Greater Improvement In Quality Of Life Research Articles

Membrane-Stabilizing Agents Improve Quality-of-Life Outcomes for Patients with Lumbar Stenosis

Study Design Retrospective cohort controlled study. Objective To determine quality-of-life (QOL) outcomes for patients with lumbar spinal stenosis (LSS) treated with membrane-stabilizing agents (MSAs). Methods Patients with LSS and concordant neurogenic claudication treated with MSAs (n = 701) or conservatively without MSAs (n = 2104) at a single tertiary care hospital were identified. Patient QOL measures (Patient Health Questionnaire-9 [PHQ9], EuroQOL-5 Dimensions [EQ-5D], Pain Disability Questionnaire [PDQ]) were recorded pretreatment and then 4 months following treatment. Propensity score matching was used to account for baseline demographic differences between the two groups. The primary outcome measure was posttreatment improvement in these QOL measures. Results Patients in both groups had statistically significant improvements in the EQ-5D. However, the EQ-5D improvement in the MSA group was significantly greater than the improvement in the control group (0.11 versus 0.06; p = 0.0494). The EQ-5D change in the MSA group also exceeded the minimum clinically important difference, thereby suggesting a clinical significance. Both groups had significant pre- to posttreatment improvements in PDQ and PHQ-9, but these changes were not significantly different between the groups. Conclusion The results of this study suggest that patients with LSS and neurogenic claudication can have greater QOL improvements when treated with MSAs compared with other forms of conservative management without MSAs.

Phase II, randomised, double-blind, placebo-controlled trial of methylphenidate for reduction of fatigue levels in patients with prostate cancer receiving LHRH-agonist therapy

To investigate whether methylphenidate can alleviate fatigue, as measured by the Functional Assessment of Cancer Therapy: Fatigue subscale, in men with prostate cancer (PCa) treated with a luteinizing hormone-releasing hormone (LHRH) for a minimum of 6 months, and to assess changes in global fatigue and quality of life (QoL) as measured by the Bruera Global Fatigue Severity Scale (BFS) and the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), respectively. We performed a single-centre, randomised, double-blind, placebo-controlled trial with the aim of recruiting 128 participants. Men treated with a LHRH agonist for PCa were screened between February 2008 and June 2012 for fatigue at our outpatient clinics using the BFS. Participants were randomised to receive either 10 mg daily of methylphenidate or placebo. Change in fatigue levels and in SF-36 scores between both groups were compared using linear regression, adjusted for baseline scores. The study was closed prematurely because of poor accrual. Of the 790 subjects screened, 24 men were randomised to methylphenidate or placebo (12 per group). After 10 weeks, the improvement in mean [sd] fatigue score was greater in the methylphenidate than in the placebo arm (+7.7 [7.7] vs +1.4 [7.6]; P = 0.022). The within-group analysis showed a significant improvement in fatigue scores in the methylphenidate arm (P = 0.008) but not in the placebo arm (P = 0.82). The use of methylphenidate also resulted in a significantly greater improvement in QoL as measured by the physical and mental component summary scores than did the use of placebo (P = 0.04 for both component scores). Our findings support the beneficial effect of methylphenidate on fatigue and QoL among men with LHRH-induced fatigue. Clinicians should be aware of these benefits and should consider discussing these findings with patients who have high levels of fatigue.

Psychosocial Telephone Counseling for Survivors of Cervical Cancer: Results of a Randomized Biobehavioral Trial

Survivors of cervical cancer experience quality-of-life (QOL) disruptions that persist years after treatment. This study examines the effect of a psychosocial telephone counseling (PTC) intervention on QOL domains and associations with biomarkers. We conducted a randomized clinical trial in survivors of cervical cancer, who were ≥ 9 and less than 30 months from diagnosis (n = 204), to compare PTC to usual care (UC). PTC included five weekly sessions and a 1-month booster. Patient-reported outcomes (PROs) and biospecimens were collected at baseline and 4 and 9 months after enrollment. Changes in PROs over time and associations with longitudinal change in cytokines as categorical variables were analyzed using multivariable analysis of variance for repeated measures. Participant mean age was 43 years; 40% of women were Hispanic, and 51% were non-Hispanic white. Adjusting for age and baseline scores, participants receiving PTC had significantly improved depression and improved gynecologic and cancer-specific concerns at 4 months compared with UC participants (all P < .05); significant differences in gynecologic and cancer-specific concerns (P < .05) were sustained at 9 months. Longitudinal change in overall QOL and anxiety did not reach statistical significance. Participants with decreasing interleukin (IL) -4, IL-5, IL-10, and IL-13 had significantly greater improvement in QOL than those with increasing cytokine levels. This trial confirms that PTC benefits mood and QOL cancer-specific and gynecologic concerns for a multiethnic underserved population of survivors of cancer. The improvement in PROs with decreases in T-helper type 2 and counter-regulatory cytokines supports a potential biobehavioral pathway relevant to cancer survivorship.

Symptomatic remission and patient quality of life in an observational study of schizophrenia: Is there a relationship?

This analysis aimed to examine the association between remission and quality of life (QOL) in schizophrenia. In post-hoc analyses of the 3-year, prospective, observational Schizophrenia Outpatients Health Outcomes (SOHO) study, we compared the QOL of patients who achieved symptomatic and clinical remission with those who did not, and the factors associated. Symptomatic remission was defined as achieving a score of ≤3 on the Clinical Global Impression-Schizophrenia (CGI-SCH) scale, maintained for 6 months and without hospitalization. QOL was patient self-rated using the European-QOL. Of the 6516 patients analyzed, 38% were in symptomatic remission 12 months post-baseline and 52% at 36 months. Functional remission remained fairly constant from 12 months to 36 months (22.4% at both time points). At all visits from 12 to 36 months, patient QOL and social functioning were significantly higher for patients in symptomatic remission. QOL was higher in patients in functional remission. Patients with maintained symptomatic remission over the 3-year follow-up had a much greater improvement in QOL than patients with no symptomatic remission or symptomatic remission for part of the period. Factors associated with a better QOL also included paid employment, socially active, a higher CGI-SCH cognitive score, good compliance, and a better baseline QOL.

Existential behavioral therapy for informal caregivers of palliative patients: barriers and promoters of support utilization.

Several interventions have been developed during recent years to support informal caregivers of palliative patients. However, these trials reported low enrollment rates. Employing a newly developed group intervention, existential behavioral therapy (EBT), one study reported that only 13.6% of approached informal caregivers participated. The purpose of our present study was to identify the reasons for this low enrollment rate in order to improve future support designs. All participants in the EBT trial (intervention vs. standard-care control group) as well as those who declined participation during a 4-month recruitment period were studied prospectively over 12 months. Andersen's behavioral model of healthcare service use was employed to identify group differences between acceptors and decliners: predisposing (age, gender, education, family status, relationship), enabling (social support, distance to hospital, caring vs. bereaved), and need factors (psychological distress, quality of life) were evaluated in a binary-logistic model. Some 94 decliners were compared to 160 EBT participants (n = 81 intervention, n = 79 control). Caregivers who took part were significantly more distressed and suffered from a lower quality of life compared to decliners. Not only these need factors but also predisposing (age <55 years) and enabling (use of social/professional support, familiarity with caregiving institution) factors were associated with EBT utilization. At the 12-month follow-up, EBT intervention participants reported greater quality of life improvements than decliners or controls (p = 0.05). While all groups had mean anxiety scores below the cutoff at 12-month follow-up, decliners showed better improvement in anxiety compared to EBT participants (intervention p = 0.04, controls p = 0.03). On average, decliners are less burdened: they may be more resilient, may have better coping strategies, or already have a sufficient support network in place. Screening caregivers with regard to their experienced quality of life and targeting those in need, especially younger caregivers with low levels of quality of life, may help to allocate resources more appropriately.

RTMS in fibromyalgia

This double-blind, randomized, placebo-controlled study investigated the impact of repetitive transcranial magnetic stimulation (rTMS) on quality of life (QoL) of patients with fibromyalgia, and its possible brain metabolic substrate. Thirty-eight patients were randomly assigned to receive high-frequency rTMS (n = 19) or sham stimulation (n = 19), applied to left primary motor cortex in 14 sessions over 10 weeks. Primary clinical outcomes were QoL changes at the end of week 11, measured using the Fibromyalgia Impact Questionnaire (FIQ). Secondary clinical outcomes were mental and physical QoL component measured using the 36-Item Short Form Health Survey (SF-36), but also pain, mood, and anxiety. Resting-state [(18)F]-fluorodeoxyglucose-PET metabolism was assessed at baseline, week 2, and week 11. Whole-brain voxel-based analysis was performed to study between-group metabolic changes over time. At week 11, patients of the active rTMS group had greater QoL improvement in the FIQ (p = 0.032) and in the mental component of the SF-36 (p = 0.019) than the sham stimulation group. No significant impact was found for other clinical outcomes. Compared with the sham stimulation group, patients of the active rTMS group presented an increase in right medial temporal metabolism between baseline and week 11 (p < 0.001), which was correlated with FIQ and mental component SF-36 concomitant changes (r = -0.38, p = 0.043; r = 0.51, p = 0.009, respectively). QoL improvement involved mainly affective, emotional, and social dimensions. Our study shows that rTMS improves QoL of patients with fibromyalgia. This improvement is associated with a concomitant increase in right limbic metabolism, arguing for a neural substrate to the impact of rTMS on emotional dimensions involved in QoL. This study provides Class II evidence that rTMS compared with sham rTMS improves QoL in patients with fibromyalgia.

Adjuvant Therapy with Bioavailability‐Boosted Curcuminoids Suppresses Systemic Inflammation and Improves Quality of Life in Patients with Solid Tumors: A Randomized Double‐Blind Placebo‐Controlled Trial

Curcuminoids are bioactive polyphenolics with potent antiinflammatory properties. Although several lines of in vitro and preclinical evidence suggest potent anticancer effects of curcuminoids, clinical findings have not been conclusive. The present randomized double-blind placebo-controlled trial aimed to evaluate the efficacy of curcuminoids as adjuvant therapy in cancer patients. Eighty subjects with solid tumors who were under standard chemotherapy regimens were randomly assigned to a bioavailability-boosted curcuminoids preparation (180 mg/day; n = 40) or matched placebo (n = 40) for a period of 8 weeks. Efficacy measures were changes in the health-related quality of life (QoL) score (evaluated using the University of Washington index) and serum levels of a panel of mediators implicated in systemic inflammation including interleukins 6 (IL-6) and 8 (IL-8), TNF-α, transforming growth factor-β (TGFβ), high-sensitivity C-reactive protein (hs-CRP), calcitonin gene-related peptide (CGRP), substance P and monocyte chemotactic protein-1 (MCP-1). Curcuminoid supplementation was associated with a significantly greater improvement in QoL compared with placebo (p < 0.001). Consistently, the magnitude of reductions in TNF-α (p < 0.001), TGFβ (p < 0.001), IL-6 (p = 0.061), substance P (p = 0.005), hs-CRP (p < 0.001), CGRP (p < 0.001) and MCP-1 (p < 0.001) were all significantly greater in the curcuminoids versus placebo group. In contrast, the extent of reduction in serum IL-8 was significantly greater with placebo versus curcuminoids (p = 0.012). Quality of life variations were associated with changes in serum TGFβ levels in both correlation and regression analyses. Adjuvant therapy with a bioavailable curcuminoid preparation can significantly improve QoL and suppress systemic inflammation in patients with solid tumors who are under treatment with standard chemotherapy protocols.

Effect of pharmacotherapy for anxiety disorders on quality of life: a meta-analysis

Pharmacotherapy is an effective treatment for anxiety disorders, but its effects on quality of life (QOL) have not been examined systematically. Our objective was to conduct an effect size analysis of pharmacological interventions on QOL outcomes in patients with DSM-IV anxiety disorders. Manual and electronic searches using PubMed, PsycINFO, and the Cochrane Library were conducted for records from the first available date through May 1, 2013 for trials of pharmacological interventions in patients with anxiety disorders, which had measures of QOL before and after treatment. Of 1,865 entries, 93 studies were identified as potentially relevant and 32 met inclusion criteria, of which results were examined from 22 studies reporting 27 distinct pharmacological trials, representing data from 4,344 anxiety disorder patients. Data were extracted independently by multiple observers to estimate within-group and placebo-controlled random effects of the treatment changes on QOL. We hypothesized that pharmacotherapy improves QOL, which is associated with improvement in anxiety symptoms. Pharmacological interventions effectively improved QOL from before to after treatment (Hedges' g = 0.59), although the controlled effect size is smaller among those trials with placebo interventions (Hedges' g = 0.32). These effect sizes were robust, increased with publication year, and increased with reductions in anxiety symptoms. Pharmacological therapy is effective for improving QOL in anxiety disorders, and larger symptom reductions are associated with greater improvement in QOL.

Cochlear implants in adults over 60: A study of communicative benefits and the impact on quality of life

ObjectivesQuantifying the improvement in quality of life (QoL) of cochlear implant (CI) patients over 60, its relation to audiometric benefits and the subjective impact on specific areas of life.MethodsAn observational retrospective study was conducted on 26 individuals (17 male and 9 female) older than 60, all implanted in our unit between 1 January 1999 and 31 January 2009. And 10 patients (5 male and 5 female) aged between 40 and 60 were the control group. A full postoperative audiological evaluation was completed. Sociodemographic characteristics and history of hearing loss were collected. To evaluate QoL benefits, the Glasgow Benefit Inventory test and the Specific Questionnaire were filled in.ResultsPatients in the test and control groups had similar preoperative speech recognition levels. Preoperative audiometric thresholds were significantly worse in patients from 40 to 60 years of age although they scored better in speech recognition after implantation. Patients experienced significant improvement in their QoL in all areas, especially in general health, while they experienced a smaller improvement in social interaction. Age, duration of deafness, and years wearing the processor were statistically related to QoL regardless of audiometric benefit. Unilateral CI users and patients without tinnitus obtain better QoL although no statistical relation was found.ConclusionsCochlear implantation improves QoL of patients over 60 by the mere fact of having been implanted, regardless of poorer audiological benefits. Older patients, with long-term deafness experience a greater improvement in QoL after implantation. The results of this study should aid other centers when counseling patients on the expected, daily functional benefits of cochlear implantation.

Therapeutic outcome and quality of life between urethral and detrusor botulinum toxin treatment for patients with spinal cord lesions and detrusor sphincter dyssynergia

Patients with spinal cord lesions and detrusor sphincter dyssynergia (DSD) may be treated with urethral sphincter botulinum toxin A (BoNT-A) injection for difficult urination or detrusor BoNT-A injection for incontinence. Although objective data showed improvement, patients might not be satisfied with the result especially in quality of life (QOL) issue. This study investigated the therapeutic results and QOL and patients' satisfaction to these two treatments. Patients with spinal cord lesion and DSD were treated with urethral sphincter injection of 100 U of BoNT-A for main symptoms of difficult urination and detrusor injection of 200 U of BoNT-A for main symptom of incontinence. The urodynamic parameters, QOL scores using UDI-6 and IIIQ-7 and general satisfaction were compared between two groups. The overall satisfactory result was perceived in 60.6% and 77.3% in patients who received urethral and detrusor BoNT-A injection, respectively. Urodynamic parameters showed significant improvement in both groups. Urethral injection group had improvement in IIQ-7, but not in UDI-6 scores whereas detrusor injection group had improvement in all scores. The improvement of UDI-6 and IIQ-7 was significantly greater in detrusor than urethral injection group. Increase in incontinence grade was the major cause of dissatisfaction in urethral injection group, whereas increase in difficult urination and needing catheterisation were the main dissatisfaction causes in detrusor injection group. There was discrepancy between the objective urodynamic results and patient satisfaction in treatment of DSD by BoNT-A injection. Patients with DSD and treated with detrusor BoNT-A had greater QOL improvement than those treated with urethral injection.

Maintenance of response after open-label treatment with atomoxetine hydrochloride in international European and non-European adult outpatients with attention-deficit/hyperactivity disorder: a placebo-controlled, randomised withdrawal study

Background and Objectives:We evaluated maintenance of response to atomoxetine during a 25-week, double-blind, placebo-controlled, randomised withdrawal period in adults with attention-deficit/hyperactivity disorder (ADHD) who previously responded to atomoxetine during a 12 week open-label treatment period and maintained that response during a 12-week double-blind maintenance period. Methods: Patients (N = 2017), 18 to 50 years of age, diagnosed with ADHD from 152 outpatient sites in 18 countries received 12 weeks of open-label atomoxetine (40-100 mg/day) followed by 12 weeks of double-blind maintenance (80 or 100 mg/day). Responders were randomized to atomoxetine (N = 266) or placebo (N = 258) for 25-weeks of double-blind treatment. The percentage of patients with a reduction .30% in their baseline Conners�f ADHD Rating Scale Investigator-Rated: Screening Version (CAARS-Inv:SV) total score and a score of .3 on the Clinical Global Impression ADHD-Severity (CGIADHD- S) after 25 weeks was compared between treatment groups with a Fisher�fs exact test. Mean changes from baseline in the CAARS-Inv:SV and Adult Attention-Deficit/Hyperactivity Disorder Quality of Life (AAQoL) were analysed. Results: Most patients enrolled (60%) were from Europe. More atomoxetine- than placebo- treated patients maintained a satisfactory response postrandomisation (64.3% vs. 50.0%; p <.001). Time-to-relapse was significantly longer for atomoxetine than placebo (p = .004). Atomoxetine maintained greater improvements in ADHD symptoms compared with placebo (LS mean worsening in the CAARS-Inv:SV total score was 0.9 vs. 4.8 [p <.001] and in the CGI-ADHD-S rating was 0.0 vs. 0.5 [p <.001]). These results were supported by self- or observer- rated measures. Lastly, atomoxetine maintained greater improvements in quality of life compared with placebo (AAQoL total score was 0.4 vs. -4.0; p = .002). Conclusions: This study demonstrated that atomoxetine was superior to placebo in maintaining significantly greater treatment responses for up to 1 year in adults with ADHD.

Do swallowing exercises improve swallowing dynamic and quality of life in Parkinson's disease?

To investigate the effect of motor swallowing exercises on swallowing dynamic, quality of life and swallowing complaints in Parkinson's disease (PD). A before-after trial. University Medical Center. Parkinson's disease patients with dysphagia complaints. Motor swallowing exercises designed to increase the strength and range of motion of the mouth, larynx and pharyngeal structures, coordination between breathing and swallowing, and airway protection. Patients should perform the exercises twice a day, five days a week, for five weeks. The primary outcome was the difference before and after the intervention in number of swallowing videofluoroscopic events (Swallowing Score). The secondary outcomes were quality of life (QOL) and swallowing complaints. Fifteen patients concluded the study (10 man/5 woman; mean age 59.2 ± 9.17). The videofluoroscopic events with greater improvement were loss of bolus control (P < 0.03), piecemeal swallow (P = 0.05) and residue on the tongue (P < 0.01), valleculae (P = 0.01) and pyriform sinuses (P = 0.05). Lingual pumping and dental absence were interfering factors associated with treatment failure (beta standardized coefficient = -16.6, 26.2; P = 0.02, 0.002, respectively). The domains with greater improvements in QOL were fear (P = 0.02) and symptom frequency (P = 0.05). Regarding swallowing complaints, patients reported to have reduced mainly their difficulty in moving food in the mouth when chewing (P = 0.02). Reduction in swallowing disorders was not related with QOL improvement (cor = 0.13, [95% CI, 0.6-0.4], P = 0.63). Motor swallowing exercises may reduce swallowing disorders in PD patients without lingual pumping and dental absence and impact positively QOL and swallowing complaints in individuals with PD.

Response to GH treatment in adult GH deficiency is predicted by gender, age, and IGF1 SDS but not by stimulated GH-peak

We studied whether the severity of GH deficiency (GHD) defined as i) GH-peak on stimulation tests (insulin tolerance test (ITT), arginine, and glucagon), ii) number of additional pituitary deficits, or iii) baseline IGF1 SDS could impact the response to GH treatment. We further explored whether iv) IGF1 SDS after 24 months of GH replacement or v) ΔIGF1 SDS from baseline to 24 months was related to the phenotypic response to GH treatment. DESIGN, PATIENTS, AND MEASUREMENTS: The patient cohort (n=1752; 50% women) was obtained from KIMS (Pfizer International Metabolic Database). The patients were divided into three groups of approximately equal size (tertiles) according to the stimulated GH-peak values and baseline IGF1 SDS and were studied at baseline, 12, and 24 months of GH therapy. Lower baseline IGF1 SDS predicted better response in weight, BMI, total cholesterol, and triglycerides, while IGF1 SDS after 24 months was associated with reduction in waist/hip ratio, total cholesterol, and improved quality of life (QoL). Age-correlated negatively with the response in body weight, BMI, waist, IGF1 SDS, and total and LDL-cholesterol. Response in weight and BMI was greater in men than in women, whereas women showed greater improvement in QoL than men. Patients with more severe GHD as assessed by lower GH-peaks and more pituitary hormone deficiencies had a greater increase in IGF1 SDS. The increase in IGF1 SDS was associated with a reduction in waist/hip ratio and an increase in weight, BMI, and triglycerides. There was no correlation with other lipids, blood pressure, or glucose. Our findings indicate that baseline and 24 months, IGF1 and its degree of increase during GH replacement were more important than stimulated peak GH to predict the phenotypic response.

Pain and function in eight hundred and fifty nine patients comparing shoulder hemiprostheses, resurfacing prostheses, reversed total and conventional total prostheses

Functional results of reversed total prostheses (RTP) have-to a very limited degree-been compared with those of other shoulder prosthesis types. The aim of our study was to compare results of four different types of shoulder prostheses in terms of function, pain, and quality of life (QoL). Questionnaires were completed by 859 patients with shoulder prostheses registered in the Norwegian Arthroplasty Register. Patients with osteoarthritis (OA), rheumatoid arthritis (RA), or fracture sequela (FS) were included. Symptoms and function were assessed using the Oxford Shoulder Score (OSS, scale 0-48), and the EuroQoL-5D (EQ-5D) was used to assess QoL. Best functional results were obtained using conventional total prostheses (TPs) and RTPs -mean OSS improvement 18 and 16 units, respectively, vs 11 with hemiprostheses (HPs). For patients with OA, TPs performed best; for those with RA and FS, RTPs performed best; and those with HPs had the worst results in all diagnostic groups. The greatest improvement in QoL was seen in patients with TPs and RTPs. Conventional TPs provide the best improvement in pain, function and QoL in OA patients; RTPs are superior in patients with RA and FS.

Cardiac Resynchronization and Quality of Life in Patients With Minimally Symptomatic Heart Failure

This study compared the quality of life (QOL) of patients with cardiac resynchronization therapy (CRT) and an implantable cardioverter-defibrillator (ICD) to patients with an ICD only. CRT with ICD is associated with a reduction in heart failure risk among minimally symptomatic patients. It is unknown whether this improves QOL. This study uses the MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy) data. The MADIT-CRT enrolled 1,820 patients at 110 centers across 14 countries. Patients had ischemic cardiomyopathy (New York Heart Association [NYHA] functional class I or II) or nonischemic cardiomyopathy (NYHA functional class II only), sinus rhythm, an ejection fraction of 30% or less, and prolonged intraventricular conduction with a QRS duration of 130 ms or more. QOL was evaluated on the 1,699 patients with baseline and follow-up measures using the Kansas City Cardiomyopathy Questionnaire (KCCQ). Six dimensions (Physical Limitation, Symptom Stability, Symptom Frequency, Symptom Burden, Quality of Life, and Social Limitations) and 3 summary scores (Total Symptom, Clinical Summary, and Overall Summary) were analyzed. During an average follow-up of 2.4 years, the CRT-ICD group had greater improvement than the ICD-only group on all KCCQ measures (p < 0.05 on each scale). These differences were significant among patients with left bundle branch block conduction disturbance (n = 1,204, p < 0.01 on each scale), but not among patients without left bundle branch block (n = 494). Compared with patients with ICD only, CRT-ICD is associated with greater improvement in QOL among relatively asymptomatic patients, specifically among those with left bundle branch conduction disturbance.

Long‐Term Comparison of Video‐Assisted Thoracic Sympathectomy and Clinical Observation for the Treatment of Palmar Hyperhidrosis in Children Younger Than 14

The results of video-assisted thoracic sympathectomy (VATS)in children are unknown. To investigate the improvement in quality of life (QOL) of a group of 45 children who did and did not undergo VATS for the treatment of palmar hyperhidrosis (PH) 4 years after the initial evaluation. Forty-five children with PH were initially evaluated. Children were divided into two groups: 30 in the VATS group and 15 in the control group. We studied the evolution of PH, negative effect of hyperhidrosis on the QOL before the treatment, and improvement in QOL after treatment. Twenty-five patients (83.4%) in the VATS group experienced great improvement in PH, and five (16.6%) experienced partial improvement; 12 (80.0%) children from the control group had some type of improvement, and three (20.0%) had partial improvement. Two (13.3%) children in the control group and 23 (76.7%) in the VATS group had great improvement in QOL. For children with PH and poor QOL, VATS is better than no treatment. It produces better results with regard to sweating and greater improvement in QOL.

Adalimumab for the induction and maintenance of clinical remission in Japanese patients with Crohn's disease

Background and aimsAdalimumab has been shown to be efficacious and well-tolerated in Western patients with Crohn's disease. These 2 randomized, double-blind clinical trials evaluated adalimumab efficacy and safety in Japanese patients with moderate to severe Crohn's disease. Methods90 patients enrolled in the induction trial and were randomized to receive adalimumab 160/80mg, adalimumab 80/40mg or placebo at Weeks 0/2. At Week 4, patients who achieved a decrease in CDAI≥70 points versus Baseline entered the maintenance trial and were randomized to adalimumab 40mg every other week or placebo for 52weeks. All other patients received 4 more weeks of blinded adalimumab before entering the open-label portion of the maintenance trial. At/after Week 4 of the maintenance trial, blinded patients who flared/failed to respond entered the open-label portion. Open-label maintenance patients received adalimumab 40mg every other week with the option of 80mg every other week for flare/non-response. ResultsClinical remission rates at Week 4 in the induction trial were 33.3%, 17.6% and 13.0% in the adalimumab 160/80mg, adalimumab 80/40mg and placebo groups, respectively. Maintenance remission rates were 38.1% for adalimumab and 9.1% for placebo at Week 52. Anti-TNF naïve patients achieved greater efficacy than anti-TNF exposed patients. Patients randomized to adalimumab achieved greater quality of life improvement versus placebo. There were no clinically relevant differences in safety between adalimumab and placebo. ConclusionsAdalimumab is effective and well-tolerated for inducing and maintaining clinical remission in Japanese patients with moderate to severe Crohn's disease. NCT00445939; NCT00445432.

Factors that influence trajectories of change in frequency of substance use and quality of life among adolescents receiving a brief intervention

This study aimed to identify factors influencing trajectories of change in two outcome domains, frequency of substance use and quality of life (QOL), among adolescents receiving a brief evidence-based intervention. Participants were 106 adolescents, aged 13 to 21 years, who met criteria for a substance use disorder. The adolescents received a five-session intervention and completed four assessments over 12 months. Based upon a theoretical and empirical review, five putative predictors were tested: gender, age, severity of conduct disorder, severity of depression, and peer substance involvement. Results of a parallel-process latent growth curve model indicated that higher peer substance involvement and conduct severity predicted higher frequency of use at baseline, whereas higher peer substance involvement and depression severity predicted poorer QOL at baseline. Counter to predictions, higher depression severity predicted greater improvements in QOL following substance use treatment. The implications of baseline risk factors on adolescents' response to intervention are discussed.

Patient Quality of Life (QOL) In Nonsplenectomized Immune Thrombocytopenia (ITP) Patients Receiving Romiplostim or Medical Standard of Care (SOC)

AbstractAbstract 569 Introduction:Romiplostim, a novel peptibody that increases platelet production, is approved for the treatment of adult chronic ITP. Positive results from a previous study suggest the potential that romiplostim could improve QOL (Kuter, ASH 2009, #679). Immunosuppressive therapies for ITP may adversely affect patient QOL. We compared QOL between SOC- and romiplostim-treated pts from this study, and examined changes among subgroups of pts. Methods:This was an open-label study of nonsplenectomized ITP pts who were randomized to receive either once-weekly subcutaneous romiplostim or SOC. SOC treatments were prescribed according to standard institutional practices or therapeutic guidelines. QOL was assessed using the ITP patient assessment questionnaire (ITP-PAQ; consisting of 10 scales scored from 0–100); assessments were taken at baseline and every 12 weeks to week 52. Scores were also assessed for subgroups of pts with the following favorable outcomes: (1) did not receive blood transfusions or rescue medications, (2) did not experience bleeding ≥ grade 2, (3) did not experience a platelet count < 20 × 109/L. Mean and change from baseline scores were computed, and differences between treatment groups and among subgroups were assessed. Clinical significance was determined from the minimal important difference (MID), which is the smallest difference in QOL considered clinically meaningful (Mathias et al., CMRO 375-83) and corresponds to an 8–15 point improvement depending on the scale. The time to MID was also computed for Symptoms, Bother, Activity and Fatigue. Results:In total, 157 pts were randomized to receive romiplostim and 77 to receive SOC. At baseline, no statistically significant differences were found between the romiplostim and the SOC group on any of the scales. At 52-weeks, change scores for both the romiplostim group and the SOC group showed improvements that exceeded the MID with the exception of Fatigue in both arms and Activity in the SOC arm (Table). In comparison to the SOC group, the romiplostim group showed statistically significantly greater improvements from baseline for all scales except Fatigue. The differences between treatment groups did not exceed the MID for any of the scales. The time to MID was significantly shorter for the romiplostim group vs the SOC group on the Symptoms and Bother (p<0.0001), and Fatigue (p=0.0068) scales. Among subgroups with favorable clinical outcomes, statistically significantly greater improvements were seen in the romiplostim group compared with the SOC group in many of the scales. The difference between treatment groups exceeded the MID only once: romiplostim-treated pts in the subgroup who did not experience platelet counts < 20 × 109/L had a 12.6 point greater improvement in Activity score compared to SOC pts. Conclusions:Nonsplenectomized ITP pts receiving romiplostim had greater improvements in QOL than pts receiving SOC. These improvements were maintained even among subgroups of pts with favorable clinical outcomes. However, the open-label study design limits our ability to make conclusions, and the clinical significance of the QOL improvements in romiplostim-treated pts relative to those receiving SOC remains uncertain. Disclosures:Kuter:Amgen Inc.: Consultancy, Research Funding; GlaxoSmithKline: Consultancy, Research Funding; ONO: Consultancy; Pfizer: Consultancy, Research Funding; Shionogi: Consultancy, Research Funding. Mandanas:Celgene: Honoraria; Genentech/Roche: Honoraria; Amgen Inc.: Honoraria; GlaxoSmithKline: Speakers Bureau; Pfizer: Speakers Bureau; Genomic Health: Speakers Bureau. Giagounidis:Celgene: Consultancy, Honoraria. Wang:Amgen Inc.: Employment, Equity Ownership. Mathias:Amgen Inc.: Consultancy. Deuson:Amgen Inc.: Employment, Equity Ownership.

The Effect of Telephone-Administered Cognitive–Behavioral Therapy on Quality of Life among Patients with Multiple Sclerosis

Past research has found that a variety of physical, psychological, and social factors can affect quality of life (QOL). These previous findings suggest that interventions that address these factors could potentially improve QOL. The purpose of this study was to examine whether cognitive behavioral therapy (CBT) can improve QOL, and if so, explore which factors might mediate this effect. This is a secondary analysis of a randomized controlled trial. One hundred twenty-seven participants with multiple sclerosis and depression were randomly assigned to either a telephone-administered CBT (T-CBT) or telephone-administered supportive emotion-focused therapy (T-SEFT) intervention. Patients assigned to T-CBT showed significantly greater improvements in QOL compared with those assigned to T-SEFT. The greater improvement in QOL among T-CBT recipients was mediated by improvements in depression and positive affect. There was also inconsistent support for the superior effect of CBT on QOL being mediated by improvement in fatigue. T-CBT provided greater QOL benefits compared with T-SEFT, which controlled for non-specific treatment components. This study further suggests that T-CBT procedures specific to the management of depression and positive affect were uniquely useful in improving QOL.