Vascular Rehabilitation Benefits of Tribulus Terrestris (TT), Taurine and High Dose Alpha Lipoic Acid (ALA) Supplementation with Interval Walking Training Program after Surgical Vascular Bypass Treatment (Pilot Study)

Background: Some of main raisons for the elderly graft occlusion after successful aortal-iliac, aortal Femoral and Femoral Distal Vein Bypass, progression of main disease, continuing bad life Habits and uncontrolled risk factors such are mostly: poor nutrition traditional or fast food, Smocking and Lacks of Walking and Physical Activity Habits. Objective: The primary objective of the study was to estimate influence of Interval Walking Training Program combine with Tribulus Terrestris, 3-5 gram of Taurine and high dose of 1800mg supplementation of ALA on primary potency and vascular treatment. Secondary goals of this study is determinate by establishing better understanding connection between ordinary vascular walking therapy 30-45 min and interval walking program combine with Tribulus Terrestris, Taurine and high dose of and ALA as secondary supplementation after surgical and endovascular treatment. Methodology: The study included 112 patients, at the Clinic of cardiovascular surgery, Clinical Center University of Sarajevo, age between 50 and 75 (50 patients surgical treated with aortic-iliac, aortic-femoral and femoral distal vein bypass with and without Linton-patch/Taylor patch-first group) and (62 endovascular Iliac treated patients (indication TASC II A and B) with and without support Tribulus Terrestris, high dose of ALA and Taurine - second group). Results: Final analysis has reveal the rehabilitation outcome in 83% patients with bypass above the knee was fully rehabilitated compared to 46,6% patients with bypass below the knee was statistically considered significant by using p value less than (p<0,05) In anamnestic history in 83% patient with amputation above the knee was documented the presence of hypertension, hyperlipidemia, nicotinismus and diabetes compared to 66,7% of patients with amputation level below the knee but there was no statistically significant difference (p>0,05). Conclusion: Interval Walking Training Program on Tribulus Terrestris, Taurine and high dose of ALA had a significantly and successfully higher bypass potency and rehabilitation prognosis compare to patients without supplementation and postsurgical physical therapy concept. It is obviously the is certain link between physical activity, life style modification and serum testosterone on primary bypass potency.

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Level of physical activity in undergraduate students in Peshawar, Pakistan

Asian Journal of Health Sciences ◽

10.15419/ajhs.v7i1.481 ◽

2021 ◽

Vol 7 (1) ◽

pp. ID20

Author(s):

Shahid Alam ◽

Sardar Bakht Khan ◽

Qamar Wahid Khattak ◽

Syed Zain Ul Abidin ◽

Salman Farooqi ◽

...

Keyword(s):

Physical Activity ◽

Undergraduate Students ◽

Physical Inactivity ◽

Short Form ◽

Demographic Data ◽

Activity Level ◽

P Value ◽

Moderate Physical Activity ◽

Significant Difference ◽

The University

Background: Physical activity is one of the leading health indicators, considered an essential factor in the population's health and quality of life promotion. Physical inactivity is the fourth leading risk factor for global mortality. Physical inactivity has been linked with chronic disease and obesity in most populations. This study aims to compare the prevalence of physical activity and overweight/obesity among students of the university. Methods: A cross-sectional survey was conducted from March to September 2019 on undergraduate students from different departments of Peshawar University. A sample of 377 (male n = 243, female n = 134) was taken through convenience sampling. Those individuals who were physically disabled and not willing to participate were excluded from the study. Those meeting the inclusion criteria were given the International Physical Activity Questionnaire (IPAQ short form). Demographic data included age, weight, and height was self-stated by the participants. The levels of physical activity in each of three domains (leisure, transport, and domestic) were calculated and presented as metabolic equivalent (M.E.T.) hour per week in the form of means, percentage, and frequency in different physical activity domains. Results: The overall sample showed that 13.70% of participants were inactive, 27.76% showed a low level of physical activity, 41.29% showed moderate physical activity level, and 17.24% showed a high level of physical activity. A total of 90.98% of participants were involved in leisure physical activities, 93.10% presented transport-related physical activity, and 74.80% were involved in domestic-related physical activity. Average time spent during sitting was found to be 53.32 hrs/week and 7.61 hrs/ day, with females being more involved in sitting activities as compared to males. A significant difference was found between B.M.I. and sitting domain (p-value 0.002) with a Pearson value of -0.12 showing a negative correlation. Conclusion: The B.M.I. and Physical Activity are found negatively associated with each other. Male students were more physically active than females as females spend their majority of time sitting. It is concluded that students are moderately active, while a minimal percent of students are highly active. There were a few numbers of respondents too who were physically inactive, which shows that there is still unawareness of physical activity on the university level.

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The Effect of Brain Breaks on Physical Activity Behaviour among Primary School Children: A Transtheoretical Perspective

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph16214283 ◽

2019 ◽

Vol 16 (21) ◽

pp. 4283 ◽

Cited By ~ 2

Author(s):

Hussein Rizal ◽

Mawar Siti Hajar ◽

Ayu Suzailiana Muhamad ◽

Yee Cheng Kueh ◽

Garry Kuan

Keyword(s):

Physical Activity ◽

Primary School ◽

Stages Of Change ◽

School Children ◽

Decisional Balance ◽

Primary School Children ◽

Control Group ◽

P Value ◽

Significant Difference ◽

Brain Breaks

Brain Breaks Physical Activity Solutions (BBPAS) is a web-based structured physical activity (PA) video that is specifically designed for school settings and can stimulate a student’s health and learning. The purpose of this study is to measure the effect of BBPAS on the stages of change, decisional balance, processes of change, self-efficacy and leisure-time exercise among Malay ethnic primary school children. A validated Malay version of three of the five constructs was derived with sound validity and was used in the present study. A total of 159 male and 163 female children aged 10 to 11 years old, mean (SD) = 10.53 (0.50), were recruited from two schools in Kelantan, Malaysia. Purposive sampling was used to divide the children into intervention (n = 177) and control (n = 145) groups. Children in the intervention group underwent BBPAS activity for an accumulated 30 min per week, while children in the control group were not involved in the BBPAS intervention. Mixed factorial analysis of variance (ANOVA) was used to examine the effect of BBPAS on the study variables. A mixed ANOVA showed significant changes (time effect) on cognitive process, F(1, 320) = 5.768, p-value = 0.017; behavioural process, F(1, 313) = 5.736, p-value = 0.017; and internal feeling, F(1, 312) = 6.050, p-value = 0.014. There was also a significant difference between groups on cons, F(1, 316) = 7.504, p-value = 0.007. A significant interaction effect was observed for stages of change, F(1, 319) = 7.861, p-value = 0.005; pros, F(1, 316) = 31.311, p-value = 0.001; internal feeling, F(1, 312) = 4.692, p-value = 0.031; and behavioural process, F(1, 313) = 7.312, p-value = 0.007. In conclusion, BBPAS was successful in improving four of the five constructs, and thus, should be recommended to be used in schools throughout Malaysia.

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Spontaneous Intracerebral Hemorrhage: Patient’s Activities before the Onset of Stroke and Localization of Intracerebral Hemorrhage in Black Africans

Research in Health Science ◽

10.22158/rhs.v4n2p101 ◽

2019 ◽

Vol 4 (2) ◽

pp. p101

Author(s):

Serge Malenga Mpaka ◽

Blaise Ngizulu Mazuka ◽

Didier Ndabahweje Ndyanabo ◽

Benjamin Longo-Mbenza ◽

Michel Lelo Tshikwela

Keyword(s):

Physical Activity ◽

Intracerebral Hemorrhage ◽

Hemorrhagic Stroke ◽

P Value ◽

Spontaneous Intracerebral Hemorrhage ◽

Logistic Regression Models ◽

Emotional Factors ◽

Increased Risk ◽

Significant Difference ◽

Republic Of The Congo

Background: Some published studies on the patient’s activity before the stroke occurrence indicate that thereis an increased risk of the onset of acute stroke during these activities. In our community, these data are not yet assessed. The purpose of this pilot study was to examine whether intracerebral hemorrhage may be linked to patient’s physical activity before the onset and to carry out any relationship with location of the hemorrhage.Methods: The patient’s activity before the onset of stroke and location of hemorrhage in 58 patients (40 men and 18 women, aged 39 to 81years) admitted with spontaneous intracerebral hemorrhage seen by CT in Kinshasa, Democratic Republic of the Congo, from 2012 to 2015, were recorded and analyzed using logistic regression models. Results: In 31% of the case, the onset developed after emotional factors, in 24% in the lavatory, in 15% during housework and in 12% during sexual activity (X-squared = 8.319, p-value = 0.081). There was no significant difference between those activities and the site of intracerebral hemorrhage (p?0.05).Conclusion: Most patients in this series seemed to be stricken by the hemorrhagic stroke during some physical activity. It is less certain that location of intracerebral hemorrhage was linked with these activities.

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Effects of Hoverboard on Balance in Young Soccer Athletes

Journal of Functional Morphology and Kinesiology ◽

10.3390/jfmk5030060 ◽

2020 ◽

Vol 5 (3) ◽

pp. 60

Author(s):

Stefano Moffa ◽

Angelica Perna ◽

Gabriele Candela ◽

Alessandro Cattolico ◽

Carmine Sellitto ◽

...

Keyword(s):

Standard Deviation ◽

Training Program ◽

Athletic Performance ◽

Training Programs ◽

P Value ◽

Balance Beam ◽

Walking Test ◽

Training Time ◽

Significant Difference ◽

Football Training

Hoverboards are always more popular among children. Hoverboards are to them like a game or a mean of transport, but they could be used as a valid and useful instrument in children’s training programs to improve their performance. In this study, we compared the athletic performance of two groups of 12 children. A total of 24 children aged between 8 and 11 years followed a similar training program for five months, but the first group used a hoverboard (Hb+ group: Age: Standard Deviation (SD) = 1.15 Mean = 9.66; Weight: SD = 5.90 Mean = 32; Height: SD = 7.64 Mean = 135.08) for some of the training time, differently from the second group (Hb- group: Age: SD = 1.15 Mean = 9.66; Weight: SD = 5.82 Mean = 31.16; Height: SD = 7.66 Mean = 136.16), which never used it. All of the children were asked to complete three tests (one leg test, stork test and balance beam walking test) before starting their own training program and after five months, to evaluate how their performances changed in terms of time. Comparing the recorded time difference between T0 and T1 of the Hb+ group with the same difference measured in Hb- group, it was found that there was a statistically significant difference (p value < 0.05) between these data for all three tests. Children who used the hoverboard in their training program achieved better result than children who did not use it. In the future, the hoverboard could help athletes to improve their performances, possibly applying it not only in football training, but even in other sports.

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IMPROVING MOOD THROUGH PHYSICAL ACTIVITY FOR CARERS AND CARE RECIPIENTS TRIAL (IMPACCT): RESULTS OF A RCT

Innovation in Aging ◽

10.1093/geroni/igz038.588 ◽

2019 ◽

Vol 3 (Supplement_1) ◽

pp. S164-S165

Author(s):

Briony Dow ◽

Susan (Sue) Malta ◽

Ellen Gaffy ◽

Melissa Russell ◽

Sue Williams ◽

...

Keyword(s):

Physical Activity ◽

Usual Care ◽

Exercise Intervention ◽

Physical Activity Intervention ◽

Group Analysis ◽

Intervention Group ◽

Exercise Group ◽

Care Recipient ◽

P Value ◽

Significant Difference

Abstract The aim of this Australian study was to investigate effects on depression of a 6-month individually tailored home-based exercise program for caregivers, designed to be done with the person they care for. Ninety-one caregiver-care recipient dyads and 30 caregiver-only participants (caregivers scoring ≥4 on the 15 item Geriatric Depression Scale (GDS-15)) were randomized into one of three groups: exercise intervention (n=50, 34 dyads and 16 caregiver only), social support control (n= 50, 42 dyads and 8 caregiver only) or usual care control (n= 21, 15 dyads and 6 caregiver only). The exercise group completed an individualised program based on the Otago-plus. The primary outcome was the proportion of participants with GDS-15 ≤4. Outcome assessors were blinded to group assignment. There were no significant difference in depression between the physical activity intervention group and the social control (OR 1.06, 95% Confidence Interval (CI) 0.44, 2.56) and the physical activity intervention group and the usual care control (OR 1.51 95% CI 0.46, 4.94) at six months or at 12-months. However, more than 50% of caregivers in all three groups no longer had a GDS-15 score >4 at 6 months. Sub-group analysis revealed that after 6 months caregivers in the exercise group caring for someone with an MMSE ≥24 were significantly less depressed than those caring for someone with an MMSE score of <24 compared with social (p value <0.02) and usual care groups (p value < 0.02). A dyad exercise intervention may be beneficial for those caring for someone without cognitive decline.

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Evaluation of the changes in Tei-index (myocardial performance index) in Doppler echocardiography before and after treating with anthracycline combinations in children with malignancy

Iranian Journal of Pediatric Hematology & Oncology ◽

10.18502/ijpho.v11i4.7166 ◽

2021 ◽

Author(s):

Majid Naderi ◽

Maryam Judi ◽

Maryam Yazdanparast ◽

Sima SavadKuhi ◽

Saeedeh Yaghoubi

Keyword(s):

Performance Index ◽

Myocardial Performance Index ◽

P Value ◽

High Dose ◽

Healthy Children ◽

Myocardial Performance ◽

Tei Index ◽

Significant Difference ◽

Group A ◽

Group B

Background: Cardiomyopathy usually causes a cardiac dysfunction resistant to treatment due to anthracycline. This study aimed to evaluate the changes in Tei-Index (myocardial performance index) in patients with malignancies treated with anthracycline. Material and Methods: This case-control study was done on 15 children who were treated with low-dose anthracycline (1-199mg/kg) called group A and 15 children who were treated with high dose (>200mg/kg) anthracycline called group B after acquiring consent from their parents. Children with no abnormality in Echo-Doppler results were included in this study. The patients’ age range between 1- 17 years with a mean age of 6.57 years. Another group of healthy children were assigned to group C as a control group who had not received chemotherapy. The first echo was performed right before the treatment and the second one, two weeks after completing chemotherapy. Data were analyzed by the SPSS statistical software. Results: Changes in mean Tei-index in group A were 0.36 ± 0.04 before treatment and 0.43 ± 0.11 after treatment. Changes in mean Tei-index in group B were 0.37 ± 0.04 before treatment and 0.45 ± 0.06 after treatment. There was no significant difference between the two groups using the independent T-test. (p-value= 0.57). No significant correlation between the changes in mean ejection fraction (EF) and treatment was found in the three groups (p-value=0.45). Conclusion: This study showed a change in the Tei-index (MPI) in patients receiving anthracycline; regardless of the dosage, they got in their regimen. Given the use of anthracycline, any abnormal cardiac finding can alert the physicians to the possibility of cardiomyopathy, hence scheduling routine follow-ups are necessary.

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Abstract 239: The Effect of an Interdisciplinary Simulation Training Program on Translational Outcomes for In-Hospital Cardiopulmonary Arrests

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/circoutcomes.11.suppl_1.239 ◽

2018 ◽

Vol 11 (suppl_1) ◽

Author(s):

John Hunninghake ◽

Justin Reis ◽

Heather Delaney ◽

Matthew Borgman ◽

Raquel Trevino ◽

...

Keyword(s):

Cardiac Arrest ◽

Training Program ◽

Hospital Discharge ◽

Team Training ◽

Quality Data ◽

P Value ◽

Significant Difference ◽

Event Location ◽

Cpr Quality ◽

Hospital Cardiac Arrest

Purpose: High-quality cardiopulmonary resuscitation (CPR) for in-hospital cardiac arrest (IHCA) is the primary component influencing return of circulation (ROSC) and survival to hospital discharge, but few hospitals regularly track these metrics. Other studies have demonstrated significant improvements in survival after IHCA events following implementation of a dedicated code team training program. Therefore, we developed a unique curriculum for a Code Team Training (CTT) course, and evaluated its post-implementation effect on CPR quality and post-IHCA patient outcomes at our institution. Methods: CPR quality data was prospectively collected for quality improvement purposes once our institution had that capability, with 12-months pre-CTT and 21 months post-CTT. Pre-CTT data shaped the elements of the four-hour CTT course that included didactics, small group sessions, and high-fidelity simulation exercises. A total of 456 multi-professional code team members were trained in 22 courses. Data collection included CPR quality and translational outcomes for events where CPR was performed, except the ED. CodeNet® software was used for CPR quality measures, cardiac rhythm, defibrillation metrics, use of continuous waveform capnography, and pauses in compressions. Target metrics for CPR quality were based on 2015 AHA guidelines. Key translational outcomes measures included event location, ROSC, and survival to hospital discharge. Results: CPR quality was obtained from 140 of 230 (61%) in- and out-of-hospital pulseless adult cardiac arrest events over 33 months (50 [36%] before CTT and 90 [64%] following the first course). There was no significant difference between groups in terms of event location within the hospital nor initial event rhythm. A total of 116,908 chest compressions were evaluated. Median compressions in target rate improved from 32% before CTT to 49% after CTT (p<0.05). When accounting for target rate and depth, the median compressions rate improved to 38% post-CTT compared to 31% pre-CTT (p<0.05). While compression depth had a non-statistically significant decline (90.8% pre-CTT and 83.4% post-CTT), mean rate and median rate-in-target improved from 119.99 +/- 15.6 cpm and 32.4% pre-CTT to 113.7 +/- 16.1 cpm and 48.6% post-CTT (p<0.05). The rate of ROSC improved from 60% (30 of 50) to 78% (70 of 90) after implementation of CTT (p=0.003), excluding IHCA in the ED. Index IHCA survival rate for our institution improved from 26% to 33% before and after CTT [p-value NS], which far surpasses the national average (23.8%). Conclusions: After the initiation of a CTT course that targets key code team member personnel, CPR quality significantly improved, which was associated with an increase in ROSC and a trend towards increased survival for in-hospital cardiac arrest patients.

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Toxicity evaluation of Dolichandrone serrulata flower extract on vital and reproductive organs in adult male rats

Brazilian Journal of Biology ◽

10.1590/1519-6984.251224 ◽

2024 ◽

Vol 84 ◽

Author(s):

C. Chaimontri ◽

S. Iamsaard

Keyword(s):

Adult Male ◽

Chronic Toxicity ◽

Vas Deferens ◽

Reproductive Organs ◽

Male Rats ◽

P Value ◽

High Dose ◽

Flower Extract ◽

Normal Ranges ◽

Significant Difference

Abstract Although Dolichandrone serrulata flower (DSF) aqueous extract has been shown to possess pharmacological properties, its systemic toxicity has still to be evaluated. The present study aimed to investigate the sub-chronic toxicity effect of DSF extract on biochemical parameters and histological structures of liver, kidney, testis, and epididymis plus vas deferens. Adult male rats were administered DSF at 100, 300, and 600 mg/kgBW via oral gavage for 48 consecutive days while control rats received distilled water. At the end of the experiment, blood, liver, kidney, testis, and epididymis plus vas deferens samples were collected to determine any changes to serum biochemical components including ALT, ALP, and creatinine levels and histological structures. The results revealed no significant difference in body weight and food or water consumption between control and the DSF-treated groups. It was found that DSF significantly increases the weight of epididymis plus vas deferens, while the kidney and liver showed a decrease in the high dose group (P value < 0.05). Histological changes in these vital and reproductive tissues including fibrosis were not observed after administration but ALT, ALP, and creatinine levels were significantly altered in the treated groups (P value < 0.05). These altered levels, however, were still within normal ranges. In conclusion, these findings demonstrated that D. serrulata flower extract had no sub-chronic toxicity on vital and reproductive structures but slightly altered some liver and kidney functions.

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CML Patients with Low OCT-1 Activity Achieve Better Molecular Responses on High Dose Imatinib Than on Standard Dose. Those with High OCT-1 Activity Have Excellent Responses on Either Dose: A TOPS Correlative Study

Blood ◽

10.1182/blood.v112.11.3187.3187 ◽

2008 ◽

Vol 112 (11) ◽

pp. 3187-3187 ◽

Cited By ~ 8

Author(s):

Deborah L White ◽

Verity A Saunders ◽

Phuong Dang ◽

Amity Frede ◽

Laura Eadie ◽

...

Keyword(s):

Standard Dose ◽

Surrogate Marker ◽

Patient Specific ◽

P Value ◽

High Dose ◽

Molecular Response ◽

Molecular Responses ◽

Significant Difference ◽

The Impact ◽

Trough Levels

Abstract We have previously demonstrated in CML patients enrolled to the Australian TIDEL trial, (600mg imatinib upfront in newly diagnosed patients) that patients with high OCT-1 activity, measured in patient blood mononuclear cells prior to imatinib start, achieve a superior molecular response, compared to those with low OCT-1 activity 1. Furthermore, the impact of low OCT-1 activity could be partially overcome with increased imatinib dose. We now prospectively test the predictive value of OCT-1 activity on the achievement of a major molecular response (<0.1 BCR-ABL IS) by 12 months, in CML patients enrolled to the TOPS trial (randomised 400 vs 800 mg imatinib). A subset of 131 TOPS2 patients had OCT-1 activity measured prior to the start of therapy, as part of the Global Novartis Correlative Science Studies. 41 had high OCT-1 activity (>7.2ng/200,000 cells) as defined in our original study. Patients with high OCT-1 activity had a markedly superior rate of MMR, on either standard or high dose imatinib (table 1). Significantly, a greater proportion of patients with low OCT-1 activity achieved MMR on the high dose arm compared to those on standard dose. This finding was not evident in the high OCT-1 activity group. The % of patients achieving MMR by 12 months (n) Total Low OCT-1 Activity High OCT-1 Activity p- value Total 48% (90) 90% (41) <0.001 400mg 59% (34) 24% (17) 94% (17) <0.001 800mg 62% (97) 53% (73) 87% (24) 0.044 p-value 0.27 0.012 0.64 Table 1: The % of patients achieving MMR based on OCT-1 activity and Randomised dose. The median OCT-1 activity for those patients achieving a MMR (n=80) was 6.05ng/200,000 cells compared to 3.9 for those patients failing to achieve MMR (n=51:p=0.003). Of the 131 patients, trough imatinib levels were available on 61. A greater proportion of patients with a trough imatinib plasma level of >1000ng/ml 3 (n=50) at 1 month achieved MMR (88%) compared to those with plasma levels of <1000ng/ml (n=11:45%: p=0.032). Importantly, OCT-1 activity is not significantly different comparing those patients with trough levels >1000ng/ml (5.6ng/200,000 cells) at 1 month to those with lower trough levels (7.3ng/200,000 cells: p=0.117). This indicates that OCT-1 activity is not providing a surrogate marker of imatinib PK. Dividing the imatinib PK data into quartiles, there is no significant difference in the % of patients achieving MMR based on trough imatinib levels, in patients with high OCT-1 activity. In contrast significantly fewer patients with low OCT-1 activity and low trough levels achieve MMR by 12 months. (Table 2) The % of patients achieving MMR by 12 months (n) Imatinib PK (ng/ml) Total Low OCT-1 Activity High OCT-1 Activity P value Quartile 1 <1600 47% (15) 12% (8) 86% (7) 0.013 Quartile 2 >1600 < 2500 80% (15) 67% (6) 89% (9) 0.469 Quartile 3 >2500 < 3500 80% (15) 77% (13) 100% (2) 0.654 Quartile 4 >3500 75% (16) 60% (10) 91% (6) 0.559 Table 2: The percentage of patients achieving MMR based on quartile analysis of imatinib PK at day 29 In the Australian cohort of 60 patients where detailed molecular response data is available the median molecular response in the 4 subgroups at 12 months shows a significant difference between the 400 mg group with low and high OCT-1 activity (Median BCR-ABL 0.2% IS v 0.02% IS p=0.03) but no difference in the 800 mg groups (low OCT-1 activity v high Median BCR-ABL 0.05% IS v 0.03% IS p=0.139). These analyses support our original proposal that OCT-1 activity defined at diagnosis has a major impact on molecular response and raises the possibility of patient-specific dosing. Patients with low OCT-1 activity are likely to achieve superior molecular responses if they receive imatinib at doses greater than 400 mg, whereas we could not find evidence of a molecular benefit to high dose imatinib for patients with high OCT-1 activity. The clinical value of monitoring trough imatinib drug levels remains to be clearly defined but it is likely to be greatly enhanced if it assessed in the context of the patient’s OCT-1 activity.

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Prospective Validation of the Predictive Power of the Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI) for HCT Outcomes At US Transplant Centers: A Center for International Blood and Marrow Transplant Research (CIBMTR) Study

Blood ◽

10.1182/blood.v120.21.733.733 ◽

2012 ◽

Vol 120 (21) ◽

pp. 733-733 ◽

Cited By ~ 3

Author(s):

Mohamed L. Sorror ◽

Brent R. Logan ◽

Xiaochun Zhu ◽

J. Douglas Rizzo ◽

Kenneth R. Cooke ◽

...

Keyword(s):

Predictive Power ◽

Hematopoietic Cell Transplantation ◽

Mononuclear Cells ◽

Conflicts Of Interest ◽

Karnofsky Performance Status ◽

P Value ◽

High Dose ◽

Kappa Statistics ◽

Allogeneic Hct ◽

Significant Difference

Abstract Abstract 733 In 2005, the HCT-CI was introduced by a single institution as a weighted scoring system to predict mortality risk following allogeneic HCT. Since then, not all investigators were able to validate the HCT-CI after testing in their respective institutions. In 2007, a new prospective multi-institutional observational study was initiated at the CIBMTR to collect comorbidities from all transplant centers by their respective evaluators and to validate the predictive power of the HCT-CI in a large sample of patients (pts). The HCT-CI was adapted into the Pre-Transplant Essential Data (pre-TED) collection form #2400. Data managers from all institutions attended an education session on comorbidity coding per the HCT-CI at the 2007 Tandem BMT Meeting in Keystone, Colarodo. This session was then made public to all data managers at the CIBMTR website. <>The study accrued 8115 consecutive pts treated with allogeneic HCT from 12/2007 to 12/2009 from related (47%) or unrelated (53%) donors. Median age was 52 [range 1–78) years. Conditioning regimens were high-dose (67%) or either reduced-intensity (RIC) or nonmyeloablative (NST) regimens (34%). Diagnoses were acute (54%) or chronic (12%) leukemia, myelodysplastic syndromes (16%), lymphomas (16%), and others (2%). GVHD prophylaxis regimens were cyclosporine-based (22%), tacrolimus-based (68%), or others (10%). Stem cell source was marrow (17%) or peripheral blood mononuclear cells (83%). Karnofsky performance status scores were <90% (33%), ≥ 90% (62%), or missing (5%). HCT-CI scores were 0 (47%), 1 (15%), 2 (11%), 3 (12%), 4 (7%), 5 (3%), ≥6 (4%), or missing (1%). About 11% of pts with score 0 had other comorbidities listed. Overall, pts experienced cumulative incidence of transplant-related mortality (TRM) of 28% and a survival rate of 48% at 3-years. Pts with HCT-CI scores of 0 vs. 1–2 vs. ≥3 had 3-year TRM incidences of 24%, 28%, and 35% (p <0.001) and 3-year overall survival (OS) rates of 54%, 47%, and 38%, respectively (p <0.001, Figure). Proportional hazards models were used to estimate the hazard ratio (HR) for TRM and OS associated with HCT-CI scores. The models were adjusted for all previously mentioned covariates in addition to disease status, CMV serology status, gender, and race. Increasing HCT-CI scores (1–2 and ≥3 vs. 0) were associated with increases in the HR [95% confidence interval (CI)] for TRM [1.12 (1.00–1.26) and 1.47 (1.31–1.65), respectively, p<0.0001] and OS [1.12 (1.03–1.22) and 1.36 (1.25–1.48), respectively, p<0.0001] in the overall pt population. No statistically significant difference could be detected between pts with score 0 + other comorbidities vs. score 0 for TRM (HR 0.93, p= 0.385) or OS (HR 0.96, p= 0.474). When the HCT-CI was modeled as scores of 0, 1, 2, 3, 4, and ≥5 the HR for TRM were 1.00 vs. 1.12 vs. 1.13 vs. 1.31 vs. 1.52 vs. 1.77, respectively (, p<0.0001) and for OS were 1.00 vs. 1.13 vs. 1.12 vs. 1.22 vs. 1.39 vs. 1.62 (p<0.0001). Likewise, the HCT-CI could discriminate outcomes well among pts given high-dose or RIC/NST regimens and those diagnosed with lymphoid or myeloid diseases (Table 1). The inter-rater reliability (IRR) rate among data managers versus their respective investigators was assessed in 3 institutions. Weighted kappa statistics were 0.54, 0.81, and 0.47 respectively, indicating fair-moderate agreement rate among evaluators. The HCT-CI is a valid tool to discriminate relative risks for TRM and OS after HCT across different institutions, different conditioning intensities, and different diagnoses. The HCT-CI should be used as a standard-of-care health measure in counseling pts for HCT, in clinical trial design, and in adjusting statistical analyses for HCT outcomes. Future efforts will focus on improving the IRR of the HCT-CI. Table 1: Multivariate analyses TRM OS HCT-CI scores HR p-value HR p-value High-dose regimens 0 1.00 <0.0001 1.00 <0.0001 1 1.19 1.14 2 1.12 1.10 3 1.34 1.19 4 1.53 1.41 5+ 1.88 1.64 RIC/NST regimens 0 1.00 0.001 1.00 <0.0001 1 0.95 1.12 2 1.10 1.12 3 1.27 1.27 4 1.46 1.39 5+ 1.66 1.65 Lymphoid diseases 0 1.00 <0.0001 1.00 <0.0001 1 1.16 1.15 2 1.24 1.12 3 1.37 1.32 4 2.13 1.67 5+ 2.15 1.88 Myeloid diseases 0 1.00 <0.0001 1.00 <0.0001 1 1.12 1.13 2 1.00 1.06 3 1.25 1.14 4 1.29 1.27 5+ 1.63 1.52 Figure: 3-year OS as stratified by HCT-CI scores of 0 vs. 1–2 vs. ≥3 Figure:. 3-year OS as stratified by HCT-CI scores of 0 vs. 1–2 vs. ≥3 Disclosures: No relevant conflicts of interest to declare.

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