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Outpatient CAR T infusions feasible using liso-cel
SALT LAKE CITY – A CD19-directed 4-1BB chimeric antigen receptor (CAR) T cell product showed efficacy and a low rate of cytokine release syndrome and neurotoxicity in patients with aggressive lymphomas and poor prognoses, raising the possibility of outpatient administration and fewer hospitalization days in this high-risk group.
A total of 86 patients who received inpatient infusions of lisocabtagene maraleucel (liso-cel, also known as JCAR017) had a mean 15.6 days of hospitalization, compared with 9.3 days for 8 outpatient recipients, said Jeremy Abramson, MD, speaking at a top abstracts session of the combined annual meetings of the Center for International Blood & Marrow Transplant Research and the American Society for Blood and Marrow Transplantation.
As of October 2017, eight patients had received liso-cel infusion as outpatients with at least 28 days of postinfusion data, Dr. Abramson said.
Although all but one required hospital admission, at a median of 5 days postinfusion (range, 4-22 days), there had been no intensive care unit admissions, and no outpatient recipients had experienced severe cytokine release syndrome (CRS) or neurotoxicity. All admitted patients presented with fever.
Among the study population, “Cytokine release syndrome was only seen in 35% of our entire dataset,” with neurologic toxicity seen in 19% of participants, Dr. Abramson said. “The majority of subjects had no CRS and no toxicity,” he said. Severe CRS occurred in 1% of the study population, and severe neurotoxicity in 12%. There were no deaths related to either complication.
Dr. Abramson reported these results from the TRANSCEND NHL 001 trial, a seamless design phase 1 pivotal trial of liso-cel enrolling patients with relapsed and refractory aggressive B cell non-Hodgkin lymphoma (NHL). Liso-cel delivers CD19-directed CD4 and CD8 CAR T cells in a 1:1 ratio, said Dr. Abramson, director of the lymphoma program at the Massachusetts General Hospital Cancer Center, Boston.
A total of 91 patients were randomized to one of the three dose-finding cohorts of the multicenter trial of liso-cel. One cohort received 5 x 107 cells in a single dose; a second cohort received the same number of cells but in two doses administered 14 days apart; the third cohort received a single dose of 1 x 108 cells.
The seamless trial design then moved to dose expansion, using the two single doses established in the dose-finding phase of the study. Ultimately, Dr. Abramson said, the third and pivotal diffuse large B-cell lymphoma (DLBCL) cohort received the higher single dose, since a dose-response relationship was seen in the earlier cohorts. No increase in cytokine release syndrome or neurotoxicity has been seen with the higher dose in patients evaluated to date.
Patients (median age, 61 years) were eligible to participate in the trial if they had relapsed or refractory DLBCL, primary mediastinal B-cell lymphoma, grade 3B follicular lymphoma, or mantle cell lymphoma. Patients with a failed prior allogeneic stem cell transplant or secondary central nervous system involvement were eligible, but all patients had to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
As the trial moved to the core pivotal phase, eligibility requirements shifted slightly to include patients with ECOG status 0 or 1, and lymphoma diagnoses narrowed to include only DLBCL not otherwise specified (NOS), transformed follicular lymphoma, and high-grade B-cell lymphoma with double- and triple-hit cytogenetics. The core group was nearing completion of accrual at the time of the presentation, which presented preliminary results from this phase of the trial.
Among the 88 evaluable patients in the initial population with DLBCL receiving any of three dose levels, the best overall response rate (ORR) was 74% (95% confidence interval, 63%-83%); 52% of these patients achieved complete response (CR; 95% CI, 41%-63%).
For patients receiving the higher dose of liso-cel, the ORR was 81% (95% CI, 62%-94%), with a 63% CR rate (95% CI, 42%-81%), bearing out the dose-response rate that had been seen earlier in the trial, Dr. Abramson said.
The median duration of response in all TRANSCEND patients was 9.2 months; the median duration of remission has not been reached, he said. “We see evidence of durable response at 3 months in all our high-risk subsets, and that includes double- and triple-hit lymphomas, double-expresser lymphomas, patients who’ve never achieved prior complete remission, and patients with refractory disease.”
“The overall results are similarly encouraging,” Dr. Abramson said, with 86% of all patients alive at 6 months. Among the complete responders, 94% are alive at the 6-month mark. “The median duration of complete responders has not been reached in this cohort,” he said.
These results are notable, Dr. Abramson said, since about 90% of study participants have at least one disease risk factor that would predict median overall survival of 3-6 months.
During the period after leukapheresis while the CAR T cells were in production, patients could have ongoing treatment, but received PET scans to confirm disease before continuing enrollment in the trial and receiving liso-cel. The time from apheresis to product release for the pivotal cohort is now under 21 days, he said.
The study was supported by Juno Therapeutics, which plans to market liso-cel. Dr. Abramson reported ties with Celgene, Gilead, Seattle Genetics, Novartis, and Genentech.
SOURCE: Abramson J et al. Abstract 5.
SALT LAKE CITY – A CD19-directed 4-1BB chimeric antigen receptor (CAR) T cell product showed efficacy and a low rate of cytokine release syndrome and neurotoxicity in patients with aggressive lymphomas and poor prognoses, raising the possibility of outpatient administration and fewer hospitalization days in this high-risk group.
A total of 86 patients who received inpatient infusions of lisocabtagene maraleucel (liso-cel, also known as JCAR017) had a mean 15.6 days of hospitalization, compared with 9.3 days for 8 outpatient recipients, said Jeremy Abramson, MD, speaking at a top abstracts session of the combined annual meetings of the Center for International Blood & Marrow Transplant Research and the American Society for Blood and Marrow Transplantation.
As of October 2017, eight patients had received liso-cel infusion as outpatients with at least 28 days of postinfusion data, Dr. Abramson said.
Although all but one required hospital admission, at a median of 5 days postinfusion (range, 4-22 days), there had been no intensive care unit admissions, and no outpatient recipients had experienced severe cytokine release syndrome (CRS) or neurotoxicity. All admitted patients presented with fever.
Among the study population, “Cytokine release syndrome was only seen in 35% of our entire dataset,” with neurologic toxicity seen in 19% of participants, Dr. Abramson said. “The majority of subjects had no CRS and no toxicity,” he said. Severe CRS occurred in 1% of the study population, and severe neurotoxicity in 12%. There were no deaths related to either complication.
Dr. Abramson reported these results from the TRANSCEND NHL 001 trial, a seamless design phase 1 pivotal trial of liso-cel enrolling patients with relapsed and refractory aggressive B cell non-Hodgkin lymphoma (NHL). Liso-cel delivers CD19-directed CD4 and CD8 CAR T cells in a 1:1 ratio, said Dr. Abramson, director of the lymphoma program at the Massachusetts General Hospital Cancer Center, Boston.
A total of 91 patients were randomized to one of the three dose-finding cohorts of the multicenter trial of liso-cel. One cohort received 5 x 107 cells in a single dose; a second cohort received the same number of cells but in two doses administered 14 days apart; the third cohort received a single dose of 1 x 108 cells.
The seamless trial design then moved to dose expansion, using the two single doses established in the dose-finding phase of the study. Ultimately, Dr. Abramson said, the third and pivotal diffuse large B-cell lymphoma (DLBCL) cohort received the higher single dose, since a dose-response relationship was seen in the earlier cohorts. No increase in cytokine release syndrome or neurotoxicity has been seen with the higher dose in patients evaluated to date.
Patients (median age, 61 years) were eligible to participate in the trial if they had relapsed or refractory DLBCL, primary mediastinal B-cell lymphoma, grade 3B follicular lymphoma, or mantle cell lymphoma. Patients with a failed prior allogeneic stem cell transplant or secondary central nervous system involvement were eligible, but all patients had to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
As the trial moved to the core pivotal phase, eligibility requirements shifted slightly to include patients with ECOG status 0 or 1, and lymphoma diagnoses narrowed to include only DLBCL not otherwise specified (NOS), transformed follicular lymphoma, and high-grade B-cell lymphoma with double- and triple-hit cytogenetics. The core group was nearing completion of accrual at the time of the presentation, which presented preliminary results from this phase of the trial.
Among the 88 evaluable patients in the initial population with DLBCL receiving any of three dose levels, the best overall response rate (ORR) was 74% (95% confidence interval, 63%-83%); 52% of these patients achieved complete response (CR; 95% CI, 41%-63%).
For patients receiving the higher dose of liso-cel, the ORR was 81% (95% CI, 62%-94%), with a 63% CR rate (95% CI, 42%-81%), bearing out the dose-response rate that had been seen earlier in the trial, Dr. Abramson said.
The median duration of response in all TRANSCEND patients was 9.2 months; the median duration of remission has not been reached, he said. “We see evidence of durable response at 3 months in all our high-risk subsets, and that includes double- and triple-hit lymphomas, double-expresser lymphomas, patients who’ve never achieved prior complete remission, and patients with refractory disease.”
“The overall results are similarly encouraging,” Dr. Abramson said, with 86% of all patients alive at 6 months. Among the complete responders, 94% are alive at the 6-month mark. “The median duration of complete responders has not been reached in this cohort,” he said.
These results are notable, Dr. Abramson said, since about 90% of study participants have at least one disease risk factor that would predict median overall survival of 3-6 months.
During the period after leukapheresis while the CAR T cells were in production, patients could have ongoing treatment, but received PET scans to confirm disease before continuing enrollment in the trial and receiving liso-cel. The time from apheresis to product release for the pivotal cohort is now under 21 days, he said.
The study was supported by Juno Therapeutics, which plans to market liso-cel. Dr. Abramson reported ties with Celgene, Gilead, Seattle Genetics, Novartis, and Genentech.
SOURCE: Abramson J et al. Abstract 5.
SALT LAKE CITY – A CD19-directed 4-1BB chimeric antigen receptor (CAR) T cell product showed efficacy and a low rate of cytokine release syndrome and neurotoxicity in patients with aggressive lymphomas and poor prognoses, raising the possibility of outpatient administration and fewer hospitalization days in this high-risk group.
A total of 86 patients who received inpatient infusions of lisocabtagene maraleucel (liso-cel, also known as JCAR017) had a mean 15.6 days of hospitalization, compared with 9.3 days for 8 outpatient recipients, said Jeremy Abramson, MD, speaking at a top abstracts session of the combined annual meetings of the Center for International Blood & Marrow Transplant Research and the American Society for Blood and Marrow Transplantation.
As of October 2017, eight patients had received liso-cel infusion as outpatients with at least 28 days of postinfusion data, Dr. Abramson said.
Although all but one required hospital admission, at a median of 5 days postinfusion (range, 4-22 days), there had been no intensive care unit admissions, and no outpatient recipients had experienced severe cytokine release syndrome (CRS) or neurotoxicity. All admitted patients presented with fever.
Among the study population, “Cytokine release syndrome was only seen in 35% of our entire dataset,” with neurologic toxicity seen in 19% of participants, Dr. Abramson said. “The majority of subjects had no CRS and no toxicity,” he said. Severe CRS occurred in 1% of the study population, and severe neurotoxicity in 12%. There were no deaths related to either complication.
Dr. Abramson reported these results from the TRANSCEND NHL 001 trial, a seamless design phase 1 pivotal trial of liso-cel enrolling patients with relapsed and refractory aggressive B cell non-Hodgkin lymphoma (NHL). Liso-cel delivers CD19-directed CD4 and CD8 CAR T cells in a 1:1 ratio, said Dr. Abramson, director of the lymphoma program at the Massachusetts General Hospital Cancer Center, Boston.
A total of 91 patients were randomized to one of the three dose-finding cohorts of the multicenter trial of liso-cel. One cohort received 5 x 107 cells in a single dose; a second cohort received the same number of cells but in two doses administered 14 days apart; the third cohort received a single dose of 1 x 108 cells.
The seamless trial design then moved to dose expansion, using the two single doses established in the dose-finding phase of the study. Ultimately, Dr. Abramson said, the third and pivotal diffuse large B-cell lymphoma (DLBCL) cohort received the higher single dose, since a dose-response relationship was seen in the earlier cohorts. No increase in cytokine release syndrome or neurotoxicity has been seen with the higher dose in patients evaluated to date.
Patients (median age, 61 years) were eligible to participate in the trial if they had relapsed or refractory DLBCL, primary mediastinal B-cell lymphoma, grade 3B follicular lymphoma, or mantle cell lymphoma. Patients with a failed prior allogeneic stem cell transplant or secondary central nervous system involvement were eligible, but all patients had to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
As the trial moved to the core pivotal phase, eligibility requirements shifted slightly to include patients with ECOG status 0 or 1, and lymphoma diagnoses narrowed to include only DLBCL not otherwise specified (NOS), transformed follicular lymphoma, and high-grade B-cell lymphoma with double- and triple-hit cytogenetics. The core group was nearing completion of accrual at the time of the presentation, which presented preliminary results from this phase of the trial.
Among the 88 evaluable patients in the initial population with DLBCL receiving any of three dose levels, the best overall response rate (ORR) was 74% (95% confidence interval, 63%-83%); 52% of these patients achieved complete response (CR; 95% CI, 41%-63%).
For patients receiving the higher dose of liso-cel, the ORR was 81% (95% CI, 62%-94%), with a 63% CR rate (95% CI, 42%-81%), bearing out the dose-response rate that had been seen earlier in the trial, Dr. Abramson said.
The median duration of response in all TRANSCEND patients was 9.2 months; the median duration of remission has not been reached, he said. “We see evidence of durable response at 3 months in all our high-risk subsets, and that includes double- and triple-hit lymphomas, double-expresser lymphomas, patients who’ve never achieved prior complete remission, and patients with refractory disease.”
“The overall results are similarly encouraging,” Dr. Abramson said, with 86% of all patients alive at 6 months. Among the complete responders, 94% are alive at the 6-month mark. “The median duration of complete responders has not been reached in this cohort,” he said.
These results are notable, Dr. Abramson said, since about 90% of study participants have at least one disease risk factor that would predict median overall survival of 3-6 months.
During the period after leukapheresis while the CAR T cells were in production, patients could have ongoing treatment, but received PET scans to confirm disease before continuing enrollment in the trial and receiving liso-cel. The time from apheresis to product release for the pivotal cohort is now under 21 days, he said.
The study was supported by Juno Therapeutics, which plans to market liso-cel. Dr. Abramson reported ties with Celgene, Gilead, Seattle Genetics, Novartis, and Genentech.
SOURCE: Abramson J et al. Abstract 5.
REPORTING FROM THE 2018 BMT TANDEM MEETINGS
Key clinical point:
Major finding: High-risk lymphoma patients had more than 6 fewer inpatient days with outpatient CAR T infusion.
Study details: Seamless phase 1 trial initially evaluating 91 patients with relapsed/refractory diffuse large B cell lymphoma.
Disclosures: Juno Therapeutics sponsored the study. Dr. Abramson reported ties with Celgene, Gilead, Seattle Genetics, Novartis, and Genentech.
Source: Abramson J et al. Abstract 5.
Toxicology reveals worse maternal and fetal outcomes with teen marijuana use
DALLAS – . Also, hypertensive disorders of pregnancy were higher in marijuana users, according to a study that incorporated universal urine toxicology testing of adolescents.
The study compared maternal and fetal/neonatal outcomes in 211 marijuana-exposed with 995 unexposed pregnancies. Christina Rodriguez, MD, and her coinvestigators found that the risk of a composite adverse pregnancy outcome was higher in marijuana users, occurring in 97/211 marijuana users (46%), and in 337/995 (33.9%) of the non–marijuana users (P less than .001).
Dr. Rodriguez said that since it used biological samples to confirm marijuana exposure, the study helps fill a gap in the literature. She presented the retrospective cohort study at the meeting sponsored by the Society for Maternal-Fetal Medicine.
Previous work, she said, had established that up to 70% of pregnant women who had positive tests for tetrahydrocannabinol also denied marijuana use. “If marijuana use is determined by self-report, some women are misclassified as nonusers,” making it difficult to ascertain the true association between marijuana use during pregnancy and pregnancy outcomes, said Dr. Rodriguez of the University of Colorado, Denver.
Whether marijuana is associated with adverse pregnancy outcomes is an increasingly pressing question given rapidly shifting legislation, said Dr. Rodriguez. “In a state with legal access to marijuana, use is common in adolescent pregnancies,” she said.
Participants who were enrolled in prenatal care through the University of Colorado’s adolescent maternity program, where Dr. Rodriguez is a fellow, and who delivered at the University of Colorado Hospital, Aurora, were eligible to participate; adolescents were excluded for multiple gestation and for known major fetal anomalies or aneuploidy.
In addition to urine toxicology testing, participants also completed a uniformly administered substance use questionnaire. Marijuana exposure was defined as either having a positive urine toxicology result or self-reported marijuana use on the questionnaire (or both). Of the marijuana-exposed pregnancies, 133 (63%) of the adolescents tested positive on urine toxicology, 18 (9%) were positive by self-report, and 60 (28%) had both positive marijuana urine toxicology and positive self-report. Toxicology was available for 91% of participants.
Participants were negative for marijuana exposure if they had a negative toxicology screen, regardless of their response on the substance-use questionnaire.
The study’s primary outcome was a composite of adverse pregnancy outcomes, including stillbirth, defined as Apgar score of 0; any hypertensive disorder of pregnancy, including gestational hypertension, preeclampsia, eclampsia, and HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count); preterm birth, defined as spontaneous delivery before 37 weeks gestation; and infants born small for gestational age, defined as a birth weight below the 10th percentile after adjustment for gestational age and sex.
Secondary outcomes included pregnancy outcomes including placental abruption, mode of delivery, and gestational age at delivery. Neonatal outcomes included weight, length, and head circumference at birth, and neonatal intensive care unit admission. An Apgar score less than 7 at 5 minutes was considered an adverse neonatal outcome.
The sample size was determined by an estimate drawn from previous chart abstraction that the composite outcome would be seen in 16% of the clinic’s non–marijuana exposed patients, and 24% of the marijuana-exposed patients. The investigators also factored in that 18% of adolescents in the clinic database were marijuana users.
Dr. Rodriguez and her collaborators used a variety of models for statistical analysis, some of which included self-report alone or in conjunction with urine toxicology. In the end, they found that significant associations between their composite endpoint and marijuana use were seen when patients were dichotomized into those who had at least one positive urine toxicology test, versus those who had no positive toxicology results.
One of the study limitations was that the study didn’t permit investigators to get accurate information about the quantity, timing, or route of marijuana dosing. Also, this methodology may primarily identify heavier marijuana users, said Dr. Rodriguez.
Tobacco use was determined only by self-report, and outcomes were followed over a relatively short period of time.
Still, said Dr. Rodriguez, the study had many strengths, including the use of biological sampling to determine exposure and the near-universal participant urine toxicology testing. The investigators were able to capture and account for many important factors that could confound the results, she said. “Uncertainty regarding the impact of [marijuana] on pregnancy outcomes in the literature may result from incomplete ascertainment of exposure,” she and her coinvestigators wrote in the abstract accompanying the presentation.
SOURCE: Rodriguez C et al. Am J Obstet Gynecol. 2018 Jan;218:S37.
DALLAS – . Also, hypertensive disorders of pregnancy were higher in marijuana users, according to a study that incorporated universal urine toxicology testing of adolescents.
The study compared maternal and fetal/neonatal outcomes in 211 marijuana-exposed with 995 unexposed pregnancies. Christina Rodriguez, MD, and her coinvestigators found that the risk of a composite adverse pregnancy outcome was higher in marijuana users, occurring in 97/211 marijuana users (46%), and in 337/995 (33.9%) of the non–marijuana users (P less than .001).
Dr. Rodriguez said that since it used biological samples to confirm marijuana exposure, the study helps fill a gap in the literature. She presented the retrospective cohort study at the meeting sponsored by the Society for Maternal-Fetal Medicine.
Previous work, she said, had established that up to 70% of pregnant women who had positive tests for tetrahydrocannabinol also denied marijuana use. “If marijuana use is determined by self-report, some women are misclassified as nonusers,” making it difficult to ascertain the true association between marijuana use during pregnancy and pregnancy outcomes, said Dr. Rodriguez of the University of Colorado, Denver.
Whether marijuana is associated with adverse pregnancy outcomes is an increasingly pressing question given rapidly shifting legislation, said Dr. Rodriguez. “In a state with legal access to marijuana, use is common in adolescent pregnancies,” she said.
Participants who were enrolled in prenatal care through the University of Colorado’s adolescent maternity program, where Dr. Rodriguez is a fellow, and who delivered at the University of Colorado Hospital, Aurora, were eligible to participate; adolescents were excluded for multiple gestation and for known major fetal anomalies or aneuploidy.
In addition to urine toxicology testing, participants also completed a uniformly administered substance use questionnaire. Marijuana exposure was defined as either having a positive urine toxicology result or self-reported marijuana use on the questionnaire (or both). Of the marijuana-exposed pregnancies, 133 (63%) of the adolescents tested positive on urine toxicology, 18 (9%) were positive by self-report, and 60 (28%) had both positive marijuana urine toxicology and positive self-report. Toxicology was available for 91% of participants.
Participants were negative for marijuana exposure if they had a negative toxicology screen, regardless of their response on the substance-use questionnaire.
The study’s primary outcome was a composite of adverse pregnancy outcomes, including stillbirth, defined as Apgar score of 0; any hypertensive disorder of pregnancy, including gestational hypertension, preeclampsia, eclampsia, and HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count); preterm birth, defined as spontaneous delivery before 37 weeks gestation; and infants born small for gestational age, defined as a birth weight below the 10th percentile after adjustment for gestational age and sex.
Secondary outcomes included pregnancy outcomes including placental abruption, mode of delivery, and gestational age at delivery. Neonatal outcomes included weight, length, and head circumference at birth, and neonatal intensive care unit admission. An Apgar score less than 7 at 5 minutes was considered an adverse neonatal outcome.
The sample size was determined by an estimate drawn from previous chart abstraction that the composite outcome would be seen in 16% of the clinic’s non–marijuana exposed patients, and 24% of the marijuana-exposed patients. The investigators also factored in that 18% of adolescents in the clinic database were marijuana users.
Dr. Rodriguez and her collaborators used a variety of models for statistical analysis, some of which included self-report alone or in conjunction with urine toxicology. In the end, they found that significant associations between their composite endpoint and marijuana use were seen when patients were dichotomized into those who had at least one positive urine toxicology test, versus those who had no positive toxicology results.
One of the study limitations was that the study didn’t permit investigators to get accurate information about the quantity, timing, or route of marijuana dosing. Also, this methodology may primarily identify heavier marijuana users, said Dr. Rodriguez.
Tobacco use was determined only by self-report, and outcomes were followed over a relatively short period of time.
Still, said Dr. Rodriguez, the study had many strengths, including the use of biological sampling to determine exposure and the near-universal participant urine toxicology testing. The investigators were able to capture and account for many important factors that could confound the results, she said. “Uncertainty regarding the impact of [marijuana] on pregnancy outcomes in the literature may result from incomplete ascertainment of exposure,” she and her coinvestigators wrote in the abstract accompanying the presentation.
SOURCE: Rodriguez C et al. Am J Obstet Gynecol. 2018 Jan;218:S37.
DALLAS – . Also, hypertensive disorders of pregnancy were higher in marijuana users, according to a study that incorporated universal urine toxicology testing of adolescents.
The study compared maternal and fetal/neonatal outcomes in 211 marijuana-exposed with 995 unexposed pregnancies. Christina Rodriguez, MD, and her coinvestigators found that the risk of a composite adverse pregnancy outcome was higher in marijuana users, occurring in 97/211 marijuana users (46%), and in 337/995 (33.9%) of the non–marijuana users (P less than .001).
Dr. Rodriguez said that since it used biological samples to confirm marijuana exposure, the study helps fill a gap in the literature. She presented the retrospective cohort study at the meeting sponsored by the Society for Maternal-Fetal Medicine.
Previous work, she said, had established that up to 70% of pregnant women who had positive tests for tetrahydrocannabinol also denied marijuana use. “If marijuana use is determined by self-report, some women are misclassified as nonusers,” making it difficult to ascertain the true association between marijuana use during pregnancy and pregnancy outcomes, said Dr. Rodriguez of the University of Colorado, Denver.
Whether marijuana is associated with adverse pregnancy outcomes is an increasingly pressing question given rapidly shifting legislation, said Dr. Rodriguez. “In a state with legal access to marijuana, use is common in adolescent pregnancies,” she said.
Participants who were enrolled in prenatal care through the University of Colorado’s adolescent maternity program, where Dr. Rodriguez is a fellow, and who delivered at the University of Colorado Hospital, Aurora, were eligible to participate; adolescents were excluded for multiple gestation and for known major fetal anomalies or aneuploidy.
In addition to urine toxicology testing, participants also completed a uniformly administered substance use questionnaire. Marijuana exposure was defined as either having a positive urine toxicology result or self-reported marijuana use on the questionnaire (or both). Of the marijuana-exposed pregnancies, 133 (63%) of the adolescents tested positive on urine toxicology, 18 (9%) were positive by self-report, and 60 (28%) had both positive marijuana urine toxicology and positive self-report. Toxicology was available for 91% of participants.
Participants were negative for marijuana exposure if they had a negative toxicology screen, regardless of their response on the substance-use questionnaire.
The study’s primary outcome was a composite of adverse pregnancy outcomes, including stillbirth, defined as Apgar score of 0; any hypertensive disorder of pregnancy, including gestational hypertension, preeclampsia, eclampsia, and HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count); preterm birth, defined as spontaneous delivery before 37 weeks gestation; and infants born small for gestational age, defined as a birth weight below the 10th percentile after adjustment for gestational age and sex.
Secondary outcomes included pregnancy outcomes including placental abruption, mode of delivery, and gestational age at delivery. Neonatal outcomes included weight, length, and head circumference at birth, and neonatal intensive care unit admission. An Apgar score less than 7 at 5 minutes was considered an adverse neonatal outcome.
The sample size was determined by an estimate drawn from previous chart abstraction that the composite outcome would be seen in 16% of the clinic’s non–marijuana exposed patients, and 24% of the marijuana-exposed patients. The investigators also factored in that 18% of adolescents in the clinic database were marijuana users.
Dr. Rodriguez and her collaborators used a variety of models for statistical analysis, some of which included self-report alone or in conjunction with urine toxicology. In the end, they found that significant associations between their composite endpoint and marijuana use were seen when patients were dichotomized into those who had at least one positive urine toxicology test, versus those who had no positive toxicology results.
One of the study limitations was that the study didn’t permit investigators to get accurate information about the quantity, timing, or route of marijuana dosing. Also, this methodology may primarily identify heavier marijuana users, said Dr. Rodriguez.
Tobacco use was determined only by self-report, and outcomes were followed over a relatively short period of time.
Still, said Dr. Rodriguez, the study had many strengths, including the use of biological sampling to determine exposure and the near-universal participant urine toxicology testing. The investigators were able to capture and account for many important factors that could confound the results, she said. “Uncertainty regarding the impact of [marijuana] on pregnancy outcomes in the literature may result from incomplete ascertainment of exposure,” she and her coinvestigators wrote in the abstract accompanying the presentation.
SOURCE: Rodriguez C et al. Am J Obstet Gynecol. 2018 Jan;218:S37.
REPORTING FROM THE PREGNANCY MEETING
Key clinical point: Maternal and fetal outcomes were worse when marijuana use was detected by urine toxicology.
Major finding: A composite adverse outcome occurred in 46% of adolescent marijuana users, compared with 34% of non–marijuana users (P less than .001).
Study details: Retrospective cohort study of participants in an adolescent maternity clinic.
Disclosures: The authors reported no conflicts of interest.
Source: Rodriguez C et al. Am J Obstet Gynecol. 2018 Jan;218:S37.
No clear winner in Pfannenstiel vs. vertical incision for high BMI cesareans
DALLAS – though enrollment difficulties limited study numbers, with almost two-thirds of eligible women declining to participate in the surgical trial.
At 6 weeks postdelivery, 21.1% of women who had a vertical incision experienced wound complications, compared with 18.6% of those who had a Pfannenstiel incision, a nonsignificant difference. This was a smaller difference than was seen at 2 weeks postpartum, when 20% of the vertical incision group had wound complications, compared with 10.4% of those who had a Pfannenstiel, also a nonsignificant difference. Maternal and fetal outcomes didn’t differ significantly with the two surgical approaches.
Though there had been several observational studies comparing vertical with Pfannenstiel incisions for cesarean delivery in women with obesity, no randomized, controlled trials had been conducted, and observational study results were mixed, said Dr. Marrs.
Each approach comes with theoretical pros and cons: For women who have a large pannus, the incision site may lie in a moist environment with a low transverse incision, and oxygen tension may be low. However, a Pfannenstiel incision usually will have better cosmesis than will a vertical incision, and generally will result in less postoperative pain.
On the other hand, said Dr. Marrs, vertical incisions can provide improved exposure of the uterus during delivery, and the moist environment underlying the pannus is avoided. However, wound tension may be higher, and subcutaneous thickness is likely to be higher than at the Pfannenstiel incision site.
The study, conducted at two academic medical centers, enrolled women with a body mass index (BMI) of at least 40 kg/m2 at a gestational age of 24 weeks or greater who required cesarean delivery. Consenting women were then randomized to receive Pfannenstiel or vertical incisions.
Women who had clinical chorioamnionitis, whose amniotic membranes had been ruptured for 18 hours or more, or who had placenta accreta were excluded. Also excluded were women with a private physician and those desiring vaginal delivery, said Dr. Marrs, a maternal-fetal medicine fellow at the University of Texas Medical Branch, Galveston.
The study’s primary outcome measure was a composite of wound complications seen within 6 weeks of delivery, including surgical site infection, whether superficial, deep, or involving an organ or tissue space; cellulitis; seroma or hematoma; and wound separation. Other maternal outcomes tracked in the study included postoperative length of stay, transfusion requirement, sepsis, readmission, and death.
Cesarean-specific secondary outcomes included operative time and time from skin incision to delivery, estimated blood loss, and any incidence of hysterectomy through a low transverse incision. Neonatal outcomes included a 5-minute Apgar score of less than 7, umbilical cord pH of less than 7, and neonatal ICU admissions.
Dr. Mars said that the goal enrollment for the study was 300 patients, to ensure adequate statistical power. However, they found enrollment a challenge, with low consent rates during the defined time period from October 2013 to May 2017. They shifted their statistical technique to a Bayesian analysis, taking into account the estimated probability of treatment benefit.
Using this approach, they found a 59% probability that a Pfannenstiel incision would lead to a lower primary outcome rate – a better result – than would a vertical incision. This result just missed the predetermined threshold of 60%, said Dr. Marrs.
Of the 789 women who met the BMI threshold for eligibility assessment, 420 (65%) who passed the screening declined to participate. Of those who consented to participation, an additional 137 women either withdrew consent or failed further screening, leaving 50 women who were randomized to the Pfannenstiel arm and 41 who were randomized to the vertical incision arm.
Baseline characteristics were similar between groups, with a mean maternal age of 30 years in the Pfannenstiel group and 28 years in the vertical incision group. Gestational age at delivery was a mean of 37 weeks in both groups, and mean BMI was 48-50 kg/m2.
Most patients (80%-90%) had public insurance. Diabetes was more common in the Pfannenstiel group (48%) than in the vertical incision cohort (32%). Just over 40% of patients were African American.
Two women in the Pfannenstiel group and three in the vertical incision group did not receive the intended incision. After accounting for patients lost to follow-up by 6 weeks, 43 women who received Pfannenstiel and 38 women who received vertical incisions were available for full evaluation.
Dr. Marrs said that the study, the first randomized trial to address this issue, had several strengths, including its being conducted at two sites with appropriate stratification for the sites. Also, an independent data safety monitoring board and two chart reviewers helped overcome some of the limitations of a surgical study, where complete blinding is impossible.
The Bayesian analysis allowed ascertainment of the probability of treatment benefit despite the lower-than-hoped-for enrollment numbers. The primary weakness of the study, said Dr. Marrs, centered around the low consent rate, which led to a small study that was prematurely terminated.
“It’s difficult to enroll women in a trial that requires random allocation of skin incision, due to their preference to choose their own incision. A larger trial would likewise be challenging, and unlikely to yield different results,” said Dr. Marrs.
Dr. Marrs reported no conflicts of interest.
SOURCE: Marrs CC et al. Am J Obstet Gynecol. 2018 Jan;218:S29.
DALLAS – though enrollment difficulties limited study numbers, with almost two-thirds of eligible women declining to participate in the surgical trial.
At 6 weeks postdelivery, 21.1% of women who had a vertical incision experienced wound complications, compared with 18.6% of those who had a Pfannenstiel incision, a nonsignificant difference. This was a smaller difference than was seen at 2 weeks postpartum, when 20% of the vertical incision group had wound complications, compared with 10.4% of those who had a Pfannenstiel, also a nonsignificant difference. Maternal and fetal outcomes didn’t differ significantly with the two surgical approaches.
Though there had been several observational studies comparing vertical with Pfannenstiel incisions for cesarean delivery in women with obesity, no randomized, controlled trials had been conducted, and observational study results were mixed, said Dr. Marrs.
Each approach comes with theoretical pros and cons: For women who have a large pannus, the incision site may lie in a moist environment with a low transverse incision, and oxygen tension may be low. However, a Pfannenstiel incision usually will have better cosmesis than will a vertical incision, and generally will result in less postoperative pain.
On the other hand, said Dr. Marrs, vertical incisions can provide improved exposure of the uterus during delivery, and the moist environment underlying the pannus is avoided. However, wound tension may be higher, and subcutaneous thickness is likely to be higher than at the Pfannenstiel incision site.
The study, conducted at two academic medical centers, enrolled women with a body mass index (BMI) of at least 40 kg/m2 at a gestational age of 24 weeks or greater who required cesarean delivery. Consenting women were then randomized to receive Pfannenstiel or vertical incisions.
Women who had clinical chorioamnionitis, whose amniotic membranes had been ruptured for 18 hours or more, or who had placenta accreta were excluded. Also excluded were women with a private physician and those desiring vaginal delivery, said Dr. Marrs, a maternal-fetal medicine fellow at the University of Texas Medical Branch, Galveston.
The study’s primary outcome measure was a composite of wound complications seen within 6 weeks of delivery, including surgical site infection, whether superficial, deep, or involving an organ or tissue space; cellulitis; seroma or hematoma; and wound separation. Other maternal outcomes tracked in the study included postoperative length of stay, transfusion requirement, sepsis, readmission, and death.
Cesarean-specific secondary outcomes included operative time and time from skin incision to delivery, estimated blood loss, and any incidence of hysterectomy through a low transverse incision. Neonatal outcomes included a 5-minute Apgar score of less than 7, umbilical cord pH of less than 7, and neonatal ICU admissions.
Dr. Mars said that the goal enrollment for the study was 300 patients, to ensure adequate statistical power. However, they found enrollment a challenge, with low consent rates during the defined time period from October 2013 to May 2017. They shifted their statistical technique to a Bayesian analysis, taking into account the estimated probability of treatment benefit.
Using this approach, they found a 59% probability that a Pfannenstiel incision would lead to a lower primary outcome rate – a better result – than would a vertical incision. This result just missed the predetermined threshold of 60%, said Dr. Marrs.
Of the 789 women who met the BMI threshold for eligibility assessment, 420 (65%) who passed the screening declined to participate. Of those who consented to participation, an additional 137 women either withdrew consent or failed further screening, leaving 50 women who were randomized to the Pfannenstiel arm and 41 who were randomized to the vertical incision arm.
Baseline characteristics were similar between groups, with a mean maternal age of 30 years in the Pfannenstiel group and 28 years in the vertical incision group. Gestational age at delivery was a mean of 37 weeks in both groups, and mean BMI was 48-50 kg/m2.
Most patients (80%-90%) had public insurance. Diabetes was more common in the Pfannenstiel group (48%) than in the vertical incision cohort (32%). Just over 40% of patients were African American.
Two women in the Pfannenstiel group and three in the vertical incision group did not receive the intended incision. After accounting for patients lost to follow-up by 6 weeks, 43 women who received Pfannenstiel and 38 women who received vertical incisions were available for full evaluation.
Dr. Marrs said that the study, the first randomized trial to address this issue, had several strengths, including its being conducted at two sites with appropriate stratification for the sites. Also, an independent data safety monitoring board and two chart reviewers helped overcome some of the limitations of a surgical study, where complete blinding is impossible.
The Bayesian analysis allowed ascertainment of the probability of treatment benefit despite the lower-than-hoped-for enrollment numbers. The primary weakness of the study, said Dr. Marrs, centered around the low consent rate, which led to a small study that was prematurely terminated.
“It’s difficult to enroll women in a trial that requires random allocation of skin incision, due to their preference to choose their own incision. A larger trial would likewise be challenging, and unlikely to yield different results,” said Dr. Marrs.
Dr. Marrs reported no conflicts of interest.
SOURCE: Marrs CC et al. Am J Obstet Gynecol. 2018 Jan;218:S29.
DALLAS – though enrollment difficulties limited study numbers, with almost two-thirds of eligible women declining to participate in the surgical trial.
At 6 weeks postdelivery, 21.1% of women who had a vertical incision experienced wound complications, compared with 18.6% of those who had a Pfannenstiel incision, a nonsignificant difference. This was a smaller difference than was seen at 2 weeks postpartum, when 20% of the vertical incision group had wound complications, compared with 10.4% of those who had a Pfannenstiel, also a nonsignificant difference. Maternal and fetal outcomes didn’t differ significantly with the two surgical approaches.
Though there had been several observational studies comparing vertical with Pfannenstiel incisions for cesarean delivery in women with obesity, no randomized, controlled trials had been conducted, and observational study results were mixed, said Dr. Marrs.
Each approach comes with theoretical pros and cons: For women who have a large pannus, the incision site may lie in a moist environment with a low transverse incision, and oxygen tension may be low. However, a Pfannenstiel incision usually will have better cosmesis than will a vertical incision, and generally will result in less postoperative pain.
On the other hand, said Dr. Marrs, vertical incisions can provide improved exposure of the uterus during delivery, and the moist environment underlying the pannus is avoided. However, wound tension may be higher, and subcutaneous thickness is likely to be higher than at the Pfannenstiel incision site.
The study, conducted at two academic medical centers, enrolled women with a body mass index (BMI) of at least 40 kg/m2 at a gestational age of 24 weeks or greater who required cesarean delivery. Consenting women were then randomized to receive Pfannenstiel or vertical incisions.
Women who had clinical chorioamnionitis, whose amniotic membranes had been ruptured for 18 hours or more, or who had placenta accreta were excluded. Also excluded were women with a private physician and those desiring vaginal delivery, said Dr. Marrs, a maternal-fetal medicine fellow at the University of Texas Medical Branch, Galveston.
The study’s primary outcome measure was a composite of wound complications seen within 6 weeks of delivery, including surgical site infection, whether superficial, deep, or involving an organ or tissue space; cellulitis; seroma or hematoma; and wound separation. Other maternal outcomes tracked in the study included postoperative length of stay, transfusion requirement, sepsis, readmission, and death.
Cesarean-specific secondary outcomes included operative time and time from skin incision to delivery, estimated blood loss, and any incidence of hysterectomy through a low transverse incision. Neonatal outcomes included a 5-minute Apgar score of less than 7, umbilical cord pH of less than 7, and neonatal ICU admissions.
Dr. Mars said that the goal enrollment for the study was 300 patients, to ensure adequate statistical power. However, they found enrollment a challenge, with low consent rates during the defined time period from October 2013 to May 2017. They shifted their statistical technique to a Bayesian analysis, taking into account the estimated probability of treatment benefit.
Using this approach, they found a 59% probability that a Pfannenstiel incision would lead to a lower primary outcome rate – a better result – than would a vertical incision. This result just missed the predetermined threshold of 60%, said Dr. Marrs.
Of the 789 women who met the BMI threshold for eligibility assessment, 420 (65%) who passed the screening declined to participate. Of those who consented to participation, an additional 137 women either withdrew consent or failed further screening, leaving 50 women who were randomized to the Pfannenstiel arm and 41 who were randomized to the vertical incision arm.
Baseline characteristics were similar between groups, with a mean maternal age of 30 years in the Pfannenstiel group and 28 years in the vertical incision group. Gestational age at delivery was a mean of 37 weeks in both groups, and mean BMI was 48-50 kg/m2.
Most patients (80%-90%) had public insurance. Diabetes was more common in the Pfannenstiel group (48%) than in the vertical incision cohort (32%). Just over 40% of patients were African American.
Two women in the Pfannenstiel group and three in the vertical incision group did not receive the intended incision. After accounting for patients lost to follow-up by 6 weeks, 43 women who received Pfannenstiel and 38 women who received vertical incisions were available for full evaluation.
Dr. Marrs said that the study, the first randomized trial to address this issue, had several strengths, including its being conducted at two sites with appropriate stratification for the sites. Also, an independent data safety monitoring board and two chart reviewers helped overcome some of the limitations of a surgical study, where complete blinding is impossible.
The Bayesian analysis allowed ascertainment of the probability of treatment benefit despite the lower-than-hoped-for enrollment numbers. The primary weakness of the study, said Dr. Marrs, centered around the low consent rate, which led to a small study that was prematurely terminated.
“It’s difficult to enroll women in a trial that requires random allocation of skin incision, due to their preference to choose their own incision. A larger trial would likewise be challenging, and unlikely to yield different results,” said Dr. Marrs.
Dr. Marrs reported no conflicts of interest.
SOURCE: Marrs CC et al. Am J Obstet Gynecol. 2018 Jan;218:S29.
REPORTING FROM THE PREGNANCY MEETING
Key clinical point: Wound complication rates were similar with Pfannenstiel and vertical incisions in women with obesity.
Major finding: At 6 weeks, 21.1% of vertical incision recipients and 18.6% of Pfannenstiel recipients had wound complications.
Study details: Randomized controlled trial of 91 women with obesity receiving cesarean section.
Disclosures: Dr. Marrs reported no conflicts of interest.
Source: Marrs CC et al. Am J Obstet Gynecol. 2018 Jan;218:S29.
High efficacy, no safety signals for herpes zoster vaccine post-HSCT
SALT LAKE CITY – A recently approved adjuvanted herpes zoster vaccine)(Shingrix) effectively and safely prevented herpes zoster in a population of patients with multiple myeloma and other hematologic malignancies who received autologous hematopoietic stem cell transplantation.
The use of recombinant varicella zoster virus glycoprotein E in combination with an adjuvant system gives immunosuppressed individuals who have received hematopoietic stem cell transplantation (HSCT) a safe option for prevention of herpes zoster (HZ), said Javier de la Serna, MD, PhD, speaking at the combined annual meetings of the Center for International Blood & Marrow Transplant Research and the American Society for Blood and Marrow Transplantation.
Presenting the findings at a late-breaking abstract session, Dr. de la Serna said that for the 1,721 participants in a placebo-controlled multicenter trial who received both doses of the vaccine, the incidence of HZ for vaccine recipients was 3.0%, compared with 9.4% of placebo recipients, for a vaccine efficacy of 68.2% (95% confidence interval, 55.6-77.5; P less than 0.0001). These results met the study’s primary objective.
Postherpetic neuralgia (PHN) prevention efficacy – a secondary endpoint – was 89.3% for those receiving the vaccine (HZ/su); the incidence of PHN was 0.5% in the HZ/su study arm, compared with 4.9% for those who received placebo (95% CI, 22.5-99.8). The study also tracked other HZ complications as a secondary endpoint, finding efficacy of 77.8% (95% CI, 19.1–95.0). “The vaccine was highly efficacious in preventing all the secondary outcomes,” said Dr. de la Serna of the Hospital Universitario 12 de Octubre, Madrid.
The randomized, observer-blind phase 3 trial was conducted in 28 countries.Adults who received autologous HSCT were randomized 1:1 to receive HZ/su (n = 922) or placebo (n = 924) within 50-70 days of their transplant. Patients were excluded if they were expected to receive more than 6 months of anti–varicella zoster prophylaxis posttransplant, Dr. de la Serna said.
Participants received the first dose of HZ/su at the first study visit, and the second dose 30-60 days later. Patients were seen 1 month after the last vaccine dose, and then again at months 13 and 25, with telephone follow-up between the later visits. All participants were followed for at least 1 year, Dr. de la Serna said.
Episodes of HZ were confirmed by polymerase chain reaction assay, or, when samples were lacking or indeterminate, by agreement of at least three members of an ascertainment committee.
Of the two components of the HZ/su vaccine, glycoprotein E triggers both humoral immunity and activity of varicella zoster–specific CD4+ T cells; the adjuvant system – dubbed ASO1 – boosts immune response. The vaccine was approved by the Food and Drug Administration in October 2017 for use in adults aged 50 years and older.
In addition to the primary endpoint of vaccine efficacy in prevention of HZ cases during the study period, secondary objectives included monitoring vaccine reactogenicity and safety, and evaluating vaccine efficacy for the prevention of PHN and other complications of HZ.
Tertiary objectives included vaccine efficacy in preventing HZ during the first year posttransplant (vaccine efficacy 84.7%; 95% CI, 32.2-96.6), as well as efficacy in preventing hospitalizations related to HZ (vaccine efficacy 76.2%, 95% CI 61.1-86.0).
An exploratory analysis found vaccine efficacy of 71.8% for participants younger than 50 years (95% CI, 38.8 – 88.3). For patients aged 50 years and older, vaccine efficacy was 67.3% (95% CI, 52.6–77.9).
The safety of HZ/su was determined by analyzing data for all participants, but efficacy data included only those who received the second dose and did not develop HZ within a month of receiving the second vaccine dose.
In the efficacy group (n = 1,721), patients were mostly (n = 1,296) aged 50 years or older. Most patients (n = 937) received HSCT for multiple myeloma. Overall, participants were about 63% male, and 77% were of Caucasian/European ancestry.
Adverse events, solicited for the first 7 days after injections, were mostly mild and related to the local site pain and inflammation expected with an adjuvanted vaccine; HZ/su recipients also experienced more fatigue and muscle aches than did those receiving placebo. Median duration of symptoms was up to 3 days, with grade 3 events lasting up to 2 days.
Unsolicited and serious adverse events were similar between study arms, with a median safety follow-up period of 29 months. The investigators judged that no deaths were related to the vaccine, and there were no signals for increased rate of relapse or immune-mediated diseases.
The study was funded by GlaxoSmithKline; HZ/su(Shingrix) is marketed by GlaxoSmithKline. Dr. de la Serna reported being on the advisory board or receiving honoraria from multiple pharmaceutical companies.
SOURCE: de la Serna J et al. 2018 BMT Tandem Meetings, Abstract LBA2.
SALT LAKE CITY – A recently approved adjuvanted herpes zoster vaccine)(Shingrix) effectively and safely prevented herpes zoster in a population of patients with multiple myeloma and other hematologic malignancies who received autologous hematopoietic stem cell transplantation.
The use of recombinant varicella zoster virus glycoprotein E in combination with an adjuvant system gives immunosuppressed individuals who have received hematopoietic stem cell transplantation (HSCT) a safe option for prevention of herpes zoster (HZ), said Javier de la Serna, MD, PhD, speaking at the combined annual meetings of the Center for International Blood & Marrow Transplant Research and the American Society for Blood and Marrow Transplantation.
Presenting the findings at a late-breaking abstract session, Dr. de la Serna said that for the 1,721 participants in a placebo-controlled multicenter trial who received both doses of the vaccine, the incidence of HZ for vaccine recipients was 3.0%, compared with 9.4% of placebo recipients, for a vaccine efficacy of 68.2% (95% confidence interval, 55.6-77.5; P less than 0.0001). These results met the study’s primary objective.
Postherpetic neuralgia (PHN) prevention efficacy – a secondary endpoint – was 89.3% for those receiving the vaccine (HZ/su); the incidence of PHN was 0.5% in the HZ/su study arm, compared with 4.9% for those who received placebo (95% CI, 22.5-99.8). The study also tracked other HZ complications as a secondary endpoint, finding efficacy of 77.8% (95% CI, 19.1–95.0). “The vaccine was highly efficacious in preventing all the secondary outcomes,” said Dr. de la Serna of the Hospital Universitario 12 de Octubre, Madrid.
The randomized, observer-blind phase 3 trial was conducted in 28 countries.Adults who received autologous HSCT were randomized 1:1 to receive HZ/su (n = 922) or placebo (n = 924) within 50-70 days of their transplant. Patients were excluded if they were expected to receive more than 6 months of anti–varicella zoster prophylaxis posttransplant, Dr. de la Serna said.
Participants received the first dose of HZ/su at the first study visit, and the second dose 30-60 days later. Patients were seen 1 month after the last vaccine dose, and then again at months 13 and 25, with telephone follow-up between the later visits. All participants were followed for at least 1 year, Dr. de la Serna said.
Episodes of HZ were confirmed by polymerase chain reaction assay, or, when samples were lacking or indeterminate, by agreement of at least three members of an ascertainment committee.
Of the two components of the HZ/su vaccine, glycoprotein E triggers both humoral immunity and activity of varicella zoster–specific CD4+ T cells; the adjuvant system – dubbed ASO1 – boosts immune response. The vaccine was approved by the Food and Drug Administration in October 2017 for use in adults aged 50 years and older.
In addition to the primary endpoint of vaccine efficacy in prevention of HZ cases during the study period, secondary objectives included monitoring vaccine reactogenicity and safety, and evaluating vaccine efficacy for the prevention of PHN and other complications of HZ.
Tertiary objectives included vaccine efficacy in preventing HZ during the first year posttransplant (vaccine efficacy 84.7%; 95% CI, 32.2-96.6), as well as efficacy in preventing hospitalizations related to HZ (vaccine efficacy 76.2%, 95% CI 61.1-86.0).
An exploratory analysis found vaccine efficacy of 71.8% for participants younger than 50 years (95% CI, 38.8 – 88.3). For patients aged 50 years and older, vaccine efficacy was 67.3% (95% CI, 52.6–77.9).
The safety of HZ/su was determined by analyzing data for all participants, but efficacy data included only those who received the second dose and did not develop HZ within a month of receiving the second vaccine dose.
In the efficacy group (n = 1,721), patients were mostly (n = 1,296) aged 50 years or older. Most patients (n = 937) received HSCT for multiple myeloma. Overall, participants were about 63% male, and 77% were of Caucasian/European ancestry.
Adverse events, solicited for the first 7 days after injections, were mostly mild and related to the local site pain and inflammation expected with an adjuvanted vaccine; HZ/su recipients also experienced more fatigue and muscle aches than did those receiving placebo. Median duration of symptoms was up to 3 days, with grade 3 events lasting up to 2 days.
Unsolicited and serious adverse events were similar between study arms, with a median safety follow-up period of 29 months. The investigators judged that no deaths were related to the vaccine, and there were no signals for increased rate of relapse or immune-mediated diseases.
The study was funded by GlaxoSmithKline; HZ/su(Shingrix) is marketed by GlaxoSmithKline. Dr. de la Serna reported being on the advisory board or receiving honoraria from multiple pharmaceutical companies.
SOURCE: de la Serna J et al. 2018 BMT Tandem Meetings, Abstract LBA2.
SALT LAKE CITY – A recently approved adjuvanted herpes zoster vaccine)(Shingrix) effectively and safely prevented herpes zoster in a population of patients with multiple myeloma and other hematologic malignancies who received autologous hematopoietic stem cell transplantation.
The use of recombinant varicella zoster virus glycoprotein E in combination with an adjuvant system gives immunosuppressed individuals who have received hematopoietic stem cell transplantation (HSCT) a safe option for prevention of herpes zoster (HZ), said Javier de la Serna, MD, PhD, speaking at the combined annual meetings of the Center for International Blood & Marrow Transplant Research and the American Society for Blood and Marrow Transplantation.
Presenting the findings at a late-breaking abstract session, Dr. de la Serna said that for the 1,721 participants in a placebo-controlled multicenter trial who received both doses of the vaccine, the incidence of HZ for vaccine recipients was 3.0%, compared with 9.4% of placebo recipients, for a vaccine efficacy of 68.2% (95% confidence interval, 55.6-77.5; P less than 0.0001). These results met the study’s primary objective.
Postherpetic neuralgia (PHN) prevention efficacy – a secondary endpoint – was 89.3% for those receiving the vaccine (HZ/su); the incidence of PHN was 0.5% in the HZ/su study arm, compared with 4.9% for those who received placebo (95% CI, 22.5-99.8). The study also tracked other HZ complications as a secondary endpoint, finding efficacy of 77.8% (95% CI, 19.1–95.0). “The vaccine was highly efficacious in preventing all the secondary outcomes,” said Dr. de la Serna of the Hospital Universitario 12 de Octubre, Madrid.
The randomized, observer-blind phase 3 trial was conducted in 28 countries.Adults who received autologous HSCT were randomized 1:1 to receive HZ/su (n = 922) or placebo (n = 924) within 50-70 days of their transplant. Patients were excluded if they were expected to receive more than 6 months of anti–varicella zoster prophylaxis posttransplant, Dr. de la Serna said.
Participants received the first dose of HZ/su at the first study visit, and the second dose 30-60 days later. Patients were seen 1 month after the last vaccine dose, and then again at months 13 and 25, with telephone follow-up between the later visits. All participants were followed for at least 1 year, Dr. de la Serna said.
Episodes of HZ were confirmed by polymerase chain reaction assay, or, when samples were lacking or indeterminate, by agreement of at least three members of an ascertainment committee.
Of the two components of the HZ/su vaccine, glycoprotein E triggers both humoral immunity and activity of varicella zoster–specific CD4+ T cells; the adjuvant system – dubbed ASO1 – boosts immune response. The vaccine was approved by the Food and Drug Administration in October 2017 for use in adults aged 50 years and older.
In addition to the primary endpoint of vaccine efficacy in prevention of HZ cases during the study period, secondary objectives included monitoring vaccine reactogenicity and safety, and evaluating vaccine efficacy for the prevention of PHN and other complications of HZ.
Tertiary objectives included vaccine efficacy in preventing HZ during the first year posttransplant (vaccine efficacy 84.7%; 95% CI, 32.2-96.6), as well as efficacy in preventing hospitalizations related to HZ (vaccine efficacy 76.2%, 95% CI 61.1-86.0).
An exploratory analysis found vaccine efficacy of 71.8% for participants younger than 50 years (95% CI, 38.8 – 88.3). For patients aged 50 years and older, vaccine efficacy was 67.3% (95% CI, 52.6–77.9).
The safety of HZ/su was determined by analyzing data for all participants, but efficacy data included only those who received the second dose and did not develop HZ within a month of receiving the second vaccine dose.
In the efficacy group (n = 1,721), patients were mostly (n = 1,296) aged 50 years or older. Most patients (n = 937) received HSCT for multiple myeloma. Overall, participants were about 63% male, and 77% were of Caucasian/European ancestry.
Adverse events, solicited for the first 7 days after injections, were mostly mild and related to the local site pain and inflammation expected with an adjuvanted vaccine; HZ/su recipients also experienced more fatigue and muscle aches than did those receiving placebo. Median duration of symptoms was up to 3 days, with grade 3 events lasting up to 2 days.
Unsolicited and serious adverse events were similar between study arms, with a median safety follow-up period of 29 months. The investigators judged that no deaths were related to the vaccine, and there were no signals for increased rate of relapse or immune-mediated diseases.
The study was funded by GlaxoSmithKline; HZ/su(Shingrix) is marketed by GlaxoSmithKline. Dr. de la Serna reported being on the advisory board or receiving honoraria from multiple pharmaceutical companies.
SOURCE: de la Serna J et al. 2018 BMT Tandem Meetings, Abstract LBA2.
REPORTING FROM THE 2018 BMT TANDEM MEETINGS
Key clinical point:
Major finding: Efficacy was 68.17% for preventing herpes zoster among HSCT recipients.
Study details: A randomized, observer blind, placebo-controlled phase 3 study of 1,846 post-HSCT recipients.
Disclosures: The study was sponsored by GlaxoSmithKline. Dr. de la Serna reported relationships with multiple pharmaceutical companies.
Source: de la Serna J et al. 2018 BMT Tandem Meetings, Abstract LBA2.
‘Update in Hospital Medicine’ to highlight practice pearls
Barbara Slawski, MD, MS, SFHM, and Cynthia Cooper, MD, hadn’t met in person until early 2018. But that doesn’t mean they haven’t spent a lot of time together.
Once a month, usually on a Friday afternoon, the two hospitalists checked in with one another through relaxed, wide-ranging phone calls. Together they have combed the medical literature and conferred over the past year, making long lists of candidate studies for the “top 20” journal articles of 2018 for practicing hospitalists.
The two physicians are preparing for the “Update in Hospital Medicine” session they will comoderate at HM18 – historically one of the most popular at SHM annual meetings – where the research findings of these “Top 20” articles are summarized for conference attendees. Their hope, they said, is to present research that each attendee can bring home to improve patient outcomes on a daily basis, while making for a smoother and more efficient practice of hospital medicine.
Through a process each physician describes as collegial, Dr. Slawski and Dr. Cooper have winnowed their lists and are nearly ready to make their final calls. Since hospital medicine crosses so many disciplines, each physician said, in separate interviews, that doing justice to the literature has been time-consuming and intellectually challenging – but worthwhile.
Dr. Cooper, a hospitalist at Massachusetts General Hospital, Boston, said that although she and Dr. Slawski practice in geographically diverse areas, their practice settings – academic medical centers – have many similarities. She said that as she reviewed the medical literature over the past year, she gave considerable thought to the particular challenges and demands of hospitalists who practice in community hospitals and rural settings, where the level of support and access to subspecialty consults might be very different from the academic milieu where both she and Dr. Slawski practice.
“We hope that our unique approaches lend more breadth to the session,” said Dr. Slawski. “We want to make sure we have a good representation of SHM’s constituency, and that we present high-impact studies.”
In addition to her work at Mass General, Dr. Cooper also holds an appointment at Harvard Medical School. She said that the challenge over the past year has been to find the studies that are not focused just on primary care, but that really touch on the unique practice demands and skill set of physicians who practice hospital-based medicine.
Dr. Slawski said that cardiology is one of the areas that’s had relevant, practice-changing findings this past year: She expects to put at least one practice-changing cardiology article on the “Top 20” list. “How do we address patients with suspected acute coronary syndromes? Well, we have some new direction this year,” she said.
To hit the mark of articles that are relevant for all, Dr. Cooper said she wants to make sure to include a focus on research that touches on the practicalities of hospital-based practice – possible topics include prediction scores, hepatic encephalopathy, and the management of sepsis.
Dr. Slawski said that in addition to relevance, she and Dr. Cooper looked for methodological rigor in the studies they’ll be presenting; they agreed that having an adequate sample size for statistical power was a must.
The two presenters said they’re working hard to put together a session that’s as enjoyable as it is relevant. “I hope we’ll be able to inject some humor into the presentation, too,” Dr. Cooper said. Dr. Slawski agreed, noting that the bar has been set high at SHM. “It feels like a community,” she said. “There are always great speakers with a sense of humor.”
Dr. Slawski stressed that even though they’ll have their list ready to go for HM18, they will still be scouring journals until the week of the meeting so they can update their presentation with any late-breaking news of significance.
Neither Dr. Slawski nor Dr. Cooper reported any relevant conflicts of interest.
Barbara Slawski, MD, MS, SFHM, and Cynthia Cooper, MD, hadn’t met in person until early 2018. But that doesn’t mean they haven’t spent a lot of time together.
Once a month, usually on a Friday afternoon, the two hospitalists checked in with one another through relaxed, wide-ranging phone calls. Together they have combed the medical literature and conferred over the past year, making long lists of candidate studies for the “top 20” journal articles of 2018 for practicing hospitalists.
The two physicians are preparing for the “Update in Hospital Medicine” session they will comoderate at HM18 – historically one of the most popular at SHM annual meetings – where the research findings of these “Top 20” articles are summarized for conference attendees. Their hope, they said, is to present research that each attendee can bring home to improve patient outcomes on a daily basis, while making for a smoother and more efficient practice of hospital medicine.
Through a process each physician describes as collegial, Dr. Slawski and Dr. Cooper have winnowed their lists and are nearly ready to make their final calls. Since hospital medicine crosses so many disciplines, each physician said, in separate interviews, that doing justice to the literature has been time-consuming and intellectually challenging – but worthwhile.
Dr. Cooper, a hospitalist at Massachusetts General Hospital, Boston, said that although she and Dr. Slawski practice in geographically diverse areas, their practice settings – academic medical centers – have many similarities. She said that as she reviewed the medical literature over the past year, she gave considerable thought to the particular challenges and demands of hospitalists who practice in community hospitals and rural settings, where the level of support and access to subspecialty consults might be very different from the academic milieu where both she and Dr. Slawski practice.
“We hope that our unique approaches lend more breadth to the session,” said Dr. Slawski. “We want to make sure we have a good representation of SHM’s constituency, and that we present high-impact studies.”
In addition to her work at Mass General, Dr. Cooper also holds an appointment at Harvard Medical School. She said that the challenge over the past year has been to find the studies that are not focused just on primary care, but that really touch on the unique practice demands and skill set of physicians who practice hospital-based medicine.
Dr. Slawski said that cardiology is one of the areas that’s had relevant, practice-changing findings this past year: She expects to put at least one practice-changing cardiology article on the “Top 20” list. “How do we address patients with suspected acute coronary syndromes? Well, we have some new direction this year,” she said.
To hit the mark of articles that are relevant for all, Dr. Cooper said she wants to make sure to include a focus on research that touches on the practicalities of hospital-based practice – possible topics include prediction scores, hepatic encephalopathy, and the management of sepsis.
Dr. Slawski said that in addition to relevance, she and Dr. Cooper looked for methodological rigor in the studies they’ll be presenting; they agreed that having an adequate sample size for statistical power was a must.
The two presenters said they’re working hard to put together a session that’s as enjoyable as it is relevant. “I hope we’ll be able to inject some humor into the presentation, too,” Dr. Cooper said. Dr. Slawski agreed, noting that the bar has been set high at SHM. “It feels like a community,” she said. “There are always great speakers with a sense of humor.”
Dr. Slawski stressed that even though they’ll have their list ready to go for HM18, they will still be scouring journals until the week of the meeting so they can update their presentation with any late-breaking news of significance.
Neither Dr. Slawski nor Dr. Cooper reported any relevant conflicts of interest.
Barbara Slawski, MD, MS, SFHM, and Cynthia Cooper, MD, hadn’t met in person until early 2018. But that doesn’t mean they haven’t spent a lot of time together.
Once a month, usually on a Friday afternoon, the two hospitalists checked in with one another through relaxed, wide-ranging phone calls. Together they have combed the medical literature and conferred over the past year, making long lists of candidate studies for the “top 20” journal articles of 2018 for practicing hospitalists.
The two physicians are preparing for the “Update in Hospital Medicine” session they will comoderate at HM18 – historically one of the most popular at SHM annual meetings – where the research findings of these “Top 20” articles are summarized for conference attendees. Their hope, they said, is to present research that each attendee can bring home to improve patient outcomes on a daily basis, while making for a smoother and more efficient practice of hospital medicine.
Through a process each physician describes as collegial, Dr. Slawski and Dr. Cooper have winnowed their lists and are nearly ready to make their final calls. Since hospital medicine crosses so many disciplines, each physician said, in separate interviews, that doing justice to the literature has been time-consuming and intellectually challenging – but worthwhile.
Dr. Cooper, a hospitalist at Massachusetts General Hospital, Boston, said that although she and Dr. Slawski practice in geographically diverse areas, their practice settings – academic medical centers – have many similarities. She said that as she reviewed the medical literature over the past year, she gave considerable thought to the particular challenges and demands of hospitalists who practice in community hospitals and rural settings, where the level of support and access to subspecialty consults might be very different from the academic milieu where both she and Dr. Slawski practice.
“We hope that our unique approaches lend more breadth to the session,” said Dr. Slawski. “We want to make sure we have a good representation of SHM’s constituency, and that we present high-impact studies.”
In addition to her work at Mass General, Dr. Cooper also holds an appointment at Harvard Medical School. She said that the challenge over the past year has been to find the studies that are not focused just on primary care, but that really touch on the unique practice demands and skill set of physicians who practice hospital-based medicine.
Dr. Slawski said that cardiology is one of the areas that’s had relevant, practice-changing findings this past year: She expects to put at least one practice-changing cardiology article on the “Top 20” list. “How do we address patients with suspected acute coronary syndromes? Well, we have some new direction this year,” she said.
To hit the mark of articles that are relevant for all, Dr. Cooper said she wants to make sure to include a focus on research that touches on the practicalities of hospital-based practice – possible topics include prediction scores, hepatic encephalopathy, and the management of sepsis.
Dr. Slawski said that in addition to relevance, she and Dr. Cooper looked for methodological rigor in the studies they’ll be presenting; they agreed that having an adequate sample size for statistical power was a must.
The two presenters said they’re working hard to put together a session that’s as enjoyable as it is relevant. “I hope we’ll be able to inject some humor into the presentation, too,” Dr. Cooper said. Dr. Slawski agreed, noting that the bar has been set high at SHM. “It feels like a community,” she said. “There are always great speakers with a sense of humor.”
Dr. Slawski stressed that even though they’ll have their list ready to go for HM18, they will still be scouring journals until the week of the meeting so they can update their presentation with any late-breaking news of significance.
Neither Dr. Slawski nor Dr. Cooper reported any relevant conflicts of interest.
March 2018: Click for Credit
Here are 4 articles in the March issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):
1. Prenatal Maternal Anxiety Linked to Hyperactivity in Offspring as Teenagers
To take the posttest, go to: http://bit.ly/2BLXsRs
Expires November 15, 2018
2. The Better Mammogram: Experts Explore Sensitivity of New Modalities
To take the posttest, go to: http://bit.ly/2nQaJii
Expires November 14, 2018
3. Large Database Analysis Suggests Safety of Bariatric Surgery in Seniors
To take the posttest, go to: http://bit.ly/2E3tcmJ
Expires November 14, 2018
4. Salivary Biomarker for Huntington Disease Identified
To take the posttest, go to: http://bit.ly/2BGQpJP
Expires November 13, 2018
Here are 4 articles in the March issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):
1. Prenatal Maternal Anxiety Linked to Hyperactivity in Offspring as Teenagers
To take the posttest, go to: http://bit.ly/2BLXsRs
Expires November 15, 2018
2. The Better Mammogram: Experts Explore Sensitivity of New Modalities
To take the posttest, go to: http://bit.ly/2nQaJii
Expires November 14, 2018
3. Large Database Analysis Suggests Safety of Bariatric Surgery in Seniors
To take the posttest, go to: http://bit.ly/2E3tcmJ
Expires November 14, 2018
4. Salivary Biomarker for Huntington Disease Identified
To take the posttest, go to: http://bit.ly/2BGQpJP
Expires November 13, 2018
Here are 4 articles in the March issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):
1. Prenatal Maternal Anxiety Linked to Hyperactivity in Offspring as Teenagers
To take the posttest, go to: http://bit.ly/2BLXsRs
Expires November 15, 2018
2. The Better Mammogram: Experts Explore Sensitivity of New Modalities
To take the posttest, go to: http://bit.ly/2nQaJii
Expires November 14, 2018
3. Large Database Analysis Suggests Safety of Bariatric Surgery in Seniors
To take the posttest, go to: http://bit.ly/2E3tcmJ
Expires November 14, 2018
4. Salivary Biomarker for Huntington Disease Identified
To take the posttest, go to: http://bit.ly/2BGQpJP
Expires November 13, 2018
Maternal hypertension QI initiative cuts severe morbidity by 41%
DALLAS – A statewide quality improvement initiative to address treatment strategies for women with severe maternal hypertension resulted in a 41% reduction in severe maternal morbidity, from 15% before the initiative to 9% after the suite of interventions was fully implemented.
A total of 102 Illinois hospitals participated in the quality improvement (QI) initiative, which eventually included 12,718 women with severe maternal hypertension, defined as blood pressure greater than 160/110 mm Hg.
The number of patients who were scheduled for follow-up appointments within 10 days of discharge increased from 53% to 83% after the QI initiative was implemented. The proportion of cases of severe maternal hypertension that were subject to a provider-nurse debrief analyzing time to treatment went from 2% before the intervention to 53%.
Dr. Lee King presented the findings to a receptive audience at a plenary session of the meeting sponsored by the Society for Maternal-Fetal Medicine. “We had a philosophy of ‘leave no hospital behind,’ and of ‘leave no patient behind,’ ” she said, to wide applause.
“The key prevention of maternal morbidity and mortality associated with severe maternal hypertension is timely treatment; the primary cause of maternal death associated with hypertensive disorders of pregnancy is maternal hemorrhagic stroke,” said Dr. Lee King.
The multidisciplinary, multistakeholder project was coordinated by the Illinois Perinatal Quality Collaborative (ILPQC), housed at Northwestern University, Chicago. The participating hospitals account for over 95% of the births in the state of Illinois, said Dr. Lee King, ILPQC state project director.
The approach used for implementation of the hypertension QI initiative included collaborative learning and the use of rapid response data to give near–real time feedback on how institutions were faring in meeting national guidelines to treat severe maternal hypertension.
Specific clinical interventions included both “system changes and culture changes,” said Dr. Lee King. They included adopting facility-wide protocols for timely identification and treatment of women with severe maternal hypertension; standardizing patient education and discharge planning; increasing provider and nurse education about severe maternal hypertension protocols; and creating rapid access to medication and standardized treatment order sets.
The ILPQC facilitated collaboration between hospitals in meeting these aims, including monthly web-based updates and seminars and construction of the database that gave institutions rapid access to data for ongoing QI efforts. Newsletters, website updates, and QI support were also part of the ILPQC package.
The proportion of participating hospitals meeting time-to-treatment goals for severe maternal hypertension went from 13% at baseline to 71% at the end of data collection, said Dr. Lee King.
In looking at hospital characteristics such as rurality, size, and patient mix, Dr. Lee King and her collaborators found no significant differences in time to treatment, patient education, and number of cases that were debriefed.
“These strategies helped hospitals achieve initiative goals, regardless of hospital characteristics,” said Dr. Lee King. The only significant association the research team found was that hospitals with fewer than 500 deliveries per year were less likely to reach the goal of early follow-up appointments (P less than .02).
“Participation in a statewide perinatal quality collaborative increases hospitals’ QI capacity. A statewide QI initiative can achieve significant population-level improvements in care for women with severe maternal hypertension and – more importantly – a reduction in severe maternal morbidity,” Dr. Lee King said.
The QI initiative and the follow-up study were conducted by the Illinois Perinatal Quality Collaborative, and the work was funded by the Centers for Disease Control and Prevention, the Illinois Department of Health, and the Alliance for Intervention on Maternal Health. Materials related to the maternal hypertension initiative are available at http://ilpqc.org/?q=Hypertension. Dr. Lee King reported no conflicts of interest.
SOURCE: Lee King P et al. Am J Obstet Gynecol. 2018 Jan;218:S4.
DALLAS – A statewide quality improvement initiative to address treatment strategies for women with severe maternal hypertension resulted in a 41% reduction in severe maternal morbidity, from 15% before the initiative to 9% after the suite of interventions was fully implemented.
A total of 102 Illinois hospitals participated in the quality improvement (QI) initiative, which eventually included 12,718 women with severe maternal hypertension, defined as blood pressure greater than 160/110 mm Hg.
The number of patients who were scheduled for follow-up appointments within 10 days of discharge increased from 53% to 83% after the QI initiative was implemented. The proportion of cases of severe maternal hypertension that were subject to a provider-nurse debrief analyzing time to treatment went from 2% before the intervention to 53%.
Dr. Lee King presented the findings to a receptive audience at a plenary session of the meeting sponsored by the Society for Maternal-Fetal Medicine. “We had a philosophy of ‘leave no hospital behind,’ and of ‘leave no patient behind,’ ” she said, to wide applause.
“The key prevention of maternal morbidity and mortality associated with severe maternal hypertension is timely treatment; the primary cause of maternal death associated with hypertensive disorders of pregnancy is maternal hemorrhagic stroke,” said Dr. Lee King.
The multidisciplinary, multistakeholder project was coordinated by the Illinois Perinatal Quality Collaborative (ILPQC), housed at Northwestern University, Chicago. The participating hospitals account for over 95% of the births in the state of Illinois, said Dr. Lee King, ILPQC state project director.
The approach used for implementation of the hypertension QI initiative included collaborative learning and the use of rapid response data to give near–real time feedback on how institutions were faring in meeting national guidelines to treat severe maternal hypertension.
Specific clinical interventions included both “system changes and culture changes,” said Dr. Lee King. They included adopting facility-wide protocols for timely identification and treatment of women with severe maternal hypertension; standardizing patient education and discharge planning; increasing provider and nurse education about severe maternal hypertension protocols; and creating rapid access to medication and standardized treatment order sets.
The ILPQC facilitated collaboration between hospitals in meeting these aims, including monthly web-based updates and seminars and construction of the database that gave institutions rapid access to data for ongoing QI efforts. Newsletters, website updates, and QI support were also part of the ILPQC package.
The proportion of participating hospitals meeting time-to-treatment goals for severe maternal hypertension went from 13% at baseline to 71% at the end of data collection, said Dr. Lee King.
In looking at hospital characteristics such as rurality, size, and patient mix, Dr. Lee King and her collaborators found no significant differences in time to treatment, patient education, and number of cases that were debriefed.
“These strategies helped hospitals achieve initiative goals, regardless of hospital characteristics,” said Dr. Lee King. The only significant association the research team found was that hospitals with fewer than 500 deliveries per year were less likely to reach the goal of early follow-up appointments (P less than .02).
“Participation in a statewide perinatal quality collaborative increases hospitals’ QI capacity. A statewide QI initiative can achieve significant population-level improvements in care for women with severe maternal hypertension and – more importantly – a reduction in severe maternal morbidity,” Dr. Lee King said.
The QI initiative and the follow-up study were conducted by the Illinois Perinatal Quality Collaborative, and the work was funded by the Centers for Disease Control and Prevention, the Illinois Department of Health, and the Alliance for Intervention on Maternal Health. Materials related to the maternal hypertension initiative are available at http://ilpqc.org/?q=Hypertension. Dr. Lee King reported no conflicts of interest.
SOURCE: Lee King P et al. Am J Obstet Gynecol. 2018 Jan;218:S4.
DALLAS – A statewide quality improvement initiative to address treatment strategies for women with severe maternal hypertension resulted in a 41% reduction in severe maternal morbidity, from 15% before the initiative to 9% after the suite of interventions was fully implemented.
A total of 102 Illinois hospitals participated in the quality improvement (QI) initiative, which eventually included 12,718 women with severe maternal hypertension, defined as blood pressure greater than 160/110 mm Hg.
The number of patients who were scheduled for follow-up appointments within 10 days of discharge increased from 53% to 83% after the QI initiative was implemented. The proportion of cases of severe maternal hypertension that were subject to a provider-nurse debrief analyzing time to treatment went from 2% before the intervention to 53%.
Dr. Lee King presented the findings to a receptive audience at a plenary session of the meeting sponsored by the Society for Maternal-Fetal Medicine. “We had a philosophy of ‘leave no hospital behind,’ and of ‘leave no patient behind,’ ” she said, to wide applause.
“The key prevention of maternal morbidity and mortality associated with severe maternal hypertension is timely treatment; the primary cause of maternal death associated with hypertensive disorders of pregnancy is maternal hemorrhagic stroke,” said Dr. Lee King.
The multidisciplinary, multistakeholder project was coordinated by the Illinois Perinatal Quality Collaborative (ILPQC), housed at Northwestern University, Chicago. The participating hospitals account for over 95% of the births in the state of Illinois, said Dr. Lee King, ILPQC state project director.
The approach used for implementation of the hypertension QI initiative included collaborative learning and the use of rapid response data to give near–real time feedback on how institutions were faring in meeting national guidelines to treat severe maternal hypertension.
Specific clinical interventions included both “system changes and culture changes,” said Dr. Lee King. They included adopting facility-wide protocols for timely identification and treatment of women with severe maternal hypertension; standardizing patient education and discharge planning; increasing provider and nurse education about severe maternal hypertension protocols; and creating rapid access to medication and standardized treatment order sets.
The ILPQC facilitated collaboration between hospitals in meeting these aims, including monthly web-based updates and seminars and construction of the database that gave institutions rapid access to data for ongoing QI efforts. Newsletters, website updates, and QI support were also part of the ILPQC package.
The proportion of participating hospitals meeting time-to-treatment goals for severe maternal hypertension went from 13% at baseline to 71% at the end of data collection, said Dr. Lee King.
In looking at hospital characteristics such as rurality, size, and patient mix, Dr. Lee King and her collaborators found no significant differences in time to treatment, patient education, and number of cases that were debriefed.
“These strategies helped hospitals achieve initiative goals, regardless of hospital characteristics,” said Dr. Lee King. The only significant association the research team found was that hospitals with fewer than 500 deliveries per year were less likely to reach the goal of early follow-up appointments (P less than .02).
“Participation in a statewide perinatal quality collaborative increases hospitals’ QI capacity. A statewide QI initiative can achieve significant population-level improvements in care for women with severe maternal hypertension and – more importantly – a reduction in severe maternal morbidity,” Dr. Lee King said.
The QI initiative and the follow-up study were conducted by the Illinois Perinatal Quality Collaborative, and the work was funded by the Centers for Disease Control and Prevention, the Illinois Department of Health, and the Alliance for Intervention on Maternal Health. Materials related to the maternal hypertension initiative are available at http://ilpqc.org/?q=Hypertension. Dr. Lee King reported no conflicts of interest.
SOURCE: Lee King P et al. Am J Obstet Gynecol. 2018 Jan;218:S4.
REPORTING FROM THE PREGNANCY MEETING
Key clinical point: The statewide QI initiative targeted treatment of women with severe maternal hypertension.
Major finding: Severe maternal morbidity fell 41%, from 15% to 9%, with the initiative.
Study details: Pre-post QI initiative analysis of data from 102 Illinois hospitals treating 12,718 women with severe maternal hypertension.
Disclosures: The study was funded by the Centers for Disease Control and Prevention, the Illinois Department of Health, and the Alliance for Intervention on Mental Health. Dr. Lee King is employed by the Illinois Perinatal Quality Collaborative, which conducted the study.
Source: Lee King P et al. Am J Obstet Gynecol. 2018 Jan;218:S4.
Salpingectomy at cesarean feasible, but adds to operative time
DALLAS – Salpingectomy – which can reduce the risk for later ovarian cancer – was completed successfully in about two-thirds of women who desired permanent contraception at cesarean delivery and were randomized to receive this procedure rather than simple tubal ligation.
In a study of 80 patients, operative times were longer by 15 minutes for those who received salpingectomy, and neither group had adverse outcomes or serious complications, according to Akila Subramaniam, MD, who presented the findings of the single-site Salpingectomy at Cesarean Delivery for Ovarian Cancer Reduction (SCORE) trial at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The strategy to perform salpingectomy during cesarean delivery may be one way to reduce the incidence of ovarian cancer, “the most lethal gynecologic malignancy in the United States,” said Dr. Subramaniam, a maternal-fetal medicine specialist at the University of Alabama at Birmingham. “Primary prevention is the focus to reduce the ovarian cancer burden.”
However, Dr. Subramaniam said, there had been limited prospective data on salpingectomy performed at the time of cesarean delivery. One theoretical concern is an increased risk of bleeding; another is the additional operative time required for a potentially difficult dissection of the entire fallopian tube.
Dr. Subramaniam and her colleagues constructed a clinical trial that asked patients who were receiving cesarean delivery and who desired surgical sterilization to agree to randomization to complete salpingectomy or standard tubal ligation. Patient allocation was determined by computer-generated numbers, placed in a sealed envelope, and revealed to the surgeon only at the time of the opening incision for the cesarean procedure. Patients were unaware of the allocation until hospital discharge.
The single-center trial enrolled women undergoing a planned cesarean delivery at 35 or more weeks’ gestation, including those who had previous cesareans and women with multiple gestations or fetal malpresentations. Women who went on to cesarean after a trial of labor after prior cesarean were also eligible.
Patients younger than 25 years and patients with known fetal anomalies or fetal demise were excluded, as were women with previous tubal surgery and those who were anticoagulated or had immunodeficiency. The study did not enroll women who were known to carry the BRCA mutation.
Patients who were randomized to the intervention arm received a complete salpingectomy involving excision from the fimbriae to within 1 cm of the cornua, when technically feasible. The control arm participants received a standard bilateral tubal ligation using either the modified Pomeroy technique or the Parkland technique.
All study participants received routine pre- and postoperative care and instructions, and had study follow-up visits at 1 and 6 weeks post partum.
The study had two primary endpoints: rate of bilateral completion of the randomized procedure, and mean total operative time measured from skin incision to closure. Secondary outcomes included assessments of blood loss and surgical complications, followed through the 6-week postpartum visit.
The study just met the predetermined statistical power needed to detect a 10-minute difference in operative time, enrolling 80 patients and randomizing 40 to each arm.
Of the 40 patients randomized to salpingectomy, 27 (67.5%) received the intended complete salpingectomy. Three had a unilateral salpingectomy, with a tubal ligation contralaterally. Eight patients received bilateral tubal ligations, and in two patients, the surgeon was unable to perform any sterilization procedure at all.
In the tubal ligation arm, 38 patients (95%) received bilateral tubal ligation, 1 patient received a unilateral tubal ligation and a unilateral salpingectomy, and 1 patient received no procedure. The difference in success of completing the intended procedures between the two study arms was statistically significant (P = .002); in both groups, adhesions and scarring were the primary impediments to successful completion of the intended procedure, Dr. Subramaniam said.
Operative times were longer by about 15 minutes in the salpingectomy arm, with the difference accounted for by the longer duration of the sterilization procedure. No significant differences were seen in estimated blood loss or decrease in hematocrit between the two groups, and pain scores were similar.
The study, which successfully recruited 80 women from 221 approached, “may be underpowered for safety outcomes,” said Dr. Subramaniam. She also pointed out that there was no assessment of ovarian reserve, and that it’s not possible to assess the true risk reduction of salpingectomy in this study design.
Still, “It’s reasonable to consider this surgical sterilization method during cesarean as an ovarian cancer risk-reducing strategy.” One impediment to study recruitment, she said, was that after receiving education about salpingectomy, many patients desired salpingectomy and were not willing to risk randomization to simple tubal ligation.
Dr. Subramaniam reported receiving research funding for the study from the Debra Kogan Lyda Memorial Ovarian Cancer Fund.
SOURCE: Subramaniam A et al. Am J Obstet Gynecol. 2018 Jan;218:S27-8.
DALLAS – Salpingectomy – which can reduce the risk for later ovarian cancer – was completed successfully in about two-thirds of women who desired permanent contraception at cesarean delivery and were randomized to receive this procedure rather than simple tubal ligation.
In a study of 80 patients, operative times were longer by 15 minutes for those who received salpingectomy, and neither group had adverse outcomes or serious complications, according to Akila Subramaniam, MD, who presented the findings of the single-site Salpingectomy at Cesarean Delivery for Ovarian Cancer Reduction (SCORE) trial at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The strategy to perform salpingectomy during cesarean delivery may be one way to reduce the incidence of ovarian cancer, “the most lethal gynecologic malignancy in the United States,” said Dr. Subramaniam, a maternal-fetal medicine specialist at the University of Alabama at Birmingham. “Primary prevention is the focus to reduce the ovarian cancer burden.”
However, Dr. Subramaniam said, there had been limited prospective data on salpingectomy performed at the time of cesarean delivery. One theoretical concern is an increased risk of bleeding; another is the additional operative time required for a potentially difficult dissection of the entire fallopian tube.
Dr. Subramaniam and her colleagues constructed a clinical trial that asked patients who were receiving cesarean delivery and who desired surgical sterilization to agree to randomization to complete salpingectomy or standard tubal ligation. Patient allocation was determined by computer-generated numbers, placed in a sealed envelope, and revealed to the surgeon only at the time of the opening incision for the cesarean procedure. Patients were unaware of the allocation until hospital discharge.
The single-center trial enrolled women undergoing a planned cesarean delivery at 35 or more weeks’ gestation, including those who had previous cesareans and women with multiple gestations or fetal malpresentations. Women who went on to cesarean after a trial of labor after prior cesarean were also eligible.
Patients younger than 25 years and patients with known fetal anomalies or fetal demise were excluded, as were women with previous tubal surgery and those who were anticoagulated or had immunodeficiency. The study did not enroll women who were known to carry the BRCA mutation.
Patients who were randomized to the intervention arm received a complete salpingectomy involving excision from the fimbriae to within 1 cm of the cornua, when technically feasible. The control arm participants received a standard bilateral tubal ligation using either the modified Pomeroy technique or the Parkland technique.
All study participants received routine pre- and postoperative care and instructions, and had study follow-up visits at 1 and 6 weeks post partum.
The study had two primary endpoints: rate of bilateral completion of the randomized procedure, and mean total operative time measured from skin incision to closure. Secondary outcomes included assessments of blood loss and surgical complications, followed through the 6-week postpartum visit.
The study just met the predetermined statistical power needed to detect a 10-minute difference in operative time, enrolling 80 patients and randomizing 40 to each arm.
Of the 40 patients randomized to salpingectomy, 27 (67.5%) received the intended complete salpingectomy. Three had a unilateral salpingectomy, with a tubal ligation contralaterally. Eight patients received bilateral tubal ligations, and in two patients, the surgeon was unable to perform any sterilization procedure at all.
In the tubal ligation arm, 38 patients (95%) received bilateral tubal ligation, 1 patient received a unilateral tubal ligation and a unilateral salpingectomy, and 1 patient received no procedure. The difference in success of completing the intended procedures between the two study arms was statistically significant (P = .002); in both groups, adhesions and scarring were the primary impediments to successful completion of the intended procedure, Dr. Subramaniam said.
Operative times were longer by about 15 minutes in the salpingectomy arm, with the difference accounted for by the longer duration of the sterilization procedure. No significant differences were seen in estimated blood loss or decrease in hematocrit between the two groups, and pain scores were similar.
The study, which successfully recruited 80 women from 221 approached, “may be underpowered for safety outcomes,” said Dr. Subramaniam. She also pointed out that there was no assessment of ovarian reserve, and that it’s not possible to assess the true risk reduction of salpingectomy in this study design.
Still, “It’s reasonable to consider this surgical sterilization method during cesarean as an ovarian cancer risk-reducing strategy.” One impediment to study recruitment, she said, was that after receiving education about salpingectomy, many patients desired salpingectomy and were not willing to risk randomization to simple tubal ligation.
Dr. Subramaniam reported receiving research funding for the study from the Debra Kogan Lyda Memorial Ovarian Cancer Fund.
SOURCE: Subramaniam A et al. Am J Obstet Gynecol. 2018 Jan;218:S27-8.
DALLAS – Salpingectomy – which can reduce the risk for later ovarian cancer – was completed successfully in about two-thirds of women who desired permanent contraception at cesarean delivery and were randomized to receive this procedure rather than simple tubal ligation.
In a study of 80 patients, operative times were longer by 15 minutes for those who received salpingectomy, and neither group had adverse outcomes or serious complications, according to Akila Subramaniam, MD, who presented the findings of the single-site Salpingectomy at Cesarean Delivery for Ovarian Cancer Reduction (SCORE) trial at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The strategy to perform salpingectomy during cesarean delivery may be one way to reduce the incidence of ovarian cancer, “the most lethal gynecologic malignancy in the United States,” said Dr. Subramaniam, a maternal-fetal medicine specialist at the University of Alabama at Birmingham. “Primary prevention is the focus to reduce the ovarian cancer burden.”
However, Dr. Subramaniam said, there had been limited prospective data on salpingectomy performed at the time of cesarean delivery. One theoretical concern is an increased risk of bleeding; another is the additional operative time required for a potentially difficult dissection of the entire fallopian tube.
Dr. Subramaniam and her colleagues constructed a clinical trial that asked patients who were receiving cesarean delivery and who desired surgical sterilization to agree to randomization to complete salpingectomy or standard tubal ligation. Patient allocation was determined by computer-generated numbers, placed in a sealed envelope, and revealed to the surgeon only at the time of the opening incision for the cesarean procedure. Patients were unaware of the allocation until hospital discharge.
The single-center trial enrolled women undergoing a planned cesarean delivery at 35 or more weeks’ gestation, including those who had previous cesareans and women with multiple gestations or fetal malpresentations. Women who went on to cesarean after a trial of labor after prior cesarean were also eligible.
Patients younger than 25 years and patients with known fetal anomalies or fetal demise were excluded, as were women with previous tubal surgery and those who were anticoagulated or had immunodeficiency. The study did not enroll women who were known to carry the BRCA mutation.
Patients who were randomized to the intervention arm received a complete salpingectomy involving excision from the fimbriae to within 1 cm of the cornua, when technically feasible. The control arm participants received a standard bilateral tubal ligation using either the modified Pomeroy technique or the Parkland technique.
All study participants received routine pre- and postoperative care and instructions, and had study follow-up visits at 1 and 6 weeks post partum.
The study had two primary endpoints: rate of bilateral completion of the randomized procedure, and mean total operative time measured from skin incision to closure. Secondary outcomes included assessments of blood loss and surgical complications, followed through the 6-week postpartum visit.
The study just met the predetermined statistical power needed to detect a 10-minute difference in operative time, enrolling 80 patients and randomizing 40 to each arm.
Of the 40 patients randomized to salpingectomy, 27 (67.5%) received the intended complete salpingectomy. Three had a unilateral salpingectomy, with a tubal ligation contralaterally. Eight patients received bilateral tubal ligations, and in two patients, the surgeon was unable to perform any sterilization procedure at all.
In the tubal ligation arm, 38 patients (95%) received bilateral tubal ligation, 1 patient received a unilateral tubal ligation and a unilateral salpingectomy, and 1 patient received no procedure. The difference in success of completing the intended procedures between the two study arms was statistically significant (P = .002); in both groups, adhesions and scarring were the primary impediments to successful completion of the intended procedure, Dr. Subramaniam said.
Operative times were longer by about 15 minutes in the salpingectomy arm, with the difference accounted for by the longer duration of the sterilization procedure. No significant differences were seen in estimated blood loss or decrease in hematocrit between the two groups, and pain scores were similar.
The study, which successfully recruited 80 women from 221 approached, “may be underpowered for safety outcomes,” said Dr. Subramaniam. She also pointed out that there was no assessment of ovarian reserve, and that it’s not possible to assess the true risk reduction of salpingectomy in this study design.
Still, “It’s reasonable to consider this surgical sterilization method during cesarean as an ovarian cancer risk-reducing strategy.” One impediment to study recruitment, she said, was that after receiving education about salpingectomy, many patients desired salpingectomy and were not willing to risk randomization to simple tubal ligation.
Dr. Subramaniam reported receiving research funding for the study from the Debra Kogan Lyda Memorial Ovarian Cancer Fund.
SOURCE: Subramaniam A et al. Am J Obstet Gynecol. 2018 Jan;218:S27-8.
REPORTING FROM THE PREGNANCY MEETING
Key clinical point: Salpingectomy was successful in two-thirds of patients but added 15 minutes to operative time.
Major finding: The intended procedure was successful in 27 of 40 salpingectomy patients (67.5%) and 38 of 40 tubal ligation patients (95%; P = .02).
Study details: Randomized controlled trial of 80 women receiving bilateral salpingectomy or tubal ligation at cesarean delivery.
Disclosures: Study funding was received from the Debra Kogan Lyda Memorial Ovarian Cancer Fund.
Source: Subramaniam A et al. Am J Obstet Gynecol. 2018 Jan;218:S27-8.
Postcesarean SSI rate declines with care bundle*
DALLAS – A surgical site infection care bundle reduced the rate of surgical site infections (SSIs) after cesarean delivery by more than half, according to a case-control study examining data from more than 2,000 patients.
At the health center where the SSI bundle was implemented, rates per 1,000 women undergoing cesarean delivery fell from 2.44 to 1.10 (P = .013).
The study showed the effectiveness of implementing evidence-based and -supported recommendations, and of having standardized protocols with little variation, said Christina Davidson, MD, presenting the pre-post findings during a plenary session at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The bundle of interventions was developed over the course of 3 months in late 2013 and early 2014 by a multidisciplinary task force, drawing from colorectal surgery literature about SSI prevention. Both nurses and physicians were on the task force, and representatives came from the departments of obstetrics and gynecology, anesthesia, and infection prevention, said Dr. Davidson of the Baylor College of Medicine, Houston. All inpatient and outpatient clinical care sites had representation.
After the bundle elements were identified, a full month was devoted to education and team training, with full bundle implementation occurring in April 2014. “Visual aids were placed in close proximity to the operating rooms,” said Dr. Davidson. For example, antimicrobial prophylaxis cards were placed on all anesthetic carts.
“A surgical checklist was placed in the chart for each patient undergoing cesarean delivery and compliance was tracked for the first 12 months of implementation,” said Dr. Davidson. Additionally, members of the care team received feedback in the form of quarterly reports on SSI rates and statistics about bundle compliance.
Care bundle elements included a set of instructions for pre- and postoperative antiseptic skin cleaning, wound care, and glycemic control in patients. Women were given chlorhexidine cleanser and asked to use it when showering the day before and the morning of surgery for planned deliveries. Forced warm-air blankets maintained patient normothermia in the preoperative holding area.
A group of intraoperative interventions included use of antiseptic skin and vaginal preparations, double-gloving, and having all scrubbed members of the surgical team change their outer gloves for fascial closure. A new instrument tray also was used for fascial closure. Prophylactic antibiotics were administered within 1 hour of skin incision, and doses were readministered based on the length of the procedure.
Postoperatively, said Dr. Davidson, “a set of insulin orders within the electronic medical record [was] used to maintain euglycemia in all diabetic patients.”
After the surgical dressing was removed on the 2nd postoperative day, patients were given a handout and education about wound control and infection prevention.
Finally, all patients received postdischarge follow-up calls from nurses within 72 hours after discharge.
Patient characteristics generally were similar before (n = 1,085) and after (n = 1,261) SSI bundle implementation. Body mass index was slightly higher in the postbundle group, and women in this group also were less likely to have had a prior cesarean delivery. There were no significant differences in age, gravidity, ethnicity, or race.
The study showed that with continued tracking, data-sharing, and reeducation efforts, “The SSI rate was sustained after bundle implementation,” said Dr. Davidson. The implementation team, working with hospital departments, was able to achieve a high compliance rate. And, she said, the effect size of the intervention was large enough to show significant reduction from an already low SSI rate.
However, Dr. Davidson also noted some limitations: All of the bundle elements were implemented simultaneously, so it wasn’t possible to tell which components had the greatest effect. Also, not all demographic data were available, and the type of SSI was sometimes unavailable from the deidentified data repository used for analysis, she said. “We weren’t able to tease out individual patient-level characteristics” about the timing and type of SSI in a patient-by-patient fashion, she said during discussion following her presentation.
All in all, she said, the bundle’s effectiveness “supports the synergistic effects of multiple strategies and the impact of a multidisciplinary team approach.”
The study authors reported no conflicts of interest.
SOURCE: Davidson C et al. Am J Obstet Gynecol. 2018 Jan;218:S46.
Correction, 3/5/18: An earlier version of this article omitted the word "rate" from the headline and Vitals section.
DALLAS – A surgical site infection care bundle reduced the rate of surgical site infections (SSIs) after cesarean delivery by more than half, according to a case-control study examining data from more than 2,000 patients.
At the health center where the SSI bundle was implemented, rates per 1,000 women undergoing cesarean delivery fell from 2.44 to 1.10 (P = .013).
The study showed the effectiveness of implementing evidence-based and -supported recommendations, and of having standardized protocols with little variation, said Christina Davidson, MD, presenting the pre-post findings during a plenary session at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The bundle of interventions was developed over the course of 3 months in late 2013 and early 2014 by a multidisciplinary task force, drawing from colorectal surgery literature about SSI prevention. Both nurses and physicians were on the task force, and representatives came from the departments of obstetrics and gynecology, anesthesia, and infection prevention, said Dr. Davidson of the Baylor College of Medicine, Houston. All inpatient and outpatient clinical care sites had representation.
After the bundle elements were identified, a full month was devoted to education and team training, with full bundle implementation occurring in April 2014. “Visual aids were placed in close proximity to the operating rooms,” said Dr. Davidson. For example, antimicrobial prophylaxis cards were placed on all anesthetic carts.
“A surgical checklist was placed in the chart for each patient undergoing cesarean delivery and compliance was tracked for the first 12 months of implementation,” said Dr. Davidson. Additionally, members of the care team received feedback in the form of quarterly reports on SSI rates and statistics about bundle compliance.
Care bundle elements included a set of instructions for pre- and postoperative antiseptic skin cleaning, wound care, and glycemic control in patients. Women were given chlorhexidine cleanser and asked to use it when showering the day before and the morning of surgery for planned deliveries. Forced warm-air blankets maintained patient normothermia in the preoperative holding area.
A group of intraoperative interventions included use of antiseptic skin and vaginal preparations, double-gloving, and having all scrubbed members of the surgical team change their outer gloves for fascial closure. A new instrument tray also was used for fascial closure. Prophylactic antibiotics were administered within 1 hour of skin incision, and doses were readministered based on the length of the procedure.
Postoperatively, said Dr. Davidson, “a set of insulin orders within the electronic medical record [was] used to maintain euglycemia in all diabetic patients.”
After the surgical dressing was removed on the 2nd postoperative day, patients were given a handout and education about wound control and infection prevention.
Finally, all patients received postdischarge follow-up calls from nurses within 72 hours after discharge.
Patient characteristics generally were similar before (n = 1,085) and after (n = 1,261) SSI bundle implementation. Body mass index was slightly higher in the postbundle group, and women in this group also were less likely to have had a prior cesarean delivery. There were no significant differences in age, gravidity, ethnicity, or race.
The study showed that with continued tracking, data-sharing, and reeducation efforts, “The SSI rate was sustained after bundle implementation,” said Dr. Davidson. The implementation team, working with hospital departments, was able to achieve a high compliance rate. And, she said, the effect size of the intervention was large enough to show significant reduction from an already low SSI rate.
However, Dr. Davidson also noted some limitations: All of the bundle elements were implemented simultaneously, so it wasn’t possible to tell which components had the greatest effect. Also, not all demographic data were available, and the type of SSI was sometimes unavailable from the deidentified data repository used for analysis, she said. “We weren’t able to tease out individual patient-level characteristics” about the timing and type of SSI in a patient-by-patient fashion, she said during discussion following her presentation.
All in all, she said, the bundle’s effectiveness “supports the synergistic effects of multiple strategies and the impact of a multidisciplinary team approach.”
The study authors reported no conflicts of interest.
SOURCE: Davidson C et al. Am J Obstet Gynecol. 2018 Jan;218:S46.
Correction, 3/5/18: An earlier version of this article omitted the word "rate" from the headline and Vitals section.
DALLAS – A surgical site infection care bundle reduced the rate of surgical site infections (SSIs) after cesarean delivery by more than half, according to a case-control study examining data from more than 2,000 patients.
At the health center where the SSI bundle was implemented, rates per 1,000 women undergoing cesarean delivery fell from 2.44 to 1.10 (P = .013).
The study showed the effectiveness of implementing evidence-based and -supported recommendations, and of having standardized protocols with little variation, said Christina Davidson, MD, presenting the pre-post findings during a plenary session at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The bundle of interventions was developed over the course of 3 months in late 2013 and early 2014 by a multidisciplinary task force, drawing from colorectal surgery literature about SSI prevention. Both nurses and physicians were on the task force, and representatives came from the departments of obstetrics and gynecology, anesthesia, and infection prevention, said Dr. Davidson of the Baylor College of Medicine, Houston. All inpatient and outpatient clinical care sites had representation.
After the bundle elements were identified, a full month was devoted to education and team training, with full bundle implementation occurring in April 2014. “Visual aids were placed in close proximity to the operating rooms,” said Dr. Davidson. For example, antimicrobial prophylaxis cards were placed on all anesthetic carts.
“A surgical checklist was placed in the chart for each patient undergoing cesarean delivery and compliance was tracked for the first 12 months of implementation,” said Dr. Davidson. Additionally, members of the care team received feedback in the form of quarterly reports on SSI rates and statistics about bundle compliance.
Care bundle elements included a set of instructions for pre- and postoperative antiseptic skin cleaning, wound care, and glycemic control in patients. Women were given chlorhexidine cleanser and asked to use it when showering the day before and the morning of surgery for planned deliveries. Forced warm-air blankets maintained patient normothermia in the preoperative holding area.
A group of intraoperative interventions included use of antiseptic skin and vaginal preparations, double-gloving, and having all scrubbed members of the surgical team change their outer gloves for fascial closure. A new instrument tray also was used for fascial closure. Prophylactic antibiotics were administered within 1 hour of skin incision, and doses were readministered based on the length of the procedure.
Postoperatively, said Dr. Davidson, “a set of insulin orders within the electronic medical record [was] used to maintain euglycemia in all diabetic patients.”
After the surgical dressing was removed on the 2nd postoperative day, patients were given a handout and education about wound control and infection prevention.
Finally, all patients received postdischarge follow-up calls from nurses within 72 hours after discharge.
Patient characteristics generally were similar before (n = 1,085) and after (n = 1,261) SSI bundle implementation. Body mass index was slightly higher in the postbundle group, and women in this group also were less likely to have had a prior cesarean delivery. There were no significant differences in age, gravidity, ethnicity, or race.
The study showed that with continued tracking, data-sharing, and reeducation efforts, “The SSI rate was sustained after bundle implementation,” said Dr. Davidson. The implementation team, working with hospital departments, was able to achieve a high compliance rate. And, she said, the effect size of the intervention was large enough to show significant reduction from an already low SSI rate.
However, Dr. Davidson also noted some limitations: All of the bundle elements were implemented simultaneously, so it wasn’t possible to tell which components had the greatest effect. Also, not all demographic data were available, and the type of SSI was sometimes unavailable from the deidentified data repository used for analysis, she said. “We weren’t able to tease out individual patient-level characteristics” about the timing and type of SSI in a patient-by-patient fashion, she said during discussion following her presentation.
All in all, she said, the bundle’s effectiveness “supports the synergistic effects of multiple strategies and the impact of a multidisciplinary team approach.”
The study authors reported no conflicts of interest.
SOURCE: Davidson C et al. Am J Obstet Gynecol. 2018 Jan;218:S46.
Correction, 3/5/18: An earlier version of this article omitted the word "rate" from the headline and Vitals section.
REPORTING FROM THE PREGNANCY MEETING
Key clinical point: The postcesarean surgical site infection rate dropped by more than half after a multicomponent care bundle was put in place.*
Major finding: SSIs patients went from 2.44 to 1.10/1,000 after the bundle was implemented (P = .013).
Study details: Case-control study of 1,085 women pre– and 1,261 women post–care bundle implementation.
Disclosures: The authors reported no conflicts of interest.
Source: Davidson C et al. Am J Obstet Gynecol. 2018 Jan;218:S46.
Can case management cut hypertension’s consequences?
MONTREAL – who received phone calls, care coordination, and coaching from a nurse case manager, according to a retrospective population-based cohort study of almost 85,000 patients with hypertension.
The reduction yielded a hazard ratio for all-cause mortality of 0.504, with a number needed to treat (NNT) of 25 (P less than .05).
Service utilization also decreased for those participating in the intervention, compared with those receiving usual care: Hospitalizations fell by 7 per 100 patient-years, with greater reductions seen in emergency department, specialist, and primary care utilization (P less than .05 for all).
At the time the study was conceived, the Hong Kong Hospital Authority cared for about 200,000 hypertensive patients, of whom more than 40% hadn’t achieved the target blood pressure of less than 140/90 mm Hg, said Dr. Yu.
Dr. Yu of the department of family medicine and primary care at the University of Hong Kong said there are challenges in bringing more hypertension patients into good blood pressure control in Hong Kong. These include the “idiosyncratic practice” of some frontline physicians, who also often have limited time for patient consultations and only limited access to the services of allied health professionals to help them in their work. Patient adherence, she said, is also an issue.
To tackle these persistent high rates of patients whose blood pressures remained too high, Dr. Yu and her colleagues at the Hospital Authority launched the Risk Assessment and Management Program – Hypertension (RAMP-HT) in 2011. The program, she said, is an “evidence-based, structured, protocol-driven, multidisciplinary program” that includes risk assessment and screening for complications, and uses a risk-guided management approach.
Patients in RAMP-HT received interventions according to a matrix for risk management of patients with hypertension. Patients with a blood pressure between 140/90 and 160/100 mm Hg who were assessed as being low and medium risk according to the Joint British Societies guidelines for cardiovascular risk continued to receive management from their primary care physician. High-risk patients with blood pressure in this range also received a statin if their low-density lipoprotein cholesterol level was suboptimal.
Patients whose blood pressure was at least 160/100 mm Hg were followed by a RAMP-HT nurse. For those with this degree of blood pressure elevation who were already on at least three antihypertensive medications, specialty appointments were also arranged.
Other targeted interventions were also available to participants, including the services of dietitians and physical therapists for those with a body mass index (BMI) of at least 27.5 kg/m2; smoking cessation and mental health services were also available, as appropriate.
After 3 years, those participating in the RAMP-HT program (n = 79,116) were compared with those in the usual care group (n = 43,901). In both arms, adult patients with complete data and without preexisting cardiovascular disease, diabetes, or end-stage renal disease were included. In each group, about 58% of participants were female, and the mean age was about 65 years.
Primary outcome measures included the incidence of cardiovascular disease, an outcome that included coronary heart disease, heart failure, and stroke; end-stage renal disease; and all-cause mortality. The significant reductions in these measures for the RAMP-HT group remained after multivariable analysis accounted for sex, age, smoking status, renal function, lipid values, BMI, comorbidities, and antihypertensive and lipid-lowering medication use.
The reduced care utilization seen among RAMP-HT participants also persisted after multivariable analysis for these potential confounders.
Dr. Yu said the systematic, protocol-driven program was a primary strength of RAMP-HT. The key to the program was use of nurses to provide patient education and physicians and allied health resources only as needed, she said; the program reinforced the importance of self-management and adherence because patients heard a unified message from many different health care professionals.
However, lifestyle factors such as diet and exercise weren’t tracked, and the retrospective study design introduced the potential for some bias, she said. In ongoing work, the long-term efficacy and cost-effectiveness of the RAMP-HT program are being tracked.
Dr. Yu reported that the study was funded by the Hong Kong Health and Medical Research Fund. She reported no relevant conflicts of interest.
SOURCE: Yu, Esther et al. NAPCRG 2017, Abstract HY33.
MONTREAL – who received phone calls, care coordination, and coaching from a nurse case manager, according to a retrospective population-based cohort study of almost 85,000 patients with hypertension.
The reduction yielded a hazard ratio for all-cause mortality of 0.504, with a number needed to treat (NNT) of 25 (P less than .05).
Service utilization also decreased for those participating in the intervention, compared with those receiving usual care: Hospitalizations fell by 7 per 100 patient-years, with greater reductions seen in emergency department, specialist, and primary care utilization (P less than .05 for all).
At the time the study was conceived, the Hong Kong Hospital Authority cared for about 200,000 hypertensive patients, of whom more than 40% hadn’t achieved the target blood pressure of less than 140/90 mm Hg, said Dr. Yu.
Dr. Yu of the department of family medicine and primary care at the University of Hong Kong said there are challenges in bringing more hypertension patients into good blood pressure control in Hong Kong. These include the “idiosyncratic practice” of some frontline physicians, who also often have limited time for patient consultations and only limited access to the services of allied health professionals to help them in their work. Patient adherence, she said, is also an issue.
To tackle these persistent high rates of patients whose blood pressures remained too high, Dr. Yu and her colleagues at the Hospital Authority launched the Risk Assessment and Management Program – Hypertension (RAMP-HT) in 2011. The program, she said, is an “evidence-based, structured, protocol-driven, multidisciplinary program” that includes risk assessment and screening for complications, and uses a risk-guided management approach.
Patients in RAMP-HT received interventions according to a matrix for risk management of patients with hypertension. Patients with a blood pressure between 140/90 and 160/100 mm Hg who were assessed as being low and medium risk according to the Joint British Societies guidelines for cardiovascular risk continued to receive management from their primary care physician. High-risk patients with blood pressure in this range also received a statin if their low-density lipoprotein cholesterol level was suboptimal.
Patients whose blood pressure was at least 160/100 mm Hg were followed by a RAMP-HT nurse. For those with this degree of blood pressure elevation who were already on at least three antihypertensive medications, specialty appointments were also arranged.
Other targeted interventions were also available to participants, including the services of dietitians and physical therapists for those with a body mass index (BMI) of at least 27.5 kg/m2; smoking cessation and mental health services were also available, as appropriate.
After 3 years, those participating in the RAMP-HT program (n = 79,116) were compared with those in the usual care group (n = 43,901). In both arms, adult patients with complete data and without preexisting cardiovascular disease, diabetes, or end-stage renal disease were included. In each group, about 58% of participants were female, and the mean age was about 65 years.
Primary outcome measures included the incidence of cardiovascular disease, an outcome that included coronary heart disease, heart failure, and stroke; end-stage renal disease; and all-cause mortality. The significant reductions in these measures for the RAMP-HT group remained after multivariable analysis accounted for sex, age, smoking status, renal function, lipid values, BMI, comorbidities, and antihypertensive and lipid-lowering medication use.
The reduced care utilization seen among RAMP-HT participants also persisted after multivariable analysis for these potential confounders.
Dr. Yu said the systematic, protocol-driven program was a primary strength of RAMP-HT. The key to the program was use of nurses to provide patient education and physicians and allied health resources only as needed, she said; the program reinforced the importance of self-management and adherence because patients heard a unified message from many different health care professionals.
However, lifestyle factors such as diet and exercise weren’t tracked, and the retrospective study design introduced the potential for some bias, she said. In ongoing work, the long-term efficacy and cost-effectiveness of the RAMP-HT program are being tracked.
Dr. Yu reported that the study was funded by the Hong Kong Health and Medical Research Fund. She reported no relevant conflicts of interest.
SOURCE: Yu, Esther et al. NAPCRG 2017, Abstract HY33.
MONTREAL – who received phone calls, care coordination, and coaching from a nurse case manager, according to a retrospective population-based cohort study of almost 85,000 patients with hypertension.
The reduction yielded a hazard ratio for all-cause mortality of 0.504, with a number needed to treat (NNT) of 25 (P less than .05).
Service utilization also decreased for those participating in the intervention, compared with those receiving usual care: Hospitalizations fell by 7 per 100 patient-years, with greater reductions seen in emergency department, specialist, and primary care utilization (P less than .05 for all).
At the time the study was conceived, the Hong Kong Hospital Authority cared for about 200,000 hypertensive patients, of whom more than 40% hadn’t achieved the target blood pressure of less than 140/90 mm Hg, said Dr. Yu.
Dr. Yu of the department of family medicine and primary care at the University of Hong Kong said there are challenges in bringing more hypertension patients into good blood pressure control in Hong Kong. These include the “idiosyncratic practice” of some frontline physicians, who also often have limited time for patient consultations and only limited access to the services of allied health professionals to help them in their work. Patient adherence, she said, is also an issue.
To tackle these persistent high rates of patients whose blood pressures remained too high, Dr. Yu and her colleagues at the Hospital Authority launched the Risk Assessment and Management Program – Hypertension (RAMP-HT) in 2011. The program, she said, is an “evidence-based, structured, protocol-driven, multidisciplinary program” that includes risk assessment and screening for complications, and uses a risk-guided management approach.
Patients in RAMP-HT received interventions according to a matrix for risk management of patients with hypertension. Patients with a blood pressure between 140/90 and 160/100 mm Hg who were assessed as being low and medium risk according to the Joint British Societies guidelines for cardiovascular risk continued to receive management from their primary care physician. High-risk patients with blood pressure in this range also received a statin if their low-density lipoprotein cholesterol level was suboptimal.
Patients whose blood pressure was at least 160/100 mm Hg were followed by a RAMP-HT nurse. For those with this degree of blood pressure elevation who were already on at least three antihypertensive medications, specialty appointments were also arranged.
Other targeted interventions were also available to participants, including the services of dietitians and physical therapists for those with a body mass index (BMI) of at least 27.5 kg/m2; smoking cessation and mental health services were also available, as appropriate.
After 3 years, those participating in the RAMP-HT program (n = 79,116) were compared with those in the usual care group (n = 43,901). In both arms, adult patients with complete data and without preexisting cardiovascular disease, diabetes, or end-stage renal disease were included. In each group, about 58% of participants were female, and the mean age was about 65 years.
Primary outcome measures included the incidence of cardiovascular disease, an outcome that included coronary heart disease, heart failure, and stroke; end-stage renal disease; and all-cause mortality. The significant reductions in these measures for the RAMP-HT group remained after multivariable analysis accounted for sex, age, smoking status, renal function, lipid values, BMI, comorbidities, and antihypertensive and lipid-lowering medication use.
The reduced care utilization seen among RAMP-HT participants also persisted after multivariable analysis for these potential confounders.
Dr. Yu said the systematic, protocol-driven program was a primary strength of RAMP-HT. The key to the program was use of nurses to provide patient education and physicians and allied health resources only as needed, she said; the program reinforced the importance of self-management and adherence because patients heard a unified message from many different health care professionals.
However, lifestyle factors such as diet and exercise weren’t tracked, and the retrospective study design introduced the potential for some bias, she said. In ongoing work, the long-term efficacy and cost-effectiveness of the RAMP-HT program are being tracked.
Dr. Yu reported that the study was funded by the Hong Kong Health and Medical Research Fund. She reported no relevant conflicts of interest.
SOURCE: Yu, Esther et al. NAPCRG 2017, Abstract HY33.
REPORTING FROM NAPCRG 2017
Key clinical point:
Major finding: The hazard ratio for all-cause mortality was 0.504 for patients in the intervention arm.
Study details: A retrospective population-based cohort study of almost 85,000 Hong Kong patients with hypertension.
Disclosures: The study was funded by the Hong Kong Health and Medical Research Fund. Dr. Yu reported no relevant financial disclosures.
Source: Yu E et al. NAPCRG 2017, Abstract HY33.