Changes In Quality Of Life Scores Research Articles

Comparison of quality of life between 2-year and 3-or-more-year administration of leuprorelin acetate every-3-months depot in combination with tamoxifen as adjuvant endocrine treatment in premenopausal patients with endocrine-responsive breast cancer: a randomized controlled trial

BackgroundWe conducted an open-label, randomized controlled trial evaluating the appropriate treatment duration of leuprorelin acetate 3-month depot, TAP-144-SR (3M), administered postsurgically every 3 months for 2 years versus 3 or more (up to 5) years, in combination with tamoxifen, for 5 years in premenopausal endocrine-responsive breast cancer patients and reported similar survival benefit in the two treatment groups. We hereby present patient-reported quality of life (QOL) data obtained from this trial.MethodsThree self-administered QOL questionnaires (QOL-ACD, QOL-ACD-B, FACT-ES subscale) were used, and the difference in QOL score changes between the two groups was analyzed using a mixed-effects model for repeated measures.ResultsEligible patients (N = 222) were randomly assigned to a 2-year (2YG, N = 112) or 3-or-more-year treatment group (3YG, N = 110). The time courses of the three QOL scores during the trial period were similar in the two groups. The mean changes in the QOL scores from week 96 were largely stable through week 240 in the 3YG, but showed significantly greater improvement in the score changes from week 96 in the 2YG than the 3YG. Symptoms associated with menopause such as hot flashes and sweating contributed to these results. Menstruation recovery was associated with significantly greater improvement of these symptoms in the 2YG than the 3YG.ConclusionsPatient-reported menopause-associated symptoms and QOL improved after discontinuation of the LH-RH agonist administration and menstruation recovery. QOL information should be a consideration in long-term treatment.

Quality of Life in Children and Youth with Obsessive-Compulsive Disorder.

The study examined clinical correlates of quality of life (QoL), impact of treatment on QoL, and predictors of QoL change among children with obsessive-compulsive disorder (OCD). One hundred forty-two children with primary OCD who were enrolled as part of a larger clinical trial participated. Children were administered a structured diagnostic interview, as well as clinician-administered measures of OCD and depression symptom severity. Children and parents completed reports of QoL, as well as measures of impairment and internalizing and externalizing symptoms. Youth received 10 sessions of family-based cognitive-behavioral therapy (CBT). At baseline, QoL was inversely related to obsessive-compulsive symptom severity, impairment, externalizing and internalizing symptoms, and severity of depression symptoms according to children and parents. After CBT, QoL improved according to parent ratings, but not child ratings. None of the predictors examined were associated with changes in QoL scores over time. Impairment, and externalizing and internalizing symptoms predicted QoL after accounting for OCD symptom severity. After accounting for OCD symptoms, externalizing symptoms inversely predicted changes in QoL. These data suggest that QoL is related to more severe clinical presentation and improves with evidence-based treatment, but QoL improvements may be inversely related to externalizing symptomology.

Quality of life in responders after palliative radiation therapy for painful bone metastases using EORTC QLQ-C30 and EORTC QLQ-BM22: results of a Brazilian cohort.

Bone metastases cause pain, suffering and impaired quality of life (QoL). Palliative radiotherapy (RT) and/or chemotherapy are effective methods in controlling pain, reducing analgesics use and improving QoL. This study goal was to investigate the changes in QoL scores among patients who responded to palliative treatment. A prospective study evaluating the role of radiation therapy in a public academic hospital in São Paulo-Brazil recorded patients' opioid use, pain score, Portuguese version of QLQ-BM22 and QLQ-C30 before and 2 months after radiotherapy. Analgesic use and pain score were used to calculate international pain response category. Overall response was defined as the sum of complete response (CR) and partial response (PR). CR was defined as pain score of 0 with no increase in analgesic intake whereas PR was defined as pain reduction ≥2 without analgesic increase or analgesic reduction in ≥25% without increase in pain at the treated site. From September 2014 to October 2015, 25 patients with bone metastases responded to RT or chemotherapy (1 CR, 24 PR). There were 8 male and 17 female patients. The median age of the 25 patients was 59 (range, 22 to 80) years old. Patient's primary cancer site was breast [11], prostate [5], lung [2], others [7]. For QLQ-BM 22, the mean scores of 4 categories at baseline were: pain site (PS) 39, pain characteristics (PC) 61, function interference (FI) 49 and psycho-social aspects (PA) 57. At 2 month follow up, the scores were PS 27, PC 37, FI 70 and PA 59. Statistical significant improvement (P<0.05) was seen in PS, PC, FI but not PA. In the QLQ-C30, the scores were not statistically different for all categories, except for pain that demonstrated a 33 point decrease in the median pain score domain (66 to 33). Responders to RT at 2 months presented improvement in BM22 and C30 pain domains, and also improvement in functional interference domain of the BM22 questionnaire.

A randomized phase II trial comparing different schedules of nab-paclitaxel (nabP) combined with gemcitabine (GEM) as first line treatment for metastatic pancreatic adenocarcinoma (mPDAC).

4100 Background: NabP+GEM chemotherapy improves survival compared with GEM monotherapy as treatment for mPDAC. A PDAC mouse model suggested that nabP potentiates GEM activity by reducing cytidine deaminase levels and scheduling may be critical to optimise clinical benefit. Methods: Patients (pts) were randomised to receive standard concomitant (CON) nabP+GEM or sequential (SEQ) administration, with nabP given 24 hours before GEM. After 6 cycles, pts benefiting from treatment could continue the same regimen until disease progression. The primary endpoint was progression-free survival (PFS) by RECIST v1.1; secondary endpoints included safety, objective response rate (ORR), overall survival (OS) and quality of life (QoL). Serial blood and baseline tumour samples were collected for exploratory biomarkers. Results: Between March 2014 and 2016, 146 pts (71 SEQ, 75 CON) were recruited. Median age (range) was 66 (45-82) years; Karnofsky performance status was 70 (in 12% pts), 80 (27%), 90 (38%) or 100 (24%); 47% had pancreatic head primaries; 84% had liver metastases. Median no. cycles received was 4 SEQ, 3 CON; 51 pts (35%) received ≥6 cycles of treatment (42% SEQ, 28% CON). A 24+2hr interval was achieved in &gt; 90% SEQ admin. Grade ≥3 adverse events experienced by ≥10% pts (SEQ, CON) were neutropaenia (54%, 30%; p = 0.003), febrile neutropaenia (12%, 12%), fatigue (22%, 15%), vomiting (7%, 11%) and anaemia (10%, 5%). G-CSF was administered at local investigator's discretion to 35 pts (23 SEQ, 12 CON; p = 0.015). To date, 112 pts have died. 6 month (m) PFS by SEQ and CON arms were 47% and 33%; median PFS were 5.8 and 4.0m; hazard ratio (HR) = 0.66, 95% CI = 0.46-0.95; 12m OS by SEQ and CON arms were 29% and 26%; median OS were 10.1 and 7.9m; HR = 0.88, 95% CI = 0.61-1.29. ORR was 50% SEQ and 33% CON (p = 0.065). Mean baseline QoL Global health status score was 60.6 SEQ and 63.4 CON. The mean change in QoL score from baseline at 24 weeks was -2.1 SEQ and -12.1 CON. Conclusions: Sequential delivery of nabP combined with GEM trended towards improving all clinically relevant efficacy end points: PFS, OS, and ORR. Translational correlates will be reported in due course. Clinical trial information: ISRCTN71070888.

Quality of life on TSU-68: Combination of docetaxel and TSU-68, an oral antiangiogenic agent, in patients with metastatic breast cancer previously treated with anthracycline.

The aim of this study is to investigate whether the addition of TSU-68 would affect on the quality of life (QOL) of Korean metastatic breast cancer patients treated with docetaxel. Sixty-three of 78 patients completed the baseline QOL questionnaires and at least one follow-up questionnaire comprising questions from the Korean Functional Assessment of Cancer Therapy-Breast (FACT-B), hospital anxiety and depression scale (HAD), the shortened form of the profile of mood states (BPOMS), and anticipation and anxiety for treatment scale. Changes in QOL scores from baseline were compared by analysis of covariance at each time point (6, 12 weeks, 9, 12 and 18 months) and at the end of treatment (EOT), and the longitudinal changes over time were evaluated by repeated measure analysis. The two-treatment groups (TSU-68 plus docetaxel [A] vs docetaxel alone [B]) were well balanced regarding sociodemographic characteristics, including age (P = 0.450), religion (P = 1.000), education (P = 0.257), ECOG performance status (P = 0.261), and employment status (P = 0.325). The return rate at EOT was 61.9%. In analyses at each QOL measuring time, A group showed a higher FACT-B total score and FACT-G score than B at 12 months (P = 0.031 and P = 0.024, respectively). The anticipation and anxiety for treatment scale of A group was higher than that of B at 12 weeks and EOT (P = 0.046 and P = 0.022, respectively). However, repeated measure analysis for longitudinal changes over time showed no significant group wise differences. The combination of TSU-68 with docetaxel showed no additional adverse effects on patient QOL during the study period, as compared with docetaxel monotherapy.

Abstract MP077: Longitudinal Associations Between Venous Disease Progression and Change in Quality of Life: San Diego Population Study

Background: Chronic venous disease, one of the most common chronic diseases in the United States, is associated with lower quality of life (QOL). Although earlier studies have identified a significant association between the cross-sectional prevalence of venous disease and QOL, few studies have investigated the association between venous disease progression and change in QOL. Therefore, the aim of this study was to investigate the relationship between progression of venous disease and change in QOL in a longitudinal cohort. Methods: A population-based cohort of 1103 participants were examined at baseline and 11 years later. At both visits, QOL and risk factors were assessed by questionnaire, anthropometric measures obtained by clinical examination, and venous disease assessed by visual inspection and duplex ultrasound. QOL was measured with the Medical Outcomes Study 36-Item Short Form (SF-36) with the resulting physical component (PCS) and mental component scores (MCS) being used in the analysis. Using ANCOVA methods to control for age, gender, and ethnicity, changes in venous disease were compared against QOL stratified into tertiles. Then, linear regression models were used to examine the longitudinal association of venous disease at baseline and change in QOL score at follow-up after controlling for covariates. Results: In the study population of 1103 individuals, 78 had regression, 340 had progression, and 685 were stable. The average age was 58.7 years (SD 10.4); 33% were male, 61% were non-Hispanic White, 15% were Hispanic, 12% were African American, and 12% were Asian. Mean BMI was 27.1 (SD 5.3), 45.4% had hypertension, 9.9% were diabetic, 3.6% were current smokers, and 34.8% were on medication for hyperlipidemia. Progression of venous disease was significantly associated with change in PCS after controlling for age, gender, and ethnicity ( β =-0.075; p =.04). The association was only slightly attenuated ( β =-.065, p=.08) after adjustment for BMI, high blood pressure, injury to either leg, smoking history, previous vein procedure, previous hernia surgery, flat feet, marital status, education level, occupation, cardiovascular-related morbidity, diabetes, and heaviness in either leg. No association was found with MCS before or after multiple covariate adjustment. Conclusions: This study confirms that individuals with progression of chronic venous disease have a greater decrease in QOL as identified by the physical component score of SF-36. Prevention of chronic venous disease progression may help retain QOL.

A preliminary investigation of body composition in prediction of malnutrition in patients with nasopharyngeal carcinoma

Objective To investigate the relationship between nutritional status and quality of life (QOL) in patients with nasopharyngeal carcinoma undergoing concurrent chemoradiotherapy, and to identify the optimal indices of body composition for evaluation of malnutrition. Methods Based on the European Society Parenteral and Enteral Nutrition (ESPEN) consensus on the diagnosis of malnutrition and patient-generated subjective global assessment (PG-SGA), a prospective study was performed in 48 patients with nasopharyngeal carcinoma who received concurrent chemoradiotherapy in our hospital from 2014 to 2015. Changes in body composition and nutritional status were evaluated in those patients. The relationship between nutritional status and QOL was studied. The predictive factors for nutritional status in patients with nasopharyngeal carcinoma were explored. The correlation between datasets was evaluated by the Pearson correlation coefficient. The influencing factors for nutritional status were analyzed by Logistic regression. Results During concurrent chemoradiotherapy, some indices of body composition, including weight, body mass index (BMI), fat mass index (FMI), fat-free mass index (FFMI), body cell mass (BCM), skeletal muscle mass (SM), and phase angle (PA) had different degrees of reduction (P=0.00), while the PG-SGA score gradually increased. The incidence of malnutrition in patients with nasopharyngeal carcinoma during radiotherapy was 2.1%-39.6% based on 2015 ESPEN consensus on the diagnosis of malnutrition and 12.5%-41.7% based on PG-SGA. These two methods showed good agreement at the fourth and sixth weeks of radiotherapy (Kappa=0.911; Kappa=0.957). The changes in QOL score were correlated with changes in FFMI and weight during radiotherapy (r=0.805, P=0.00; r=0.777, P=0.00). Logistic regression indicated that age, FMI, and FFMI were influencing factors for nutritional status (P=0.035, 0.013, 0.043). Conclusions Patients with nasopharyngeal carcinoma have substantial nutritional deterioration during chemoradiotherapy. The nutritional status is closely associated with QOL. A prediction model of nutritional status can provide a comprehensive and accurate judgment of nutritional status in patients. Key words: Malnutrition; Body composition; Consensus on the diagnosis of malnutrition, European Society Parenteral and Enteral Nutrition; Patient-generated subjective global assessment; Nasopharyngeal neoplasms/chemoradiotherapy

Plan quality and dosimetric association of patient-reported rectal and urinary toxicities for prostate stereotactic body radiotherapy

Background and purposeTo study the association between dosimetric parameters with patient-reported quality-of-life (QOL) in urinary irritative/incontinency and bowel functions for prostate stereotactic body radiotherapy (SBRT). Material and methodsThe patient-reported QOL was evaluated using the Expanded Prostate Cancer Index Composite (EPIC-26). According to the progression in QOL score over 12months, patients were assigned to one of three subgroups: score decrement, no change, or increment. The dosimetric parameters were cross-compared among subgroups in urinary and bowel domains using univariate Analysis of Variance (ANOVA). The evaluated dosimetric metrics included target volume, V100 (volume receiving 100% prescription dose); rectal volume/dose–volume endpoints, maximum/mean doses; bladder volume/dose–volume endpoints, and maximum/mean doses. ResultsPatients with consistent QOL reduction in urinary irritation function were significantly associated with greater mean bladder dose, greater V85/V90/V95/V100 and D2cc/D10cc. Patients with QOL reduction in urinary incontinence were marginally associated with greater mean bladder dose (p=0.06). None of the evaluated dosimetric parameters showed a significant correlation with QOL score change in bowel function. ConclusionsPatients with large prostate size were more susceptible to QOL decrements for urinary irritative and incontinency functions. Large bladder V85/V90/V95/V100 was associated with QOL decrements in the urinary irritative domain at 1-year after prostate SBRT.

Randomised phase III study of S-1 alone versus S-1 plus lentinan for unresectable or recurrent gastric cancer (JFMC36-0701)

BackgroundLentinan (LNT) is a purified β-1, 3-glucan that augments immune responses. The present study was conducted to assess the efficacy of LNT in combination with S-1 as a first-line treatment for unresectable or recurrent gastric cancer. Patients and methodsEligible patients were randomly assigned to receive S-1 alone or S-1 plus LNT. The primary end-point was overall survival (OS). Secondary end-points were time-to-treatment failure (TTF), overall response rate (ORR), safety, quality of life (QOL), and biomarker. The percentages of LNT-binding monocytes in peripheral blood prior to treatment were analysed for the biomarker assessment. ResultsOne hundred and fifty-four and 155 patients were randomly assigned to receive S-1 alone or S-1 plus LNT, respectively. The median OS was 13.8 and 9.9 months (P = 0.208), the median TTF was 4.3 and 2.6 months (P < 0.001), the ORR was 22.3% and 18.7% for the S-1 and S-1 plus LNT groups, respectively. The incidences of haematologic and non-haematologic adverse events were similar, and no significant changes in QOL scores were observed during the treatment in both groups. In a subpopulation of patients with LNT-binding monocytes ≥2%, patients who received more than two cycles of chemotherapy showed a longer survival time in the S-1 plus LNT group. ConclusionsOS did not improve and TTF was significantly worse in the S-1 plus LNT group as compared with the S-1-only group. This study showed no efficacy of LNT when combined with S-1 treatment in patients with unresectable or recurrent gastric cancer. Clinical trial registration ID numberUMIN 000000574.

Patient-reported outcomes of a multicenter phase 2 study investigating gemcitabine and stereotactic body radiation therapy in locally advanced pancreatic cancer

PurposeWe previously reported clinical outcomes and physician-reported toxicity of gemcitabine and hypofractionated stereotactic body radiation therapy (SBRT) in locally advanced pancreatic cancer (LAPC). Here we prospectively investigate the impact of gemcitabine and SBRT on patient-reported quality of life (QoL). Methods and materialsForty-nine LAPC patients received 33 Gy SBRT (6.6 Gy daily fractions) upfront or after ≤3 doses of gemcitabine (1000 mg/m2) followed by gemcitabine until progression. European Organization for Research and Treatment of Cancer QoL core cancer (QLQ-C30) and pancreatic cancer-specific (European Organization for Research and Treatment of Cancer QLQ-PAN26) questionnaires were administered to patients pre-SBRT and at 4 to 6 weeks (first follow-up [1FUP]) and 4 months (2FUP) post-SBRT. Changes in QoL scores were deemed clinically relevant if median changes were at least 5 points in magnitude. ResultsForty-three (88%) patients completed pre-SBRT questionnaires. Of these, 88% and 51% completed questionnaires at 1FUP and 2FUP, respectively. There was no change in global QoL from pre-SBRT to 1FUP (P = .17) or 2FUP (P > .99). Statistical and clinical improvements in pancreatic pain (P = .001) and body image (P = .007) were observed from pre-SBRT to 1FUP. Patients with 1FUP and 2FUP questionnaires reported statistically and clinically improved body image (P = .016) by 4 months. Although pancreatic pain initially demonstrated statistical and clinical improvement (P = .020), scores returned to enrollment levels by 2FUP (P = .486). A statistical and clinical decline in role functioning (P = .002) was observed in patients at 2FUP. ConclusionsGlobal QoL scores are not reduced with gemcitabine and SBRT. In this exploratory analysis, patients experience clinically relevant short-term improvements in pancreatic cancer-specific symptoms. Previously demonstrated acceptable clinical outcomes combined with these favorable QoL data indicate that SBRT can be easily integrated with other systemic therapies and may be a potential standard of care option in patients with LAPC.

PHS139 - Independent Factors Affecting Patient Compliance to Private Insurer-Funded Health Case Management in Canada

Exploring independent factors affecting patient compliance via a 6-month, Great-West Life (GWL) - funded HealthForward health case management program (HCM). The HCM program is aimed at monitoring health outcomes and managing costs relating to certain specialty drugs. The data analysis included patients with rheumatoid arthritis (RA) or Crohn’s disease (CD) who participated the 6-month HCM program prior to June, 2015. Student tests and Fisher’s exact test were used to compare, for each disease group, patient baseline characteristics, communications via phone, and withdrawal from the HCM program. Cox survival regression analyses explored independent factors affecting HCM withdrawal risk. 318 patients with RA and 247 patients with CD were eligible for data analysis. Unadjusted comparisons between the RA group and CD group observed significant differences in age (50.6 years vs. 39.7 years, p<0.001), male proportion (23.0% vs. 54.3%, p<0.001), body mass index (kg/m2) (27.9 vs. 25.1, p=0.026), disability (3.8% vs. 0.8%, p=0.028), initial baseline quality of life score (20.9 vs. 15.2, p<0.001), administration frequency distribution, and infusion administration (15.1% vs. 21.9%, p=0.047). Patient communications over phone were comparable between the two disease groups. The RA group was associated with significantly lower HCM withdrawal rate (14.2% vs. 23.5%, p=0.006) when compared to the CD group. HCM duration and the quality of life score change in the two groups were comparable. The identified factors affecting the HCM withdrawal risk included administration frequency every 6 weeks (hazard ratio (HR) 2.899, p=0.032) and patient communication time over phone (HR 0.973, p=0.006). Patients participating in the HCM program had different disease and treatment characteristics that could impact HCM withdrawal risk. There was a significant reduction in HCM withdrawal risk for patients with less frequent treatment administration and longer duration of phone calls which can guide future strategies to maximize patient compliance with HCM.

A prospective study of pain and psychological functioning following traumatic spinal cord injury

Longitudinal study. To study prospectively pain characteristics, change in pain over time and the associations between pain and psychological functioning in adults with traumatic spinal cord injury (SCI). Neurosurgical departments, SCI rehabilitation centres and the community. Adults with traumatic SCI admitted over a 3-year period to two neurosurgical departments underwent clinical examination and questionnaires within 3 months after injury (baseline) and at 6, 12 and 42 months following SCI. Pain intensity and interference within the last 7 days, a global quality of life (QoL) item, the 5-item Mental Health Index and the 6-item Catastrophizing scale were used. Ninety individuals were recruited, of which 81 completed a telephone interview on average 3.5 (s.d., 0.6) years after the SCI. Pain was present in 75% at 3.5 years. Baseline pain catastrophizing scores did not predict pain intensity at 3.5 years. Both psychological functioning and QoL increased over time. QoL scores increased less in participants who reported an increase in pain intensity from baseline to the 3.5-year follow-up, and the change in QoL score correlated with the change in pain interference. Neuropathic pain had an onset within the first 12 months and tended to become persistent, whereas musculoskeletal pain more often had a late onset or resolved in cases of early onset. A large proportion of SCI participants continue to experience pain many years after SCI. Teaching individuals with SCI skills to minimise pain's impact on function as soon as possible following injury may prove beneficial.

Endolymphatic duct blockage: quality of life assessment of a novel surgical technique for Ménière disease.

The aim of this study is to evaluate the quality of life (QOL) of patients treated by endolymphatic duct blockage (EDB) for Ménière's disease with a dedicated questionnaire. This is a retrospective cross-sectional study which included 54 patients diagnosed with severe, refractory Ménière's disease according to the AAO-HNS criteria and treated with EDB between 2010 and 2013. Answers to the first 38 questions have assigned scores from 0 to 4 (0 corresponding to the poorest QOL). A preoperative score called S1 was calculated as follows: S1=sum of preoperative question scores/maximum possible preoperative score ×100. The same formula was used to calculate the postoperative score S2. The change in QOL score, S3, was then calculated (S3=S2-S1). All answers were analyzed anonymously. Statistical analysis was done using Student t test and Chi square test. A response rate of 89% was obtained with the Ménière's disease outcome questionnaire. The preoperative (S1) score was 21.4 (±12.6) and the postoperative score (S2) was 64.6 (±21.6) with a change in QOL (S3) of 43.3 (p<0.001). Postoperatively, 89.9% reported no Ménière's attacks (p<0.001). Seventy-nine percent (15/19) of the questions showed a significant improvement after surgery. These results show that EDB is associated with a significant improvement of the QOL of patients suffering from severe Ménière's disease.

Proton Therapy as Salvage Treatment for Local Relapse of Prostate Cancer Following Cryosurgery or High-Intensity Focused Ultrasound

Local recurrence of prostate cancer after cryosurgery (CS) and high-intensity focused ultrasound (HIFU) is an emerging problem for which optimal management is unknown. Proton therapy (PT) may offer advantages over other local therapeutic options. This article reviews a single institution's experience using PT for salvage of local recurrent disease after HIFU or CS. We reviewed the medical records of 21 consecutive patients treated with salvage PT following a local recurrence of prostate cancer after CS (n=12) or HIFU (n=9) between January 2007 and July 2014. Patients were treated to a median dose of 74 Gy(relative biological effectiveness [RBE]; range: 74-82 Gy[RBE]) and 8 patients received androgen deprivation therapy with radiation therapy. Patients were evaluated for quality of life (QOL) by using the Expanded Prostate Index Composite questionnaire and toxicity by using Common Terminology Criteria for Adverse Events, version 3.0, weekly during treatment, every 6 months for 2 years after treatment, and then annually. Median follow-up was 37 months (range: 6-95 months). The 3-year biochemical progression-free survival (bPFS) rate was 77%. The 3-year grade 3 toxicity rate was 17%; however, 2 of these patients had pre-existing grade 3 GU toxicities from their HIFU/CRYO prior to PT. At 1 year, bowel summary, urinary incontinence, and urinary obstructive QOL scores declined, but only the bowel QOL score at 12 months met the minimally important difference threshold. PT achieved a high rate of bPFS with acceptable toxicity and minimal changes in QOL scores compared with baseline pre-PT functions. Although most patients have done fairly well, the study size is small, follow-up is short, and early results suggest that outcomes with PT for salvage after HIFU or CS failure are inferior to outcomes with PT given in the de novo setting with respect to disease control, toxicity, and QOL.

The Impact of Location of Progressive Visual Field Loss on Longitudinal Changes in Quality of Life of Patients with Glaucoma

To evaluate the association between rates of progressive loss in different regions of the visual field and longitudinal changes in quality of life (QoL). Prospective, observational cohort study. The study included 236 patients with glaucomatous visual field loss followed for an average of 4.3±1.5 years. All subjects had the 25-item National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) performed annually and standard automated perimetry (SAP) at 6-month intervals. Subjects were included if they had a minimum of 2 NEI VFQ-25 and 5 SAP tests during follow-up. Evaluation of rates of visual field change was performed using 4 different regions (central inferior, central superior, peripheral inferior, and peripheral superior) of the integrated binocular visual field. The association between change in NEI VFQ-25 Rasch-calibrated scores and change in different regions of the visual field was investigated with a joint multivariable longitudinal linear mixed model. The relationship between change in QoL scores and change of mean sensitivity in different regions of the visual field. There was a significant correlation between change in the NEI VFQ-25 Rasch scores during follow-up and change in different regions of the visual field. Each 1 decibel (dB)/year change in binocular mean sensitivity of the central inferior area was associated with a decline of 2.6 units/year in the NEI VFQ-25 scores (R(2) = 35%; P < 0.001). Corresponding associations with change in QoL scores for the peripheral inferior, central superior, and peripheral superior areas of the visual field had R(2) values of 30%, 24%, and 19%, respectively. The association for the central inferior visual field area was statistically significantly stronger than those of the central superior area (P = 0.011) and peripheral superior area (P = 0.001), but not the peripheral inferior area (P = 0.171). Greater declines in NEI VFQ-25 scores were also seen in patients who had worse visual field sensitivity at baseline. Progressive decline in sensitivity in the central inferior area of the visual field had the strongest association with longitudinal decline in QoL of patients with glaucoma.

Effect of catheter ablation on quality of life in patients with atrial fibrillation and its correlation with arrhythmia outcome

ObjectiveTo assess the effect of catheter ablation on atrial fibrillation (AF) symptoms and quality of life (QoL).MethodsPatients with AF scheduled for ablation were recruited. Pulmonary vein isolation (PVI) was performed...

The effect of standard dose multivitamin supplementation on disease progression in HIV-infected adults initiating HAART: a randomized double blind placebo-controlled trial in Uganda.

BackgroundEfficacy trials investigating the effect of multivitamin (MV) supplementations among patients on Highly Active Antiretroviral Therapy (HAART) have so far been inconclusive. We conducted a randomized, double blind, placebo controlled trial to determine the effect of one recommended daily allowance (RDA) of MV supplementation on disease progression in patients initiating HAART.MethodsEligible subjects were randomized to receive placebo or MV supplementation including vitamins B-complex, C and E. Participants were followed for up to 18 months. Primary endpoints were: change in CD4 cell count, weight and quality of life (QoL). Secondary endpoints were: i) development of a new or recurrent HIV disease progression event, including all-cause mortality; ii) switching from first- to second-line antiretroviral therapy (ART); and iii) occurrence of an adverse event. Intent-to-treat analysis, using linear regression mixed effects models were used to compare changes over time in the primary endpoints between the study arms. Kaplan-Meier time-to-event analysis and the log-rank test was used to compare HIV disease progression events and all-cause mortality.ResultsFour hundred participants were randomized, 200 onto MV and 200 onto placebo. By month 18, the average change in CD4 cell count in the MV arm was 141 cells/uL compared to 147 cells/uL in the placebo arm, a mean difference of −6 · 17 [95 % CI −29 · 3, 16 · 9]. The average change in weight in the MV arm was 3 · 9 kg compared to 3 · 3 kg in the placebo arm, a mean difference of 0 · 54 [95 % CI −0 · 40, 1 · 48]; whereas average change in QoL scores in the MV arm was 6 · 8 compared to 8 · 8 in the placebo arm, a mean difference of −2.16 [95 % CI −4 · 59,0 · 27]. No significant differences were observed in these primary endpoints, or in occurrence of adverse events between the trial arms.ConclusionsOne RDA of MV supplementation was safe but did not have an effect on indicators of disease progression among HIV infected adults initiating HAART.Trial registrationClinical trials NCT01228578, registered on 15th October 2010.

Efficacy of Ashwagandha (Withania somnifera [L.] Dunal) in improving cardiorespiratory endurance in healthy athletic adults.

Introduction:Ashwagandha (Withania somnifera [L.] Dunal) has been traditionally used for various actions ranging from vitalizer, improve endurance and stamina, promote longevity, improve immunity, and male and female fertility. However, clinical studies are needed to prove the clinical efficacy of this herb, especially in cardiovascular endurance and physical performance.Aims:This prospective, double-blind, randomized, and placebo-controlled study evaluated the efficacy of Ashwagandha roots extract in enhancing cardiorespiratory endurance and improving the quality of life (QOL) in 50 healthy male/female athletic adults.Materials and Methods:Cardiorespiratory endurance was assessed by measuring the oxygen consumption at peak physical exertion (VO2 max) levels during a 20 m shuttle run test. The World Health Organization self-reported QOL questionnaire (physical health, psychological health, social relationships, and environmental factors) was used to assess the QOL. Student's t-test was used to compare the differences in a mean and change from baseline VO2 max levels, whereas Wilcoxon signed-rank test was used to assess changes in QOL scores from baseline in the two groups.Results:There was a greater increase from baseline (P < 0.0001) in the mean VO2 max with KSM-66 Ashwagandha (n = 24) compared to placebo (n = 25) at 8 weeks (4.91 and 1.42, respectively) and at 12 weeks (5.67 and 1.86 respectively). The QOL scores for all subdomains significantly improved to a greater extent in the Ashwagandha group at 12 weeks compared to placebo (P < 0.05).Conclusion:The findings suggest that Ashwagandha root extract enhances the cardiorespiratory endurance and improves QOL in healthy athletic adults.

Comprehensive quality of life outcomes for pediatric patients undergoing endoscopic sinus surgery.

Limited quality of life data exist for pediatric chronic rhinosinusitis (CRS) patients undergoing endoscopic sinus surgery (ESS). Further exploration of the following areas will enhance understanding and support clinical decision-making: baseline and post-ESS general and disease-specific quality of life, parent vs. child report, and correlation of nasal endoscopy to sinus CT scores. A prospective cohort study evaluated CRS patients age 5-18 undergoing ESS. Surveys were completed at two timepoints: (1) pre-ESS and (2) 30-90 days post-ESS, with parents completing general (PedsQLTM) and CRS-specific (SNOT-16 and SN-5) quality of life surveys and children completing PedsQLTM and SNOT-16 surveys. Preoperative Lund-Kennedy nasal endoscopy and Lund-Mackay sinus CT scores were calculated. Where appropriate, outcomes were stratified by cystic fibrosis status. Impaired preoperative general quality of life was evidenced by parent proxy-report of PedsQLTM scores in 10 cystic fibrosis and 11 non-CF patients. ESS was associated with decreased sinus symptoms at 1-3 months postoperatively with SN-5 change scores of -1.85 and -2.2, in CF and non-CF patients, respectively. Parents reported worse CRS symptoms via higher preoperative SNOT-16 scores than their children did. Nasal endoscopy and sinus CT scores correlated with a Spearman correlation coefficient of 0.51. Scores not reaching statistical significance included CF-related CRS SNOT-16 change scores and PedsQLTM general quality of life change scores. In pediatric patients with CRS electing ESS, general quality of life is impaired preoperatively and sinus symptoms improve significantly 1-3 months after sinus surgery. Parents report statistically worse CRS symptom scores than their children do. Nasal endoscopy scores in this cohort correlated with sinus CT scores.

Quality-of-life (QoL) as a predictive biomarker in patients with advanced pancreatic cancer (APC) receiving chemotherapy: results from a prospective multicenter phase 2 trial.

Pancreatic cancer is rapidly fatal with median survival of only 6 months (mo). Quality-of-life (QoL) was analyzed prospectively in a phase 2 study of gemcitabine (G), capecitabine (C) and bevacizumab (B) in APC patients. A total of 50 patients with APC received B 15 mg/kg, C 1,300 mg/m(2) daily for 2 weeks and G 1,000 mg/m(2) weekly 2 times; cycles were repeated every 21 days. progression free survival (PFS), overall survival (OS) and assessment of QoL prior to each cycle using the European organization for research and treatment of cancer (EORTC) PAN-26 QoL questionnaire. An exact 95% confidence interval (CI) (Clopper-Pearson method) was used to assess rate of improved QoL (defined as >5% decrease in two consecutive scores compared with baseline). Patient characteristics- Stage IIB/III/IV: 3/5/42; Sex: 28 M/22 F; Median age: 64 years. QoL in patients- improved: 56%, no improvement: 24%; unevaluable: 20%. Median PFS: 5.8 mo, OS: 9.8 mo. QoL improvement rate: 28/40=0.7 (95% CI: 0.53-0.83) in evaluable patients. Using QoL improvement rate, no significant difference was seen in patients with OS ≥6 mo compared to OS <6 mo. However QoL scores at 3 and 6 weeks from start of treatment correlated strongly with ≥6 mo survival (P value 0.0092 and 0.0081, respectively). Baseline score and change in QoL scores of patients on G, C and B were not predictive of survival ≥6 mo. Post treatment scores at 3 and 6 weeks from start of therapy however, were predictive of survival ≥6 mo suggesting the potential predictive value of this tool for use in future studies.