scholarly journals Geriatric Assessment and Frailty Changes in Older Patients with Newly-Diagnosed Multiple Myeloma Undergoing Treatment

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4774-4774 ◽  
Author(s):  
Hira S Mian ◽  
Gregory R Pond ◽  
Sascha A Tuchman ◽  
Mark A. Fiala ◽  
Tanya M. Wildes

Introduction Multiple myeloma (MM) is a malignant plasma cell disease with a median age at diagnosis of 70 years. Geriatric assessment and frailty measures are increasingly being utilized at the time of diagnosis for prognostication. Gait speed at baseline has recently emerged as a powerful prognostic tool which identifies frailty and predicts outcomes independent of performance status among older patients with blood cancers including myeloma (Liu et al, Blood 2019). However, the longitudinal assessment and responsiveness of change in geriatric assessment measures and functional frailty parameters, including physical performance such as gait speed, over time remains unknown. Objectives We conducted a prospective study of patients with newly diagnosed MM aged 65 and older at two institutions. The prevalence of geriatric domains at baseline has been previously published by Wildes et al (JAGS, 2019). We aimed to conduct a secondary analysis to understand the changes in geriatric and frailty assessment including physical performance as older patients underwent treatment for their myeloma. Methods Older patients with newly-diagnosed myeloma underwent a comprehensive geriatric assessment including a gait function using the Timed Up and Go test at baseline and at 6 months between the years 2012-2014. Results At baseline, forty patients were enrolled in the study with a mean age of 71.6 years; 25 (62.5%) were males. Thirty-six patients completed the 6-month follow-up with 18 patients having undergone a stem cell transplant in the interim. Overall, there were no significant change in the measured geriatric domains, including dependence, physical activity, falls, polypharmacy and cognition, at 6 months compared to baseline. Overall mental health well-being, measured with the Mental Health Inventory-17, improved over time (Table I). Physical performance, assessed with the Timed Up and Go test, showed a trend toward improvement as patients underwent treatment (11.0 seconds at the 6-month follow-up versus 12.3 at baseline, p=0.057). Additionally, two out of four individuals who were unable to complete the Timed Up and Go test at baseline were subsequently able to complete it 6 months following treatment. Conclusion Our study suggests that, for older patients with MM, treatment does not significantly lead to geriatric impairment at 6-months of follow-up, as compared to baseline and in fact is associated with improved overall mental health well-being. Additionally, both the incremental change in Timed Up and Go test and the number of individuals able to complete it may in fact improve as patients undergo treatment. This highlights that gait speed may not be static and improve with treatment, suggesting a dynamic model of frailty. Larger studies conducted longitudinally will be required to further evaluate these findings to explore the evolving concept of frailty in myeloma. Disclosures Mian: Amgen: Consultancy; Janssen: Consultancy, Honoraria; Celgene: Consultancy, Honoraria. Pond:Roche Canada: Employment, Other: Stock; Takeda (DSMC membership): Other: Honorarium. Tuchman:Alnylam: Honoraria, Research Funding; Celgene: Honoraria, Research Funding, Speakers Bureau; Karyopharm: Honoraria; Amgen: Research Funding; Sanofi: Research Funding; Merck: Research Funding; Prothena: Research Funding; Roche: Research Funding. Fiala:Incyte: Research Funding. Wildes:Janssen: Research Funding; Carvive: Consultancy.

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 511-511
Author(s):  
Patrice Chevallier ◽  
Thibault Leguay ◽  
Michael Doubek ◽  
Francoise Huguet ◽  
Cyril Salek ◽  
...  

Abstract On behalf of the GRAALL group, the Czech Republic ALL group, the Finland ALL group and the EWALL group. Introduction. Treatment of older patients (pts) with B-cell precursor acute lymphoblastic leukemia (BCP-ALL) remains an unmet medical need. Inotuzumab ozogamicin (INO), an anti-CD22 antibody conjugated to calicheamicin, is approved for the treatment of relapsed/refractory BCP-ALL in adults, sinusoidal obstruction syndrome (SOS) being the major adverse event associated with INO. A previous first line study conducted by the MDACC in pts 60 years or older successfully used INO in combination with a lower intensity version of the hyper-CVAD (mini-hyper-CVD). Due to the occurrence of SOS, the total doses were fixed at 1.3 mg/m² for cycle 1 followed by 3 cycles at 1 mg/m² (Kantarjian H et al. Lancet Oncol, 2018). Here, we aimed to assess the activity and safety of fractionated INO at a reduced dosage in combination with low-intensity chemotherapy as frontline therapy for older pts with CD22+ Philadelphia chromosome-negative (Ph-neg) BCP-ALL. Methods. EWALL-INO is a single arm prospective phase 2 multicentric study conducted in European centers belonging to the EWALL group. Eligibility criteria were pts aged 55y or older, performance status ≤2, and newly diagnosed CD22+ (20% or more of positive blast cells) Ph-neg BCP-ALL without central nervous system involvement. After a prephase including 5 days (D) of dexamethasone (DEX) 10mg per D and a single intrathecal injection (IT), the induction regimen was begun and split in 2 parts. Induction part I (Induc1) consisted of one triple IT, vincristine (VCR) 2 mg (1 mg over 70y) D1 D8 D15 D22 and DEX 20 mg D1D2 D8D9 D15D16 D22D23 combined with 3 injections of INO (0.8 mg/m² D1, 0.5 mg/m² D8 and D15). Induction part II (Induc2) was offered to pts in CR or CRp (CR with platelets < 100 G/l) after Induc1 or as salvage therapy. Induc2 consisted of DEX 20mg D1D8, cyclophosphamide (CY) 300 mg/m² D1 to D3, one triple IT D2 and 2 injections of INO (0.5 mg/m² D1 and D8). Pts in CR/CRp were programmed to receive 6 blocks of consolidation (Ara-C 1.5g/m²/12h adapted to renal clearance D1D2 and DEX 10mg/12h D1D2, cycles 1 and 4; Methotrexate (MTX) 1.5 g/m² over 24h D1, VCR 1 or 2 mg D1, one triple IT D2 and 6-mercaptopurin (6-MP) D1 to D7, cycles 2 and 5; CY 500 mg/m² D1D2, VP16 75 mg/m² D1D2, one triple IT D2 and MTX 25 mg/m² D1, cycles 3 and 6) followed by a POMP maintenance (VCR, 6-MP, MTX, DEX) during 18 months. Allograft was allowed after at least 3 blocks of consolidation at the discretion of the investigators. The evaluable population was pts who received at least 1 dose of INO. Analyses were by modified intention to treat and performed JUN 28, 2021. All pts gave informed consent. The study is registered at ClinicalTrials.gov under the NCT number: NCT03249870. Results. Between DEC 29, 2017 and JUN 22, 2021, 115 pts (out of 130 planned pts) were enrolled including 6 pts with screen failure. The first 90 eligible pts (up to MAR 1, 2021) were considered for this analysis to obtain a minimum of 4 months follow-up. Median age was 69y (range 55-84) and median follow-up for alive pts was 1.18 years (range 0.3-3.5). At time of analysis, 90 and 88 pts had started induc1 and induc2, respectively. Treatment related mortality was 2.2% (2/90) and CR/CRp rate was 85.5% (77/90, 6 CRp) after induc1. Three cases relapsed between induc1 and induc2 and 5 pts were salvaged by induc2 allowing to a CR/CRp rate of 87.7% (79/90, 8 CRp) after induc2. One pts died from refractory disease during induc2. One, 2, 3 4 and 5 injections of INO were administered to 2 (2.2%), 2(2.2%), 11 (12.2%), 2 (2.2%) and 73 pts (81.1%) respectively. Only 6 pts were allografted. One-year OS was estimated to be 78.5% (95%CI 68-85.9) and median OS was not reached. One-year relapse free survival was 74.5% (95CI 63.5-82.6) (Figure 1). Grade 3-4 liver toxicity was observed in 8 pts (8.8%) during the study including 3 pts (3.3%) developing SOS, 2 related to INO during induc1 and one occurred after transplant. Twenty-nine pts died during the follow-up, 16 from relapses (overall incidence 18%) and 13 from adverse events (overall incidence 14.4%), including one COVID19 fatal infection during consolidation. Conclusion. Fractionated inotuzumab ozogamicin at reduced doses (0.8/0.5/0.5/0.5 mg/m²) combined with low-intensity chemotherapy is a very active and well tolerated frontline therapy for older patients with CD22+ Ph-neg BCP-ALL. Figure 1 Figure 1. Disclosures Doubek: Janssen-Cilag, AbbVie, AstraZeneca, Amgen, Gilead, Novartis: Honoraria, Research Funding. Huguet: Novartis: Other: Advisor; Jazz Pharmaceuticals: Other: Advisor; Celgene: Other: Advisor; BMS: Other: Advisor; Amgen: Other: Advisor; Pfizer: Other: Advisor. Raffoux: ABBVIE: Consultancy; PFIZER: Consultancy; CELGENE/BMS: Consultancy; ASTELLAS: Consultancy. Boissel: CELGENE: Honoraria; Servier: Consultancy, Honoraria; Incyte: Honoraria; Amgen: Consultancy, Honoraria, Research Funding; Novartis: Consultancy, Honoraria, Research Funding; Bristol-Myers Squibb: Honoraria, Research Funding; PFIZER: Consultancy, Honoraria; JAZZ Pharma: Honoraria, Research Funding; SANOFI: Honoraria. Dombret: Amgen: Honoraria, Research Funding; Incyte: Honoraria, Research Funding; Jazz Pharmaceuticals: Honoraria, Research Funding; Novartis: Research Funding; Pfizer: Honoraria, Research Funding; Servier: Research Funding; Abbvie: Honoraria; BMS-Celgene: Honoraria; Daiichi Sankyo: Honoraria. Rousselot: Incyte, Pfizer: Consultancy, Research Funding. OffLabel Disclosure: Inotuzumab ozogamicin as first line therapy in newly diagnosed CD22+ Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia


Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 4273-4273 ◽  
Author(s):  
Shane A Gangatharan ◽  
John Kuruvilla ◽  
Vishal Kukreti ◽  
Rodger E. Tiedemann ◽  
Mary Gospodarowicz ◽  
...  

Abstract Introduction Adolescents and young adults with hematologic malignancies have distinct tumor biology, treatment outcomes and psychosocial consequences from cancer diagnosis and its treatment. Follicular lymphoma (FL) is generally considered to be a disease of the elderly, with a median age at diagnosis of 67 years and 65% of patients 60 years or older. FL is rare among young adults (age<40, YA), and the clinical features, natural history and treatment outcomes have not been well defined in this vulnerable patient population, who have unique life challenges while facing what is often considered an incurable lymphoma. We describe the characteristics and outcomes of a large group of YA with newly diagnosed FL treated at our center and compare them to older patients Methods The Princess Margaret Cancer Centre lymphoma database was interrogated for patients registered with FL between 1995 and 2009. Database and retrospective chart review was undertaken to collect data on FLIPI score at diagnosis, time to first and subsequent second treatments, histologic transformation and overall survival (OS). Outcomes were compared between YA and older patients (age 40-65). The older age group was limited to< 65 years to ensure comparable therapies, and because patients in this age range may be potentially eligible for intensive therapy including stem cell transplantation. Results 410 patients with newly diagnosed FL were identified. Stage at diagnosis: I:34.1%; II: 18.3%, III: 21%, IV: 26.7%; FLIPI score: 0 22.9%, 1: 25.8%, 2: 32.8%, 3: 15%, 4: 2.6%, 5: 1%. Fifty five patients (13.4%) were age< 40 at diagnosis. Median age in the YA cohort was 36 years, and 53 years in the older adults. Chi-square testing showed no difference in sex, stage or FLIPI score at diagnosis between YA and older adults. Initial treatment consisted of observation in 105 patients (25.7%); 11 of those managed expectantly were YA. With median follow-up in the observed group of 7.3 years (range 0.68-14.64), 52.3% required therapy (radiation, chemotherapy or combined modality), with median time to therapy from diagnosis of 22 months. Among all patients eventually treated, intial treatment included chemotherapy alone in 37.4%, radiotherapy in 33.8% and combined modality therapy in 25.6%. The most common chemotherapy regimens were CHOP and CVP, alone or with rituximab. Probability of requiring second treatment following initial radiation or chemotherapy was 54.5% at 2 years. FLIPI score strongly predicted time to second treatment (0=0.0047). Time to second treatment was similar for those initially observed compared to those receiving treatment at time of diagnosis, and for young compared to older adults. For the entire cohort, with median follow-up of 8.1 years (range 0.34-17.75), 5-year OS was 86.9%. On univariable analysis there was a significant difference in survival between YA and older patients: 10-year OS 89.3% v 74.2%, p=0.04. On analysis of lymphoma-specific death, there was lower probability of death in YA at 10 years: 4% compared to 15.3% for older adults, although this was not statistically significant (p=0.088). There was no significant difference in survival for patients initially observed compared to those receiving therapy at diagnosis (10-year OS 82.9% v 74%, respectively, p=0.18). Multivariable analysis demonstrated that FLIPI score at diagnosis and age<40 were significant independent variables predictive of OS. Furthermore, despite lack of significance on univariable analysis, in this model patients managed initially with observation had significantly improved OS compared to patients treated at diagnosis with radiation, chemotherapy or both (HR 2.05, p=0.0223). Histologic transformation occurred in 53 patients, 8 in YA (14.5% of all YA) and 45 in the older cohort (12.7% of all older patients). Conclusions YA with follicular lymphoma present with similar clinical characteristics to older patients, and comparable proportions of patients requiring therapy at diagnosis for symptomatic disease. YA demonstrate improved OS independent of FLIPI score compared to older adults. Whether this reflects competing mortality risks or age-related differences in lymphoma biology warrants further investigation. Disclosures: Kuruvilla: Roche: Honoraria. Kukreti:Millennium Pharmaceuticals: Research Funding; Onyx: Research Funding. Tiedemann:Celgene: Honoraria; Janssen: Honoraria. Crump:Roche: Honoraria; Jansen-Ortho: Honoraria; Celgene: Honoraria; Lundbeck: Honoraria; Novartis: Research Funding; Seattle Genetics: Honoraria.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 1368-1368 ◽  
Author(s):  
Yumeng Zhang ◽  
Hannah H Asghari ◽  
Onyee Chan ◽  
Dasom Lee ◽  
Martine Extermann ◽  
...  

Background: Older patients with acute myeloid leukemia (AML) have inferior outcomes when compared to younger patients. Hypomethylating agents (HMA) were established as the standard of care for patients who are unfit for intensive induction chemotherapy until HMA and venetoclax (HMA+ven) combination approval by the FDA in December 2018. Approval of HMA+ven was based on an early phase study which produced high response rates; however, the combination was not compared head-to-head with HMA alone. A randomized phase 3 study is currently underway. There is no data available comparing HMA+ven to HMA monotherapy in older patients (age ≥70 years), thus we aimed to characterize responses in older patients when treated with these two regimens. Methods: We retrospectively reviewed clinical and molecular data on 225 patients at Moffitt Cancer Center and Memorial Health System with newly diagnosed AML who were ≥ 70 years old and were treated with HMA monotherapy or HMA+ven combination. Clinical data was abstracted in accordance with institutional review board approved protocol. Patients were then divided in two subgroups: Cohort A) HMA monotherapy and B) HMA+ven combination. We calculated overall response rates (ORR) defined as patients achieving complete remission (CR), CR with incomplete hematologic recovery (CRi) or morphologic leukemia free state (MLFS). Fisher's Exact method was utilized to determine significance for categorical variables. All reported p-values are two sided. Next generation sequencing (NGS) results were analyzed using the TruSight Myeloid-54 gene panel with a sensitivity of 5%, and were characterized in patients treated in cohort B. Results: Among the 225 patients, 87% (n=196) were in cohort A and 13% (n=29) in cohort B. In cohort A, 36.7% were females compared to 27.6% in cohort B. Median age in both cohorts was 76 years (range: 70-90 years in cohort A) (range: 72-86 years in cohort B). Overall, 26% of the patients had adverse risk disease as defined by European Leukemia Net (ELN) classification in cohort A and 51.7% in cohort B. Baseline characteristics are described in Table 1. Overall response rate (ORR) of the entire cohort was 43.6% (n=92) (Table 2). ORR in cohort A was 25.5% (n=47) compared to 66.7% (n=18) in cohort B (p&lt;0.001). The median time to response in cohort A was 3.8 mos and was 1.9 mos in cohort B. Looking only at the 66 patients with ELN-defined adverse risk, response data were available in 62 patients, and the ORR in both cohorts was 25.8% (n=16), and was significantly lower in cohort A compared to B (14.9% vs. 60%, respectively, p=0.001) (Figure 1). Among the 136 patients with favorable or intermediate risk disease, response data were available in 127 patients, and the ORR was 35.4% (n=45). In cohort A the ORR in favorable/intermediate patients was 28.9% (n=37), and in cohort B it was significantly higher at 100% (n=8) (p&lt;0.001). Ten responding patients in cohort B had NGS data available at diagnosis and at the time of best response. Mutations cleared from the bone marrow in 60% (n=6) of these patients. With a median follow up of 11.7 months, the median overall survival (mOS) of the entire cohort was 15.03 months. The median follow-up time in cohort A is 46 months and in cohort B is 5.4 months, making assessment of relapse free survival or overall survival in cohort B premature. Early mortality rate was not different between the two cohorts (1.5% vs 3.4%, p=0.42). Conclusion: Our data provides convincing support that HMA+ven combination yields significantly higher response rates when compared to HMA monotherapy in newly diagnosed AML patients ≥70 years of age; an observation that is further strengthened by the short duration of follow-up in the HMA+Ven cohort. Responses are particularly striking in favorable and intermediate risk patients when treated with HMA+Ven. Overall our data supports the use of HMA+ven in the upfront setting for older patients with newly diagnosed AML. Additional follow-up in HMA+ven arm is needed to evaluate survival outcomes. Disclosures Kuykendall: Incyte: Honoraria, Speakers Bureau; Abbvie: Honoraria; Janssen: Consultancy; Celgene: Honoraria. List:Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding. Lancet:Agios, Biopath, Biosight, Boehringer Inglheim, Celator, Celgene, Janssen, Jazz Pharmaceuticals, Karyopharm, Novartis: Consultancy; Pfizer: Consultancy, Research Funding; Daiichi Sankyo: Consultancy, Other: fees for non-CME/CE services . Komrokji:JAZZ: Speakers Bureau; Novartis: Speakers Bureau; JAZZ: Consultancy; Agios: Consultancy; Incyte: Consultancy; DSI: Consultancy; pfizer: Consultancy; celgene: Consultancy. Sallman:Celyad: Membership on an entity's Board of Directors or advisory committees. Talati:Celgene: Honoraria; Agios: Honoraria; Jazz Pharmaceuticals: Honoraria, Speakers Bureau; Daiichi-Sankyo: Honoraria; Astellas: Honoraria, Speakers Bureau; Pfizer: Honoraria. Sweet:Pfizer: Consultancy; Incyte: Research Funding; Jazz: Speakers Bureau; Stemline: Consultancy; Bristol Myers Squibb: Membership on an entity's Board of Directors or advisory committees; Celgene: Speakers Bureau; Agios: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Astellas: Membership on an entity's Board of Directors or advisory committees; Abbvie: Membership on an entity's Board of Directors or advisory committees.


2021 ◽  
pp. 1-14
Author(s):  
Nina Reinholt ◽  
Morten Hvenegaard ◽  
Anne Bryde Christensen ◽  
Anita Eskildsen ◽  
Carsten Hjorthøj ◽  
...  

<b><i>Introduction:</i></b> The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) delivered in a group format could facilitate the implementation of evidence-based psychological treatments. <b><i>Objective:</i></b> This study compared the efficacy of group UP and diagnosis-specific cognitive behavioral therapy (dCBT) for anxiety and depression in outpatient mental health services. <b><i>Methods:</i></b> In this pragmatic, multi-center, single-blinded, non-inferiority, randomized controlled trial (RCT), we assigned 291 patients with major depressive disorder, social anxiety disorder, panic disorder, or agoraphobia to 14 weekly sessions in mixed-diagnosis UP or single-diagnosis dCBT groups. The primary test was non-inferiority, using a priori criteria, on the World Health Organisation 5 Well-Being Index (WHO-5) at the end of the treatment. Secondary outcomes were functioning and symptoms. We assessed outcomes at baseline, end-of-treatment, and at a 6-month follow-up. A modified per-protocol analysis was performed. <b><i>Results:</i></b> At end-of-treatment, WHO-5 mean scores for patients in UP (<i>n</i> = 148) were non-inferior to those of patients in dCBT (<i>n</i> = 143; mean difference –2.94; 95% CI –8.10 to 2.21). Results were inconclusive for the WHO-5 at the 6-month follow-up. Results for secondary outcomes were non-inferior at end-of-treatment and the 6-month follow-up. Client satisfaction and rates of attrition, response, remission, and deterioration were similar across conditions. <b><i>Conclusions:</i></b> This RCT demonstrated non-inferior acute-phase outcomes of group-delivered UP compared with dCBT for major depressive disorder, social anxiety disorder, panic disorder, and agoraphobia in outpatient mental health services. The long-term effects of UP on well-being need further investigation. If study findings are replicated, UP should be considered a viable alternative to dCBT for common anxiety disorders and depression in outpatient mental health services.


Nutrients ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 407
Author(s):  
Laetitia Lengelé ◽  
Olivier Bruyère ◽  
Charlotte Beaudart ◽  
Jean-Yves Reginster ◽  
Médéa Locquet

This study aimed to assess the impact of malnutrition on the 5-year evolution of physical performance, muscle mass and muscle strength in participants from the SarcoPhAge cohort, consisting of community-dwelling older adults. The malnutrition status was assessed at baseline (T0) according to the “Global Leadership Initiatives on Malnutrition” (GLIM) criteria, and the muscle parameters were evaluated both at T0 and after five years of follow-up (T5). Lean mass, muscle strength and physical performance were assessed using dual X-ray absorptiometry, handgrip dynamometry, the short physical performance battery test and the timed up and go test, respectively. Differences in muscle outcomes according to nutritional status were tested using Student’s t-test. The association between malnutrition and the relative 5-year change in the muscle parameters was tested using multiple linear regressions adjusted for several covariates. A total of 411 participants (mean age of 72.3 ± 6.1 years, 56% women) were included. Of them, 96 individuals (23%) were diagnosed with malnutrition at baseline. Their muscle parameters were significantly lower than those of the well-nourished patients both at baseline and after five years of follow-up (all p-values < 0.05), except for muscle strength in women at T5, which was not significantly lower in the presence of malnutrition. However, the 5-year changes in muscle parameters of malnourished individuals were not significantly different than those of well-nourished individuals (all p-values > 0.05).


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Salzwedel ◽  
I Koran ◽  
E Langheim ◽  
A Schlitt ◽  
J Nothroff ◽  
...  

Abstract Introduction Comprehensive cardiac rehabilitation (CR) programs based on the bio-psycho-social approach of the international classification of functioning and disease are carried out to achieve improved prognosis, superior health-related quality of life (HRQL) and social integration. We aimed to identify predictors of returning to work (RTW) and HRQL among cardiovascular risk factors and physical performance as well as patient-reported outcome measures (PROMs) modifiable during CR. Methods We designed a prospective observational multi-center study and enrolled 1,586 patients (2017/18) in 12 German rehabilitation centers regardless of their primary allocation diagnoses (e.g. acute myocardial infarction (AMI), coronary artery bypass grafting (CABG), coronary artery disease (CAD), valvular disease). Besides general data (e.g. age, gender, diagnoses), parameters of risk factor management (e.g. smoking, lipid profile, hypertension, lifestyle change motivation), physical performance (e.g. maximum exercise capacity, endurance training load, 6-min walking distance), and PROMs (e.g. depression, heart-focused anxiety, HRQL, subjective well-being, somatic and mental health, pain, general self-efficacy, pension desire as well as self-assessment of occupational prognosis using several questionnaires) were documented at CR admission and discharge. 6 months after discharge, status of RTW and HRQL (SF-12) were captured by a follow-up (FU) survey and analyzed in multivariable regression models with multiple imputation of missing values. Results Out of the study participants, 1,262 patients (54±7 years, 77% men) responded to the follow-up survey and could be analyzed regarding the outcome parameters. Most of them were assigned to CR primarily due to AMI (40%) or CAD without myocardial infarction (18%), followed by heart valve diseases in 12% of patients and CABG (8%). 864 patients (69%) returned to work within the follow-up period. Pension desire, negative self-assessed occupational prognosis, heart-focussed anxiety, major life events, smoking and heart failure were negatively associated with RTW, while higher endurance training load, HRQL and work stress were positively associated (Figure 1). HRQL after 6 months was determined more by PROMs (e.g. pension desire, heart-focused anxiety, physical/mental HRQL in SF-12, physical/mental health in indicators of rehab-status questionnaire (IRES-24), stress, well-being in the World Health Organization well-being index and self-efficacy expectations) than by clinical parameters or physical performance. Conclusions Patient-reported outcome measures predominantly influenced RTW and HRQL in heart-disease patients, whereas patients' pension desire and heart-focussed anxiety had a dominant impact on all investigated endpoints. Therefore, the multi-component CR approach focussing on psychosocial support is crucial for subjective health prognosis and occupational resumption. Figure 1. Predictors of returning to work Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): German pension insurance


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Egle Tamulevičiūtė-Prascienė ◽  
Aurelija Beigienė ◽  
Mark James Thompson ◽  
Kristina Balnė ◽  
Raimondas Kubilius ◽  
...  

Abstract Background To evaluate the short- and mid-term effect of a specially tailored resistance and balance training provided in addition to usual cardiac rehabilitation (CR) care program in older patients after valve surgery/intervention. Methods Single-center (inpatient CR clinic in Lithuania) randomized controlled trial. Two hundred fifty-two patients were assessed for eligibility on the first day of admittance to CR early after (14.5 ± 5.9 days) valve surgery/intervention between January 2018 and November 2019. Participants were coded centrally in accordance with randomization 1:1 using a computerized list. Control group (CG) patients were provided with usual care phase-II-CR inpatient multidisciplinary CR program, while intervention group (IG) patients received additional resistance and balance training (3 d/wk). Patients participated in a 3-month follow-up. Main outcome measures were functional capacity (6 min walk test (6MWT, meters), cardiopulmonary exercise testing), physical performance (Short Physical Performance Battery (SPPB, score) and 5-m walk test (5MWT, meters/second)), strength (one repetition maximum test for leg press), physical frailty (SPPB, 5MWT). Results One hundred sixteen patients (76.1 ± 6.7 years, 50% male) who fulfilled the study inclusion criteria were randomized to IG (n = 60) or CG (n = 56) and participated in CR (18.6 ± 2.7 days). As a result, 6MWT (IG 247 ± 94.1 vs. 348 ± 100.1, CG 232 ± 102.8 vs. 333 ± 120.7), SPPB (IG 8.31 ± 2.21 vs. 9.51 ± 2.24, CG 7.95 ± 2.01 vs. 9.08 ± 2.35), 5MWT (IG 0.847 ± 0.31 vs. 0.965 ± 0.3, CG 0.765 ± 0.24 vs 0.879 ± 0.29) all other outcome variables and physical frailty level improved significantly (p < 0.05) in both groups with no significant difference between groups. Improvements were sustained over the 3-month follow-up for 6MWT (IG 348 ± 113 vs. CG 332 ± 147.4), SPPB (IG 10.37 ± 1.59 vs CG 9.44 ± 2.34), 5MWT (IG 1.086 ± 0. 307 vs CG 1.123 ± 0.539) and other variables. Improvement in physical frailty level was significantly more pronounced in IG (p < 0.05) after the 3-month follow-up. Conclusion Exercise-based CR improves functional and exercise capacity, physical performance, and muscular strength, and reduces physical frailty levels in patients after valve surgery/intervention in the short and medium terms. SPPB score and 5MWT were useful for physical frailty assessment, screening and evaluation of outcomes in a CR setting. Additional benefit from the resistance and balance training could not be confirmed. Trial registration NCT04234087, retrospectively registered 21 January 2020.


2018 ◽  
Vol 6 (12) ◽  
pp. 1-248 ◽  
Author(s):  
Steven Cummins ◽  
Charlotte Clark ◽  
Daniel Lewis ◽  
Neil Smith ◽  
Claire Thompson ◽  
...  

Background There is limited evidence for public health policy-makers on the health impacts of urban regeneration programmes. Objectives To assess whether or not the London 2012 Olympic and Paralympic Games, and related urban regeneration, were associated with an increase in physical activity and mental health and well-being; to assess whether or not any benefits were sustained over time; and to capture the experiences of residents of the Olympic host boroughs. Design Quasi-experimental prospective cohort study of adolescents and their parents/carers, with a nested qualitative longitudinal study of families. Setting London boroughs of Newham, Barking and Dagenham, Tower Hamlets and Hackney. Participants A cohort of 2254 adolescents in 25 schools; a repeat cross-sectional study of parents/carers and a sample of 20 families for the qualitative study. Intervention The London 2012 Olympic and Paralympic Games, and urban regeneration primarily associated with the redevelopment of the Olympic Park for legacy use. Primary outcome measures Change in the proportion of respondents meeting physical activity recommendations (using self-reported physical activity); change in the proportion of respondents reporting depression and anxiety and change in well-being score. Main results At 6 months, adolescents who became inactive were less likely to come from the intervention borough (Newham) than from comparison boroughs [risk ratio (RR) = 0.69, 95% confidence interval (CI) 0.51 to 0.93]. At 18 months, there were no statistically significant differences between intervention and comparison boroughs for all adolescent physical activity and screen-time transitions. Those who visited the Olympic Park more than once a month were the least likely to remain inactive (RR 0.11, 95% CI 0.02 to 0.48) and the least likely to become inactive (RR 0.38, 95% CI 0.24 to 0.60) compared with those who were active at baseline and at the 18-month follow-up. No impacts on parental/carer physical activity were observed. Adolescents who were ‘no longer depressed’ (RR 1.53, 95% CI 1.07 to 2.20) or ‘remained depressed’ (RR 1.78, 95% CI 1.12 to 2.83) at 6 months were more likely to be from the intervention borough. For well-being, there was no association between boroughs and change in well-being between baseline and the 6-month follow-up. At 18 months’ follow-up, adolescents who ‘remained depressed’ (RR 1.93, 95% CI 1.01 to 3.70) were more likely to be from the intervention borough than from comparison boroughs. No associations were observed for well-being at 18 months. There was limited evidence of change for parental mental health and well-being. The qualitative study found that residents generally welcomed the unexpected chance to live in a cleaner, safer and more unified environment. The findings suggested that the Games temporarily alleviated certain stressors in the social and physical environment. Overall, the Games lessened participants’ sense of social exclusion and appeared to generate a sense of inclusion and respite, even if this was only temporary. Study limitations include the potential for adolescents to not be assigned the correct level of exposure to urban regeneration and the effect of reductions in central and local public budgets owing to the UK Government’s deficit reduction programme. Conclusions This study provided the highest quality data to date on the short- and medium-term social and health impacts of sporting mega-events. We found limited evidence that the London 2012 Olympic and Paralympic Games had a positive effect on adolescent or parental physical activity, mental health or well-being. Funding The National Institute for Health Research Public Health Research programme.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5701-5701
Author(s):  
Justin King ◽  
Mark A. Fiala ◽  
Scott R. Goldsmith ◽  
Keith E. Stockerl-Goldstein ◽  
Mark A. Schroeder ◽  
...  

Historically, high-dose therapy in combination with autologous stem cell transplants (ASCT) for multiple myeloma (MM) was reserved for younger patients. In more recent years, the use of ASCT has expanded in the older population. However, there is still limited data on the utilization and efficacy of ASCT in older patients, particularly those over the age of 75. To further evaluate this issue, we retrospectively analyzed all patients with newly diagnosed MM between the ages of 75-78, the institutional cutoff for ASCT eligibility, that were referred to the stem cell transplant unit at our institution for consultation from the years 2012-2018. Baseline characteristics, anti-myeloma treatments, and patient outcomes were abstracted through chart review. Seventy-five patients were referred to our institution. 71% were male, 29% female. 39% patients were considered ineligible for ASCT by the consulting transplant physician. Most patients were considered transplant ineligible due to comorbidities or poor performance status. Of the 46 patients eligible for ASCT, 52% underwent the procedure during their first-line therapy. The majority of those patients received reduced intensity melphalan (140 mg/m2) while 2 patients received conventional dosing (200 mg/m2). The other 22 patients eligible for ASCT declined or elected to defer the procedure and to be treated with conventional therapy. The characteristics of these three groups were similar and are detailed in Table 1. After a median follow-up of 30 months, 25% of the patients had expired. Estimated median overall survival (OS) was 71.3 months (unable to quantitate 95% CI) for all patients. Compared to transplant eligible patients, regardless of transplant receipt, those who were transplant ineligible had a 186% increase risk for death (HR 2.86; 95% CI 1.12-7.35; p = 0.029). There was also a notable trend for longer OS in those who underwent ASCT compared to those who were eligible but declined the procedure, but it was not statistically significant (HR 0.36; 95% CI 0.10-1.28; p = 0.114). At a transplant center, two-thirds of patients referred for newly diagnosed MM between the ages 75-78 were considered eligible for ASCT and one-third underwent the procedure. Outcomes were better for patients eligible for ASCT, regardless of whether they underwent the procedure. There was also a trend for better OS in patients who underwent the procedure compared to those who declined. While small sample sizes and the retrospective nature of the study limit our ability to draw conclusions, it appears that ASCT has an OS benefit among patients age 75-78. Disclosures Fiala: Incyte: Research Funding. Stockerl-Goldstein:AbbVie: Equity Ownership; Abbott: Equity Ownership. Vij:Genentech: Honoraria; Janssen: Honoraria; Bristol-Myers Squibb: Honoraria, Research Funding; Sanofi: Honoraria; Karyopharm: Honoraria; Takeda: Honoraria, Research Funding; Celgene: Honoraria, Research Funding. Wildes:Janssen: Research Funding; Carevive: Consultancy.


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