Biosimilar Compared With Originator Filgrastim For Related-Donor Allogeneic Stem Cell Mobilisation: A Prospective-Historical Control Study

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 5512-5512 ◽  
Author(s):  
Francois Lefrère ◽  
Jean-Antoine Ribeil ◽  
Matthew Turner ◽  
Olivier Hermine ◽  
Stephane Blanche ◽  
...  
Keyword(s):  
Body Weight ◽  
Stem Cell ◽  
Historical Control Group ◽  
Historical Control ◽  
Control Group ◽  
Platelet Recovery ◽  
Cell Counts ◽  
Stem Cell Mobilisation ◽  
Related Donor ◽  
Biosimilar Filgrastim

Abstract Introduction Biosimilars of filgrastim have been available for over five years In Europe, where their use now exceeds that of the originator product. However, some professional bodies have raised concerns over their use in healthy donors for allogeneic mobilisation given the absence of clinical data in this setting. Here we report the use of biosimilar filgrastim compared with a matched historical control group in allogeneic transplant. Methods A total of 26 healthy related-donors (parent or sibling) received biosimilar filgrastim (HX575) for allogeneic stem cell mobilisation at a single centre between 2011 and 2013. Donors and recipients were compared with a matched historical control group (n=48) who had been treated with original filgrastim (Neupogen) at the same centre between 2005 and 2011. Donors and patients in both groups were treated according to the same clinical protocol, with G-CSF 10 µg/kg/day administered to donors on days 1-5 with leukapheresis performed on day 5. Results Donor and recipient characteristics (age, gender, body weight) were similar in both groups. Both the biosimilar and originator groups had similar donor mean white blood cell counts at baseline (6.13 vs 6.24 x 109/l) and on day 5 (46.9 vs 45.3 x 109/l). Mean donor CD34+ cell count on day 5 was 92/µl in the biosimilar group and 88/µl in the originator group (p=0.713). Mean number of CD34+ cells per recipient body weight was 9.7 x 106 in the biosimilar group and 8.00 x 106 in the originator group (p=0.437). Occurrence and intensity of bone pain was similar in donors in both groups. The majority of recipients in both groups had acute leukemia, myeloma, lymphoma or congenital immunodeficiency syndrome and around half underwent a non-myeloablative transplant. Median time to neutrophil engraftment (>500/µl) was similar in both the biosimilar and originator groups (16.5 [range 11-44] vs 15.0 [range 9-23] days; p=0.078), as was platelet recovery (>20 g/l) (12.5 [range 8-28] vs 12.5 [range 3-38] days; p=0.990). Acute graft-versus-host disease (GVHD) occurred in 27% of patients in the biosimilar group and 38% patients in the original group, while chronic GVHD occurred in 15% and 19% of recipients, respectively. Conclusions Biosimilar G-CSF is as effective and well tolerated as originator G-CSF for related-donor allogeneic stem cell mobilisation. Long-term follow-up of donors is required to confirm the safety of biosimilar and originator G-CSF. Disclosures: Lefrère: Sandoz Biopharmaceuticals: Consultancy, Honoraria. Turner:Sandoz Biopharmaceuticals: Employment.

Comparison of Outcomes of Advanced Myelofibrosis Patients Treated with Ruxolitinib (INCB018424) to Those of a Historical Control Group: Survival Advantage of Ruxolitinib Therapy

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 793-793 ◽  
Author(s):  
Srdan Verstovsek ◽  
Hagop M. Kantarjian ◽  
Zeev Estrov ◽  
Jorge E. Cortes ◽  
Deborah A. Thomas ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
High Risk ◽  
Phase I ◽  
Historical Control Group ◽  
Historical Control ◽  
Control Group ◽  
Spleen Size ◽  
Cell Counts ◽  
Significant Factors

Abstract Abstract 793FN2 Background: Myelofibrosis (MF) is a myeloproliferative neoplasm associated with splenomegaly, debilitating symptoms, cytopenias and progressive bone marrow fibrosis that leads to early death. Patients (pts) with high-risk MF according to International Prognosis Scoring System (IPSS) have particularly poor outcome with a median survival of 2 years (yrs). No approved or effective therapy exists. Ruxolitinib is a JAK1 and JAK2 inhibitor with established clinical benefit in the treatment of pts with MF by reducing spleen size and improving quality of life. Objective: The objective of this analysis was to compare assorted outcomes of MF pts receiving ruxolitinib to those of a matched historical control group. Methods: Overall survival (OS) of 107 pts enrolled in a Phase I/II trial (INCB18424-251; NCT00509899) and followed at the MD Anderson Cancer Center (MDACC) was compared to that of 310 pts with MF identified in 3 large databases (MDACC, U. of Pavia and Hospital Niguarda cà Granda, Milano) with characteristics that would have allowed them to enroll in INCB18424-251. Thus, the pt features between the 2 groups were matched based on enrollment criteria. Among 107 ruxolitinib treated pts, 63 had high risk, 34 intermediate (int)-2 and 10 int-1 risk according to IPSS. In the control group (n=310), 165 pts had high and 145 pts int-2 risk; most pts were treated with conventional or investigational therapies during follow-up. Results: Ruxolitinib-treated pts had a median age of 66 yrs, hemoglobin (Hb) of 10.2 g/dL, WBC of 19×10^9/L, platelets of 277×10^9/L, and palpable spleen of 19 cm. Control pts had a median age of 70 yrs, Hb of 9.7 g/dL, WBC of 12×10^9/L, platelets of 265×10^9/L, and palpable spleen of 6 cm. Baseline characteristics that differed between 2 groups included: significantly more int-2 vs high-risk pts (according to both IPSS and dynamic IPSS [DIPSS]), older age and lower Hb in the controls, as contrasted to higher WBC and larger spleen in those on ruxolitinib. There were no differences between the groups with regard to male:female ratio, platelet count, and cytogenetic characteristics. With regard to OS comparison between the 2 groups, a significant difference was seen in favor of ruxolitinib (p=0.022). Indeed, 33 of 107 pts (30.8%) in the ruxolitinib group vs. 189 of 310 (60.9%) in the control group died, after a median follow-up of 32 and 22 months, respectively. The difference in OS was highly significant in the high-risk pt subgroup (p=0.006), in that 21/63 (33.3%) vs. 112/165 (67.9%) died in the ruxolitinib and control groups, respectively. In the univariate analysis, significant factors associated with longer OS were int-2 (vs. high) risk (per IPSS/ DIPSS), platelets >400×10^9/L, and age <65 years, but not gender, abnormal cytogenetics, high WBC (>25×10^9/L), anemia (Hb <10g/dL), or spleen size. In the multivariate analysis, using age and blood cell counts as continuous variables, independent significant factors for better survival were IPSS int-2 risk, younger age, higher platelets, and treatment with ruxolitinib (p=0.02; HR=0.63). Conclusions: We have identified a historical control group of pts with clinical characteristics that would have allowed them to participate in the Phase I/II study of ruxolitinib in MF. We compared their survival to 107 pts who participated in that trial, and were followed at the MDACC. The survival of pts with high-risk MF that were treated with ruxolitinib was found to be significantly longer than that of the matched control group. Further, ruxolitinib therapy was identified as an independent factor influencing better survival in the multivariate analysis. Our data suggest the potential of ruxolitinib to change the natural progression of MF pts with advanced disease. Disclosures: Verstovsek: Incyte Corporation: Research Funding.

Use Of Biosimilar G-CSF Compared With Lenograstim In Autologous Haematopoietic Stem Cell Transplant and In Sibling Allogeneic Transplant

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2170-2170 ◽  
Author(s):  
Shab Uddin ◽  
Pippa Russell ◽  
Maresa Farrell ◽  
Barbara Davy ◽  
Samir G. Agrawal
Keyword(s):  
Stem Cell ◽  
Stem Cell Transplant ◽  
Haematopoietic Stem Cell Transplant ◽  
Haematopoietic Stem Cell ◽  
Cell Transplant ◽  
Allogeneic Transplant ◽  
Platelet Recovery ◽  
Stem Cell Mobilisation ◽  
Biosimilar Filgrastim ◽  
Autologous Hsct

Abstract Introduction Biosimilar filgrastim is now widely used for haematopoietic stem cell mobilisation in Europe. Previous studies have reported differences in mobilisation efficacy between originator filgrastim and lenograstim, although others have reported comparable efficacy. This is the first study to compare biosimilar filgrastim with lenograstim for autologous haematopoietic stem cell transplant (HSCT). We also report our use of biosimilar filgrastim for mobilisation in sibling allogeneic transplant, for which there is limited previous data. Methods Data from patients with lymphoma or multiple myeloma (MM) who underwent autologous HSCT mobilised with biosimilar filgrastim (HX575) between October 2011 and April 2013 at St Bartholomew's Hospital, London, were compared with a historical control group of patients who underwent HCST using a similar mobilisation protocol with lenograstim from January 2009 to September 2011. Peripheral blood (PB) cells counts (white blood cell [WBC] and CD34+ cells) were monitored after 7–8 consecutive days of G-CSF injection (approximately 5 μg/kg) and apheresis was performed on day 8 if PB CD34+ cell count was ≥10 cells/µl. G-CSF administration and apheresis were then performed daily until a PB CD34+ cell dose of ≥2.0 x106/kg (lymphoma), ≥ 4.0 x106/kg (MM ≥60 years old) or ≥ 8.0 x106/kg (MM <60 years old) was achieved. Data from a separate group of sibling donors and recipients with haematological malignancies who underwent allogeneic HSCT between October 2010 and April 2013 are also reported. Results A total of 259 patients were included in the autologous HSCT comparison (biosimilar filgrastim, n=104; lenograstim, n=155). Both groups had similar characteristics (overall, 66% male, median age 56 years) although the biosimilar group had a lower percentage of patients with lymphoma (19% vs 35%). In patients with lymphoma and older MM patients (≥60 years old), no significant differences were observed between groups with regard to stem cell mobilisation parameters. However, in MM patients <60 years old, all parameters were significantly superior in the biosimilar filgrastim group compared with lenograstim, including the need for one rather the two aphereses (Table 1). Among patients who proceeded to transplant, no significant differences were observed between biosimilar filgrastim and lenograstim in median number of days to ANC recovery > 0.5 x109/l (lymphoma: 13 [9, 35] vs 13 days [9, 36]; MM: 14 [9, 34] vs 12 [10, 33] days) or platelet recovery > 20 x109/l (lymphoma: 21 [9, 35] vs 23 days [10, 35]; MM: 19 [9, 38] vs 18 [9, 39] days). In the allogeneic setting, 48 sibling donors received biosimilar filgrastim. Mean CD34+ count at the first apheresis was 6.1 x 106/kg. Thirteen donors needed a second apheresis, four of whom required a third. Among the recipients, median days to ANC recovery was 16 (10–28) and to platelet recovery was 13 (9–54). Conclusions Biosimilar filgrastim is as effective as lenograstim for autologous HSCT in patients with lymphoma or MM patients ≥60 years old. However, mobilisation with biosimilar filgrastim appeared to be superior to that with lenograstim in younger MM patients. Biosimilar filgrastim was also successfully used to mobilise sibling donors for allogeneic transplantation. Disclosures: Agrawal: Sandoz Biopharmaceuticals: Consultancy, Honoraria, Research Funding.

scholarly journals Biosimilar Compared with Originator Filgrastim for Autologous Stems CELL Mobilisation: A Prospective-Historical Control Study in Multiple Myeloma REAL-Life Setting

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 5825-5825
Author(s):  
Massimo Martino ◽  
Tiziana Moscato ◽  
Iolanda Donatella Vincelli ◽  
Francesca Ronco ◽  
Roberta Fedele ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Peripheral Blood ◽  
Real Life ◽  
Historical Control ◽  
Control Group ◽  
Published Data ◽  
Platelet Recovery ◽  
Real Life Setting ◽  
Cd34 Cells ◽  
Biosimilar Filgrastim

Abstract Introduction:Biosimilars of filgrastim have been available since 2008 and are now in widespread use also for stem cells (SCs) mobilization. There are no previously published data on the use of biosimilar G-CSF for peripheral blood (PB) SCs collection only in patients with Multiple Myeloma (MM) as they always had been presented aggregated with other different hematological malignancies. Here we report the use of a biosimilar filgrastim (Zarzio®) compared with a matched historical control group in PBSCs in patients with de-novo MM treated with reference product (Neupogen®) and scheduled to receive a double autologous transplantation. Material and Methods: A total of 26 consecutive patients received biosimilar filgrastim after cyclophosphamide (CTX) 4g/m2 chemotherapy for PBSCs mobilization between January and July 2014, this group was compared with a matched historical control cohort (n=26) who had been treated with originator filgrastim between 2012 and 2013. In both groups G-CSF was administered 5 μg/kg/day until almost a minimal count of 4 x106 CD34+ cells/kg was collect. Monitoring of peripheral blood CD34+ cell concentrations began as soon as WBC recovery reached 1x109/L and leukapheresis was initiated when the CD34+cell concentration reached 10/mL. Results: Characteristics (age, gender, body weight, type of induction CHT, radiation therapy) were similar in both groups. The median peak CD34+ cells value was 187.8 ± 159.5 x ml in the biosimilar group compared with 223.7 ± 206.5 x ml in the originator group (P=n.s.). The median number of leukapheresis necessary to harvest a minimal count of 4 and 8 x10E6 CD34+/kg was similar in both biosimilar and originator groups: 1.4 ± 0.6 vs 1.3 ± 0.6 (P=n.s.) and 1.8 ± 0.8 vs 1.4 ± 0.7 (P=n.s), respectively. One and 3 patients failed to mobilize 4 and 8 x 10 E /kg CD34+ cells in the biosimilar group compared with 3 and 8 patients in the originator group (P=n.s), respectively). Short-term hematological reconstitution was evaluated for all transplanted patients. Number of CD34+ cells reinfused at the first transplant were 4.8 ± 0.75x10E6/Kg in the biosimilar group compared with 5.1 ± 0.75x10E6/Kg in the originator group (P=n.s.). Median time to neutrophil engraftment (>500/μl) was similar in both the biosimilar and originator groups (10.7 ± 0.8 vs 10.3 ± 1.1 days; P=n.s), as was platelet recovery (13.6 ± 1.8 vs13.4 ± 1.2 days; P=n.s. Conclusions:Our study shows that biosimilar filgrastim administered following chemotherapy is equivalent to originator filgrastim for autologous stem cell mobilization and PBSCs collection when used with the same schedules and doses in a MM real life setting. Long-term follow-up is required to confirm the safety of biosimilar and originator G-CSF. Disclosures No relevant conflicts of interest to declare.

Impact of a pharmacy team–led intervention program on the readmission rate of elderly patients with heart failure

2018 ◽  
Vol 75 (4) ◽  
pp. 183-190 ◽  
Author(s):  
Pamela M. Moye ◽  
Pui Shan Chu ◽  
Teresa Pounds ◽  
Maria Miller Thurston
Keyword(s):  
Heart Failure ◽  
Older Patients ◽  
Readmission Rate ◽  
Academic Medical Center ◽  
Hospital Readmissions ◽  
Intervention Group ◽  
Historical Control Group ◽  
Historical Control ◽  
Control Group ◽  
Patients With Heart Failure

Purpose The results of a study to determine whether pharmacy team–led postdischarge intervention can reduce the rate of 30-day hospital readmissions in older patients with heart failure (HF) are reported. Methods A retrospective chart review was performed to identify patients 60 years of age or older who were admitted to an academic medical center with a primary diagnosis of HF during the period March 2013–June 2014 and received standard postdischarge follow-up care provided by physicians, nurses, and case managers. The rate of 30-day readmissions in that historical control group was compared with the readmission rate in a group of older patients with HF who were admitted to the hospital during a 15-month intervention period (July 2014–October 2015); in addition to usual postdischarge care, these patients received medication reconciliation and counseling from a team of pharmacists, pharmacy residents, and pharmacy students. Results Twelve of 97 patients in the intervention group (12%) and 20 of 80 patients in the control group (25%) were readmitted to the hospital within 30 days of discharge (p = 0.03); 11 patients in the control group (55%) and 7 patients in the intervention group (58%) had HF-related readmissions (p = 0.85). Conclusion In a population of older patients with HF, the rate of 30-day all-cause readmissions in a group of patients targeted for a pharmacy team–led postdischarge intervention was significantly lower than the all-cause readmission rate in a historical control group.

The use of PAMG-1 testing in patients with preterm labor, intact membranes and a short sonographic cervix reduces the rate of unnecessary antenatal glucocorticoid administration

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Sven Kehl ◽  
Christel Weiss ◽  
Jutta Pretscher ◽  
Friederike Baier ◽  
Florian Faschingbauer ◽  
...  
Keyword(s):  
Neonatal Intensive Care ◽  
Cervical Length ◽  
Historical Control Group ◽  
Historical Control ◽  
Control Group ◽  
Sonographic Examination ◽  
Gestational Age At Delivery ◽  
Biomarker Testing ◽  
Nicu Admission ◽  
Time To Delivery

Abstract Objectives To assess the frequency of antenatal corticosteroid (ACS) administration in cases with shortened cervical length by addition of placental alpha-microglobulin-1 (PAMG-1) testing to sonographic examination. Methods Single centre retrospective cohort study. Rate of ACS administration was compared between cases with cervical length between 15 and 25 mm and cases with positive PAMG-1 testing and cervical length between 15 and 25 mm. We evaluated the following outcome parameters: Rate of ACS administration, gestational age at delivery, time to delivery, delivery within seven days, delivery <34 and <37 weeks’ gestation, rate of admission to neonatal intensive care unit (NICU). Results In total, 130 cases were included. “PAMG-1 group” consisted of 68 women, 62 cases built the “historical control group”. ACS administration was performed less frequently in the “PAMG-1 cohort” (18 (26%) vs. 46 (74%); p<0.001). The rate of delivery within seven days did not differ (2 (3%) vs. 4 (6.5%); p=0.4239). The rates of delivery <34 weeks’ gestation (7 (10%) vs. 9 (15%); p=0.4643) and <37 weeks’ gestation (19 (28%) vs. 26 (42%); p=0.0939) did not differ. Time to delivery interval was longer in the PAMG-1 group (61.5 vs. 43 days, p=0.0117). NICU admission occurred more often in the “historical control group” (22 (38%) vs. 28 (60%); p=0.0272). Conclusions Addition of biomarker testing can help to avoid unnecessary ACS administrations in women with shortened cervical length.

scholarly journals Financial Incentives to Increase Stool Collection Rates for Microbiome Studies in Adult Bone Marrow Transplant Patients

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5775-5775
Author(s):  
Jillian C. Thompson ◽  
Yi Ren ◽  
Kristi M. Romero ◽  
Meagan V. Lew ◽  
Amy T. Bush ◽  
...  
Keyword(s):  
Financial Incentives ◽  
Research Funding ◽  
Intervention Group ◽  
Outpatient Setting ◽  
Historical Control Group ◽  
Historical Control ◽  
Categorical Variables ◽  
Control Group ◽  
Continuous Variables ◽  
Stool Samples

Introduction: Dysbiosis of the gut microbiome during hematopoietic stem cell transplantation (HCT) is associated with adverse post-transplant outcomes such as graft-versus-host disease, bloodstream infections, and mortality. In order to learn more about the role of the microbiome in HCT in adverse clinical outcomes, researchers collect stool samples from patients at various time points throughout HCT. However, unlike blood samples or skin swabs, stool collection requires active subject participation, particularly in the outpatient setting, and may be limited by patient aversion to handling stool. By providing study participants with compensation for their stool samples, we hypothesize that we can significantly increase stool collection rates. Methods: We performed a prospective cohort study on the impact of financial incentives on stool collection rates for microbiome studies. The intervention group consisted of allogeneic (allo)-HCT patients from 05/2017-05/2018 who were compensated with a $10 gas gift card for each stool sample. The intervention group was compared to a historical control group consisting of allo-HCT patients from 11/2016-05/2017 who provided stool samples before the incentive was implemented. To control for potential changes in collections over time, we also compared a contemporaneous control group of autologous (auto)-HCT patients from 05/2017-05/2018 with a historical control group of auto-HCT patients from 11/2016-05/2017; neither auto-HCT groups were compensated. Allo-HCT patients were required to give samples at pre-HCT, day 0 (the day of HCT), and days 7, 14, 21, 30, 60, and 90 post-HCT. Auto-HCT patients were required to give samples at pre-HCT and days 7, 14, and 90 post-HCT. Collection rates were defined as the number of samples provided divided by the number of time points for which we attempted to obtain samples. Patient characteristics were summarized by proportions for categorical variables and median with interquartile ranges for continuous variables. Chi-square tests or Fisher's exact tests were used to compare categorical variables, as appropriate, and Wilcoxon Rank Sum tests or t-tests were used to compare continuous variables, as appropriate. This study was approved by the Duke Institutional Review Board, and informed consent was obtained from all patients. Results: There were 35 allo-HCT patients in the intervention group, 19 allo-HCT patients in the historical control group, 142 auto-HCT patients in the contemporaneous control group, and 75 auto-HCT patients in the historical control group. Groups were similar with regard to baseline demographics such as age, race, and gender. While allo-HCT patients were more likely to have leukemia and auto-HCT patients were more likely to have lymphoma and multiple myeloma, there were no differences in disease rates across the study periods. Allo-HCT patients in the intervention group had significantly higher average overall collection rates when compared to the historical control group allo-HCT patients (80% vs 37%, p<0.001), as well has significantly higher average outpatient collection rates (84% vs 23%, p<0.001) and average inpatient collection rates (71% vs 46%, p=0.04). In contrast, there were no significant differences in overall average collection rates between the auto-HCT patients in the contemporaneous control and historical control group (36% vs 32%, p=0.28), as well as the average outpatient collection rates (30% vs 28%, p=0.54) and the average inpatient collection rates (46% vs 59%, p=0.25). Discussion: Our results demonstrate that even a modest incentive can significantly increase collection rates. Use of a contemporaneous control group to account for potential differences in stool collection rates over time strengthens our finding that financial incentives increase stool collection rates. Furthermore, the significant increase in collection rates in the outpatient setting highlights the role of the incentive when patient participation is needed, as opposed to the inpatient setting in which the nurse assists with collection. While this study uses a specialized HCT patient population, these results may be generalizable to future studies and aid other researchers in obtaining stool samples needed for future microbiome studies. Disclosures Peled: Seres Therapeutics: Other: IP licensing fees, Research Funding. van den Brink:Acute Leukemia Forum (ALF): Consultancy, Honoraria; Juno Therapeutics: Other: Licensing; Merck & Co, Inc.: Consultancy, Honoraria; Seres Therapeutics: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Therakos: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Flagship Ventures: Consultancy, Honoraria; Evelo: Consultancy, Honoraria; Jazz Pharmaceuticals: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Magenta and DKMS Medical Council: Membership on an entity's Board of Directors or advisory committees. Sung:Novartis: Research Funding; Merck: Research Funding; Seres: Research Funding.

scholarly journals The effect of requesting a reason for non-adherence to a guideline in a long running automated reminder system for PONV prophylaxis

2017 ◽  
Vol 26 (01) ◽  
pp. 313-321 ◽  
Author(s):  
Fabian O. Kooij ◽  
Toni Klok ◽  
Benedikt Preckel ◽  
Markus W. Hollmann ◽  
Jasper E. Kal
Keyword(s):  
Decision Support ◽  
Support System ◽  
Guideline Adherence ◽  
Postoperative Nausea And Vomiting ◽  
Study Groups ◽  
Historical Control Group ◽  
Historical Control ◽  
Control Group ◽  
Reminder System ◽  
Screening Clinic

SummaryBackground: Automated reminders are employed frequently to improve guideline adherence, but limitations of automated reminders are becoming more apparent. We studied the reasons for non-adherence in the setting of automated reminders to test the hypothesis that a separate request for a reason in itself may further improve guideline adherence.Methods: In a previously implemented automated reminder system on prophylaxis for postoperative nausea and vomiting (PONV), we included additional automated reminders requesting a reason for non-adherence. We recorded these reasons in the pre-operative screening clinic, the OR and the PACU. We compared adherence to our PONV guideline in two study groups with a historical control group.Results: Guideline adherence on prescribing and administering PONV prophylaxis (dexamethasone and granisetron) all improved compared to the historical control group (89 vs. 82% (p< 0.0001), 96 vs 95% (not significant) and 90 vs 82% (p<0.0001)) while decreasing unwarranted prescription for PONV prophylaxis (10 vs. 13 %). In the pre-operative screening clinic, the main reason for not prescribing PONV prophylaxis was disagreement with the risk estimate by the decision support system. In the OR/PACU, the main reasons for not administering PONV prophylaxis were: ‘unintended non-adherence’ and ‘failure to document’.Conclusions: In this study requesting a reason for non-adherence is associated with improved guideline adherence. The effect seems to depend on the underlying reason for non-adherence. It also illustrates the importance of human factors principles in the design of decision support. Some reasons for non-adherence may not be influenced by automated reminders.

A comparison of randomized concurrent control groups with matched historical control groups: are historical controls valid?

1986 ◽  
Vol 4 (7) ◽  
pp. 1114-1120 ◽  
Author(s):  
L F Diehl ◽  
D J Perry
Keyword(s):  
Historical Control Group ◽  
Historical Control ◽  
Disease Stage ◽  
Control Group ◽  
Control Groups ◽  
Relapse Free Survival ◽  
Free Survival ◽  
Concurrent Control ◽  
Percentage Points ◽  
Concurrent Control Group

The use of a historical control group is predicated on the assumption that survival and relapse-free survival in the historical control group closely approximate the survival and relapse-free survival in a randomized concurrent control group. This assumption has never been tested. This study compares survival and relapse-free survival in randomized control groups with historical control groups matched for disease, stage, and follow-up. Of the 43 matched control groups, 42% varied by more than 10 percentage points, 21% varied by more than 20 percentage points, and 5% varied by more than 30 percentage points. Of the 18 that varied by greater than 10 percentage points, 17 had superior survival or relapse-free survival in the randomized concurrent control group. This study indicates that the assumption that historical control groups may replace randomized concurrent control groups is not valid.

Heparin-induced thrombocytopenia with thromboembolic complications: meta-analysis of 2 prospective trials to assess the value of parenteral treatment with lepirudin and its therapeutic aPTT range

Blood ◽  
2000 ◽  
Vol 96 (3) ◽  
pp. 846-851 ◽  
Author(s):  
Andreas Greinacher ◽  
Petra Eichler ◽  
Norbert Lubenow ◽  
Harald Kwasny ◽  
Matthias Luz
Keyword(s):  
Meta Analysis ◽  
Bleeding Risk ◽  
Thromboembolic Complication ◽  
Historical Control Group ◽  
Historical Control ◽  
Limb Amputation ◽  
Rank Test ◽  
Control Group ◽  
Bleeding Events ◽  
Heparin Induced Thrombocytopenia

This meta-analysis focuses on 2 prospective studies in patients with heparin-induced thrombocytopenia (HIT) and thromboembolic complication (TEC) who were treated with lepirudin (n = 113). Data were compared with those of a historical control group (n = 91). The primary endpoint (combined incidence of death, new TEC, and limb amputation) occurred in 25 lepirudin-treated patients (22.1%; 95% CI, 14.5%-29.8%): 11 died (9.7%; 95% CI, 4.9%-16.8%), 7 underwent limb amputation (6.2%; 95% CI, 2.5%-12.3%), and 12 experienced new TEC (10.6%; 95% CI, 5.8%-18.3%). The risk was highest in the period between diagnosis of HIT and the start of lepirudin therapy (combined event rate per patient day 6.1%). It markedly decreased to 1.3% during lepirudin treatment and to 0.7% in the posttreatment period. From the start of lepirudin therapy to the end of follow-up, lepirudin-treated patients had consistently lower incidences of the combined endpoint than the historical control group (P = .004, log-rank test), primarily because of a reduced risk for new TEC (P = .005). Thrombin–antithrombin levels in the pretreatment period (median, 43.9 μg/L) decreased after the initiation of lepirudin (at 24 hours ± 6 hours; median, 9.18 μg/L.) During treatment with lepirudin, aPTT ratios of 1.5 to 2.5 produced optimal clinical efficacy with a moderate risk for bleeding, aPTT ratios lower than 1.5 were subtherapeutic, and aPTT levels greater than 2.5 were associated with high bleeding risk. Bleeding events requiring transfusion were significantly more frequent in patients taking lepirudin than in historical control patients (P = .02). In conclusion, this meta-analysis provides further evidence that lepirudin is an effective and acceptably safe treatment for patients with HIT.

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