Study Overview

Objective. To examine receipt of provider advice to lose weight among primary care patients who are overweight or obese.

Design. Cross-sectional study.

Setting and participants. Participants were recruited through convenience sampling of primary care practices that were members in a national practice-based research network or part of federally qualified health care system based in the Southeastern United States. Each practice used 1 or more of the following recruitment strategies: self-referral from study flyers posted in practices, given during clinic appointments, or posted on the practice portal (n = 3 practices); mailed invitations to patients part of a practice registry (n = 7 practices); and on-site recruitment by research staff during clinic hours (n = 2 practices). Inclusion criteria included having at least a 3-year history of being a patient in the practice, being aged 18 years or older, and having an overweight or obese status according to Centers for Disease Control definitions (body mass index [BMI] 25.0–29.9 kg/m² = overweight, ≥ 30 kg/m² = obese). After completing informed consent, participants completed an interview comprising a 20-minute survey, either in English or Spanish, either in-person or by telephone.

Measures. The survey obtained measures related to sociodemographic characteristics (race, gender, age, marital status, education level, employment status, income level), clinical characteristics (height and weight, history of diabetes/hypertension), psychological variables (readiness to make weight loss or maintenance efforts and confidence in their ability to lose or maintain weight), shared decision-making about weight loss/management (using the SDM-Q-9, with a higher total score indicating greater shared decision-making), and physician advice about weight loss (whether they had ever been advised by a doctor or other health care professional to lose weight or reduce their weight).

Main results. Among the study sample (n = 282), 65% were female, 60% were from racial and ethnic minority groups, 55% were married, 57% had some college education or higher, and 37% had an income level below $20,000/year. The mean age of participants was 53.1 (± 14.4) years. 59% had been advised by their physician to lose weight.

The percentage of participants who reported receiving provider advice was statistically different from 50% using the binomial test (P = 0.0035). Based on bivariate analysis of provider advice about weight loss, women were significantly more likely than men to report that their provider had advised them to lose weight (P = 0.001). Both actual and perceived obesity were associated significantly with receiving provider advice about weight loss (both P = 0.001). Diabetic patients were also significantly more likely than nondiabetic patients to report that their provider had advised them to lose weight (P = 0.01). Participants who reported greater readiness to lose or maintain their weight were more likely to report provider advice about weight loss compared to those with less readiness (P = 0.003). While employed patients, those who had at least some college education, and those who were hypertensive were more likely to report provider advice compared to those who were unemployed, had less education, and were not hypertensive, these associations were not statistically significant (P = 0.06, P = 0.06, P = 0.10, respectively). There were no racial/ethnic differences in receipt of provider advice to lose weight (P = 0.76). Participants with greater shared decision-making were more likely to report provider advice about weight loss (P < 0.001).

Based on results of the multivariate logistic regression analysis, obesity status, perceived obesity, and SDM about weight loss/management had significant independent associations with receiving physician advice about weight loss. Participants with obesity were more likely than those with overweight status to report provider advice (odds ratio [OR] = 1.31, 95% CI = 1.25–4.34, P = 0.001). Similarly, participants who believed they had overweight/obesity had a greater likelihood of reporting provider advice compared with those who did not believe they were obese/overweight (OR = 1.40, 95% CI = 2.43–6.37, P < 0.001). Shared decision making about weight loss/management was associated with an increased likelihood of reporting provider advice (OR = 3.30, 95% CI = 2.62–4.12, P < 0.001).

Conclusions. Many patients with overweight/obesity may not be receiving advice to lose/manage their weight by their provider. While providers should advise patients with overweight/obesity about weight loss and management, patient beliefs about their weight status and perceptions about shared decision-making are important to reporting receipt of provider advice about weight loss/management. Patient beliefs as well as provider behaviors should be addressed as part of efforts to improve the management of obesity/overweight in primary care.

Commentary

Over 35% of adults in the United States have a BMI in the obese range [1], putting them at risk for obesity-related comorbidities [2], often diagnosed and treated within primary care settings. The US Preventive Services Task Force recommends that all patients be screened for obesity and offered intensive lifestyle counseling, since modest weight loss can have significant health benefits [3]. Providers, particularly within the primary care setting, are ideally situated to promote weight loss via effective obesity counseling, as multiple clinic visits over time have the potential to enable rapport building and behavioral change management [4]. Indeed, a 2013 systematic review and meta-analysis of published studies of survey data examining provider weight loss counseling and its association with changes in patient weight loss behavior found that primary care provider advice on weight loss appears to have a significant impact on patient attempts to change behaviors related to their weight [5]. In this study, the authors reported higher rates of physician advice about weight loss compared to other studies, however, the results still demonstrate that based on patient reporting, not all providers are advising weight management or weight loss. Several studies have discussed barriers to weight management and obesity counseling among adults by physicians, which include lack of training, time, and perceived ineffectiveness of their own efforts [6–8].

Additionally, and perhaps more importantly, different factors can impact patient perception of provider advice and/or counseling around weight management, weight loss, or obesity. These can include race/ethnicity [9], health literacy [10], and motivation [11]. This study adds to the literature by shedding new light on variables that are important to patients being advised by providers to lose/manage their weight, including actual and perceived obesity status, and perceived shared decision-making. Previous research has focused on patient-provider communication and shared decision-making in the areas of antibiotic use [12], diabetes management [13], and weight loss [14].

Strengths of this study included the variety of recruitment methods employed to enroll patients from multiple clinic sites, the diverse sociodemographic characteristics of the study sample that resulted, the assessment of variables using standard or previously used measures, and the use of both bivariate and multivariate analyses to assess relationships between variables. Key limitations were acknowledged by the authors and included the cross-sectional design, which does not allow for causality to be assessed; the use of surveys for data collection, which relies on subjective and self-reported data; the assessment of weight management/loss advice only from the perspective of the patient, as opposed to including the provider perspective or using objective observations/data; and the lack of assessment of advice content or frequency of advice given.

Applications for Clinical Practice

As the authors suggest, this study highlights opportunities for improving weight-related advice for patients. Providers should incorporate obesity screening and counseling with all patients, as recommended by clinical care guidelines and the literature. In weight management conversations, providers should also be mindful of patient beliefs and understanding of their weight status, and incorporate shared decision-making practices to increase patient self-efficacy (ie, confidence, readiness) to make weight loss efforts.)

Study Overview

Objective. To examine receipt of provider advice to lose weight among primary care patients who are overweight or obese.

Design. Cross-sectional study.

Setting and participants. Participants were recruited through convenience sampling of primary care practices that were members in a national practice-based research network or part of federally qualified health care system based in the Southeastern United States. Each practice used 1 or more of the following recruitment strategies: self-referral from study flyers posted in practices, given during clinic appointments, or posted on the practice portal (n = 3 practices); mailed invitations to patients part of a practice registry (n = 7 practices); and on-site recruitment by research staff during clinic hours (n = 2 practices). Inclusion criteria included having at least a 3-year history of being a patient in the practice, being aged 18 years or older, and having an overweight or obese status according to Centers for Disease Control definitions (body mass index [BMI] 25.0–29.9 kg/m² = overweight, ≥ 30 kg/m² = obese). After completing informed consent, participants completed an interview comprising a 20-minute survey, either in English or Spanish, either in-person or by telephone.

Measures. The survey obtained measures related to sociodemographic characteristics (race, gender, age, marital status, education level, employment status, income level), clinical characteristics (height and weight, history of diabetes/hypertension), psychological variables (readiness to make weight loss or maintenance efforts and confidence in their ability to lose or maintain weight), shared decision-making about weight loss/management (using the SDM-Q-9, with a higher total score indicating greater shared decision-making), and physician advice about weight loss (whether they had ever been advised by a doctor or other health care professional to lose weight or reduce their weight).

Main results. Among the study sample (n = 282), 65% were female, 60% were from racial and ethnic minority groups, 55% were married, 57% had some college education or higher, and 37% had an income level below $20,000/year. The mean age of participants was 53.1 (± 14.4) years. 59% had been advised by their physician to lose weight.

The percentage of participants who reported receiving provider advice was statistically different from 50% using the binomial test (P = 0.0035). Based on bivariate analysis of provider advice about weight loss, women were significantly more likely than men to report that their provider had advised them to lose weight (P = 0.001). Both actual and perceived obesity were associated significantly with receiving provider advice about weight loss (both P = 0.001). Diabetic patients were also significantly more likely than nondiabetic patients to report that their provider had advised them to lose weight (P = 0.01). Participants who reported greater readiness to lose or maintain their weight were more likely to report provider advice about weight loss compared to those with less readiness (P = 0.003). While employed patients, those who had at least some college education, and those who were hypertensive were more likely to report provider advice compared to those who were unemployed, had less education, and were not hypertensive, these associations were not statistically significant (P = 0.06, P = 0.06, P = 0.10, respectively). There were no racial/ethnic differences in receipt of provider advice to lose weight (P = 0.76). Participants with greater shared decision-making were more likely to report provider advice about weight loss (P < 0.001).

Based on results of the multivariate logistic regression analysis, obesity status, perceived obesity, and SDM about weight loss/management had significant independent associations with receiving physician advice about weight loss. Participants with obesity were more likely than those with overweight status to report provider advice (odds ratio [OR] = 1.31, 95% CI = 1.25–4.34, P = 0.001). Similarly, participants who believed they had overweight/obesity had a greater likelihood of reporting provider advice compared with those who did not believe they were obese/overweight (OR = 1.40, 95% CI = 2.43–6.37, P < 0.001). Shared decision making about weight loss/management was associated with an increased likelihood of reporting provider advice (OR = 3.30, 95% CI = 2.62–4.12, P < 0.001).

Conclusions. Many patients with overweight/obesity may not be receiving advice to lose/manage their weight by their provider. While providers should advise patients with overweight/obesity about weight loss and management, patient beliefs about their weight status and perceptions about shared decision-making are important to reporting receipt of provider advice about weight loss/management. Patient beliefs as well as provider behaviors should be addressed as part of efforts to improve the management of obesity/overweight in primary care.

Commentary

Over 35% of adults in the United States have a BMI in the obese range [1], putting them at risk for obesity-related comorbidities [2], often diagnosed and treated within primary care settings. The US Preventive Services Task Force recommends that all patients be screened for obesity and offered intensive lifestyle counseling, since modest weight loss can have significant health benefits [3]. Providers, particularly within the primary care setting, are ideally situated to promote weight loss via effective obesity counseling, as multiple clinic visits over time have the potential to enable rapport building and behavioral change management [4]. Indeed, a 2013 systematic review and meta-analysis of published studies of survey data examining provider weight loss counseling and its association with changes in patient weight loss behavior found that primary care provider advice on weight loss appears to have a significant impact on patient attempts to change behaviors related to their weight [5]. In this study, the authors reported higher rates of physician advice about weight loss compared to other studies, however, the results still demonstrate that based on patient reporting, not all providers are advising weight management or weight loss. Several studies have discussed barriers to weight management and obesity counseling among adults by physicians, which include lack of training, time, and perceived ineffectiveness of their own efforts [6–8].

Additionally, and perhaps more importantly, different factors can impact patient perception of provider advice and/or counseling around weight management, weight loss, or obesity. These can include race/ethnicity [9], health literacy [10], and motivation [11]. This study adds to the literature by shedding new light on variables that are important to patients being advised by providers to lose/manage their weight, including actual and perceived obesity status, and perceived shared decision-making. Previous research has focused on patient-provider communication and shared decision-making in the areas of antibiotic use [12], diabetes management [13], and weight loss [14].

Strengths of this study included the variety of recruitment methods employed to enroll patients from multiple clinic sites, the diverse sociodemographic characteristics of the study sample that resulted, the assessment of variables using standard or previously used measures, and the use of both bivariate and multivariate analyses to assess relationships between variables. Key limitations were acknowledged by the authors and included the cross-sectional design, which does not allow for causality to be assessed; the use of surveys for data collection, which relies on subjective and self-reported data; the assessment of weight management/loss advice only from the perspective of the patient, as opposed to including the provider perspective or using objective observations/data; and the lack of assessment of advice content or frequency of advice given.

Applications for Clinical Practice

As the authors suggest, this study highlights opportunities for improving weight-related advice for patients. Providers should incorporate obesity screening and counseling with all patients, as recommended by clinical care guidelines and the literature. In weight management conversations, providers should also be mindful of patient beliefs and understanding of their weight status, and incorporate shared decision-making practices to increase patient self-efficacy (ie, confidence, readiness) to make weight loss efforts.)

Study Overview

Objective. To examine receipt of provider advice to lose weight among primary care patients who are overweight or obese.

Design. Cross-sectional study.

Setting and participants. Participants were recruited through convenience sampling of primary care practices that were members in a national practice-based research network or part of federally qualified health care system based in the Southeastern United States. Each practice used 1 or more of the following recruitment strategies: self-referral from study flyers posted in practices, given during clinic appointments, or posted on the practice portal (n = 3 practices); mailed invitations to patients part of a practice registry (n = 7 practices); and on-site recruitment by research staff during clinic hours (n = 2 practices). Inclusion criteria included having at least a 3-year history of being a patient in the practice, being aged 18 years or older, and having an overweight or obese status according to Centers for Disease Control definitions (body mass index [BMI] 25.0–29.9 kg/m² = overweight, ≥ 30 kg/m² = obese). After completing informed consent, participants completed an interview comprising a 20-minute survey, either in English or Spanish, either in-person or by telephone.

Measures. The survey obtained measures related to sociodemographic characteristics (race, gender, age, marital status, education level, employment status, income level), clinical characteristics (height and weight, history of diabetes/hypertension), psychological variables (readiness to make weight loss or maintenance efforts and confidence in their ability to lose or maintain weight), shared decision-making about weight loss/management (using the SDM-Q-9, with a higher total score indicating greater shared decision-making), and physician advice about weight loss (whether they had ever been advised by a doctor or other health care professional to lose weight or reduce their weight).

Main results. Among the study sample (n = 282), 65% were female, 60% were from racial and ethnic minority groups, 55% were married, 57% had some college education or higher, and 37% had an income level below $20,000/year. The mean age of participants was 53.1 (± 14.4) years. 59% had been advised by their physician to lose weight.

The percentage of participants who reported receiving provider advice was statistically different from 50% using the binomial test (P = 0.0035). Based on bivariate analysis of provider advice about weight loss, women were significantly more likely than men to report that their provider had advised them to lose weight (P = 0.001). Both actual and perceived obesity were associated significantly with receiving provider advice about weight loss (both P = 0.001). Diabetic patients were also significantly more likely than nondiabetic patients to report that their provider had advised them to lose weight (P = 0.01). Participants who reported greater readiness to lose or maintain their weight were more likely to report provider advice about weight loss compared to those with less readiness (P = 0.003). While employed patients, those who had at least some college education, and those who were hypertensive were more likely to report provider advice compared to those who were unemployed, had less education, and were not hypertensive, these associations were not statistically significant (P = 0.06, P = 0.06, P = 0.10, respectively). There were no racial/ethnic differences in receipt of provider advice to lose weight (P = 0.76). Participants with greater shared decision-making were more likely to report provider advice about weight loss (P < 0.001).

Based on results of the multivariate logistic regression analysis, obesity status, perceived obesity, and SDM about weight loss/management had significant independent associations with receiving physician advice about weight loss. Participants with obesity were more likely than those with overweight status to report provider advice (odds ratio [OR] = 1.31, 95% CI = 1.25–4.34, P = 0.001). Similarly, participants who believed they had overweight/obesity had a greater likelihood of reporting provider advice compared with those who did not believe they were obese/overweight (OR = 1.40, 95% CI = 2.43–6.37, P < 0.001). Shared decision making about weight loss/management was associated with an increased likelihood of reporting provider advice (OR = 3.30, 95% CI = 2.62–4.12, P < 0.001).

Conclusions. Many patients with overweight/obesity may not be receiving advice to lose/manage their weight by their provider. While providers should advise patients with overweight/obesity about weight loss and management, patient beliefs about their weight status and perceptions about shared decision-making are important to reporting receipt of provider advice about weight loss/management. Patient beliefs as well as provider behaviors should be addressed as part of efforts to improve the management of obesity/overweight in primary care.

Commentary

Over 35% of adults in the United States have a BMI in the obese range [1], putting them at risk for obesity-related comorbidities [2], often diagnosed and treated within primary care settings. The US Preventive Services Task Force recommends that all patients be screened for obesity and offered intensive lifestyle counseling, since modest weight loss can have significant health benefits [3]. Providers, particularly within the primary care setting, are ideally situated to promote weight loss via effective obesity counseling, as multiple clinic visits over time have the potential to enable rapport building and behavioral change management [4]. Indeed, a 2013 systematic review and meta-analysis of published studies of survey data examining provider weight loss counseling and its association with changes in patient weight loss behavior found that primary care provider advice on weight loss appears to have a significant impact on patient attempts to change behaviors related to their weight [5]. In this study, the authors reported higher rates of physician advice about weight loss compared to other studies, however, the results still demonstrate that based on patient reporting, not all providers are advising weight management or weight loss. Several studies have discussed barriers to weight management and obesity counseling among adults by physicians, which include lack of training, time, and perceived ineffectiveness of their own efforts [6–8].

Additionally, and perhaps more importantly, different factors can impact patient perception of provider advice and/or counseling around weight management, weight loss, or obesity. These can include race/ethnicity [9], health literacy [10], and motivation [11]. This study adds to the literature by shedding new light on variables that are important to patients being advised by providers to lose/manage their weight, including actual and perceived obesity status, and perceived shared decision-making. Previous research has focused on patient-provider communication and shared decision-making in the areas of antibiotic use [12], diabetes management [13], and weight loss [14].

Strengths of this study included the variety of recruitment methods employed to enroll patients from multiple clinic sites, the diverse sociodemographic characteristics of the study sample that resulted, the assessment of variables using standard or previously used measures, and the use of both bivariate and multivariate analyses to assess relationships between variables. Key limitations were acknowledged by the authors and included the cross-sectional design, which does not allow for causality to be assessed; the use of surveys for data collection, which relies on subjective and self-reported data; the assessment of weight management/loss advice only from the perspective of the patient, as opposed to including the provider perspective or using objective observations/data; and the lack of assessment of advice content or frequency of advice given.

Applications for Clinical Practice

As the authors suggest, this study highlights opportunities for improving weight-related advice for patients. Providers should incorporate obesity screening and counseling with all patients, as recommended by clinical care guidelines and the literature. In weight management conversations, providers should also be mindful of patient beliefs and understanding of their weight status, and incorporate shared decision-making practices to increase patient self-efficacy (ie, confidence, readiness) to make weight loss efforts.)

ANAHEIM – If blood pressure isn’t measured the way it was in the SPRINT trial, it shouldn’t be treated all the way down to the SPRINT target of less than 120 mm Hg; it’s best to aim a little higher, according to investigators from Kaiser Permanente of Northern California.

SPRINT (the Systolic Blood Pressure Intervention Trial) found that treating hypertension to below 120 mm Hg – as opposed to below 140 mm Hg – reduced the risk of cardiovascular events and death, but blood pressure wasn’t measured the way it usually is in standard practice. Among other differences, SPRINT subjects rested for 5 minutes beforehand, sometimes unobserved, and then three automated measurements were taken and averaged (N Engl J Med. 2015 Nov 26;373[22]:2103-16).

[email protected]

ANAHEIM – If blood pressure isn’t measured the way it was in the SPRINT trial, it shouldn’t be treated all the way down to the SPRINT target of less than 120 mm Hg; it’s best to aim a little higher, according to investigators from Kaiser Permanente of Northern California.

SPRINT (the Systolic Blood Pressure Intervention Trial) found that treating hypertension to below 120 mm Hg – as opposed to below 140 mm Hg – reduced the risk of cardiovascular events and death, but blood pressure wasn’t measured the way it usually is in standard practice. Among other differences, SPRINT subjects rested for 5 minutes beforehand, sometimes unobserved, and then three automated measurements were taken and averaged (N Engl J Med. 2015 Nov 26;373[22]:2103-16).

[email protected]

ANAHEIM – If blood pressure isn’t measured the way it was in the SPRINT trial, it shouldn’t be treated all the way down to the SPRINT target of less than 120 mm Hg; it’s best to aim a little higher, according to investigators from Kaiser Permanente of Northern California.

SPRINT (the Systolic Blood Pressure Intervention Trial) found that treating hypertension to below 120 mm Hg – as opposed to below 140 mm Hg – reduced the risk of cardiovascular events and death, but blood pressure wasn’t measured the way it usually is in standard practice. Among other differences, SPRINT subjects rested for 5 minutes beforehand, sometimes unobserved, and then three automated measurements were taken and averaged (N Engl J Med. 2015 Nov 26;373[22]:2103-16).

[email protected]

SAN DIEGO – Results from two phase 2 studies of the investigational agent anabasum provide evidence supporting its safety and efficacy in patients with refractory skin-predominant dermatomyositis or diffuse cutaneous systemic sclerosis.

Anabasum (JBT-101) is a nonimmunosuppressive, synthetic, oral cannabinoid receptor type 2 agonist being developed by Norwood, Mass.–based Corbus Pharmaceuticals. It works by triggering resolution of innate immune responses, said Barbara White, MD, a rheumatologist who is chief medical officer for Corbus. “It restores homeostasis, gets rid of inflammation, turns off active fibrotic processes, and helps clear bacteria if it is present – all without immunosuppression,” she explained in an interview at the annual meeting of the American College of Rheumatology. “A drug that would restore homeostasis in the setting of an ongoing immune response has the potential to be helpful in multiple autoimmune diseases.”

Doug Brunk/Frontline Medical News

[email protected]

SAN DIEGO – Results from two phase 2 studies of the investigational agent anabasum provide evidence supporting its safety and efficacy in patients with refractory skin-predominant dermatomyositis or diffuse cutaneous systemic sclerosis.

Anabasum (JBT-101) is a nonimmunosuppressive, synthetic, oral cannabinoid receptor type 2 agonist being developed by Norwood, Mass.–based Corbus Pharmaceuticals. It works by triggering resolution of innate immune responses, said Barbara White, MD, a rheumatologist who is chief medical officer for Corbus. “It restores homeostasis, gets rid of inflammation, turns off active fibrotic processes, and helps clear bacteria if it is present – all without immunosuppression,” she explained in an interview at the annual meeting of the American College of Rheumatology. “A drug that would restore homeostasis in the setting of an ongoing immune response has the potential to be helpful in multiple autoimmune diseases.”

Doug Brunk/Frontline Medical News

[email protected]

SAN DIEGO – Results from two phase 2 studies of the investigational agent anabasum provide evidence supporting its safety and efficacy in patients with refractory skin-predominant dermatomyositis or diffuse cutaneous systemic sclerosis.

Anabasum (JBT-101) is a nonimmunosuppressive, synthetic, oral cannabinoid receptor type 2 agonist being developed by Norwood, Mass.–based Corbus Pharmaceuticals. It works by triggering resolution of innate immune responses, said Barbara White, MD, a rheumatologist who is chief medical officer for Corbus. “It restores homeostasis, gets rid of inflammation, turns off active fibrotic processes, and helps clear bacteria if it is present – all without immunosuppression,” she explained in an interview at the annual meeting of the American College of Rheumatology. “A drug that would restore homeostasis in the setting of an ongoing immune response has the potential to be helpful in multiple autoimmune diseases.”

Doug Brunk/Frontline Medical News

[email protected]

At Mount Sinai Hospital, Choosing Wisely’s guidelines for hospital medicine inspired Harry Cho, MD, FACP, and his colleagues to work on the rates of catheter-associated urinary tract infection in their hospital.

They launched their “Lose the Tube” project, creating an electronic catheter identification tool and instituting a daily multidisciplinary query. “On our patient list, we had a column with a green or red dot, indicating if the patient had a catheter or not,” Dr. Cho said. “From there, we wanted to give the onus to the provider. During multidisciplinary rounds, we queried the doctor – we were not ordering them – ‘Does this patient need the Foley?’ After a while, people started coming into multidisciplinary rounds knowing if their patients had a Foley. It was a culture shift.”

Reference

Cho HJ et al. “Lose the Tube”: A Choosing Wisely initiative to reduce catheter-associated urinary tract infections in hospitalist-led inpatient units. Am J Infect Control. 2017 Mar 1;45(3):333-5.

At Mount Sinai Hospital, Choosing Wisely’s guidelines for hospital medicine inspired Harry Cho, MD, FACP, and his colleagues to work on the rates of catheter-associated urinary tract infection in their hospital.

They launched their “Lose the Tube” project, creating an electronic catheter identification tool and instituting a daily multidisciplinary query. “On our patient list, we had a column with a green or red dot, indicating if the patient had a catheter or not,” Dr. Cho said. “From there, we wanted to give the onus to the provider. During multidisciplinary rounds, we queried the doctor – we were not ordering them – ‘Does this patient need the Foley?’ After a while, people started coming into multidisciplinary rounds knowing if their patients had a Foley. It was a culture shift.”

Reference

Cho HJ et al. “Lose the Tube”: A Choosing Wisely initiative to reduce catheter-associated urinary tract infections in hospitalist-led inpatient units. Am J Infect Control. 2017 Mar 1;45(3):333-5.

At Mount Sinai Hospital, Choosing Wisely’s guidelines for hospital medicine inspired Harry Cho, MD, FACP, and his colleagues to work on the rates of catheter-associated urinary tract infection in their hospital.

They launched their “Lose the Tube” project, creating an electronic catheter identification tool and instituting a daily multidisciplinary query. “On our patient list, we had a column with a green or red dot, indicating if the patient had a catheter or not,” Dr. Cho said. “From there, we wanted to give the onus to the provider. During multidisciplinary rounds, we queried the doctor – we were not ordering them – ‘Does this patient need the Foley?’ After a while, people started coming into multidisciplinary rounds knowing if their patients had a Foley. It was a culture shift.”

Reference

Cho HJ et al. “Lose the Tube”: A Choosing Wisely initiative to reduce catheter-associated urinary tract infections in hospitalist-led inpatient units. Am J Infect Control. 2017 Mar 1;45(3):333-5.

Infants with possible prenatal exposure to Zika who test positive for the virus should receive an in-depth ophthalmologic exam, intensified hearing testing, and a thorough neurologic evaluation with brain imaging within one month of birth, according to new interim guidance from the Centers for Disease Control and Prevention (CDC).

The new clinical management guidelines, published in the October 20 issue of Morbidity and Mortality Weekly Report, supersede the CDC guidance issued in August 2016. The update was the product of a forum on the diagnosis, evaluation, and management of Zika in infants that the centers convened with the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists. Practicing clinicians and federal agency representatives reviewed the evolving body of knowledge on how best to care for these infants. Since Zika emerged as a public health concern, clinicians have reported postnatal onset of some symptoms, including eye abnormalities, incident microcephaly in infants with a normal head circumference at birth, EEG abnormalities, and diaphragmatic paralysis.

Infants With Clinical Findings Consistent With Zika Syndrome

Infants with clinical findings consistent with congenital Zika syndrome who are born to mothers with possible Zika virus exposure in pregnancy should be tested for Zika virus with serum and urine tests. If those tests are negative, and there is no other apparent cause of the symptoms, they should have a CSF sample tested for Zika RNA and IgM Zika antibodies.

By one month, these infants should undergo a head ultrasound and a detailed ophthalmologic exam. The eye exam should pick up any anomalies of the anterior and posterior eye, including microphthalmia, coloboma, intraocular calcifications, optic nerve hypoplasia and atrophy, and macular scarring with focal pigmentary retinal mottling.

By one month, these infants also should undergo auditory brainstem response (ABR) audiometry, especially if the initial newborn hearing screen was done by otoacoustic emissions alone. Zika syndrome can include sensorineural hearing loss, although late-onset hearing loss has not been seen. Therefore, the follow-up ABR previously recommended at four to six months is no longer deemed necessary.

A comprehensive neurologic exam also is recommended. Seizures are sometimes part of Zika syndrome, but infants can also have subclinical EEG abnormalities. Advanced neuroimaging can identify obvious and subtle brain abnormalities, such as cortical thinning, corpus callosum abnormalities, calcifications at the junction of white and gray matter, and ventricular enlargement.

As infants grow, clinicians should be alert for signs of increased intracranial pressure that could signal postnatal hydrocephalus. Diaphragmatic paralysis also has been seen; it manifests as respiratory distress. Dysphagia that interferes with feeding can develop as well.

“The follow-up care of [these infants] requires a multidisciplinary team and an established medical home to facilitate the coordination of care and ensure that abnormal findings are addressed,” said Dr. Adebanjo and colleagues.

Asymptomatic Infants of Mothers With Possible Infection

Infants without clinical findings born to mothers with laboratory evidence of possible Zika virus infection during pregnancy should have the same early head ultrasound, hearing, and eye exams as those with clinical findings. All of these infants also should be tested for Zika virus just as those with clinical findings should be.

If tests are positive, these infants should have all the investigations and follow-up recommended for babies with clinical findings. If laboratory testing is negative, and clinical findings are normal, Zika infection is highly unlikely, and the infants can receive routine care. Clinicians and parents should be on the lookout, however, for new symptoms that might suggest postnatal Zika syndrome.

Asymptomatic Infants Whose Mothers Had Unconfirmed Zika Exposure

Infants without clinical findings consistent with congenital Zika syndrome born to mothers with possible Zika virus exposure in pregnancy, but without laboratory evidence of possible Zika virus infection during pregnancy, constitute a large group. Some women, for example, are never tested during pregnancy, and others have false negative test results. “Because the latter issues are not easily discerned, all mothers with possible exposure to Zika virus during pregnancy who do not have laboratory evidence of possible Zika virus infection, including those who tested negative with currently available technology, should be considered in this group,” said Dr. Adebanjo and colleagues.

The CDC do not recommend further Zika evaluation for these infants unless additional testing confirms maternal infection. For older infants, parents and clinicians should decide together whether further evaluations would be helpful. “If findings consistent with congenital Zika syndrome are identified at any time, referrals to the appropriate specialists should be made, and subsequent evaluation should follow recommendations for infants with clinical findings consistent with congenital Zika syndrome,” said the authors.

The CDC also reiterated their special recommendations for infants who had a prenatal diagnosis of Zika infection. For now, these recommendations remain unchanged, although “as more data become available, understanding of the diagnostic role of prenatal ultrasound and amniocentesis … will improve, and guidance will be updated.”

The optimal timing for a Zika diagnostic ultrasound is uncertain. The CDC recommend that serial ultrasounds be performed every three to four weeks for women with laboratory-confirmed prenatal Zika exposure. Women with possible exposure need only routine ultrasound screenings.

While Zika RNA has been identified in amniotic fluid, there is no consensus on the value of amniocentesis as a prenatal diagnostic tool. Investigations of serial amniocentesis suggest that viral shedding into the amniotic fluid might be transient. If amniocentesis is performed for other reasons, Zika nucleic acid testing can be incorporated.

A shared decision-making process about screening is key, said Dr. Adebanjo and colleagues. “For example, serial ultrasound examinations might be inconvenient, unpleasant, and expensive, and might prompt unnecessary interventions; amniocentesis carries additional known risks such as fetal loss. These potential harms of prenatal screening for congenital Zika syndrome might outweigh the clinical benefits for some patients; therefore, these decisions should be individualized.”

—Michele G. Sullivan

Suggested Reading

Adebanjo T, Godfred-Cato S, Viens L, et al. Update: Interim guidance for the diagnosis, evaluation, and management of infants with possible congenital Zika virus infection - United States, October 2017. MMWR Morb Mortal Wkly Rep. 2017;66(41):1089-1099.

Infants with possible prenatal exposure to Zika who test positive for the virus should receive an in-depth ophthalmologic exam, intensified hearing testing, and a thorough neurologic evaluation with brain imaging within one month of birth, according to new interim guidance from the Centers for Disease Control and Prevention (CDC).

The new clinical management guidelines, published in the October 20 issue of Morbidity and Mortality Weekly Report, supersede the CDC guidance issued in August 2016. The update was the product of a forum on the diagnosis, evaluation, and management of Zika in infants that the centers convened with the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists. Practicing clinicians and federal agency representatives reviewed the evolving body of knowledge on how best to care for these infants. Since Zika emerged as a public health concern, clinicians have reported postnatal onset of some symptoms, including eye abnormalities, incident microcephaly in infants with a normal head circumference at birth, EEG abnormalities, and diaphragmatic paralysis.

Infants With Clinical Findings Consistent With Zika Syndrome

Infants with clinical findings consistent with congenital Zika syndrome who are born to mothers with possible Zika virus exposure in pregnancy should be tested for Zika virus with serum and urine tests. If those tests are negative, and there is no other apparent cause of the symptoms, they should have a CSF sample tested for Zika RNA and IgM Zika antibodies.

By one month, these infants should undergo a head ultrasound and a detailed ophthalmologic exam. The eye exam should pick up any anomalies of the anterior and posterior eye, including microphthalmia, coloboma, intraocular calcifications, optic nerve hypoplasia and atrophy, and macular scarring with focal pigmentary retinal mottling.

By one month, these infants also should undergo auditory brainstem response (ABR) audiometry, especially if the initial newborn hearing screen was done by otoacoustic emissions alone. Zika syndrome can include sensorineural hearing loss, although late-onset hearing loss has not been seen. Therefore, the follow-up ABR previously recommended at four to six months is no longer deemed necessary.

A comprehensive neurologic exam also is recommended. Seizures are sometimes part of Zika syndrome, but infants can also have subclinical EEG abnormalities. Advanced neuroimaging can identify obvious and subtle brain abnormalities, such as cortical thinning, corpus callosum abnormalities, calcifications at the junction of white and gray matter, and ventricular enlargement.

As infants grow, clinicians should be alert for signs of increased intracranial pressure that could signal postnatal hydrocephalus. Diaphragmatic paralysis also has been seen; it manifests as respiratory distress. Dysphagia that interferes with feeding can develop as well.

“The follow-up care of [these infants] requires a multidisciplinary team and an established medical home to facilitate the coordination of care and ensure that abnormal findings are addressed,” said Dr. Adebanjo and colleagues.

Asymptomatic Infants of Mothers With Possible Infection

Infants without clinical findings born to mothers with laboratory evidence of possible Zika virus infection during pregnancy should have the same early head ultrasound, hearing, and eye exams as those with clinical findings. All of these infants also should be tested for Zika virus just as those with clinical findings should be.

If tests are positive, these infants should have all the investigations and follow-up recommended for babies with clinical findings. If laboratory testing is negative, and clinical findings are normal, Zika infection is highly unlikely, and the infants can receive routine care. Clinicians and parents should be on the lookout, however, for new symptoms that might suggest postnatal Zika syndrome.

Asymptomatic Infants Whose Mothers Had Unconfirmed Zika Exposure

Infants without clinical findings consistent with congenital Zika syndrome born to mothers with possible Zika virus exposure in pregnancy, but without laboratory evidence of possible Zika virus infection during pregnancy, constitute a large group. Some women, for example, are never tested during pregnancy, and others have false negative test results. “Because the latter issues are not easily discerned, all mothers with possible exposure to Zika virus during pregnancy who do not have laboratory evidence of possible Zika virus infection, including those who tested negative with currently available technology, should be considered in this group,” said Dr. Adebanjo and colleagues.

The CDC do not recommend further Zika evaluation for these infants unless additional testing confirms maternal infection. For older infants, parents and clinicians should decide together whether further evaluations would be helpful. “If findings consistent with congenital Zika syndrome are identified at any time, referrals to the appropriate specialists should be made, and subsequent evaluation should follow recommendations for infants with clinical findings consistent with congenital Zika syndrome,” said the authors.

The CDC also reiterated their special recommendations for infants who had a prenatal diagnosis of Zika infection. For now, these recommendations remain unchanged, although “as more data become available, understanding of the diagnostic role of prenatal ultrasound and amniocentesis … will improve, and guidance will be updated.”

The optimal timing for a Zika diagnostic ultrasound is uncertain. The CDC recommend that serial ultrasounds be performed every three to four weeks for women with laboratory-confirmed prenatal Zika exposure. Women with possible exposure need only routine ultrasound screenings.

While Zika RNA has been identified in amniotic fluid, there is no consensus on the value of amniocentesis as a prenatal diagnostic tool. Investigations of serial amniocentesis suggest that viral shedding into the amniotic fluid might be transient. If amniocentesis is performed for other reasons, Zika nucleic acid testing can be incorporated.

A shared decision-making process about screening is key, said Dr. Adebanjo and colleagues. “For example, serial ultrasound examinations might be inconvenient, unpleasant, and expensive, and might prompt unnecessary interventions; amniocentesis carries additional known risks such as fetal loss. These potential harms of prenatal screening for congenital Zika syndrome might outweigh the clinical benefits for some patients; therefore, these decisions should be individualized.”

—Michele G. Sullivan

Suggested Reading

Adebanjo T, Godfred-Cato S, Viens L, et al. Update: Interim guidance for the diagnosis, evaluation, and management of infants with possible congenital Zika virus infection - United States, October 2017. MMWR Morb Mortal Wkly Rep. 2017;66(41):1089-1099.

Infants with possible prenatal exposure to Zika who test positive for the virus should receive an in-depth ophthalmologic exam, intensified hearing testing, and a thorough neurologic evaluation with brain imaging within one month of birth, according to new interim guidance from the Centers for Disease Control and Prevention (CDC).

The new clinical management guidelines, published in the October 20 issue of Morbidity and Mortality Weekly Report, supersede the CDC guidance issued in August 2016. The update was the product of a forum on the diagnosis, evaluation, and management of Zika in infants that the centers convened with the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists. Practicing clinicians and federal agency representatives reviewed the evolving body of knowledge on how best to care for these infants. Since Zika emerged as a public health concern, clinicians have reported postnatal onset of some symptoms, including eye abnormalities, incident microcephaly in infants with a normal head circumference at birth, EEG abnormalities, and diaphragmatic paralysis.

Infants With Clinical Findings Consistent With Zika Syndrome

Infants with clinical findings consistent with congenital Zika syndrome who are born to mothers with possible Zika virus exposure in pregnancy should be tested for Zika virus with serum and urine tests. If those tests are negative, and there is no other apparent cause of the symptoms, they should have a CSF sample tested for Zika RNA and IgM Zika antibodies.

By one month, these infants should undergo a head ultrasound and a detailed ophthalmologic exam. The eye exam should pick up any anomalies of the anterior and posterior eye, including microphthalmia, coloboma, intraocular calcifications, optic nerve hypoplasia and atrophy, and macular scarring with focal pigmentary retinal mottling.

By one month, these infants also should undergo auditory brainstem response (ABR) audiometry, especially if the initial newborn hearing screen was done by otoacoustic emissions alone. Zika syndrome can include sensorineural hearing loss, although late-onset hearing loss has not been seen. Therefore, the follow-up ABR previously recommended at four to six months is no longer deemed necessary.

A comprehensive neurologic exam also is recommended. Seizures are sometimes part of Zika syndrome, but infants can also have subclinical EEG abnormalities. Advanced neuroimaging can identify obvious and subtle brain abnormalities, such as cortical thinning, corpus callosum abnormalities, calcifications at the junction of white and gray matter, and ventricular enlargement.

As infants grow, clinicians should be alert for signs of increased intracranial pressure that could signal postnatal hydrocephalus. Diaphragmatic paralysis also has been seen; it manifests as respiratory distress. Dysphagia that interferes with feeding can develop as well.

“The follow-up care of [these infants] requires a multidisciplinary team and an established medical home to facilitate the coordination of care and ensure that abnormal findings are addressed,” said Dr. Adebanjo and colleagues.

Asymptomatic Infants of Mothers With Possible Infection

Infants without clinical findings born to mothers with laboratory evidence of possible Zika virus infection during pregnancy should have the same early head ultrasound, hearing, and eye exams as those with clinical findings. All of these infants also should be tested for Zika virus just as those with clinical findings should be.

If tests are positive, these infants should have all the investigations and follow-up recommended for babies with clinical findings. If laboratory testing is negative, and clinical findings are normal, Zika infection is highly unlikely, and the infants can receive routine care. Clinicians and parents should be on the lookout, however, for new symptoms that might suggest postnatal Zika syndrome.

Asymptomatic Infants Whose Mothers Had Unconfirmed Zika Exposure

Infants without clinical findings consistent with congenital Zika syndrome born to mothers with possible Zika virus exposure in pregnancy, but without laboratory evidence of possible Zika virus infection during pregnancy, constitute a large group. Some women, for example, are never tested during pregnancy, and others have false negative test results. “Because the latter issues are not easily discerned, all mothers with possible exposure to Zika virus during pregnancy who do not have laboratory evidence of possible Zika virus infection, including those who tested negative with currently available technology, should be considered in this group,” said Dr. Adebanjo and colleagues.

The CDC do not recommend further Zika evaluation for these infants unless additional testing confirms maternal infection. For older infants, parents and clinicians should decide together whether further evaluations would be helpful. “If findings consistent with congenital Zika syndrome are identified at any time, referrals to the appropriate specialists should be made, and subsequent evaluation should follow recommendations for infants with clinical findings consistent with congenital Zika syndrome,” said the authors.

The CDC also reiterated their special recommendations for infants who had a prenatal diagnosis of Zika infection. For now, these recommendations remain unchanged, although “as more data become available, understanding of the diagnostic role of prenatal ultrasound and amniocentesis … will improve, and guidance will be updated.”

The optimal timing for a Zika diagnostic ultrasound is uncertain. The CDC recommend that serial ultrasounds be performed every three to four weeks for women with laboratory-confirmed prenatal Zika exposure. Women with possible exposure need only routine ultrasound screenings.

While Zika RNA has been identified in amniotic fluid, there is no consensus on the value of amniocentesis as a prenatal diagnostic tool. Investigations of serial amniocentesis suggest that viral shedding into the amniotic fluid might be transient. If amniocentesis is performed for other reasons, Zika nucleic acid testing can be incorporated.

A shared decision-making process about screening is key, said Dr. Adebanjo and colleagues. “For example, serial ultrasound examinations might be inconvenient, unpleasant, and expensive, and might prompt unnecessary interventions; amniocentesis carries additional known risks such as fetal loss. These potential harms of prenatal screening for congenital Zika syndrome might outweigh the clinical benefits for some patients; therefore, these decisions should be individualized.”

—Michele G. Sullivan

Suggested Reading

Adebanjo T, Godfred-Cato S, Viens L, et al. Update: Interim guidance for the diagnosis, evaluation, and management of infants with possible congenital Zika virus infection - United States, October 2017. MMWR Morb Mortal Wkly Rep. 2017;66(41):1089-1099.

In patients with malignant biliary strictures, radiofrequency ablation may improve stent patency and prolong survival, according to results of a recent meta-analysis.

Radiofrequency ablation was also safe and well tolerated. The report appears in Gastrointestinal Endoscopy (2017. doi: 10.1016/j.gie.2017.10.029).

Although the data to date are limited and mostly observational, radiofrequency ablation “may be a promising adjuvant therapy in patients with malignant biliary obstruction who otherwise have dismal outcomes with current standard of therapy,” wrote Aijaz Ahmed Sofi, MD, of the department of gastroenterology, Arizona Center for Digestive Health, Gilbert, and coauthors.

Use of radiofrequency ablation is thought to improve the patency of biliary stents placed as a palliative measure in patients with unresectable malignant biliary strictures. However, several studies evaluating this and other endpoints have produced “variable results,” the authors said in the report.

In a comprehensive literature search, Dr. Sofi and colleagues identified nine studies including 505 patients. Only one of the studies was randomized and controlled, and results from it were preliminary, they noted.

Combined results showed a 50.6-day pooled weighted mean difference in stent patency (95% confidence interval, 32.83-68.48) in favor of radiofrequency ablation, according to reported data. In addition, there was a significant difference in survival favoring use of radiofrequency ablation (hazard ratio, 1.395; 95% confidence interval, 1.145-1.7; P less than .001).

While there was no difference between groups in risk of cholangitis, pancreatitis, hemobilia, and acute cholecystitis, abdominal pain after the procedure was more frequent in the radiofrequency ablation group (31% vs. 20%, P = .003).

This is the first systematic review and meta-analysis evaluating radiofrequency ablation as an adjuvant therapy in patients who receive biliary stents for malignant biliary obstruction, according to the investigators.

Despite the findings, Dr. Sofi and colleagues were careful to emphasize the limitations of the analysis, writing that it provides “very low quality evidence” in favor of radiofrequency ablation therapy for management of malignant biliary strictures.

“The results of currently ongoing controlled studies examining the role of RFA [radiofrequency ablation] in malignant biliary obstruction are keenly awaited,” they wrote.

Dr. Sofi and colleagues reported no potential conflicts of interest associated with the study.

In patients with malignant biliary strictures, radiofrequency ablation may improve stent patency and prolong survival, according to results of a recent meta-analysis.

Radiofrequency ablation was also safe and well tolerated. The report appears in Gastrointestinal Endoscopy (2017. doi: 10.1016/j.gie.2017.10.029).

Although the data to date are limited and mostly observational, radiofrequency ablation “may be a promising adjuvant therapy in patients with malignant biliary obstruction who otherwise have dismal outcomes with current standard of therapy,” wrote Aijaz Ahmed Sofi, MD, of the department of gastroenterology, Arizona Center for Digestive Health, Gilbert, and coauthors.

Use of radiofrequency ablation is thought to improve the patency of biliary stents placed as a palliative measure in patients with unresectable malignant biliary strictures. However, several studies evaluating this and other endpoints have produced “variable results,” the authors said in the report.

In a comprehensive literature search, Dr. Sofi and colleagues identified nine studies including 505 patients. Only one of the studies was randomized and controlled, and results from it were preliminary, they noted.

Combined results showed a 50.6-day pooled weighted mean difference in stent patency (95% confidence interval, 32.83-68.48) in favor of radiofrequency ablation, according to reported data. In addition, there was a significant difference in survival favoring use of radiofrequency ablation (hazard ratio, 1.395; 95% confidence interval, 1.145-1.7; P less than .001).

While there was no difference between groups in risk of cholangitis, pancreatitis, hemobilia, and acute cholecystitis, abdominal pain after the procedure was more frequent in the radiofrequency ablation group (31% vs. 20%, P = .003).

This is the first systematic review and meta-analysis evaluating radiofrequency ablation as an adjuvant therapy in patients who receive biliary stents for malignant biliary obstruction, according to the investigators.

Despite the findings, Dr. Sofi and colleagues were careful to emphasize the limitations of the analysis, writing that it provides “very low quality evidence” in favor of radiofrequency ablation therapy for management of malignant biliary strictures.

“The results of currently ongoing controlled studies examining the role of RFA [radiofrequency ablation] in malignant biliary obstruction are keenly awaited,” they wrote.

Dr. Sofi and colleagues reported no potential conflicts of interest associated with the study.

In patients with malignant biliary strictures, radiofrequency ablation may improve stent patency and prolong survival, according to results of a recent meta-analysis.

Radiofrequency ablation was also safe and well tolerated. The report appears in Gastrointestinal Endoscopy (2017. doi: 10.1016/j.gie.2017.10.029).

Although the data to date are limited and mostly observational, radiofrequency ablation “may be a promising adjuvant therapy in patients with malignant biliary obstruction who otherwise have dismal outcomes with current standard of therapy,” wrote Aijaz Ahmed Sofi, MD, of the department of gastroenterology, Arizona Center for Digestive Health, Gilbert, and coauthors.

Use of radiofrequency ablation is thought to improve the patency of biliary stents placed as a palliative measure in patients with unresectable malignant biliary strictures. However, several studies evaluating this and other endpoints have produced “variable results,” the authors said in the report.

In a comprehensive literature search, Dr. Sofi and colleagues identified nine studies including 505 patients. Only one of the studies was randomized and controlled, and results from it were preliminary, they noted.

Combined results showed a 50.6-day pooled weighted mean difference in stent patency (95% confidence interval, 32.83-68.48) in favor of radiofrequency ablation, according to reported data. In addition, there was a significant difference in survival favoring use of radiofrequency ablation (hazard ratio, 1.395; 95% confidence interval, 1.145-1.7; P less than .001).

While there was no difference between groups in risk of cholangitis, pancreatitis, hemobilia, and acute cholecystitis, abdominal pain after the procedure was more frequent in the radiofrequency ablation group (31% vs. 20%, P = .003).

This is the first systematic review and meta-analysis evaluating radiofrequency ablation as an adjuvant therapy in patients who receive biliary stents for malignant biliary obstruction, according to the investigators.

Despite the findings, Dr. Sofi and colleagues were careful to emphasize the limitations of the analysis, writing that it provides “very low quality evidence” in favor of radiofrequency ablation therapy for management of malignant biliary strictures.

“The results of currently ongoing controlled studies examining the role of RFA [radiofrequency ablation] in malignant biliary obstruction are keenly awaited,” they wrote.

Dr. Sofi and colleagues reported no potential conflicts of interest associated with the study.

ANAHEIM, CALIF. – More than half of the BP measurements of patients in the SPRINT trial were at least partially attended by clinic staff, but those efforts made no difference in outcomes, according to a survey presented by SPRINT investigators at the American Heart Association scientific sessions.

“It really didn’t matter” whether measurements were observed or not; blood pressure control and outcomes – fewer deaths and cardiovascular events when hypertension was treated to below 120 mm Hg instead of below 140 mm Hg – were largely the same either way, said the survey’s lead investigator Karen C. Johnson, MD, professor of women’s health and preventive medicine at the University of Tennessee in Memphis.

[email protected]

ANAHEIM, CALIF. – More than half of the BP measurements of patients in the SPRINT trial were at least partially attended by clinic staff, but those efforts made no difference in outcomes, according to a survey presented by SPRINT investigators at the American Heart Association scientific sessions.

“It really didn’t matter” whether measurements were observed or not; blood pressure control and outcomes – fewer deaths and cardiovascular events when hypertension was treated to below 120 mm Hg instead of below 140 mm Hg – were largely the same either way, said the survey’s lead investigator Karen C. Johnson, MD, professor of women’s health and preventive medicine at the University of Tennessee in Memphis.

[email protected]

ANAHEIM, CALIF. – More than half of the BP measurements of patients in the SPRINT trial were at least partially attended by clinic staff, but those efforts made no difference in outcomes, according to a survey presented by SPRINT investigators at the American Heart Association scientific sessions.

“It really didn’t matter” whether measurements were observed or not; blood pressure control and outcomes – fewer deaths and cardiovascular events when hypertension was treated to below 120 mm Hg instead of below 140 mm Hg – were largely the same either way, said the survey’s lead investigator Karen C. Johnson, MD, professor of women’s health and preventive medicine at the University of Tennessee in Memphis.

[email protected]

BOSTON – An investigational Alzheimer’s drug intended to potentiate acetylcholine release didn’t pass muster in a global phase 3 study, despite a successful phase 2 trial.

Intepirdine on a background of stable-dose donepezil failed to confer any cognitive or functional benefit in patients with mild to moderate Alzheimer’s disease, Ilise Lombardo, PhD, said at the Clinical Trials on Alzheimer’s Disease conference.

[email protected]

On Twitter @alz_gal

BOSTON – An investigational Alzheimer’s drug intended to potentiate acetylcholine release didn’t pass muster in a global phase 3 study, despite a successful phase 2 trial.

Intepirdine on a background of stable-dose donepezil failed to confer any cognitive or functional benefit in patients with mild to moderate Alzheimer’s disease, Ilise Lombardo, PhD, said at the Clinical Trials on Alzheimer’s Disease conference.

[email protected]

On Twitter @alz_gal

BOSTON – An investigational Alzheimer’s drug intended to potentiate acetylcholine release didn’t pass muster in a global phase 3 study, despite a successful phase 2 trial.

Intepirdine on a background of stable-dose donepezil failed to confer any cognitive or functional benefit in patients with mild to moderate Alzheimer’s disease, Ilise Lombardo, PhD, said at the Clinical Trials on Alzheimer’s Disease conference.

[email protected]

On Twitter @alz_gal

The use of biologic therapy during pregnancy did not lower antibody titers among infants vaccinated against Haemophilus influenzae B (HiB) or tetanus toxin, according to the results of a study of 179 mothers reported in the January issue of Clinical Gastroenterology and Hepatology (2017. doi: 10.1016/j.cgh.2017.08.041).

Additionally, there was no link between median infliximab concentration in uterine cord blood and antibody titers among infants aged 7 months and older, wrote Dawn B. Beaulieu, MD, with her associates. “In a limited cohort of exposed infants given the rotavirus vaccine, there was no association with significant adverse reactions,” they also reported.

Sean Locke/iStockphoto

The use of biologic therapy during pregnancy did not lower antibody titers among infants vaccinated against Haemophilus influenzae B (HiB) or tetanus toxin, according to the results of a study of 179 mothers reported in the January issue of Clinical Gastroenterology and Hepatology (2017. doi: 10.1016/j.cgh.2017.08.041).

Additionally, there was no link between median infliximab concentration in uterine cord blood and antibody titers among infants aged 7 months and older, wrote Dawn B. Beaulieu, MD, with her associates. “In a limited cohort of exposed infants given the rotavirus vaccine, there was no association with significant adverse reactions,” they also reported.

Sean Locke/iStockphoto

The use of biologic therapy during pregnancy did not lower antibody titers among infants vaccinated against Haemophilus influenzae B (HiB) or tetanus toxin, according to the results of a study of 179 mothers reported in the January issue of Clinical Gastroenterology and Hepatology (2017. doi: 10.1016/j.cgh.2017.08.041).

Additionally, there was no link between median infliximab concentration in uterine cord blood and antibody titers among infants aged 7 months and older, wrote Dawn B. Beaulieu, MD, with her associates. “In a limited cohort of exposed infants given the rotavirus vaccine, there was no association with significant adverse reactions,” they also reported.

Sean Locke/iStockphoto

ANAHEIM, CALIF. – Targeting the anti-inflammatory drug canakinumab to cardiovascular disease patients with a robust response to a single dose may be an effective way to enhance the cost benefit of this novel treatment that is effective but also expensive.

A post hoc analysis of data collected in the ground-breaking CANTOS trial showed that among patients with a robust anti-inflammatory response to their first dose of canakinumab, the 4-year rate of major adverse cardiovascular events fell by 25% compared with patients who received placebo, a much higher relative risk reduction compared with all canakinumab recipients in the study. In this responsive subgroup, which constituted 55% of all patients assessed after their first dose, canakinumab also cut both cardiovascular death and all-cause death by 31% each relative to placebo, statistically significant reductions that had not been seen in the trial’s primary analysis that included all drug recipients, Paul M. Ridker, MD, said at the American Heart Association scientific sessions.

“The current analysis suggests that the magnitude of hsCRP [high sensitivity C-reactive protein] reduction following a single dose of canakinumab may provide a simple clinical method to identify individuals most likely to accrue the largest cardiovascular and cancer benefits from continued treatment.” The findings have importance “for patient selection, cost-effectiveness, and personalized medicine” as researchers and clinicians begin using anti-inflammatory drugs such as canakinumab to treat cardiovascular disease patients, said Dr. Ridker, professor of medicine at Harvard Medical School and director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital, both in Boston.

“The magnitude of the hsCRP reduction” after the first dose “is telling us who benefits most,” Dr. Ridker said in a video interview.

The Canakinumab Anti-inflammatory Thrombosis Outcome Study (CANTOS) enrolled patients with a history of a MI and a “residual” inflammatory risk based on having an hsCRP level above 2 mg/L at baseline despite receiving optimized standard treatments and having a median LDL cholesterol level of 82 mg/dL. Dr. Ridker and his associates reported the study’s primary outcome results in August at the European Society of Cardiology meeting and in a simultaneously-published article (N Engl J Med. 2017 Sept 21; 377[12]:1119-31).

For the current analyses they defined a robust anti-inflammatory response as CANTOS patients who maintained an hsCRP level below 2 mg/L when measured 3 months after their first canakinumab dose. When the researchers divided all canakinumab recipients into tertiles based on their achieved hsCRP level after one dose, those with the lowest level, less than 1.2 mg/L, also had the best outcome, with a 4-year rate of major adverse cardiovascular events that was 29% lower than the placebo patients. Patients in the middle tertile of achieved hsCRP, from 1.2 up to but not including 2.6 mg/L, showed a smaller but still statistically significant relative 17% reduction in events, while patients with the tertile with the highest hsCRP levels following one canakinumab dose had essentially no difference in their outcomes compared with placebo-treated control patients.

These findings suggest that for hsCRP, “lower is better,” Dr. Ridker noted. “It’s similar to where we were in 1994” when trial results showed how LDL levels related to cardiovascular disease events and the potential that statin treatment held had for reducing event rates.

The new analyses included three additional notable findings:

• The main serious adverse effect from canakinumab treatment, fatal infections, which occurred at a small but significantly higher rate than in control patients, had a similar incidence of about one episode/300 patient years regardless of whether the achieved hsCRP level fell below 2 mg/L or remained above that level. The placebo rate of fatal infections was about one for every 500 patient years.

• The substantially reduced incidence of lung cancer seen in the primary CANTOS results also tracked with achieved hsCRP. Patients with an achieved hsCRP that was below the median for all treated patients had a 71% cut in new-onset lung cancer compared with controls, while patients with hsCRP levels that fell above the median showed no significant difference compared with control patients.

• All three doses of canakinumab tested in CANTOS – 50 mg, 150 mg, and 300 mg administered by subcutaneous injection once every 3 months – produced a drop in hsCRP to below 2 mg/L in some patients, but the rate at which patients reached this level differed depending on dose: 44% among patients who received the lowest dose, 55% of those who received a 150-mg dose, and 65% among those on the highest dose.

But this “responder analysis” of patients who received canakinumab received a strong cautionary caveat from Robert M. Califf, MD, professor of medicine and vice chancellor for health data sciences at Duke University in Durham, N.C.

“Beware of responder analyses,” Dr. Califf said during a talk at the meeting in which he commented on the new CANTOS findings. “There is a long history in cardiology of being misled” by responder analyses, he said.

Dr. Ridker added that the mechanism that determines whether patients have a robust or modest response to canakinumab remains unclear, although it likely depends on genetic factors. He also noted that research being done by himself and others is investigating the efficacy of other anti-inflammatory drugs that could potentially cut cardiovascular disease rates, including methotrexate and colchicine.

Canakinumab (Ilaris) had Food and Drug Administration marketing approval to treat systemic juvenile idiopathic arthritis and pediatric fever syndromes. Concurrently with the meeting report, the results appeared in an article online (Lancet 2017 Nov 13. doi: 10.1016/S0140-6736[17]32814-3).

CANTOS was sponsored by Novartis, the company that markets canakinumab. Dr. Ridker has been a consultant to Novartis and was lead investigator of CANTOS. He also holds patents on using hsCRP to assess cardiovascular disease risk. Dr. Califf is an adviser to Verily Health Sciences.

[email protected]

On Twitter @mitchelzoler

ANAHEIM, CALIF. – Targeting the anti-inflammatory drug canakinumab to cardiovascular disease patients with a robust response to a single dose may be an effective way to enhance the cost benefit of this novel treatment that is effective but also expensive.

A post hoc analysis of data collected in the ground-breaking CANTOS trial showed that among patients with a robust anti-inflammatory response to their first dose of canakinumab, the 4-year rate of major adverse cardiovascular events fell by 25% compared with patients who received placebo, a much higher relative risk reduction compared with all canakinumab recipients in the study. In this responsive subgroup, which constituted 55% of all patients assessed after their first dose, canakinumab also cut both cardiovascular death and all-cause death by 31% each relative to placebo, statistically significant reductions that had not been seen in the trial’s primary analysis that included all drug recipients, Paul M. Ridker, MD, said at the American Heart Association scientific sessions.

“The current analysis suggests that the magnitude of hsCRP [high sensitivity C-reactive protein] reduction following a single dose of canakinumab may provide a simple clinical method to identify individuals most likely to accrue the largest cardiovascular and cancer benefits from continued treatment.” The findings have importance “for patient selection, cost-effectiveness, and personalized medicine” as researchers and clinicians begin using anti-inflammatory drugs such as canakinumab to treat cardiovascular disease patients, said Dr. Ridker, professor of medicine at Harvard Medical School and director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital, both in Boston.

“The magnitude of the hsCRP reduction” after the first dose “is telling us who benefits most,” Dr. Ridker said in a video interview.

The Canakinumab Anti-inflammatory Thrombosis Outcome Study (CANTOS) enrolled patients with a history of a MI and a “residual” inflammatory risk based on having an hsCRP level above 2 mg/L at baseline despite receiving optimized standard treatments and having a median LDL cholesterol level of 82 mg/dL. Dr. Ridker and his associates reported the study’s primary outcome results in August at the European Society of Cardiology meeting and in a simultaneously-published article (N Engl J Med. 2017 Sept 21; 377[12]:1119-31).

For the current analyses they defined a robust anti-inflammatory response as CANTOS patients who maintained an hsCRP level below 2 mg/L when measured 3 months after their first canakinumab dose. When the researchers divided all canakinumab recipients into tertiles based on their achieved hsCRP level after one dose, those with the lowest level, less than 1.2 mg/L, also had the best outcome, with a 4-year rate of major adverse cardiovascular events that was 29% lower than the placebo patients. Patients in the middle tertile of achieved hsCRP, from 1.2 up to but not including 2.6 mg/L, showed a smaller but still statistically significant relative 17% reduction in events, while patients with the tertile with the highest hsCRP levels following one canakinumab dose had essentially no difference in their outcomes compared with placebo-treated control patients.

These findings suggest that for hsCRP, “lower is better,” Dr. Ridker noted. “It’s similar to where we were in 1994” when trial results showed how LDL levels related to cardiovascular disease events and the potential that statin treatment held had for reducing event rates.

The new analyses included three additional notable findings:

• The main serious adverse effect from canakinumab treatment, fatal infections, which occurred at a small but significantly higher rate than in control patients, had a similar incidence of about one episode/300 patient years regardless of whether the achieved hsCRP level fell below 2 mg/L or remained above that level. The placebo rate of fatal infections was about one for every 500 patient years.

• The substantially reduced incidence of lung cancer seen in the primary CANTOS results also tracked with achieved hsCRP. Patients with an achieved hsCRP that was below the median for all treated patients had a 71% cut in new-onset lung cancer compared with controls, while patients with hsCRP levels that fell above the median showed no significant difference compared with control patients.

• All three doses of canakinumab tested in CANTOS – 50 mg, 150 mg, and 300 mg administered by subcutaneous injection once every 3 months – produced a drop in hsCRP to below 2 mg/L in some patients, but the rate at which patients reached this level differed depending on dose: 44% among patients who received the lowest dose, 55% of those who received a 150-mg dose, and 65% among those on the highest dose.

But this “responder analysis” of patients who received canakinumab received a strong cautionary caveat from Robert M. Califf, MD, professor of medicine and vice chancellor for health data sciences at Duke University in Durham, N.C.

“Beware of responder analyses,” Dr. Califf said during a talk at the meeting in which he commented on the new CANTOS findings. “There is a long history in cardiology of being misled” by responder analyses, he said.

Dr. Ridker added that the mechanism that determines whether patients have a robust or modest response to canakinumab remains unclear, although it likely depends on genetic factors. He also noted that research being done by himself and others is investigating the efficacy of other anti-inflammatory drugs that could potentially cut cardiovascular disease rates, including methotrexate and colchicine.

Canakinumab (Ilaris) had Food and Drug Administration marketing approval to treat systemic juvenile idiopathic arthritis and pediatric fever syndromes. Concurrently with the meeting report, the results appeared in an article online (Lancet 2017 Nov 13. doi: 10.1016/S0140-6736[17]32814-3).

CANTOS was sponsored by Novartis, the company that markets canakinumab. Dr. Ridker has been a consultant to Novartis and was lead investigator of CANTOS. He also holds patents on using hsCRP to assess cardiovascular disease risk. Dr. Califf is an adviser to Verily Health Sciences.

[email protected]

On Twitter @mitchelzoler

ANAHEIM, CALIF. – Targeting the anti-inflammatory drug canakinumab to cardiovascular disease patients with a robust response to a single dose may be an effective way to enhance the cost benefit of this novel treatment that is effective but also expensive.

A post hoc analysis of data collected in the ground-breaking CANTOS trial showed that among patients with a robust anti-inflammatory response to their first dose of canakinumab, the 4-year rate of major adverse cardiovascular events fell by 25% compared with patients who received placebo, a much higher relative risk reduction compared with all canakinumab recipients in the study. In this responsive subgroup, which constituted 55% of all patients assessed after their first dose, canakinumab also cut both cardiovascular death and all-cause death by 31% each relative to placebo, statistically significant reductions that had not been seen in the trial’s primary analysis that included all drug recipients, Paul M. Ridker, MD, said at the American Heart Association scientific sessions.

“The current analysis suggests that the magnitude of hsCRP [high sensitivity C-reactive protein] reduction following a single dose of canakinumab may provide a simple clinical method to identify individuals most likely to accrue the largest cardiovascular and cancer benefits from continued treatment.” The findings have importance “for patient selection, cost-effectiveness, and personalized medicine” as researchers and clinicians begin using anti-inflammatory drugs such as canakinumab to treat cardiovascular disease patients, said Dr. Ridker, professor of medicine at Harvard Medical School and director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital, both in Boston.

“The magnitude of the hsCRP reduction” after the first dose “is telling us who benefits most,” Dr. Ridker said in a video interview.

The Canakinumab Anti-inflammatory Thrombosis Outcome Study (CANTOS) enrolled patients with a history of a MI and a “residual” inflammatory risk based on having an hsCRP level above 2 mg/L at baseline despite receiving optimized standard treatments and having a median LDL cholesterol level of 82 mg/dL. Dr. Ridker and his associates reported the study’s primary outcome results in August at the European Society of Cardiology meeting and in a simultaneously-published article (N Engl J Med. 2017 Sept 21; 377[12]:1119-31).

For the current analyses they defined a robust anti-inflammatory response as CANTOS patients who maintained an hsCRP level below 2 mg/L when measured 3 months after their first canakinumab dose. When the researchers divided all canakinumab recipients into tertiles based on their achieved hsCRP level after one dose, those with the lowest level, less than 1.2 mg/L, also had the best outcome, with a 4-year rate of major adverse cardiovascular events that was 29% lower than the placebo patients. Patients in the middle tertile of achieved hsCRP, from 1.2 up to but not including 2.6 mg/L, showed a smaller but still statistically significant relative 17% reduction in events, while patients with the tertile with the highest hsCRP levels following one canakinumab dose had essentially no difference in their outcomes compared with placebo-treated control patients.

These findings suggest that for hsCRP, “lower is better,” Dr. Ridker noted. “It’s similar to where we were in 1994” when trial results showed how LDL levels related to cardiovascular disease events and the potential that statin treatment held had for reducing event rates.

The new analyses included three additional notable findings:

• The main serious adverse effect from canakinumab treatment, fatal infections, which occurred at a small but significantly higher rate than in control patients, had a similar incidence of about one episode/300 patient years regardless of whether the achieved hsCRP level fell below 2 mg/L or remained above that level. The placebo rate of fatal infections was about one for every 500 patient years.

• The substantially reduced incidence of lung cancer seen in the primary CANTOS results also tracked with achieved hsCRP. Patients with an achieved hsCRP that was below the median for all treated patients had a 71% cut in new-onset lung cancer compared with controls, while patients with hsCRP levels that fell above the median showed no significant difference compared with control patients.

• All three doses of canakinumab tested in CANTOS – 50 mg, 150 mg, and 300 mg administered by subcutaneous injection once every 3 months – produced a drop in hsCRP to below 2 mg/L in some patients, but the rate at which patients reached this level differed depending on dose: 44% among patients who received the lowest dose, 55% of those who received a 150-mg dose, and 65% among those on the highest dose.

But this “responder analysis” of patients who received canakinumab received a strong cautionary caveat from Robert M. Califf, MD, professor of medicine and vice chancellor for health data sciences at Duke University in Durham, N.C.

“Beware of responder analyses,” Dr. Califf said during a talk at the meeting in which he commented on the new CANTOS findings. “There is a long history in cardiology of being misled” by responder analyses, he said.

Dr. Ridker added that the mechanism that determines whether patients have a robust or modest response to canakinumab remains unclear, although it likely depends on genetic factors. He also noted that research being done by himself and others is investigating the efficacy of other anti-inflammatory drugs that could potentially cut cardiovascular disease rates, including methotrexate and colchicine.

Canakinumab (Ilaris) had Food and Drug Administration marketing approval to treat systemic juvenile idiopathic arthritis and pediatric fever syndromes. Concurrently with the meeting report, the results appeared in an article online (Lancet 2017 Nov 13. doi: 10.1016/S0140-6736[17]32814-3).

CANTOS was sponsored by Novartis, the company that markets canakinumab. Dr. Ridker has been a consultant to Novartis and was lead investigator of CANTOS. He also holds patents on using hsCRP to assess cardiovascular disease risk. Dr. Califf is an adviser to Verily Health Sciences.

[email protected]

On Twitter @mitchelzoler