15. Aultman, J.M. When humor in the hospital is no laughing matter. J Clin Ethics. 2009;20:227-35.
15. Sobel, R.K. Does laughter make good medicine? N Engl J Med. 2006;354:1114-5.
Dr. Adams is a clinical lecturer in the division of gastroenterology, University of Michigan, Ann Arbor, an investigator with the VA Center for Clinical Management Research, a staff physician in the VA Ann Arbor Healthcare System, and a member of the Institute for Healthcare Policy and Innovation, Ann Arbor. She has no conflicts of interest.
Last year, while sedated for colonoscopy, a patient covertly recorded conversations between endoscopy staff and providers. Comments about the patient were egregious and resulted in loss of employment for those involved and a large financial settlement. The reality of today’s world is that we all are subject to constant (real or potential) surveillance. Nothing is private and nothing recorded is temporary, yet physicians value private conversations with our patients. When a patient records a visit, either covertly or overtly, most physicians pause and have some emotional reaction (either positive or negative). Some welcome the ability to communicate accurately to a wider audience, while others believe the act of recording violates an interpersonal bond. In this month’s issue, Dr. Adams discusses the legal and ethical ramifications when a patient records our clinical interactions. She offers an excellent analysis and practical risk management strategies. Personally, I follow my wife’s dictum to act as if I am always on camera.
John I. Allen, MD, MBA, AGAF
Editor in Chief
Patients and physicians were collectively horrified last year when news broke of a Virginia man who recorded conversations between his gastroenterologist, his anesthesiologist, and other endoscopy unit staff, including a number of disparaging remarks about the patient, while sedated for his colonoscopy. Among other objectionable comments, providers mocked the patient for being demanding in the preprocedure area and for the amount of sedation he required, made comments implying that he had syphilis or tuberculosis, and discussed avoiding the patient following the procedure via an urgent “fake page.”1 The patient sued, resulting in a $500,000 judgment against the anesthesiologist for defamation and malpractice, including punitive damages. Although this case clearly represents an extreme example of unprofessional behavior, it also raises thought-provoking questions regarding the evolving relationship between patients and their physicians, as well as the legal and ethical implications of covert recording that deserve further discussion.
This article reviews the current state of knowledge regarding the frequency of and motivation for covert patient recording of medical encounters, and the legal and ethical principles informing this area. It concludes by proposing several strategies gastroenterologists can use to mitigate risk of liability while also preserving the patient-physician relationship and upholding professional autonomy.
Weighing the benefits and harms of patient electronic recording
Patient recording of medical encounters, whether covert or overt, presents both benefits and risks of harm. Theoretically, recording medical encounters could assist patients in remembering and/or better understanding recommendations provided by their physicians. It may also secondarily improve patient compliance and overall engagement in medical care and help patients accurately communicate recommendations to family members and other caregivers who are not immediately available during the clinical encounter. Patients may also view these recordings as a mechanism for empowerment, allowing them to shift the power dynamic between patient and provider.2,3 However, there is also the potential for recorded comments to be taken out of context or misinterpreted, leading to confusion on the part of the patient or family. Overt recording of medical encounters also may alter physician decision-making, leading to more aggressive testing and expense for the patient and the healthcare system. Even worse, covert recording of medical encounters (if discovered) may irreparably harm the physician-patient relationship by introducing distrust and causing the physician to take a more defensive posture in subsequent dealings with a given patient.
Recent research has shed new light on the potential frequency of patient covert recording of medical encounters, suggesting that it is alarmingly common. In a mixed-methods study of 130 patients in the United Kingdom who were recruited via radio and social media, 15% of respondents indicated that they had secretly recorded a clinical encounter, and an additional 11% personally knew someone who had covertly recorded.4 Those who reported having covertly recorded were significantly more likely to be less educated and male than those who had not. An additional 35% of respondents indicated that they would consider covertly recording a clinical encounter in the future. Although the generalizability of these results may be challenged based on the potential for sampling bias, the results suggest a shifting paradigm in the way in which patients view the physician-patient relationship and a fundamental breakdown in communication and erosion of trust.
The underlying motivations for patient recording of medical encounters are complex and multifaceted. These recordings seem to be a relatively new phenomenon and one that elicits strong reactions, positive and negative, on the part of patients, physicians, and society.2 Qualitative studies reveal that, whether covertly or overtly recording, most patients are driven by a common desire to replay, relisten, and/or share the recording with family, friends, and other caregivers.4 Indeed, the patient involved in the previously mentioned litigation purportedly intended to record the postcolonoscopy discharge instructions from his gastroenterologist, only to later discover much more. Patients who record covertly report being motivated by a fear of being denied permission to record or by prior experiences of poor quality care and the prospect of gathering verifiable evidence to support their experience. In contrast, patients who ask permission to record seem to be motivated primarily by a desire to preserve or enhance the physician-patient relationship.4 These insights are valuable in that they allow clinicians to view medical encounters from the perspective of patients, understand the power-dynamics at play, and ultimately, use this information to enlighten future care.
Legal guidance: “One-party” versus “all-party” consent
Although the prospect of covert patient recording may be unsettling to physicians, is it illegal? Because of a paucity of legal precedent in this area, the legal landscape is rather murky. Through the provisions of the Electronic Communications Privacy Act, federal law prohibits the interception and disclosure of wire, oral, or electronic communications without specific consent of at least one party to the conversation.5 This so-called “one-party” consent standard affords a baseline level of legal protection. A handful of states offer additional protection under state law by requiring all parties to the conversation to consent to the recording (so-called “all-party” consent). Virginia, where the audio recording of the previously mentioned colonoscopy took place, is a “one-party” consent state.6 In contrast, states such as California and Florida have adopted an “all-party” consent rule.7,8
However, uncertainty remains. For instance, if medical providers have a conversation in the same room as a sedated patient during a medical procedure on that patient, is the patient a “party” to the conversation? Furthermore, can such a conversation be considered private when held in front of a patient during a medical procedure? Is the patient in such a scenario “eavesdropping”? Given a lack of legal precedent in the form of case law and given the unique features of each clinical scenario, this is likely to remain an area of significant legal ambiguity. Although the possibility of covert patient recording may be unnerving for providers, the reality is that, in most cases, it is likely legally permissible.
Ethical principles: Navigating an evolving physician-patient relationship
The relationship between physician and patient, a core aspect of medical ethics, has evolved markedly over time. This relationship was historically paternalistic: The patient was seen to be dependent on the physician’s professional authority in determining the appropriateness of care, and patient’s preferences were seen as secondary to physician judgment. In recent years, however, the physician-patient relationship has evolved toward one privileging patient-centered care and shared decision-making based on a patient’s unique values, beliefs, and preferences.9,10
Concomitantly, the public’s view of doctoring has transitioned from “unquestioning acceptance of physician authority to a more ‘consumerist’ view accompanied by a questioning and bargaining approach to medicine, physicians and the medical encounter,” according to a 2001 study published in the Journal of Health and Social Behavior.11 In this context, many patients, attorneys, bioethicists, and patient advocates see patient recording of medical encounters as a legitimate check on the health care system, ensuring transparency and honesty and empowering patients to become more active participants in their medical care.2
Policy responses
Although recognition of patient recording of medical encounters has been growing, there have been few direct policy responses to date. One notable example was an effort by Wisconsin legislators in 2015 to mandate that any place where surgery is performed (including hospitals, ambulatory surgical centers, and other sites) offer patients the option to have their procedure videotaped and audiotaped.12 The proposed legislation was written broadly enough to include locations where gastroenterologists perform routine endoscopic procedures under sedation. Recordings would have been treated as part of the patient’s health care record and been admissible as evidence in subsequent legal proceedings relating to the medical care provided. Although this bill ultimately failed to pass pursuant to a Joint Resolution in the Wisconsin Senate in April 2016, it is a poignant example of the possible policy actions that may govern this area in the future.
In 2012, the National Institute for Health and Clinical Excellence, England, issued a guidance document focused on improving the patient care experience, which recommends that clinicians routinely ask patients if they would like to take notes and/or record the clinical encounter.13 Although not explicitly referencing covert recording, this guidance effectively aims to promote increased transparency by openly encouraging recording as a component of optimal medical practice. Although the American Medical Association Code of Ethics offers guidance regarding physicians recording patient encounters, it does not comment on patient-initiated recordings.14
Risk management strategies for gastroenterology providers
So, how can gastroenterologists and other providers protect themselves in a world of covert recording, while also preserving their relationships with patients and optimizing medical care? First, despite their harried days and varied responsibilities, gastroenterologists must recognize the possibility of covert recording and seek to maintain professionalism in all clinical environments, whether in an examination room or in an endoscopy suite with a sedated patient. Physicians set the tone for the entire team and also have an obligation to intervene if other members of the medical team are not adhering to professional standards. Although physicians and other medical providers often use cynical and derogatory humor as a coping mechanism given the heavy workload and amplified stressors of the clinical environment, it is important to be mindful of how such comments are perceived by patient bystanders.15,16 Although achieving a robust therapeutic alliance with a patient can take months, this trust can be easily broken by a single flippant remark by the physician.
Second, rather than assuming a defensive posture driven by fear of medical liability, it is vital for gastroenterologists to directly confront situations in which covert recording is suspected while also preserving the physician-patient relationship. In fact, by openly encouraging patient recording as a matter of routine practice, gastroenterologists can promote an environment of trust and transparency and bolster the therapeutic alliance between patient and provider.15 This approach also encourages providers to hone their communication skills and ensure they are communicating essential medical information clearly and succinctly and conveying medical nuance where appropriate. For example, in a clinic setting, a patient with inflammatory bowel disease who records might better remember or understand the risks and benefits of various treatment strategies and the common side effects of medications such as azathioprine and biologics. Patients recording medical encounters in the endoscopy suite might better recall postprocedure instructions, including recommended follow-up intervals and risks of postendoscopy complications. In this era of shared decision-making and patient-centered care, optimizing both physician delivery and patient understanding and recall of essential medical information is of critical importance.
Finally, although adoption of the above practices would serve the dual goals of enhancing patient-provider communication and mitigating legal risk, certain system interventions may further minimize the risk of covert recording. For instance, endoscopy units can store patients’ personal effects, including electronic devices, in a locker outside the endoscopy room rather than on the gurney. Retrieving patient belongings before postprocedure instructions are delivered would protect the patient’s ability to record this advice for future recall.
Conclusions
Recording by patients of clinical encounters, whether covert or overt, has become increasingly common as a result of the digital revolution. These recordings most often represent an attempt by the patient to gain more information relevant to their medical care. Rather than being threatened by this new reality, gastroenterologists should consider embracing this practice as an opportunity to enhance effective communication with patients, encourage shared decision making, and deliver truly patient-centered care.
Acknowledgments
This article is intended as general commentary and should not be interpreted as legal advice applicable to individual circumstances. Do not act or rely on information contained in this article without first seeking the advice of a personal attorney.
References
1. Washington Post. (2015 June 24). Audio: Anesthesiologist trashes sedated patient. Available at: https://youtu.be/Kar52idHgho. Accessed May 15, 2016.
2. Tsulukidze, M., Grande, S.W., Thompson, R., et al. Patients covertly recording clinical encounters: threat or opportunity? A qualitative analysis of online texts. PLoS One. 2015;10:e0125824.
3. Rodriguez, M., Morrow, J., Selfi, A. Ethical implications of patients and families secretly recording conversations with physicians. JAMA. 2015;313(16):1615-6.
4. Elwyn, G., Barr, P.J., Grande, S.W. Patients recording clinical encounters: a path to empowerment? Assessment by mixed methods. BMJ Open. 2015;5(8):e008566.
5. 18 U.S.C. §2511(2)(d).
6. VA Code §19.2-62.
7. Cal. Penal Code §632.
8. Fla. Stat. Ann. §934.03(3)(d).
9. Truog, R.D. Patients and doctors: the evolution of a relationship. N Engl J Med. 2012;366:581-5.
10. Barry, M.J., Edgman-Levitan, S. Shared decision making: the pinnacle of patient-centered care. N Engl J Med. 2012;366:780-1.
11. Pescosolido, B.A., Tuch, S.A., Martin, J.K. The profession of medicine and the public: examining Americans’ changing confidence in physician authority from the beginning of the ‘health care crisis’ to the era of health care reform. J Health Social Behavior. 2001;42(1):1-16.
12. Wisconsin Assembly Bill 255. (2015). Available at: https://docs.legis.wisconsin.gov/2015/proposals/ab255. Accessed June 29, 2016.
13. National Institute for Health and Clinical Excellence. (2012 Feb). Patient experience in adult NHS services: improving the experience of care for people using adult NHS service. Available at: https://www.nice.org.uk/guidance/cg138/chapter/1-guidance. Accessed June 29, 2016.
14. American Medical Association Code of Medical Ethics, Opinion 5.045 - Filming Patients in Health Care Settings. Updated June 2006. Available at: http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion5045.page? Accessed June 29, 2016.
15. Aultman, J.M. When humor in the hospital is no laughing matter. J Clin Ethics. 2009;20:227-35.
15. Sobel, R.K. Does laughter make good medicine? N Engl J Med. 2006;354:1114-5.
Dr. Adams is a clinical lecturer in the division of gastroenterology, University of Michigan, Ann Arbor, an investigator with the VA Center for Clinical Management Research, a staff physician in the VA Ann Arbor Healthcare System, and a member of the Institute for Healthcare Policy and Innovation, Ann Arbor. She has no conflicts of interest.
Last year, while sedated for colonoscopy, a patient covertly recorded conversations between endoscopy staff and providers. Comments about the patient were egregious and resulted in loss of employment for those involved and a large financial settlement. The reality of today’s world is that we all are subject to constant (real or potential) surveillance. Nothing is private and nothing recorded is temporary, yet physicians value private conversations with our patients. When a patient records a visit, either covertly or overtly, most physicians pause and have some emotional reaction (either positive or negative). Some welcome the ability to communicate accurately to a wider audience, while others believe the act of recording violates an interpersonal bond. In this month’s issue, Dr. Adams discusses the legal and ethical ramifications when a patient records our clinical interactions. She offers an excellent analysis and practical risk management strategies. Personally, I follow my wife’s dictum to act as if I am always on camera.
John I. Allen, MD, MBA, AGAF
Editor in Chief
Patients and physicians were collectively horrified last year when news broke of a Virginia man who recorded conversations between his gastroenterologist, his anesthesiologist, and other endoscopy unit staff, including a number of disparaging remarks about the patient, while sedated for his colonoscopy. Among other objectionable comments, providers mocked the patient for being demanding in the preprocedure area and for the amount of sedation he required, made comments implying that he had syphilis or tuberculosis, and discussed avoiding the patient following the procedure via an urgent “fake page.”1 The patient sued, resulting in a $500,000 judgment against the anesthesiologist for defamation and malpractice, including punitive damages. Although this case clearly represents an extreme example of unprofessional behavior, it also raises thought-provoking questions regarding the evolving relationship between patients and their physicians, as well as the legal and ethical implications of covert recording that deserve further discussion.
This article reviews the current state of knowledge regarding the frequency of and motivation for covert patient recording of medical encounters, and the legal and ethical principles informing this area. It concludes by proposing several strategies gastroenterologists can use to mitigate risk of liability while also preserving the patient-physician relationship and upholding professional autonomy.
Weighing the benefits and harms of patient electronic recording
Patient recording of medical encounters, whether covert or overt, presents both benefits and risks of harm. Theoretically, recording medical encounters could assist patients in remembering and/or better understanding recommendations provided by their physicians. It may also secondarily improve patient compliance and overall engagement in medical care and help patients accurately communicate recommendations to family members and other caregivers who are not immediately available during the clinical encounter. Patients may also view these recordings as a mechanism for empowerment, allowing them to shift the power dynamic between patient and provider.2,3 However, there is also the potential for recorded comments to be taken out of context or misinterpreted, leading to confusion on the part of the patient or family. Overt recording of medical encounters also may alter physician decision-making, leading to more aggressive testing and expense for the patient and the healthcare system. Even worse, covert recording of medical encounters (if discovered) may irreparably harm the physician-patient relationship by introducing distrust and causing the physician to take a more defensive posture in subsequent dealings with a given patient.
Recent research has shed new light on the potential frequency of patient covert recording of medical encounters, suggesting that it is alarmingly common. In a mixed-methods study of 130 patients in the United Kingdom who were recruited via radio and social media, 15% of respondents indicated that they had secretly recorded a clinical encounter, and an additional 11% personally knew someone who had covertly recorded.4 Those who reported having covertly recorded were significantly more likely to be less educated and male than those who had not. An additional 35% of respondents indicated that they would consider covertly recording a clinical encounter in the future. Although the generalizability of these results may be challenged based on the potential for sampling bias, the results suggest a shifting paradigm in the way in which patients view the physician-patient relationship and a fundamental breakdown in communication and erosion of trust.
The underlying motivations for patient recording of medical encounters are complex and multifaceted. These recordings seem to be a relatively new phenomenon and one that elicits strong reactions, positive and negative, on the part of patients, physicians, and society.2 Qualitative studies reveal that, whether covertly or overtly recording, most patients are driven by a common desire to replay, relisten, and/or share the recording with family, friends, and other caregivers.4 Indeed, the patient involved in the previously mentioned litigation purportedly intended to record the postcolonoscopy discharge instructions from his gastroenterologist, only to later discover much more. Patients who record covertly report being motivated by a fear of being denied permission to record or by prior experiences of poor quality care and the prospect of gathering verifiable evidence to support their experience. In contrast, patients who ask permission to record seem to be motivated primarily by a desire to preserve or enhance the physician-patient relationship.4 These insights are valuable in that they allow clinicians to view medical encounters from the perspective of patients, understand the power-dynamics at play, and ultimately, use this information to enlighten future care.
Legal guidance: “One-party” versus “all-party” consent
Although the prospect of covert patient recording may be unsettling to physicians, is it illegal? Because of a paucity of legal precedent in this area, the legal landscape is rather murky. Through the provisions of the Electronic Communications Privacy Act, federal law prohibits the interception and disclosure of wire, oral, or electronic communications without specific consent of at least one party to the conversation.5 This so-called “one-party” consent standard affords a baseline level of legal protection. A handful of states offer additional protection under state law by requiring all parties to the conversation to consent to the recording (so-called “all-party” consent). Virginia, where the audio recording of the previously mentioned colonoscopy took place, is a “one-party” consent state.6 In contrast, states such as California and Florida have adopted an “all-party” consent rule.7,8
However, uncertainty remains. For instance, if medical providers have a conversation in the same room as a sedated patient during a medical procedure on that patient, is the patient a “party” to the conversation? Furthermore, can such a conversation be considered private when held in front of a patient during a medical procedure? Is the patient in such a scenario “eavesdropping”? Given a lack of legal precedent in the form of case law and given the unique features of each clinical scenario, this is likely to remain an area of significant legal ambiguity. Although the possibility of covert patient recording may be unnerving for providers, the reality is that, in most cases, it is likely legally permissible.
Ethical principles: Navigating an evolving physician-patient relationship
The relationship between physician and patient, a core aspect of medical ethics, has evolved markedly over time. This relationship was historically paternalistic: The patient was seen to be dependent on the physician’s professional authority in determining the appropriateness of care, and patient’s preferences were seen as secondary to physician judgment. In recent years, however, the physician-patient relationship has evolved toward one privileging patient-centered care and shared decision-making based on a patient’s unique values, beliefs, and preferences.9,10
Concomitantly, the public’s view of doctoring has transitioned from “unquestioning acceptance of physician authority to a more ‘consumerist’ view accompanied by a questioning and bargaining approach to medicine, physicians and the medical encounter,” according to a 2001 study published in the Journal of Health and Social Behavior.11 In this context, many patients, attorneys, bioethicists, and patient advocates see patient recording of medical encounters as a legitimate check on the health care system, ensuring transparency and honesty and empowering patients to become more active participants in their medical care.2
Policy responses
Although recognition of patient recording of medical encounters has been growing, there have been few direct policy responses to date. One notable example was an effort by Wisconsin legislators in 2015 to mandate that any place where surgery is performed (including hospitals, ambulatory surgical centers, and other sites) offer patients the option to have their procedure videotaped and audiotaped.12 The proposed legislation was written broadly enough to include locations where gastroenterologists perform routine endoscopic procedures under sedation. Recordings would have been treated as part of the patient’s health care record and been admissible as evidence in subsequent legal proceedings relating to the medical care provided. Although this bill ultimately failed to pass pursuant to a Joint Resolution in the Wisconsin Senate in April 2016, it is a poignant example of the possible policy actions that may govern this area in the future.
In 2012, the National Institute for Health and Clinical Excellence, England, issued a guidance document focused on improving the patient care experience, which recommends that clinicians routinely ask patients if they would like to take notes and/or record the clinical encounter.13 Although not explicitly referencing covert recording, this guidance effectively aims to promote increased transparency by openly encouraging recording as a component of optimal medical practice. Although the American Medical Association Code of Ethics offers guidance regarding physicians recording patient encounters, it does not comment on patient-initiated recordings.14
Risk management strategies for gastroenterology providers
So, how can gastroenterologists and other providers protect themselves in a world of covert recording, while also preserving their relationships with patients and optimizing medical care? First, despite their harried days and varied responsibilities, gastroenterologists must recognize the possibility of covert recording and seek to maintain professionalism in all clinical environments, whether in an examination room or in an endoscopy suite with a sedated patient. Physicians set the tone for the entire team and also have an obligation to intervene if other members of the medical team are not adhering to professional standards. Although physicians and other medical providers often use cynical and derogatory humor as a coping mechanism given the heavy workload and amplified stressors of the clinical environment, it is important to be mindful of how such comments are perceived by patient bystanders.15,16 Although achieving a robust therapeutic alliance with a patient can take months, this trust can be easily broken by a single flippant remark by the physician.
Second, rather than assuming a defensive posture driven by fear of medical liability, it is vital for gastroenterologists to directly confront situations in which covert recording is suspected while also preserving the physician-patient relationship. In fact, by openly encouraging patient recording as a matter of routine practice, gastroenterologists can promote an environment of trust and transparency and bolster the therapeutic alliance between patient and provider.15 This approach also encourages providers to hone their communication skills and ensure they are communicating essential medical information clearly and succinctly and conveying medical nuance where appropriate. For example, in a clinic setting, a patient with inflammatory bowel disease who records might better remember or understand the risks and benefits of various treatment strategies and the common side effects of medications such as azathioprine and biologics. Patients recording medical encounters in the endoscopy suite might better recall postprocedure instructions, including recommended follow-up intervals and risks of postendoscopy complications. In this era of shared decision-making and patient-centered care, optimizing both physician delivery and patient understanding and recall of essential medical information is of critical importance.
Finally, although adoption of the above practices would serve the dual goals of enhancing patient-provider communication and mitigating legal risk, certain system interventions may further minimize the risk of covert recording. For instance, endoscopy units can store patients’ personal effects, including electronic devices, in a locker outside the endoscopy room rather than on the gurney. Retrieving patient belongings before postprocedure instructions are delivered would protect the patient’s ability to record this advice for future recall.
Conclusions
Recording by patients of clinical encounters, whether covert or overt, has become increasingly common as a result of the digital revolution. These recordings most often represent an attempt by the patient to gain more information relevant to their medical care. Rather than being threatened by this new reality, gastroenterologists should consider embracing this practice as an opportunity to enhance effective communication with patients, encourage shared decision making, and deliver truly patient-centered care.
Acknowledgments
This article is intended as general commentary and should not be interpreted as legal advice applicable to individual circumstances. Do not act or rely on information contained in this article without first seeking the advice of a personal attorney.
References
1. Washington Post. (2015 June 24). Audio: Anesthesiologist trashes sedated patient. Available at: https://youtu.be/Kar52idHgho. Accessed May 15, 2016.
2. Tsulukidze, M., Grande, S.W., Thompson, R., et al. Patients covertly recording clinical encounters: threat or opportunity? A qualitative analysis of online texts. PLoS One. 2015;10:e0125824.
3. Rodriguez, M., Morrow, J., Selfi, A. Ethical implications of patients and families secretly recording conversations with physicians. JAMA. 2015;313(16):1615-6.
4. Elwyn, G., Barr, P.J., Grande, S.W. Patients recording clinical encounters: a path to empowerment? Assessment by mixed methods. BMJ Open. 2015;5(8):e008566.
5. 18 U.S.C. §2511(2)(d).
6. VA Code §19.2-62.
7. Cal. Penal Code §632.
8. Fla. Stat. Ann. §934.03(3)(d).
9. Truog, R.D. Patients and doctors: the evolution of a relationship. N Engl J Med. 2012;366:581-5.
10. Barry, M.J., Edgman-Levitan, S. Shared decision making: the pinnacle of patient-centered care. N Engl J Med. 2012;366:780-1.
11. Pescosolido, B.A., Tuch, S.A., Martin, J.K. The profession of medicine and the public: examining Americans’ changing confidence in physician authority from the beginning of the ‘health care crisis’ to the era of health care reform. J Health Social Behavior. 2001;42(1):1-16.
12. Wisconsin Assembly Bill 255. (2015). Available at: https://docs.legis.wisconsin.gov/2015/proposals/ab255. Accessed June 29, 2016.
13. National Institute for Health and Clinical Excellence. (2012 Feb). Patient experience in adult NHS services: improving the experience of care for people using adult NHS service. Available at: https://www.nice.org.uk/guidance/cg138/chapter/1-guidance. Accessed June 29, 2016.
14. American Medical Association Code of Medical Ethics, Opinion 5.045 - Filming Patients in Health Care Settings. Updated June 2006. Available at: http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion5045.page? Accessed June 29, 2016.
15. Aultman, J.M. When humor in the hospital is no laughing matter. J Clin Ethics. 2009;20:227-35.
15. Sobel, R.K. Does laughter make good medicine? N Engl J Med. 2006;354:1114-5.
Dr. Adams is a clinical lecturer in the division of gastroenterology, University of Michigan, Ann Arbor, an investigator with the VA Center for Clinical Management Research, a staff physician in the VA Ann Arbor Healthcare System, and a member of the Institute for Healthcare Policy and Innovation, Ann Arbor. She has no conflicts of interest.
Long-acting growth hormone moves forward based on positive phase II data
ORLANDO – An extended-release human growth hormone formulation proved safe and effective in both children and adults, offering the prospect of a less-rigorous dosing schedule and potentially better patient compliance with treatment.
The two phase II studies examined somavaratan, which is being developed by Versartis of Menlo Park, Calif. Kevin Yuen, MD, an endocrinologist at the Swedish Medical Center, Seattle, and Wayne V. Moore, MD, a pediatric endocrinologist at Children’s Mercy Hospital, Kansas City, Mo., presented the data at the annual meeting of the Endocrine Society.
“Despite the fact that human growth hormone is a proven treatment for growth hormone deficiency, daily use of our current formulations can be a factor that affects compliance,” said Dr. Yuen. He cited a 2008 study of 158 men taking growth hormone, which found that only one-third were highly compliant (Endocr Pract. 2008 Mar;14[2]:143-54). “And even among this group, there were 21 doses missed over just a 3-month period.”
The group of 55 international experts described several strategies for creating long-acting growth hormone formulations, including depot formulations, pegylation, prodrugs, noncovalent albumin binding growth hormone compounds, and growth hormone fusion proteins. These preparations are currently in various stages of development, with some already approved in Europe and Asia.
Somavaratan (VRS-317) is a fusion protein produced in Escherichia coli. The active portion is recombinant human growth hormone, which is bound to long chains of hydrophilic amino acids. This reduces renal filtration, Dr. Yuen said. The growth hormone loses some potency in this construct, but its delayed clearance, with a half-life 30-60 times longer than recombinant human growth hormone (rhGH) allows it to exert a prolonged effect in target tissue.
Of the two phase II studies of the molecule, one was conducted in 64 prepubertal children who were naive to any growth hormone treatment, and one in 36 adults with adult-onset growth hormone deficiency. The company also has made these presentations available online.
The pediatric study reported 3-year data on the cohort, which began treatment of children at a mean age of 7 years. At baseline, the children were about 2.6 standard deviations (SDs) below their expected height, and their mean IGF-1 levels, about 1.7 SDs below. They showed a mean maximum stimulated growth hormone level of 5.4 ng/mL. Although they were a mean of 7.8 years chronologically at the study’s outset, their mean bone age was 6.4 years.
The first 12 months of the study consisted of dose-ranging trials, with initial doses of 5 mg/kg each month, then 2.5 mg/kg twice a month, and then 1.15 mg/kg weekly. During the last 2 years of the study, all children were taking 3.5 mg/kg, once a month.
Within the first year, all children taking the 3.5-mg/kg dose had achieved normal IGF-1 levels, which were consistent with levels achieved in the ANSWER registry dataset of somatropin (rDNA origin) injection (Norditropin) recombinant human growth hormone (Clin Epidemiol. 2013;5:119-27).
Height velocity improved, as did height standard deviation. By year 3, patients were a mean of 1.25 SDs below expected height – a significant improvement over baseline. These findings were almost superimposable with those in the ANSWER registry. Bone age and chronological age came into alignment within the first year and that association was maintained throughout the study – again, in almost superimposable curves with the registry data.
Somavaratan exerted no untoward metabolic effects. There were no adverse changes in body mass index. At baseline, the mean hemoglobin A1c was 5.2%; this was unchanged at 3 years. No patient developed diabetes. The most commonly reported adverse event was injection site pain (48%). Injection site erythema was reported in 5% of patients, but no injection site nodules occurred.
Other adverse events were headache, extremity pain, arthralgia, and musculoskeletal pain. Although the numbers were small overall, reports did increase after all the children were switched to the 3.5-mg/kg dose. However, they occurred in 5% or less of the patient group. There were no withdrawals due to adverse events.
The second trial was a dose-ranging study conducted in 49 adults aged 23-70 years. They all had been diagnosed with adult-onset growth hormone deficiency, but had stable pituitary function. If they were on any growth hormone therapy, they underwent a 14-day washout period.
The subjects were divided and dosed by age and gender. All subjects received one injection per month for 5 months.
Cohort A comprised 21 men and women aged 35 years or older, who took 0.6 mg/kg per month. Cohort B comprised six men and women younger than 35 years, who took 0.8 mg/kg per month. Cohort C comprised eight women taking oral estrogen contraceptives. These women received 1 mg/kg per month.
The cohorts were similar in body mass index and weight, but they did differ significantly in baseline IGF-1 levels. In cohort A, the level was 0.52 SDs below normal. In cohort B, it was 2.89 SDs below normal, and in cohort C, it was 2.29 SDs below.
Overall, somavaratan induced a rapid and dramatic increase in IGF-1 that tailed off over 30 days. By day 8 after injection, IGF-1 had risen from a mean baseline of -1 SDs to more than 2 SDs above. By day 22, it had returned to baseline levels. The response to the fifth injection was identical to that of the first, Dr. Yuen said.
Response varied somewhat by cohort, with the younger, mixed-gender group responding the most dramatically, with a mean increase of about 4 SDs from baseline. This put the group above the maximum response target of 1.5 SDs.
The older, mixed-gender cohort experienced about a 3 SDs increase – also above the target level. The women taking estrogen experienced the flattest response, gaining about 2 SDs. However, the response curve was nearly identical, with a rapid, sharp increase in IGF-1 within the first week, followed by a gradual decline to baseline by 22 days.
The adverse event profile was not quite as benign as it was in the pediatric study. Virtually all patients experienced at least one adverse event. A third were mild and 58% moderate. The rest were serious, with one severe and one life-threatening event. Dr. Yuen did not discuss adverse events; these were, however, included in supplementary slides available on the Versartis Inc. slide set.
The finding of a predictable, 3-week tailing-off of efficacy, combined with the fact that patients responded so dramatically, exceeding the maximum target of a 1.5 SDs increase in IGF-1, has prompted a new dosing protocol for the somavaratan open-label extension study, which includes all the phase II completers, plus an additional 40 adult patients.
Doses will be titrated to each subject’s individual IGF-1 responses, based on the IGF-I level 7 days post dose until a maintenance dose is reached. Subjects receiving somavaratan in a previous somavaratan study will have their dose decreased by half (minimum dose of 20 mg, or 40 mg for women on estrogen).
Dr. Yuen is a member of the Versartis advisory board. Dr. Moore has received research support from the company.
[email protected]
On Twitter @Alz_Gal
ORLANDO – An extended-release human growth hormone formulation proved safe and effective in both children and adults, offering the prospect of a less-rigorous dosing schedule and potentially better patient compliance with treatment.
The two phase II studies examined somavaratan, which is being developed by Versartis of Menlo Park, Calif. Kevin Yuen, MD, an endocrinologist at the Swedish Medical Center, Seattle, and Wayne V. Moore, MD, a pediatric endocrinologist at Children’s Mercy Hospital, Kansas City, Mo., presented the data at the annual meeting of the Endocrine Society.
“Despite the fact that human growth hormone is a proven treatment for growth hormone deficiency, daily use of our current formulations can be a factor that affects compliance,” said Dr. Yuen. He cited a 2008 study of 158 men taking growth hormone, which found that only one-third were highly compliant (Endocr Pract. 2008 Mar;14[2]:143-54). “And even among this group, there were 21 doses missed over just a 3-month period.”
The group of 55 international experts described several strategies for creating long-acting growth hormone formulations, including depot formulations, pegylation, prodrugs, noncovalent albumin binding growth hormone compounds, and growth hormone fusion proteins. These preparations are currently in various stages of development, with some already approved in Europe and Asia.
Somavaratan (VRS-317) is a fusion protein produced in Escherichia coli. The active portion is recombinant human growth hormone, which is bound to long chains of hydrophilic amino acids. This reduces renal filtration, Dr. Yuen said. The growth hormone loses some potency in this construct, but its delayed clearance, with a half-life 30-60 times longer than recombinant human growth hormone (rhGH) allows it to exert a prolonged effect in target tissue.
Of the two phase II studies of the molecule, one was conducted in 64 prepubertal children who were naive to any growth hormone treatment, and one in 36 adults with adult-onset growth hormone deficiency. The company also has made these presentations available online.
The pediatric study reported 3-year data on the cohort, which began treatment of children at a mean age of 7 years. At baseline, the children were about 2.6 standard deviations (SDs) below their expected height, and their mean IGF-1 levels, about 1.7 SDs below. They showed a mean maximum stimulated growth hormone level of 5.4 ng/mL. Although they were a mean of 7.8 years chronologically at the study’s outset, their mean bone age was 6.4 years.
The first 12 months of the study consisted of dose-ranging trials, with initial doses of 5 mg/kg each month, then 2.5 mg/kg twice a month, and then 1.15 mg/kg weekly. During the last 2 years of the study, all children were taking 3.5 mg/kg, once a month.
Within the first year, all children taking the 3.5-mg/kg dose had achieved normal IGF-1 levels, which were consistent with levels achieved in the ANSWER registry dataset of somatropin (rDNA origin) injection (Norditropin) recombinant human growth hormone (Clin Epidemiol. 2013;5:119-27).
Height velocity improved, as did height standard deviation. By year 3, patients were a mean of 1.25 SDs below expected height – a significant improvement over baseline. These findings were almost superimposable with those in the ANSWER registry. Bone age and chronological age came into alignment within the first year and that association was maintained throughout the study – again, in almost superimposable curves with the registry data.
Somavaratan exerted no untoward metabolic effects. There were no adverse changes in body mass index. At baseline, the mean hemoglobin A1c was 5.2%; this was unchanged at 3 years. No patient developed diabetes. The most commonly reported adverse event was injection site pain (48%). Injection site erythema was reported in 5% of patients, but no injection site nodules occurred.
Other adverse events were headache, extremity pain, arthralgia, and musculoskeletal pain. Although the numbers were small overall, reports did increase after all the children were switched to the 3.5-mg/kg dose. However, they occurred in 5% or less of the patient group. There were no withdrawals due to adverse events.
The second trial was a dose-ranging study conducted in 49 adults aged 23-70 years. They all had been diagnosed with adult-onset growth hormone deficiency, but had stable pituitary function. If they were on any growth hormone therapy, they underwent a 14-day washout period.
The subjects were divided and dosed by age and gender. All subjects received one injection per month for 5 months.
Cohort A comprised 21 men and women aged 35 years or older, who took 0.6 mg/kg per month. Cohort B comprised six men and women younger than 35 years, who took 0.8 mg/kg per month. Cohort C comprised eight women taking oral estrogen contraceptives. These women received 1 mg/kg per month.
The cohorts were similar in body mass index and weight, but they did differ significantly in baseline IGF-1 levels. In cohort A, the level was 0.52 SDs below normal. In cohort B, it was 2.89 SDs below normal, and in cohort C, it was 2.29 SDs below.
Overall, somavaratan induced a rapid and dramatic increase in IGF-1 that tailed off over 30 days. By day 8 after injection, IGF-1 had risen from a mean baseline of -1 SDs to more than 2 SDs above. By day 22, it had returned to baseline levels. The response to the fifth injection was identical to that of the first, Dr. Yuen said.
Response varied somewhat by cohort, with the younger, mixed-gender group responding the most dramatically, with a mean increase of about 4 SDs from baseline. This put the group above the maximum response target of 1.5 SDs.
The older, mixed-gender cohort experienced about a 3 SDs increase – also above the target level. The women taking estrogen experienced the flattest response, gaining about 2 SDs. However, the response curve was nearly identical, with a rapid, sharp increase in IGF-1 within the first week, followed by a gradual decline to baseline by 22 days.
The adverse event profile was not quite as benign as it was in the pediatric study. Virtually all patients experienced at least one adverse event. A third were mild and 58% moderate. The rest were serious, with one severe and one life-threatening event. Dr. Yuen did not discuss adverse events; these were, however, included in supplementary slides available on the Versartis Inc. slide set.
The finding of a predictable, 3-week tailing-off of efficacy, combined with the fact that patients responded so dramatically, exceeding the maximum target of a 1.5 SDs increase in IGF-1, has prompted a new dosing protocol for the somavaratan open-label extension study, which includes all the phase II completers, plus an additional 40 adult patients.
Doses will be titrated to each subject’s individual IGF-1 responses, based on the IGF-I level 7 days post dose until a maintenance dose is reached. Subjects receiving somavaratan in a previous somavaratan study will have their dose decreased by half (minimum dose of 20 mg, or 40 mg for women on estrogen).
Dr. Yuen is a member of the Versartis advisory board. Dr. Moore has received research support from the company.
[email protected]
On Twitter @Alz_Gal
ORLANDO – An extended-release human growth hormone formulation proved safe and effective in both children and adults, offering the prospect of a less-rigorous dosing schedule and potentially better patient compliance with treatment.
The two phase II studies examined somavaratan, which is being developed by Versartis of Menlo Park, Calif. Kevin Yuen, MD, an endocrinologist at the Swedish Medical Center, Seattle, and Wayne V. Moore, MD, a pediatric endocrinologist at Children’s Mercy Hospital, Kansas City, Mo., presented the data at the annual meeting of the Endocrine Society.
“Despite the fact that human growth hormone is a proven treatment for growth hormone deficiency, daily use of our current formulations can be a factor that affects compliance,” said Dr. Yuen. He cited a 2008 study of 158 men taking growth hormone, which found that only one-third were highly compliant (Endocr Pract. 2008 Mar;14[2]:143-54). “And even among this group, there were 21 doses missed over just a 3-month period.”
The group of 55 international experts described several strategies for creating long-acting growth hormone formulations, including depot formulations, pegylation, prodrugs, noncovalent albumin binding growth hormone compounds, and growth hormone fusion proteins. These preparations are currently in various stages of development, with some already approved in Europe and Asia.
Somavaratan (VRS-317) is a fusion protein produced in Escherichia coli. The active portion is recombinant human growth hormone, which is bound to long chains of hydrophilic amino acids. This reduces renal filtration, Dr. Yuen said. The growth hormone loses some potency in this construct, but its delayed clearance, with a half-life 30-60 times longer than recombinant human growth hormone (rhGH) allows it to exert a prolonged effect in target tissue.
Of the two phase II studies of the molecule, one was conducted in 64 prepubertal children who were naive to any growth hormone treatment, and one in 36 adults with adult-onset growth hormone deficiency. The company also has made these presentations available online.
The pediatric study reported 3-year data on the cohort, which began treatment of children at a mean age of 7 years. At baseline, the children were about 2.6 standard deviations (SDs) below their expected height, and their mean IGF-1 levels, about 1.7 SDs below. They showed a mean maximum stimulated growth hormone level of 5.4 ng/mL. Although they were a mean of 7.8 years chronologically at the study’s outset, their mean bone age was 6.4 years.
The first 12 months of the study consisted of dose-ranging trials, with initial doses of 5 mg/kg each month, then 2.5 mg/kg twice a month, and then 1.15 mg/kg weekly. During the last 2 years of the study, all children were taking 3.5 mg/kg, once a month.
Within the first year, all children taking the 3.5-mg/kg dose had achieved normal IGF-1 levels, which were consistent with levels achieved in the ANSWER registry dataset of somatropin (rDNA origin) injection (Norditropin) recombinant human growth hormone (Clin Epidemiol. 2013;5:119-27).
Height velocity improved, as did height standard deviation. By year 3, patients were a mean of 1.25 SDs below expected height – a significant improvement over baseline. These findings were almost superimposable with those in the ANSWER registry. Bone age and chronological age came into alignment within the first year and that association was maintained throughout the study – again, in almost superimposable curves with the registry data.
Somavaratan exerted no untoward metabolic effects. There were no adverse changes in body mass index. At baseline, the mean hemoglobin A1c was 5.2%; this was unchanged at 3 years. No patient developed diabetes. The most commonly reported adverse event was injection site pain (48%). Injection site erythema was reported in 5% of patients, but no injection site nodules occurred.
Other adverse events were headache, extremity pain, arthralgia, and musculoskeletal pain. Although the numbers were small overall, reports did increase after all the children were switched to the 3.5-mg/kg dose. However, they occurred in 5% or less of the patient group. There were no withdrawals due to adverse events.
The second trial was a dose-ranging study conducted in 49 adults aged 23-70 years. They all had been diagnosed with adult-onset growth hormone deficiency, but had stable pituitary function. If they were on any growth hormone therapy, they underwent a 14-day washout period.
The subjects were divided and dosed by age and gender. All subjects received one injection per month for 5 months.
Cohort A comprised 21 men and women aged 35 years or older, who took 0.6 mg/kg per month. Cohort B comprised six men and women younger than 35 years, who took 0.8 mg/kg per month. Cohort C comprised eight women taking oral estrogen contraceptives. These women received 1 mg/kg per month.
The cohorts were similar in body mass index and weight, but they did differ significantly in baseline IGF-1 levels. In cohort A, the level was 0.52 SDs below normal. In cohort B, it was 2.89 SDs below normal, and in cohort C, it was 2.29 SDs below.
Overall, somavaratan induced a rapid and dramatic increase in IGF-1 that tailed off over 30 days. By day 8 after injection, IGF-1 had risen from a mean baseline of -1 SDs to more than 2 SDs above. By day 22, it had returned to baseline levels. The response to the fifth injection was identical to that of the first, Dr. Yuen said.
Response varied somewhat by cohort, with the younger, mixed-gender group responding the most dramatically, with a mean increase of about 4 SDs from baseline. This put the group above the maximum response target of 1.5 SDs.
The older, mixed-gender cohort experienced about a 3 SDs increase – also above the target level. The women taking estrogen experienced the flattest response, gaining about 2 SDs. However, the response curve was nearly identical, with a rapid, sharp increase in IGF-1 within the first week, followed by a gradual decline to baseline by 22 days.
The adverse event profile was not quite as benign as it was in the pediatric study. Virtually all patients experienced at least one adverse event. A third were mild and 58% moderate. The rest were serious, with one severe and one life-threatening event. Dr. Yuen did not discuss adverse events; these were, however, included in supplementary slides available on the Versartis Inc. slide set.
The finding of a predictable, 3-week tailing-off of efficacy, combined with the fact that patients responded so dramatically, exceeding the maximum target of a 1.5 SDs increase in IGF-1, has prompted a new dosing protocol for the somavaratan open-label extension study, which includes all the phase II completers, plus an additional 40 adult patients.
Doses will be titrated to each subject’s individual IGF-1 responses, based on the IGF-I level 7 days post dose until a maintenance dose is reached. Subjects receiving somavaratan in a previous somavaratan study will have their dose decreased by half (minimum dose of 20 mg, or 40 mg for women on estrogen).
Dr. Yuen is a member of the Versartis advisory board. Dr. Moore has received research support from the company.
[email protected]
On Twitter @Alz_Gal
AT ENDO 2017
Key clinical point:
Major finding: In the 64-patient pediatric study, the molecule raised growth velocity and IGF-1 levels by several standard deviations. In the 48-patient adult study, it raised IGF-1 levels by up to 4 standard deviations.
Data source: A 64-patient pediatric dose-ranging study and a 48-patient adult study.
Disclosures: Versartis sponsored the studies. Dr. Yuen is on the company’s advisory board. Dr. Moore has received research support from the company.