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Background and Objectives Outdoor falls can negatively affect the independence and well-being of community-dwelling older adults. Although there is some overlap, there are also differences in risk factors for indoor and outdoor falls. There are no existing community-based fall prevention programs that specifically target outdoor fall prevention. To fill this gap, the Stroll Safe program was developed. Research Design and Methods A cluster-randomized controlled trial design was used with randomization at the site level. Participants (N = 86) were aged 60 and older, with a history of an outdoor fall or who had a fear of falling outdoors. Eight naturally occurring retirement community program sites were randomly assigned to the treatment or wait list control group. Outcome measures included the Outdoor Falls Questionnaire, the Falls Behavioral Scale for the Older Person, and the Falls Efficacy Scale-International to examine knowledge of risks, safe strategy use, protective behaviors, and fear of falling. An Analysis of Covariance (ANCOVA) was used to compare change scores between groups with covariates included for any initial differences between groups. A linear mixed model was also conducted to account for any clustering effects. Results Significant differences (p s <.05) were found between groups for knowledge of outdoor fall risks and safe strategy use. Effect sizes were large (Cohen's d = 1.2–1.9). Results were retained at 6-week follow-up. Discussion and Implications Stroll Safe is effective in improving knowledge of outdoor fall risks and increasing safe strategy use for community mobility. Stroll Safe fills a gap in outdoor fall prevention programs. Clinical Trials Registration Number: NCT03624777 [ABSTRACT FROM AUTHOR]

Aims Tai Chi is a promising exercise option in cardiac rehabilitation to manage coronary heart disease (CHD). Increasing attention was paid on home-based cardiac rehabilitation to improve participation rate, but no study has yet emphasized the effect of home-based Tai Chi. A single-blinded randomized controlled trial is used to examine the effects of a group- plus home-based Tai Chi program on functional health. Methods and results Ninety-eight community-dwelling patients with CHD were randomly assigned to the Tai Chi and control groups. Participants in the Tai Chi group attended 6-week group- plus 6-week home-based Tai Chi program. Outcome measures included physical functions, cardiovascular risk factors, and exercise self-efficacy. Data were collected at baseline, 6-week, 12-week, and 24-week. Intervention effects were analysed using the generalized estimating equation model. Compared with changes in the control group, the intervention group achieved significant improvements in aerobic endurance, lower-body strength, agility and dynamic balance, diastolic blood pressure, and exercise self-efficacy over the 24-week study period (all Ps < 0.05). Intervention adherence was high (79.6% of participants attending >75% of all Tai Chi sessions). Conclusions This Tai Chi program significantly improved the functional health of patients with CHD, indicating that Tai Chi could be taught in group sessions and then continued independently as a home exercise routine for health promotion. [ABSTRACT FROM AUTHOR]

Aims: Medical procedures and hospitalizations can be experienced as traumatic and can lead to post-traumatic stress reactions. Eye movement desensitization and reprocessing (EMDR) shows promising results but very few long-term studies have been published. Therefore, our aim was to test the long-term (8 months post-treatment) effectiveness of EMDR in children and adolescents with medically related subthreshold post-traumatic stress disorder (PTSD). Methods and results: Seventy-four children (including 39 with congenital or acquired heart disease) aged 4–15 (M = 9.6 years) with subthreshold PTSD after previous hospitalization were included into a parallel group randomized controlled trial. Participants were randomized to EMDR (n = 37) or care-as-usual (CAU) (n = 37; medical care only). The primary outcome was PTSD symptoms of the child. Secondary outcomes were symptoms of depression and blood–injection–injury (BII) phobia, sleep problems, and health-related quality of life (HrQoL) of the child. Assessments of all outcomes were planned at baseline and 8 weeks and 8 months after the start of EMDR/CAU. We hypothesized that the EMDR group would show significantly more improvements on all outcomes over time. Both groups showed improvements over time on child's symptoms of PTSD (only parent report), depression, BII phobia, sleep problems, and most HrQoL subscales. GEE analyses showed no significant differences between the EMDR group (nT2 = 33, nT3 = 30) and the CAU group (nT2 = 35, nT3 = 32) on the primary outcome. One superior effect of EMDR over time was found for reducing parent-reported BII phobia of the child. Conclusion: EMDR did not perform better than CAU in reducing subthreshold PTSD up to 8 months post-treatment in previously hospitalized children. Possible explanations and clinical implications are discussed. [ABSTRACT FROM AUTHOR]

Accumulating studies have shown that high-frequency (HF) repetitive transcranial magnetic stimulation (rTMS) may improve cognitive dysfunction of the patients with schizophrenia (SCZ), but with inconsistent results. The present study aims to assess the efficacy of different frequencies of neuronavigated rTMS in ameliorating cognitive impairments and alleviating the psychotic symptoms. A total of 120 patients were randomly assigned to 3 groups: 20 Hz rTMS (n = 40), 10 Hz rTMS (n = 40), or sham stimulation (n = 40) for 8 weeks, and then followed up at week 32. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) was performed to assess the cognitive functions of the patients at baseline, at the end of week 8, and week 32 follow-up. Psychotic symptoms were assessed with the Positive and Negative Syndrome Scale (PANSS) at baseline and at the end of week 2, week 4, week 6, week 8, and week 32 follow-up. Our results demonstrated that 20 Hz rTMS treatment produced an effective therapeutic benefit on immediate memory of patients with chronic SCZ at week 8, but not in the 10 Hz group. Interestingly, both 10 Hz and 20 Hz rTMS treatments produced delayed effects on cognitive functions at the 6-month follow-up. Moreover, in both 10 Hz rTMS and 20 Hz rTMS, the improvements in RBANS total score were positively correlated with the reduction of PANSS positive subscore at the 6-month follow-up. Stepwise regression analysis identified that the visuospatial/constructional index, immediate memory index, and prolactin at baseline were predictors for the improvement of cognitive impairments in the patients. Our results suggest that add-on HF rTMS could be an effective treatment for cognitive impairments in patients with chronic SCZ, with a delayed effect. Trial registration: clinicaltrials.gov identifier—NCT03774927. [ABSTRACT FROM AUTHOR]

Background Although adults with low vitamin D status are at increased risk of acute respiratory infection (ARI), randomized controlled trials of vitamin D supplementation have provided inconsistent results. Methods We performed a randomized, double-blinded, placebo-controlled trial of 5110 adults aged 50–84 years. In 2011–2012, participants were randomized to an initial oral dose of 200 000 IU vitamin D3 followed by 100 000 IU monthly (n = 2558) or placebo (n = 2552) until late 2013 (median follow-up, 1.6 years). Participants reported upper and lower ARIs on monthly questionnaires. Cox models analyzed time to first ARI (upper or lower) by treatment group. Results Participants' mean age was 66 years and 58% were male; 83% were of European/other ethnicity, with the rest Maori, Polynesian, or South Asian. Mean (SD) baseline blood 25-hydroxyvitamin D [25(OH)D] level was 63 (24) nmol/L; 25% were <50 nmol/L. In a random sample (n = 441), vitamin D supplementation increased mean 25(OH)D to 135 nmol/L at 3 years, while those on placebo remained at 63 nmol/L. During follow-up, 3737 participants reported ≥1 ARI: 74.1% in the vitamin D group versus 73.7% in the placebo group. The hazard ratio for vitamin D compared with placebo was 1.01 (95% CI, 0.94, 1.07). Similar results were seen in most subgroups, including those with baseline 25(OH)D <50 nmol/L and in analyses of the upper/lower components of the ARI outcome. Conclusions Monthly high-dose vitamin D supplementation does not prevent ARI in older adults with a low prevalence of profound vitamin D deficiency at baseline. Whether effects of daily or weekly dosing differ requires further study. Clinical Trials Registration Australian New Zealand Clinical Trials Registry, identifier ACTRN12611000402943. [ABSTRACT FROM AUTHOR]

Background: Relevant discharge information about the use of analgesic medication and other strategies may help patients to manage their pain more effectively and prevent postoperative persistent pain. Aims: To examine patients’ pain characteristics, analgesic intake and the impact of an educational pain management booklet intervention on postoperative pain control after cardiac surgery. Concerns about pain and pain medication prior to surgery will also be described. Methods: From March 2012 to September 2013, 416 participants (23% women) were consecutively enrolled in a randomized controlled trial. The intervention group received usual care plus an educational booklet at discharge with supportive telephone follow-up on postoperative day 10, and the control group received only usual care. The primary outcome was worst pain intensity (The Brief Pain Inventory – Short Form). Data about pain characteristics and analgesic use were collected at 2 weeks and at 1, 3, 6 and 12 months post-surgery. General linear mixed models were used to determine between-group differences over time. Results: Twenty-nine percent of participants reported surgically related pain at rest and 9% reported moderate to severe pain at 12 months post-surgery. Many participants had concerns about pain and pain medication, and analgesic intake was insufficient post-discharge. No statistically significant differences between the groups were observed in terms of the outcome measures following surgery. Conclusion: Postoperative pain and inadequate analgesic use were problems for many participants regardless of group allocation, and the current intervention did not reduce worst pain intensity compared with control. Further examination of supportive follow-up monitoring and/or self-management strategies post-discharge is required. [ABSTRACT FROM AUTHOR]

Background: Impaired emotional well-being has detrimental effects on health outcomes in patients with chronic heart failure (CHF). Aims: To evaluate a nurse-led Coping Effectiveness Training (CET) group intervention for patients with CHF. It was hypothesized that CET would increase emotional well-being (primary outcome) and health-related quality (HRQoL) of life and improve clinical outcomes. Furthermore, changes in appraisal and coping as mediators of the intervention effect were examined. Methods: Participants were randomized to either control group (n=51) receiving standard health care or CET intervention group (n=52). Self-assessments of positive affect, negative affect, depression, anxiety, HRQoL, illness perception, coping strategies and social support were performed pre- and post-intervention and after six weeks, six months and 12 months. Time to death and hospitalizations were measured during the entire follow-up (median 35 months, interquartile range 11 months). Results: No significant improvements for emotional well-being and HRQoL in the intervention group compared with the control group were found. After excluding patients with clinical anxiety and depression at baseline the intervention group had significantly lower negative affect (p = 0.022). There were no significant differences regarding cardiovascular events between the groups. The intervention group had greater sense of control over their illness in the short-term (p = 0.036). Conclusion: CET intervention was found to increase sense of control over the illness in the short term. Psychosocial support programmes, like CET, for patients with CHF is currently lacking evidence for implementing in clinical practice. However, the results provide a basis for future studies with a modified CET intervention design and increased study size. [ABSTRACT FROM AUTHOR]

Introduction. Colorectal cancer (CRC) and its treatments can cause distressing sequelae. We conducted a multicenter randomized controlled trial aiming to improve psychological distress, supportive care needs (SCNs), and quality of life (QOL) of patients with CRC. The intervention, called SurvivorCare (SC), comprised educational materials, needs assessment, survivorship care plan, end-of-treatment session, and three follow-up telephone calls. Methods. At the end of treatment for stage I-III CRC, eligible patients were randomized 1:1 to usual care (UC) or to UC plus SC. Distress (Brief Symptom Inventory 18), SCNs (Cancer Survivors' Unmet Needs measure), and QOL (European Organization for Research and Treatment of Cancer [EORTC] QOL questionnaires C30 and EORTC CRC module CR29) were assessed at baseline and at 2 and 6 months (follow-up 1 [FU1] and FU2, respectively). The primary hypothesis was that SC would have a beneficial effect on distress at FU1. The secondary hypotheses were that SC would have a beneficial effect on (a) SCN and QOL at FU1 and on (b) distress, SCNs, and QOL at FU2. A total of 15 items assessed experience of care. Results. Of 221 patients randomly assigned, 4 were ineligible for the study and 1 was lost to FU, leaving 110 in the UC group and 106 in the SC group. Patients' characteristics included the following: median age, 64 years; men, 52%; colon cancer, 56%; rectal cancer, 35%; overlapping sites of disease, 10%; stage I disease, 7%; stage II, 22%; stage III, 71%. Baseline distress and QOL scores were similar to population norms. Between-group differences in distress at FU1 (primary outcome) and at FU2, and SCNs and QOLat FU1 and FU2 were small and nonsignificant. Patients in the SC group were more satisfied with survivorship care than those in the UC group (significant differences on 10 of 15 items). Conclusion. The addition of SC to UC did not have a beneficial effect on distress, SCNs, or QOL outcomes, but patients in the SC group were more satisfied with care. [ABSTRACT FROM AUTHOR]

Objective. To study for the first time in a randomized controlled trial the feasibility, safety and efficacy of an exercise training programme in children and adolescents with JDM. Methods. Patients were randomly assigned to the Intervention Group (IG; n = 14) or Waiting Control Group (WCG; n = 12). The intervention comprised an individually tailored 12-week home-based exercise programme of treadmill interval training and strength exercises. The efficacy of the IG over usual care (WCG) was examined with mixed linear regression (intention-to-treat). Effect sustainability during 12 weeks follow-up was also examined. Results. Seventy-five percent of the participants completed the intervention. Reasons for discontinuation were motivation/fatigue, recurrent infections and increasing physical complaints. No hospitalizations occurred and immune suppressive therapy remained stable or decreased in the patients who participated in the intervention. The estimated marginal means after the intervention period were significantly in favour of the IG compared with the WCG for standing long jump distance [difference between groups (95% CI): 13cm (2-23)], the 30-s number of push-ups [8 (3-13)] and sit-ups [4 (0.4-8)], and the parent Childhood Health Assessment Questionnaire 30 + 8 score [-0.13 (-0.24 to-0.01)] and effects sustained at follow-up. A trend was seen for the maximal oxygen uptake divided by body mass during maximal exercise treadmill testing; the IG scored 3.0ml/kg/min (-1.3 to 7.3) higher compared with the WCG. Other outcomes (e.g. isometric muscle strength and perception of fatigue) did not differ between IG and WCG. Conclusion. Exercise training is of value in the clinical management of JDM. [ABSTRACT FROM AUTHOR]

Objectives: Being and feeling generative, defined as exhibiting concern and behavior to benefit others, is an important developmental goal of midlife and beyond. Although a growing body of evidence suggests mental and physical health benefits of feeling generative in later life, little information exists as to the modifiability of generativity perceptions. The present study examines whether participation in the intergenerational civic engagement program, Experience Corps (EC), benefits older adults' self-perceptions of generativity. Method: Levels of generativity were compared in older adults randomized to serve as EC volunteers or controls (usual volunteer opportunities) in the Baltimore Experience Corps Trial at 4-, 12-, and 24-month evaluation points over the 2-year trial. Analyses utilized intention-to-treat and complier average causal effects (CACE) analyses which incorporate degree of intervention exposure in analytic models. Results: Participants randomized to the EC group had significantly higher levels of generative desire and perceptions of generative achievement than controls at each follow-up point; CACE analyses indicate a dose-response effect with a greater magnitude of intervention effect with greater exposure to the EC program. Discussion: Results provide the first-ever, large-scale experimental demonstration that participation in an intergenerational civic engagement program can positively alter self-perceptions of generativity in older adulthood. [ABSTRACT FROM AUTHOR]

Purpose of the Study: This study determined whether the NYU Caregiver Intervention for Adult Children (the NYUCI-AC) significantly reduced primary subjective stress for adult child caregivers of persons with dementia. Design and Methods: The NYUCI-AC was evaluated within a single-blinded randomized controlled trial. The sample included 107 adult child caregivers of persons with dementia (n = 54 assigned to the multicomponent treatment group; n = 53 assigned to a contact control group). Participants completed comprehensive assessments at baseline and at 4-month intervals during the first year and every 6 months thereafter. The focus of the current analysis was on the effects of the NYUCI-AC on change in primary subjective stress over 8, 12, and 18 months. Results: Individual growth curve models found that caregivers in the NYUCI-AC treatment condition indicated statistically significant (p < .05) linear declines in overall negative reactions to behavior problems over a 1-year period when compared with controls. Adult child caregivers in the NYUCI-AC also indicated greater decreases in negative reactions to disruptive behavior problems when compared with controls over 8, 12, and 18 months. Implications: The NYUCI-AC offered adult child caregivers counseling and support that improved their ability to manage their reactions to disruptive behaviors. This occurred despite the fact that other primary subjective stressors, such as role captivity and role overload, were not reduced. [ABSTRACT FROM AUTHOR]

This study's objective was to investigate healthy aging in older French adults 5 years after a period of daily nutritional-dose supplementation with antioxidant nutrients. The study was based on the double-blind, randomized trial, Supplementation with Antioxidant Vitamins and Minerals (SU.VI.MAX) Study (1994-2002) and the SU.VI.MAX 2 Follow-up Study (2007-2009). During 1994-2002, participants received a daily combination of vitamin C (120 mg), β-carotene (6 mg), vitamin E (30 mg), selenium (100 µg), and zinc (20 mg) or placebo. Healthy aging was assessed in 2007-2009 by using multiple criteria, including the absence of major chronic disease and good physical and cognitive functioning. Data from a subsample of the SU.VI.MAX 2 cohort, initially free of major chronic disease, with a mean age of 65.3 years in 2007-2009 (n = 3,966), were used to calculate relative risks. Supplementation was associated with a greater healthy aging probability among men (relative risk = 1.16, 95% confidence interval: 1.04, 1.29) but not among women (relative risk = 0.98, 95%confidence interval: 0.86, 1.11) or all participants (relative risk = 1.07, 95%confidence interval: 0.99, 1.16). Moreover, exploratory subgroup analyses indicated effect modification by initial serum concentrations of zinc and vitamin C. In conclusion, an adequate supply of antioxidant nutrients (equivalent to quantities provided by a balanced diet rich in fruits and vegetables) may have a beneficial role for healthy aging. [ABSTRACT FROM AUTHOR]

Process evaluation is valuable in guiding development of effective intervention programmes but rare in adolescent weight management. This paper presents a process evaluation of the Loozit® randomized controlled trial, a community-based behavioural lifestyle intervention for obese 13-16 year olds. Adolescents were randomized to receive the two-phase Loozit® group programme, with (n = 73) or without (n = 78), additional therapeutic contact (telephone coaching, short message service and/or emails) in Phase 2. Quantitative and qualitative process data were collected. Facilitators used a standardized evaluation form to document participant attendance, and comment on lesson adherence and process delivery. Adolescents and parents completed satisfaction questionnaires at 2-, 12- and 24-month follow-ups. Following the intervention, 14 adolescents who provided informed written consent were interviewed about their experience with additional therapeutic contact. Data were analysed using descriptive statistics, parametric and non-parametric tests to compare group means, and thematic analyses. Group attendance rates averaged 85 and 47% during Phases 1 (0-2 months) and 2 (3-24 months), respectively. Facilitators frequently noted that participants reported making healthy lifestyle changes. Elements enjoyed in the sessions included practical activities, fun active games, resistance training and forming new friendships. Adolescents struggled with setting specific, measurable, achievable, realistic and timely (SMART) goals. Overall, participants were satisfied with the help received including the telephone and electronic contact. More than 80% of participants found the programme changed adolescents' eating and physical activity habits, and 89% of parents reported changing parenting strategies. Future adolescent group-based programmes may enhance participant engagement and programme effectiveness by including more interactive and frequent telephone and electronic contact. [ABSTRACT FROM AUTHOR]

Overweight and obesity are common health risks, but it can be difficult to effect weight change. This randomized controlled trial examined the effects of a novel Cookery skills intervention on body mass index (BMI) in overweight and obese patients with cardiovascular disease, who had previously attended a cardiac rehabilitation programme. Patients with BMI >27 kg/m² were randomized to either a 5-week cookery skills course with written educational materials, or to written materials only. Questionnaires on lifestyle risk factors and food frequencies were administered at baseline, 6 and 24 months. The primary outcome in an intention-to-treat analysis was a change in BMI at 6 months. Secondary outcome was a change in BMI at 24 months. Changes in macronutrient consumption were examined in both analysis of covariance and repeated measures ANOVA models. Of the 172 patients, 116 (67.4%) patients consented to participate in the study. The intervention was found to be well accepted and attended by the patients (70.5% of patients in the intervention group attended the sessions). Whilst both intervention and control groups were noted to have a small reduction in BMI, there was no significant difference between the groups. There was no significant group effect noted for any change in macronutrient consumption at 6- or 24-month follow-up. This pilot study of a novel cookery skills project was well accepted amongst this population. Although the majority of participants had a net loss in BMI, the cookery skills intervention was not associated with any change in BMI beyond that achieved by written information alone. [ABSTRACT FROM AUTHOR]

Introduction Discogenic low back pain ( LBP) affects a considerable number of patients suffering from chronic LBP. Recently, a growing interest has emerged in minimally invasive treatment options for discogenic LBP. Intradiscal biacuplasty ( IDB), which uses cooled radiofrequency technology to ablate nociceptors in the posterior aspect of the intervertebral disc, is one such option. We previously presented 6-month results of a randomized, double-blinded, sham-controlled study. Now, we present the unblinded, 12-month follow-up data for treatment patients and 6-month data for cross-over subjects from the original sham group. Methods Physical function, pain relief, and disability were assessed using the Short Form-36, numerical rating scale, and Oswestry Disability Index, respectively. Subjects were unblinded at 6 months, and those initially randomized to sham procedure were given the option to cross over to IDB. Results Twenty-two out of 27 subjects in the original active treatment group were followed until 12 months and had clinically significant improvements in physical function (Δ = 22) and pain (Δ = −2.9). Out of 30 subjects originally in the sham group, 24 chose to cross over, and 20 cross-over patients completed follow-up at 6 months. In cross-over patients, improvements in physical function and pain did not differ statistically from those of patients originally randomized to IDB treatment. No complications or adverse events related to the procedure were reported. Conclusions Clinically significant improvements after IDB initially reported at 6 months were maintained at 9 and 12 months. The cross-over subjects had similar improvement in all outcome measures at all observed time points. [ABSTRACT FROM AUTHOR]

Objectives. The study used a randomized controlled trial to investigate the short-term and long-term effects of life-review as online-guided self-help in adults (40+) with moderate depressive symptomatology. We evaluated ego-integrity and rumination as mediators and assessed whether the effects of the intervention did not differ across middle-aged and older adults. Method. Effects of life-review (n = 58) were compared with a waiting list group (n = 58) and an expressive writing intervention (n = 58) on depressive symptoms (primary outcome), anxiety, and well-being (secondary outcomes). Mediator and moderator analyses were also applied. Results. Compared with the waiting list, life-review reduced depressive symptoms (d = 0.35) and enhanced emotional (d = 0.16) and psychological well-being (d = 0.27). Life-review was not more effective than expressive writing. The effects on depressive symptoms were partly related with increases in ego-integrity and decreases in rumination. The intervention is applicable for middle-aged and older adults. Conclusion. Life-review is effective as self-help for middle-aged and older adults with moderate depressive symptomatology compared with a waiting list group. Future research should investigate whether stimulating ego-integrity and reducing rumination enhance the effects of the intervention. [ABSTRACT FROM PUBLISHER]

Objectives. Cardiovascular disease (CVD) is responsible for 50% of the excess mortality for patients with RA. This study aimed to evaluate a novel 8-week cognitive behavioural patient education intervention designed to effect behavioural change with regard to modifiable CVD risk factors in people with RA.Methods. This was a non-blinded randomized controlled trial with a delayed intervention arm. Participants were randomly assigned to receive the cognitive behavioural education intervention or a control information leaflet at a ratio of 1:1. The primary outcome measure was patient’s knowledge of CVD in RA; secondary measures were psychological measures relating to effecting behaviour change, actual behaviour changes and clinical risk factors. Data were collected at baseline, 2 and 6 months.Results. A total of 110 participants consented (52 in the intervention group and 58 in the control group) to participate in the study. At 6 months, those in the intervention group had significantly higher knowledge scores (P < 0.001); improved behavioural intentions to increase exercise (P < 0.001), eat a low-fat diet (P = 0.01) and lose weight (P = 0.06); and lower mean diastolic blood pressure by 3.7 mmHg, whereas the control group’s mean diastolic blood pressure increased by 0.8 mmHg. There was no difference between the groups on actual behaviours.Conclusions. Patient education has a significant role to play in CVD risk factor modification for patients with RA, and the detailed development of this programme probably contributed to its successful results. It is disappointing that behaviours, as we measured them, did not change. The challenge, as always, is how to translate behavioural intentions into action. Larger studies, powered specifically to look at behavioural changes, are required.Trial registration. National Institute for Health Research, UKCRN 4566. [ABSTRACT FROM PUBLISHER]

Objective. To evaluate the prevention of joint destruction and clinical efficacy of low-dose etanercept (ETN) (25 mg/week) compared with standard-dose ETN (50 mg/week) in RA.Methods. In this prospective, randomized, open-label study, 70 patients were assigned to receive ETN at either 50 or 25 mg/week for 52 weeks. The primary endpoint was the variation in modified total Sharp score (mTSS), and secondary endpoints were variations in disease activity score in 28 joints (DAS-28), modified HAQ and adverse event rate. Values of mTSS were calculated at baseline and after 52 weeks. Non-progression was estimated as ΔmTSS &leq;0.5, and the non-progression rate was compared between groups.Results. Mean values at baseline were as follows: disease duration 9.2 years; DAS-28 5.45; and annual progression of mTSS 26.1. No significant differences in background were seen between groups. At 52 weeks, the non-progression rate was significantly less in the 25 mg/week group (36.7%) than in the 50 mg/week group (67.7%) (P = 0.041). Mean ΔmTSS was higher at 25 mg/week (1.03) than at 50 mg/week (−0.13). DAS-28 was significantly improved at 4 weeks, and the effect of treatment lasted for 52 weeks in both groups. No differences in adverse event rates were seen between groups.Conclusion. Low-dose ETN is not inferior to standard-dose ETN in terms of effects on clinical manifestations. However, in terms of the radiographic non-progression rate, the effects of low-dose ETN may be inferior to the effects of standard-dose ETN.Trial Registration: UMIN Clinical Trials Registry, http://www.umin.ac.jp/ctr/, UMIN000001798. [ABSTRACT FROM PUBLISHER]

Objective. Anti-inflammatory therapies are effective analgesics for OA. This study determined whether low-dose oral prednisolone (PNL) was an effective analgesic for hand OA.Methods. This was a randomized, double-blind, placebo-controlled trial of people with ACR criteria hand OA and baseline hand pain visual analogue scale (VAS) of >40/100 mm. Participants received 5 mg PNL or placebo daily for 4 weeks. Pain VAS, disease activity VAS, Australian/Canadian Hand Osteoarthritis Index and joint counts were performed at baseline, 4 and 12 weeks. Primary outcome was the change in hand pain VAS at 4 weeks. Analysis of covariance was used for analysis, controlling for baseline values. To explore potential mechanism of action of PNL, non-contrast 0.2 Tesla MRI was performed on the most painful hand at baseline and 4 weeks.Results. A total of 70 participants were recruited (57 women, mean age 61 years, mean baseline pain VAS 61.5 mm); 75% had more than one joint with definite MRI synovitis/effusion. At 4 weeks the adjusted mean reduction in pain VAS was 19.9 mm (PNL group) and 16.8 mm (placebo group) (P = 0.54). There were no statistically significant differences in VAS, Australian/Canadian Hand Osteoarthritis Index or joint counts between placebo and PNL groups at 4 or 12 weeks. A total of 20 participants in each group achieved an Outcome Measures in Rheumatology-Osteoarthritis Research Society International response. Baseline synovitis/effusion did not predict response to treatment.Conclusion. This is the first randomized controlled trial of low-dose corticosteroid alone for painful hand OA, which demonstrated that short-term low-dose oral PNL is not an effective analgesic treatment for hand OA.Trial registration. International Standard Randomised Controlled Trial Number Register, www.isrctn.org, Trial number 99697616. [ABSTRACT FROM PUBLISHER]

Objective. To investigate the effect of tocilizumab on patient-reported outcomes (PROs) in RA patients with inadequate responses to TNF inhibitors (TNFis).Methods. In a Phase III randomized controlled trial, 489 patients received 4 or 8 mg/kg tocilizumab or placebo every 4 weeks plus MTX for 24 weeks. Mean changes from baseline over time and proportions of patients reporting improvements greater than or equal to minimum clinically important differences (MCIDs) in PROs were analyzed.Results. At week 24, 8 mg/kg resulted in significantly greater improvements vs placebo in pain, global assessment of disease activity (P = 0.001), Health Assessment Questionnaire-Disability Index (HAQ-DI; P < 0.0001), Functional Assessment of Chronic Illness Therapy-Fatigue (P = 0.0150) and Medical Outcomes Survey Short Form 36 (SF-36 v2) Physical Component Summary (PCS; P = 0.0003) scores, all greater than MCID; 4 mg/kg resulted in greater improvements in pain (P = 0.0100), HAQ-DI (P = 0.0030) and SF-36 PCS (P = 0.0020) scores. Tocilizumab-associated improvements were evident as early as week 2. At week 24, more tocilizumab-treated than control patients reported improvements greater than or equal to MCID in SF-36 domain scores and related PROs (50.9–84.9% vs 35.0–51.7%) and achieved ACR50 responses and/or Disease Activity Score 28 (DAS28) remission with PRO improvements greater than or equal to MCID (36.2–51.2% vs 10–20.7% and 10.7–37.5% vs 0.0–3.4%, respectively).Conclusion. Tocilizumab treatment in patients with inadequate responses to TNFis resulted in rapid and sustained improvements in multiple PROs that were statistically significant and clinically meaningful, consistent with previous efficacy reports.Trial Registration. ClinicalTrials.gov, http://clinicaltrials.gov/, NCT00106522. [ABSTRACT FROM PUBLISHER]

Objective. MTX is widely used to treat synovitis in PsA without supporting trial evidence. The aim of our study was to test the value of MTX in the first large randomized placebo-controlled trial (RCT) in PsA.Methods. A 6-month double-blind RCT compared MTX (15 mg/week) with placebo in active PsA. The primary outcome was PsA response criteria (PsARC). Other outcomes included ACR20, DAS-28 and their individual components. Missing data were imputed using multiple imputation methods. Treatments were compared using logistic regression analysis (adjusted for age, sex, disease duration and, where appropriate, individual baseline scores).Results. Four hundred and sixty-two patients were screened and 221 recruited. One hundred and nine patients received MTX and 112 received placebo. Forty-four patients were lost to follow-up (21 MTX, 23 placebo). Twenty-six patients discontinued treatment (14 MTX, 12 placebo). Comparing MTX with placebo in all randomized patients at 6 months showed no significant effect on PsARC [odds ratio (OR) 1.77, 95% CI 0.97, 3.23], ACR20 (OR 2.00, 95% CI 0.65, 6.22) or DAS-28 (OR 1.70, 95% CI 0.90, 3.17). There were also no significant treatment effects on tender and swollen joint counts, ESR, CRP, HAQ and pain. The only benefits of MTX were reductions in patient and assessor global scores and skin scores at 6 months (P = 0.03, P < 0.001 and P = 0.02, respectively). There were no unexpected adverse events.Conclusions. This trial of active PsA found no evidence for MTX improving synovitis and consequently raises questions about its classification as a disease-modifying drug in PsA.Trial registration. Current Controlled Trials, www.controlled-trials.com, ISRCTN:54376151. [ABSTRACT FROM AUTHOR]