scholarly journals The Impact of Pre-Apheresis Health Related Quality of Life on Peripheral Blood Progenitor Cell Yield and Donor's Health and Outcome: Secondary Analysis of Rdsafe and BMT CTN 0201

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 1772-1772
Author(s):  
Nosha Farhadfar ◽  
Stephanie Bo-Subait ◽  
Kwang Woo Ahn ◽  
Brent R. Logan ◽  
Heather E. Stefanski ◽  
...  

Abstract Introduction: The adverse events associated with hematopoietic stem cell donation have been extensively studied. There is an increasing literature linking psychological factors including stress, anxiety and depression to higher levels of inflammatory burden leading to poorer post-procedural outcomes including longer hospital stays and increased pain perception. Here, we aimed to evaluate whether pre-donation health related quality of life (HRQoL) markers predict toxicity profile and stem cell yield following stem cell donation in healthy donors. Methods: The study population included adult granulocyte colony-stimulating factor (G-CSF) mobilized peripheral blood stem cell (PBSC) related donors (RD) (n= 157) and unrelated donors (URD) (n=179) who were enrolled in Related Donor Safety Study (RDSafe) and Blood and Marrow Transplant Clinical Trials Network (BMT CTN) 0201 clinical trials. Pre-donation HR QoL was assessed using the Short-Form (SF-8) in RDSafe and SF-12 questionnaire in BMT CTN 0201 (higher score is better). Pain and toxicity were collected on study specific forms. The primary outcome was the incidence of skeletal pain on day 5 of G-CSF administration. The secondary outcomes were the incidence of skeletal pain and highest toxicity level across selected body symptoms at 1 month, 6 months and 1-year post-donation. Another secondary outcome included CD34+ per liter of blood processed (x10 6/L) on day 5 of G-CSF as a measure of collection yield. The association between pre-apheresis HRQOL measures and pain and acute toxicities was characterized using means and SDs and compared using the t-test. Association between HRQoL and cell yield was assessed using the Pearson correlation coefficient. RD and URD were analyzed separately. Results: URDs were younger than RDs (median age 35 vs. 63). A higher proportion of RDs were female (50% vs. 40%) and obese (41% vs. 35%). A higher proportion of RD PBSC donations required 2 days or more (44% vs 21%). More RDs were collected with lower volume procedures (<18L, 28% vs. 16%), and required a central line (28% vs. 11%). RDs were more likely to report pre-donation grade 1-2 pain (27% vs. 8%) and other toxicities (16% vs. 6%). The mean pre-donation physical component summary (PCS) and mental component summary (MCS) score of RDs were 54.5 (SD 7.0) and 55.1 (SD 5.8), respectively . In the univariate analysis (table 1), pre-donation lower PCS score of RDs was associated with significantly more grade 2-4 pain at 1 month (p=0.0038) and 1-year post-donation (p=0.0099) (Table 1). In multivariable analysis (table 2), pre-donation PCS remained significantly associated with grade 2-4 pain 1-month post-donation (p=0.0098). More specifically, RDs with pre-donation PCS scores in the higher quartile were less likely to experience pain compared with donors with PCS scores in the lower quartile (OR 0.1; 95% CI 0.01-0.83; p=0.005). There was also a trend toward increased grade 2-4 pain at 1-year post-donation among RDs with lower PCS score (p=0.0176). Other outcomes such as pain at day 5 of G-CSF, other toxicities at day 5 of G-CSF, 1 month, 6 months and 1-year post-donation were not associated with pre-donation PCS score. Similarly, there was no significant association between RD pre-donation MCS score and collection-related symptoms at any time point. The mean pre-donation PCS and MCS scores of URDs were 56.2 (SD 4.7) and 54.5 (SD 5.5), respectively . In a univariate analysis, there was no association between PCS score or MCS score and donation associated pain and toxicities at any time point post-donation. Due to low event rates, multivariable analysis was not performed in the URD setting. Based on the multivariable regression analysis, there was no correlation between pre-apheresis HRQoL score (PCS or MSC) and PBSC collection yield in either the RD or URD setting. Conclusion: Our study demonstrates that pre-donation QoL markers are significantly associated with the toxicity profile after PBSC donation in the RD setting as adult RD with lower pre-donation physical QOL experience increased levels of pain after a PBSC collection procedure. There were no such associations found in URD in this small sample. Our findings may help clinicians to identify donors at higher risk of pain with donation, and lead to personalized information and interventions (e.g. increased analgesia) for specific donors. Future study with a larger sample is required to validate the results. Figure 1 Figure 1. Disclosures Farhadfar: Incyte: Consultancy. Stefanski: Novartis: Honoraria. Pulsipher: Equillium: Membership on an entity's Board of Directors or advisory committees; Adaptive: Research Funding; Jasper Therapeutics: Honoraria. Shaw: mallinkrodt: Other: payments; Orca bio: Consultancy.

2018 ◽  
Vol 13 (8) ◽  
pp. 824-831 ◽  
Author(s):  
Chen Lin ◽  
Rajbeer Sangha ◽  
Jungwha Lee ◽  
Carlos Corado ◽  
Anvesh Jalasutram ◽  
...  

Background In patients with mild ischemic stroke, small but eloquent infarcts may have devastating effects, particularly on health-related quality of life. Aim This study investigates the association between acute infarct location and three-month health-related quality of life in patients with mild ischemic stroke. Methods We evaluated consecutively enrolled patients from a single center between August 2012 and July 2013. Our primary outcome at three months was impairment in any health-related quality of life domain (upper extremity, lower extremity, executive function, and general concerns) defined by a T-score <45. We analyzed the association between acute infarct locations and impaired health-related quality of life at three months in univariate and multivariable analysis. Results Among 229 patients (mean age 64.9 years, 55% male, 29.7% black, and median initial NIHSS score 1), impaired health-related quality of life was noted in 84 (36.2%) patients at three months. In univariate analysis, patients with subcortical infarcts (56.0% vs. 39.3%, p = 0.02) and brainstem infarcts (21.4% vs. 10.3%, p = 0.02) were more likely to have impaired health-related quality of life. In multivariable analysis, patients with subcortical and/or brainstem infarcts had increased odds of impaired health-related quality of life (adjusted OR 2.54, 95% CI 1.29–5.01, p = 0.01). Conclusions After mild ischemic stroke, subcortical and brainstem infarct locations predict impairment in health-related quality of life.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mina Pakkhesal ◽  
Elham Riyahi ◽  
AliAkbar Naghavi Alhosseini ◽  
Parisa Amdjadi ◽  
Nasser Behnampour

Abstract Background Childhood dental caries can affect the children’s and their parents’ oral health-related quality of life. The aim of the present study was to evaluate the impact of oral and dental health conditions on the oral health-related quality of life in preschool children and their parents. Methods In this descriptive-analytical cross-sectional study, samples were selected from children 3 to 6 years old enrolled in licensed kindergartens using "proportional allocation" sampling. Then, the parents of the children were asked to complete the Early Childhood Oral Health Impact Scale (ECOHIS). Results In this study, 350 children aged 3 to 6 years were evaluated with a mean age of 4.73 years. The mean dmft index (decayed, missed, and filled teeth) was 3.94 ± 4.17. The mean score of oral health-related quality of life was 11.88 ± 6.9, which 9.36 ± 5.02 belongs to the impact on children and 2.52 ± 3.20 to parents' impact. Conclusions The mean score of ECOHIS increased with the dmft index increase in children, indicating a significant relationship between the dmft and ECOHIS score. These outcomes can be used as proper resources to develop preventive policies and promote oral health in young children.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 645.2-646
Author(s):  
A. Kivitz ◽  
Y. Tanaka ◽  
S. Lee ◽  
L. Ye ◽  
H. Hu ◽  
...  

Background:In the FINCH 1 study, filgotinib (FIL)—an oral, potent, selective Janus kinase 1 inhibitor—in combination with methotrexate (MTX) provided significant improvements in the signs and symptoms of rheumatoid arthritis (RA) in patients (pts) with inadequate response to MTX.1While EULAR guidelines recommend a treat-to-target approach focusing on reducing inflammation to prevent joint damage, physical disability, and mortality, pts consider control of pain and fatigue, along with maintenance of physical function and health-related quality of life (HRQoL), to be important aspects for their care.2,3Objectives:To evaluate the rate and magnitude of change in patient-reported outcomes (PROs) from FINCH 1.Methods:In the FINCH 1 study (NCT02889796), pts with active RA received oral FIL 200 mg + MTX, FIL 100 mg + MTX, PBO + MTX, or subcutaneous adalimumab (ADA) 40 mg + MTX for up to 52 weeks (W); pts receiving PBO at W24 were rerandomised 1:1 to FIL 100 or 200 mg. PROs included the HAQ-DI and VAS pain scale, SF-36, and FACIT-Fatigue questionnaire. The change from baseline (CFB) at each time point was assessed up to W52 for each treatment group. The mixed-effects model for repeated measures was used to compare each FIL group with PBO for the CFB at each time point through W24. The logistic regression model was used to compare each FIL group with PBO for the proportion of pts achieving the minimum clinically important difference (MCID) of ≥0.22 reduction in CFB in HAQ-DI at each time point through W24.Results:Of 1755 pts randomised and treated (475 FIL 200 mg + MTX; 480 FIL 100 mg + MTX; 325 ADA + MTX; and 475 PBO + MTX), 1417 (80.7%) received study drug through W52. As early as W2 through W24, pts receiving either dose of FIL experienced nominally significantly greater (p <0.001) CFB in HAQ-DI and VAS pain scale than those receiving PBO; CFB improvements were maintained through W52 (Fig 1A, B). At W2, compared with PBO (40.2%), a nominally significantly greater proportion of pts achieved the HAQ-DI MCID in both the FIL 200 (52.5%; p <0.001) and 100 mg (46.7%; p = 0.043) groups. This benefit vs PBO was maintained up to W24 and the proportion of pts who achieved a HAQ-DI reduction of ≥0.22 remained ≥75.8% in the FIL 200 mg group and ≥71.5% in the FIL 100 mg group from W12 through W52. FIL provided nominally significantly greater improvement in HRQoL vs PBO at W4 and W12 for both the CFB of the SF-36 Physical Component Summary (PCS) (p <0.001) and Mental Component Summary (MCS) (p ≤0.006); nominal significance was also seen at W24 for CFB of SF-36 PCS (Fig 2A, B). By W4, pts receiving either dose of FIL reported a nominally significantly greater mean CFB in FACIT-Fatigue scores vs PBO (p <0.001); significance was maintained through W24 and improvement in reported fatigue continued through W52 in the FIL groups (Fig 2C). In general, CFB for HAQ-DI, VAS pain scale, and FACIT-Fatigue observed for the FIL groups was higher or comparable to ADA at various time points (Fig 1, 2).Conclusion:Both doses of FIL provided rapid and sustained improvements in functional status, pain, HRQoL, and fatigue compared with PBO for pts with RA and inadequate response to MTX throughout the 52-week period.References:[1]Combe BG, et al.Ann Rheum Dis.2019;78 (Suppl 2):A77.[2]Fautrel B, et al.Rheumatol Int.2018;38:935–47.[3]Smolen JS, et al.Ann Rheum Dis.2017;76:960–77.Disclosure of Interests:Alan Kivitz Shareholder of: AbbVie, Amgen, Gilead, GSK, Pfizer Inc, Sanofi, Consultant of: AbbVie, Boehringer Ingelheim,,Flexion, Genzyme, Gilead, Janssen, Novartis, Pfizer Inc, Regeneron, Sanofi, SUN Pharma Advanced Research, UCB, Paid instructor for: Celgene, Genzyme, Horizon, Merck, Novartis, Pfizer, Regeneron, Sanofi, Speakers bureau: AbbVie, Celgene, Flexion, Genzyme, Horizon, Merck, Novartis, Pfizer Inc, Regeneron, Sanofi, Yoshiya Tanaka Grant/research support from: Asahi-kasei, Astellas, Mitsubishi-Tanabe, Chugai, Takeda, Sanofi, Bristol-Myers, UCB, Daiichi-Sankyo, Eisai, Pfizer, and Ono, Consultant of: Abbvie, Astellas, Bristol-Myers Squibb, Eli Lilly, Pfizer, Speakers bureau: Daiichi-Sankyo, Astellas, Chugai, Eli Lilly, Pfizer, AbbVie, YL Biologics, Bristol-Myers, Takeda, Mitsubishi-Tanabe, Novartis, Eisai, Janssen, Sanofi, UCB, and Teijin, Susan Lee Shareholder of: Gilead Sciences Inc., Employee of: Gilead Sciences Inc., Lei Ye Shareholder of: Gilead Sciences Inc., Employee of: Gilead Sciences Inc., Hao Hu Shareholder of: Gilead Sciences Inc., Employee of: Gilead Sciences Inc., Robin Besuyen Shareholder of: Galapagos, Employee of: Galapagos, Bernard Combe Grant/research support from: Novartis, Pfizer, Roche-Chugai, Consultant of: AbbVie; Gilead Sciences, Inc.; Janssen; Eli Lilly and Company; Pfizer; Roche-Chugai; Sanofi, Speakers bureau: Bristol-Myers Squibb; Gilead Sciences, Inc.; Eli Lilly and Company; Merck Sharp & Dohme; Pfizer; Roche-Chugai; UCB


Hematology ◽  
2010 ◽  
Vol 2010 (1) ◽  
pp. 248-254 ◽  
Author(s):  
Margaret Bevans

Abstract It is common knowledge that an allogeneic hematopoietic stem cell transplantation (HSCT) will have an enormous impact on the lives of transplant recipients and their families. Once an appropriate donor is identified, the curative potential of this treatment often drives the decision to proceed knowing that there will be intense physiologic toxicities and adverse effects on health-related quality of life (HRQL). Twenty-five years ago, HRQL was identified as an efficacy parameter in the evaluation of new anticancer drug therapy. Overall, the evidence suggests that an allogeneic HSCT has a significant impact on the overall HRQL of recipients, which is a result of decrements across all dimensions, including a significant symptom profile. The degree of impact on overall HRQL and the multiple dimensions varies across the transplant trajectory. Specific HRQL dimensions, such as physical function and symptoms, are easily incorporated into a clinician's assessment whereas other dimensions (eg, psychosocial) are less commonly integrated. The translation of HRQL results to improve clinical practice is not well established. Clinicians are often uncertain when to assess the scope of HRQL and how to interpret the information in a clinically meaningful way. The purpose of this review is to highlight the quality-of-life effects of allogeneic HSCT and discuss application into clinical practice.


2019 ◽  
pp. 35-42
Author(s):  
Tri Vo Duc ◽  
Ngoc Nguyen Phuoc Bich

Background: The prevalence of diabetes mellitus (DM) has been increasing significantly in the world as well as in Viet Nam. DM is a serious and complex chronic disease that affects the physical health of the patients and lower health-related quality of life (HRQoL). Objectives: (1) To analyze the HRQoL in DM outpatients at Hue University of Medicine and Pharmacy Hospital. (2) To evaluate the associated factorsin outpatients with DM. Materials and method: A cross-sectional descriptive study was conducted on 253 outpatients at Hue University of Medicine and Pharmacy Hospital. EuroQoL-5 dimension-5 level (EQ-5D-5L) scale was used for the assessment of HRQoL. Results: The median of the EQ-5D index was 0.85(interquartile range (IQR) = 0.28). The mean of EQ-VAS score was 64.07 (SD=16.99). Aging was associated with lower HRQoL. Unemployed participants had the lowest HRQoL index compared to workers. Higher educational levels led to higher HRQoL. Patients withDM duration of over 10 years had lower HRQoL index than the other groups. Conclusion: The median of the EQ-5D index was 0.85 (IQR = 0.28). The mean of EQ-VAS score was 64.07 (SD=16.99). The HRQoL in diabetic patients was associated with age, occupation, level of education and DM duration. Key words: EQ-5D-5L, quality of life, diabetes mellitus.


2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Julia Colombijn ◽  
Anna Bonenkamp ◽  
Anita Van Eck van der Sluijs ◽  
Alferso C Abrahams ◽  
Joost Bijlsma ◽  
...  

Abstract Background and Aims Dialysis patients are often prescribed a large number of medications to improve metabolic control and manage co-existing comorbidities. However, several studies suggest that a large number of medications can also detrimentally affect their health-related quality of life (HRQoL). Therefore, this study aims to provide insight in the association between the number of medications and various aspects of HRQoL in dialysis patients. Method A multicentre study was conducted among dialysis patients from Dutch dialysis centres three months after initiation of dialysis as part of the ongoing prospective DOMESTICO study. The number of medications, defined as the number of concomitantly prescribed types of drugs, was obtained from electronic patient records. Primary outcome was HRQoL measured with the Physical Component Summary (PCS) score and Mental Component Summary (MCS) score (range 0-100) of the Short Form 12. Secondary outcomes were number of symptoms (range 0-30) measured with the Dialysis Symptoms Index and self-rated health (range 0-100) measured with the visual analogue scale of the EuroQol-5D-5L. Data were analysed using linear regression and adjusted for possible confounders, including age, sex, dialysis modality, and comorbidity. Analyses for MCS and number of symptoms were performed after categorising patients in tertiles according to their number of medications because assumptions of linearity were violated for these outcomes. Results A total of 162 patients were included. Mean age of patients was 58 ± 17 years, 35% were female, and 80% underwent haemodialysis. The mean number of medications was 12.2 ± 4.5. Mean PCS and MCS were 36.6 ± 10.2 and 46.8 ± 10.0, respectively. The mean number of symptoms was 12.3 ± 6.9 and mean self-rated health 60.1 ± 20.6. In adjusted analyses, PCS was 0.6 point lower for each additional medication (95%CI -0.9 – -0.2; p=0.002). MCS was 4.9 point lower (95%CI -8.8 – -1.0; p=0.01) and 1.0 point lower (95%CI -5.1 – 3.1; p=0.63) for the highest and middle tertiles of medications, respectively, compared to the lowest tertile. Patients in the highest tertile of medications reported 4.1 more symptoms compared to the lowest tertile (95%CI 1.5 – 6.6; p=0.002) but no significant difference in the number of symptoms was observed between the middle and lowest tertile. Self-rated health was 1.5 point lower for each medication (95%CI -2.2 – -0.7; p&lt;0.001). Conclusion After adjustment for comorbidity and other confounders, a higher number of medications was associated with a lower PCS, MCS, and self-rated health in dialysis patients and with more symptoms. This suggests that it may be relevant to weigh expected therapeutic benefits of medication against their possible harmful effects on HRQoL. An unfavourable balance between expected benefits and impact on HRQoL might be ground to deviate from clinical guidelines, especially for patients with a limited life-expectancy and for whom a kidney transplant is unattainable.


Author(s):  
Silva Hovsepian ◽  
Mostafa Qorbani ◽  
Mohammad Esmaeil Motlagh ◽  
Aryan Madady ◽  
Morteza Mansourian ◽  
...  

AbstractBackground:Considering the role of different ethnical, cultural and geographical factors in health related quality of life (HRQOL) as well as the perception of different populations regarding various weight disorders, we aimed to evaluate the association between body mass index (BMI) and HRQOL in Iranian children and adolescents.Methods:This cross-sectional study was part of the Weight Disorders Survey of the CASPIAN-IV study. During this study, students aged 6–18 years from urban and rural areas of 30 provinces of Iran were selected. HRQOL of the students was evaluated by using the Persian version of the Pediatric Quality of Life inventory (PedsQL™ 4.0™ 4.0) Generic Core Scales. The mean of total HRQOL and its subscales were compared in underweight, normal weight, overweight and obese students.Results:The mean of total HRQOL, physical functioning and psychological functioning scores in the total population were 83.31, 84.25 and 82.79, respectively. The mean of the total HRQOL score and the psychosocial score were significantly lower in underweight students aged 6–12 years than in other groups (p<0.05). The mean of the total HRQOL score and psychosocial score were significantly lower in obese students aged 13–18 years than in other groups (p<0.05). Overweight and obesity was negatively associated with total HRQOL, psychosocial and school functioning subscales (p<0.05). There was a significant negative association between emotional functioning and obesity (p<0.05).Conclusions:The findings or this study support the importance of personal perception and cultural norm roles in HRQOL. Given the association between weight disorders and psychosocial health, it is suggested that social and cultural factors have a more crucial role in the HRQOL of children and adolescents.


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