CHICAGO – An abbreviated magnetic resonance imaging (MRI) protocol for screening individuals at high risk for breast cancer performed as well as a standard protocol, in about half the time and with greater patient satisfaction.

The abbreviated protocol also resulted in fewer false positive findings, with 5% fewer patients receiving biopsies for benign lesions than with a standard protocol (8.4% versus 13.7%, P less than .001).

Findings from the prospective 10-month trial conducted in the province of Ontario were presented by Jean Seely, MD, professor of radiology at the University of Ottawa, at the annual meeting of the Radiological Society of North America.

“The abbreviated protocol was shown to be as effective as the standard protocol in high-risk screening breast MRI, supporting previous studies,” said Dr. Seely. The shorter protocol took 16.3 minutes on average, compared with 27 minutes for the standard MRI protocol. This difference resulted in a 50% increase in institutional capacity, or a jump from two to three patients screened per hour.

In the province of Ontario, said Dr. Seely, women assessed at being at a 25% or greater lifetime risk of breast cancer receive MRIs as part of the Ontario Breast Screening Program (OBSP), which calculates risk by using the International Breast Cancer Intervention Study model.

For high-risk patients, the OBSP model provides annual mammography and an MRI for women between the ages of 30 and 60 years. Not only is the half-hour duration of the standard protocol resource-intensive, especially in regions with limited scanner availability, but patients may either be reluctant to undergo a half-hour scan, or not tolerate a lengthy scan very well.

Dr. Seely cited previous work (J Clin Oncol. 2014 Aug 1;32[22]:2304-10) showing that an abbreviated MRI protocol has similar accuracy as the full standard protocol. With the foundation of evidence from this study, Dr. Seely and her collaborators compared outcomes for high-risk patients who were screened with an abbreviated versus a standard protocol.

The abbreviated protocol, approved by the American College of Radiology, omits a final round of image acquisition sequences at the 9-minute mark after gadolinium administration, instead performing acquisition at 1, 2, 3, and 4 minutes after contrast delivery. Total time required for this protocol is just over 13 minutes, said Dr. Seely, and additional diagnostic MRIs were not required.

The trial was constructed so that the abbreviated protocol was used for the entire OBSP cohort for 10 months in 2018. Results were compared with those from the 12 previous months, when OBSP patients’ MRIs were performed using the standard protocol.

A total of 881 patients received standard-protocol MRIs; about three quarters (651) of those patients had previous MRI screening, while the remaining 230 patients had a baseline screen via the standard protocol.

Of the 658 patients in the abbreviated protocol group, 135, or about 20%, received the briefer scans as a baseline screen; the remast of the patients in this arm had received earlier MRI screening.

In addition to tracking scanning times, Dr. Seely and her collaborators also compared cancer detection rates, Breast Imaging Reporting and Data System (BI-RADS) assessment categories, positive predictive values, and the abnormal interpretation rate – that is, how many scans fell into BI-RADS categories 0, 4, and 5.

No significant difference was found between the rates of BI-RADs 0, 3, or 5 studies between the groups. Significantly fewer abbreviated scans fell into the BI-RADS 4 category, however (9.3% vs. 14.9%; P less than .001).

Similarly, the abnormal interpretation rate was 12.5% for the abbreviated protocol, compared with 17.5% for the standard protocol (P less than .007), with a correspondingly lower biopsy rate of 8.4% for the abbreviated protocol, compared with 13.7% for the standard protocol (P less than .001). The overall cancer detection rate did not differ between groups.

The net effect of the abbreviated protocol, said Dr. Seely, was an increase in positive predictive value without a drop in cancer detection rates. She and her colleagues will continue to track outcomes for those receiving abbreviated screening within the province of Ontario to track performance over time.

Dr. Seely reported that she had no relevant conflicts of interest. She reported no funding source beyond the province of Ontario.

[email protected]

SOURCE: Seely J et al. RSNA 2019, Session RC-215-04.

CHICAGO – An abbreviated magnetic resonance imaging (MRI) protocol for screening individuals at high risk for breast cancer performed as well as a standard protocol, in about half the time and with greater patient satisfaction.

The abbreviated protocol also resulted in fewer false positive findings, with 5% fewer patients receiving biopsies for benign lesions than with a standard protocol (8.4% versus 13.7%, P less than .001).

Findings from the prospective 10-month trial conducted in the province of Ontario were presented by Jean Seely, MD, professor of radiology at the University of Ottawa, at the annual meeting of the Radiological Society of North America.

“The abbreviated protocol was shown to be as effective as the standard protocol in high-risk screening breast MRI, supporting previous studies,” said Dr. Seely. The shorter protocol took 16.3 minutes on average, compared with 27 minutes for the standard MRI protocol. This difference resulted in a 50% increase in institutional capacity, or a jump from two to three patients screened per hour.

In the province of Ontario, said Dr. Seely, women assessed at being at a 25% or greater lifetime risk of breast cancer receive MRIs as part of the Ontario Breast Screening Program (OBSP), which calculates risk by using the International Breast Cancer Intervention Study model.

For high-risk patients, the OBSP model provides annual mammography and an MRI for women between the ages of 30 and 60 years. Not only is the half-hour duration of the standard protocol resource-intensive, especially in regions with limited scanner availability, but patients may either be reluctant to undergo a half-hour scan, or not tolerate a lengthy scan very well.

Dr. Seely cited previous work (J Clin Oncol. 2014 Aug 1;32[22]:2304-10) showing that an abbreviated MRI protocol has similar accuracy as the full standard protocol. With the foundation of evidence from this study, Dr. Seely and her collaborators compared outcomes for high-risk patients who were screened with an abbreviated versus a standard protocol.

The abbreviated protocol, approved by the American College of Radiology, omits a final round of image acquisition sequences at the 9-minute mark after gadolinium administration, instead performing acquisition at 1, 2, 3, and 4 minutes after contrast delivery. Total time required for this protocol is just over 13 minutes, said Dr. Seely, and additional diagnostic MRIs were not required.

The trial was constructed so that the abbreviated protocol was used for the entire OBSP cohort for 10 months in 2018. Results were compared with those from the 12 previous months, when OBSP patients’ MRIs were performed using the standard protocol.

A total of 881 patients received standard-protocol MRIs; about three quarters (651) of those patients had previous MRI screening, while the remaining 230 patients had a baseline screen via the standard protocol.

Of the 658 patients in the abbreviated protocol group, 135, or about 20%, received the briefer scans as a baseline screen; the remast of the patients in this arm had received earlier MRI screening.

In addition to tracking scanning times, Dr. Seely and her collaborators also compared cancer detection rates, Breast Imaging Reporting and Data System (BI-RADS) assessment categories, positive predictive values, and the abnormal interpretation rate – that is, how many scans fell into BI-RADS categories 0, 4, and 5.

No significant difference was found between the rates of BI-RADs 0, 3, or 5 studies between the groups. Significantly fewer abbreviated scans fell into the BI-RADS 4 category, however (9.3% vs. 14.9%; P less than .001).

Similarly, the abnormal interpretation rate was 12.5% for the abbreviated protocol, compared with 17.5% for the standard protocol (P less than .007), with a correspondingly lower biopsy rate of 8.4% for the abbreviated protocol, compared with 13.7% for the standard protocol (P less than .001). The overall cancer detection rate did not differ between groups.

The net effect of the abbreviated protocol, said Dr. Seely, was an increase in positive predictive value without a drop in cancer detection rates. She and her colleagues will continue to track outcomes for those receiving abbreviated screening within the province of Ontario to track performance over time.

Dr. Seely reported that she had no relevant conflicts of interest. She reported no funding source beyond the province of Ontario.

[email protected]

SOURCE: Seely J et al. RSNA 2019, Session RC-215-04.

CHICAGO – An abbreviated magnetic resonance imaging (MRI) protocol for screening individuals at high risk for breast cancer performed as well as a standard protocol, in about half the time and with greater patient satisfaction.

The abbreviated protocol also resulted in fewer false positive findings, with 5% fewer patients receiving biopsies for benign lesions than with a standard protocol (8.4% versus 13.7%, P less than .001).

Findings from the prospective 10-month trial conducted in the province of Ontario were presented by Jean Seely, MD, professor of radiology at the University of Ottawa, at the annual meeting of the Radiological Society of North America.

“The abbreviated protocol was shown to be as effective as the standard protocol in high-risk screening breast MRI, supporting previous studies,” said Dr. Seely. The shorter protocol took 16.3 minutes on average, compared with 27 minutes for the standard MRI protocol. This difference resulted in a 50% increase in institutional capacity, or a jump from two to three patients screened per hour.

In the province of Ontario, said Dr. Seely, women assessed at being at a 25% or greater lifetime risk of breast cancer receive MRIs as part of the Ontario Breast Screening Program (OBSP), which calculates risk by using the International Breast Cancer Intervention Study model.

For high-risk patients, the OBSP model provides annual mammography and an MRI for women between the ages of 30 and 60 years. Not only is the half-hour duration of the standard protocol resource-intensive, especially in regions with limited scanner availability, but patients may either be reluctant to undergo a half-hour scan, or not tolerate a lengthy scan very well.

Dr. Seely cited previous work (J Clin Oncol. 2014 Aug 1;32[22]:2304-10) showing that an abbreviated MRI protocol has similar accuracy as the full standard protocol. With the foundation of evidence from this study, Dr. Seely and her collaborators compared outcomes for high-risk patients who were screened with an abbreviated versus a standard protocol.

The abbreviated protocol, approved by the American College of Radiology, omits a final round of image acquisition sequences at the 9-minute mark after gadolinium administration, instead performing acquisition at 1, 2, 3, and 4 minutes after contrast delivery. Total time required for this protocol is just over 13 minutes, said Dr. Seely, and additional diagnostic MRIs were not required.

The trial was constructed so that the abbreviated protocol was used for the entire OBSP cohort for 10 months in 2018. Results were compared with those from the 12 previous months, when OBSP patients’ MRIs were performed using the standard protocol.

A total of 881 patients received standard-protocol MRIs; about three quarters (651) of those patients had previous MRI screening, while the remaining 230 patients had a baseline screen via the standard protocol.

Of the 658 patients in the abbreviated protocol group, 135, or about 20%, received the briefer scans as a baseline screen; the remast of the patients in this arm had received earlier MRI screening.

In addition to tracking scanning times, Dr. Seely and her collaborators also compared cancer detection rates, Breast Imaging Reporting and Data System (BI-RADS) assessment categories, positive predictive values, and the abnormal interpretation rate – that is, how many scans fell into BI-RADS categories 0, 4, and 5.

No significant difference was found between the rates of BI-RADs 0, 3, or 5 studies between the groups. Significantly fewer abbreviated scans fell into the BI-RADS 4 category, however (9.3% vs. 14.9%; P less than .001).

Similarly, the abnormal interpretation rate was 12.5% for the abbreviated protocol, compared with 17.5% for the standard protocol (P less than .007), with a correspondingly lower biopsy rate of 8.4% for the abbreviated protocol, compared with 13.7% for the standard protocol (P less than .001). The overall cancer detection rate did not differ between groups.

The net effect of the abbreviated protocol, said Dr. Seely, was an increase in positive predictive value without a drop in cancer detection rates. She and her colleagues will continue to track outcomes for those receiving abbreviated screening within the province of Ontario to track performance over time.

Dr. Seely reported that she had no relevant conflicts of interest. She reported no funding source beyond the province of Ontario.

[email protected]

SOURCE: Seely J et al. RSNA 2019, Session RC-215-04.

White Hispanic adults report a lower quality of life and less knowledge of skin cancer and sun protection behaviors than white non-Hispanic adults, survey results of 175 adults with nonmelanoma skin cancer show.

“The incidence of nonmelanoma skin cancer (NMSC) is lower in Hispanics when compared to Caucasians, but a high index of suspicion is needed given ethnic differences in presentation,” wrote Ali Rajabi-Estarabadi, MD, of the University of Miami, and colleagues.

Hispanic patients with NMSC tend to be younger than non-Hispanic white patients, and their basal cell carcinomas are more likely to be pigmented, the investigators noted. Although previous research suggests ethnic disparities in NMSC, factors including sun safety knowledge and quality of life after diagnosis have not been well studied, they said.

With this in mind, the investigators conducted a survey of white Hispanics and non-Hispanics treated for NMSC. The results were published as a research letter in the Journal of the American Academy of Dermatology.

The investigators recruited 175 consecutive patients being treated for NMSC with Mohs surgery at a single center. The average age of the patients was 67 years; 58 identified as white Hispanic, 116 identified as white non-Hispanic.

Skin cancer quality of life scores were significantly higher (worse) among white Hispanic patients, compared with white non-Hispanic patients (9.7 vs. 6.0).

White Hispanic patients had significantly lower skin cancer knowledge scores, compared with white non-Hispanics (P = .003). White Hispanics were significantly more likely than white non-Hispanics to report never wearing hats (39% vs. 12%) and never wearing sunglasses (26% vs. 9%) for sun protection.

The findings were limited by the study population that included only residents of South Florida. However, the results highlight the need for “targeted patient education initiatives to bridge ethnic disparities regarding cancer knowledge and ultimately improve [quality of life] among Hispanic skin cancer suffers,” the investigators concluded.

The study received no outside funding. The investigators declared no conflicts of interest.

SOURCE: Rajabi-Estarabadi A et al. J Am Acad Dermatol. 2020 Feb 4. doi: 10.1016/j.jaad.2020.01.063.

White Hispanic adults report a lower quality of life and less knowledge of skin cancer and sun protection behaviors than white non-Hispanic adults, survey results of 175 adults with nonmelanoma skin cancer show.

“The incidence of nonmelanoma skin cancer (NMSC) is lower in Hispanics when compared to Caucasians, but a high index of suspicion is needed given ethnic differences in presentation,” wrote Ali Rajabi-Estarabadi, MD, of the University of Miami, and colleagues.

Hispanic patients with NMSC tend to be younger than non-Hispanic white patients, and their basal cell carcinomas are more likely to be pigmented, the investigators noted. Although previous research suggests ethnic disparities in NMSC, factors including sun safety knowledge and quality of life after diagnosis have not been well studied, they said.

With this in mind, the investigators conducted a survey of white Hispanics and non-Hispanics treated for NMSC. The results were published as a research letter in the Journal of the American Academy of Dermatology.

The investigators recruited 175 consecutive patients being treated for NMSC with Mohs surgery at a single center. The average age of the patients was 67 years; 58 identified as white Hispanic, 116 identified as white non-Hispanic.

Skin cancer quality of life scores were significantly higher (worse) among white Hispanic patients, compared with white non-Hispanic patients (9.7 vs. 6.0).

White Hispanic patients had significantly lower skin cancer knowledge scores, compared with white non-Hispanics (P = .003). White Hispanics were significantly more likely than white non-Hispanics to report never wearing hats (39% vs. 12%) and never wearing sunglasses (26% vs. 9%) for sun protection.

The findings were limited by the study population that included only residents of South Florida. However, the results highlight the need for “targeted patient education initiatives to bridge ethnic disparities regarding cancer knowledge and ultimately improve [quality of life] among Hispanic skin cancer suffers,” the investigators concluded.

The study received no outside funding. The investigators declared no conflicts of interest.

SOURCE: Rajabi-Estarabadi A et al. J Am Acad Dermatol. 2020 Feb 4. doi: 10.1016/j.jaad.2020.01.063.

White Hispanic adults report a lower quality of life and less knowledge of skin cancer and sun protection behaviors than white non-Hispanic adults, survey results of 175 adults with nonmelanoma skin cancer show.

“The incidence of nonmelanoma skin cancer (NMSC) is lower in Hispanics when compared to Caucasians, but a high index of suspicion is needed given ethnic differences in presentation,” wrote Ali Rajabi-Estarabadi, MD, of the University of Miami, and colleagues.

Hispanic patients with NMSC tend to be younger than non-Hispanic white patients, and their basal cell carcinomas are more likely to be pigmented, the investigators noted. Although previous research suggests ethnic disparities in NMSC, factors including sun safety knowledge and quality of life after diagnosis have not been well studied, they said.

With this in mind, the investigators conducted a survey of white Hispanics and non-Hispanics treated for NMSC. The results were published as a research letter in the Journal of the American Academy of Dermatology.

The investigators recruited 175 consecutive patients being treated for NMSC with Mohs surgery at a single center. The average age of the patients was 67 years; 58 identified as white Hispanic, 116 identified as white non-Hispanic.

Skin cancer quality of life scores were significantly higher (worse) among white Hispanic patients, compared with white non-Hispanic patients (9.7 vs. 6.0).

White Hispanic patients had significantly lower skin cancer knowledge scores, compared with white non-Hispanics (P = .003). White Hispanics were significantly more likely than white non-Hispanics to report never wearing hats (39% vs. 12%) and never wearing sunglasses (26% vs. 9%) for sun protection.

The findings were limited by the study population that included only residents of South Florida. However, the results highlight the need for “targeted patient education initiatives to bridge ethnic disparities regarding cancer knowledge and ultimately improve [quality of life] among Hispanic skin cancer suffers,” the investigators concluded.

The study received no outside funding. The investigators declared no conflicts of interest.

SOURCE: Rajabi-Estarabadi A et al. J Am Acad Dermatol. 2020 Feb 4. doi: 10.1016/j.jaad.2020.01.063.

GRAPEVINE, TEX. – College education and high socioeconomic status do not erase U.S. racial disparities in birth outcomes, according to a new analysis of all U.S. live births from 2015-2017.

Very early preterm birth – birth before 28 weeks gestational age – was five times more likely to occur in non-Hispanic black women of high socioeconomic status as similarly situated white women, even after statistical adjustment for a host of potentially confounding factors.

Being of non-Hispanic black race was the single strongest predictor of preterm birth (PTB) at less than 28 weeks’ gestation. The adjusted odds ratio (aOR) of 4.99 surpassed an interpregnancy interval under 1 year (aOR, 4.47), chronic hypertension (aOR, 2.84), and prior history of preterm birth (aOR, 2.81).

[email protected]

SOURCE: Johnson J et al. Obstet Gynecol. 2020 Jan;222(1):S-37-8, Abstract 44.

GRAPEVINE, TEX. – College education and high socioeconomic status do not erase U.S. racial disparities in birth outcomes, according to a new analysis of all U.S. live births from 2015-2017.

Very early preterm birth – birth before 28 weeks gestational age – was five times more likely to occur in non-Hispanic black women of high socioeconomic status as similarly situated white women, even after statistical adjustment for a host of potentially confounding factors.

Being of non-Hispanic black race was the single strongest predictor of preterm birth (PTB) at less than 28 weeks’ gestation. The adjusted odds ratio (aOR) of 4.99 surpassed an interpregnancy interval under 1 year (aOR, 4.47), chronic hypertension (aOR, 2.84), and prior history of preterm birth (aOR, 2.81).

[email protected]

SOURCE: Johnson J et al. Obstet Gynecol. 2020 Jan;222(1):S-37-8, Abstract 44.

GRAPEVINE, TEX. – College education and high socioeconomic status do not erase U.S. racial disparities in birth outcomes, according to a new analysis of all U.S. live births from 2015-2017.

Very early preterm birth – birth before 28 weeks gestational age – was five times more likely to occur in non-Hispanic black women of high socioeconomic status as similarly situated white women, even after statistical adjustment for a host of potentially confounding factors.

Being of non-Hispanic black race was the single strongest predictor of preterm birth (PTB) at less than 28 weeks’ gestation. The adjusted odds ratio (aOR) of 4.99 surpassed an interpregnancy interval under 1 year (aOR, 4.47), chronic hypertension (aOR, 2.84), and prior history of preterm birth (aOR, 2.81).

[email protected]

SOURCE: Johnson J et al. Obstet Gynecol. 2020 Jan;222(1):S-37-8, Abstract 44.

Glioma treatment goals traditionally have focused on tumor shrinkage or prolonging survival, but it’s time for those endpoints to be supplemented by clinical outcomes that are meaningful to the patient, according to a recently published report from a neuro-oncology working group.

The group, which includes representatives of previous oncology working groups, the Food and Drug Administration, and observers from the European Medicines Agency, has established a core set of symptoms and functional points that they say could be used in clinical trials and clinical care for patients with high-grade gliomas.

“Patients want to live longer, but they also want to continue to function as well as possible for as long as possible,” said Terri S. Armstrong, PhD, of the National Cancer Institute (NCI), and coauthors in a report that sums up the work to date of the Fast Track COA Group.

That work, while specific to gliomas, echoes results from broader initiatives that seek to standardize patient-reported outcomes in oncology trials, Dr. Armstrong and coauthors wrote. The report was published in the Lancet Oncology.

The core set of symptom constructs and functional issues identified by the work group are represented already in patient-reported outcome measures, according to the authors.

The symptoms worth measuring fall into five categories, including pain, difficulty communicating, perceived cognition, seizures, and symptomatic adverse events. The functional issues were divided into two categories, physical functioning, including weakness or walking, and role functioning, which they defined as the ability to work or participate in social or leisure activities.

Some of those outcomes can be challenging or cumbersome to track, Dr. Armstrong and coauthors said.

Pain has “many dimensions“ and is important to track, the group wrote. Likewise, patients’ concerns related to language function also are important, but are very “noisy“ as a variable and can be specific to tumor location.

Collecting data on seizure frequency and severity is important yet complicated, because of the variability in seizures and considerable difference between focal and generalized seizures. Assessment of cognitive functioning can be lengthy and burdensome to patients.

Adverse events of relevance will vary, depending on the drug used, its mechanism of action, and available data, though some allowance needs to be made for the possibility of “overlap“ with disease-related symptoms, the report said.

Physical functioning, including walking and weakness, should be evaluated. It also would be useful to distinguish the duration of time that patients have deficits in physical functioning in the later stages of their disease progression, authors said.

Role and social functioning should be assessed in most patients with high-grade gliomas, who will have symptoms and deficits that prevent returning to a job. “Patients might spend a substantial portion of their lives feeling ill, unable to do usual activities, or meet occupational, social, financial, and family obligations,” said Dr. Armstrong and coauthors in the report.

The scales and tools used to measure symptoms and functional concerns need to be those that best fit a particular clinical trial or clinical practice scenario. Several instruments that would be appropriate are discussed in the report, including the NCI Patient-Reported Outcome of the Common Toxicity Criteria Adverse Events (NCI PRO-CTCAE) and symptom and function scales or items in the Patient-Reported Outcomes Measurement System (PROMIS).

The next steps, according to report authors, will be to figure out how the symptom and function constructs align with typical primary endpoints of glioma clinical trials, such as time to recurrence or survival.

“Strategies for introducing these constructs to clinical trial cooperative groups and sponsors will be necessary,” they concluded.

Dr. Armstrong reported employment as a senior investigator and deputy chief of the neuro-oncology branch of the Center for Cancer Research at the NCI. His coauthors reported disclosures related to several companies and interests, including AbbVie, AstraZeneca, Bristol-Myers Squibb, Genentech, Merck, Taiho, and Tocagen.

SOURCE: Armstrong TS et al. Lancet Oncol. 2020;21(2):e97-103.

Glioma treatment goals traditionally have focused on tumor shrinkage or prolonging survival, but it’s time for those endpoints to be supplemented by clinical outcomes that are meaningful to the patient, according to a recently published report from a neuro-oncology working group.

The group, which includes representatives of previous oncology working groups, the Food and Drug Administration, and observers from the European Medicines Agency, has established a core set of symptoms and functional points that they say could be used in clinical trials and clinical care for patients with high-grade gliomas.

“Patients want to live longer, but they also want to continue to function as well as possible for as long as possible,” said Terri S. Armstrong, PhD, of the National Cancer Institute (NCI), and coauthors in a report that sums up the work to date of the Fast Track COA Group.

That work, while specific to gliomas, echoes results from broader initiatives that seek to standardize patient-reported outcomes in oncology trials, Dr. Armstrong and coauthors wrote. The report was published in the Lancet Oncology.

The core set of symptom constructs and functional issues identified by the work group are represented already in patient-reported outcome measures, according to the authors.

The symptoms worth measuring fall into five categories, including pain, difficulty communicating, perceived cognition, seizures, and symptomatic adverse events. The functional issues were divided into two categories, physical functioning, including weakness or walking, and role functioning, which they defined as the ability to work or participate in social or leisure activities.

Some of those outcomes can be challenging or cumbersome to track, Dr. Armstrong and coauthors said.

Pain has “many dimensions“ and is important to track, the group wrote. Likewise, patients’ concerns related to language function also are important, but are very “noisy“ as a variable and can be specific to tumor location.

Collecting data on seizure frequency and severity is important yet complicated, because of the variability in seizures and considerable difference between focal and generalized seizures. Assessment of cognitive functioning can be lengthy and burdensome to patients.

Adverse events of relevance will vary, depending on the drug used, its mechanism of action, and available data, though some allowance needs to be made for the possibility of “overlap“ with disease-related symptoms, the report said.

Physical functioning, including walking and weakness, should be evaluated. It also would be useful to distinguish the duration of time that patients have deficits in physical functioning in the later stages of their disease progression, authors said.

Role and social functioning should be assessed in most patients with high-grade gliomas, who will have symptoms and deficits that prevent returning to a job. “Patients might spend a substantial portion of their lives feeling ill, unable to do usual activities, or meet occupational, social, financial, and family obligations,” said Dr. Armstrong and coauthors in the report.

The scales and tools used to measure symptoms and functional concerns need to be those that best fit a particular clinical trial or clinical practice scenario. Several instruments that would be appropriate are discussed in the report, including the NCI Patient-Reported Outcome of the Common Toxicity Criteria Adverse Events (NCI PRO-CTCAE) and symptom and function scales or items in the Patient-Reported Outcomes Measurement System (PROMIS).

The next steps, according to report authors, will be to figure out how the symptom and function constructs align with typical primary endpoints of glioma clinical trials, such as time to recurrence or survival.

“Strategies for introducing these constructs to clinical trial cooperative groups and sponsors will be necessary,” they concluded.

Dr. Armstrong reported employment as a senior investigator and deputy chief of the neuro-oncology branch of the Center for Cancer Research at the NCI. His coauthors reported disclosures related to several companies and interests, including AbbVie, AstraZeneca, Bristol-Myers Squibb, Genentech, Merck, Taiho, and Tocagen.

SOURCE: Armstrong TS et al. Lancet Oncol. 2020;21(2):e97-103.

Glioma treatment goals traditionally have focused on tumor shrinkage or prolonging survival, but it’s time for those endpoints to be supplemented by clinical outcomes that are meaningful to the patient, according to a recently published report from a neuro-oncology working group.

The group, which includes representatives of previous oncology working groups, the Food and Drug Administration, and observers from the European Medicines Agency, has established a core set of symptoms and functional points that they say could be used in clinical trials and clinical care for patients with high-grade gliomas.

“Patients want to live longer, but they also want to continue to function as well as possible for as long as possible,” said Terri S. Armstrong, PhD, of the National Cancer Institute (NCI), and coauthors in a report that sums up the work to date of the Fast Track COA Group.

That work, while specific to gliomas, echoes results from broader initiatives that seek to standardize patient-reported outcomes in oncology trials, Dr. Armstrong and coauthors wrote. The report was published in the Lancet Oncology.

The core set of symptom constructs and functional issues identified by the work group are represented already in patient-reported outcome measures, according to the authors.

The symptoms worth measuring fall into five categories, including pain, difficulty communicating, perceived cognition, seizures, and symptomatic adverse events. The functional issues were divided into two categories, physical functioning, including weakness or walking, and role functioning, which they defined as the ability to work or participate in social or leisure activities.

Some of those outcomes can be challenging or cumbersome to track, Dr. Armstrong and coauthors said.

Pain has “many dimensions“ and is important to track, the group wrote. Likewise, patients’ concerns related to language function also are important, but are very “noisy“ as a variable and can be specific to tumor location.

Collecting data on seizure frequency and severity is important yet complicated, because of the variability in seizures and considerable difference between focal and generalized seizures. Assessment of cognitive functioning can be lengthy and burdensome to patients.

Adverse events of relevance will vary, depending on the drug used, its mechanism of action, and available data, though some allowance needs to be made for the possibility of “overlap“ with disease-related symptoms, the report said.

Physical functioning, including walking and weakness, should be evaluated. It also would be useful to distinguish the duration of time that patients have deficits in physical functioning in the later stages of their disease progression, authors said.

Role and social functioning should be assessed in most patients with high-grade gliomas, who will have symptoms and deficits that prevent returning to a job. “Patients might spend a substantial portion of their lives feeling ill, unable to do usual activities, or meet occupational, social, financial, and family obligations,” said Dr. Armstrong and coauthors in the report.

The scales and tools used to measure symptoms and functional concerns need to be those that best fit a particular clinical trial or clinical practice scenario. Several instruments that would be appropriate are discussed in the report, including the NCI Patient-Reported Outcome of the Common Toxicity Criteria Adverse Events (NCI PRO-CTCAE) and symptom and function scales or items in the Patient-Reported Outcomes Measurement System (PROMIS).

The next steps, according to report authors, will be to figure out how the symptom and function constructs align with typical primary endpoints of glioma clinical trials, such as time to recurrence or survival.

“Strategies for introducing these constructs to clinical trial cooperative groups and sponsors will be necessary,” they concluded.

Dr. Armstrong reported employment as a senior investigator and deputy chief of the neuro-oncology branch of the Center for Cancer Research at the NCI. His coauthors reported disclosures related to several companies and interests, including AbbVie, AstraZeneca, Bristol-Myers Squibb, Genentech, Merck, Taiho, and Tocagen.

SOURCE: Armstrong TS et al. Lancet Oncol. 2020;21(2):e97-103.

SAN DIEGO – When clinicians ask patients to quantify their level of chronic pain on a scale of 1-10, and they rate it as a 7, what does that really mean?

Robert A. Bonakdar, MD, said posing such a question as the main determinator of the treatment approach during a pain assessment “depersonalizes medicine to the point where you’re making a patient a number.” Dr. Bonakdar spoke at Natural Supplements: An Evidence-Based Update, presented by Scripps Center for Integrative Medicine.

“A personalized approach to pain, on the other hand, considers each patient’s individual journey: their sensitivities, experiences, and failures,” he said. “It considers areas that are often overlooked, such as the role of the gut microbiome, mood, and epigenetics.”

Over the past two decades, the number of American adults suffering from pain has increased from 120 million to 178 million, or to 41% of the adult population, said Dr. Bonakdar, a family physician who is director of pain management at the Scripps Center for Integrative Medicine. Data from the National Institutes of Health estimate that Americans spend more than $600 billion each year on the treatment of pain, which surpasses monies spent on cancer, heart disease, and diabetes. According to a 2016 report from the United States Bone and Joint Initiative, arthritis and rheumatologic conditions resulted in an estimated 6.7 million annual hospitalizations, and the average annual cost per person for treatment of a musculoskeletal condition is $7,800.

“If we continue on our current trajectory, we are choosing to accept more prevalence and incidence of these disorders, spiraling costs, restricted access to needed services, and less success in alleviating pain and suffering – a high cost,” Edward H. Yelin, PhD, cochair of the report’s steering committee, and professor of medicine and health policy at the University of California, San Francisco, said in a prepared statement in 2016. That same year, Brian F. Mandell, MD, PhD, editor of the Cleveland Clinic Journal of Medicine, penned an editorial in which he stated that “The time has come to move past using a one-size-fits-all fifth vital sign . . . and reflexively prescribing an opioid when pain is characterized as severe” (Clev Clin J Med. 2016. Jun;83[6]:400-1). A decade earlier, authors of a cross-sectional review at a single Department of Veterans Affairs medical center set out to assess the impact of the VA’s “Pain as the 5th Vital Sign” initiative on the quality of pain management (J Gen Intern Med. 2006;21[6]:607–12). They found that patients with substantial pain documented by the fifth vital sign often had inadequate pain management. The preponderance of existing evidence suggests that a different approach is needed to prescribing opioids, Dr. Bonakdar said. “It’s coming from every voice in pain care: that what we are doing is not working,” he said. “It’s not only not working; it’s dangerous. That’s the consequence of depersonalized medicine. What’s the consequence of depersonalized nutrition? It’s the same industrialized approach.”

The typical American diet, he continued, is rife with processed foods and lacks an adequate proportion of plant-based products. “It’s basically a setup for inflammation,” Dr. Bonakdar said. “Most people who come into our clinic are eating 63% processed foods, 25% animal foods, and 12% plant foods. When we are eating, we’re oversizing it because that’s the American thing to do. At the end of the day, this process is not only killing us from heart disease and stroke as causes of death, but it’s also killing us as far as pain. The same diet that’s causing heart disease is the same diet that’s increasing pain.”

Dr. Bonakdar said that the ingestion of ultra-processed foods over time jumpstarts the process of dysbiosis, which increases gut permeability. “When gut permeability happens, and you have high levels of polysaccharides and inflammatory markers such as zonulin and lipopolysaccharide (LPS), it not only goes on to affect adipose tissue and insulin resistance, it can affect the muscle and joints,” he explained. “That is a setup for sarcopenia, or muscle loss, which then makes it harder for patients to be fully functional and active. It goes on to cause joint problems as well.”

He likened an increase in gut permeability to “a bomb going off in the gut.” Routine consumption of highly processed foods “creates this wave of inflammation that goes throughout your body affecting joints and muscles, and causes an increased amount of pain. Over time, patients make the connection but it’s much easier to say, ‘take this NSAID’ or ‘take this Cox-2 inhibitor’ to suppress the pain. But if all you’re doing is suppressing, you’re not going to the source of the pain.”

Dr. Bonakdar cited several recent articles that help to make the connection between dysbiosis and pain, including a review that concluded that dysbiosis of gut microbiota can influence the onset and progression of chronic degenerative diseases (Nutrients. 2019;11[8]:1707). Authors of a separate review concluded that human microbiome studies strongly suggest an incriminating role of microbes in the pathophysiology and progression of RA. Lastly, several studies have noted that pain conditions such as fibromyalgia may have microbiome “signatures” related to dysbiosis, which may pave the way for interventions, such as dietary shifting and probiotics that target individuals with microbiome abnormalities (Pain. 2019 Nov;160[11]:2589-602 and EBioMedicine. 2019 Aug 1;46:499-511).

Clinicians can begin to help patients who present with pain complaints “by listening to what their current pattern is: strategies that have worked, and those that haven’t,” he said. “If we’re not understanding the person and we’re just ordering genetic studies or microbiome studies and going off of the assessment, we sometime miss what interventions to start. In many cases, a simple intervention like a dietary shift is all that’s required.”

A survey of more than 1 million individuals found that BMI and daily pain are positively correlated in the United States (Obesity 2012;20[7]:1491-5). “This is increased more significantly for women and the elderly,” said Dr. Bonakdar, who was not affiliated with the study. “If we can change the diet that person is taking, that’s going to begin the process of reversing this to the point where they’re having less pain from inflammation that’s affecting the adipose tissue and adipokines traveling to their joints, which can cause less dysbiosis. It is very much a vicious cycle that patients follow, but if you begin to unwind it, it’s going to help multiple areas.”

In the Intensive Diet and Exercise for Arthritis (IDEA) trial, researchers randomized 450 patients with osteoarthritis to intensive dietary restriction only, exercise only, or a combination of both (BMC Musculoskelet Disord. 2009;10:93). They found that a 5% weight loss over the course of 18 months led to a 30% reduction in pain and a 24% improvement in function.

Inspired by the IDEA trial design, Dr. Bonakdar and his colleagues completed an unpublished 12-week pilot program with 12 patients with a BMI of 27 kg/m² or greater plus comorbidities. The program consisted of weekly group meetings, including a lecture by team clinicians, dietician, and fitness staff; group support sessions with a behavioral counselor; and a group exercise session. It also included weekly 1:1 personal training sessions and biweekly 1:1 dietitian meetings. The researchers also evaluated several deficiencies linked to pain, including magnesium, vitamin D, vitamins B1, B2, and B12, folate, calcium, amino acids, omega 3s, zinc, coenzyme Q10, carnitine, and vitamin C. The goal was a weight reduction of 5%.

The intervention consisted of a 28-day detox/protein shake consumed 1-3 times per day, which contained 17 g of protein per serving. Nutritional supplementation was added based on results of individual diagnostics.

According to preliminary results from the trial, the intended weight goal was achieved. “More importantly, there were significant improvements in markers of dysbiosis, including zonulin and lipopolysaccharide, as well as the adipokine leptin, which appeared to be associated with improvement in quality of life measures and pain,” Dr. Bonakdar said.

He concluded his presentation by highlighting a pilot study conducted in an Australian tertiary pain clinic. It found that a personalized dietitian-delivered dietary intervention can improve pain scores, quality of life, and dietary intake of people experiencing chronic pain (Nutrients. 2019 Jan 16;11[1] pii: E181). “This is another piece of the puzzle showing that these dietary interventions can be done in multiple settings, including tertiary centers with nutrition staff, and that this important step can improve pain and quality of life,” he said.

Dr. Bonakdar disclosed that he receives royalties from Oxford University Press, Lippincott, and Elsevier. He is also a consultant to Standard Process.

[email protected]

SAN DIEGO – When clinicians ask patients to quantify their level of chronic pain on a scale of 1-10, and they rate it as a 7, what does that really mean?

Robert A. Bonakdar, MD, said posing such a question as the main determinator of the treatment approach during a pain assessment “depersonalizes medicine to the point where you’re making a patient a number.” Dr. Bonakdar spoke at Natural Supplements: An Evidence-Based Update, presented by Scripps Center for Integrative Medicine.

“A personalized approach to pain, on the other hand, considers each patient’s individual journey: their sensitivities, experiences, and failures,” he said. “It considers areas that are often overlooked, such as the role of the gut microbiome, mood, and epigenetics.”

Over the past two decades, the number of American adults suffering from pain has increased from 120 million to 178 million, or to 41% of the adult population, said Dr. Bonakdar, a family physician who is director of pain management at the Scripps Center for Integrative Medicine. Data from the National Institutes of Health estimate that Americans spend more than $600 billion each year on the treatment of pain, which surpasses monies spent on cancer, heart disease, and diabetes. According to a 2016 report from the United States Bone and Joint Initiative, arthritis and rheumatologic conditions resulted in an estimated 6.7 million annual hospitalizations, and the average annual cost per person for treatment of a musculoskeletal condition is $7,800.

“If we continue on our current trajectory, we are choosing to accept more prevalence and incidence of these disorders, spiraling costs, restricted access to needed services, and less success in alleviating pain and suffering – a high cost,” Edward H. Yelin, PhD, cochair of the report’s steering committee, and professor of medicine and health policy at the University of California, San Francisco, said in a prepared statement in 2016. That same year, Brian F. Mandell, MD, PhD, editor of the Cleveland Clinic Journal of Medicine, penned an editorial in which he stated that “The time has come to move past using a one-size-fits-all fifth vital sign . . . and reflexively prescribing an opioid when pain is characterized as severe” (Clev Clin J Med. 2016. Jun;83[6]:400-1). A decade earlier, authors of a cross-sectional review at a single Department of Veterans Affairs medical center set out to assess the impact of the VA’s “Pain as the 5th Vital Sign” initiative on the quality of pain management (J Gen Intern Med. 2006;21[6]:607–12). They found that patients with substantial pain documented by the fifth vital sign often had inadequate pain management. The preponderance of existing evidence suggests that a different approach is needed to prescribing opioids, Dr. Bonakdar said. “It’s coming from every voice in pain care: that what we are doing is not working,” he said. “It’s not only not working; it’s dangerous. That’s the consequence of depersonalized medicine. What’s the consequence of depersonalized nutrition? It’s the same industrialized approach.”

The typical American diet, he continued, is rife with processed foods and lacks an adequate proportion of plant-based products. “It’s basically a setup for inflammation,” Dr. Bonakdar said. “Most people who come into our clinic are eating 63% processed foods, 25% animal foods, and 12% plant foods. When we are eating, we’re oversizing it because that’s the American thing to do. At the end of the day, this process is not only killing us from heart disease and stroke as causes of death, but it’s also killing us as far as pain. The same diet that’s causing heart disease is the same diet that’s increasing pain.”

Dr. Bonakdar said that the ingestion of ultra-processed foods over time jumpstarts the process of dysbiosis, which increases gut permeability. “When gut permeability happens, and you have high levels of polysaccharides and inflammatory markers such as zonulin and lipopolysaccharide (LPS), it not only goes on to affect adipose tissue and insulin resistance, it can affect the muscle and joints,” he explained. “That is a setup for sarcopenia, or muscle loss, which then makes it harder for patients to be fully functional and active. It goes on to cause joint problems as well.”

He likened an increase in gut permeability to “a bomb going off in the gut.” Routine consumption of highly processed foods “creates this wave of inflammation that goes throughout your body affecting joints and muscles, and causes an increased amount of pain. Over time, patients make the connection but it’s much easier to say, ‘take this NSAID’ or ‘take this Cox-2 inhibitor’ to suppress the pain. But if all you’re doing is suppressing, you’re not going to the source of the pain.”

Dr. Bonakdar cited several recent articles that help to make the connection between dysbiosis and pain, including a review that concluded that dysbiosis of gut microbiota can influence the onset and progression of chronic degenerative diseases (Nutrients. 2019;11[8]:1707). Authors of a separate review concluded that human microbiome studies strongly suggest an incriminating role of microbes in the pathophysiology and progression of RA. Lastly, several studies have noted that pain conditions such as fibromyalgia may have microbiome “signatures” related to dysbiosis, which may pave the way for interventions, such as dietary shifting and probiotics that target individuals with microbiome abnormalities (Pain. 2019 Nov;160[11]:2589-602 and EBioMedicine. 2019 Aug 1;46:499-511).

Clinicians can begin to help patients who present with pain complaints “by listening to what their current pattern is: strategies that have worked, and those that haven’t,” he said. “If we’re not understanding the person and we’re just ordering genetic studies or microbiome studies and going off of the assessment, we sometime miss what interventions to start. In many cases, a simple intervention like a dietary shift is all that’s required.”

A survey of more than 1 million individuals found that BMI and daily pain are positively correlated in the United States (Obesity 2012;20[7]:1491-5). “This is increased more significantly for women and the elderly,” said Dr. Bonakdar, who was not affiliated with the study. “If we can change the diet that person is taking, that’s going to begin the process of reversing this to the point where they’re having less pain from inflammation that’s affecting the adipose tissue and adipokines traveling to their joints, which can cause less dysbiosis. It is very much a vicious cycle that patients follow, but if you begin to unwind it, it’s going to help multiple areas.”

In the Intensive Diet and Exercise for Arthritis (IDEA) trial, researchers randomized 450 patients with osteoarthritis to intensive dietary restriction only, exercise only, or a combination of both (BMC Musculoskelet Disord. 2009;10:93). They found that a 5% weight loss over the course of 18 months led to a 30% reduction in pain and a 24% improvement in function.

Inspired by the IDEA trial design, Dr. Bonakdar and his colleagues completed an unpublished 12-week pilot program with 12 patients with a BMI of 27 kg/m² or greater plus comorbidities. The program consisted of weekly group meetings, including a lecture by team clinicians, dietician, and fitness staff; group support sessions with a behavioral counselor; and a group exercise session. It also included weekly 1:1 personal training sessions and biweekly 1:1 dietitian meetings. The researchers also evaluated several deficiencies linked to pain, including magnesium, vitamin D, vitamins B1, B2, and B12, folate, calcium, amino acids, omega 3s, zinc, coenzyme Q10, carnitine, and vitamin C. The goal was a weight reduction of 5%.

The intervention consisted of a 28-day detox/protein shake consumed 1-3 times per day, which contained 17 g of protein per serving. Nutritional supplementation was added based on results of individual diagnostics.

According to preliminary results from the trial, the intended weight goal was achieved. “More importantly, there were significant improvements in markers of dysbiosis, including zonulin and lipopolysaccharide, as well as the adipokine leptin, which appeared to be associated with improvement in quality of life measures and pain,” Dr. Bonakdar said.

He concluded his presentation by highlighting a pilot study conducted in an Australian tertiary pain clinic. It found that a personalized dietitian-delivered dietary intervention can improve pain scores, quality of life, and dietary intake of people experiencing chronic pain (Nutrients. 2019 Jan 16;11[1] pii: E181). “This is another piece of the puzzle showing that these dietary interventions can be done in multiple settings, including tertiary centers with nutrition staff, and that this important step can improve pain and quality of life,” he said.

Dr. Bonakdar disclosed that he receives royalties from Oxford University Press, Lippincott, and Elsevier. He is also a consultant to Standard Process.

[email protected]

SAN DIEGO – When clinicians ask patients to quantify their level of chronic pain on a scale of 1-10, and they rate it as a 7, what does that really mean?

Robert A. Bonakdar, MD, said posing such a question as the main determinator of the treatment approach during a pain assessment “depersonalizes medicine to the point where you’re making a patient a number.” Dr. Bonakdar spoke at Natural Supplements: An Evidence-Based Update, presented by Scripps Center for Integrative Medicine.

“A personalized approach to pain, on the other hand, considers each patient’s individual journey: their sensitivities, experiences, and failures,” he said. “It considers areas that are often overlooked, such as the role of the gut microbiome, mood, and epigenetics.”

Over the past two decades, the number of American adults suffering from pain has increased from 120 million to 178 million, or to 41% of the adult population, said Dr. Bonakdar, a family physician who is director of pain management at the Scripps Center for Integrative Medicine. Data from the National Institutes of Health estimate that Americans spend more than $600 billion each year on the treatment of pain, which surpasses monies spent on cancer, heart disease, and diabetes. According to a 2016 report from the United States Bone and Joint Initiative, arthritis and rheumatologic conditions resulted in an estimated 6.7 million annual hospitalizations, and the average annual cost per person for treatment of a musculoskeletal condition is $7,800.

“If we continue on our current trajectory, we are choosing to accept more prevalence and incidence of these disorders, spiraling costs, restricted access to needed services, and less success in alleviating pain and suffering – a high cost,” Edward H. Yelin, PhD, cochair of the report’s steering committee, and professor of medicine and health policy at the University of California, San Francisco, said in a prepared statement in 2016. That same year, Brian F. Mandell, MD, PhD, editor of the Cleveland Clinic Journal of Medicine, penned an editorial in which he stated that “The time has come to move past using a one-size-fits-all fifth vital sign . . . and reflexively prescribing an opioid when pain is characterized as severe” (Clev Clin J Med. 2016. Jun;83[6]:400-1). A decade earlier, authors of a cross-sectional review at a single Department of Veterans Affairs medical center set out to assess the impact of the VA’s “Pain as the 5th Vital Sign” initiative on the quality of pain management (J Gen Intern Med. 2006;21[6]:607–12). They found that patients with substantial pain documented by the fifth vital sign often had inadequate pain management. The preponderance of existing evidence suggests that a different approach is needed to prescribing opioids, Dr. Bonakdar said. “It’s coming from every voice in pain care: that what we are doing is not working,” he said. “It’s not only not working; it’s dangerous. That’s the consequence of depersonalized medicine. What’s the consequence of depersonalized nutrition? It’s the same industrialized approach.”

The typical American diet, he continued, is rife with processed foods and lacks an adequate proportion of plant-based products. “It’s basically a setup for inflammation,” Dr. Bonakdar said. “Most people who come into our clinic are eating 63% processed foods, 25% animal foods, and 12% plant foods. When we are eating, we’re oversizing it because that’s the American thing to do. At the end of the day, this process is not only killing us from heart disease and stroke as causes of death, but it’s also killing us as far as pain. The same diet that’s causing heart disease is the same diet that’s increasing pain.”

Dr. Bonakdar said that the ingestion of ultra-processed foods over time jumpstarts the process of dysbiosis, which increases gut permeability. “When gut permeability happens, and you have high levels of polysaccharides and inflammatory markers such as zonulin and lipopolysaccharide (LPS), it not only goes on to affect adipose tissue and insulin resistance, it can affect the muscle and joints,” he explained. “That is a setup for sarcopenia, or muscle loss, which then makes it harder for patients to be fully functional and active. It goes on to cause joint problems as well.”

He likened an increase in gut permeability to “a bomb going off in the gut.” Routine consumption of highly processed foods “creates this wave of inflammation that goes throughout your body affecting joints and muscles, and causes an increased amount of pain. Over time, patients make the connection but it’s much easier to say, ‘take this NSAID’ or ‘take this Cox-2 inhibitor’ to suppress the pain. But if all you’re doing is suppressing, you’re not going to the source of the pain.”

Dr. Bonakdar cited several recent articles that help to make the connection between dysbiosis and pain, including a review that concluded that dysbiosis of gut microbiota can influence the onset and progression of chronic degenerative diseases (Nutrients. 2019;11[8]:1707). Authors of a separate review concluded that human microbiome studies strongly suggest an incriminating role of microbes in the pathophysiology and progression of RA. Lastly, several studies have noted that pain conditions such as fibromyalgia may have microbiome “signatures” related to dysbiosis, which may pave the way for interventions, such as dietary shifting and probiotics that target individuals with microbiome abnormalities (Pain. 2019 Nov;160[11]:2589-602 and EBioMedicine. 2019 Aug 1;46:499-511).

Clinicians can begin to help patients who present with pain complaints “by listening to what their current pattern is: strategies that have worked, and those that haven’t,” he said. “If we’re not understanding the person and we’re just ordering genetic studies or microbiome studies and going off of the assessment, we sometime miss what interventions to start. In many cases, a simple intervention like a dietary shift is all that’s required.”

A survey of more than 1 million individuals found that BMI and daily pain are positively correlated in the United States (Obesity 2012;20[7]:1491-5). “This is increased more significantly for women and the elderly,” said Dr. Bonakdar, who was not affiliated with the study. “If we can change the diet that person is taking, that’s going to begin the process of reversing this to the point where they’re having less pain from inflammation that’s affecting the adipose tissue and adipokines traveling to their joints, which can cause less dysbiosis. It is very much a vicious cycle that patients follow, but if you begin to unwind it, it’s going to help multiple areas.”

In the Intensive Diet and Exercise for Arthritis (IDEA) trial, researchers randomized 450 patients with osteoarthritis to intensive dietary restriction only, exercise only, or a combination of both (BMC Musculoskelet Disord. 2009;10:93). They found that a 5% weight loss over the course of 18 months led to a 30% reduction in pain and a 24% improvement in function.

Inspired by the IDEA trial design, Dr. Bonakdar and his colleagues completed an unpublished 12-week pilot program with 12 patients with a BMI of 27 kg/m² or greater plus comorbidities. The program consisted of weekly group meetings, including a lecture by team clinicians, dietician, and fitness staff; group support sessions with a behavioral counselor; and a group exercise session. It also included weekly 1:1 personal training sessions and biweekly 1:1 dietitian meetings. The researchers also evaluated several deficiencies linked to pain, including magnesium, vitamin D, vitamins B1, B2, and B12, folate, calcium, amino acids, omega 3s, zinc, coenzyme Q10, carnitine, and vitamin C. The goal was a weight reduction of 5%.

The intervention consisted of a 28-day detox/protein shake consumed 1-3 times per day, which contained 17 g of protein per serving. Nutritional supplementation was added based on results of individual diagnostics.

According to preliminary results from the trial, the intended weight goal was achieved. “More importantly, there were significant improvements in markers of dysbiosis, including zonulin and lipopolysaccharide, as well as the adipokine leptin, which appeared to be associated with improvement in quality of life measures and pain,” Dr. Bonakdar said.

He concluded his presentation by highlighting a pilot study conducted in an Australian tertiary pain clinic. It found that a personalized dietitian-delivered dietary intervention can improve pain scores, quality of life, and dietary intake of people experiencing chronic pain (Nutrients. 2019 Jan 16;11[1] pii: E181). “This is another piece of the puzzle showing that these dietary interventions can be done in multiple settings, including tertiary centers with nutrition staff, and that this important step can improve pain and quality of life,” he said.

Dr. Bonakdar disclosed that he receives royalties from Oxford University Press, Lippincott, and Elsevier. He is also a consultant to Standard Process.

[email protected]

Transgender health care can be a successful component of a primary care practice, with sufficient commitment to staff training and a host of practical matters.

In a new “blueprint” for practices planning to implement a transgender care program, Anna M. Morenz, MD, and her coauthors emphasized that more than technical skills are needed to build an effective and welcoming transgender health practice.

All patient-facing staff – from schedulers and receptionists to nurses and billers – should “receive a foundational level of training in cultural sensitivity and effective communication with transgender and gender-diverse persons,” they wrote. In addition, they emphasized, “the workplace culture must ensure that chatter behind closed doors does not differ from patient-facing language.”

One thing that’s become clear over time, noted the authors of the blueprint, is that transgender care is no longer limited to the endocrinologist’s office. “After years of referring transgender and gender-diverse patients to specialty clinics and endocrinologists, transgender health experts have come to agree that gender-affirming hormone therapy can be safely delivered as part of routine care by a trained primary care clinician,” wrote Dr. Morenz, an internal medicine resident at the University of Washington, Seattle, and her coauthors.

Nor do most adults receiving gender-affirming care require mental health services, unless the patient or the primary care clinician sees a need or utility for psychological care. The blueprint was published in the Annals of Family Medicine.

The first step to setting up transgender services within a primary care practice is to conduct a needs assessment, suggested Dr. Morenz and her colleagues. Whether in-person focus groups or online surveys or questionnaires are best might depend on the community climate, they wrote. When stigma is high, the opportunity for anonymity might provide more robust results. Other considerations include whether there’s a concentration of transgender people with particularly high need or risk in the community – for example, transgender women of color, who might be at higher risk of HIV/AIDS than the general population. Depending on the needs of a particular community, initial transgender care efforts may have a focus on such a population.

A practice also should conduct a realistic appraisal of its own strengths and areas of weakness: Is signage inclusive? Do intake forms afford flexibility in gender and pronoun preference? Are front office staff comfortable greeting members of the lesbian-gay-bisexual-transgender-queer-intersex-asexual (LGBTQIA) community? What about restroom signage – is there a gender-inclusive option?

Competent provision of trauma-informed care goes hand in hand with assessment and preparation for providing transgender care, noted the blueprint authors, because “transgender and gender-diverse people experience high levels of trauma and stress related to minority status.”

Performing outreach within an organization and community also can unearth existing services, so that a primary care transgender practice dovetails with and complements those ongoing efforts, avoiding unnecessarily duplicative services. “All transgender health programs can benefit from developing broad relationships with external agencies, community-based organizatons, and individual practitioners who provide a range of services and can function as a network for knowledge-sharing and referrals,” noted Dr. Morenz and her coauthors.

“Starting a new program, especially one focused on a stigmatized population, can generate staff concerns and resistance,” acknowledged Dr. Morenz and her colleagues. Efforts at getting organizational buy-in can emphasize that providing transgender care helps meet ethical obligations within medicine. Emphasizing that making such care available is really at the vanguard of best practices might help overcome some resistance, they said.

The best success in implementation will be seen when at least two internal “champions” who are knowledgeable and committed lead the transition, with at least one champion having a leadership role within the organization, wrote Dr. Morenz and her colleagues.

A variety of care models can work when a practice is initiating transgender care, depending on community needs, internal resources, and the commitment level of various stakeholders. An evening clinic staffed by a small number of clinicians can be a good way to test the waters in some cases. Other facilities might wish to identify clinicians who are competent to offer hormone therapy, while still other clinics might be able to incorporate transgender care more globally within their practice. Regardless of which service model a practice opts for, however, it’s crucial to have staff members who are savvy navigators of insurance reimbursement for gender-affirming care.

And when transgender care is nested within a practice, those patients must not feel like second-class citizens of the clinic, or that they’re receiving care that’s somehow different or substandard. For example, wrote Dr. Morenz and her coauthors, a facility must consider what will happen when a transgender patient presents for urgent health needs and the primary care clinician is not available.

The nuts and bolts of providing safe and effective gender-affirming hormone therapy, said the blueprint authors, can be mastered with training and practice. “Despite common concerns that transgender health care is complicated, it is in fact as straightforward as managing common chronic diseases.”

The first step, they said, is providing risk-benefit education and counseling to patients, and reviewing fertility preservation considerations and options. Then, either estradiol or testosterone is initiated; Further suppression of endogenous hormones also might be indicated in feminization therapy in particular. The authors provided several continuing education resources for clinicians and other health care team members, and noted that a “train the trainer” model can prove effective, with a core team training others once they’ve become comfortable with the ins and outs of hormone prescribing and monitoring.

Having a staff that looks like the patient panel can go a long way toward promoting authentic inclusivity, but Dr. Morenz and her colleagues cautioned against hiring practices that amount to tokenism, or expecting transgender or gender-diverse staff to be ambassadors or spokespeople for others.

Taken together, the start-up costs for providing transgender care can be “minimal,” wrote the blueprint authors, because many free and low-cost educational resources are available. Some of the only real outlays may come from altering restroom signage and tweaking the electronic health record to accommodate gender diversity.

A practice that goes forward with transgender care, they conclude, “will provide a unique opportunity to holistically improve wellness and quality of life for transgender and gender-diverse people,” joining the “growing and passionate network of clinical practice teams who are committed to health care, innovation, and equity for transgender and gender-diverse communities.”

Dr. Morenz reported no outside sources of funding and reported that she has no relevant conflicts of interest.
 

[email protected]

SOURCE: Morenz AM et al. Ann Fam Med. 2020 Jan;18(1):73-9.
 

Transgender health care can be a successful component of a primary care practice, with sufficient commitment to staff training and a host of practical matters.

In a new “blueprint” for practices planning to implement a transgender care program, Anna M. Morenz, MD, and her coauthors emphasized that more than technical skills are needed to build an effective and welcoming transgender health practice.

All patient-facing staff – from schedulers and receptionists to nurses and billers – should “receive a foundational level of training in cultural sensitivity and effective communication with transgender and gender-diverse persons,” they wrote. In addition, they emphasized, “the workplace culture must ensure that chatter behind closed doors does not differ from patient-facing language.”

One thing that’s become clear over time, noted the authors of the blueprint, is that transgender care is no longer limited to the endocrinologist’s office. “After years of referring transgender and gender-diverse patients to specialty clinics and endocrinologists, transgender health experts have come to agree that gender-affirming hormone therapy can be safely delivered as part of routine care by a trained primary care clinician,” wrote Dr. Morenz, an internal medicine resident at the University of Washington, Seattle, and her coauthors.

Nor do most adults receiving gender-affirming care require mental health services, unless the patient or the primary care clinician sees a need or utility for psychological care. The blueprint was published in the Annals of Family Medicine.

The first step to setting up transgender services within a primary care practice is to conduct a needs assessment, suggested Dr. Morenz and her colleagues. Whether in-person focus groups or online surveys or questionnaires are best might depend on the community climate, they wrote. When stigma is high, the opportunity for anonymity might provide more robust results. Other considerations include whether there’s a concentration of transgender people with particularly high need or risk in the community – for example, transgender women of color, who might be at higher risk of HIV/AIDS than the general population. Depending on the needs of a particular community, initial transgender care efforts may have a focus on such a population.

A practice also should conduct a realistic appraisal of its own strengths and areas of weakness: Is signage inclusive? Do intake forms afford flexibility in gender and pronoun preference? Are front office staff comfortable greeting members of the lesbian-gay-bisexual-transgender-queer-intersex-asexual (LGBTQIA) community? What about restroom signage – is there a gender-inclusive option?

Competent provision of trauma-informed care goes hand in hand with assessment and preparation for providing transgender care, noted the blueprint authors, because “transgender and gender-diverse people experience high levels of trauma and stress related to minority status.”

Performing outreach within an organization and community also can unearth existing services, so that a primary care transgender practice dovetails with and complements those ongoing efforts, avoiding unnecessarily duplicative services. “All transgender health programs can benefit from developing broad relationships with external agencies, community-based organizatons, and individual practitioners who provide a range of services and can function as a network for knowledge-sharing and referrals,” noted Dr. Morenz and her coauthors.

“Starting a new program, especially one focused on a stigmatized population, can generate staff concerns and resistance,” acknowledged Dr. Morenz and her colleagues. Efforts at getting organizational buy-in can emphasize that providing transgender care helps meet ethical obligations within medicine. Emphasizing that making such care available is really at the vanguard of best practices might help overcome some resistance, they said.

The best success in implementation will be seen when at least two internal “champions” who are knowledgeable and committed lead the transition, with at least one champion having a leadership role within the organization, wrote Dr. Morenz and her colleagues.

A variety of care models can work when a practice is initiating transgender care, depending on community needs, internal resources, and the commitment level of various stakeholders. An evening clinic staffed by a small number of clinicians can be a good way to test the waters in some cases. Other facilities might wish to identify clinicians who are competent to offer hormone therapy, while still other clinics might be able to incorporate transgender care more globally within their practice. Regardless of which service model a practice opts for, however, it’s crucial to have staff members who are savvy navigators of insurance reimbursement for gender-affirming care.

And when transgender care is nested within a practice, those patients must not feel like second-class citizens of the clinic, or that they’re receiving care that’s somehow different or substandard. For example, wrote Dr. Morenz and her coauthors, a facility must consider what will happen when a transgender patient presents for urgent health needs and the primary care clinician is not available.

The nuts and bolts of providing safe and effective gender-affirming hormone therapy, said the blueprint authors, can be mastered with training and practice. “Despite common concerns that transgender health care is complicated, it is in fact as straightforward as managing common chronic diseases.”

The first step, they said, is providing risk-benefit education and counseling to patients, and reviewing fertility preservation considerations and options. Then, either estradiol or testosterone is initiated; Further suppression of endogenous hormones also might be indicated in feminization therapy in particular. The authors provided several continuing education resources for clinicians and other health care team members, and noted that a “train the trainer” model can prove effective, with a core team training others once they’ve become comfortable with the ins and outs of hormone prescribing and monitoring.

Having a staff that looks like the patient panel can go a long way toward promoting authentic inclusivity, but Dr. Morenz and her colleagues cautioned against hiring practices that amount to tokenism, or expecting transgender or gender-diverse staff to be ambassadors or spokespeople for others.

Taken together, the start-up costs for providing transgender care can be “minimal,” wrote the blueprint authors, because many free and low-cost educational resources are available. Some of the only real outlays may come from altering restroom signage and tweaking the electronic health record to accommodate gender diversity.

A practice that goes forward with transgender care, they conclude, “will provide a unique opportunity to holistically improve wellness and quality of life for transgender and gender-diverse people,” joining the “growing and passionate network of clinical practice teams who are committed to health care, innovation, and equity for transgender and gender-diverse communities.”

Dr. Morenz reported no outside sources of funding and reported that she has no relevant conflicts of interest.
 

[email protected]

SOURCE: Morenz AM et al. Ann Fam Med. 2020 Jan;18(1):73-9.
 

Transgender health care can be a successful component of a primary care practice, with sufficient commitment to staff training and a host of practical matters.

In a new “blueprint” for practices planning to implement a transgender care program, Anna M. Morenz, MD, and her coauthors emphasized that more than technical skills are needed to build an effective and welcoming transgender health practice.

All patient-facing staff – from schedulers and receptionists to nurses and billers – should “receive a foundational level of training in cultural sensitivity and effective communication with transgender and gender-diverse persons,” they wrote. In addition, they emphasized, “the workplace culture must ensure that chatter behind closed doors does not differ from patient-facing language.”

One thing that’s become clear over time, noted the authors of the blueprint, is that transgender care is no longer limited to the endocrinologist’s office. “After years of referring transgender and gender-diverse patients to specialty clinics and endocrinologists, transgender health experts have come to agree that gender-affirming hormone therapy can be safely delivered as part of routine care by a trained primary care clinician,” wrote Dr. Morenz, an internal medicine resident at the University of Washington, Seattle, and her coauthors.

Nor do most adults receiving gender-affirming care require mental health services, unless the patient or the primary care clinician sees a need or utility for psychological care. The blueprint was published in the Annals of Family Medicine.

The first step to setting up transgender services within a primary care practice is to conduct a needs assessment, suggested Dr. Morenz and her colleagues. Whether in-person focus groups or online surveys or questionnaires are best might depend on the community climate, they wrote. When stigma is high, the opportunity for anonymity might provide more robust results. Other considerations include whether there’s a concentration of transgender people with particularly high need or risk in the community – for example, transgender women of color, who might be at higher risk of HIV/AIDS than the general population. Depending on the needs of a particular community, initial transgender care efforts may have a focus on such a population.

A practice also should conduct a realistic appraisal of its own strengths and areas of weakness: Is signage inclusive? Do intake forms afford flexibility in gender and pronoun preference? Are front office staff comfortable greeting members of the lesbian-gay-bisexual-transgender-queer-intersex-asexual (LGBTQIA) community? What about restroom signage – is there a gender-inclusive option?

Competent provision of trauma-informed care goes hand in hand with assessment and preparation for providing transgender care, noted the blueprint authors, because “transgender and gender-diverse people experience high levels of trauma and stress related to minority status.”

Performing outreach within an organization and community also can unearth existing services, so that a primary care transgender practice dovetails with and complements those ongoing efforts, avoiding unnecessarily duplicative services. “All transgender health programs can benefit from developing broad relationships with external agencies, community-based organizatons, and individual practitioners who provide a range of services and can function as a network for knowledge-sharing and referrals,” noted Dr. Morenz and her coauthors.

“Starting a new program, especially one focused on a stigmatized population, can generate staff concerns and resistance,” acknowledged Dr. Morenz and her colleagues. Efforts at getting organizational buy-in can emphasize that providing transgender care helps meet ethical obligations within medicine. Emphasizing that making such care available is really at the vanguard of best practices might help overcome some resistance, they said.

The best success in implementation will be seen when at least two internal “champions” who are knowledgeable and committed lead the transition, with at least one champion having a leadership role within the organization, wrote Dr. Morenz and her colleagues.

A variety of care models can work when a practice is initiating transgender care, depending on community needs, internal resources, and the commitment level of various stakeholders. An evening clinic staffed by a small number of clinicians can be a good way to test the waters in some cases. Other facilities might wish to identify clinicians who are competent to offer hormone therapy, while still other clinics might be able to incorporate transgender care more globally within their practice. Regardless of which service model a practice opts for, however, it’s crucial to have staff members who are savvy navigators of insurance reimbursement for gender-affirming care.

And when transgender care is nested within a practice, those patients must not feel like second-class citizens of the clinic, or that they’re receiving care that’s somehow different or substandard. For example, wrote Dr. Morenz and her coauthors, a facility must consider what will happen when a transgender patient presents for urgent health needs and the primary care clinician is not available.

The nuts and bolts of providing safe and effective gender-affirming hormone therapy, said the blueprint authors, can be mastered with training and practice. “Despite common concerns that transgender health care is complicated, it is in fact as straightforward as managing common chronic diseases.”

The first step, they said, is providing risk-benefit education and counseling to patients, and reviewing fertility preservation considerations and options. Then, either estradiol or testosterone is initiated; Further suppression of endogenous hormones also might be indicated in feminization therapy in particular. The authors provided several continuing education resources for clinicians and other health care team members, and noted that a “train the trainer” model can prove effective, with a core team training others once they’ve become comfortable with the ins and outs of hormone prescribing and monitoring.

Having a staff that looks like the patient panel can go a long way toward promoting authentic inclusivity, but Dr. Morenz and her colleagues cautioned against hiring practices that amount to tokenism, or expecting transgender or gender-diverse staff to be ambassadors or spokespeople for others.

Taken together, the start-up costs for providing transgender care can be “minimal,” wrote the blueprint authors, because many free and low-cost educational resources are available. Some of the only real outlays may come from altering restroom signage and tweaking the electronic health record to accommodate gender diversity.

A practice that goes forward with transgender care, they conclude, “will provide a unique opportunity to holistically improve wellness and quality of life for transgender and gender-diverse people,” joining the “growing and passionate network of clinical practice teams who are committed to health care, innovation, and equity for transgender and gender-diverse communities.”

Dr. Morenz reported no outside sources of funding and reported that she has no relevant conflicts of interest.
 

[email protected]

SOURCE: Morenz AM et al. Ann Fam Med. 2020 Jan;18(1):73-9.
 

Metabolic syndrome is common among patients with schizophrenia, and those with metabolic syndrome are at significantly higher risk for cardiovascular disease, according to Shadi Naderyan Fe’li of the department of biostatistics and epidemiology at Shahid Sadoughi University of Medical Sciences in Yazd, Iran, and associates.

The cross-sectional study, performed on 100 patients with schizophrenia (83 men, 17 women), was published in the Medical Journal of the Islamic Republic of Iran. The overall prevalence of metabolic syndrome was 27% (men, 21.7%; women, 52.9%); the most common component of metabolic disorder was low HDL cholesterol in males and abdominal adiposity in females.

Based on Framingham Risk Scores, 76% of study participants had a low risk of cardiovascular disease, 16% had intermediate risk, and 8% had high risk. However, patients were almost twice as likely to have intermediate or high risk of cardiovascular disease if they also had metabolic syndrome (P = .042).

“Considering the findings of this study as well as other recent reports, psychiatrists and health care staff should be informed about the potential metabolic side effects of antipsychotics and unhealthy lifestyles among these patients. Furthermore, regular monitoring of metabolic risk factors is suggested. In addition, medical and behavioral interventions should be conducted for patients with [metabolic syndrome],” the investigators concluded.

The investigators reported that they had no conflicts of interest.

[email protected]

SOURCE: Fe’li SN et al. Med J Islam Repub Iran. 2019 Sep 16. doi: 10.34171/mjiri.33.97.

Metabolic syndrome is common among patients with schizophrenia, and those with metabolic syndrome are at significantly higher risk for cardiovascular disease, according to Shadi Naderyan Fe’li of the department of biostatistics and epidemiology at Shahid Sadoughi University of Medical Sciences in Yazd, Iran, and associates.

The cross-sectional study, performed on 100 patients with schizophrenia (83 men, 17 women), was published in the Medical Journal of the Islamic Republic of Iran. The overall prevalence of metabolic syndrome was 27% (men, 21.7%; women, 52.9%); the most common component of metabolic disorder was low HDL cholesterol in males and abdominal adiposity in females.

Based on Framingham Risk Scores, 76% of study participants had a low risk of cardiovascular disease, 16% had intermediate risk, and 8% had high risk. However, patients were almost twice as likely to have intermediate or high risk of cardiovascular disease if they also had metabolic syndrome (P = .042).

“Considering the findings of this study as well as other recent reports, psychiatrists and health care staff should be informed about the potential metabolic side effects of antipsychotics and unhealthy lifestyles among these patients. Furthermore, regular monitoring of metabolic risk factors is suggested. In addition, medical and behavioral interventions should be conducted for patients with [metabolic syndrome],” the investigators concluded.

The investigators reported that they had no conflicts of interest.

[email protected]

SOURCE: Fe’li SN et al. Med J Islam Repub Iran. 2019 Sep 16. doi: 10.34171/mjiri.33.97.

Metabolic syndrome is common among patients with schizophrenia, and those with metabolic syndrome are at significantly higher risk for cardiovascular disease, according to Shadi Naderyan Fe’li of the department of biostatistics and epidemiology at Shahid Sadoughi University of Medical Sciences in Yazd, Iran, and associates.

The cross-sectional study, performed on 100 patients with schizophrenia (83 men, 17 women), was published in the Medical Journal of the Islamic Republic of Iran. The overall prevalence of metabolic syndrome was 27% (men, 21.7%; women, 52.9%); the most common component of metabolic disorder was low HDL cholesterol in males and abdominal adiposity in females.

Based on Framingham Risk Scores, 76% of study participants had a low risk of cardiovascular disease, 16% had intermediate risk, and 8% had high risk. However, patients were almost twice as likely to have intermediate or high risk of cardiovascular disease if they also had metabolic syndrome (P = .042).

“Considering the findings of this study as well as other recent reports, psychiatrists and health care staff should be informed about the potential metabolic side effects of antipsychotics and unhealthy lifestyles among these patients. Furthermore, regular monitoring of metabolic risk factors is suggested. In addition, medical and behavioral interventions should be conducted for patients with [metabolic syndrome],” the investigators concluded.

The investigators reported that they had no conflicts of interest.

[email protected]

SOURCE: Fe’li SN et al. Med J Islam Repub Iran. 2019 Sep 16. doi: 10.34171/mjiri.33.97.

A new study has found that patients with atrial fibrillation (AF) who take oral anticoagulants and then suffer from lower GI bleeding have a much higher risk of being diagnosed with colorectal cancer.

“Our data indicate that lower GI bleeding in these patients should not be dismissed as a mere consequence of anticoagulation treatment,” wrote Peter Vibe Rasmussen, MD, of the University of Copenhagen in Denmark and his coauthors, adding that “timely examination could potentially provide early detection of malignant colorectal lesions.” The study was published in the European Heart Journal.

To determine whether being treated with oral anticoagulants (OACs) and subsequently undergoing GI bleeding indicates colorectal cancer, the researchers examined data from 125,418 Danish AF patients gathered from a nationwide registry. Their median age was 73 years old, and 58% (n = 73,271) were males.

Over a 3-year follow-up period, 2,576 cases of lower GI bleeding were identified; 140 of those cases led to a diagnosis of colorectal cancer within a year. The absolute 1-year risk of colorectal cancer after bleeding was 8.1% (95% confidence interval, 6.1-10.6%) in patients aged 76-80 and 3.7% (95% CI, 2.2-6.2%) in patients 65 years old or younger.

All age groups had a higher risk of colorectal cancer after bleeding, compared with patients without bleeding. Patients 65 or younger had a risk ratio of 24.2 (95% CI, 14.5-40.4) while patients over 85 had a risk ratio of 12.3 (95% CI, 7.9-19.0).

The authors acknowledged their study’s limitations, including a lack of information regarding certain risk factors, such as alcohol consumption, dietary habits, and obesity. In addition, they noted that the absolute risk of colorectal cancer in patients without bleeding is likely underdiagnosed, as “patients without GI bleeding are less likely to undergo diagnostic procedures.”

Two of the authors are employees at Bristol-Myers Squibb and Pfizer, respectively. Six additional authors reported receiving grants, speaker honoraria and consulting fees from various pharmaceutical companies. The remaining authors reported no conflicts of interest.

SOURCE: Rasmussen PV et al. Eur Heart J. 2020 Feb 7. doi: 10.1093/eurheartj/ehz964.

A new study has found that patients with atrial fibrillation (AF) who take oral anticoagulants and then suffer from lower GI bleeding have a much higher risk of being diagnosed with colorectal cancer.

“Our data indicate that lower GI bleeding in these patients should not be dismissed as a mere consequence of anticoagulation treatment,” wrote Peter Vibe Rasmussen, MD, of the University of Copenhagen in Denmark and his coauthors, adding that “timely examination could potentially provide early detection of malignant colorectal lesions.” The study was published in the European Heart Journal.

To determine whether being treated with oral anticoagulants (OACs) and subsequently undergoing GI bleeding indicates colorectal cancer, the researchers examined data from 125,418 Danish AF patients gathered from a nationwide registry. Their median age was 73 years old, and 58% (n = 73,271) were males.

Over a 3-year follow-up period, 2,576 cases of lower GI bleeding were identified; 140 of those cases led to a diagnosis of colorectal cancer within a year. The absolute 1-year risk of colorectal cancer after bleeding was 8.1% (95% confidence interval, 6.1-10.6%) in patients aged 76-80 and 3.7% (95% CI, 2.2-6.2%) in patients 65 years old or younger.

All age groups had a higher risk of colorectal cancer after bleeding, compared with patients without bleeding. Patients 65 or younger had a risk ratio of 24.2 (95% CI, 14.5-40.4) while patients over 85 had a risk ratio of 12.3 (95% CI, 7.9-19.0).

The authors acknowledged their study’s limitations, including a lack of information regarding certain risk factors, such as alcohol consumption, dietary habits, and obesity. In addition, they noted that the absolute risk of colorectal cancer in patients without bleeding is likely underdiagnosed, as “patients without GI bleeding are less likely to undergo diagnostic procedures.”

Two of the authors are employees at Bristol-Myers Squibb and Pfizer, respectively. Six additional authors reported receiving grants, speaker honoraria and consulting fees from various pharmaceutical companies. The remaining authors reported no conflicts of interest.

SOURCE: Rasmussen PV et al. Eur Heart J. 2020 Feb 7. doi: 10.1093/eurheartj/ehz964.

A new study has found that patients with atrial fibrillation (AF) who take oral anticoagulants and then suffer from lower GI bleeding have a much higher risk of being diagnosed with colorectal cancer.

“Our data indicate that lower GI bleeding in these patients should not be dismissed as a mere consequence of anticoagulation treatment,” wrote Peter Vibe Rasmussen, MD, of the University of Copenhagen in Denmark and his coauthors, adding that “timely examination could potentially provide early detection of malignant colorectal lesions.” The study was published in the European Heart Journal.

To determine whether being treated with oral anticoagulants (OACs) and subsequently undergoing GI bleeding indicates colorectal cancer, the researchers examined data from 125,418 Danish AF patients gathered from a nationwide registry. Their median age was 73 years old, and 58% (n = 73,271) were males.

Over a 3-year follow-up period, 2,576 cases of lower GI bleeding were identified; 140 of those cases led to a diagnosis of colorectal cancer within a year. The absolute 1-year risk of colorectal cancer after bleeding was 8.1% (95% confidence interval, 6.1-10.6%) in patients aged 76-80 and 3.7% (95% CI, 2.2-6.2%) in patients 65 years old or younger.

All age groups had a higher risk of colorectal cancer after bleeding, compared with patients without bleeding. Patients 65 or younger had a risk ratio of 24.2 (95% CI, 14.5-40.4) while patients over 85 had a risk ratio of 12.3 (95% CI, 7.9-19.0).

The authors acknowledged their study’s limitations, including a lack of information regarding certain risk factors, such as alcohol consumption, dietary habits, and obesity. In addition, they noted that the absolute risk of colorectal cancer in patients without bleeding is likely underdiagnosed, as “patients without GI bleeding are less likely to undergo diagnostic procedures.”

Two of the authors are employees at Bristol-Myers Squibb and Pfizer, respectively. Six additional authors reported receiving grants, speaker honoraria and consulting fees from various pharmaceutical companies. The remaining authors reported no conflicts of interest.

SOURCE: Rasmussen PV et al. Eur Heart J. 2020 Feb 7. doi: 10.1093/eurheartj/ehz964.

For adults aged 50 and older in first or second remission after induction therapy for acute myeloid leukemia, hematopoietic stem cell transplants (HSCT) from young matched unrelated donors was associated with better overall survival and lower risk for relapse than transplants from haploidentical donors, a retrospective study suggests,

Among 823 patients from the aged 50 to 75 with acute myeloid leukemia (AML) in a transplant registry, hazard ratios for both mortality and relapse were significantly higher for patients who received transplants from haploidentical siblings or offspring, compared with patients who received transplants from HLA-matched unrelated donors aged 40 or younger, reported Miguel-Angel Perales, MD, who is affiliated with Memorial Sloan Kettering Cancer Center in New York City, and colleagues.

“Our findings lend support to our hypothesis that a young [matched unrelated donor] should be the donor of choice when available. Furthermore, the data presented here suggest comparable times to transplantation in both treatment groups, confirming timely access to unrelated donors is no longer a barrier,” they wrote in Haematologica.Allogeneic transplants from matched unrelated donors have been performed ­­­for more than 30 years for treatment of patients with advanced myeloid and lymphoid malignancies. More recently, T-cell-replete bone marrow or peripheral blood transplants from haploidentical relatives, with post-transplant cyclophosphamide, tacrolimus, and mycophenolate mofetil to lower risk for graft-versus-host disease (GvHD) have become commonplace worldwide, and are established treatment options for patients with myeloid and lymphoid malignancies. There are conflicting studies suggesting that outcomes with haploidentical transplants are equivalent or superior to those seen with matched unrelated donors, the authors noted, but pointed to a 2018 study from the Acute Leukemia Working Party of the European Society for Blood and Marrow Transplant and the Center for International Blood and Marrow Transplant Research (CIBMTR). Those study results found that, among transplant recipients aged 55 through 76, graft failure, nonrelapse mortality, and overall mortality were higher when the donors were haploidentical offspring rather than HLA-matched siblings.

To see whether patients aged 50 and older with AML might benefit more with transplants from hapolidentical relatives or matched unrelated donors, the investigators used CIBMTR data to review outcomes for 823 adults with AML who received a transplant in first or second remission at one of 90 U.S. centers from 2008 through 2015.

Of this cohort, 192 patients received grafts from haploidentical donors (25% from siblings and 75% from offspring), and 631 received grafts from matched unrelated donors ranging from 18 to 40 years of age.

Although the two groups were generally similar in demographic and disease characteristics, patients in the matched unrelated donor group had significantly higher frequency of poor-risk cytogenetics (P = .03) and were significantly more likely to have received a myeloablative condition regimen than a reduced-intensity regimen (P less than .001).

In the haploidentical group, 76% of patients were in first complete remission, and the remaining 24% were in second complete remission. In the HLA-matched group the respective proportions were 83% and 17%.

The median follow-up was 42 months in the haploidentical group and 47 months in the HLA-matched group. Five-year overall survival rates were 32% and 42%, respectively.

In multivariable models controlling for donor and recipient age, sex, performance score, hematopoietic cell transplant comorbidity score, cytomegalovirus serostatus, disease status, cytogenetic risk, transplant conditioning regimen intensity and transplant period, the hazard ratio (HR) for the primary endpoint of overall mortality was 1.27 for haploidentical vs. HLA-matched grafts (P = .04). The HR for relapse risk with haploidentical transplants was 1.32 (P =.04). No significant differences in risk of nonrelapse mortality were found between the two study arms.

Bone marrow grafts from matched unrelated donors were associated with significantly higher risk for chronic GvHD than haploidentical grafts (HR, 3.12; P less than .001), but there was no difference in chronic graft-versus-host disease (GvHD) incidence between peripheral blood grafts from matched unrelated donors and haploidentical grafts.

“These data support the view that matched unrelated donor transplant with donors younger than 40 years is to be preferred,” the investigators wrote.

But in an interview, coauthor Benjamin K. Tomlinson, MD, of the University Hospitals Seidman Cancer Center in Cleveland, acknowledged that their findings might not be sufficiently large to sway opinions or clinical practice.

“Even though there appears to be that clinical benefit for this older AML patient population, that benefit is not huge, and when you’re also accounting for the process of finding a donor and just getting someone into transplant, a lot of us weren’t sure if this was really going to be practice changing as the field does move into haploidentical transplants being more common,” he said.

He noted that the better outcomes among patients who received transplants from matched unrelated donors may be at least in part explained by the higher proportion of patients with unrelated donors who received myeloablative conditioning regimens. In this study, 65% of patients with haploidentical donors underwent reduced-intensity conditioning with total body irradiation, cyclophosphamide, and fludarabine.“If we do a comparison of equal conditioning regimens, are we really going to see the same outcomes in this setting? This might actually argue that, if you’re going to do a haploidentical transplant, you might start thinking about those newer, more ablative conditioning regimens,” he said.Dr. Tomlinson added that the data are reassuring, because of the modest size of the benefit, and because “many, many of our studies are showing that haploidentical transplants do almost as well as the matched ones. The big question mark will be what are the long-term outcomes? What happens after 3 years from those transplants? And that is going to take a lot more high quality, mature data.”In an editorial accompanying the study, Richard E. Champlin, MD, of the University of Texas MD Anderson Cancer Center in Houston, noted that the more frequent use of reduced-intensity conditioning used for most patients in the haploidentical group has been associated in other studies with higher relapse rates, compared with other, more intense reduced-intensity regimens.

While he agreed that the study by Dr. Perales and colleagues “should give pause for thought, however, for those considering jumping to haploidentical transplants as a preferred approach in general,” he also noted that the study’s conclusion might not apply to cases where time-to-transplant is critical, or when other conditioning and GvHD prophylaxis regimens are used.

“The ideal study would compare optimized versions of both haploidentical and unrelated donor transplants, and use “intention-to-treat” analysis, including all patients for whom a transplant is intended from the time of initial HLA typing,” he wrote.

The study was funded by grants from the National Institutes of Health and the Office of Naval Research. Dr. Tomlinson reported no relevant disclosures. Dr. Champlin did not report disclosures.

SOURCE: Perales M-A et al. Haematologica. 2020 Jan 31;105(2):407-13.

For adults aged 50 and older in first or second remission after induction therapy for acute myeloid leukemia, hematopoietic stem cell transplants (HSCT) from young matched unrelated donors was associated with better overall survival and lower risk for relapse than transplants from haploidentical donors, a retrospective study suggests,

Among 823 patients from the aged 50 to 75 with acute myeloid leukemia (AML) in a transplant registry, hazard ratios for both mortality and relapse were significantly higher for patients who received transplants from haploidentical siblings or offspring, compared with patients who received transplants from HLA-matched unrelated donors aged 40 or younger, reported Miguel-Angel Perales, MD, who is affiliated with Memorial Sloan Kettering Cancer Center in New York City, and colleagues.

“Our findings lend support to our hypothesis that a young [matched unrelated donor] should be the donor of choice when available. Furthermore, the data presented here suggest comparable times to transplantation in both treatment groups, confirming timely access to unrelated donors is no longer a barrier,” they wrote in Haematologica.Allogeneic transplants from matched unrelated donors have been performed ­­­for more than 30 years for treatment of patients with advanced myeloid and lymphoid malignancies. More recently, T-cell-replete bone marrow or peripheral blood transplants from haploidentical relatives, with post-transplant cyclophosphamide, tacrolimus, and mycophenolate mofetil to lower risk for graft-versus-host disease (GvHD) have become commonplace worldwide, and are established treatment options for patients with myeloid and lymphoid malignancies. There are conflicting studies suggesting that outcomes with haploidentical transplants are equivalent or superior to those seen with matched unrelated donors, the authors noted, but pointed to a 2018 study from the Acute Leukemia Working Party of the European Society for Blood and Marrow Transplant and the Center for International Blood and Marrow Transplant Research (CIBMTR). Those study results found that, among transplant recipients aged 55 through 76, graft failure, nonrelapse mortality, and overall mortality were higher when the donors were haploidentical offspring rather than HLA-matched siblings.

To see whether patients aged 50 and older with AML might benefit more with transplants from hapolidentical relatives or matched unrelated donors, the investigators used CIBMTR data to review outcomes for 823 adults with AML who received a transplant in first or second remission at one of 90 U.S. centers from 2008 through 2015.

Of this cohort, 192 patients received grafts from haploidentical donors (25% from siblings and 75% from offspring), and 631 received grafts from matched unrelated donors ranging from 18 to 40 years of age.

Although the two groups were generally similar in demographic and disease characteristics, patients in the matched unrelated donor group had significantly higher frequency of poor-risk cytogenetics (P = .03) and were significantly more likely to have received a myeloablative condition regimen than a reduced-intensity regimen (P less than .001).

In the haploidentical group, 76% of patients were in first complete remission, and the remaining 24% were in second complete remission. In the HLA-matched group the respective proportions were 83% and 17%.

The median follow-up was 42 months in the haploidentical group and 47 months in the HLA-matched group. Five-year overall survival rates were 32% and 42%, respectively.

In multivariable models controlling for donor and recipient age, sex, performance score, hematopoietic cell transplant comorbidity score, cytomegalovirus serostatus, disease status, cytogenetic risk, transplant conditioning regimen intensity and transplant period, the hazard ratio (HR) for the primary endpoint of overall mortality was 1.27 for haploidentical vs. HLA-matched grafts (P = .04). The HR for relapse risk with haploidentical transplants was 1.32 (P =.04). No significant differences in risk of nonrelapse mortality were found between the two study arms.

Bone marrow grafts from matched unrelated donors were associated with significantly higher risk for chronic GvHD than haploidentical grafts (HR, 3.12; P less than .001), but there was no difference in chronic graft-versus-host disease (GvHD) incidence between peripheral blood grafts from matched unrelated donors and haploidentical grafts.

“These data support the view that matched unrelated donor transplant with donors younger than 40 years is to be preferred,” the investigators wrote.

But in an interview, coauthor Benjamin K. Tomlinson, MD, of the University Hospitals Seidman Cancer Center in Cleveland, acknowledged that their findings might not be sufficiently large to sway opinions or clinical practice.

“Even though there appears to be that clinical benefit for this older AML patient population, that benefit is not huge, and when you’re also accounting for the process of finding a donor and just getting someone into transplant, a lot of us weren’t sure if this was really going to be practice changing as the field does move into haploidentical transplants being more common,” he said.

He noted that the better outcomes among patients who received transplants from matched unrelated donors may be at least in part explained by the higher proportion of patients with unrelated donors who received myeloablative conditioning regimens. In this study, 65% of patients with haploidentical donors underwent reduced-intensity conditioning with total body irradiation, cyclophosphamide, and fludarabine.“If we do a comparison of equal conditioning regimens, are we really going to see the same outcomes in this setting? This might actually argue that, if you’re going to do a haploidentical transplant, you might start thinking about those newer, more ablative conditioning regimens,” he said.Dr. Tomlinson added that the data are reassuring, because of the modest size of the benefit, and because “many, many of our studies are showing that haploidentical transplants do almost as well as the matched ones. The big question mark will be what are the long-term outcomes? What happens after 3 years from those transplants? And that is going to take a lot more high quality, mature data.”In an editorial accompanying the study, Richard E. Champlin, MD, of the University of Texas MD Anderson Cancer Center in Houston, noted that the more frequent use of reduced-intensity conditioning used for most patients in the haploidentical group has been associated in other studies with higher relapse rates, compared with other, more intense reduced-intensity regimens.

While he agreed that the study by Dr. Perales and colleagues “should give pause for thought, however, for those considering jumping to haploidentical transplants as a preferred approach in general,” he also noted that the study’s conclusion might not apply to cases where time-to-transplant is critical, or when other conditioning and GvHD prophylaxis regimens are used.

“The ideal study would compare optimized versions of both haploidentical and unrelated donor transplants, and use “intention-to-treat” analysis, including all patients for whom a transplant is intended from the time of initial HLA typing,” he wrote.

The study was funded by grants from the National Institutes of Health and the Office of Naval Research. Dr. Tomlinson reported no relevant disclosures. Dr. Champlin did not report disclosures.

SOURCE: Perales M-A et al. Haematologica. 2020 Jan 31;105(2):407-13.

For adults aged 50 and older in first or second remission after induction therapy for acute myeloid leukemia, hematopoietic stem cell transplants (HSCT) from young matched unrelated donors was associated with better overall survival and lower risk for relapse than transplants from haploidentical donors, a retrospective study suggests,

Among 823 patients from the aged 50 to 75 with acute myeloid leukemia (AML) in a transplant registry, hazard ratios for both mortality and relapse were significantly higher for patients who received transplants from haploidentical siblings or offspring, compared with patients who received transplants from HLA-matched unrelated donors aged 40 or younger, reported Miguel-Angel Perales, MD, who is affiliated with Memorial Sloan Kettering Cancer Center in New York City, and colleagues.

“Our findings lend support to our hypothesis that a young [matched unrelated donor] should be the donor of choice when available. Furthermore, the data presented here suggest comparable times to transplantation in both treatment groups, confirming timely access to unrelated donors is no longer a barrier,” they wrote in Haematologica.Allogeneic transplants from matched unrelated donors have been performed ­­­for more than 30 years for treatment of patients with advanced myeloid and lymphoid malignancies. More recently, T-cell-replete bone marrow or peripheral blood transplants from haploidentical relatives, with post-transplant cyclophosphamide, tacrolimus, and mycophenolate mofetil to lower risk for graft-versus-host disease (GvHD) have become commonplace worldwide, and are established treatment options for patients with myeloid and lymphoid malignancies. There are conflicting studies suggesting that outcomes with haploidentical transplants are equivalent or superior to those seen with matched unrelated donors, the authors noted, but pointed to a 2018 study from the Acute Leukemia Working Party of the European Society for Blood and Marrow Transplant and the Center for International Blood and Marrow Transplant Research (CIBMTR). Those study results found that, among transplant recipients aged 55 through 76, graft failure, nonrelapse mortality, and overall mortality were higher when the donors were haploidentical offspring rather than HLA-matched siblings.

To see whether patients aged 50 and older with AML might benefit more with transplants from hapolidentical relatives or matched unrelated donors, the investigators used CIBMTR data to review outcomes for 823 adults with AML who received a transplant in first or second remission at one of 90 U.S. centers from 2008 through 2015.

Of this cohort, 192 patients received grafts from haploidentical donors (25% from siblings and 75% from offspring), and 631 received grafts from matched unrelated donors ranging from 18 to 40 years of age.

Although the two groups were generally similar in demographic and disease characteristics, patients in the matched unrelated donor group had significantly higher frequency of poor-risk cytogenetics (P = .03) and were significantly more likely to have received a myeloablative condition regimen than a reduced-intensity regimen (P less than .001).

In the haploidentical group, 76% of patients were in first complete remission, and the remaining 24% were in second complete remission. In the HLA-matched group the respective proportions were 83% and 17%.

The median follow-up was 42 months in the haploidentical group and 47 months in the HLA-matched group. Five-year overall survival rates were 32% and 42%, respectively.

In multivariable models controlling for donor and recipient age, sex, performance score, hematopoietic cell transplant comorbidity score, cytomegalovirus serostatus, disease status, cytogenetic risk, transplant conditioning regimen intensity and transplant period, the hazard ratio (HR) for the primary endpoint of overall mortality was 1.27 for haploidentical vs. HLA-matched grafts (P = .04). The HR for relapse risk with haploidentical transplants was 1.32 (P =.04). No significant differences in risk of nonrelapse mortality were found between the two study arms.

Bone marrow grafts from matched unrelated donors were associated with significantly higher risk for chronic GvHD than haploidentical grafts (HR, 3.12; P less than .001), but there was no difference in chronic graft-versus-host disease (GvHD) incidence between peripheral blood grafts from matched unrelated donors and haploidentical grafts.

“These data support the view that matched unrelated donor transplant with donors younger than 40 years is to be preferred,” the investigators wrote.

But in an interview, coauthor Benjamin K. Tomlinson, MD, of the University Hospitals Seidman Cancer Center in Cleveland, acknowledged that their findings might not be sufficiently large to sway opinions or clinical practice.

“Even though there appears to be that clinical benefit for this older AML patient population, that benefit is not huge, and when you’re also accounting for the process of finding a donor and just getting someone into transplant, a lot of us weren’t sure if this was really going to be practice changing as the field does move into haploidentical transplants being more common,” he said.

He noted that the better outcomes among patients who received transplants from matched unrelated donors may be at least in part explained by the higher proportion of patients with unrelated donors who received myeloablative conditioning regimens. In this study, 65% of patients with haploidentical donors underwent reduced-intensity conditioning with total body irradiation, cyclophosphamide, and fludarabine.“If we do a comparison of equal conditioning regimens, are we really going to see the same outcomes in this setting? This might actually argue that, if you’re going to do a haploidentical transplant, you might start thinking about those newer, more ablative conditioning regimens,” he said.Dr. Tomlinson added that the data are reassuring, because of the modest size of the benefit, and because “many, many of our studies are showing that haploidentical transplants do almost as well as the matched ones. The big question mark will be what are the long-term outcomes? What happens after 3 years from those transplants? And that is going to take a lot more high quality, mature data.”In an editorial accompanying the study, Richard E. Champlin, MD, of the University of Texas MD Anderson Cancer Center in Houston, noted that the more frequent use of reduced-intensity conditioning used for most patients in the haploidentical group has been associated in other studies with higher relapse rates, compared with other, more intense reduced-intensity regimens.

While he agreed that the study by Dr. Perales and colleagues “should give pause for thought, however, for those considering jumping to haploidentical transplants as a preferred approach in general,” he also noted that the study’s conclusion might not apply to cases where time-to-transplant is critical, or when other conditioning and GvHD prophylaxis regimens are used.

“The ideal study would compare optimized versions of both haploidentical and unrelated donor transplants, and use “intention-to-treat” analysis, including all patients for whom a transplant is intended from the time of initial HLA typing,” he wrote.

The study was funded by grants from the National Institutes of Health and the Office of Naval Research. Dr. Tomlinson reported no relevant disclosures. Dr. Champlin did not report disclosures.

SOURCE: Perales M-A et al. Haematologica. 2020 Jan 31;105(2):407-13.

The median highest pain score in a randomized trial of 38 women undergoing vulvar biopsies was 25.7 mm lower, on a 100 mm visual analogue scale, when they received 5% lidocaine-prilocaine cream instead of a 1% lidocaine injection, according to a report from Duke University, in Durham, N.C.

“In the current study, we found that application of lidocaine-prilocaine cream, alone, for a minimum of 10 minutes before vulvar biopsy on a non–hair-bearing surface results in a significantly lower maximum pain score and a significantly better patient rating of the biopsy experience,” said investigators led by Logan K. Williams, MD, of the department of obstetrics and gynecology at Duke University, Durham, N.C.

Given the “clear advantage” of the cream, it “should be considered as an anesthetic method for vulvar biopsy in a non-hair-bearing area,” Dr. Williams and colleagues concluded (Obstet Gynecol. 2020 Feb;135{2]:311-8).

Studies have pitted the cream against the injection before, but they did not compare patients’ maximal pain scores. The team wanted to do that because “comparing the highest score allows us to consider the possibility that the pain of anesthesia application” – injection versus cream – “may be greater than the pain of any other portion of the biopsy procedure.”

They randomized 19 women to the cream, approximately 5 g at the site of biopsy at least 10 minutes beforehand, and 18 others to the injection, 2 mL using a 27-gauge needle, at least 1 minute prior.

The median highest pain score in the lidocaine-prilocaine group was 20 mm, but 56.5 mm in the injection group. Patients randomized to lidocaine-prilocaine also had a significantly better (P = 0.02) experience than those receiving injected lidocaine, also assessed by visual analog scale (VAS). The median baseline pain level was 0 mm.

Anxiety was assessed after patients knew whether they were going to get the cream or the injection, but before the biopsy. The median score in the cream group was of 19 mm on another VAS, compared with 31.5 mm.

The team had planned to enroll 106 women, but given the results on interim analysis, they stopped the trial early.

Participants were 60 years old on average, and almost all had prior vulvar biopsies. Two in the cream group and three in the injection group had punch biopsies; cervical biopsy forceps were used for the rest. More than half the women had benign findings, and most of the others had vulvar intraepithelial neoplasia, but there was one invasive cancer. At Duke, the cost of the injection was $0.99, compared with $7.36 for the cream.

Dr. Williams and colleagues cited a few limitations. One is that the patients and clinicians in the study were not blinded. Another is that most of the patients had undergone vulvar biopsy before, possibly predisposing them to bias.

“In the future, consideration could be taken to studying lidocaine-prilocaine cream applications to hair-bearing surfaces, which were excluded in this study.” Also, “there is a question of the histologic effect of lidocaine-prilocaine on tissues and whether this could affect pathologic diagnoses.

“We are conducting a separate ancillary study in conjunction with our dermatopathology colleagues to investigate this question,” the investigators said.

The work was funded by Duke and the National Institutes of Health. Dr. Williams had no disclosures.

[email protected]

SOURCE: Williams LK et al. Obstet Gynecol. 2020 Feb;135(2):311-8.

The median highest pain score in a randomized trial of 38 women undergoing vulvar biopsies was 25.7 mm lower, on a 100 mm visual analogue scale, when they received 5% lidocaine-prilocaine cream instead of a 1% lidocaine injection, according to a report from Duke University, in Durham, N.C.

“In the current study, we found that application of lidocaine-prilocaine cream, alone, for a minimum of 10 minutes before vulvar biopsy on a non–hair-bearing surface results in a significantly lower maximum pain score and a significantly better patient rating of the biopsy experience,” said investigators led by Logan K. Williams, MD, of the department of obstetrics and gynecology at Duke University, Durham, N.C.

Given the “clear advantage” of the cream, it “should be considered as an anesthetic method for vulvar biopsy in a non-hair-bearing area,” Dr. Williams and colleagues concluded (Obstet Gynecol. 2020 Feb;135{2]:311-8).

Studies have pitted the cream against the injection before, but they did not compare patients’ maximal pain scores. The team wanted to do that because “comparing the highest score allows us to consider the possibility that the pain of anesthesia application” – injection versus cream – “may be greater than the pain of any other portion of the biopsy procedure.”

They randomized 19 women to the cream, approximately 5 g at the site of biopsy at least 10 minutes beforehand, and 18 others to the injection, 2 mL using a 27-gauge needle, at least 1 minute prior.

The median highest pain score in the lidocaine-prilocaine group was 20 mm, but 56.5 mm in the injection group. Patients randomized to lidocaine-prilocaine also had a significantly better (P = 0.02) experience than those receiving injected lidocaine, also assessed by visual analog scale (VAS). The median baseline pain level was 0 mm.

Anxiety was assessed after patients knew whether they were going to get the cream or the injection, but before the biopsy. The median score in the cream group was of 19 mm on another VAS, compared with 31.5 mm.

The team had planned to enroll 106 women, but given the results on interim analysis, they stopped the trial early.

Participants were 60 years old on average, and almost all had prior vulvar biopsies. Two in the cream group and three in the injection group had punch biopsies; cervical biopsy forceps were used for the rest. More than half the women had benign findings, and most of the others had vulvar intraepithelial neoplasia, but there was one invasive cancer. At Duke, the cost of the injection was $0.99, compared with $7.36 for the cream.

Dr. Williams and colleagues cited a few limitations. One is that the patients and clinicians in the study were not blinded. Another is that most of the patients had undergone vulvar biopsy before, possibly predisposing them to bias.

“In the future, consideration could be taken to studying lidocaine-prilocaine cream applications to hair-bearing surfaces, which were excluded in this study.” Also, “there is a question of the histologic effect of lidocaine-prilocaine on tissues and whether this could affect pathologic diagnoses.

“We are conducting a separate ancillary study in conjunction with our dermatopathology colleagues to investigate this question,” the investigators said.

The work was funded by Duke and the National Institutes of Health. Dr. Williams had no disclosures.

[email protected]

SOURCE: Williams LK et al. Obstet Gynecol. 2020 Feb;135(2):311-8.

The median highest pain score in a randomized trial of 38 women undergoing vulvar biopsies was 25.7 mm lower, on a 100 mm visual analogue scale, when they received 5% lidocaine-prilocaine cream instead of a 1% lidocaine injection, according to a report from Duke University, in Durham, N.C.

“In the current study, we found that application of lidocaine-prilocaine cream, alone, for a minimum of 10 minutes before vulvar biopsy on a non–hair-bearing surface results in a significantly lower maximum pain score and a significantly better patient rating of the biopsy experience,” said investigators led by Logan K. Williams, MD, of the department of obstetrics and gynecology at Duke University, Durham, N.C.

Given the “clear advantage” of the cream, it “should be considered as an anesthetic method for vulvar biopsy in a non-hair-bearing area,” Dr. Williams and colleagues concluded (Obstet Gynecol. 2020 Feb;135{2]:311-8).

Studies have pitted the cream against the injection before, but they did not compare patients’ maximal pain scores. The team wanted to do that because “comparing the highest score allows us to consider the possibility that the pain of anesthesia application” – injection versus cream – “may be greater than the pain of any other portion of the biopsy procedure.”

They randomized 19 women to the cream, approximately 5 g at the site of biopsy at least 10 minutes beforehand, and 18 others to the injection, 2 mL using a 27-gauge needle, at least 1 minute prior.

The median highest pain score in the lidocaine-prilocaine group was 20 mm, but 56.5 mm in the injection group. Patients randomized to lidocaine-prilocaine also had a significantly better (P = 0.02) experience than those receiving injected lidocaine, also assessed by visual analog scale (VAS). The median baseline pain level was 0 mm.

Anxiety was assessed after patients knew whether they were going to get the cream or the injection, but before the biopsy. The median score in the cream group was of 19 mm on another VAS, compared with 31.5 mm.

The team had planned to enroll 106 women, but given the results on interim analysis, they stopped the trial early.

Participants were 60 years old on average, and almost all had prior vulvar biopsies. Two in the cream group and three in the injection group had punch biopsies; cervical biopsy forceps were used for the rest. More than half the women had benign findings, and most of the others had vulvar intraepithelial neoplasia, but there was one invasive cancer. At Duke, the cost of the injection was $0.99, compared with $7.36 for the cream.

Dr. Williams and colleagues cited a few limitations. One is that the patients and clinicians in the study were not blinded. Another is that most of the patients had undergone vulvar biopsy before, possibly predisposing them to bias.

“In the future, consideration could be taken to studying lidocaine-prilocaine cream applications to hair-bearing surfaces, which were excluded in this study.” Also, “there is a question of the histologic effect of lidocaine-prilocaine on tissues and whether this could affect pathologic diagnoses.

“We are conducting a separate ancillary study in conjunction with our dermatopathology colleagues to investigate this question,” the investigators said.

The work was funded by Duke and the National Institutes of Health. Dr. Williams had no disclosures.

[email protected]

SOURCE: Williams LK et al. Obstet Gynecol. 2020 Feb;135(2):311-8.