scholarly journals PIH57 KNOWLEDEGES AND EXPERIENCES OF PREGNANT WOMEN ON PRENATAL CARE PROGRAMS OF A SUBSIDIZED HEALTH CARE COMPANY FROM THE CARIBBEAN REGION OF COLOMBIA: A QUALITATIVE ANALYSIS

2019 ◽  
Vol 22 ◽  
pp. S192
Author(s):  
L. Moyano Tamara ◽  
N. Alvis Zakzuk ◽  
L. Bustamante ◽  
M. Jerez Arias ◽  
J. Alvis Zakzuk ◽  
...  
Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 36-37
Author(s):  
Henry Chan ◽  
Alana Cavadino ◽  
Clinton Lewis

Background: Acute myeloid leukaemia (AML) is a blood cancer characterised by the expansion of a malignant myeloid progenitor. The estimated age-standardised incidence rate in many western countries has remained static over the last 2 decades at 3-4 per 100,000, whilst long-term survival has improved, especially for the younger individuals. However, disparities remain for the older individuals, people of ethnic minority background, and those who are more socio-economically deprived. Previous evaluation of population data from New Zealand has shown a similar pattern, but a more recent analysis has not been done. Here we present the incidence and long-term survival of patients with AML in New Zealand (NZ), using the New Zealand Cancer Registry (NZCR). Method: The NZCR was established in 1948 and it became mandatory by law to report all new cases of malignancy by 1994. We extracted all AML cases from the registry between 1 January 1997 and 31 December 2016. Cases with an ICD-10-CM code for acute myeloid leukaemia and its subtypes including acute promyelocytic leukaemia (e.g. C92.0) were included. Individuals residing overseas or without an address were excluded, and individuals with a diagnosis of acute promyelocytic leukaemia (APML) were analyzed separately. The socio-economic status of the individual was estimated based on their domicile area using the New Zealand 2013 Index of Deprivation (NZDep2013) which is a geographically based composite measure of deprivation. Overall survival was calculated from the date of diagnosis to the date of death or last follow-up (31 December 2016). Multivariable Cox-proportional hazard models were used to evaluate potential associations with survival time in NZ AML cases. Results: During this 20-year period, 154 cases of APML and 2876 cases of AML (excluding APML) were reported to the registry on individuals residing in New Zealand. Of the AML cases, 53% were male and the median age at the time of diagnosis was 67 (IQR 52-77), with a small positive correlation between year of diagnosis and age at diagnosis (Spearman's rho=0.05, p=0.009). The majority of cases (77%) were of European descent, 12% were New Zealand Maori, and 6% were Pacific Islanders. Individuals of European descent were significantly older at diagnosis compared to other ethnicities (median of 70 vs 51 for Maori, 56 for Pacific Islanders, and 58 for all other ethnicities, p<0.001). AML appeared to disproportionally affect those more socio-economically deprived, with 23% of cases reported in the most deprived 20% of the population, compared with only 16% of the cases in the least deprived 20%. The annual crude incidence remained stable during this period at an average of 3.42 per 100,000 (ranging from 2.57 to 4.29, figure 1), and was significantly higher in the older adults (figure 2). Age-standardised rates were lower (figure 1), with an average of 2.6 (range 1.9 to 3.4) cases per 100,000, and a small but significant average annual decrease over the study period. The estimated 1, 2, and 5-year survival for the entire cohort was 38%, 27%, and 22%, respectively. Age at diagnosis was a significant predictor of inferior survival, with a hazard ratio (HR) for all-cause mortality of 2.06, 3.95, 6.39 and 10.84 for the 50-59, 60-69, 70-79 and >80 age groups, respectively, compared to those aged <50. Shorter overall survival was also noted in individuals in the more socio-economically deprived 50% of the population (HR 1.13, 95% CI 1.03-1.23). Conclusion The incidence of AML in New Zealand has remained static in the last 2 decades, consistent with data from other western countries. Lower age-standardised rates and the small decrease in these observed over the study period are likely to reflect the increasingly and comparatively older population in NZ. Maori and Pacific Islanders appeared to present at a younger age than individuals of European descent. Age at diagnosis and socio-economic deprivation were shown to be an adverse prognostic factor for overall survival. Further in-depth analysis is required to determine the cause of these observations at a population level. Disclosures Chan: AbbVie:Membership on an entity's Board of Directors or advisory committees;Janssen:Membership on an entity's Board of Directors or advisory committees, Other: TRAVEL, ACCOMODATIONS, EXPENSES (paid by any for-profit health care company), Research Funding, Speakers Bureau;Celgene:Other: TRAVEL, ACCOMODATIONS, EXPENSES (paid by any for-profit health care company);Amgen:Other: TRAVEL, ACCOMODATIONS, EXPENSES (paid by any for-profit health care company);Roche:Other: TRAVEL, ACCOMODATIONS, EXPENSES (paid by any for-profit health care company).


Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 25-25
Author(s):  
Sebastian Grosicki ◽  
Genadi Iosava ◽  
Mamia Zodelava ◽  
Nikolay Tzvetkov ◽  
Tadeusz Robak ◽  
...  

Introduction: Despite high response rates to initial treatment, relapse is common in CLL. Although newer agents are approved for treatment recently, CLL remains an incurable disease. Tenalisib (RP6530) is a highly specific and orally available PI3K δ/γ+SIK3 inhibitor. In in-vitro studies, Tenalisib was highly effective (62nM) in demonstrating a cytotoxic effect in patient derived CLL cells and showed very good synergism in combination with fludarabine and ibrutinib at very low concentrations in patient derived primary CLL cells. Tenalisib has demonstrated good clinical activity in patients with T cell lymphomas. Previously, a pooled safety analysis of 93 patients treated with tenalisib monotherapy demonstrated a differentiated safety profile which is largely devoid of immune mediated toxicities (Iyer, ASH 2018). Methods: This trial is a Phase II, open label, multi-center, Simon's two stage study design to evaluate the efficacy and safety of Tenalisib in patients with CLL who have relapsed or are refractory after at least one prior therapy. In stage 1, 20 patients were to be enrolled and an additional 41 patients to be enrolled in stage 2 based efficacy results of stage 1 (>8 responders needed to proceed to stage 2). Patients with previously treated CLL with adequate bone marrow, liver, and renal function, ECOG ≤2, and measurable disease are eligible. Patients with prior exposure to drug that specifically inhibits PI3K were excluded. The primary objective was to assess the anti-tumor activity. The secondary objectives were to assess safety and tolerability, and progression free survival (PFS). The responses were assessed using iwCLL criteria (Hallek 2018). Results: A total of 21 CLL patients predominantly male (86%) with median age was 66 years (range 44-79) were enrolled between Dec 2019 and March 2020 in Stage 1 of the study. 67% of patients had an ECOG score of 1, and 43% had Rai Stage III/IV disease with 67% having spleno/hepatomegaly. Patients had a median of 2 (range: 1-3) prior treatment regimens and 16 (76%) were refractory to last therapy. High risk patients included 15% del 17p, 10% del 11q, 5% ZAP and 5% TP53 mutations. In all 21 evaluable pts with a median follow-up of 4.9 months, 7 patients showed partial response (33%) while the remaining 14 patients showed stable disease (67%). 19 patients (90%) were still continuing therapy while 2 patients discontinued due to disease progression after showing a stable response. There was a median reduction in nodal disease to the extent of 54% in responding patients. The data readouts at C8D1 for all patients is currently awaited. The most common AEs which were mild-moderate in severity included transaminitis (19%), GGT elevation (5%) and neutropenia (5%). There was a related Grade 3 AE of neutropenia (5%). None of the related AEs led to study discontinuation. There were no events of diarrhoea/colitis or pneumonitis in patients who were on therapy for more than 6 months. Conclusions: Tenalisib showed promising single agent anti-tumor activity in patients with CLL with a favourable safety profile. Further data is awaited to estimate the response rates and the decision to move to Stage 2 of the study. Disclosures Robak: Momenta: Consultancy; BioGene: Honoraria, Research Funding; Janssen: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Research Funding; Takeda: Consultancy; Pfizer: Research Funding; UCB: Honoraria, Research Funding; Pharmacyclics LLC, an AbbVie Company: Honoraria, Research Funding; Novartis: Honoraria, Research Funding; UTX-TGR: Research Funding; Acerta: Research Funding; Morphosys: Research Funding; AstraZeneca: Honoraria, Research Funding; Bristol Meyers Squibb: Research Funding; Sandoz: Consultancy, Honoraria; Octapharma: Honoraria; Medical University of Lodz: Current Employment; AbbVie: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Research Funding; GSK: Research Funding; Roche: Consultancy, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Research Funding. Routhu:Rhizen Pharmaceuticals S.A>.: Current Employment. Barde:Rhizen Pharmaceuticals S.A: Current Employment. Nair:Rhizen Pharmaceuticals S.A.: Current Employment.


Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 37-38
Author(s):  
Raffaele Palmieri ◽  
Alfonso Piciocchi ◽  
Valentina Arena ◽  
Luca Maurillo ◽  
Maria Ilaria Del Principe ◽  
...  

Background: In Acute Myeloid Leukemia (AML), identification of measurable residual disease (MRD) thresholds with clinical significance is still a matter of debate. For this purpose, multiparametric flow cytometry (MFC) is extensively employed for MRD quantification, due to high sensitivity (down to 1:10-3/10-5 cells) and wide applicability (up to 90% of cases). The identification of 20 clustered residual leukemic cells seems sufficient for the recognition of MRD presence (lower limit of detection [LOD]), whereas a cluster of 50 events may be the minimum threshold for the quantification of a cell population (lower limit of quantitation [LOQ]), provided a sufficient denominator of relevant events (500'000-1'000'000) is acquired. Methods: Using a MFC assay, we assessed the predictive power of a threshold calculated applying the criteria of LOD and LOQ on 261 intensively treated AML patients enrolled in the GIMEMA AML1310 prospective trial.According to the protocol design, patients with a bone marrow residual leukemic cells count (RLCc) equal or above 0.035% of the total no. of mononuclear (MNC) cells qualified as MRDpos,, whileusing LOD and LOQ, we selected the following categories of patients: 1) LODneg if RLCc was below LOD (20x100/total no. of events); 2) LODpos-LOQneg if RLCc was between LOD and LOQ; and 3) LOQpos if RLCc was above LOQ (50x100/total no. of events). Results: The ELN target of 500'000 events was reached in 182/261 (69.6%) patients. Overall, using the predefined AML1310 protocol MRD threshold, 154 (59%) and 107 (41%) were MRDneg and MRDpos, respectively, whereas 74 (28.4%), 43 (16.5%) and 144 (54.4%) patients were classified as LODneg, LODpos-LOQneg and LOQpos, respectively. Two-year overall survival (OS) was 75.4% vs. 79.8% vs. 66.4% for LODneg, LODpos-LOQneg and LODpos, respectively (p=0.1197), and 74.5% vs. 66.4% according to AML1310 protocol 0.035% threshold for MRDneg and MRDpos patients, respectively (p=0.3521). Due to superimposable outcome, LOD-LOQneg and LODpos-LOQneg categories were combined. Accordingly, LODneg/LODpos-LOQneg and LOQpos groups clearly differed in terms of OS (77% vs. 66.4%, p=0.0437) [FIGURE 1A]. Such a figure was challenged in multivariate analysis (p=0.048, HR 0.628, 95% CI 0.396-0.997) that confirmed the independent role of LOD-LOQ approach in influencing OS. To enhance the predictivity of LOD-LOQ estimate, we then focused on samples acquisition of which passed the 500'000 events, according to ELN guidelines. Among 182/261 (69.7%) cases with > 500'000 MNC events as denominator, LODneg/LODpos-LOQneg and LOQpos subgroups were clearly distinct in terms of OS (2-years OS of 83.5% vs. 69.4%, p=0.009). [FIGURE 1B] Similarly, also when selecting those patients (158/261 [60.5%]) whose acquisition passed 500'000 CD45+ events, LODneg/LODpos-LOQneg and LOQpos showed a different behavior with 2-years OS of 86.7% vs. 69.0%, respectively (p=0.004). [FIGURE 1C] Finally, when considering the interaction of the 3 LOD-LOQ categories with possible post-remissional strategies, LODneg/LODpos-LOQneg patients submitted to autologous stem cell transplant showed the best 2-years OS (88.9%) as compared to all the other categories (allogeneic stem cells transplant and no graft-based treatments) (p=0.026). Summary/Conclusion: In conclusion, the use of LOD-LOQ method results in a more sensitive detection of MRD that, in turn, translates in a more accurate recognition of patients with different prognosis. Actually, such an approach allowed to dissect even further the category of patients called MRDneg according to the AML1310 protocol definition, since MRDneg subjects who belonged to a "true negative" LOD-LOQ sub-group [LODneg/LODpos-LOQneg] had a better outcome than the other MRDneg ones. This MRD approach could serve as a useful tool to personalize post-remission strategy in intensively treated AML patients, through selection of high-quality remission patients who may benefit from less intensive post-consolidation therapies. Disclosures Voso: Bristol Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Venditti:Novartis: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company); Pfizer: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Speakers Bureau; Amgen: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company); Jazz: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company); AbbVie: Consultancy, Honoraria, Other: TRAVEL, ACCOMODATIONS, EXPENSES (paid by any for-profit health care company); Janssen: Consultancy, Honoraria, Other: TRAVEL, ACCOMODATIONS, EXPENSES (paid by any for-profit health care company).


2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Huay Ling Tay ◽  
Hui Sen Aw

Purpose Outsourcing logistical activities have become a widely used approach for firms to avoid high fixed costs and heavy investment requirements and to achieve competitive advantages. Lean six sigma (LSS) has been accepted globally across sectors as a management strategy for achieving process excellence. The purpose of this paper is to feature the application of LSS for improving the supplier selection process (SSP) of outsourced logistics services in a multinational health-care company. Design/methodology/approach This study is based on an action research case study conducted on the SSP of the freight and distribution department in a multinational health-care company. This paper reports on the application of the LSS define-measure-analyze-improve-control (DMAIC) approach for reducing supplier selection lead time. Findings The study features a real-world case study of the LSS DMAIC application to improve the supplier selection process of a large health-care company. The key issues that were identified are lack of information visibility, top-down changes and unclear communication lines. To counteract these three root causes, the lean six sigma techniques that are implemented are the 5S, stakeholder analysis and standard operating procedure. Research limitations/implications This research provided empirical evidence of how practical challenges in SSP can be managed with the use of LSS. It further proposed plausible solutions for reducing and sustaining improved outcomes. As the study is limited to one case, the validity of the results can be improved by including more organisations and more case studies from other similar organisations. Originality/value Research in supplier selection processes rarely links continuous improvement ideology such as LSS to support strategic selection and procurement of logistics services. This paper could serve as a resource for both practitioners to derive useful implications and to academicians as it contributes to the LSS body of knowledge for further theory testing.


Author(s):  
Linda C. Fentiman

This chapter examines the use of drugs—both legal and illegal–by pregnant women, noting increased medical and legal supervision of pregnancy and women’s substance use and abuse. Many states require health care professionals to report pregnant women who admit to, or are suspected of, using alcohol or other drugs. The result can be involuntary detention commitment for “treatment.” Women have been prosecuted for homicide after they suffer a stillbirth despite weak evidence that the stillbirth was caused by drug use. Prosecution of these women is counterproductive, because it drives pregnant drug users underground, away from both prenatal care and drug treatment.


2018 ◽  
Vol 28 (13) ◽  
pp. 2033-2047 ◽  
Author(s):  
Kyoko Wada ◽  
Marilyn K. Evans ◽  
Barbra de Vrijer ◽  
Jeff Nisker

Limited clinical research with pregnant women has resulted in insufficient data to promote evidence-informed prenatal care. Charmaz’s constructivist grounded theory methodology was used to explore how research with pregnant women would be determined ethically acceptable from the perspectives of pregnant women, health care providers, and researchers in reproductive sciences. Semistructured interviews were conducted with a purposive sample of 12 pregnant women, 10 health care providers, and nine reproductive science researchers. All three groups suggested the importance of informed consent and that permissible risk would be very limited and complex, being dependent on the personal benefits and risks of each particular study. Pregnant women, clinicians, and researchers shared concerns about the well-being of the woman and her fetus, and expressed a dilemma between promoting research for evidence-informed prenatal care while securing the safety in the course of research participation.


Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 19-20
Author(s):  
Maria Teresa Voso ◽  
Tatjana Pandzic ◽  
Michail Iskas ◽  
Marija Denčić-Fekete ◽  
Eleonora De Bellis ◽  
...  

Clonal haematopoiesis of indeterminate potential (CHIP) is defined by the detection of somatic mutations in genes recurrently mutated in myeloid neoplasms (MNs), in the blood of healthy individuals with normal blood values and lack of morphological evidence of MN. Recent studies have highlighted the potential association between CHIP and the development of MN, in particular therapy-related MN (t-MN) in patients with lymphoma treated with chemotherapy and/or autologous stem-cell transplantation. In the present study, we investigated whether the presence of CHIP is associated with a higher risk for the development of t-MN in patients with chronic lymphocytic leukemia (CLL) treated with chemo(immuno)therapy, including fludarabine and cyclophosphamide combinations. To this end, we studied 9 patients with CLL who developed a t-MN [acute myeloid leukemia (AML): n=6, myelodysplastic syndrome (MDS): n=3] after the administration of chemo(immuno)therapy (FCR: n=7, other, n=2), with available samples collected both before CLL treatment and at diagnosis of t-MN. The median interval between the two samples was 26 months (range: 9-38months). NGS was performed on DNA extracted from bone marrow mononuclear cells (MNCs) at t-MN diagnosis, using the Trusight Myeloid Sequencing Panel (n=4) and the Archer VariantPlex Myeloid kit (n=5). Backtracking of the variants detected at the t-MN phase was performed by NGS of DNA extracted from peripheral blood MNCs (n=8) or CD19+ selected cells (n=1) in the samples from the CLL phase. In case no variants were detected in the t-MN phase, targeted digital droplet PCR (ddPCR) was also performed in paired CLL samples to confirm the presence of the variants. Moreover, using the Trusight Myeloid Sequencing Panel, we evaluated the prevalence of CHIP in a population cohort of 285 patients with CLL at the time of diagnosis. The variant allele frequency (VAF) cut-off for the detection of the variants was set to 5%. Variants were reported if meeting the following criteria: (i) located within an exonic or splicing region; (ii) be non-synonymous; (iii) not listed in the gnomAD database, if not also recurrently reported in Cosmic v85. Overall, 16 variants were detected in 7/9 cases analyzed at the time of t-MN [NRAS (n=4), DNMT3A (n=3), TET2 (n=2), EH2 (n=2), TP53 (n=2), KRAS (n=1), U2AF1 (n=1) and SF3B1 (n=1)], while no variants were detected in 2 t-MN samples. In 6/7 cases with detectable variants at t-MN diagnosis, the same variants were present at the CLL phase with either lower (n=4) or similar (n=2) VAF. Overall, CHIP was detectable in 6/9 (66.7%) CLL patients who later developed a t-MN. Among the untreated CLL patients, 45 CHIP-related variants were detected in 35/285 cases (12%) as 7 patients harbored more than one variant. The median VAF was 12.7% (5.1-58.6%) with 27/45 (60%) having a VAF<20%. The affected genes were: DNMT3A (n=9), ASXL1 (n=8), KRAS (n=7), BCOR (n=3), NRAS (n=3), TET2 (n=2), U2AF1 (n=2), PTPN11 (n=2), HRAS (n=2), JAK2 (n=1), CBL (n=1), CALR (n=1), IDH2 (n=1), MPL (n=1), PHF6 (n=1) and ETV6 (n=1). CHIP was not associated with advanced age. Subgroup-analysis amongst CHIP-patients revealed: (i) enrichment of additional CHIP-related variants, male gender and younger age in carriers of ASXL1 variants and (p=0.1, p=0.008 and p=0.06; (ii) a bias towards female gender in patients with DNMT3A variants (p=0.008). The difference in the prevalence of CHIP between patients with CLL developing a t-MN (6/7) and those in the untreated cohort (35/285) was statistically significant (p<0.001). In conclusion, CHIP is significantly enriched in patients with CLL developing t-MNs after the administration of chemo(immuno)therapy, with obvious therapeutic implications especially in the era of targeted agents. The significance of CHIP in CLL should be further evaluated in the context of large clinical studies. MTV and TP contributed equally. EF and PB contributed equally. Disclosures Voso: Bristol Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Scarfo:Janssen: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; AstraZeneca: Honoraria; Abbvie: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Gilead: Membership on an entity's Board of Directors or advisory committees. Ghia:ArQule: Consultancy, Honoraria; BeiGene: Consultancy, Honoraria; Gilead: Consultancy, Honoraria, Research Funding; AbbVie: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Research Funding; Acerta/AstraZeneca: Consultancy, Honoraria; Adaptive, Dynamo: Consultancy, Honoraria; Novartis: Research Funding; Janssen: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Research Funding; Sunesis: Consultancy, Honoraria, Research Funding; MEI: Consultancy, Honoraria; Lilly: Consultancy, Honoraria; Celgene/Juno: Consultancy, Honoraria. Stamatopoulos:AstraZeneca: Honoraria; Janssen, Gilead, Abbvie: Honoraria, Research Funding.


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