Quality of life in patients with advanced melanoma receiving vaccine therapy alone (V) or vaccine with high-dose interleukin-2 (V-HIL2)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 8549-8549
Author(s):  
S. F. Marden ◽  
P. Muehlbauer ◽  
K. Soeken ◽  
N. Kline Leidy ◽  
D. Parchen ◽  
...  

8549 Background: Melanoma is a public health concern with 1 in 75 Americans diagnosed during their lifetime and 5-year survival rate of about 10% for those with advanced melanoma. With curative options limited, new regimens must be evaluated and attention given to outcomes of how patients feel and function as a result of therapy. Methods: We examined the effect of biotherapy and fatigue on health-related quality of life (HRQL) in patients with stage IV melanoma enrolled in phase II clinical trials at the NCI receiving peptide vaccines with or without high dose IL-2. Generic HRQL was measured by physical (PCS) and mental (MCS) summary scores of the Short Form-36 health survey (SF-36). The Functional Assessment of Cancer Therapy-General (FACT-G) with a fatigue scale (FS) measured disease-specific HRQL and fatigue. Higher scores on measures indicate better physical, emotional, social function and well-being and less fatigue. Between 2000–2003, patients (F=22, M=47; mean age 46 ± 11) completed measures by computer at baseline (BL) and first follow-up after 2 cycles of treatment, before discussion of response to therapy. Data were analyzed using two-way ANCOVA with biotherapy (V or V-HIL2) and fatigue (worse (W) or improved/stable (I/S)) as factors and BL HRQL as covariate. A clinically important difference on FS is reported as 3 points. Fatigue levels with decrease of 3 from BL to follow-up were classified as W and <3 as I/S. Results: Patients were Caucasian (99%), married (77%), BL ECOG 0 or 1 (99%), mean BL Hgb 13 ± 2 and received 2 prior therapies (38%) or more (42%). Adjusting for BL HRQL, there was no biotherapy (p >.30) or interaction effect (p >.60; table ). There was a fatigue effect (p <.001) with lower HRQL adjusted mean scores in W versus I/S. Conclusions: HRQL does not differ in patients with advanced melanoma ECOG 0 or 1 who receive investigational V versus V-HIL2 at follow-up evaluation. Patients’ reporting of worsened fatigue is associated with poorer HRQL, regardless of the biotherapy received. [Table: see text] [Table: see text]

1999 ◽  
Vol 17 (11) ◽  
pp. 3612-3620 ◽  
Author(s):  
Hans Heinzer ◽  
Thomas S. Mir ◽  
Edith Huland ◽  
Hartwig Huland

PURPOSE: We conducted both a subjective and objective, prospective quality-of-life analysis during high-dose (36 × 106 immunizing units/d) inhalational interleukin (IL)-2 treatment (mean treatment time, 13.4 months) of 15 patients with metastatic renal cell carcinoma (mRCC). Additionally, quality of life for 10 patients with mRCC receiving low-dose (9 × 106 IU/m2/d for 5 days) intravenous IL-2 treatment also was evaluated. PATIENTS AND METHODS: Patients responded to the European Organization for Research and Treatment of Cancer quality-of-life questionnaire QLQ-C30 before and during inhalational IL-2 treatment at 1, 3, 6, 9, and 12 months and before and once during intravenous IL-2 treatment. A clinician assessed patient well-being using the Quality of Well-Being scale to calculate once weekly quality-adjusted life-years (QALYs) during inhalational IL-2 treatment. RESULTS: Patients completed 103 questionnaires and clinicians performed 892 QALY calculations. For patients treated with inhalational IL-2, the mean quality-of-life score deteriorated modestly but significantly 1 month after treatment initiation (15.1%, P = .01) but did not differ significantly from pretreatment scores after 3, 6, 9, and 12 months of treatment. Inhalational IL-2 therapy stabilized patient quality of life for a mean of 13.4 months. The resulting QALY calculation for patients on inhalation IL-2 was 70.1% of 13.4 months, representing 9.4 months of QALY. In comparison, patients who received intravenous IL-2 showed a more marked, statistically significant deterioration in mean quality-of-life score during treatment (27%, P = .006); moreover, three of these 10 patients experienced treatment-related toxicity that prevented questionnaire completion. CONCLUSION: Quality-of-life analysis during immunotherapy provides valuable information regarding cancer treatment outcomes.


2020 ◽  
pp. 33-38
Author(s):  
E. Yu. Gan ◽  
L. P. Evstigneeva

Purpose of the study. Assessing the association between the life quality of patients with Sjogren’s Disease and ongoing therapy with various disease-modifying antirheumatic drugs.Material and methods. The study was conducted on the basis of the regional rheumatology center of the consultative diagnostic clinic of the Sverdlovsk Regional Clinical Hospital No. 1. This work is based on the results of a simultaneous study of 74 patients with primary Sjogren’s Disease (SD), distributed in three comparison groups receiving various disease-modifying antirheumatic drugs chlorambucil, methotrexate and hydroxychloroquine. The diagnosis of SD was carried out according to European-American criteria AECGC (2002) [18]. In order to analyze the quality of life of patients with SD, the 36-Item Short Form Health Survey (SF‑36) was used. Statistical data processing was carried out using Statistica 7.0 program.Results. Assessment of the quality of life of patients with SD, which is an integrative criterion of human health and well-being, revealed the absence of statistically significant differences (p > 0.05) on eight scales and two health components of the SF‑36 questionnaire in the analyzed groups that differ in the treatment of disease-modifying antirheumatic drugs chlorambucil, methotrexate and hydroxychloroquine.Conclusions. The obtained data indicate an equivalent quality of life in SD patients treated with different disease-modifying antirheumatic drugs methotrexate, chlorambucil and hydroxychloroquine, and therefore hydroxychloroquine can be considered as an alternative basic therapy in patients with SD with certain limitations and contraindications methotrexate and chlorambucil.


Author(s):  
Loay Shoubash ◽  
Jörg Baldauf ◽  
Marc Matthes ◽  
Michael Kirsch ◽  
Matthias Rath ◽  
...  

AbstractThe aim of this study is to analyze the long-term quality of life after surgery of cavernoma. A monocentric retrospective study was conducted on 69 patients with cavernoma treated microsurgically between 2000 and 2016. The eloquence was adopted from Spetzler-Martin definition. A most recent follow-up was elicited between 2017 and 2019, in which the quality of life (QoL) was evaluated with the Short Form-12 questionnaire (SF12). Forty-one lesions were in eloquent group (EG), 22 in non-eloquent group (NEG), 3 in orbit, and 3 in the spinal cord. Postoperative worsening of the modified Rankin scale (mRS) occurred in 19.5% of cases in EG versus 4.5% in NEG. After a mean follow-up of 6.5 years (SD 4.6), the neurological status was better or unchanged compared to baseline in 85.4% of EG and 100% of NEG. Regarding QoL assessment of 44 patients (EG n = 27, NEG n = 14) attended the last follow-up. Patients after eloquent cavernoma resection reported a non-inferior QoL in most SF12 domains (except for physical role) compared to NEG. However, they reported general health perception inferior to norms, which was affected by the limited physical and emotional roles. At a late follow-up, the surgical morbidity was transient in the NEG and mostly recovered in the EG. The QoL comparison between eloquent and non-eloquent cavernomas created interesting and new data after prolonged follow-up. These results add value for decision-making as well as patient counseling for future encountered cases. Preoperative evaluation of QoL is recommended for future studies to assess QoL dynamics.


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


Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Joan M ODonnell ◽  
Maurizio Manuguerra ◽  
Jemma L Hodge ◽  
Greg Savage ◽  
Michael K Morgan

Background: Studies have questioned the effectiveness of surgery for the management of unruptured intracranial aneurysm (uIA). Few studies have examined the ability to drive and quality of life (QOL) after surgery for uIA. Objective: This study examined the effectiveness of surgical management of uIA by measuring patients’ perceived quality of life and their cognitive abilities related to driving. Methods: Between January 2011 and January 2016 patients with a uIA were assessed using the Quality Metric Short Form 36 (SF36) and the off-road driver screening instrument DriveSafeDriveAware. Reassessments were conducted at the 6-week post-operative follow-up for surgical patients and at 12-month follow-up for surgical and conservatively managed patients. Results: 175 patients enrolled in the study, of which 112(66%) had surgical management of their aneurysm. For the surgical cases who completed all assessments (N=74), there was a trend for the DriveSafe pre-operative mean score of 108 (SD 10.7) to be lower than the 6-week and 12-month post-operative mean scores (111 SD 9.7 and 112 SD 10.2 respectively)(p=0.05). There were no significant changes in DriveAware scores at any epoch or between patient groups nor in the MCS in the surgical group.. There was a significant decline in PCS scores at 6 weeks post-operatively which recovered at 12 months (52 SD 8.1, 46 SD 6.8 and 52 SD 7.1 respectively)( p <0.01). There was no significant difference in 12-month mRS scores between the surgical cases who completed with cases who did not complete all assessments. Conclusion: Surgery for uIA did not affect cognitive abilities for driving at 6 weeks or 12 months after surgery. There was a decline in the QOL in the first months after surgery, however QOL returned to pre-surgical status 12 months after surgery. If the risk of seizures is low and there are no post-operative complications, returning to driving can be recommended.


Author(s):  
Shanmuga Sundaram Rajagopal ◽  
Krishnaveni Kandasamy ◽  
Agilan Natarajan ◽  
Joyal Sebastian ◽  
Manikanta Konakalla ◽  
...  

ABSTRACTObjective: Hypertension (HTN) expends a consequential public health concern on cardiovascular health status and health-care systems in India. Theeffectuation of the pharmaceutical care program in the health care is an extremely important need to achieve the optimum therapeutic effect. Theobjective of the study was to assess the impact of pharmacist intervention on patient’s blood pressure (BP) level, quality of life (QOL), and knowledge,attitude, and practice (KAP) of hypertensive patients.Methods: A randomized controlled pilot study was carried out for 6 months. The hypertensive patients were randomized into control and interventiongroup based on age, and both the groups were interviewed using KAP and WHO QOL-BREF questionnaires, screened BP, respectively, at baseline andeach follow-up after post counseling section to the intervention group. The effect of pharmacist intervention on QOL and KAP among control andintervention was statistically analyzed by paired t-test using SPSS version 16.Results: The total sample studied was 60, of which 20 (33.33%) were males and 40 (66.67%) were females. In our study, the QOL score for eachdomain of both intervention and control groups were almost poor (p˃0.05) at baseline and for the intervention group, a highly significant improvement(p<0.001) was observed for all domains in final follow-up. KAP score of intervention group also showed a significant improvement (p<0.001) frombaseline to final follow-up. In this study, intervention group showed a significant mean reduction of systolic BP from baseline 150.13±25.670 to finalfollow-up 145.33±12.914.Conclusion: The results of the study showed a significant improvement in the patient’s KAP toward different aspects of HTN and QOL followingpharmacist mediated counseling. Involvement of pharmacy practitioners in the management of HTN significantly improves QOL and KAPs.Keywords: Hypertension, Quality of life, Knowledge, Attitude and practice, Pharmacist intervention, Patient counseling.


2018 ◽  
Vol 100 (1) ◽  
pp. 26-32 ◽  
Author(s):  
L Ramage ◽  
C Yen ◽  
S Qiu ◽  
C Simillis ◽  
C Kontovounisios ◽  
...  

Introduction This study aimed to ascertain whether missed obstetric anal sphincter injury at delivery had worse functional and quality of life outcomes than primary repair immediately following delivery. Materials and methods Two to one propensity matching was undertaken of patients presenting to a tertiary pelvic floor unit with ultrasound evidence of missed obstetric anal sphincter injury within 24 months of delivery with patients who underwent primary repair at the time of delivery by parity, grade of injury and time to assessment. Outcomes compared included Birmingham Bowel, Bladder and Urinary Symptom Questionnaire (BBUSQ), Wexner Incontinence Score, Short Form-36, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire and anorectal physiology results. Results Thirty-two missed anal sphincter injuries were matched two to one with sixty-two patients who underwent primary repair of an anal sphincter defect. Mean time to follow-up was 9.31 ± 6.79 months. Patients with a missed anal sphincter injury had suffered more incontinence, as seen in higher the Birmingham Bowel, Bladder and Urinary Symptom Questionnaire (BBUSQ; 30.56% ± 14.41% vs. 19.75% ± 15.65%, P = 0.002) and Wexner scores (6.00 ± 3.76 vs. 3.67 ± 4.06, P = 0.009). They also had a worse BBUSQ urinary domain score (28.25% ± 14.9% vs. 17.01 ± 13.87%, P = 0.001) and worse physical functioning as measured by the Short Form-36 questionnaire (P = 0.045). There were no differences in other outcomes compared, including anorectal physiology and sexual function. Discussion In the short-term, patients with a missed obstetric anal sphincter injury had significantly worse faecal incontinence and urinary function scores, however quality of life and sexual function were largely comparable between groups. Conclusions Longer-term follow-up is needed to assess the effects of missed obstetric anal sphincter injury over time.


Author(s):  
Ilona Stolpner ◽  
Jörg Heil ◽  
Fabian Riedel ◽  
Markus Wallwiener ◽  
Benedikt Schäfgen ◽  
...  

Abstract Background Poor patient-reported satisfaction after breast-conserving therapy (BCT) has been associated with impaired health-related quality of life (HRQOL) and subsequent depression in retrospective analysis. This prospective cohort study aimed to assess the HRQOL of patients who have undergone BCT using the BREAST-Q, and to identify clinical risk factors for lower patient satisfaction. Methods Patients with primary breast cancer undergoing BCT were asked to complete the BREAST-Q preoperatively (T1) for baseline evaluation, then 3 to 4 weeks postoperatively (T2), and finally 1 year after surgery (T3). Clinicopathologic data were extracted from the patients’ charts. Repeated measures analysis of variance (ANOVA) was used to determine significant differences in mean satisfaction and well-being levels among the test intervals. Multiple linear regression was used to evaluate risk factors for lower satisfaction. Results The study enrolled 250 patients. The lowest baseline BREAST-Q score was reported for “satisfaction with breast” (mean, 61 ± 19), but this increased postoperatively (mean, 66 ± 18) and was maintained at the 1 year follow-up evaluation (mean, 67 ± 21). “Physical well-being” decreased from T1 (mean, 82 ± 17) to T2 (mean, 28 ± 13) and did not recover much by T3 (mean, 33 ± 13), being the lowest BREAST-Q score postoperatively and in the 1-year follow-up evaluation. In multiple regression, baseline psychosocial well-being, body mass index (BMI), and type of incision were risk factors for lower “satisfaction with breasts.” Conclusion Both the aesthetic/surgery-related and psychological aspects are equally important with regard to “satisfaction with breasts” after BCT. The data could serve as the benchmark for future studies.


Neurosurgery ◽  
2017 ◽  
Vol 80 (6) ◽  
pp. 967-974 ◽  
Author(s):  
Christoph Schwartz ◽  
Thomas Pfefferkorn ◽  
Caroline Ebrahimi ◽  
Caroline Ottomeyer ◽  
Gunther Fesl ◽  
...  

Abstract BACKGROUND: Detailed data on long-term functional outcome of patients with World Federation of Neurosurgical Societies (WFNS) grades IV and V aneurysmal subarachnoid hemorrhages (aSAH) are still scarce. OBJECTIVE: Assessment of long-term outcome of WFNS IV and V aSAH patients. METHODS: Functional outcome and quality of life were assessed by the modified Rankin scale (mRS) and the 36-item short-form health survey in consecutively treated aSAH WFNS IV and V patients between 2005 and 2010. Scores from the 36-item short-form health survey were compared to a healthy German population. Prognostic factors were analyzed by uni- and multivariate models. RESULTS: One hundred and seven eligible patients (median age: 53.0 years) were identified. After interdisciplinary consensus on optimal treatment, aneurysms were obliterated either by clipping (n = 35) or by coiling (n = 72). Ten patients were lost to long-term follow-up; the median clinical follow-up period was 3.2 years for the remaining 97 cases. Twenty-five of 97 died during the acute hospital phase and another 10 patients over the follow-up period leaving 62 long-term survivors. At the end of clinical follow-up, 40/97 patients, including 40/62 of long-term survivors, reached functional independence (mRS ≤ 2). Twelve of 97 patients were moderately (mRS = 3), 10/97 patients were severely disabled (mRS ≥ 4). Younger age (≤ 53 years; P = .001) and radiological absence of cerebral infarction (P = .03) were the strongest predictors for favorable outcome. Quality of life was perceived to be only moderately reduced compared to the healthy control group. CONCLUSION: Poor-grade aSAH is not necessarily associated with poor long-term functional outcome; after aneurysm repair ∼60% of patients survived and among long-term survivors ∼ 60% regained functional independence.


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