DURBAN, SOUTH AFRICA – The all-oral, interferon-free, triple- or double-direct-acting antiviral regimens informally known as 3D and 2D proved effective and safe for treatment of chronic hepatitis C due to HCV genotypes 1 and 4 in HIV-coinfected patients taking various antiretroviral combinations in the phase III, multicenter TURQUOISE-1, Part 2 trial, Jürgen K. Rockstroh, MD, reported at the 21st International AIDS Conference.

TURQUOISE-1, Part 2 included 228 patients coinfected with HCV/HIV. Of the 154 with HCV genotype 1a and 44 with genotype 1b, 21 of whom had compensated cirrhosis, 98% of subjects achieved a sustained virologic response (SVR) 12 weeks after conclusion of the 3D regimen, or SVR12, in a modified intent-to-treat analysis. A handful of patients with missing data, or those who stopped treatment for reasons other than virologic failure, were excluded from the analysis.

Bruce Jancin/Frontline Medical News

In the 28 patients coinfected with HCV genotype 4, none of whom had cirrhosis, the modified SVR12 rate was 100%.

The so-called 3D regimen consists of the NS5A inhibitor ombitasvir coformulated in once-daily, fixed-dose fashion with the NS3/4A protease inhibitor paritaprevir boosted with ritonavir, along with twice-daily dasabuvir, a nonnucleoside NS5B RNA polymerase inhibitor. This combination has received Food and Drug Administration approval and is marketed as Viekira Pak for treatment of HCV genotype 1 in HIV-coinfected patients on the basis of the TURQUOISE-1, Part 1a trial (JAMA 2015;313[12]:1223-32). But this study was confined to 63 U.S. patients, and European investigators wanted to see how 3D worked in a larger, more diverse population, explained Dr. Rockstroh, professor of medicine and head of the outpatient HIV clinic at the University of Bonn (Germany).

In TURQUOISE-1, Part 2, patients with HCV genotype 1a without cirrhosis received 12 weeks of the 3D regimen plus ribavirin, while those with compensated cirrhosis got 24 weeks. Patients with genotype 1b received 12 weeks of 3D without ribavirin, regardless of whether or not they had compensated cirrhosis.

Because dasabuvir is ineffective against HCV genotype 4, those patients got 12 weeks of the 2D regimen – the coformulated ombitasvir/paritaprevir/ritonavir – along with ribavirin.

All subjects were on antiretroviral regimens based upon either darunavir (Prezista), atazanavir (Reyataz), raltegravir (Isentress), or dolutegravir (Tivicay). Nearly all (97%) of the patients had an HIV RNA viral load of less than 40 copies/mL at baseline. Those on ritonavir-boosted antiretroviral therapy discontinued the ritonavir and received it instead via their 3D or 2D hepatitis C therapy.

HIV suppression was well maintained throughout the study. Intermittent episodes of HIV viremia affected 4% of participants, but in all cases the peak was less than 200 copies/mL. None of the episodes met standard criteria for HIV genotypic resistance testing, according to Dr. Rockstroh.

In contrast to the former standard therapy consisting of pegylated interferon and ribavirin, which had an SVR of about 30% in HCV/HIV coinfected patients and was fraught with serious side effects, no one discontinued treatment due to adverse events in TURQUOISE-1, Part 2. No cases of hepatic decompensation occurred. The only serious adverse event deemed possibly treatment related was a single case of depression. Mild fatigue, nausea, diarrhea, insomnia, headache, or itching each occurred in 10%-20% of subjects.

As effective antiretroviral therapy enables HIV-infected patients to have a lifespan approaching normal, HCV coinfection has emerged as a major issue. Roughly one-third of HIV-positive individuals are coinfected with HCV, and the rate of death due to HCV-related liver disease in coinfected patients exceeds the rate of death due to HIV. HCV genotype 1 accounts for three-quarters of chronic hepatitis C in the United States, while genotype 4 predominates in Africa, where the bulk of HIV infections occur.

During the AIDS 2016 conference, the Food and Drug Administration approved Viekira XR, an extended-release coformulation of the 3D regimen. Each tablet contains 200 mg of dasabuvir, 8.33 mg of ombitasvir, 50 mg of paritaprevir, and 33.33 mg of ritonavir. The standard dosing is three oral tablets taken once daily.

The TURQUOISE-1, Part 2 trial was sponsored by AbbVie. Dr. Rockstroh is a consultant to AbbVie and seven other pharmaceutical companies.

[email protected]

DURBAN, SOUTH AFRICA – The all-oral, interferon-free, triple- or double-direct-acting antiviral regimens informally known as 3D and 2D proved effective and safe for treatment of chronic hepatitis C due to HCV genotypes 1 and 4 in HIV-coinfected patients taking various antiretroviral combinations in the phase III, multicenter TURQUOISE-1, Part 2 trial, Jürgen K. Rockstroh, MD, reported at the 21st International AIDS Conference.

TURQUOISE-1, Part 2 included 228 patients coinfected with HCV/HIV. Of the 154 with HCV genotype 1a and 44 with genotype 1b, 21 of whom had compensated cirrhosis, 98% of subjects achieved a sustained virologic response (SVR) 12 weeks after conclusion of the 3D regimen, or SVR12, in a modified intent-to-treat analysis. A handful of patients with missing data, or those who stopped treatment for reasons other than virologic failure, were excluded from the analysis.

Bruce Jancin/Frontline Medical News

In the 28 patients coinfected with HCV genotype 4, none of whom had cirrhosis, the modified SVR12 rate was 100%.

The so-called 3D regimen consists of the NS5A inhibitor ombitasvir coformulated in once-daily, fixed-dose fashion with the NS3/4A protease inhibitor paritaprevir boosted with ritonavir, along with twice-daily dasabuvir, a nonnucleoside NS5B RNA polymerase inhibitor. This combination has received Food and Drug Administration approval and is marketed as Viekira Pak for treatment of HCV genotype 1 in HIV-coinfected patients on the basis of the TURQUOISE-1, Part 1a trial (JAMA 2015;313[12]:1223-32). But this study was confined to 63 U.S. patients, and European investigators wanted to see how 3D worked in a larger, more diverse population, explained Dr. Rockstroh, professor of medicine and head of the outpatient HIV clinic at the University of Bonn (Germany).

In TURQUOISE-1, Part 2, patients with HCV genotype 1a without cirrhosis received 12 weeks of the 3D regimen plus ribavirin, while those with compensated cirrhosis got 24 weeks. Patients with genotype 1b received 12 weeks of 3D without ribavirin, regardless of whether or not they had compensated cirrhosis.

Because dasabuvir is ineffective against HCV genotype 4, those patients got 12 weeks of the 2D regimen – the coformulated ombitasvir/paritaprevir/ritonavir – along with ribavirin.

All subjects were on antiretroviral regimens based upon either darunavir (Prezista), atazanavir (Reyataz), raltegravir (Isentress), or dolutegravir (Tivicay). Nearly all (97%) of the patients had an HIV RNA viral load of less than 40 copies/mL at baseline. Those on ritonavir-boosted antiretroviral therapy discontinued the ritonavir and received it instead via their 3D or 2D hepatitis C therapy.

HIV suppression was well maintained throughout the study. Intermittent episodes of HIV viremia affected 4% of participants, but in all cases the peak was less than 200 copies/mL. None of the episodes met standard criteria for HIV genotypic resistance testing, according to Dr. Rockstroh.

In contrast to the former standard therapy consisting of pegylated interferon and ribavirin, which had an SVR of about 30% in HCV/HIV coinfected patients and was fraught with serious side effects, no one discontinued treatment due to adverse events in TURQUOISE-1, Part 2. No cases of hepatic decompensation occurred. The only serious adverse event deemed possibly treatment related was a single case of depression. Mild fatigue, nausea, diarrhea, insomnia, headache, or itching each occurred in 10%-20% of subjects.

As effective antiretroviral therapy enables HIV-infected patients to have a lifespan approaching normal, HCV coinfection has emerged as a major issue. Roughly one-third of HIV-positive individuals are coinfected with HCV, and the rate of death due to HCV-related liver disease in coinfected patients exceeds the rate of death due to HIV. HCV genotype 1 accounts for three-quarters of chronic hepatitis C in the United States, while genotype 4 predominates in Africa, where the bulk of HIV infections occur.

During the AIDS 2016 conference, the Food and Drug Administration approved Viekira XR, an extended-release coformulation of the 3D regimen. Each tablet contains 200 mg of dasabuvir, 8.33 mg of ombitasvir, 50 mg of paritaprevir, and 33.33 mg of ritonavir. The standard dosing is three oral tablets taken once daily.

The TURQUOISE-1, Part 2 trial was sponsored by AbbVie. Dr. Rockstroh is a consultant to AbbVie and seven other pharmaceutical companies.

[email protected]

DURBAN, SOUTH AFRICA – The all-oral, interferon-free, triple- or double-direct-acting antiviral regimens informally known as 3D and 2D proved effective and safe for treatment of chronic hepatitis C due to HCV genotypes 1 and 4 in HIV-coinfected patients taking various antiretroviral combinations in the phase III, multicenter TURQUOISE-1, Part 2 trial, Jürgen K. Rockstroh, MD, reported at the 21st International AIDS Conference.

TURQUOISE-1, Part 2 included 228 patients coinfected with HCV/HIV. Of the 154 with HCV genotype 1a and 44 with genotype 1b, 21 of whom had compensated cirrhosis, 98% of subjects achieved a sustained virologic response (SVR) 12 weeks after conclusion of the 3D regimen, or SVR12, in a modified intent-to-treat analysis. A handful of patients with missing data, or those who stopped treatment for reasons other than virologic failure, were excluded from the analysis.

Bruce Jancin/Frontline Medical News

In the 28 patients coinfected with HCV genotype 4, none of whom had cirrhosis, the modified SVR12 rate was 100%.

The so-called 3D regimen consists of the NS5A inhibitor ombitasvir coformulated in once-daily, fixed-dose fashion with the NS3/4A protease inhibitor paritaprevir boosted with ritonavir, along with twice-daily dasabuvir, a nonnucleoside NS5B RNA polymerase inhibitor. This combination has received Food and Drug Administration approval and is marketed as Viekira Pak for treatment of HCV genotype 1 in HIV-coinfected patients on the basis of the TURQUOISE-1, Part 1a trial (JAMA 2015;313[12]:1223-32). But this study was confined to 63 U.S. patients, and European investigators wanted to see how 3D worked in a larger, more diverse population, explained Dr. Rockstroh, professor of medicine and head of the outpatient HIV clinic at the University of Bonn (Germany).

In TURQUOISE-1, Part 2, patients with HCV genotype 1a without cirrhosis received 12 weeks of the 3D regimen plus ribavirin, while those with compensated cirrhosis got 24 weeks. Patients with genotype 1b received 12 weeks of 3D without ribavirin, regardless of whether or not they had compensated cirrhosis.

Because dasabuvir is ineffective against HCV genotype 4, those patients got 12 weeks of the 2D regimen – the coformulated ombitasvir/paritaprevir/ritonavir – along with ribavirin.

All subjects were on antiretroviral regimens based upon either darunavir (Prezista), atazanavir (Reyataz), raltegravir (Isentress), or dolutegravir (Tivicay). Nearly all (97%) of the patients had an HIV RNA viral load of less than 40 copies/mL at baseline. Those on ritonavir-boosted antiretroviral therapy discontinued the ritonavir and received it instead via their 3D or 2D hepatitis C therapy.

HIV suppression was well maintained throughout the study. Intermittent episodes of HIV viremia affected 4% of participants, but in all cases the peak was less than 200 copies/mL. None of the episodes met standard criteria for HIV genotypic resistance testing, according to Dr. Rockstroh.

In contrast to the former standard therapy consisting of pegylated interferon and ribavirin, which had an SVR of about 30% in HCV/HIV coinfected patients and was fraught with serious side effects, no one discontinued treatment due to adverse events in TURQUOISE-1, Part 2. No cases of hepatic decompensation occurred. The only serious adverse event deemed possibly treatment related was a single case of depression. Mild fatigue, nausea, diarrhea, insomnia, headache, or itching each occurred in 10%-20% of subjects.

As effective antiretroviral therapy enables HIV-infected patients to have a lifespan approaching normal, HCV coinfection has emerged as a major issue. Roughly one-third of HIV-positive individuals are coinfected with HCV, and the rate of death due to HCV-related liver disease in coinfected patients exceeds the rate of death due to HIV. HCV genotype 1 accounts for three-quarters of chronic hepatitis C in the United States, while genotype 4 predominates in Africa, where the bulk of HIV infections occur.

During the AIDS 2016 conference, the Food and Drug Administration approved Viekira XR, an extended-release coformulation of the 3D regimen. Each tablet contains 200 mg of dasabuvir, 8.33 mg of ombitasvir, 50 mg of paritaprevir, and 33.33 mg of ritonavir. The standard dosing is three oral tablets taken once daily.

The TURQUOISE-1, Part 2 trial was sponsored by AbbVie. Dr. Rockstroh is a consultant to AbbVie and seven other pharmaceutical companies.

[email protected]

Stromal or mesenchymal tumors account for about 1% of gastrointestinal (GI) tract neoplasms and are divided into 2 main categories: the gastrointestinal stromal tumors (GISTs; 60%- 90% of mesencymal tumors), and the non-GIST neoplasms (10%-30% of mesencymal tumors).¹ The non-GIST neoplasms consist of a heterogenous group of soft-tissue tumors, identical to soft-tissue tumors elsewhere in the body.

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Stromal or mesenchymal tumors account for about 1% of gastrointestinal (GI) tract neoplasms and are divided into 2 main categories: the gastrointestinal stromal tumors (GISTs; 60%- 90% of mesencymal tumors), and the non-GIST neoplasms (10%-30% of mesencymal tumors).¹ The non-GIST neoplasms consist of a heterogenous group of soft-tissue tumors, identical to soft-tissue tumors elsewhere in the body.

Click on the PDF icon at the top of this introduction to read the full article.

Stromal or mesenchymal tumors account for about 1% of gastrointestinal (GI) tract neoplasms and are divided into 2 main categories: the gastrointestinal stromal tumors (GISTs; 60%- 90% of mesencymal tumors), and the non-GIST neoplasms (10%-30% of mesencymal tumors).¹ The non-GIST neoplasms consist of a heterogenous group of soft-tissue tumors, identical to soft-tissue tumors elsewhere in the body.

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Background Sleep impairment, fatigue, and anxiety are common conditions in cancer survivors. Small studies suggest mindfulness- based interventions may be helpful for cancer-related fatigue.

Objective To evaluate mindfulness-based cancer recovery (MBCR) for cancer survivors who are recovering from chemotherapy or radiation therapy.

Methods 42 cancer survivors who were within 6 months of completion of chemotherapy or radiation were randomized 2:1 to 8 weekly MBCR classes (n = 28) or wait-list control (n = 14). The Pittsburgh Sleep Quality Index (PSQI), Functional Assessment in Cancer Therapy – Fatigue (FACT-F), and 20-item State-Trait Anxiety Inventory (STAI) were used to assess sleep, fatigue, and anxiety at baseline (time of enrollment), at 2 months (on completion of the MBCR course), and 4 months (2 months after completion of the course). 32 of 42 participants participated in an optional blood draw to assess immune function.

Results 79% of the MBCR group attended at least 7 of the 9 MBCR sessions. At the 2-month assessment, sleep quality (PSQI, range 0-21, >5 = poorer sleep quality) in the MBCR group improved from the baseline 8.9 to 6.4, compared with the wait-list group (baseline 7.2 to 7.6); and at 4 months after course completion, it was 6.1 compared with 7.8, respectively (P = .03). There was a non-statistically significant improvement in fatigue (FACIT-F, P = .19). There was a trend toward improvement in the anxiety scores (STAI, range 20-80, higher score = greater anxiety) in the MBCR group compared with the wait-list group at 2 months (31.8 vs 39.4, respectively; P = .07) and 4 months (32.8 vs 40.7; P = .10). Immune function measures were not statistically significant.

Limitations It is possible the psychological support of being in contact with a facilitator and/or other cancer survivors had a beneficial effect in the outcomes of those in the MBCR group.

Conclusion MBCR has a high compliance rate and results in sustained improvements in sleep quality, fatigue, and anxiety. MBCR may be useful for cancer survivors struggling with sleep, fatigue, and anxiety.

Funding Hourglass Fund, Masonic Cancer Center, University of Minnesota; University of Minnesota Foundation (immune function protocol); National Institutes of Health Office of Women’s Health Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) NIH # K12-HD055887.

Click on the PDF icon at the top of this introduction to read the full article.

Background Sleep impairment, fatigue, and anxiety are common conditions in cancer survivors. Small studies suggest mindfulness- based interventions may be helpful for cancer-related fatigue.

Objective To evaluate mindfulness-based cancer recovery (MBCR) for cancer survivors who are recovering from chemotherapy or radiation therapy.

Methods 42 cancer survivors who were within 6 months of completion of chemotherapy or radiation were randomized 2:1 to 8 weekly MBCR classes (n = 28) or wait-list control (n = 14). The Pittsburgh Sleep Quality Index (PSQI), Functional Assessment in Cancer Therapy – Fatigue (FACT-F), and 20-item State-Trait Anxiety Inventory (STAI) were used to assess sleep, fatigue, and anxiety at baseline (time of enrollment), at 2 months (on completion of the MBCR course), and 4 months (2 months after completion of the course). 32 of 42 participants participated in an optional blood draw to assess immune function.

Results 79% of the MBCR group attended at least 7 of the 9 MBCR sessions. At the 2-month assessment, sleep quality (PSQI, range 0-21, >5 = poorer sleep quality) in the MBCR group improved from the baseline 8.9 to 6.4, compared with the wait-list group (baseline 7.2 to 7.6); and at 4 months after course completion, it was 6.1 compared with 7.8, respectively (P = .03). There was a non-statistically significant improvement in fatigue (FACIT-F, P = .19). There was a trend toward improvement in the anxiety scores (STAI, range 20-80, higher score = greater anxiety) in the MBCR group compared with the wait-list group at 2 months (31.8 vs 39.4, respectively; P = .07) and 4 months (32.8 vs 40.7; P = .10). Immune function measures were not statistically significant.

Limitations It is possible the psychological support of being in contact with a facilitator and/or other cancer survivors had a beneficial effect in the outcomes of those in the MBCR group.

Conclusion MBCR has a high compliance rate and results in sustained improvements in sleep quality, fatigue, and anxiety. MBCR may be useful for cancer survivors struggling with sleep, fatigue, and anxiety.

Funding Hourglass Fund, Masonic Cancer Center, University of Minnesota; University of Minnesota Foundation (immune function protocol); National Institutes of Health Office of Women’s Health Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) NIH # K12-HD055887.

Click on the PDF icon at the top of this introduction to read the full article.

Background Sleep impairment, fatigue, and anxiety are common conditions in cancer survivors. Small studies suggest mindfulness- based interventions may be helpful for cancer-related fatigue.

Objective To evaluate mindfulness-based cancer recovery (MBCR) for cancer survivors who are recovering from chemotherapy or radiation therapy.

Methods 42 cancer survivors who were within 6 months of completion of chemotherapy or radiation were randomized 2:1 to 8 weekly MBCR classes (n = 28) or wait-list control (n = 14). The Pittsburgh Sleep Quality Index (PSQI), Functional Assessment in Cancer Therapy – Fatigue (FACT-F), and 20-item State-Trait Anxiety Inventory (STAI) were used to assess sleep, fatigue, and anxiety at baseline (time of enrollment), at 2 months (on completion of the MBCR course), and 4 months (2 months after completion of the course). 32 of 42 participants participated in an optional blood draw to assess immune function.

Results 79% of the MBCR group attended at least 7 of the 9 MBCR sessions. At the 2-month assessment, sleep quality (PSQI, range 0-21, >5 = poorer sleep quality) in the MBCR group improved from the baseline 8.9 to 6.4, compared with the wait-list group (baseline 7.2 to 7.6); and at 4 months after course completion, it was 6.1 compared with 7.8, respectively (P = .03). There was a non-statistically significant improvement in fatigue (FACIT-F, P = .19). There was a trend toward improvement in the anxiety scores (STAI, range 20-80, higher score = greater anxiety) in the MBCR group compared with the wait-list group at 2 months (31.8 vs 39.4, respectively; P = .07) and 4 months (32.8 vs 40.7; P = .10). Immune function measures were not statistically significant.

Limitations It is possible the psychological support of being in contact with a facilitator and/or other cancer survivors had a beneficial effect in the outcomes of those in the MBCR group.

Conclusion MBCR has a high compliance rate and results in sustained improvements in sleep quality, fatigue, and anxiety. MBCR may be useful for cancer survivors struggling with sleep, fatigue, and anxiety.

Funding Hourglass Fund, Masonic Cancer Center, University of Minnesota; University of Minnesota Foundation (immune function protocol); National Institutes of Health Office of Women’s Health Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) NIH # K12-HD055887.

Click on the PDF icon at the top of this introduction to read the full article.

A new classification tool helped guide the treatment of bacteremic patients while clinicians awaited antibiotic resistance results, investigators reported.

The clinical decision tree had a positive predictive value of 91% and a negative predictive value of 92% for determining whether certain gram-negative infections produced extended-spectrum beta-lactamase (ESBL), Catherine Goodman, PhD, of the Johns Hopkins Bloomberg School of Public Health, Baltimore, and her associates wrote online in Clinical Infectious Diseases. “These predictions may assist empiric treatment decisions in order to optimize clinical outcomes while reducing administration of overly broad antibiotic agents that can select for further resistance emergence,” they added.

Bacteria that produce ESBL can hydrolyze all broad-spectrum beta-lactam antibiotics except carbapenems. Rapid tests for beta-lactamase genes can shorten the lag time between gram-stain identification and antimicrobial resistance results, but are cost prohibitive for most clinical laboratories and often do not assess ESBL gene groups, the researchers said. To find a way to predict which infections are characterized by ESBL production, they studied adults hospitalized at Johns Hopkins from October 2008 to March 2015 with bloodstream isolates of Klebsiella pneumoniae (40% of patients), Klebsiella oxytoca (4% of patients), and Escherichia coli (56% of patients). Most bacteremias began as urinary tract infections (34% of cases), followed by intra-abdominal infections (24%), catheter-related infections (16%), and biliary infections (14%) (Clin Infect Dis. 2016 Jul 26. doi:10.1093/cid/ciw425).

A total of 194 patients (15%) had bacteremias that produced ESBL, according to the investigators. Using a technique called binary recursive partitioning, they compared these patients with ESBL-negative patients to create a clinical decision tree based on five yes-or-no questions. The tree first asked if the patient had been colonized or infected with ESBL-producing bacteria within 6 months, and if so, whether the patient currently had an indwelling catheter. Patients meeting both criteria had a 92% chance of being ESBL positive. Patients with a recent history of ESBL but no catheter had an 81% chance of being ESBL positive if they were at least 43 years old, but a 75% chance of being ESBL negative if they were under age 43 years.

Among patients with no recent history of ESBL, the decision tree asked about hospitalization in a country with a high ESBL burden and antibiotic therapy during the past 6 months. Patients responding “yes” to both questions had a 100% chance of being ESBL positive. Patients with only the geographic risk factor had a 63% chance of being ESBL negative, and patients with neither risk factor had a 93% chance of being ESBL negative.

The decision tree detected only half of ESBL cases because there was a subgroup with no recent ESBL history or geographic exposure, the investigators noted. “The poor predictive nature of health care–associated variables within this patient subset may suggest a high proportion of community-acquired ESBL infections. Indeed, although risk factors for ESBLs have traditionally focused on the health care setting, increasing reports describe the community as an important ESBL reservoir,” they added. Nonetheless, of 194 patients with ESBL bacteremia, 35% received empiric carbapenem treatment within 6 hours after identification of the bacterial genus and species, the investigators emphasized. “Utilization of the decision tree would have increased ESBL case detection during the empiric treatment window by approximately 50%.”

The National Institutes of Health funded the study. The researchers reported having no conflicts of interest.

A new classification tool helped guide the treatment of bacteremic patients while clinicians awaited antibiotic resistance results, investigators reported.

The clinical decision tree had a positive predictive value of 91% and a negative predictive value of 92% for determining whether certain gram-negative infections produced extended-spectrum beta-lactamase (ESBL), Catherine Goodman, PhD, of the Johns Hopkins Bloomberg School of Public Health, Baltimore, and her associates wrote online in Clinical Infectious Diseases. “These predictions may assist empiric treatment decisions in order to optimize clinical outcomes while reducing administration of overly broad antibiotic agents that can select for further resistance emergence,” they added.

Bacteria that produce ESBL can hydrolyze all broad-spectrum beta-lactam antibiotics except carbapenems. Rapid tests for beta-lactamase genes can shorten the lag time between gram-stain identification and antimicrobial resistance results, but are cost prohibitive for most clinical laboratories and often do not assess ESBL gene groups, the researchers said. To find a way to predict which infections are characterized by ESBL production, they studied adults hospitalized at Johns Hopkins from October 2008 to March 2015 with bloodstream isolates of Klebsiella pneumoniae (40% of patients), Klebsiella oxytoca (4% of patients), and Escherichia coli (56% of patients). Most bacteremias began as urinary tract infections (34% of cases), followed by intra-abdominal infections (24%), catheter-related infections (16%), and biliary infections (14%) (Clin Infect Dis. 2016 Jul 26. doi:10.1093/cid/ciw425).

A total of 194 patients (15%) had bacteremias that produced ESBL, according to the investigators. Using a technique called binary recursive partitioning, they compared these patients with ESBL-negative patients to create a clinical decision tree based on five yes-or-no questions. The tree first asked if the patient had been colonized or infected with ESBL-producing bacteria within 6 months, and if so, whether the patient currently had an indwelling catheter. Patients meeting both criteria had a 92% chance of being ESBL positive. Patients with a recent history of ESBL but no catheter had an 81% chance of being ESBL positive if they were at least 43 years old, but a 75% chance of being ESBL negative if they were under age 43 years.

Among patients with no recent history of ESBL, the decision tree asked about hospitalization in a country with a high ESBL burden and antibiotic therapy during the past 6 months. Patients responding “yes” to both questions had a 100% chance of being ESBL positive. Patients with only the geographic risk factor had a 63% chance of being ESBL negative, and patients with neither risk factor had a 93% chance of being ESBL negative.

The decision tree detected only half of ESBL cases because there was a subgroup with no recent ESBL history or geographic exposure, the investigators noted. “The poor predictive nature of health care–associated variables within this patient subset may suggest a high proportion of community-acquired ESBL infections. Indeed, although risk factors for ESBLs have traditionally focused on the health care setting, increasing reports describe the community as an important ESBL reservoir,” they added. Nonetheless, of 194 patients with ESBL bacteremia, 35% received empiric carbapenem treatment within 6 hours after identification of the bacterial genus and species, the investigators emphasized. “Utilization of the decision tree would have increased ESBL case detection during the empiric treatment window by approximately 50%.”

The National Institutes of Health funded the study. The researchers reported having no conflicts of interest.

A new classification tool helped guide the treatment of bacteremic patients while clinicians awaited antibiotic resistance results, investigators reported.

The clinical decision tree had a positive predictive value of 91% and a negative predictive value of 92% for determining whether certain gram-negative infections produced extended-spectrum beta-lactamase (ESBL), Catherine Goodman, PhD, of the Johns Hopkins Bloomberg School of Public Health, Baltimore, and her associates wrote online in Clinical Infectious Diseases. “These predictions may assist empiric treatment decisions in order to optimize clinical outcomes while reducing administration of overly broad antibiotic agents that can select for further resistance emergence,” they added.

Bacteria that produce ESBL can hydrolyze all broad-spectrum beta-lactam antibiotics except carbapenems. Rapid tests for beta-lactamase genes can shorten the lag time between gram-stain identification and antimicrobial resistance results, but are cost prohibitive for most clinical laboratories and often do not assess ESBL gene groups, the researchers said. To find a way to predict which infections are characterized by ESBL production, they studied adults hospitalized at Johns Hopkins from October 2008 to March 2015 with bloodstream isolates of Klebsiella pneumoniae (40% of patients), Klebsiella oxytoca (4% of patients), and Escherichia coli (56% of patients). Most bacteremias began as urinary tract infections (34% of cases), followed by intra-abdominal infections (24%), catheter-related infections (16%), and biliary infections (14%) (Clin Infect Dis. 2016 Jul 26. doi:10.1093/cid/ciw425).

A total of 194 patients (15%) had bacteremias that produced ESBL, according to the investigators. Using a technique called binary recursive partitioning, they compared these patients with ESBL-negative patients to create a clinical decision tree based on five yes-or-no questions. The tree first asked if the patient had been colonized or infected with ESBL-producing bacteria within 6 months, and if so, whether the patient currently had an indwelling catheter. Patients meeting both criteria had a 92% chance of being ESBL positive. Patients with a recent history of ESBL but no catheter had an 81% chance of being ESBL positive if they were at least 43 years old, but a 75% chance of being ESBL negative if they were under age 43 years.

Among patients with no recent history of ESBL, the decision tree asked about hospitalization in a country with a high ESBL burden and antibiotic therapy during the past 6 months. Patients responding “yes” to both questions had a 100% chance of being ESBL positive. Patients with only the geographic risk factor had a 63% chance of being ESBL negative, and patients with neither risk factor had a 93% chance of being ESBL negative.

The decision tree detected only half of ESBL cases because there was a subgroup with no recent ESBL history or geographic exposure, the investigators noted. “The poor predictive nature of health care–associated variables within this patient subset may suggest a high proportion of community-acquired ESBL infections. Indeed, although risk factors for ESBLs have traditionally focused on the health care setting, increasing reports describe the community as an important ESBL reservoir,” they added. Nonetheless, of 194 patients with ESBL bacteremia, 35% received empiric carbapenem treatment within 6 hours after identification of the bacterial genus and species, the investigators emphasized. “Utilization of the decision tree would have increased ESBL case detection during the empiric treatment window by approximately 50%.”

The National Institutes of Health funded the study. The researchers reported having no conflicts of interest.

Background Reproductive-age women who are undergoing cancer treatment are at risk for heavy menstrual bleeding, unintended pregnancy, and have a contraindication to estrogen-containing products. The incidence of vaginal bleeding and contraception use is not known.

Objective To describe clinical practices regarding menstrual suppression, estimate the incidence of vaginal bleeding complaints, and investigate contraceptive counseling and provision in women undergoing chemotherapy.

Methods We performed a chart review using ICD-9 codes to identify women aged 14-40 years who received chemotherapy at our institution during July 2008-June 2013. Electronic medical records were examined for menstrual suppression therapy, contraception counseling, and abnormal vaginal bleeding.

Results We identified 137 women for this study. 24 (18%) received prophylactic menstrual suppression counseling, of whom 17 (71%) initiated treatment, primarily with combined oral contraceptives, all prescribed by hematologist-oncologists. During the first 6 months of chemotherapy, 36 women (26%) complained of abnormal vaginal bleeding, including 10 women who were on prophylactic treatment. 19 women noted moderate to severe bleeding. 11 (12%) women received contraceptive counseling before chemotherapy, all from hematologist-oncologists; 86 women (63%) initiated chemotherapy without a documented contraceptive method.

Limitations Data were generated from billing codes, so all eligible women may not have been included.

Conclusions Reproductive-age women undergoing chemotherapy may not receive adequate contraception and menstrual suppression counseling. We encourage consulting gynecologists, especially family planning specialists, at the time of cancer diagnosis to support women with decisions about menstrual suppression and contraception.

Funding/sponsorship Society of Family Planning, National Center for Advancing Translational Sciences, National Institutes of Health, Lillian Mae Rapp Research Endowment

Click on the PDF icon at the top of this introduction to read the full article.

Background Reproductive-age women who are undergoing cancer treatment are at risk for heavy menstrual bleeding, unintended pregnancy, and have a contraindication to estrogen-containing products. The incidence of vaginal bleeding and contraception use is not known.

Objective To describe clinical practices regarding menstrual suppression, estimate the incidence of vaginal bleeding complaints, and investigate contraceptive counseling and provision in women undergoing chemotherapy.

Methods We performed a chart review using ICD-9 codes to identify women aged 14-40 years who received chemotherapy at our institution during July 2008-June 2013. Electronic medical records were examined for menstrual suppression therapy, contraception counseling, and abnormal vaginal bleeding.

Results We identified 137 women for this study. 24 (18%) received prophylactic menstrual suppression counseling, of whom 17 (71%) initiated treatment, primarily with combined oral contraceptives, all prescribed by hematologist-oncologists. During the first 6 months of chemotherapy, 36 women (26%) complained of abnormal vaginal bleeding, including 10 women who were on prophylactic treatment. 19 women noted moderate to severe bleeding. 11 (12%) women received contraceptive counseling before chemotherapy, all from hematologist-oncologists; 86 women (63%) initiated chemotherapy without a documented contraceptive method.

Limitations Data were generated from billing codes, so all eligible women may not have been included.

Conclusions Reproductive-age women undergoing chemotherapy may not receive adequate contraception and menstrual suppression counseling. We encourage consulting gynecologists, especially family planning specialists, at the time of cancer diagnosis to support women with decisions about menstrual suppression and contraception.

Funding/sponsorship Society of Family Planning, National Center for Advancing Translational Sciences, National Institutes of Health, Lillian Mae Rapp Research Endowment

Click on the PDF icon at the top of this introduction to read the full article.

Background Reproductive-age women who are undergoing cancer treatment are at risk for heavy menstrual bleeding, unintended pregnancy, and have a contraindication to estrogen-containing products. The incidence of vaginal bleeding and contraception use is not known.

Objective To describe clinical practices regarding menstrual suppression, estimate the incidence of vaginal bleeding complaints, and investigate contraceptive counseling and provision in women undergoing chemotherapy.

Methods We performed a chart review using ICD-9 codes to identify women aged 14-40 years who received chemotherapy at our institution during July 2008-June 2013. Electronic medical records were examined for menstrual suppression therapy, contraception counseling, and abnormal vaginal bleeding.

Results We identified 137 women for this study. 24 (18%) received prophylactic menstrual suppression counseling, of whom 17 (71%) initiated treatment, primarily with combined oral contraceptives, all prescribed by hematologist-oncologists. During the first 6 months of chemotherapy, 36 women (26%) complained of abnormal vaginal bleeding, including 10 women who were on prophylactic treatment. 19 women noted moderate to severe bleeding. 11 (12%) women received contraceptive counseling before chemotherapy, all from hematologist-oncologists; 86 women (63%) initiated chemotherapy without a documented contraceptive method.

Limitations Data were generated from billing codes, so all eligible women may not have been included.

Conclusions Reproductive-age women undergoing chemotherapy may not receive adequate contraception and menstrual suppression counseling. We encourage consulting gynecologists, especially family planning specialists, at the time of cancer diagnosis to support women with decisions about menstrual suppression and contraception.

Funding/sponsorship Society of Family Planning, National Center for Advancing Translational Sciences, National Institutes of Health, Lillian Mae Rapp Research Endowment

Click on the PDF icon at the top of this introduction to read the full article.

The first dose of rotavirus vaccine was again linked to a small, short-term increase in the risk of hospitalization for intussusception, but the benefits of the vaccine exceed this risk, according to a report.

In absolute numbers, there were an estimated 7 to 26 more intussusception cases per year among U.S. children aged 8-11 weeks during the postvaccine era, compared with the prevaccine era, said Jacqueline E. Tate, PhD, of the National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, and her associates.

©jarun011/Thinkstock

The increased risk did not extend to older children, which “is consistent with other U.S. studies,” the investigators said. “[Given] the magnitude of the declines in rotavirus disease compared with the small increased risk of intussusception, the public health benefits of rotavirus vaccination far exceed the increased risk of intussusception.”

Human rotavirus vaccines have been linked to rare events of intussusception since at least 1999, when Rotashield was withdrawn from the market for this reason. The next two rotavirus vaccines to receive Food and Drug Administration approval, RotaTeq and Rotarix, were not linked to intussusception in large trials or early postmarketing studies, but were estimated to cause 1-5 excess cases of intussusception per 100,000 population in more recent studies. Furthermore, a prior analysis of U.S. hospital discharge data found a small increase in the risk of intussusception hospitalization among 8- to 11-week-olds between 2007 to 2009, compared with baseline data from the prevaccine era, the investigators noted (Pediatrics. 2016 Aug 24. doi: 10.1542/peds.2016-1082).

To build on that analysis, they calculated rates of intussusception between 2000 and 2013 overall and among recommended age windows for rotavirus vaccination, which are 6-14 weeks for the first dose, 15-24 weeks for the second dose, and 25-34 weeks for the third dose. For consistency, they also looked at hospitalization rates among children aged 8-11 weeks.

The investigators identified 15,231 intussusception hospitalizations among children under 1 year of age during the study from 2000-2013. There were no overall trends in intussusception hospitalizations for all children under 1 year of age or subgroups of children aged 15-24 weeks or 25-34 weeks. Among children aged 8-11 weeks, intussusception hospitalization rates did rise significantly during the postvaccine era, compared with the prevaccine era for all years except 2011 and 2013. Excluding those two years, annual rates of intussusception hospitalizations among 8- to 11-week-olds were 46%-101% higher (16.7 to 22.9 hospitalizations per 100,000 population) during the postvaccine era than during the prevaccine era (11.4 hospitalizations per 100,000 population).

These results are “consistent with other U.S. studies that have been able to associate an increased risk of intussusception in the first week after the first dose of vaccine,” the researchers concluded. The advent of rotavirus vaccination prevented more than 176,000 hospitalizations, 242,000 emergency department visits, and 1.1 million outpatient visits from 2007 to 2011 (JAMA. 2015;313(22):2282-4), they noted.

The investigators reported no external funding sources and had no disclosures.

The first dose of rotavirus vaccine was again linked to a small, short-term increase in the risk of hospitalization for intussusception, but the benefits of the vaccine exceed this risk, according to a report.

In absolute numbers, there were an estimated 7 to 26 more intussusception cases per year among U.S. children aged 8-11 weeks during the postvaccine era, compared with the prevaccine era, said Jacqueline E. Tate, PhD, of the National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, and her associates.

©jarun011/Thinkstock

The increased risk did not extend to older children, which “is consistent with other U.S. studies,” the investigators said. “[Given] the magnitude of the declines in rotavirus disease compared with the small increased risk of intussusception, the public health benefits of rotavirus vaccination far exceed the increased risk of intussusception.”

Human rotavirus vaccines have been linked to rare events of intussusception since at least 1999, when Rotashield was withdrawn from the market for this reason. The next two rotavirus vaccines to receive Food and Drug Administration approval, RotaTeq and Rotarix, were not linked to intussusception in large trials or early postmarketing studies, but were estimated to cause 1-5 excess cases of intussusception per 100,000 population in more recent studies. Furthermore, a prior analysis of U.S. hospital discharge data found a small increase in the risk of intussusception hospitalization among 8- to 11-week-olds between 2007 to 2009, compared with baseline data from the prevaccine era, the investigators noted (Pediatrics. 2016 Aug 24. doi: 10.1542/peds.2016-1082).

To build on that analysis, they calculated rates of intussusception between 2000 and 2013 overall and among recommended age windows for rotavirus vaccination, which are 6-14 weeks for the first dose, 15-24 weeks for the second dose, and 25-34 weeks for the third dose. For consistency, they also looked at hospitalization rates among children aged 8-11 weeks.

The investigators identified 15,231 intussusception hospitalizations among children under 1 year of age during the study from 2000-2013. There were no overall trends in intussusception hospitalizations for all children under 1 year of age or subgroups of children aged 15-24 weeks or 25-34 weeks. Among children aged 8-11 weeks, intussusception hospitalization rates did rise significantly during the postvaccine era, compared with the prevaccine era for all years except 2011 and 2013. Excluding those two years, annual rates of intussusception hospitalizations among 8- to 11-week-olds were 46%-101% higher (16.7 to 22.9 hospitalizations per 100,000 population) during the postvaccine era than during the prevaccine era (11.4 hospitalizations per 100,000 population).

These results are “consistent with other U.S. studies that have been able to associate an increased risk of intussusception in the first week after the first dose of vaccine,” the researchers concluded. The advent of rotavirus vaccination prevented more than 176,000 hospitalizations, 242,000 emergency department visits, and 1.1 million outpatient visits from 2007 to 2011 (JAMA. 2015;313(22):2282-4), they noted.

The investigators reported no external funding sources and had no disclosures.

The first dose of rotavirus vaccine was again linked to a small, short-term increase in the risk of hospitalization for intussusception, but the benefits of the vaccine exceed this risk, according to a report.

In absolute numbers, there were an estimated 7 to 26 more intussusception cases per year among U.S. children aged 8-11 weeks during the postvaccine era, compared with the prevaccine era, said Jacqueline E. Tate, PhD, of the National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, and her associates.

©jarun011/Thinkstock

The increased risk did not extend to older children, which “is consistent with other U.S. studies,” the investigators said. “[Given] the magnitude of the declines in rotavirus disease compared with the small increased risk of intussusception, the public health benefits of rotavirus vaccination far exceed the increased risk of intussusception.”

Human rotavirus vaccines have been linked to rare events of intussusception since at least 1999, when Rotashield was withdrawn from the market for this reason. The next two rotavirus vaccines to receive Food and Drug Administration approval, RotaTeq and Rotarix, were not linked to intussusception in large trials or early postmarketing studies, but were estimated to cause 1-5 excess cases of intussusception per 100,000 population in more recent studies. Furthermore, a prior analysis of U.S. hospital discharge data found a small increase in the risk of intussusception hospitalization among 8- to 11-week-olds between 2007 to 2009, compared with baseline data from the prevaccine era, the investigators noted (Pediatrics. 2016 Aug 24. doi: 10.1542/peds.2016-1082).

To build on that analysis, they calculated rates of intussusception between 2000 and 2013 overall and among recommended age windows for rotavirus vaccination, which are 6-14 weeks for the first dose, 15-24 weeks for the second dose, and 25-34 weeks for the third dose. For consistency, they also looked at hospitalization rates among children aged 8-11 weeks.

The investigators identified 15,231 intussusception hospitalizations among children under 1 year of age during the study from 2000-2013. There were no overall trends in intussusception hospitalizations for all children under 1 year of age or subgroups of children aged 15-24 weeks or 25-34 weeks. Among children aged 8-11 weeks, intussusception hospitalization rates did rise significantly during the postvaccine era, compared with the prevaccine era for all years except 2011 and 2013. Excluding those two years, annual rates of intussusception hospitalizations among 8- to 11-week-olds were 46%-101% higher (16.7 to 22.9 hospitalizations per 100,000 population) during the postvaccine era than during the prevaccine era (11.4 hospitalizations per 100,000 population).

These results are “consistent with other U.S. studies that have been able to associate an increased risk of intussusception in the first week after the first dose of vaccine,” the researchers concluded. The advent of rotavirus vaccination prevented more than 176,000 hospitalizations, 242,000 emergency department visits, and 1.1 million outpatient visits from 2007 to 2011 (JAMA. 2015;313(22):2282-4), they noted.

The investigators reported no external funding sources and had no disclosures.

At the summer meetings of the American Academy of Dermatology, AAD President Abel Torres screened a video of members responding to the question, “What keeps you up at night?” A recurring refrain in many of their responses was, “loss of autonomy.”

Many physicians feel they are losing autonomy. No doubt they are right. But physicians are not alone in their loss.

A young academic friend of mine had a similar lament. “Some assistant dean sent me an email ordering me to grade my students in a way that made no sense,” he said. “I challenged him to explain why. He answered that my school was following the guidelines of some organization I’d never heard of.”

“Academics used to be autonomous,” he said. “No more.”

Another professor friend decided to retire. “Forty years in the department,” he said, “10 as chair. Now a junior administrator tells me that I have to spend more hours on campus, even though I don’t have anything useful to do when I’m there. She said there are new rules for more academic efficiency.”

New administrators. Guidelines. Efficiency. Experienced hands dropping out or retiring out of frustration. Any of these sound familiar?

Teachers also complain to me about their loss of autonomy. “I used to be able to use judgment,” said one. “I knew what worked for a specific student. Now I just teach to the standardized test.

“For every one of my 23 kindergartners, I spent 1 hour filling out an iPad questionnaire on reading readiness. I’ve had it.”

“What will you do instead?” I asked him.

“Something with dogs,” he said.

And so it goes. Accountants and attorneys complain about heavy reporting regulations, with new ones added each year. Judges in Wisconsin make sentencing decisions using proprietary algorithms that no one outside the company that sells the algorithms has validated. Financial advisers have clients sign boilerplate statements documenting that they accept a certain level of risk. These clients may or may not understand what “level of risk” really implies, but either way they must sign a form, and the form must be filed. If you didn’t document it, you didn’t do it. If you documented it, you did it, even though you may not have really done anything meaningful.

An internist told me how things are in her new dispensation.

“They allow 15 minutes for a physical,” she said, “which is not enough anyway. But I also have to check off boxes for the EMR that add nothing to patient care. Last year we had to start asking about gender status. ‘What was your gender assignment at birth?’ ‘What is it now?’ We have to ask that every year – and click the box that says we did it.

“Several docs in our group retired. Another bunch went concierge. They couldn’t deal with it anymore.”

Metrics. Algorithms. Higher authorities who tell professionals what to do, how to do it, how to record it, business quants with scant understanding of what professionals actually profess. All so familiar and tiresome. It’s everywhere, and it’s bigger than any of us.

Loss of autonomy by professionals across the board reflects a changed understanding by society at large of what quality service is and how it should be judged. Numbers are in. Personal judgment – in our case, clinical judgment – is out. Since judgment can’t be measured, it cannot be trusted.

To a certain extent, autonomy is an illusion. We can do what we want as long as powers larger than we are – natural, social, political – let us do it. Those powers may lie dormant for a while, but they’re always there, and always have been. When they wake up and change the rules of the game, everyone has to adapt. New burdens in the practice of medicine are just one instance of a much broader trend.

Our professional organizations know this well. They are hard at work giving the authorities, government, and insurance administrators what they demand: data showing that what we do is useful, in the quantitative terms the authorities will accept.

To the extent that they succeed, we will be able to do some of what we want to do. Young people entering the medical field will expect nothing more. Some of their older colleagues will be satisfied that they are autonomous enough. The rest will have to find something else to do.

Dr. Rockoff practices dermatology in Brookline, Mass. He is on the clinical faculty at Tufts University School of Medicine, Boston, and has taught senior medical students and other trainees for 30 years.

At the summer meetings of the American Academy of Dermatology, AAD President Abel Torres screened a video of members responding to the question, “What keeps you up at night?” A recurring refrain in many of their responses was, “loss of autonomy.”

Many physicians feel they are losing autonomy. No doubt they are right. But physicians are not alone in their loss.

A young academic friend of mine had a similar lament. “Some assistant dean sent me an email ordering me to grade my students in a way that made no sense,” he said. “I challenged him to explain why. He answered that my school was following the guidelines of some organization I’d never heard of.”

“Academics used to be autonomous,” he said. “No more.”

Another professor friend decided to retire. “Forty years in the department,” he said, “10 as chair. Now a junior administrator tells me that I have to spend more hours on campus, even though I don’t have anything useful to do when I’m there. She said there are new rules for more academic efficiency.”

New administrators. Guidelines. Efficiency. Experienced hands dropping out or retiring out of frustration. Any of these sound familiar?

Teachers also complain to me about their loss of autonomy. “I used to be able to use judgment,” said one. “I knew what worked for a specific student. Now I just teach to the standardized test.

“For every one of my 23 kindergartners, I spent 1 hour filling out an iPad questionnaire on reading readiness. I’ve had it.”

“What will you do instead?” I asked him.

“Something with dogs,” he said.

And so it goes. Accountants and attorneys complain about heavy reporting regulations, with new ones added each year. Judges in Wisconsin make sentencing decisions using proprietary algorithms that no one outside the company that sells the algorithms has validated. Financial advisers have clients sign boilerplate statements documenting that they accept a certain level of risk. These clients may or may not understand what “level of risk” really implies, but either way they must sign a form, and the form must be filed. If you didn’t document it, you didn’t do it. If you documented it, you did it, even though you may not have really done anything meaningful.

An internist told me how things are in her new dispensation.

“They allow 15 minutes for a physical,” she said, “which is not enough anyway. But I also have to check off boxes for the EMR that add nothing to patient care. Last year we had to start asking about gender status. ‘What was your gender assignment at birth?’ ‘What is it now?’ We have to ask that every year – and click the box that says we did it.

“Several docs in our group retired. Another bunch went concierge. They couldn’t deal with it anymore.”

Metrics. Algorithms. Higher authorities who tell professionals what to do, how to do it, how to record it, business quants with scant understanding of what professionals actually profess. All so familiar and tiresome. It’s everywhere, and it’s bigger than any of us.

Loss of autonomy by professionals across the board reflects a changed understanding by society at large of what quality service is and how it should be judged. Numbers are in. Personal judgment – in our case, clinical judgment – is out. Since judgment can’t be measured, it cannot be trusted.

To a certain extent, autonomy is an illusion. We can do what we want as long as powers larger than we are – natural, social, political – let us do it. Those powers may lie dormant for a while, but they’re always there, and always have been. When they wake up and change the rules of the game, everyone has to adapt. New burdens in the practice of medicine are just one instance of a much broader trend.

Our professional organizations know this well. They are hard at work giving the authorities, government, and insurance administrators what they demand: data showing that what we do is useful, in the quantitative terms the authorities will accept.

To the extent that they succeed, we will be able to do some of what we want to do. Young people entering the medical field will expect nothing more. Some of their older colleagues will be satisfied that they are autonomous enough. The rest will have to find something else to do.

Dr. Rockoff practices dermatology in Brookline, Mass. He is on the clinical faculty at Tufts University School of Medicine, Boston, and has taught senior medical students and other trainees for 30 years.

At the summer meetings of the American Academy of Dermatology, AAD President Abel Torres screened a video of members responding to the question, “What keeps you up at night?” A recurring refrain in many of their responses was, “loss of autonomy.”

Many physicians feel they are losing autonomy. No doubt they are right. But physicians are not alone in their loss.

A young academic friend of mine had a similar lament. “Some assistant dean sent me an email ordering me to grade my students in a way that made no sense,” he said. “I challenged him to explain why. He answered that my school was following the guidelines of some organization I’d never heard of.”

“Academics used to be autonomous,” he said. “No more.”

Another professor friend decided to retire. “Forty years in the department,” he said, “10 as chair. Now a junior administrator tells me that I have to spend more hours on campus, even though I don’t have anything useful to do when I’m there. She said there are new rules for more academic efficiency.”

New administrators. Guidelines. Efficiency. Experienced hands dropping out or retiring out of frustration. Any of these sound familiar?

Teachers also complain to me about their loss of autonomy. “I used to be able to use judgment,” said one. “I knew what worked for a specific student. Now I just teach to the standardized test.

“For every one of my 23 kindergartners, I spent 1 hour filling out an iPad questionnaire on reading readiness. I’ve had it.”

“What will you do instead?” I asked him.

“Something with dogs,” he said.

And so it goes. Accountants and attorneys complain about heavy reporting regulations, with new ones added each year. Judges in Wisconsin make sentencing decisions using proprietary algorithms that no one outside the company that sells the algorithms has validated. Financial advisers have clients sign boilerplate statements documenting that they accept a certain level of risk. These clients may or may not understand what “level of risk” really implies, but either way they must sign a form, and the form must be filed. If you didn’t document it, you didn’t do it. If you documented it, you did it, even though you may not have really done anything meaningful.

An internist told me how things are in her new dispensation.

“They allow 15 minutes for a physical,” she said, “which is not enough anyway. But I also have to check off boxes for the EMR that add nothing to patient care. Last year we had to start asking about gender status. ‘What was your gender assignment at birth?’ ‘What is it now?’ We have to ask that every year – and click the box that says we did it.

“Several docs in our group retired. Another bunch went concierge. They couldn’t deal with it anymore.”

Metrics. Algorithms. Higher authorities who tell professionals what to do, how to do it, how to record it, business quants with scant understanding of what professionals actually profess. All so familiar and tiresome. It’s everywhere, and it’s bigger than any of us.

Loss of autonomy by professionals across the board reflects a changed understanding by society at large of what quality service is and how it should be judged. Numbers are in. Personal judgment – in our case, clinical judgment – is out. Since judgment can’t be measured, it cannot be trusted.

To a certain extent, autonomy is an illusion. We can do what we want as long as powers larger than we are – natural, social, political – let us do it. Those powers may lie dormant for a while, but they’re always there, and always have been. When they wake up and change the rules of the game, everyone has to adapt. New burdens in the practice of medicine are just one instance of a much broader trend.

Our professional organizations know this well. They are hard at work giving the authorities, government, and insurance administrators what they demand: data showing that what we do is useful, in the quantitative terms the authorities will accept.

To the extent that they succeed, we will be able to do some of what we want to do. Young people entering the medical field will expect nothing more. Some of their older colleagues will be satisfied that they are autonomous enough. The rest will have to find something else to do.

Dr. Rockoff practices dermatology in Brookline, Mass. He is on the clinical faculty at Tufts University School of Medicine, Boston, and has taught senior medical students and other trainees for 30 years.

Fluorouracil or 5-fluorouracil (5-FU) is an effective cytotoxic drug that is incorporated into various chemotherapeutic regimens for the treatment of numerous tumor types, but its clinical utility is limited by its narrow therapeutic index and the risk of overdose and serious toxic effects. Until recently, these outcomes were managed with supportive care, but the approval of uridine triacetate provides an antidote to reverse 5-FU-associated toxicity, to prevent death and potentially allow some patients to resume chemotherapy.

Fluorouracil or 5-fluorouracil (5-FU) is an effective cytotoxic drug that is incorporated into various chemotherapeutic regimens for the treatment of numerous tumor types, but its clinical utility is limited by its narrow therapeutic index and the risk of overdose and serious toxic effects. Until recently, these outcomes were managed with supportive care, but the approval of uridine triacetate provides an antidote to reverse 5-FU-associated toxicity, to prevent death and potentially allow some patients to resume chemotherapy.

Fluorouracil or 5-fluorouracil (5-FU) is an effective cytotoxic drug that is incorporated into various chemotherapeutic regimens for the treatment of numerous tumor types, but its clinical utility is limited by its narrow therapeutic index and the risk of overdose and serious toxic effects. Until recently, these outcomes were managed with supportive care, but the approval of uridine triacetate provides an antidote to reverse 5-FU-associated toxicity, to prevent death and potentially allow some patients to resume chemotherapy.