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Introduction: The aim of this article is to discuss methods used to analyze health-related quality of life (HRQoL) data from randomized controlled trials (RCTs) for decision analytic models. The analysis presented in this paper was used to provide HRQoL data for the ivabradine health technology assessment (HTA) submission in chronic heart failure.Methods: We have used a large, longitudinal EuroQol five-dimension questionnaire (EQ-5D) dataset from the Systolic Heart Failure Treatment with the I f Inhibitor Ivabradine Trial (SHIFT) (clinicaltrials.gov: NCT02441218) to illustrate issues and methods. HRQoL weights (utility values) were estimated from a mixed regression model developed using SHIFT EQ-5D data (n = 5313 patients). The regression model was used to predict HRQoL outcomes according to treatment, patient characteristics, and key clinical outcomes for patients with a heart rate ≥75 bpm.Results: Ivabradine was associated with an HRQoL weight gain of 0.01. HRQoL weights differed according to New York Heart Association (NYHA) class (NYHA I-IV, no hospitalization: standard care 0.82-0.46; ivabradine 0.84-0.47). A reduction in HRQoL weight was associated with hospitalizations within 30 days of an HRQoL assessment visit, with this reduction varying by NYHA class [-0.07 (NYHA I) to -0.21 (NYHA IV)].Conclusion: The mixed model explained variation in EQ-5D data according to key clinical outcomes and patient characteristics, providing essential information for long-term predictions of patient HRQoL in the cost-effectiveness model. This model was also used to estimate the loss in HRQoL associated with hospitalizations. In SHIFT many hospitalizations did not occur close to EQ-5D visits; hence, any temporary changes in HRQoL associated with such events would not be captured fully in observed RCT evidence, but could be predicted in our cost-effectiveness analysis using the mixed model. Given the large reduction in hospitalizations associated with ivabradine this was an important feature of the analysis.Funding: The Servier Research Group. [ABSTRACT FROM AUTHOR]

Objectives: This paper aimed to compare the outcome of suprapatellar and infrapatellar approaches for the tibia intramedullary nailing.Methods: From February 2010 to August 2013, a total of 162 skeletally mature participants with tibia shaft fractures were identified and divided into suprapatellar approach group (SPAG) and infrapatellar approach group (IPAG) randomly. Fluoroscopy time, length of hospital stay, operative time, blood loss and complications were recorded. Visual analog score (VAS), Lysholm knee score and range of motion (ROM) were reviewed at one, three, six, 12 and 24 months post-operatively. All patients were required to complete short form 36 questionnaire (SF-36) at six, 12 and 24 months postoperatively.Results: The follow-ups lasted two years at least. No significant differences were in major complication rate, operation time, blood loss, the ROM of injured extremity and length of hospital stay between SPAG and IPAG. Nevertheless, the fluoroscopy time was significantly lower in SPAG. VAS pain scores were lower in SPAG at six, 12 and 24 months post-operatively. A higher Lysholm knee score was observed in SPAG at six and 24 months post-operatively. Besides, a better overall physical components score was observed in SPAG except at six months post-operatively.Conclusions: The suprapatellar approach was superior to infrapatrellar approach for the treatment of tibia shaft fracture. Therefore, we recommend the suprapatellar approach as a preferable approach in tibia intramedullary nailing. [ABSTRACT FROM AUTHOR]

Objective: This paper evaluates the effectiveness of motivational enhancement therapy plus cognitive behavioural therapy on depressive symptoms, glycosylated haemoglobin, fasting glucose, body mass index (BMI), and health-related quality of life in type II diabetes patients.Methods: A controlled trial was conducted to compare patients who received the behavioural intervention with untreated controls on measures of health outcomes. A total of 31 intervention group participants and 30 controls were selected from patients that met the inclusion criteria from a hospital-based endocrinology outpatient department. The outcome measures including depressive symptoms, glycosylated haemoglobin, fasting glucose, BMI, and both physical and mental quality of life were collected before (T1), after (T2), and after 90 days (T3) following the intervention.Results: The experimental group showed a significant reduction in glycosylated haemoglobin, fasting glucose, and depressive symptoms and a significant increase in physical quality of life and mental quality of life at T2 and T3, while patients in the control group with usual care showed no changes over time.Conclusion: The behavioural intervention facilitated a significant improvement in psychological adjustment and glycemic control, thus strengthening diabetes control skills and leading to healthy outcomes. It is feasible that nurses and psychiatrists can deliver the behavioural intervention for diabetes patients to decrease their depressive symptoms. Sharing discussion and problem-solving experiences is particularly helpful method for self-control, and these will be beneficially influential on further research. [ABSTRACT FROM AUTHOR]

Purpose: This paper is to evaluate the efficacy and safety of transforaminal lumbar interbody fusion (TLIF) using unilateral pedicle screws along with contralateral translaminar facet joint screw (UPS+TFS) fixation in comparison with the method using bilateral pedicle screws fixation (BPS) in degenerative lumbar diseases.Methods: Forty patients with single-level lumbar diseases were divided into two groups randomly. One group was treated by TLIF with BPS fixation while the other group was treated by the new technique with UPS+TFS fixation. The preoperative and postoperative ODI, JOA, VAPS scores, mean operation time, mean operation blood loss, fusion rate and complications were collected for comparison under two surgical methods. In terms of complications, only two cases of superficial infection in the BPS group and one case of urinary tract infection in the other group was found.Results: The mean operation time and blood loss was significantly less in UPS+TFS group than in BPS group. The preoperation and postoperative ODI, JOA and VAPS at the intervals of 6 weeks, 3, 6 months and 1 year between the BPS and UPS+TFS group showed no significant disparities. Only one patient in UPS+TFS group was not fused with pseudoarthrosis formation.Conclusions: The clinical efficacy and safety of TLIF with UPS+TFS fixation were comparable to BPS fixation; however, the soft tissue injury and the corresponding operation cost were reduced with unilateral pedicle screw plus translaminar facet screw fixation. [ABSTRACT FROM AUTHOR]

Background: The effect of a self-regulatory intervention with its focus on planning sunscreen use is evaluated in comparison to a standard educational condition. Purpose: This paper studied whether planning mediates between the experimental conditions and the behavioral outcome. Further, it is examined who benefits more: already motivated or unmotivated individuals. Method: College students ( N = 253) were randomly assigned to two groups: a self-regulatory and a standard-care condition. Sunscreen use, intention to use sunscreen, and planning were assessed at two points in time, 1 month apart. Results: The self-regulatory intervention improved planning to use sunscreen but not the behavior directly. Planning emerged as the mediator between conditions and later sunscreen use, controlling for baseline behavior. Moreover, participants who were less motivated benefited more from the intervention. Conclusions: Although it is generally assumed that planning interventions are best designed for already motivated persons, the present findings suggest that less prepared individuals might have more to gain from a brief self-regulatory intervention. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the efficacy and safety of Jianpi Jieyu Decoction (JJD) for treating patients with mild-to-moderate depression of Xin (Heart)-Pi (Spleen) deficiency (XPD) syndrome. Methods: In this multi-center, randomized, controlled study, 140 patients with mild-to-moderate depression of XPD syndrome were included from Xiyuan Hospital of China Academy of Chinese Medical Sciences and Botou Hospital of Traditional Chinese Medicine from December 2017 to December 2019. They were randomly divided into JJD group and paroxetine group by using a random number table, with 70 cases in each group. The patients in the JJD group were given JJD one dose per day (twice daily at morning and evening, 100 mL each time), and the patients in the paroxetine group were given paroxetine (10 mg/d in week 1; 20 mg/d in weeks 2–6), both orally administration for a total of 6 weeks. The primary outcome was the change of 17-item Hamilton Depression Rating Scale (HAMD-17) score at week 6 from baseline. The secondary outcomes included the Hamilton Anxiety Scale (HAMA) score, Traditional Chinese Medicine Symptom Scale (TCMSS), and Clinlcal Global Impression (CGI) scores at the 2nd, 4th, and 6th weekends of treatment, HAMD-17 response (defined as a reduction in score of >50%) and HAMD-17 remission (defined as a score of ⩽7) at the end of the 6th week of treatment. Adverse events (AEs) were also recorded. Results: From baseline to week 6, the HAMD-17 scores decreased 10.2 ± 4.0 and 9.1 ± 4.9 points in the JJD and paroxetine groups, respectively (P=0.689). The HAMD-17 response occurred in 60% of patients in the JJD group and in 50% of those in the paroxetine group (P=0.292); HAMD-17 remission occurred in 45.7% and 30% of patients, respectively (P=0.128). The differences of CGI scores at the 6th week were not statistically significant (P>0.05). There were significant differences in HAMD-17 scores between the two groups at 2nd and 4th week (P=0.001 and P=0.014). The HAMA scores declined 8.1 ± 3.0 and 6.9 ± 4.3 points from baseline to week 6 in the JJD and paroxetine groups, respectively (P=0.905 between groups). At 4th week of treatment, there was a significant difference in HAMA between the two groups (P=0.037). TCMSS decreased 11.4 ± 5.1, and 10.1 ± 6.8 points in the JJD and paroxetine groups, respectively (P=0.080 between groups). At the 6th week, the incidence of AEs in the JJD group was significantly lower than that in the paroxetine group (7.14% vs. 22.86%, P<0.05). Conclusion: Compared with paroxetine, JJD was associated with a significantly lower incidence of AEs in patients with mild-to-moderate depression of XPD syndrome, with no difference in efficacy at 6 weeks. (Trial registration No. ChiCTR2000040922) [ABSTRACT FROM AUTHOR]

Introduction: In a randomized controlled trial, we previously investigated if melanoma patients receiving checkpoint inhibitors had fewer severe immune-related adverse events (irAEs) when they reported symptoms using electronic patient-reported outcomes (ePRO) with triggered alerts as an add-on to standard care, compared to standard care alone. The aim of this study is to examine between-group differences in health-related quality of life (HRQoL) and associations between irAEs severity and HRQoL. Methods: The study population of 138 patients completed the EuroQol EQ-5D-5L Index and FACT-M questionnaires at baseline and weeks 24 and 48. We analyzed HRQoL from all patients who completed at least one questionnaire. Missing FACT-M items were imputed following existing guidelines. Results: There was no difference in HRQoL at baseline as measured EQ-5D-5L between the intervention and the control group. Between baseline and 48 weeks, mean EQ-5D-5L scores were unchanged among patients in the intervention group (p = 0.81) but decreased significantly among patients in the control group (p = 0.03). Consequently, patients in the intervention group had higher mean scores than those in the control group (p = 0.05) at 48 weeks. Mean FACT-M scores did not differ significantly between the two groups at any of the time points. There were observed no between-group differences in mean EQ-5D-5 and mean FACT-M scores between patients with severe irAEs and patients who had none. Conclusion: Melanoma patients receiving CPIs who self-reported irAEs using ePRO with triggered alerts as a supplement to standard care maintained their HRQoL compared to patients who received standard care alone. Patients in the intervention group had a significantly better HRQoL measured by EQ-5D-5L than controls 48 weeks after baseline. The results suggest that including ePRO in standard care increases melanoma patients´ well-being. Further and larger studies are needed to confirm this finding and examine the impact of severe irAEs on cancer patients' HRQoL. Trial registration: Clinicaltrials.gov NCT03073031 Registered 8 March 2017, Retrospectively registeredhttps://clinicaltrials.gov/. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effect of comprehensive therapy based on Chinese medicine (CM) patterns on self-efficacy and satisfaction with its effectiveness in patients with chronic obstructive pulmonary disease (COPD). Methods: A total of 216 patients were randomly divided into the trial group (n =108) and the control group (n=108) based on the stratified and block randomization design. Patients in the trial group were treated with conventional Western medicine combined with Bufei Jianpi Granules (补肺健脾颗粒), Bufei Yishen Granules (补肺益肾颗粒), and Yiqi Zishen Granules (益气滋肾颗粒) according to the CM patterns respectively, and patients in the control group were treated with conventional Western medicine. The COPD Self-Efficacy Scale (CSES) and the Effectiveness Satisfaction Questionnaire for COPD (ESQ-COPD) were employed in a 6-month treatment and in further 6 month follow-up visit. Results: Among the 216 patients, 191 patients (97 in the trial group and 94 in the control group) fully completed the study. After 12-month treatment and follow-up, the mean scores of the trial group all continued to increase over time, which were significantly higher than those of the control group (P <0.05), and the improvement in the following trial group domain: negative affect domain (12.13%), intense emotional arousal domain (12.21%), physical exertion domain (11.72%), weather/environmental domain (13.77%), behavioral risk domain (7.67%) and total score (10.65%). The trial group also exhibited significantly higher mean scores in the ESQ-COPD (P <0.05) and the improvement in the following domain: capacity for life and work domain (30.59%), clinical symptoms domain (53.52%), effect of therapy domain (35.95%), convenience of therapy domain (35.54%), and whole effect domain (52.47%). Conclusions: Bufei Jianpi Granules, Bufei Yishen Granules and Yiqi Zishen Granules can improve the self-efficacy and satisfaction of COPD patients. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the feasibility of a combined upper limb and breathing exercise for a home-based program and to explore its effect on primary fatigue and quality of life in ambulatory and non-ambulatory individuals with multiple sclerosis (MS) in a short time.Method: Nineteen individuals with MS were assigned into semi-controlled pre-post feasibility study based on Expanded Disability Status Scale (EDSS) status and divided into two groups: exercise (five ambulatory, five non-ambulatory; EDSS 1.0-8.0) and related control with no exercise (four ambulatory, five non-ambulatory; EDSS 1.0-7.5). Exercise group performed combined upper limb and breathing exercise in a controlled group (2 days/week, 60 min/session) accompanied by independent home exercise (3 days/week, ≥ 20 min/session). Participants underwent measures of fatigue impact (Modified Fatigue Impact Scale (MFIS) and quality of life (RAND Medical outcomes study 36-item short-form health survey (SF-36)) before and after a 4-week period.Results: The MFIS (physical, psychosocial, total) showed statistically significant group-by-time interaction in ambulatory (p = 0.033, d = 1.60; p = 0.039, d = 1.59; p = 0.033, d = 1.62) and non-ambulatory individuals (p = 0.009, d = 2.42; p = 0.018, d = 1.96; p = 0.0008, d = 3.92). Physical functioning (SF-36) showed statistically significant group-by-time interaction in ambulatory (p = 0.014, d = 2.14) but no significance in non-ambulatory (p = 0.368, d = 0.68) individuals. Despite the absent statistical significance, there were large intervention effects on MFIS cognitive scores for ambulatory (d = 1.28) and non-ambulatory (d = 1.47), and on other SF-36 scores for ambulatory (general health: d = 1.76 and pain: d = 1.02) and non-ambulatory (physical limitation: d = 1.03 and emotional well-being: d = 0.94) individuals.Conclusion: Our 4-week program reduced some aspects of fatigue and improved some aspects of quality of life in a small group of ambulatory and non-ambulatory individuals with MS. Good feasibility and significant positive changes from baseline warrant further exploratory work.Trial Registration: Name of the registry: The Impact of Exercise Training on Living Quality in Multiple Sclerosis. Registration: The study was registered at www.clinicaltrial.gov on July 14, 2017. First participant enrollment: August 28, 2017. URL: 602-01/17-01-147; Trial registration ID: NTC03222596. [ABSTRACT FROM AUTHOR]

Background: Duloxetine and pregabalin are among the most widely used medications in the treatment of patients with fibromyalgia syndrome (FM). Objectives: To add to the very few lines of evidence that exist on the comparative safety and efficacy of these two medications. Methods: In this open-label randomized clinical trial, outpatient women, who were diagnosed with FM based on American College of Rheumatology 2010 criteria, and had an age range of 18–65 years old were assigned to either duloxetine 30-60 mg or pregabalin 75-150 mg per day for 4 weeks. Patients were excluded in cases of having used duloxetine, pregabalin, gabapentin, or antidepressants within 12 weeks prior to the study, having had a history of comorbid medical conditions that could provoke chronic pain, or having had comorbid neuropsychiatric disorders, except for major depressive/anxiety disorders. Primary outcomes were between-group differences in mean score changes from baseline to end point for Widespread Pain Index (WPI) and Beck Depression Inventory-II. Secondary outcomes were the same statistical estimates, but for Fibromyalgia Impact Questionnaire-Revised and 12-Item Short Form Survey. Descriptive statistics and independent samples t-test were the main methods of analysis. (www.irct.ir; IRCT2016030626935N1). Results: Among all the scales, only WPI scores improved with a statistically significant difference between the two treatment arms, favoring duloxetine (Mean difference in score change − 2.32, 95% CI, −4.46 to − 0.18; p = 0.034; Cohen's d 0.53 95% CI, 0.04 to 1.02). Drop out rate and cumulative incidence of nausea was significantly higher in the duloxetine arm compared to the pregabalin arm. Conclusion: This study provides further evidence on higher efficacy of duloxetine compared to pregabalin for the treatment of pain in patients with fibromyalgia. Future comprehensive pragmatic clinical trials are warranted. [ABSTRACT FROM AUTHOR]

Purpose: Health state utility values are derived from preference-based measurements and are useful in calculating quality-adjusted life years (QALYs), which is a metric commonly used in cost-effectiveness studies. The purpose of this study was to convert the Achilles Tendon Rupture Score (ATRS) to the preference-based European Quality of Life-5 Dimension Questionnaire (EQ-5D) by estimating the relationship between the two scores using mapping.Methods: Data were collected from a randomised controlled trial, where 100 patients were treated either surgically or non-surgically for Achilles tendon rupture. Forty-three and forty-four patients in surgical group and non-surgical group completed the ATRS and the EQ-5D alongside each other during follow-up at three time points. Different models of the relationship between the ATRS and the EQ-5D were developed and analysed based on direct mapping and cross-validation. The model with the lowest mean absolute error was observed as the one with the best fit.Results: Among the competing models, mapping based on using a combination of the ATRS items four, five, and six associated with limitation due to pain, during activities of daily living and when walking on uneven ground, produced the best predictor of the EQ-5D score.Conclusions: The present study provides a mapping algorithm to enable the derivation of utility values directly from the ATRS. This approach makes it feasible for researchers, as well as medical practitioners, to obtain preference-based values in clinical studies or settings where only the ATRS is being administered. The algorithm allows for the calculation of QALYs for use in cost-effectiveness analyses, making it valuable in the study of acute Achilles tendon ruptures.Level Of Evidence: II. [ABSTRACT FROM AUTHOR]

Purpose: Previous studies reported promising efficacy for celecoxib in the treatment of cancer cachexia. We designed this study to test the hypothesis that combination therapy with megestrol acetate (MA) plus celecoxib is superior to MA alone.Methods: Ninety eligible gastrointestinal cancer patients randomly received either MA 320 mg/day plus placebo (arm1) or MA 320 mg/day plus celecoxib 200 mg/day (arm2). Patients were evaluated at baseline, then 1 and 2 months after starting interventions. The primary outcome was body weight. Secondary outcomes were quality of life, grip strength, appetite score, performance status, plasma albumin, CRP, IL-6, and Glasgow Prognostic Score.Results: Patients were comparable at baseline. Sixty patients were assessable for the first month and 33 patients for the second month. After 2 months, patients in arm1 (MA + placebo) and arm2 (MA + celecoxib) experienced 4.0 ± 3.4 and 2.2 ± 3.6Kg of weight gain respectively (P = 0.163). Changes relative to baseline were statistically significant in both arms of the study (P = 0.001). Regarding secondary outcomes, comparisons between groups did not show any statistically significant difference, but within-group changes were significant in both arms of the study.Conclusion: Since both MA alone and MA plus celecoxib are associated with improvement of cachexia in GI cancer patients, this study failed to show that adding celecoxib (200 mg/day) to megestrol (320 mg/day) could enhance anti-cachexic effects of megestrol. [ABSTRACT FROM AUTHOR]

Purpose: Recent reviews have questioned the efficacy of selective serotonin reuptake inhibitors (SSRIs) above placebo response, and their working mechanisms remain unclear. New approaches to understanding the effects of SSRIs are necessary to enhance their efficacy. The aim of this study was to explore the possibilities of using cross-sectional network analysis to increase our understanding of symptom connectivity before and after SSRI treatment.Methods: In two randomized controlled trials (total N = 178), we estimated Gaussian graphical models among 20 symptoms of the Beck Depression Inventory-II before and after 8 weeks of treatment with the SSRI paroxetine. Networks were compared on connectivity, community structure, predictability (proportion explained variance), and strength centrality (i.e., connectedness to other symptoms in the network).Results: Symptom severity for all individual BDI-II symptoms significantly decreased over 8 weeks of SSRI treatment, whereas interconnectivity and predictability of the symptoms significantly increased. At baseline, three communities were detected; five communities were detected at week 8.Conclusions: Findings suggest the effects of SSRIs can be studied using the network approach. The increased connectivity, predictability, and communities at week 8 may be explained by the decrease in depressive symptoms rather than specific effects of SSRIs. Future studies with larger samples and placebo controls are needed to offer insight into the effects of SSRIs.Trial Registration: The trials described in this manuscript were funded by the NIMH. Pennsylvania/Vanderbilt study: 5 R10 MH55877 ( https://projectreporter.nih.gov/project_info_description.cfm?aid=6186633&icde=28344168&ddparam=&ddvalue=&ddsub=&cr=1&csb=default&cs=ASC&MMOpt= ). Washington study: R01 MH55502 ( https://projectreporter.nih.gov/project_info_description.cfm?aid=2034618&icde=28344217&ddparam=&ddvalue=&ddsub=&cr=5&csb=default&cs=ASC ). [ABSTRACT FROM AUTHOR]

Introduction: Directly recorded patient experience of symptoms and health-related quality of life (HRQoL) can complement lung function and exacerbation rate data in chronic obstructive pulmonary disease (COPD) clinical studies. The FULFIL study recorded daily symptoms and activity limitation together with additional patient-reported outcomes of dyspnea and HRQoL, as part of the prespecified analyses. FULFIL co-primary endpoint data have been previously reported.Methods: FULFIL was a phase III, 24-week, randomized, double-blind, double-dummy, multicenter study comparing once-daily single inhaler triple therapy [fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI)] 100 µg/62.5 µg/25 µg with twice-daily inhaled corticosteroid/long-acting β2-agonist therapy [budesonide/formoterol (BUD/FOR)] 400 µg/12 µg in patients with symptomatic COPD at risk of exacerbations. A subset participated for 52 weeks. Patient-reported assessments were: Evaluating Respiratory Symptoms in COPD™ (E-RS: COPD), St George's Respiratory Questionnaire (SGRQ) for COPD, COPD Assessment Test (CAT), baseline and transitional dyspnea indices (TDI) and daily and global anchor questions for activity limitation.Results: FF/UMEC/VI showed greater reductions from baseline in 4-weekly mean E-RS: COPD total and all subscale scores compared with BUD/FOR; differences were statistically significant (P < 0.05) at each time period. FF/UMEC/VI also demonstrated greater improvements from baseline at weeks 4 and 24 in SGRQ domain scores and TDI focal score compared with BUD/FOR. At weeks 4 and 24, improvements greater than the minimal clinically important difference from baseline were observed in CAT score with FF/UMEC/VI, but not BUD/FOR; differences were statistically significant (P ≤ 0.003).Conclusion: These findings demonstrate sustained daily symptom and HRQoL benefits of FF/UMEC/VI versus BUD/FOR. The inclusion of the CAT may provide data that are readily generalizable to everyday clinical practice.Trial Registration: ClinicalTrials.gov number: NCT02345161.Funding: GSK. [ABSTRACT FROM AUTHOR]

Summary: A 6-month randomized controlled trial of spine-strengthening exercise and posture training reduced both radiographic and clinical measures of kyphosis. Participants receiving the intervention improved self-image and satisfaction with their appearance. Results suggest that spine-strengthening exercise and postural training may be an effective treatment option for older adults with hyperkyphosis. Introduction: The purpose of the present study is to determine in a randomized controlled trial whether spine-strengthening exercises improve Cobb angle of kyphosis in community-dwelling older adults. Methods: We recruited adults ≥60 years with kyphosis ≥40° and enrolled 99 participants (71 women, 28 men), mean age 70.6 ± 0.6 years, range 60-88, with baseline Cobb angle 57.4 ± 12.5°. The intervention included group spine-strengthening exercise and postural training, delivered by a physical therapist, 1-h, three times weekly for 6 months. Controls received four group health education meetings. The primary outcome was change in the gold standard Cobb angle of kyphosis measured from standing lateral spine radiographs. Secondary outcomes included change in kyphometer-measured kyphosis, physical function (modified Physical Performance Test, gait speed, Timed Up and Go, Timed Loaded Standing, 6-Min Walk), and health-related quality of life (HRQoL) (PROMIS global health and physical function indexes, SRS-30 self-image domain). ANCOVA was used to assess treatment effects on change from baseline to 6 months in all outcomes. Results: There was a −3.0° (95% CI −5.2, −0.8) between-group difference in change in Cobb angle, p = 0.009, favoring the intervention and approximating the magnitude of change from an incident vertebral fracture. Kyphometer-measured kyphosis ( p = 0.03) and SRS-30 self-esteem ( p < 0.001) showed favorable between-group differences in change, with no group differences in physical function or additional HRQoL outcomes, p > 0.05. Conclusions: Spine-strengthening exercise and posture training over 6 months reduced kyphosis compared to control. Our randomized controlled trial results suggest that a targeted kyphosis-specific exercise program may be an effective treatment option for older adults with hyperkyphosis. Trial registration number and name of trial register: ClinicalTrials.gov; identifier NCT01751685 [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to compare the effectiveness of two sedative regimens, a benzodiazepine with either meperidine or fentanyl, in relieving pain in patients with cervical cancer undergoing intracavitary brachytherapy in terms of pain score and quality of life.Methods: Forty unselected outpatients undergoing brachytherapy (160 fractions) were enrolled with informed consent and randomized to receive a benzodiazepine with either meperidine or fentanyl. The perceived pain score according to a standard 10-item numeric rating scale was collected every 15 min during the procedure, and the perceived quality of life was determined at the end of each procedure using the EuroQol five-dimension questionnaire. The patients and medical staff members directly involved with the procedure were blinded to the medication used.Results: The patients' pain levels were mild in both analgesic groups. Meperidine appeared to be slightly more effective than fentanyl, although the differences in the average pain score and quality of life were not statistically significant.Conclusion: Both meperidine and fentanyl in combination with benzodiazepine were effective in relieving pain and discomfort in patients undergoing brachytherapy.Trial Registration: NCT02684942, ClinicalTrials.gov. [ABSTRACT FROM AUTHOR]

Purpose: Standard surgical treatment for symptomatic cervical disc disease has been discectomy and fusion, but the use of arthroplasty, designed to preserve motion, has increased, and most studies report clinical outcome in its favor. Few of these trials, however, blinded the patients. We, therefore, conducted the Norwegian Cervical Arthroplasty Trial, and present 2-year clinical outcome after arthroplasty or fusion.Methods: This multicenter trial included 136 patients with single-level cervical disc disease. The patients were randomized to arthroplasty or fusion, and blinded to the treatment modality. The surgical team was blinded to randomization until nerve root decompression was completed. Primary outcome was the self-rated Neck Disability Index. Secondary outcomes were the numeric rating scale for pain and quality of life questionnaires Short Form-36 and EuroQol-5Dimension-3 Level.Results: There was a significant improvement in the primary and all secondary outcomes from baseline to 2-year follow-up for both arthroplasty and fusion (P < 0.001), and no observed significant between-group differences at any follow-up times. However, linear mixed model analyses, correcting for baseline values, dropouts and missing data, revealed a difference in Neck Disability Index (P = 0.049), and arm pain (P = 0.027) in favor of fusion at 2 years. The duration of surgery was longer (P < 0.001), and the frequency of reoperations higher (P = 0.029) with arthroplasty.Conclusion: The present study showed excellent clinical results and no significant difference between treatments at any scheduled follow-up. However, the rate of index level reoperations was higher and the duration of surgery longer with arthroplasty.Trial Registration: http://www.clinicaltrials.gov NCT 00735176.19. [ABSTRACT FROM AUTHOR]

Purpose: The goal of chemotherapy for metastatic breast cancer (MBC) is to prolong survival and maintain health-related quality of life. This study aimed to evaluate long-term health status of patients with MBC who participated in the phase III randomized SELECT BC trial.Methods: In the SELECT BC trial, patients were randomly allocated to the S-1 or taxane (paclitaxel or docetaxel) arm. Health status was assessed by EQ-5D at pre-treatment, 3 and 6 months after randomization, and every 6 months thereafter to the extent possible. Least square mean scores were assessed to compare EQ-5D index values between groups. Time to deterioration analysis was also performed by defining the minimally important difference of EQ-5D as 0.05 or 0.1.Results: The number of patients for EQ-5D analysis was 175 and 208 in the taxane and S-1 arms, respectively. Least square mean EQ-5D index values up to 60 months were 0.741 (95 % CI [0.713-0.769]) in the taxane arm and 0.748 [0.722-0.775] in the S-1 arm. The EQ-5D index value during PFS up to 12 months in the S-1 was superior to the corresponding index value in the taxane (0.812 [0.789-0.834] vs. 0.772 [0.751-0.792], P = 0.009). Time to deterioration analysis also revealed that S-1 significantly delayed the deterioration of EQ-5D index value during the period before progression (P = 0.002 and 0.003).Conclusions: Our findings suggest that the EQ-5D index value was higher in patients treated with S-1 during first-line chemotherapy. Considering non-inferiority of S-1 in terms of OS, obtained quality-adjusted life years may be greater in the S-1 arm. [ABSTRACT FROM AUTHOR]

Purpose: To compare the clinical and radiological outcomes of patients undergoing percutaneous vertebroplasty (PVP) versus those undergoing facet blocking (FB) for severe pain due to osteoporotic vertebral compression fractures (OVCFs).Methods: Two hundred and six patients who had OVCFs on spine radiography and intractable back pain for ≤8 weeks were recruited between January 2009 and January 2013 (165 females and 41 males, age ≥55 years). Patients were randomly assigned to the PVP group (100 patients) or the FB group (106 patients). VAS, ODI, Roland Morris disability (RMD) scores, scores on the Standardized Physical Component of the SF-36 form (SPC) and scores on the Standardized Mental Component of the SF-36 form (SMC) were determined preoperatively and at each follow-up time (1 day, 1 week, 1, 3, 6, and 12 months). In addition, plain radiographs were obtained at 3, 6, and 12 months postoperatively to detect new fractures.Results: Significantly lower VAS, ODI, and RMD scores for patients in the PVP group compared to those in the FB group were observed at follow-up of 1 day and 1 week (p < 0.05). However, differences in the VAS, ODI, RMD and SPC/MCS (SF-36) scores between the two groups at follow-ups of more than 1 month were statistically insignificant (p > 0.05). Difference in numbers of new fractures in the two groups at the follow-up of 12 months was also statistically insignificant.Conclusions: PVP produced better pain relief than FB in the short term (≤1 week). However, the difference in pain-relief between these two techniques was insignificant in the long term (follow-up between 1 month and 12 months). [ABSTRACT FROM AUTHOR]

Purpose: This prospective randomized trial is to determine the effectiveness of treating lumbar facet syndrome with oral diclofenac, methylprednisolone facet joint injection or both.Methods: We enrolled lumbar facet syndrome patients treated at Srinagarind Hospital. Enrolled patients were randomly assigned to receive 100 mg/day oral diclofenac, an 80 mg injection of methylprednisolone into each symptomatic facet joint, or both. Endpoints were the Oswestry disability index (ODI) and visual analogue scale (VAS) before treatment, and at four and 12 weeks after treatment.Results: Of the 99 patients, the mean age was 46.4 years and 48 were men. The initial ODI (mean ± SD) for the diclofenac, methylprednisolone and combined treatment was 45.1 ± 9.3, 42.9 ± 15.6, and 42.2 ± 11.5, respectively. The respective four week ODI was 30.1 ± 8.1, 20.2 ± 8.0, and 15.1 ± 5.5. The 12-week ODI was 42.4 ± 9.0, 32.2 ± 15.6, and 26.2 ± 11.7. The initial VAS was 7.1 ± 1.2, 7.6 ± 1.1, and 7.3 ± 1.0. The four week VAS was 5.3 ± 1.4, 3.6 ± 0.7, and 3.3 ± 1.1. The 12-week VAS was 6.1 ± 1.1, 5.8 ± 1.4, and 5.1 ± 0.9. The four week ODI and VAS for the combined treatment and the methylprednisolone treatment were significantly less than the diclofenac alone. The combined treatment also showed better scores than the methylprednisolone injection. Within each treatment, the best treatment effect was found at four weeks after which the ODI and VAS gradually increased but were still less than the initial scores.Conclusions: The combined treatment was more effective in reducing lumbar facet pain and improving the functional index than either treatment alone. This approach should be the preferred treatment. [ABSTRACT FROM AUTHOR]

Depression is a potentially life threatening affective disorder that is highly prevalent in individuals with autism spectrum disorders (ASD). This study aimed to evaluate the feasibility, acceptability and preliminary efficacy of a cognitive behavioural intervention for depression in adolescents with ASD. Participants were randomly assigned to the intervention group, or wait-list control group. Although recruitment was extremely difficult, attendance was favourable and attrition was low, and participants reported being satisfied with the programme. No significant treatment effect was revealed on the Beck Depression Inventory or Emotion Regulation Questionnaire. However despite the small sample size ( n = 20), there was a trending treatment effect measured by the Depression Anxiety Stress Scale: Depression Subscale. Limitations and areas of future research are discussed. [ABSTRACT FROM AUTHOR]

Background: Alzheimer's disease (AD) is associated with considerable costs and has a significant impact on health and social care systems.Objective: This study assessed whether baseline comorbidities present in 2,594 patients with AD participating in two semagacestat randomized placebo-controlled trials (RCTs) would significantly impact overall costs.Methods: Resource utilization was captured using the Resource Utilization in Dementia Scale-Lite. Comorbidities and concomitant medications were tabulated via patient and caregiver reports. Only baseline data were analyzed. Direct and indirect costs per month were calculated per patient. The relationship between cost and explanatory variables was explored in a regression model.Results: The baseline monthly cost of care in this RCT population was £1,147 ± 2,483, with informal care costs accounting for 75% of costs. Gender, age, and functional status were significant predictors of costs (p ≤ 0.0001). The cost ratio was not impacted when the number of comorbidities was added to the model (cost ratio = 0.95; 95% CI 0.91-0.99) or when combined with the number of concomitant medications (cost ratio = 0.97; 95% CI 0.95-1.00). Inconsistent findings related to the impact of individual comorbidities on costs were noted in sensitivity analyses.Conclusions: The number of comorbidities, alone or when combined with concomitant medications, did not impact baseline costs of care, perhaps because RCTs often enroll less severely ill and more medically stable patients. However, higher costs were consistently associated with greater functional impairment similar to non-RCT databases. Supplemental sources (e.g., claims databases) are likely needed to better estimate the effects of disease and treatment on costs of illness captured in RCTs for AD. [ABSTRACT FROM AUTHOR]

Background: Breathlessness, cough and fatigue are distressing symptoms for patients with lung cancer. There is evidence that these three symptoms form a discreet symptom cluster. This study aimed to feasibly test a new non-pharmacological intervention for the management of the Respiratory Distress Symptom Cluster (breathlessness-cough-fatigue) in lung cancer.Method: This was a multi-centre, randomised controlled non-blinded parallel group feasibility trial. Eligible patients (patients with primary lung cancer and 'bothered' by at least two of the three cluster symptoms) received usual care plus a multicomponent intervention delivered over two intervention training sessions and a follow-up telephone call or usual care only. Follow-up was for 12 weeks, and end-points included six numerical rating scales for breathlessness severity, Dyspnoea-12, Manchester Cough in Lung Cancer scale, FACIT-Fatigue scale, Hospital Anxiety and Depression scale, Lung Cancer Symptom Scale and the EQ-5D-3L, collected at baseline, week 4 and week 12.Results: One hundred seven patients were randomised over 8 months; however, six were removed from further analysis due to protocol violations (intervention group n = 50 and control group n = 51). Of the ineligible patients (n = 608), 29 % reported either not experiencing two or more symptoms or not being 'bothered' by at least two symptoms. There was 29 % drop-out by week 4, and by week 12, a further two patients in the control group were lost to follow-up. A sample size calculation indicated that 122 patients per arm would be needed to detect a clinically important difference in the main outcome for breathlessness, cough and fatigue.Conclusions: The study has provided evidence of the feasibility and acceptability of a new intervention in the lung cancer population and warrants a fully powered trial before we reach any conclusions. The follow-on trial will test the hypothesis that the intervention improves symptom cluster of breathlessness, cough and fatigue better than usual care alone. Full economic evaluation will be conducted in the main trial. [ABSTRACT FROM AUTHOR]

Substantial evidence links antenatal depression, anxiety and stress with negative effects on foetal development, resulting in enduring problems in child development. Despite this, there is a paucity of research on intervention programmes designed to address depression and anxiety, and none that include infant outcomes. We aimed to evaluate the efficacy of a brief treatment for maternal depression and anxiety in pregnancy in a sample of women with a diagnosed depressive disorder. We developed a cognitive behavioural therapy treatment for antenatal depression and anxiety and evaluated it in a feasibility trial. This was followed by a pilot randomised controlled trial (RCT) which collected data on the efficacy of the brief intervention and follow-up data on infants. The feasibility study ( n = 25) yielded promising results for adherence, acceptability and improvements in depression and anxiety (Beck Depression Inventory and Beck Anxiety Inventory). The RCT ( n = 54) again showed excellent adherence and acceptability and supported the efficacy of the treatment. Strong reductions in anxiety were observed during pregnancy, and improvements in depression were maintained at 9 months representing a moderately large effect size. Nine-month infant outcomes showed several medium to large effects favouring the intervention in domains including problem solving, self-regulation and stress reactivity, which were independent of maternal postnatal mood. Treating severe depression and anxiety during pregnancy with a brief cognitive behavioural therapy (CBT) intervention appears feasible and worthwhile. To reliably detect clinically meaningful effects on infant outcomes, larger RCTs are likely to be required. [ABSTRACT FROM AUTHOR]

Background: Diabetes is becoming a very important health issue in rapidly developing nations and there is an urgent need to improve overall diabetes self-management education in these countries. Although e-health is an emerging theme, only a few successful web-based studies on diabetes self-management have been reported. Purpose: We describe the development, implementation, and process evaluation of an Internet-delivered dietary intervention program ( myDIDeA) for diabetic patients in a developing country. Method: Specific dietary components to be included in the intervention module were first identified through a comprehensive review of literature and guidelines. The lesson plans and the study website were then developed based on the evidence, Transtheoretical Model's Stages of Change and user-centered design approach. Finally, the effectiveness of the website was tested through a randomized-controlled trial to promote dietary change in patients with type 2 diabetes. The participants in the intervention group ( n = 66) were given access to myDIDeA for 6 months. Process evaluation in form of intervention adherence and program reception were conducted at post intervention. Results: The response rate for the process evaluation was 89 %. On average, each participant logged in at least once for each lesson plan and spent almost 12 min on the site. The participants' content satisfaction, acceptability, and usability scores were satisfactory. The primary outcome of the trial, Dietary Knowledge, Attitude, and Behavior score was strongly correlated with content satisfaction ( r = 0.826, p < 0.001), acceptability ( r = 0.793, p < 0.001) and usability of the website ( r = 0.724, p < 0.001), and moderately correlated with frequency of log-in ( r = 0.501, p < 0.05) and duration spent in the website ( r = 0.399, p < 0.05). Conclusion: The process evaluation of myDIDeA demonstrates its feasibility, and future studies should identify the possibility of extending the use of Internet-based intervention programs to other health behaviors and issues related to self-management of chronic conditions. In addition, interactivity, peer support via social media, and other means to stimulate the interest of participants can be explored. [ABSTRACT FROM AUTHOR]

Background: Aim of the study was assessment of efficacy and safety of transcutaneous stimulation of the auricular branch of the vagal nerve (t-VNS) in the treatment of chronic migraine. Methods: A monocentric, randomized, controlled, double-blind study was conducted. After one month of baseline, chronic migraine patients were randomized to receive 25 Hz or 1 Hz stimulation of the sensory vagal area at the left ear by a handhold battery driven stimulator for 4 h/day during 3 months. Headache days per 28 days were compared between baseline and the last month of treatment and the number of days with acute medication was recorded The Headache Impact Test (HIT-6) and the Migraine Disability Assessment (MIDAS) questionnaires were used to assess headache-related disability. Results: Of 46 randomized patients, 40 finished the study (per protocol). In the per protocol analysis, patients in the 1 Hz group had a significantly larger reduction in headache days per 28 days than patients in the 25 Hz group (-7.0 ± 4.6 vs. -3.3 ± 5.4 days, p = 0.035). 29.4% of the patients in the 1 Hz group had a =50% reduction in headache days vs. 13.3% in the 25 Hz group. HIT-6 and MIDAS scores were significantly improved in both groups, without group differences. There were no serious treatment-related adverse events. Conclusion: Treatment of chronic migraine by t-VNS at 1 Hz was safe and effective. The mean reduction of headache days after 12 weeks of treatment exceeded that reported for other nerve stimulating procedures. [ABSTRACT FROM AUTHOR]