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The Use of Aromatherapy as a Complementary Alternative Medicine in the Management of Cancer-Related Pain
Purpose
To identify the effectiveness of aromatherapy as an adjunct in improving pain and overall sense of well-being among patients with cancer receiving hospice care.
Background
There is limited data available on the use of aromatherapy for pain management among patients with cancer receiving end-of-life care. This project identifies the benefits of aromatherapy in a population where it was not previously evaluated.
Methods
Patients with cancer who were admitted to the hospice unit of a local hospital within a large healthcare system for at least 24 hours and taking opioids for neoplasm related pain at least once a day were included in the study. Patients with allergy to essential oils, and those suffering from allergic rhinitis and common cold, and a history of asthma were excluded. Patients who were unable to consent for study participation were also excluded.
Data Analysis
Retrospective chart analysis and surveys were used to collect the data. Univariate descriptive statistics were used for patient characteristics. A Wilcoxon Signed Rank Test was used to determine opioid use before and after aromatherapy. The t test was used to compare pain scores before and after aromatherapy. A 5-point Likert scale was used to evaluate how soothing the participants found the treatment to be. The Numeric Pain Intensity Scale was used for pain scores.
Results
There was a total of 40 participants, all of whom were male with an average age of 69 years. Pain scores before and after treatment were found to be statistically significant at an average of 5.15/10 vs 3.68/10, respectively. On a scale from 1-5 with 5 being the most soothing, there was an average rating of 3.87 among participants. There was not a statistically significant decline in opioid use from pre-treatment to post-treatment. Higher pain scores before intervention were associated with rating the lotion as more soothing.
Conclusions
The use of aromatherapy as a complement to opioids for cancer-related pain in the end-of-life was associated with an increase sense of well-being, resulted in lower pain scores and seems to have subjective comfort merit.
Implications
This study shows the potential benefits of using aromatherapy in end-of-life care among patients with cancer.
Purpose
To identify the effectiveness of aromatherapy as an adjunct in improving pain and overall sense of well-being among patients with cancer receiving hospice care.
Background
There is limited data available on the use of aromatherapy for pain management among patients with cancer receiving end-of-life care. This project identifies the benefits of aromatherapy in a population where it was not previously evaluated.
Methods
Patients with cancer who were admitted to the hospice unit of a local hospital within a large healthcare system for at least 24 hours and taking opioids for neoplasm related pain at least once a day were included in the study. Patients with allergy to essential oils, and those suffering from allergic rhinitis and common cold, and a history of asthma were excluded. Patients who were unable to consent for study participation were also excluded.
Data Analysis
Retrospective chart analysis and surveys were used to collect the data. Univariate descriptive statistics were used for patient characteristics. A Wilcoxon Signed Rank Test was used to determine opioid use before and after aromatherapy. The t test was used to compare pain scores before and after aromatherapy. A 5-point Likert scale was used to evaluate how soothing the participants found the treatment to be. The Numeric Pain Intensity Scale was used for pain scores.
Results
There was a total of 40 participants, all of whom were male with an average age of 69 years. Pain scores before and after treatment were found to be statistically significant at an average of 5.15/10 vs 3.68/10, respectively. On a scale from 1-5 with 5 being the most soothing, there was an average rating of 3.87 among participants. There was not a statistically significant decline in opioid use from pre-treatment to post-treatment. Higher pain scores before intervention were associated with rating the lotion as more soothing.
Conclusions
The use of aromatherapy as a complement to opioids for cancer-related pain in the end-of-life was associated with an increase sense of well-being, resulted in lower pain scores and seems to have subjective comfort merit.
Implications
This study shows the potential benefits of using aromatherapy in end-of-life care among patients with cancer.
Purpose
To identify the effectiveness of aromatherapy as an adjunct in improving pain and overall sense of well-being among patients with cancer receiving hospice care.
Background
There is limited data available on the use of aromatherapy for pain management among patients with cancer receiving end-of-life care. This project identifies the benefits of aromatherapy in a population where it was not previously evaluated.
Methods
Patients with cancer who were admitted to the hospice unit of a local hospital within a large healthcare system for at least 24 hours and taking opioids for neoplasm related pain at least once a day were included in the study. Patients with allergy to essential oils, and those suffering from allergic rhinitis and common cold, and a history of asthma were excluded. Patients who were unable to consent for study participation were also excluded.
Data Analysis
Retrospective chart analysis and surveys were used to collect the data. Univariate descriptive statistics were used for patient characteristics. A Wilcoxon Signed Rank Test was used to determine opioid use before and after aromatherapy. The t test was used to compare pain scores before and after aromatherapy. A 5-point Likert scale was used to evaluate how soothing the participants found the treatment to be. The Numeric Pain Intensity Scale was used for pain scores.
Results
There was a total of 40 participants, all of whom were male with an average age of 69 years. Pain scores before and after treatment were found to be statistically significant at an average of 5.15/10 vs 3.68/10, respectively. On a scale from 1-5 with 5 being the most soothing, there was an average rating of 3.87 among participants. There was not a statistically significant decline in opioid use from pre-treatment to post-treatment. Higher pain scores before intervention were associated with rating the lotion as more soothing.
Conclusions
The use of aromatherapy as a complement to opioids for cancer-related pain in the end-of-life was associated with an increase sense of well-being, resulted in lower pain scores and seems to have subjective comfort merit.
Implications
This study shows the potential benefits of using aromatherapy in end-of-life care among patients with cancer.
Palliative Care Disparities in Small Cell Carcinoma of the Prostate: An Analysis of the National Cancer Database
Purpose
This study addresses a gap in knowledge regarding palliative care utilization patterns in smallcell carcinoma of the prostate.
Background
Prostate cancer is the most common cancer affecting males. One of the most aggressive malignancies of the prostate is small cell carcinoma (SCC) of the prostate. Almost 70% of patients diagnosed with SCC present with the disseminated disease with a low 5-year survival rate of less than 2%. The role of palliative care can be beneficial in metastatic prostate cancer given its largely incurable course. Despite evidence favoring palliative care for prostate cancer in several patient populations, it remains under-utilized. Palliative care utilization patterns in SCC of the prostate have not yet been studied.
Methods
This is a retrospective study of patients diagnosed with all subtypes of AJCC staged metastatic SCC of the prostate between 2004 and 2017 in the National Cancer Database (NCDB) to determine palliative care usage (n = 615). Exclusion criteria included missing data.
Data Analysis
Variables were evaluated for significance (P < .05) in relation to the receipt of palliative care using Pearson Chi-Square, ANOVA, and Kaplan- Meier tests. Multivariate analysis was performed via binary logistics regression.
Results
Among the 961 patients diagnosed with SCC of the prostate, 64% had metastatic disease (n = 615). The metastatic cohort was more likely to receive palliative care than those that did not have distant metastasis (24.2% vs 5.7%, P < .001). Palliative care use has grown between 2004 (n = 6) and 2017 (n = 20). Patients that were uninsured were more likely than insured patients to receive palliative care (50% vs 23.5%, P = .003; 95% CI, 0.051- 0.546). Non-Hispanic patients were also more likely than Hispanic patients to receive palliative care (P = .033; 95% CI, 1.154-28.140). New England locations had the highest utilization of palliative care (43.%, P = .009). Factors that impacted palliative care use included facility region, insurance status, and Hispanic status. As palliative care continues to be utilized more frequently, we hope that this study can provide a starting point in studying and preventing palliative treatment disparities.
Purpose
This study addresses a gap in knowledge regarding palliative care utilization patterns in smallcell carcinoma of the prostate.
Background
Prostate cancer is the most common cancer affecting males. One of the most aggressive malignancies of the prostate is small cell carcinoma (SCC) of the prostate. Almost 70% of patients diagnosed with SCC present with the disseminated disease with a low 5-year survival rate of less than 2%. The role of palliative care can be beneficial in metastatic prostate cancer given its largely incurable course. Despite evidence favoring palliative care for prostate cancer in several patient populations, it remains under-utilized. Palliative care utilization patterns in SCC of the prostate have not yet been studied.
Methods
This is a retrospective study of patients diagnosed with all subtypes of AJCC staged metastatic SCC of the prostate between 2004 and 2017 in the National Cancer Database (NCDB) to determine palliative care usage (n = 615). Exclusion criteria included missing data.
Data Analysis
Variables were evaluated for significance (P < .05) in relation to the receipt of palliative care using Pearson Chi-Square, ANOVA, and Kaplan- Meier tests. Multivariate analysis was performed via binary logistics regression.
Results
Among the 961 patients diagnosed with SCC of the prostate, 64% had metastatic disease (n = 615). The metastatic cohort was more likely to receive palliative care than those that did not have distant metastasis (24.2% vs 5.7%, P < .001). Palliative care use has grown between 2004 (n = 6) and 2017 (n = 20). Patients that were uninsured were more likely than insured patients to receive palliative care (50% vs 23.5%, P = .003; 95% CI, 0.051- 0.546). Non-Hispanic patients were also more likely than Hispanic patients to receive palliative care (P = .033; 95% CI, 1.154-28.140). New England locations had the highest utilization of palliative care (43.%, P = .009). Factors that impacted palliative care use included facility region, insurance status, and Hispanic status. As palliative care continues to be utilized more frequently, we hope that this study can provide a starting point in studying and preventing palliative treatment disparities.
Purpose
This study addresses a gap in knowledge regarding palliative care utilization patterns in smallcell carcinoma of the prostate.
Background
Prostate cancer is the most common cancer affecting males. One of the most aggressive malignancies of the prostate is small cell carcinoma (SCC) of the prostate. Almost 70% of patients diagnosed with SCC present with the disseminated disease with a low 5-year survival rate of less than 2%. The role of palliative care can be beneficial in metastatic prostate cancer given its largely incurable course. Despite evidence favoring palliative care for prostate cancer in several patient populations, it remains under-utilized. Palliative care utilization patterns in SCC of the prostate have not yet been studied.
Methods
This is a retrospective study of patients diagnosed with all subtypes of AJCC staged metastatic SCC of the prostate between 2004 and 2017 in the National Cancer Database (NCDB) to determine palliative care usage (n = 615). Exclusion criteria included missing data.
Data Analysis
Variables were evaluated for significance (P < .05) in relation to the receipt of palliative care using Pearson Chi-Square, ANOVA, and Kaplan- Meier tests. Multivariate analysis was performed via binary logistics regression.
Results
Among the 961 patients diagnosed with SCC of the prostate, 64% had metastatic disease (n = 615). The metastatic cohort was more likely to receive palliative care than those that did not have distant metastasis (24.2% vs 5.7%, P < .001). Palliative care use has grown between 2004 (n = 6) and 2017 (n = 20). Patients that were uninsured were more likely than insured patients to receive palliative care (50% vs 23.5%, P = .003; 95% CI, 0.051- 0.546). Non-Hispanic patients were also more likely than Hispanic patients to receive palliative care (P = .033; 95% CI, 1.154-28.140). New England locations had the highest utilization of palliative care (43.%, P = .009). Factors that impacted palliative care use included facility region, insurance status, and Hispanic status. As palliative care continues to be utilized more frequently, we hope that this study can provide a starting point in studying and preventing palliative treatment disparities.
Implementation of Clinical Triggers for Palliative Care Consultation on the Edward Hines Jr. VA Hematology/ Oncology Inpatient Service
Purpose
Hospitalized patients with advanced malignancies often have high symptom burden and poor quality of life, which are frequently under-recognized or under-treated. Accordingly, the integration of specialty palliative care (PC) in this population is imperative. Unfortunately, a sustainable referral model to capture patients for timely PC involvement is lacking. This quality improvement study evaluated the implementation of a clinical trigger-based referral process to PC for inpatients on the Hematology/Oncology (HO) service at Hines VA Hospital. Clinical outcomes studied included: Life-Sustaining Treatment (LST) note completion rates; measurement of overall survival at 3, 6, and 12 months; rate of re-hospitalization within 30 days; and venue of death and treating specialty of deceased patients.
Methods
House staff received a weekly email that included the clinical PC triggers. Admitted patients who met trigger criteria would prompt consultation to PC. Clinical triggers included: metastatic oncologic disease or relapsed hematologic disease; uncontrolled symptoms; > 2 unscheduled hospitalizations in the prior 30 days; and unscheduled hospitalizations lasting > 7 days.
Results
A total of 63 patients were admitted to the HO service between December 2020 through February 2021. Of those, 53 (84.1%) met at least 1 trigger and 36 (68%) received PC consultation. Of the patients that met trigger criteria and received a PC consult, 85.7% died with hospice compared to 44.4% in the group who did not receive a PC consult (P < .01). Nineteen (51.3%) died within 6 months of discharge compared to 7 (26.9%) who did not receive a PC consult (P = .08). Twelve (33.3%) had recurrent hospitalizations compared to 5 (29%) who did not receive a PC consult (P = .38), and 20 (55.6%) had a new or updated LST note compared to 2 (11.8%) who did not receive PC consultation (P < .01).
Conculsions
This study demonstrated the feasibility of implementing a trigger-based system for PC consultation in a veteran inpatient HO population. Notably, a large majority of HO inpatients met criteria for at least 1 PC trigger. No significant difference was found in overall survival at 6 months; however, patients who received PC consultation were more likely to receive hospice services at the end of life.
Purpose
Hospitalized patients with advanced malignancies often have high symptom burden and poor quality of life, which are frequently under-recognized or under-treated. Accordingly, the integration of specialty palliative care (PC) in this population is imperative. Unfortunately, a sustainable referral model to capture patients for timely PC involvement is lacking. This quality improvement study evaluated the implementation of a clinical trigger-based referral process to PC for inpatients on the Hematology/Oncology (HO) service at Hines VA Hospital. Clinical outcomes studied included: Life-Sustaining Treatment (LST) note completion rates; measurement of overall survival at 3, 6, and 12 months; rate of re-hospitalization within 30 days; and venue of death and treating specialty of deceased patients.
Methods
House staff received a weekly email that included the clinical PC triggers. Admitted patients who met trigger criteria would prompt consultation to PC. Clinical triggers included: metastatic oncologic disease or relapsed hematologic disease; uncontrolled symptoms; > 2 unscheduled hospitalizations in the prior 30 days; and unscheduled hospitalizations lasting > 7 days.
Results
A total of 63 patients were admitted to the HO service between December 2020 through February 2021. Of those, 53 (84.1%) met at least 1 trigger and 36 (68%) received PC consultation. Of the patients that met trigger criteria and received a PC consult, 85.7% died with hospice compared to 44.4% in the group who did not receive a PC consult (P < .01). Nineteen (51.3%) died within 6 months of discharge compared to 7 (26.9%) who did not receive a PC consult (P = .08). Twelve (33.3%) had recurrent hospitalizations compared to 5 (29%) who did not receive a PC consult (P = .38), and 20 (55.6%) had a new or updated LST note compared to 2 (11.8%) who did not receive PC consultation (P < .01).
Conculsions
This study demonstrated the feasibility of implementing a trigger-based system for PC consultation in a veteran inpatient HO population. Notably, a large majority of HO inpatients met criteria for at least 1 PC trigger. No significant difference was found in overall survival at 6 months; however, patients who received PC consultation were more likely to receive hospice services at the end of life.
Purpose
Hospitalized patients with advanced malignancies often have high symptom burden and poor quality of life, which are frequently under-recognized or under-treated. Accordingly, the integration of specialty palliative care (PC) in this population is imperative. Unfortunately, a sustainable referral model to capture patients for timely PC involvement is lacking. This quality improvement study evaluated the implementation of a clinical trigger-based referral process to PC for inpatients on the Hematology/Oncology (HO) service at Hines VA Hospital. Clinical outcomes studied included: Life-Sustaining Treatment (LST) note completion rates; measurement of overall survival at 3, 6, and 12 months; rate of re-hospitalization within 30 days; and venue of death and treating specialty of deceased patients.
Methods
House staff received a weekly email that included the clinical PC triggers. Admitted patients who met trigger criteria would prompt consultation to PC. Clinical triggers included: metastatic oncologic disease or relapsed hematologic disease; uncontrolled symptoms; > 2 unscheduled hospitalizations in the prior 30 days; and unscheduled hospitalizations lasting > 7 days.
Results
A total of 63 patients were admitted to the HO service between December 2020 through February 2021. Of those, 53 (84.1%) met at least 1 trigger and 36 (68%) received PC consultation. Of the patients that met trigger criteria and received a PC consult, 85.7% died with hospice compared to 44.4% in the group who did not receive a PC consult (P < .01). Nineteen (51.3%) died within 6 months of discharge compared to 7 (26.9%) who did not receive a PC consult (P = .08). Twelve (33.3%) had recurrent hospitalizations compared to 5 (29%) who did not receive a PC consult (P = .38), and 20 (55.6%) had a new or updated LST note compared to 2 (11.8%) who did not receive PC consultation (P < .01).
Conculsions
This study demonstrated the feasibility of implementing a trigger-based system for PC consultation in a veteran inpatient HO population. Notably, a large majority of HO inpatients met criteria for at least 1 PC trigger. No significant difference was found in overall survival at 6 months; however, patients who received PC consultation were more likely to receive hospice services at the end of life.
Hepatitis B Virus (HBV) Testing in Veterans Receiving Systemic Anticancer Treatment
Purpose
Examine hepatitis B virus (HBV) testing in veterans receiving systemic anticancer treatment (SACT) in the Veterans Health Administration (VHA).
Background
HBV reactivation is reported in patients with chronic (HB surface antigen, HBsAg, positive) or prior (HB core antibody, HBcAb, positive) HBV infection, who receive SACT. A recent American Society of Clinical Oncology provisional clinical opinion update recommended HBV screening for all patients prior to initiation of SACT (excluding hormonal therapy). HBV testing and the incidence of hepatitis in veterans receiving SACT in the VHA has not been reported.
Methods/Data Analysis
VHA EHR data were used to identify veterans receiving SACT (01/2010-12/2021). Testing for HBsAg, HBcAb and alanine aminotransferase (ALT) was extracted. Patients known to have HBV or elevated ALT prior to first SACT, and those receiving anti-CD20 were excluded. Patients were followed until two years after the last SACT or 12/2021, whichever occurred first. Patients receiving intravenous SACT and those receiving oral SACT are described separately.
Results
Between 2010 and 2021, 215,395 veterans received an intravenous SACT, while 80,752 veterans received an oral SACT. Of patients treated with an SACT, 80% had no evidence of HBsAg or HBcAb testing prior to treatment initiation, and 8-12% experienced at least one elevated ALT between treatment initiation and two years after the last SACT. There was no evidence of increased ALT elevation in patients who were not tested compared to those that were tested prior to treatment initiation. In patients with at least one ALT elevation, approximately 30% were tested for HBV and of these, 3% tested positive.
Conclusions/Implications
Most veterans receiving SACT are not tested for HBV prior to treatment initiation, and do not experience elevated ALTs. In patients with elevated ALT during or subsequent to SACT, the majority are not tested for HBV. Veterans that are tested reveal an HBV prevalence of about 10%. Our results suggest that HBV testing prior to SACT initiation should not be at the expense of delaying treatment, given the magnitude of proposed change from current practice and the anticipated low probability of benefit.
Purpose
Examine hepatitis B virus (HBV) testing in veterans receiving systemic anticancer treatment (SACT) in the Veterans Health Administration (VHA).
Background
HBV reactivation is reported in patients with chronic (HB surface antigen, HBsAg, positive) or prior (HB core antibody, HBcAb, positive) HBV infection, who receive SACT. A recent American Society of Clinical Oncology provisional clinical opinion update recommended HBV screening for all patients prior to initiation of SACT (excluding hormonal therapy). HBV testing and the incidence of hepatitis in veterans receiving SACT in the VHA has not been reported.
Methods/Data Analysis
VHA EHR data were used to identify veterans receiving SACT (01/2010-12/2021). Testing for HBsAg, HBcAb and alanine aminotransferase (ALT) was extracted. Patients known to have HBV or elevated ALT prior to first SACT, and those receiving anti-CD20 were excluded. Patients were followed until two years after the last SACT or 12/2021, whichever occurred first. Patients receiving intravenous SACT and those receiving oral SACT are described separately.
Results
Between 2010 and 2021, 215,395 veterans received an intravenous SACT, while 80,752 veterans received an oral SACT. Of patients treated with an SACT, 80% had no evidence of HBsAg or HBcAb testing prior to treatment initiation, and 8-12% experienced at least one elevated ALT between treatment initiation and two years after the last SACT. There was no evidence of increased ALT elevation in patients who were not tested compared to those that were tested prior to treatment initiation. In patients with at least one ALT elevation, approximately 30% were tested for HBV and of these, 3% tested positive.
Conclusions/Implications
Most veterans receiving SACT are not tested for HBV prior to treatment initiation, and do not experience elevated ALTs. In patients with elevated ALT during or subsequent to SACT, the majority are not tested for HBV. Veterans that are tested reveal an HBV prevalence of about 10%. Our results suggest that HBV testing prior to SACT initiation should not be at the expense of delaying treatment, given the magnitude of proposed change from current practice and the anticipated low probability of benefit.
Purpose
Examine hepatitis B virus (HBV) testing in veterans receiving systemic anticancer treatment (SACT) in the Veterans Health Administration (VHA).
Background
HBV reactivation is reported in patients with chronic (HB surface antigen, HBsAg, positive) or prior (HB core antibody, HBcAb, positive) HBV infection, who receive SACT. A recent American Society of Clinical Oncology provisional clinical opinion update recommended HBV screening for all patients prior to initiation of SACT (excluding hormonal therapy). HBV testing and the incidence of hepatitis in veterans receiving SACT in the VHA has not been reported.
Methods/Data Analysis
VHA EHR data were used to identify veterans receiving SACT (01/2010-12/2021). Testing for HBsAg, HBcAb and alanine aminotransferase (ALT) was extracted. Patients known to have HBV or elevated ALT prior to first SACT, and those receiving anti-CD20 were excluded. Patients were followed until two years after the last SACT or 12/2021, whichever occurred first. Patients receiving intravenous SACT and those receiving oral SACT are described separately.
Results
Between 2010 and 2021, 215,395 veterans received an intravenous SACT, while 80,752 veterans received an oral SACT. Of patients treated with an SACT, 80% had no evidence of HBsAg or HBcAb testing prior to treatment initiation, and 8-12% experienced at least one elevated ALT between treatment initiation and two years after the last SACT. There was no evidence of increased ALT elevation in patients who were not tested compared to those that were tested prior to treatment initiation. In patients with at least one ALT elevation, approximately 30% were tested for HBV and of these, 3% tested positive.
Conclusions/Implications
Most veterans receiving SACT are not tested for HBV prior to treatment initiation, and do not experience elevated ALTs. In patients with elevated ALT during or subsequent to SACT, the majority are not tested for HBV. Veterans that are tested reveal an HBV prevalence of about 10%. Our results suggest that HBV testing prior to SACT initiation should not be at the expense of delaying treatment, given the magnitude of proposed change from current practice and the anticipated low probability of benefit.
The Effect of Adjuvant Therapy Type on Survival for Patients With Sage II Osteosarcoma
Background
Osteosarcoma is an aggressive bone malignancy often treated with surgery. On diagnosis, the majority of patients present with stage II disease. The objective of this study was to compare differences in survival between three commonly used adjuvant therapies: chemotherapy, radiation, and combined chemoradiation therapy in patients presenting with stage II disease.
Methods
The National Cancer Database (NCDB) was used to identify patients diagnosed with osteosarcoma from 2004 to 2018 using the ICD-O-3 histology codes 9180-9187. Patients with stage II disease and who had undergone a surgical procedure at the primary site were identified. Patients were grouped by the receipt of adjuvant chemotherapy, radiation, or chemoradiation. Descriptive statistics and Kaplan-Meier curves were used to measure survival in these patients. One way ANOVA and chi-square analyses were used to evaluate differences among treatment groups. Data were analyzed using SPSS and statistical significance was set at P = .05.
Results
Of 9955 patients in the NCDB diagnosed with osteosarcoma, 4378 (44%) presented with stage II disease. 710 (17.9%) of these surgical patients received additional adjuvant therapy. 66.0% received chemotherapy, 24.4% received radiation, and 9.57% received combined chemoradiation. Adjuvant chemotherapy had the longest median survival time of 91.7 months. Median survival for adjuvant radiotherapy was 48 months and combined chemoradiation was 50.5 months. On log-rank pairwise comparison, the difference in survival between adjuvant chemotherapy and adjuvant chemoradiation was found to be statistically significant. (P < .001). Patients receiving adjuvant chemotherapy were more likely to be younger and have private insurance. (P < .05) Conversely, patients receiving adjuvant radiation were more likely to be older and have Medicare. (P < .05). No significant differences were seen among patient race, sex, income, or Charleson-Deyo comorbidity score.
Conclusions
This study showed that patients with stage II osteosarcoma who receive adjuvant chemotherapy experience improved median survival in comparison to patients who receive adjuvant radiation. This is an important clinical finding, which should guide future treatment. However, further investigation is required to identify patient and treatment specific factors, which are contributing to mortality.
Background
Osteosarcoma is an aggressive bone malignancy often treated with surgery. On diagnosis, the majority of patients present with stage II disease. The objective of this study was to compare differences in survival between three commonly used adjuvant therapies: chemotherapy, radiation, and combined chemoradiation therapy in patients presenting with stage II disease.
Methods
The National Cancer Database (NCDB) was used to identify patients diagnosed with osteosarcoma from 2004 to 2018 using the ICD-O-3 histology codes 9180-9187. Patients with stage II disease and who had undergone a surgical procedure at the primary site were identified. Patients were grouped by the receipt of adjuvant chemotherapy, radiation, or chemoradiation. Descriptive statistics and Kaplan-Meier curves were used to measure survival in these patients. One way ANOVA and chi-square analyses were used to evaluate differences among treatment groups. Data were analyzed using SPSS and statistical significance was set at P = .05.
Results
Of 9955 patients in the NCDB diagnosed with osteosarcoma, 4378 (44%) presented with stage II disease. 710 (17.9%) of these surgical patients received additional adjuvant therapy. 66.0% received chemotherapy, 24.4% received radiation, and 9.57% received combined chemoradiation. Adjuvant chemotherapy had the longest median survival time of 91.7 months. Median survival for adjuvant radiotherapy was 48 months and combined chemoradiation was 50.5 months. On log-rank pairwise comparison, the difference in survival between adjuvant chemotherapy and adjuvant chemoradiation was found to be statistically significant. (P < .001). Patients receiving adjuvant chemotherapy were more likely to be younger and have private insurance. (P < .05) Conversely, patients receiving adjuvant radiation were more likely to be older and have Medicare. (P < .05). No significant differences were seen among patient race, sex, income, or Charleson-Deyo comorbidity score.
Conclusions
This study showed that patients with stage II osteosarcoma who receive adjuvant chemotherapy experience improved median survival in comparison to patients who receive adjuvant radiation. This is an important clinical finding, which should guide future treatment. However, further investigation is required to identify patient and treatment specific factors, which are contributing to mortality.
Background
Osteosarcoma is an aggressive bone malignancy often treated with surgery. On diagnosis, the majority of patients present with stage II disease. The objective of this study was to compare differences in survival between three commonly used adjuvant therapies: chemotherapy, radiation, and combined chemoradiation therapy in patients presenting with stage II disease.
Methods
The National Cancer Database (NCDB) was used to identify patients diagnosed with osteosarcoma from 2004 to 2018 using the ICD-O-3 histology codes 9180-9187. Patients with stage II disease and who had undergone a surgical procedure at the primary site were identified. Patients were grouped by the receipt of adjuvant chemotherapy, radiation, or chemoradiation. Descriptive statistics and Kaplan-Meier curves were used to measure survival in these patients. One way ANOVA and chi-square analyses were used to evaluate differences among treatment groups. Data were analyzed using SPSS and statistical significance was set at P = .05.
Results
Of 9955 patients in the NCDB diagnosed with osteosarcoma, 4378 (44%) presented with stage II disease. 710 (17.9%) of these surgical patients received additional adjuvant therapy. 66.0% received chemotherapy, 24.4% received radiation, and 9.57% received combined chemoradiation. Adjuvant chemotherapy had the longest median survival time of 91.7 months. Median survival for adjuvant radiotherapy was 48 months and combined chemoradiation was 50.5 months. On log-rank pairwise comparison, the difference in survival between adjuvant chemotherapy and adjuvant chemoradiation was found to be statistically significant. (P < .001). Patients receiving adjuvant chemotherapy were more likely to be younger and have private insurance. (P < .05) Conversely, patients receiving adjuvant radiation were more likely to be older and have Medicare. (P < .05). No significant differences were seen among patient race, sex, income, or Charleson-Deyo comorbidity score.
Conclusions
This study showed that patients with stage II osteosarcoma who receive adjuvant chemotherapy experience improved median survival in comparison to patients who receive adjuvant radiation. This is an important clinical finding, which should guide future treatment. However, further investigation is required to identify patient and treatment specific factors, which are contributing to mortality.
Concurrent Romiplostim With FOLFIRINOX for Secondary Prevention of Thrombocytopenia in a Patient With Myelodysplastic Syndrome and Pancreatic Adenocarcinoma
Inroduction
Romiplostim is an agonist of the thrombopoietin receptor that stimulates platelet production. Several studies have evaluated the role of romiplostim in the prevention of chemotherapy-induced thrombocytopenia (CIT). Romiplostim may reduce dose reductions, treatment delays, bleeding events, and transfusions.
Less is known about treatment of CIT in patients with pre-existing thrombocytopenia (TCP), such as those with myelodysplastic syndrome (MDS). Here we present a case of a patient with TCP secondary to MDS who was given romiplostim during the treatment of pancreatic adenocarcinoma with FOLFIRINOX.
Case Report
The patient is a 76-year-old male with history of chronic TCP (baseline platelets 50-90 K/μL) presumed secondary to myelodysplastic syndrome, although a bone marrow biopsy was inconclusive. He had not had any major bleeding events or transfusions, aside from one unit of platelets given after a cervical spine fusion.
He was later diagnosed with borderline-resectable pancreatic adenocarcinoma, Stage IbT2N0. Plan made to administer neoadjuvant FOLFIRNOX chemotherapy, followed by Whipple.
The patient was started on romiplostim with a dose range of 1-10 mcg/kg weekly to maintain platelets between 60-200. We initially planned to give all 12 cycles neoadjuvantly but found that we could not maintain a platelet count over 50 K/μL despite maximal uptitration of romiplostim so the Whipple was performed after Cycle 9. Three additional cycles were given post-operatively. There were no dose-reductions, although oxaliplatin was held after cycle 9 due to neuropathy. He developed a jejunal bleed post-Whipple that required embolization but did not require transfusion.
Summary
This was a case in which romiplostim was successfully used during FOLFIRINOX to support platelets in a patient with baseline TCP from MDS. Despite a jejunal bleed after Whipple, the patient tolerated the treatment well and was able to complete all 12 cycles of peri-operative FOLFIRINOX. This approach may be beneficial in other patients with pre-existing TCP receiving chemotherapy.
Inroduction
Romiplostim is an agonist of the thrombopoietin receptor that stimulates platelet production. Several studies have evaluated the role of romiplostim in the prevention of chemotherapy-induced thrombocytopenia (CIT). Romiplostim may reduce dose reductions, treatment delays, bleeding events, and transfusions.
Less is known about treatment of CIT in patients with pre-existing thrombocytopenia (TCP), such as those with myelodysplastic syndrome (MDS). Here we present a case of a patient with TCP secondary to MDS who was given romiplostim during the treatment of pancreatic adenocarcinoma with FOLFIRINOX.
Case Report
The patient is a 76-year-old male with history of chronic TCP (baseline platelets 50-90 K/μL) presumed secondary to myelodysplastic syndrome, although a bone marrow biopsy was inconclusive. He had not had any major bleeding events or transfusions, aside from one unit of platelets given after a cervical spine fusion.
He was later diagnosed with borderline-resectable pancreatic adenocarcinoma, Stage IbT2N0. Plan made to administer neoadjuvant FOLFIRNOX chemotherapy, followed by Whipple.
The patient was started on romiplostim with a dose range of 1-10 mcg/kg weekly to maintain platelets between 60-200. We initially planned to give all 12 cycles neoadjuvantly but found that we could not maintain a platelet count over 50 K/μL despite maximal uptitration of romiplostim so the Whipple was performed after Cycle 9. Three additional cycles were given post-operatively. There were no dose-reductions, although oxaliplatin was held after cycle 9 due to neuropathy. He developed a jejunal bleed post-Whipple that required embolization but did not require transfusion.
Summary
This was a case in which romiplostim was successfully used during FOLFIRINOX to support platelets in a patient with baseline TCP from MDS. Despite a jejunal bleed after Whipple, the patient tolerated the treatment well and was able to complete all 12 cycles of peri-operative FOLFIRINOX. This approach may be beneficial in other patients with pre-existing TCP receiving chemotherapy.
Inroduction
Romiplostim is an agonist of the thrombopoietin receptor that stimulates platelet production. Several studies have evaluated the role of romiplostim in the prevention of chemotherapy-induced thrombocytopenia (CIT). Romiplostim may reduce dose reductions, treatment delays, bleeding events, and transfusions.
Less is known about treatment of CIT in patients with pre-existing thrombocytopenia (TCP), such as those with myelodysplastic syndrome (MDS). Here we present a case of a patient with TCP secondary to MDS who was given romiplostim during the treatment of pancreatic adenocarcinoma with FOLFIRINOX.
Case Report
The patient is a 76-year-old male with history of chronic TCP (baseline platelets 50-90 K/μL) presumed secondary to myelodysplastic syndrome, although a bone marrow biopsy was inconclusive. He had not had any major bleeding events or transfusions, aside from one unit of platelets given after a cervical spine fusion.
He was later diagnosed with borderline-resectable pancreatic adenocarcinoma, Stage IbT2N0. Plan made to administer neoadjuvant FOLFIRNOX chemotherapy, followed by Whipple.
The patient was started on romiplostim with a dose range of 1-10 mcg/kg weekly to maintain platelets between 60-200. We initially planned to give all 12 cycles neoadjuvantly but found that we could not maintain a platelet count over 50 K/μL despite maximal uptitration of romiplostim so the Whipple was performed after Cycle 9. Three additional cycles were given post-operatively. There were no dose-reductions, although oxaliplatin was held after cycle 9 due to neuropathy. He developed a jejunal bleed post-Whipple that required embolization but did not require transfusion.
Summary
This was a case in which romiplostim was successfully used during FOLFIRINOX to support platelets in a patient with baseline TCP from MDS. Despite a jejunal bleed after Whipple, the patient tolerated the treatment well and was able to complete all 12 cycles of peri-operative FOLFIRINOX. This approach may be beneficial in other patients with pre-existing TCP receiving chemotherapy.
A Case Report of Palliative Pembrolizumab Monotherapy for a Poorly Differentiated Malignancy
Introduction
The critical role of palliative radiotherapy (RT) in the management of advanced cancer is evolving due to the advent of novel therapeuticapproaches. We report the case of a veteran with a soft tissue metastasis who had a robust response to pembrolizumab, allowing for the deferral of palliative RT.
Case Presentation
An 86-year-old male presented with a rapidly growing, painful, malodorous, fungating right inguinal soft tissue mass measuring 10×7×3 cm that had rendered the patient non-ambulatory, with subsequent imaging also demonstrating a left pleural-based lung mass. Biopsy was consistent with a poorly differentiated carcinoma, and molecular profiling revealed a KRAS G12C mutation, high tumor mutational burden (TMB 18 mutations/megabase), and high PD-L1 expression (TPS 100%). The patient’s poor functional status precluded the use of aggressive combination chemotherapy, but the molecular features were favorable for response to immune checkpoint inhibitor monotherapy, which is better tolerated. He was initiated on pembrolizumab with the goal of symptom palliation and potentially prolonging his life. However, as rapid responses to immunotherapy are uncommon, radiation oncology was consulted for palliative RT. Twenty days after starting pembrolizumab and 2 weeks after RT simulation, the inguinal mass had markedly regressed with an open tissue defect at the site. As the palliative goal had been achieved, RT was deferred to avoid the development of a non-healing wound.
Conclusions
Our case highlights palliative treatment modalities for soft tissue masses. Immunotherapy is now a component of first-line therapy in many cancer types, but rapid and robust responses to monotherapy are rare. There is the exciting potential to combine immunotherapy with RT, with small case series indicating synergy, although further research is needed. In cases with molecular characteristics favoring response to immunotherapy, an optimal sequencing approach may incorporate an initial run-in phase with immunotherapy to determine if symptom palliation can be achieved with unimodal therapy. The location of the mass in a non-radiation sensitive region allowed us to entertain the use of combination therapy for our patient, but ultimately was not needed. Palliative RT will remain an option at the time of cancer progression.
Introduction
The critical role of palliative radiotherapy (RT) in the management of advanced cancer is evolving due to the advent of novel therapeuticapproaches. We report the case of a veteran with a soft tissue metastasis who had a robust response to pembrolizumab, allowing for the deferral of palliative RT.
Case Presentation
An 86-year-old male presented with a rapidly growing, painful, malodorous, fungating right inguinal soft tissue mass measuring 10×7×3 cm that had rendered the patient non-ambulatory, with subsequent imaging also demonstrating a left pleural-based lung mass. Biopsy was consistent with a poorly differentiated carcinoma, and molecular profiling revealed a KRAS G12C mutation, high tumor mutational burden (TMB 18 mutations/megabase), and high PD-L1 expression (TPS 100%). The patient’s poor functional status precluded the use of aggressive combination chemotherapy, but the molecular features were favorable for response to immune checkpoint inhibitor monotherapy, which is better tolerated. He was initiated on pembrolizumab with the goal of symptom palliation and potentially prolonging his life. However, as rapid responses to immunotherapy are uncommon, radiation oncology was consulted for palliative RT. Twenty days after starting pembrolizumab and 2 weeks after RT simulation, the inguinal mass had markedly regressed with an open tissue defect at the site. As the palliative goal had been achieved, RT was deferred to avoid the development of a non-healing wound.
Conclusions
Our case highlights palliative treatment modalities for soft tissue masses. Immunotherapy is now a component of first-line therapy in many cancer types, but rapid and robust responses to monotherapy are rare. There is the exciting potential to combine immunotherapy with RT, with small case series indicating synergy, although further research is needed. In cases with molecular characteristics favoring response to immunotherapy, an optimal sequencing approach may incorporate an initial run-in phase with immunotherapy to determine if symptom palliation can be achieved with unimodal therapy. The location of the mass in a non-radiation sensitive region allowed us to entertain the use of combination therapy for our patient, but ultimately was not needed. Palliative RT will remain an option at the time of cancer progression.
Introduction
The critical role of palliative radiotherapy (RT) in the management of advanced cancer is evolving due to the advent of novel therapeuticapproaches. We report the case of a veteran with a soft tissue metastasis who had a robust response to pembrolizumab, allowing for the deferral of palliative RT.
Case Presentation
An 86-year-old male presented with a rapidly growing, painful, malodorous, fungating right inguinal soft tissue mass measuring 10×7×3 cm that had rendered the patient non-ambulatory, with subsequent imaging also demonstrating a left pleural-based lung mass. Biopsy was consistent with a poorly differentiated carcinoma, and molecular profiling revealed a KRAS G12C mutation, high tumor mutational burden (TMB 18 mutations/megabase), and high PD-L1 expression (TPS 100%). The patient’s poor functional status precluded the use of aggressive combination chemotherapy, but the molecular features were favorable for response to immune checkpoint inhibitor monotherapy, which is better tolerated. He was initiated on pembrolizumab with the goal of symptom palliation and potentially prolonging his life. However, as rapid responses to immunotherapy are uncommon, radiation oncology was consulted for palliative RT. Twenty days after starting pembrolizumab and 2 weeks after RT simulation, the inguinal mass had markedly regressed with an open tissue defect at the site. As the palliative goal had been achieved, RT was deferred to avoid the development of a non-healing wound.
Conclusions
Our case highlights palliative treatment modalities for soft tissue masses. Immunotherapy is now a component of first-line therapy in many cancer types, but rapid and robust responses to monotherapy are rare. There is the exciting potential to combine immunotherapy with RT, with small case series indicating synergy, although further research is needed. In cases with molecular characteristics favoring response to immunotherapy, an optimal sequencing approach may incorporate an initial run-in phase with immunotherapy to determine if symptom palliation can be achieved with unimodal therapy. The location of the mass in a non-radiation sensitive region allowed us to entertain the use of combination therapy for our patient, but ultimately was not needed. Palliative RT will remain an option at the time of cancer progression.
Chimeric Antigen Receptor T-cell Therapy in the Veterans Affairs Network: the Tennessee Valley Healthcare System Experience
Purpose/Background
Chimeric antigen receptor T-cell (CART) therapy has emerged as a novel treatment for hematologic malignancies, with six FDA agents approved for commercial use. The Veterans Affairs (VA) Tennessee Valley Healthcare System (TVHS) is the only VA facility authorized to administer CART therapy. As these therapies are changing the paradigm of treatment, the purpose of this review will report the TVHS experience thus far.
Methods
TVHS began coordination with pharmaceutical manufacturers of CART therapies upon first approval in 2017 and became an authorized treatment center for CART therapy in September 2019 with the first CART infusion performed in December of that year. This is a retrospective electronic chart review of all CART patients referred to TVHS from the program’s inception, December 1, 2019 through June 30, 2021. The primary objective of this analysis will be to evaluate the efficacy outcomes of veterans who received CART therapy at TVHS, including overall response rates (ORR), progression free survival (PFS), and overall survival (OS). Secondary objectives include assessment of toxicities, including rates and maximum grades of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
Results
A total of 28 patients have received CART infusion at TVHS to date. Fifteen of these patients have reached one year post-CART infusion and are included in this analysis. The majority of patients were White (67%) and were treated for diffuse large B-cell lymphoma (87%). All patients were male and ten (67%) were over the age of 65. ORR was 93% (73% achieved complete response [CR]). One-year PFS and OS were both 60%. Of patients who achieved CR by day 100, 89% remain in CR to date. CRS toxicity was observed in 73% of patients (no Grade 3 or higher). ICANS was observed in 26.7% of patients (20% Grade 3 or higher).
Conclusions
CART therapy within the VA has become a well-established practice at TVHS and appears to be a safe and effective therapeutic option for veterans with aggressive lymphoid malignancies.
Purpose/Background
Chimeric antigen receptor T-cell (CART) therapy has emerged as a novel treatment for hematologic malignancies, with six FDA agents approved for commercial use. The Veterans Affairs (VA) Tennessee Valley Healthcare System (TVHS) is the only VA facility authorized to administer CART therapy. As these therapies are changing the paradigm of treatment, the purpose of this review will report the TVHS experience thus far.
Methods
TVHS began coordination with pharmaceutical manufacturers of CART therapies upon first approval in 2017 and became an authorized treatment center for CART therapy in September 2019 with the first CART infusion performed in December of that year. This is a retrospective electronic chart review of all CART patients referred to TVHS from the program’s inception, December 1, 2019 through June 30, 2021. The primary objective of this analysis will be to evaluate the efficacy outcomes of veterans who received CART therapy at TVHS, including overall response rates (ORR), progression free survival (PFS), and overall survival (OS). Secondary objectives include assessment of toxicities, including rates and maximum grades of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
Results
A total of 28 patients have received CART infusion at TVHS to date. Fifteen of these patients have reached one year post-CART infusion and are included in this analysis. The majority of patients were White (67%) and were treated for diffuse large B-cell lymphoma (87%). All patients were male and ten (67%) were over the age of 65. ORR was 93% (73% achieved complete response [CR]). One-year PFS and OS were both 60%. Of patients who achieved CR by day 100, 89% remain in CR to date. CRS toxicity was observed in 73% of patients (no Grade 3 or higher). ICANS was observed in 26.7% of patients (20% Grade 3 or higher).
Conclusions
CART therapy within the VA has become a well-established practice at TVHS and appears to be a safe and effective therapeutic option for veterans with aggressive lymphoid malignancies.
Purpose/Background
Chimeric antigen receptor T-cell (CART) therapy has emerged as a novel treatment for hematologic malignancies, with six FDA agents approved for commercial use. The Veterans Affairs (VA) Tennessee Valley Healthcare System (TVHS) is the only VA facility authorized to administer CART therapy. As these therapies are changing the paradigm of treatment, the purpose of this review will report the TVHS experience thus far.
Methods
TVHS began coordination with pharmaceutical manufacturers of CART therapies upon first approval in 2017 and became an authorized treatment center for CART therapy in September 2019 with the first CART infusion performed in December of that year. This is a retrospective electronic chart review of all CART patients referred to TVHS from the program’s inception, December 1, 2019 through June 30, 2021. The primary objective of this analysis will be to evaluate the efficacy outcomes of veterans who received CART therapy at TVHS, including overall response rates (ORR), progression free survival (PFS), and overall survival (OS). Secondary objectives include assessment of toxicities, including rates and maximum grades of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
Results
A total of 28 patients have received CART infusion at TVHS to date. Fifteen of these patients have reached one year post-CART infusion and are included in this analysis. The majority of patients were White (67%) and were treated for diffuse large B-cell lymphoma (87%). All patients were male and ten (67%) were over the age of 65. ORR was 93% (73% achieved complete response [CR]). One-year PFS and OS were both 60%. Of patients who achieved CR by day 100, 89% remain in CR to date. CRS toxicity was observed in 73% of patients (no Grade 3 or higher). ICANS was observed in 26.7% of patients (20% Grade 3 or higher).
Conclusions
CART therapy within the VA has become a well-established practice at TVHS and appears to be a safe and effective therapeutic option for veterans with aggressive lymphoid malignancies.
New AI tech could detect type 2 diabetes without a blood test
Imagine that instead of a patient visiting their doctor for blood tests, they could rely on a noninvasive at-home test to predict their risk of diabetes, a disease that affects nearly 15% of U.S. adults (23% of whom are undiagnosed), according to the U.S. Centers for Disease Control and Prevention.
This technology could become a reality thanks to a research team that developed a machine learning algorithm to predict whether people had type 2 diabetes, prediabetes, or no diabetes. In an article published in BMJ Innovations, the researchers describe how their algorithm sorted people into these three categories with 97% accuracy on the basis of measurements of the heart’s electrical activity, determined from an electrocardiogram.
To develop and train their machine learning model – a type of artificial intelligence (AI) that keeps getting smarter over time – researchers used ECG measurements from 1,262 people in Central India. The study participants were part of the Sindhi population, an ethnic group that has been shown in past studies to be at elevated risk for type 2 diabetes.
Why ECG data? Because “cardiovascular abnormalities and diabetes, they go hand in hand,” says study author Manju Mamtani, MD, general manager of M&H Research, San Antonio, and treasurer of the Lata Medical Research Foundation. Subtle cardiovascular changes can occur even early in the development of diabetes.
“ECG has the power to detect these fluctuations, at least in theory, but those fluctuations are so tiny that many times we as humans looking at that might miss it,” says study author Hemant Kulkarni, MD, chief executive officer of M&H Research and president of the Lata Medical Research Foundation. “But the AI, which is powered to detect such specific fluctuations or subtle features, we hypothesized for the study that the AI algorithm might be able to pick those things up. And it did.”
Although this isn’t the first AI algorithm developed to predict diabetes risk, it outperforms previous models, the researchers say.
The team hopes to test and validate the algorithm in a variety of populations so that it can eventually be developed into an accessible, user-friendly technology. They envision that someday their algorithm could be used in smartwatches or other smart devices and could be integrated into telehealth so that people could be screened for diabetes even if they weren’t able to travel to a health care facility for blood testing.
The team is also studying other noninvasive methods of early disease detection and predictive models for adverse outcomes using AI.
“The fact that these algorithms are able to pick up the things of interest and learn on their own and keep learning in the future also adds excitement to their use in these settings,” says Dr. Kulkarni.
A version of this article first appeared on Medscape.com.
Imagine that instead of a patient visiting their doctor for blood tests, they could rely on a noninvasive at-home test to predict their risk of diabetes, a disease that affects nearly 15% of U.S. adults (23% of whom are undiagnosed), according to the U.S. Centers for Disease Control and Prevention.
This technology could become a reality thanks to a research team that developed a machine learning algorithm to predict whether people had type 2 diabetes, prediabetes, or no diabetes. In an article published in BMJ Innovations, the researchers describe how their algorithm sorted people into these three categories with 97% accuracy on the basis of measurements of the heart’s electrical activity, determined from an electrocardiogram.
To develop and train their machine learning model – a type of artificial intelligence (AI) that keeps getting smarter over time – researchers used ECG measurements from 1,262 people in Central India. The study participants were part of the Sindhi population, an ethnic group that has been shown in past studies to be at elevated risk for type 2 diabetes.
Why ECG data? Because “cardiovascular abnormalities and diabetes, they go hand in hand,” says study author Manju Mamtani, MD, general manager of M&H Research, San Antonio, and treasurer of the Lata Medical Research Foundation. Subtle cardiovascular changes can occur even early in the development of diabetes.
“ECG has the power to detect these fluctuations, at least in theory, but those fluctuations are so tiny that many times we as humans looking at that might miss it,” says study author Hemant Kulkarni, MD, chief executive officer of M&H Research and president of the Lata Medical Research Foundation. “But the AI, which is powered to detect such specific fluctuations or subtle features, we hypothesized for the study that the AI algorithm might be able to pick those things up. And it did.”
Although this isn’t the first AI algorithm developed to predict diabetes risk, it outperforms previous models, the researchers say.
The team hopes to test and validate the algorithm in a variety of populations so that it can eventually be developed into an accessible, user-friendly technology. They envision that someday their algorithm could be used in smartwatches or other smart devices and could be integrated into telehealth so that people could be screened for diabetes even if they weren’t able to travel to a health care facility for blood testing.
The team is also studying other noninvasive methods of early disease detection and predictive models for adverse outcomes using AI.
“The fact that these algorithms are able to pick up the things of interest and learn on their own and keep learning in the future also adds excitement to their use in these settings,” says Dr. Kulkarni.
A version of this article first appeared on Medscape.com.
Imagine that instead of a patient visiting their doctor for blood tests, they could rely on a noninvasive at-home test to predict their risk of diabetes, a disease that affects nearly 15% of U.S. adults (23% of whom are undiagnosed), according to the U.S. Centers for Disease Control and Prevention.
This technology could become a reality thanks to a research team that developed a machine learning algorithm to predict whether people had type 2 diabetes, prediabetes, or no diabetes. In an article published in BMJ Innovations, the researchers describe how their algorithm sorted people into these three categories with 97% accuracy on the basis of measurements of the heart’s electrical activity, determined from an electrocardiogram.
To develop and train their machine learning model – a type of artificial intelligence (AI) that keeps getting smarter over time – researchers used ECG measurements from 1,262 people in Central India. The study participants were part of the Sindhi population, an ethnic group that has been shown in past studies to be at elevated risk for type 2 diabetes.
Why ECG data? Because “cardiovascular abnormalities and diabetes, they go hand in hand,” says study author Manju Mamtani, MD, general manager of M&H Research, San Antonio, and treasurer of the Lata Medical Research Foundation. Subtle cardiovascular changes can occur even early in the development of diabetes.
“ECG has the power to detect these fluctuations, at least in theory, but those fluctuations are so tiny that many times we as humans looking at that might miss it,” says study author Hemant Kulkarni, MD, chief executive officer of M&H Research and president of the Lata Medical Research Foundation. “But the AI, which is powered to detect such specific fluctuations or subtle features, we hypothesized for the study that the AI algorithm might be able to pick those things up. And it did.”
Although this isn’t the first AI algorithm developed to predict diabetes risk, it outperforms previous models, the researchers say.
The team hopes to test and validate the algorithm in a variety of populations so that it can eventually be developed into an accessible, user-friendly technology. They envision that someday their algorithm could be used in smartwatches or other smart devices and could be integrated into telehealth so that people could be screened for diabetes even if they weren’t able to travel to a health care facility for blood testing.
The team is also studying other noninvasive methods of early disease detection and predictive models for adverse outcomes using AI.
“The fact that these algorithms are able to pick up the things of interest and learn on their own and keep learning in the future also adds excitement to their use in these settings,” says Dr. Kulkarni.
A version of this article first appeared on Medscape.com.
Low testosterone may raise risk of COVID hospitalization
researchers have found.
Low testosterone has long been linked to multiple chronic conditions, including obesity, heart disease, and type 2 diabetes, as well as acute conditions, such as heart attack and stroke. A study published earlier in the pandemic suggested that suppressing the sex hormone might protect against COVID-19. The new study, published in JAMA Network Open, is among the first to suggest a link between low testosterone and the risk for severe COVID.
Researchers at Washington University in St. Louis evaluated data from 723 unvaccinated men who had been infected with SARS-CoV-2. Of those, 116 had been diagnosed with hypogonadism, and 180 were receiving testosterone supplementation.
The study found that men whose testosterone levels were less than 200 ng/dL were 2.4 times more likely to experience a severe case of COVID-19 that required hospitalization than were those with normal levels of the hormone. The study accounted for the fact that participants with low testosterone were also more likely to have comorbidities such as diabetes and obesity.
Paresh Dandona, MD, PhD, distinguished professor of medicine and endocrinology at the State University of New York at Buffalo, called the findings “very exciting” and “fundamental.”
“In the world of hypogonadism, this is the first to show that low testosterone makes you vulnerable” to COVID, added Dr. Dandona, who was not involved with the research.
Men who were receiving hormone replacement therapy were at lower risk of hospitalization, compared with those who were not receiving treatment, the study found.
“Testosterone therapy seemed to negate the harmful effects of COVID,” said Sandeep Dhindsa, MD, an endocrinologist at Saint Louis University and lead author of the study.
Approximately 50% more men have died from confirmed COVID-19 than women since the start of the pandemic, according to the Sex, Gender and COVID-19 Project. Previous findings suggesting that sex may be a risk factor for death from COVID prompted researchers to consider whether hormones may play a role in the increased risk among men and whether treatments that suppress androgen levels could cut hospitalizations, but researchers consistently found that androgen suppression was not effective.
“There are other reasons women might be doing better – they may have followed public health guidelines a lot better,” according to Abhinav Diwan, MD, professor of medicine at Washington University in St. Louis, who helped conduct the new study. “It may be chromosomal and not necessarily just hormonal. The differences between men and women go beyond one factor.”
According to the researchers, the findings do not suggest that hormone therapy be used as a preventive measure against COVID.
“We don’t want patients to get excited and start to ask their doctors for testosterone,” Dr. Dhindsa said.
However, viewing low testosterone as a risk factor for COVID could be considered a shift in thinking for some clinicians, according to Dr. Dandana.
“All obese and all [men with] type 2 diabetes should be tested for testosterone, which is the practice in my clinic right now, even if they have no symptoms,” Dr. Dandana said. “Certainly, those with symptoms [of low testosterone] but no diagnosis, they should be tested, too.”
Participants in the study were infected with SARS-CoV-2 early in 2020, before vaccines were available. The researchers did not assess whether the rate of hospitalizations among participants with low testosterone would be different had they been vaccinated.
“Whatever benefits we saw with testosterone might be minor compared to getting the vaccine,” Dr. Dhindsa said.
Dr. Diwan agreed. “COVID hospitalization continues to be a problem, the strains are evolving, and new vaccines are coming in,” he said. “The bottom line is to get vaccinated.”
Dr. Dhindsa has received personal fees from Bayer and Acerus Pharmaceuticals and grants from Clarus Therapeutics outside the submitted work. Dr. Diwan has served as a consultant for the interpretation of echocardiograms for clinical trials for Clario (previously ERT) and has received nonfinancial support from Dewpoint Therapeutics outside the submitted work. Dr. Dandana has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
researchers have found.
Low testosterone has long been linked to multiple chronic conditions, including obesity, heart disease, and type 2 diabetes, as well as acute conditions, such as heart attack and stroke. A study published earlier in the pandemic suggested that suppressing the sex hormone might protect against COVID-19. The new study, published in JAMA Network Open, is among the first to suggest a link between low testosterone and the risk for severe COVID.
Researchers at Washington University in St. Louis evaluated data from 723 unvaccinated men who had been infected with SARS-CoV-2. Of those, 116 had been diagnosed with hypogonadism, and 180 were receiving testosterone supplementation.
The study found that men whose testosterone levels were less than 200 ng/dL were 2.4 times more likely to experience a severe case of COVID-19 that required hospitalization than were those with normal levels of the hormone. The study accounted for the fact that participants with low testosterone were also more likely to have comorbidities such as diabetes and obesity.
Paresh Dandona, MD, PhD, distinguished professor of medicine and endocrinology at the State University of New York at Buffalo, called the findings “very exciting” and “fundamental.”
“In the world of hypogonadism, this is the first to show that low testosterone makes you vulnerable” to COVID, added Dr. Dandona, who was not involved with the research.
Men who were receiving hormone replacement therapy were at lower risk of hospitalization, compared with those who were not receiving treatment, the study found.
“Testosterone therapy seemed to negate the harmful effects of COVID,” said Sandeep Dhindsa, MD, an endocrinologist at Saint Louis University and lead author of the study.
Approximately 50% more men have died from confirmed COVID-19 than women since the start of the pandemic, according to the Sex, Gender and COVID-19 Project. Previous findings suggesting that sex may be a risk factor for death from COVID prompted researchers to consider whether hormones may play a role in the increased risk among men and whether treatments that suppress androgen levels could cut hospitalizations, but researchers consistently found that androgen suppression was not effective.
“There are other reasons women might be doing better – they may have followed public health guidelines a lot better,” according to Abhinav Diwan, MD, professor of medicine at Washington University in St. Louis, who helped conduct the new study. “It may be chromosomal and not necessarily just hormonal. The differences between men and women go beyond one factor.”
According to the researchers, the findings do not suggest that hormone therapy be used as a preventive measure against COVID.
“We don’t want patients to get excited and start to ask their doctors for testosterone,” Dr. Dhindsa said.
However, viewing low testosterone as a risk factor for COVID could be considered a shift in thinking for some clinicians, according to Dr. Dandana.
“All obese and all [men with] type 2 diabetes should be tested for testosterone, which is the practice in my clinic right now, even if they have no symptoms,” Dr. Dandana said. “Certainly, those with symptoms [of low testosterone] but no diagnosis, they should be tested, too.”
Participants in the study were infected with SARS-CoV-2 early in 2020, before vaccines were available. The researchers did not assess whether the rate of hospitalizations among participants with low testosterone would be different had they been vaccinated.
“Whatever benefits we saw with testosterone might be minor compared to getting the vaccine,” Dr. Dhindsa said.
Dr. Diwan agreed. “COVID hospitalization continues to be a problem, the strains are evolving, and new vaccines are coming in,” he said. “The bottom line is to get vaccinated.”
Dr. Dhindsa has received personal fees from Bayer and Acerus Pharmaceuticals and grants from Clarus Therapeutics outside the submitted work. Dr. Diwan has served as a consultant for the interpretation of echocardiograms for clinical trials for Clario (previously ERT) and has received nonfinancial support from Dewpoint Therapeutics outside the submitted work. Dr. Dandana has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
researchers have found.
Low testosterone has long been linked to multiple chronic conditions, including obesity, heart disease, and type 2 diabetes, as well as acute conditions, such as heart attack and stroke. A study published earlier in the pandemic suggested that suppressing the sex hormone might protect against COVID-19. The new study, published in JAMA Network Open, is among the first to suggest a link between low testosterone and the risk for severe COVID.
Researchers at Washington University in St. Louis evaluated data from 723 unvaccinated men who had been infected with SARS-CoV-2. Of those, 116 had been diagnosed with hypogonadism, and 180 were receiving testosterone supplementation.
The study found that men whose testosterone levels were less than 200 ng/dL were 2.4 times more likely to experience a severe case of COVID-19 that required hospitalization than were those with normal levels of the hormone. The study accounted for the fact that participants with low testosterone were also more likely to have comorbidities such as diabetes and obesity.
Paresh Dandona, MD, PhD, distinguished professor of medicine and endocrinology at the State University of New York at Buffalo, called the findings “very exciting” and “fundamental.”
“In the world of hypogonadism, this is the first to show that low testosterone makes you vulnerable” to COVID, added Dr. Dandona, who was not involved with the research.
Men who were receiving hormone replacement therapy were at lower risk of hospitalization, compared with those who were not receiving treatment, the study found.
“Testosterone therapy seemed to negate the harmful effects of COVID,” said Sandeep Dhindsa, MD, an endocrinologist at Saint Louis University and lead author of the study.
Approximately 50% more men have died from confirmed COVID-19 than women since the start of the pandemic, according to the Sex, Gender and COVID-19 Project. Previous findings suggesting that sex may be a risk factor for death from COVID prompted researchers to consider whether hormones may play a role in the increased risk among men and whether treatments that suppress androgen levels could cut hospitalizations, but researchers consistently found that androgen suppression was not effective.
“There are other reasons women might be doing better – they may have followed public health guidelines a lot better,” according to Abhinav Diwan, MD, professor of medicine at Washington University in St. Louis, who helped conduct the new study. “It may be chromosomal and not necessarily just hormonal. The differences between men and women go beyond one factor.”
According to the researchers, the findings do not suggest that hormone therapy be used as a preventive measure against COVID.
“We don’t want patients to get excited and start to ask their doctors for testosterone,” Dr. Dhindsa said.
However, viewing low testosterone as a risk factor for COVID could be considered a shift in thinking for some clinicians, according to Dr. Dandana.
“All obese and all [men with] type 2 diabetes should be tested for testosterone, which is the practice in my clinic right now, even if they have no symptoms,” Dr. Dandana said. “Certainly, those with symptoms [of low testosterone] but no diagnosis, they should be tested, too.”
Participants in the study were infected with SARS-CoV-2 early in 2020, before vaccines were available. The researchers did not assess whether the rate of hospitalizations among participants with low testosterone would be different had they been vaccinated.
“Whatever benefits we saw with testosterone might be minor compared to getting the vaccine,” Dr. Dhindsa said.
Dr. Diwan agreed. “COVID hospitalization continues to be a problem, the strains are evolving, and new vaccines are coming in,” he said. “The bottom line is to get vaccinated.”
Dr. Dhindsa has received personal fees from Bayer and Acerus Pharmaceuticals and grants from Clarus Therapeutics outside the submitted work. Dr. Diwan has served as a consultant for the interpretation of echocardiograms for clinical trials for Clario (previously ERT) and has received nonfinancial support from Dewpoint Therapeutics outside the submitted work. Dr. Dandana has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN