Increasing Hemoglobin Levels with Epoetin Alfa in Anemic Hematologic Cancer Patients Receiving Chemotherapy Correlates Significantly with Improved Quality of Life.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 2213-2213
Author(s):  
Jean-Luc Harousseau ◽  
Pierre Fumoleau ◽  
Winand Lange ◽  
Manfred Welslau
Keyword(s):  
Quality Of Life ◽  
Total Population ◽  
Poor Performance ◽  
Epoetin Alfa ◽  
Analog Scale ◽  
Open Label ◽  
Linear Analog ◽  
The Mean ◽  
Clinically Significant

Abstract The majority of patients (pts) with hematologic malignancies (HM) are anemic and often have poor performance scores (Ludwig H et al. Blood.2002;100:234a). The correlation between increases in hemoglobin (Hb) with epoetin alfa and improvements in quality of life (QOL) was evaluated in this open-label, multicenter study that enrolled 736 adult pts with various solid tumors and HM (n = 122) who were receiving cytotoxic chemotherapy and had Hb levels <12 g/dL. Epoetin alfa was administered 150 IU/kg or 10,000 IU 3 times weekly (TIW) for a maximum 28 weeks (wks); dose was increased to 300 IU/kg or 20,000 IU TIW if Hb was not increased >1 g/dL above baseline within 4 wks. Results for pts with HM are compared to results from a similar 16-wk trial that included pts with HM (n = 488) and used the 40,000 IU once-weekly (QW) dose, increased to 60,000 IU QW if Hb did not increase ≥1 g/dL within 4 wks (Gabrilove J et al. Int J Hematol.2000;72:55). In the TIW study, the primary efficacy endpoint was change in QOL as measured by the Functional Assessment of Cancer Therapy-General (FACT-G), including subscales for anemia (FACT-An) and fatigue; the FACT was administered at study entry, at 8–9 wks, and at 12 wks. QOL was additionally measured by the Cancer Linear Analog Scale (CLAS; also known as the Linear Analog Scale Assessment [LASA]) administered at every study visit. Dose increases were similar in both studies (33.6% of pts in the TIW study; 36.7% of pts in the QW study). In the TIW study, mean baseline Hb was 9.6 g/dL; mean Hb increased at 4–6 wks (1.35 g/dL), 8–9 wks (2.09 g/dL) and 12 wks (2.46 g/dL) to a mean Hb of 12.0 g/dL. Almost half the HM patients in the TIW study (48.1%) had a complete response (Hb increase ≥2 g/dL without blood transfusion). Hematologic results are similar to those reported in the QW study where mean Hb increased 1.96 g/dL by end of study (P = .0001). QOL improvements were also similar between studies. Mean FACT-An scores for the total population in the TIW study increased 6.7 points after 12 wks, which is clinically significant (Patrick DL et al. Eur J Cancer.2003;39:335–345). The mean increase for overall FACT-G correlated significantly with increased Hb at 12 wks (P <.0001; r = .262). Mean CLAS scores for the total population increased steadily throughout the study. At 12 wks mean increases (based on the 100-mm scale) were clinically significant (Patrick et al): 10.9 mm for Energy, 11.2 mm for Daily Activity, and 10.3 mm for Overall QOL. Mean change for FACT-An for patients from the total population in the QW study (n = 2,230) was 6.0 points (P <.001), which is comparable to the mean changes in the TIW study and the HM population of the QW study (6.59 points, P <.0001). No unexpected adverse events were reported. Epoetin alfa TIW or QW was shown to steadily increase Hb, which significantly correlated with clinically significant improvements in QOL.

Impacting Quality of Life for Patients With Advanced Cancer With a Structured Multidisciplinary Intervention: A Randomized Controlled Trial

2006 ◽  
Vol 24 (4) ◽  
pp. 635-642 ◽  
Author(s):  
Teresa A. Rummans ◽  
Matthew M. Clark ◽  
Jeff A. Sloan ◽  
Marlene H. Frost ◽  
John Michael Bostwick ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Radiation Therapy ◽  
Advanced Cancer ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Analog Scale ◽  
Multidisciplinary Intervention ◽  
Linear Analog

Purpose The primary goal of this study was to evaluate the feasibility and effectiveness of a structured, multidisciplinary intervention targeted to maintain the overall quality of life (QOL), which is more comprehensive than psychosocial distress, of patients undergoing radiation therapy for advanced-stage cancer. Patients and Methods Radiation therapy patients with advanced cancer and an estimated 5-year survival rate of 0% to 50% were randomly assigned to either an eight-session structured multidisciplinary intervention arm or a standard care arm. The eight 90-minute sessions addressed the five domains of QOL including cognitive, physical, emotional, spiritual, and social functioning. The primary end point of maintaining overall QOL was assessed by a single-item linear analog scale (Linear Analog Scale of Assessment or modified Spitzer Uniscale). QOL was assessed at baseline, week 4 (end of multidisciplinary intervention), week 8, and week 27. Results Of the 103 participants, overall QOL at week 4 was maintained by the patients in the intervention (n = 49), whereas QOL at week 4 significantly decreased for patients in the control group (n = 54). This change reflected a 3-point increase from baseline in the intervention group and a 9-point decrease from baseline in the control group (P = .009). Intervention participants maintained their QOL, and controls gradually returned to baseline by the end of the 6-month follow-up period. Conclusion Although intervention participants maintained and actually improved their QOL during radiation therapy, control participants experienced a significant decrease in their QOL. Thus, a structured multidisciplinary intervention can help maintain or even improve QOL in patients with advanced cancer who are undergoing cancer treatment.

Impact of therapy with epoetin alfa on clinical outcomes in patients with nonmyeloid malignancies during cancer chemotherapy in community oncology practice. Procrit Study Group.

1997 ◽  
Vol 15 (3) ◽  
pp. 1218-1234 ◽  
Author(s):  
J Glaspy ◽  
R Bukowski ◽  
D Steinberg ◽  
C Taylor ◽  
S Tchekmedyian ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Functional Status ◽  
Cancer Patients ◽  
Hemoglobin Level ◽  
Activity Level ◽  
Epoetin Alfa ◽  
Open Label ◽  
Transfusion Requirements ◽  
The Impact

PURPOSE To study the impact of Procrit (epoetin alfa; Amgen Inc, Thousand Oaks, CA) on quality of life, transfusion requirements, and hemoglobin in anemic cancer patients receiving chemotherapy. PATIENTS AND METHODS More than 500 community-based oncologists enrolled 2,342 patients with malignancies undergoing cytotoxic chemotherapy in an open-label study. Patients were treated with epoetin alfa 150 U/kg three times weekly, which could be doubled if the therapuetic response was judged inadequate. Total treatment was up to 4 months. RESULTS Of the 2,342 patients enrolled, data were available for 2,030 patients. Of the 2,030, 1,047 patients completed all 4 months of epoetin alfa therapy. Epoetin alfa was associated with significant increases in mean self-rated scores for energy level, activity level, and overall quality of life; these improvements correlated with the magnitude of the hemoglobin increase and were independent of tumor response. In addition, epoetin alfa was associated with a significant increase in mean hemoglobin and with a significant decrease in the proportion of patients requiring transfusions (baseline to final value, P < .001). Epoetin alfa was well tolerated. CONCLUSION Epoetin alfa is effective in improving the functional status and quality of life in anemic cancer patients receiving chemotherapy, as well as increasing hemoglobin level and decreasing transfusion requirements. Improvement in functional status can be attributed to an increase in hemoglobin level, demonstrating that quality of life in this group of patients can be improved by aggressively treating anemia. Further studies will be required to define the optimal doses and schedules for epoetin alfa.

scholarly journals Assessment of the quality of life of patients after parathyroidectomy from standard and small access

2021 ◽  
Vol 67 (2) ◽  
pp. 40-48
Author(s):  
A. V. Ogorodnikov ◽  
S. S. Kharnas
Keyword(s):  
Quality Of Life ◽  
Surgical Treatment ◽  
Calculated Data ◽  
Long Term Results ◽  
Graphical Form ◽  
Statistical Criterion ◽  
P Value ◽  
Analog Scale ◽  
Linear Analog

BACKGROUND. Primary hyperparathyroidism (PGPT) is an increase in the secretory activity of the parathyroid glands (OSH), due to their tumor or hyperplastic changes. Due to the lack of an effective alternative to the treatment of PGPT, the surgical method is still the only correct tactical solution for the management of patients with an established diagnosis of PGPT. The paper presents the long-term results and assessment of the quality of life of patients who underwent surgical treatment from standard and small access. The results obtained showed the promise of a sparing approach to the treatment of PGPT caused by LV adenoma.AIM. To study the effectiveness of surgical treatment of patients with PGPT based on the assessment of the quality of life of patients who underwent parathyroidectomy from standard and small access.MATERIALS AND METHODS. A retrospective study of the quality of life of patients with PGPT after surgical treatment was conducted using the SF-36 questionnaire and the linear analog scale (LAS). Statistical data processing is performed in the R programming language using the FMSB package. The quantitative parameters were presented as median (Median) and interquartile range (25th (1st Qu) — lower quartile and 75th (3rd Qu ) — upper quartile). As a nonparametric statistical criterion, the Mann–Whitney U-test was used, on the basis of which the p-value was calculated. The calculated data of the research results are presented in graphical form — in the form of bar charts, spider plot and barplot.RESULTS. This study involved 264 patients. The patients were divided into 2 groups: GR1 — patients operated from the Kocher access with mandatory revision of all 4 OSH, GR2 — patients who received surgical treatment from the small access with the removal of the altered OSH, without revision of the remaining OSH. When analyzing the quality of life of patients before surgery, there were no statistically significant differences in the groups in terms of PF (Physical Functioning) and VT (Vitality). Small-access parathyroidectomy (patients with GR 2) significantly improved the quality of life in the GH (General Health) and VT (Vitality) domains. The analysis of LAS before surgery between the groups showed no statistically significant differences, while after surgical treatment, the indicators on the linear analog scale differ in the direction of improvement in GR2.CONCLUSION. The results obtained in the course of the study showed the promise of a gentle approach to the treatment of PGPT caused by LV adenoma, which is reflected in higher quality of life indicators.

scholarly journals Establishing Clinically Significant Outcomes After Meniscal Allograft Transplantation

2019 ◽  
Vol 7 (1) ◽  
pp. 232596711881846 ◽  
Author(s):  
Joseph N. Liu ◽  
Anirudh K. Gowd ◽  
Michael L. Redondo ◽  
David R. Christian ◽  
Brandon C. Cabarcas ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Short Form ◽  
Lysholm Score ◽  
Meniscal Allograft Transplantation ◽  
Allograft Transplantation ◽  
Meniscal Allograft ◽  
Patient Reported ◽  
The Mean ◽  
Clinically Significant

Background: Traditionally, the primary outcome in meniscal allograft transplantation (MAT) has been long-term survivorship; however, short-term clinically significant outcomes are necessary to fully evaluate patient improvement after surgery. Purpose: To (1) establish the minimal clinically important difference (MCID) and patient acceptable symptomatic state (PASS) with respect to patient-reported outcome measures (PROMs) and (2) evaluate preoperative and intraoperative variables correlated with achieving these threshold values. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: A prospectively maintained institutional registry was queried for all MATs performed between 1999 and 2017. The following PROM scores were collected: International Knee Documentation Committee (IKDC) score, Lysholm score, and Knee injury and Osteoarthritis Outcome Score (KOOS). Patients who completed preoperative and postoperative PROMs within a 1-month window were included to calculate the distribution-based MCID at this interval. An anchor question regarding satisfaction with surgery was asked at the same time point and was employed to determine the PASS using nonparametric receiver operating characteristic curve/area under the curve analysis. Multivariate regression analysis was performed to correlate patient demographics, medical history, and concomitant procedures to propensity in achieving the MCID and PASS. Results: A total of 98 patients who underwent MAT met the inclusion/exclusion criteria, of whom 10 underwent concomitant ligamentous procedures, 65 underwent concomitant cartilage procedures, and 7 underwent concomitant realignment procedures. The mean patient age was 29.4 ± 9.0 years, and the mean body mass index (BMI) was 26.8 ± 5.2 kg/m2. The distribution-based MCID and PASS were determined for the Lysholm score (12.3 and 66.5) and IKDC (9.9 and 36.0) as well as the KOOS Pain (9.9 and N/A ), Symptoms (9.7 and 73.0), Activities of Daily Living (9.5 and N/A), Sport (13.3 and N/A), and Quality of Life (14.6 and 53.0) subscales, respectively. A preoperative Short Form Physical Component Summary (SF PCS) score greater than 32.0 was predictive of postoperative satisfaction. Patients with work-related claims had a reduced likelihood of achieving the MCID for the IKDC and the PASS for the KOOS Symptoms. An increased BMI was also associated with failing to achieve the PASS for the KOOS Quality of Life (QOL). Conclusion: This study established the MCID and PASS for the Lysholm score, IKDC, and KOOS in patients undergoing MAT. Workers’ compensation and higher BMI were associated with failing to achieve clinically significant values. Lower preoperative Lysholm, IKDC, and KOOS scores were predictive of achieving the MCID, while higher preoperative SF PCS scores were associated with achieving satisfaction after MAT.

Quality of life of adult Fontan patients

2020 ◽  
pp. 1-8
Author(s):  
Alexandra Soufi ◽  
Marielle Gouton ◽  
Olivier Metton ◽  
Julia Mitchell ◽  
Yvette F. Bernard ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Subjective Health ◽  
Complex Congenital Heart Disease ◽  
Analog Scale ◽  
Subjective Health Status ◽  
Linear Analog ◽  
Sf 36 ◽  
Fontan Patients

Abstract Background: Progress in the management of complex congenital heart disease (CHD) led to an improvement in survival rates of adults with a Fontan-like circulation. The objective of this study was to assess the subjective health status and quality of life of this population. Methods and results: Patients aged more than 18 years at the time of the study, who underwent a Fontan-like procedure. Subjective health status was assessed by the SF-36 questionnaire and a linear analog scale was used to score patients’ self-perception of their quality of life; cardiac and demographic parameters were collected. Results: Among 65 eligible patients, 60 (23 females; mean ± SD age: 25.7 ± 7.2 years) answered the SF-36 questionnaire and 46 of these were interviewed to evaluate their perceived quality of life. Among them, 20 (33.3%) were working full-time and 21 (35%) experienced arrhythmias. The physical SF-36 scores were lower in patients than in the general population (p ≤ 0.05). The New York Hear Association (NYHA) class and occupation were correlated with SF-36 scores of physical activity (respectively, p = 0.0001 and p = 0.025). SF-36 scores of psychological status were associated with the number of drugs and occupation (respectively, p = 0.0001 and p = 0.02). The mean ± SD quality of life score measured using a linear analog scale was 7.02 ± 1.6 and was linked to education and occupation (p ≤ 0.05) but not with cardiac parameters. Conclusion: Adult Fontan patients perceive an impaired physical health but report a good overall quality of life. Education and occupation impacts significantly on Fontan patients’ quality of life.

A randomized controlled clinical trial comparing different numbers of acupuncture sessions for migraine

2021 ◽  
pp. 096452842110560
Author(s):  
Thanan Supasiri ◽  
Chanchai Jariengprasert ◽  
Mayuri Phithaksilp ◽  
Puritat Sangtongpanichakul ◽  
Suchada Anotayanonth ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Rating Scale ◽  
Acupuncture Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Open Label ◽  
Randomized Controlled ◽  
The Mean

Background: Acupuncture has shown benefit in preventing migraine attacks, but there has been no clear recommendation about the number of treatment sessions that should be provided. Objectives: The aim of this study was to examine whether 5 sessions of acupuncture treatment is non-inferior to 10 sessions for migraine. Methods: We performed a multicenter, open-label, randomized, controlled clinical trial across five hospitals in Thailand. Migraine patients were randomly assigned into two groups: treatment with 5 sessions of acupuncture (group A) or 10 sessions of acupuncture (group B). Acupuncture was performed twice a week. We measured the number of migraine days, average pain severity according to a 0–10 numeric pain rating scale (NPRS) and quality of life using the EQ-5D-5L questionnaire, comparing 4 weeks after treatment versus baseline. Results: Of 156 patients, 83 and 73 patients were assigned to groups A and B, respectively. Comparing 4 weeks after treatment with baseline, the mean reduction in the number of headache days in groups A and B was 6.4 (95% confidence interval [CI] 4.8 to 7.9) days and 6.4 (95% CI 4.5 to 8.4) days, respectively (p = 0.97). The mean difference between the reduction in headache days of the two groups was −0.1 (95% CI −2.5 to 2.4) days, which included the pre-specified non-inferiority limit of −1. The mean reduction of NPRS scores in groups A and B was 4.5 (95% CI 3.8 to 5.1) and 3.8 (95% CI 3.1 to 4.5), respectively (p = 0.17). Both groups showed an improvement in quality of life. Conclusion: Both 5 and 10 sessions of acupuncture were associated with apparent benefits in terms of preventing migraine attacks, reducing the severity of the headache and improving quality of life, based on comparisons between baseline and follow-up in both study groups. Although we were unable to demonstrate non-inferiority of 5 sessions versus 10 sessions of acupuncture, the effects in the two groups were not significantly different and the temporal effects appeared to last for at least 1 month. Trial registration number: TCTR20170612002 (Thai Clinical Trials Registry).

Intranasal Budesonide and Quality of Life in Pediatric Sleep-Disordered Breathing: A Randomized Controlled Trial

2017 ◽  
Vol 158 (4) ◽  
pp. 752-759 ◽  
Author(s):  
Gunnhildur Gudnadottir ◽  
Eva Ellegård ◽  
Johan Hellgren
Keyword(s):  
Quality Of Life ◽  
Nasal Obstruction ◽  
Nasal Spray ◽  
Sleep Disordered Breathing ◽  
Controlled Trial ◽  
Analog Scale ◽  
Double Blind ◽  
The Mean ◽  
Disordered Breathing

Objective To study the efficacy of budesonide nasal spray on the health-related quality of life and symptoms among children with sleep-disordered breathing. Study Design Randomized, parallel, double-blind, placebo-controlled trial. Setting Tertiary referral center. Subjects and Methods Sixty children (ages, 4-10 years) who were referred because of snoring and/or apneas for >3 months were included between January 2015 and June 2016 and randomized in a double-blind design to treatment with 64 μg/mL of budesonide nasal spray (n = 30) or placebo nasal spray (n = 30) twice daily for 6 weeks. The primary outcome measurement was the change in the mean OSA-18 total score from baseline. Other variables examined were individual OSA-18 domains, a visual analog scale for quality of life, symptoms (snoring, apneas, and nasal obstruction), and adenoid and tonsil size. The trial was investigator initiated and not sponsored by the pharmaceutical industry. Results Fifty-five children completed the trial. An intention-to-treat analysis revealed a significantly greater improvement in the mean OSA-18 total score after treatment with budesonide than placebo (19.5 vs 7.5, P = .0014). Intranasal budesonide also improved 2 OSA-18 domains (sleep disturbance, caregivers’ concerns), the visual analog scale score for quality of life, as well as snoring, apneas, and nasal obstruction. No serious adverse events were reported that could be linked to the treatment. Conclusion Among children with sleep-disordered breathing, 6 weeks’ treatment with intranasal budesonide significantly improved quality of life and symptoms as compared with placebo nasal spray.

scholarly journals An analysis of the quality of life of migrants in Gauteng, a province of South Africa

2015 ◽  
Vol 8 (2) ◽  
pp. 495-517 ◽  
Author(s):  
Talita Greyling
Keyword(s):  
Quality Of Life ◽  
South Africa ◽  
Categorical Data ◽  
Total Population ◽  
Composite Index ◽  
Well Being ◽  
Cross Border ◽  
Internal Migrants ◽  
The Mean

Gauteng, the economic centre of South Africa, attracts many migrants from across the African continent and other regions in South Africa: almost 44% of the total population are migrants. In this study, a composite index is constructed and the quality of life of cross-border, internal migrants and the native population of Gauteng is compared. This study uses the method of Nicoletti et al. (2009) to construct the composite index, and adapts it to be suitable for the analysis of categorical data. Furthermore, this study compares the means of the quality of life scores of the different groups using ANOVA. The results of the study show that although there are statistically significant differences between the mean quality of life scores of the groups, the effect size approaches zero. This suggests that migrants and non-migrants experience almost equal levels of quality of life in Gauteng. This result contradicts findings in existing literature that measures well-being.

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