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Family accommodation (FA) has been linked with myriad negative outcomes in pediatric obsessive-compulsive disorder (OCD), but extant literature has yielded differential relationships between FA and clinical variables of interest. Consequently, this study examined the phenomenology, clinical profile, and effects of comorbid psychopathology on FA to better understand these behaviors. A total of 150 youths and their caregivers completed clinician- and self-reported measures at a baseline visit for a larger randomized controlled trial. Sociodemographic variables were not associated with FA, but specific types of OCD symptom clusters were. Higher OC-symptom severity and functional impairment were associated with increased FA. Comorbid anxiety disorders moderated the relationship between OC-symptom severity and FA, but comorbid attention deficit hyperactivity, oppositional defiant, and mood disorders did not. Internalizing and externalizing problems both mediated the relationship between FA and functional impairment. These findings provide clinical implications for important treatment targets and factors that may impact FA. [ABSTRACT FROM AUTHOR]

Background Dexlansoprazole is a new proton pump inhibitor ( PPI) with a dual delayed-release system. Both dexlansoprazole and esomeprazole are an enantiomer of lansoprazole and omeprazole respectively. However, there is no head-to-head trial data or indirect comparison analyses between dexlansoprazole and esomeprazole. Aim To compare the efficacy of dexlansoprazole with esomeprazole in healing erosive oesophagitis ( EO), the maintenance of healed EO and the treatment of non-erosive reflux disease ( NERD). Methods Randomised Controlled Trials (RCTs) comparing dexlansoprazole or esomeprazole with either placebo or another PPI were systematically reviewed. Random-effect meta-analyses and adjusted indirect comparisons were conducted to compare the treatment effect of dexlansoprazole and esomeprazole using a common comparator. The relative risk ( RR) and 95% confidence interval ( CI) were calculated. Results The indirect comparisons revealed significant differences in symptom control of heartburn in patients with NERD at 4 weeks. Dexlansoprazole 30 mg was more effective than esomeprazole 20 mg or 40 mg ( RR: 2.01, 95% CI: 1.15-3.51; RR: 2.17, 95% CI: 1.39-3.38). However, there were no statistically significant differences between the two drugs in EO healing and maintenance of healed EO. Comparison of symptom control in healed EO was not able to be made due to different definitions used in the RCTs. Conclusions Adjusted indirect comparisons based on currently available RCT data suggested significantly better treatment effect in symptom control of heartburn in patients with NERD for dexlansoprazole against esomeprazole. No statistically significant differences were found in other EO outcomes. However, these study findings need to be interpreted with caution due to small number of studies and other limitations. [ABSTRACT FROM AUTHOR]

Background: Stroke is one of the leading causes of death and the main cause of long-term disability in the United States. The significant risk factors of stroke among Hispanics are well-documented. The majority of stroke survivors return home following a stroke and are cared for by family caregivers. Due to the abrupt nature of strokes, caregivers experience unexpected changes and demands that oftentimes lead to caregiver burden and depression. Given the significant risk factors for stroke in Hispanics and the influence of culture in family norms and family management, we developed a telephone and online problem-solving intervention for Spanish-speaking stroke caregivers. This study tests the impact of a telephone and online problem-solving intervention for Spanish-speaking stroke caregivers on caregiver outcomes. Methods: The design is a two-arm parallel randomized clinical trial with repeated measures. We will enroll 290 caregivers from 3 Veterans Affairs (VA) medical centers. Participants randomized into the intervention arm receive a problem-solving intervention that uses telephone and online education and care management tools on the previously developed and nationally available RESCUE en Español Caregiver website. In the usual care group, participants receive the information and/or support caregivers of veterans with stroke normally receive through existing VA resources (e.g., stroke-related information and support). The primary outcome is change in caregiver's depressive symptoms at 1- and 12-weeks post-intervention. Secondary outcomes include changes in stroke caregivers' burden, self-efficacy, problem-solving, and health-related quality of life (HRQOL) and veterans' functional abilities. We will also determine the budgetary impact, the acceptability of the intervention and participation barriers and facilitators for Spanish-speaking stroke caregivers. Discussion: This is an ongoing study. It is the first known randomized controlled trial testing the effect of a telephone and online problem-solving intervention in Spanish for caregivers of veterans post-stroke. If successful, findings will support an evidence-based model that can be transported into clinical practice to improve the quality of caregiving post-stroke. Trial registration: ClinicalTrials.gov: NCT03142841— Spanish Intervention for Caregivers of Veterans with Stroke (RESCUE Español). Registered on February 23, 2018. Protocol version 8. 08.11.2022. [ABSTRACT FROM AUTHOR]

Background. Evidence-based guidelines are needed to inform rehabilitation practice, including the effect of number of exercise training sessions on recovery of walking ability after stroke. Objective. The objective of this study was to determine the response to increasing number of training sessions of 2 interventions--locomotor training and strength and balance exercises--on poststroke walking recovery. Design. This is a secondary analysis of the Locomotor Experience Applied Post-Stroke (LEAPS) randomized controlled trial. Setting. Six rehabilitation sites in California and Florida and participants' homes were used. Participants. Participants were adults who dwelled in the community (N=347), had had a stroke, were able to walk at least 3 m (10 ft) with assistance, and had completed the required number of intervention sessions. Intervention. Participants received 36 sessions (3 times per week for 12 weeks), 90 minutes in duration, of locomotor training (gait training on a treadmill with bodyweight support and overground training) or strength and balance training. Measurements. Walking speed, as measured by the 10-Meter Walk Test, and 6-minute walking distance were assessed before training and following 12, 24, and 36 intervention sessions. Results. Participants at 2 and 6 months after stroke gained in gait speed and walking endurance after up to 36 sessions of treatment, but the rate of gain diminished steadily and, on average, was very low during the 25- to 36-session epoch, regardless of treatment type or severity of impairment. Limitations. Results may not generalize to people who are unable to initiate a step at 2 months after stroke or people with severe cardiac disease. Conclusions. In general, people who dwelled in the community showed improvements in gait speed and walking distance with up to 36 sessions of locomotor training or strength and balance exercises at both 2 and 6 months after stroke. However, gains beyond 24 sessions tended to be very modest. The tracking of individual response trajectories is imperative in planning treatment. [ABSTRACT FROM AUTHOR]

Background: Studies that have relied exclusively on web-based surveys to secure follow-up have yielded inadequate follow-up rates, resulting in the need to explore whether supplementing with other methods results in incremental improvements. The primary purpose of this study was to determine the effectiveness of each follow up strategy that was used to collect the follow up data in our ongoing Prevention of Low Back Pain in the Military (POLM) trial. Methods: This study represents a secondary analysis of the POLM trial. Twenty companies of Soldiers (N=4,325) were cluster randomized to complete one of four exercise programs. Since web-based response rates were lower than anticipated, a telephone call center was established to contact Soldiers who had not responded to the web-based survey. A military healthcare utilization database (M2) was also used to capture additional followup. Descriptive statistics and pairwise comparisons were performed to determine the incremental benefits of supplementing the primary web-based follow-up strategy in our ongoing POLM trial and determine whether differences existed in demographic characteristics, pain intensity, and low back pain incidence based on followup strategy. Results: Of the 4,325 Soldiers who were enrolled, 632 (14.6%) subjects completed the monthly web-based survey only; 571 (13.2%) responded only to the telephone call; and 233 (5.4%) responded to both the webbased and telephone survey. Adding the telephone call center contributed 804 unique contributions to follow-up, increasing the overall follow-up to 33.2% (n=1,436) and resulting in a net 18.6% increase in follow-up rate. Querying the M2 database yielded follow-up data for an additional 2,788 Soldiers, increasing the follow-up rate by 64.5%. This rate, combined with the web-based and telephone strategies, resulted in an overall follow-up rate of 97.7%. Compared to the web-based survey, those who responded to the telephone call center tended to be younger, white, have a lower income, more likely to smoke, more likely to exercise regularly, and less likely to have low back pain (all with P<.05). Conclusions: The results of this study can inform the design of future clinical trials by establishing the benefit of supplementing a web-based survey with a telephone call center to secure additional follow-up. [ABSTRACT FROM AUTHOR]

Objective: To assess changes in walking function and walking-related prefrontal cortical activity following two post-stroke rehabilitation interventions: an accurate adaptability (ACC) walking intervention and a steady state (SS) walking intervention. Design: Randomized, single blind, parallel group clinical trial. Setting: Hospital research setting. Subjects: Adults with chronic post-stroke hemiparesis and walking deficits. Interventions: ACC emphasized stepping accuracy and walking adaptability, while SS emphasized steady state, symmetrical stepping. Both included 36 sessions led by a licensed physical therapist. ACC walking tasks recruit cortical regions that increase corticospinal tract activation, while SS walking activates the corticospinal tract less intensely. Main measures: The primary functional outcome measure was preferred steady state walking speed. Prefrontal brain activity during walking was measured with functional near infrared spectroscopy to assess executive control demands. Assessments were conducted at baseline, post-intervention (three months), and follow-up (six months). Results: Thirty-eight participants were randomized to the study interventions (mean age 59.6 ± 9.1 years; mean months post-stroke 18.0 ± 10.5). Preferred walking speed increased from baseline to post-intervention by 0.13 ± 0.11 m/s in the ACC group and by 0.14 ± 0.13 m/s in the SS group. The Time × Group interaction was not statistically significant (P = 0.86). Prefrontal fNIRS during walking decreased from baseline to post-intervention, with a marginally larger effect in the ACC group (P = 0.05). Conclusions: The ACC and SS interventions produced similar changes in walking function. fNIRS suggested a potential benefit of ACC training for reducing demand on prefrontal (executive) resources during walking. [ABSTRACT FROM AUTHOR]

Background: Antenatal multiple micronutrient (MM) supplementation improves birth outcomes relative to iron-folic acid (IFA) in developing countries, but limited data exist on its impact on pregnancy micronutrient status.Objective: We assessed the efficacy of a daily MM (15 nutrients) compared with IFA supplement, each providing approximately 1 RDA of nutrients and given beginning at pregnancy ascertainment, on late pregnancy micronutrient status of women in rural Bangladesh. Secondarily, we explored other contributors to pregnancy micronutrient status.Methods: Within a double-masked trial (JiVitA-3) among 44,500 pregnant women, micronutrient status indicators were assessed in n = 1526 women, allocated by cluster to receive daily MM (n = 749) or IFA (n = 777), at 10 wk (baseline: before supplementation) and 32 wk (during supplementation) gestation. Efficacy of MM supplementation on micronutrient status indicators at 32 wk was assessed, controlling for baseline status and other covariates (e.g., inflammation and season), in regression models.Results: Baseline status was comparable by intervention. Prevalence of deficiency among all participants was as follows: anemia, 20.6%; iron by ferritin, 4.0%; iron by transferrin receptor, 4.7%; folate, 2.5%; vitamin B-12, 35.4%; vitamin A, 6.7%; vitamin E, 57.7%; vitamin D, 64.0%; zinc, 13.4%; and iodine, 2.6%. At 32 wk gestation, vitamin B-12, A, and D and zinc status indicators were 3.7-13.7% higher, and ferritin, γ-tocopherol, and thyroglobulin indicators were 8.7-16.6% lower, for the MM group compared with the IFA group, with a 15-38% lower prevalence of deficiencies of vitamins B-12, A, and D and zinc (all P < 0.05). However, indicators typically suggested worsening status during pregnancy, even with supplementation, and baseline status or other covariates were more strongly associated with late pregnancy indicators than was MM supplementation.Conclusions: Rural Bangladeshi women commonly entered pregnancy deficient in micronutrients other than iron and folic acid. Supplementation with MM improved micronutrient status, although deficiencies persisted. Preconception supplementation or higher nutrient doses may be warranted to support nutritional demands of pregnancy in undernourished populations. This trial was registered at clinicaltrials.gov as NCT00860470. [ABSTRACT FROM AUTHOR]

Purpose: The EORTC QLQ-C30 and the Brief Pain Inventory (BPI) are validated tools for measuring quality of life (QOL) and the impact of pain in patients with advanced cancer. Interpretation of these instrument scores can be challenging and it is difficult to know what numerical changes translate to clinically significant impact in patients' lives. To address this issue, our study sought to establish the minimal clinically important differences (MCID) for these two instruments in a prospective cohort of patients with advanced cancer and painful bone metastases.Methods: Both anchor-based and distribution-based methods were used to estimate the MCID scores from patients enrolled in a randomized phase III trial evaluating two different re-irradiation treatment schedules. For the anchor-based method, the global QOL item from the QLQ-C30 was chosen as the anchor. Spearman correlation coefficients were calculated for all items and only those items with moderate or better correlation (|r| ≥ 0.30) with the anchor were used for subsequent analysis. A 10-point difference in the global QOL score was used to classify improvement and deterioration, and the MCID scores were calculated for each of these categories. These results were compared with scores obtained by the distribution-method, which estimates the MCID purely from the statistical characteristics of the sample population.Results: A total of 375 patients were included in this study with documented pain responses and completed QOL questionnaires at 2 months. 9/14 items in the QLQ-C30 and 6/10 items in the BPI were found to have moderate or better correlation with the anchor. For deterioration, statistically significant MCID scores were found in all items of the QLQ-C30 and BPI. For improvement, statistically significant MCID scores were found in 7/9 items of the QLQ-C30 and 2/6 items of the BPI. The MCID scores for deterioration were uniformly higher than the MCIDs for improvement. Using the distribution-based method, there was good agreement between the 0.5 standard deviation (SD) values and anchor-based scores for deterioration. For improvement, there was less agreement and the anchor-based scores were lower than the 0.5 SD values obtained from the distribution-based method.Conclusion: We present MCID scores for the QLQ-C30 and BPI instruments obtained from a large cohort of patients with advanced cancer undergoing re-irradiation for painful bone metastases. The results from this study were compared to other similar studies which showed larger MCID scores for improvement compared to deterioration. We hypothesize that disease trajectory and patient expectations are important factors in understanding the contrasting results. The results of this study can guide clinicians and researchers in the interpretation of these instruments. [ABSTRACT FROM AUTHOR]

Background/Objectives: Dementia‐related behavioral symptoms and functional dependence result in poor quality of life for persons with dementia and their caregivers. The goal was to determine whether a home‐based activity program (Tailored Activity Program; TAP‐VA) would reduce behavioral symptoms and functional dependence of veterans with dementia and caregiver burden. Design: Single‐blind (interviewer), parallel, randomized, controlled trial (Clinicaltrials.gov: NCT01357564). Setting: Veteran's homes. Participants: Veterans with dementia and their family caregivers (N = 160 dyads). Intervention: Dyads in TAP‐VA underwent 8 sessions with occupational therapists to customize activities to the interests and abilities of the veterans and educate their caregivers about dementia and use of customized activity. Caregivers assigned to attention control received up to 8 telephone‐based dementia education sessions with a research team member. Measurements: Primary outcomes included number of behaviors and frequency of their occurrence multiplied by severity of occurrence; secondary outcomes were functional dependence, pain, emotional well‐being, caregiver burden (time spent caregiving, upset with behaviors) and affect at 4 (primary endpoint) and 8 months. Results: Of 160 dyads (n = 76 TAP‐VA; n = 84 control), 111 completed 4‐month interviews (n = 51 TAP‐VA; n = 60 control), and 103 completed 8‐month interviews (n = 50 TAP‐VA; n = 53 control). At 4 months, compared to controls, the TAP‐VA group showed reductions in number (difference in mean change from baseline = −0.68, 95% CI = −1.23 to −0.13) and frequency by severity (−24.3, 95% CI = −45.6 to −3.1) of behavioral symptoms, number of activities needing assistance with (−0.80, 95% CI = −1.41 to −0.20), functional dependence level (4.09, 95% CI = 1.06, 7.13), and pain (−1.18, 95% CI = −2.10 to −0.26). Caregivers of veterans in TAP‐VA reported less behavior‐related distress. Benefits did not extend to 8 months. Conclusion: TAP‐VA had positive immediate effects and no adverse events. Because TAP‐VA reduces behavioral symptoms, slows functional dependence, and alleviates pain and caregiver distress, it is a viable treatment option for families. [ABSTRACT FROM AUTHOR]

Objective: To ascertain the existence of discordance between perceived and measured balance in persons with stroke and to examine the impact on walking speed and falls. Design: A secondary analysis of a phase three, multicentered randomized controlled trial examining walking recovery following stroke. Subjects: A total of 352 participants from the Locomotor Experience Applied Post-Stroke (LEAPS) trial. Methods: Participants were categorized into four groups: two concordant and two discordant groups in relation to measured and perceived balance. Number and percentage of individuals with concordance and discordance were evaluated at two and 12 months. Walking speed and fall incidence between groups were examined. Main measures: Perceived balance was measured by the Activities-Specific Balance Confidence scale, measured balance was determined by the Berg Balance Scale and gait speed was measured by the 10-meter walk test. Results: Discordance was present for 35.8% of participants at two months post stroke with no statistically significant change in proportion at 12 months. Discordant participants with high perceived balance and low measured balance walked 0.09 m/s faster at two months than participants with concordant low perceived and measured balance (p < 0.05). Discordant participants with low perceived balance and high measured balance walked 0.15 m/s slower than those that were concordant with high perceived and measured balance (p ⩽ 0.0001) at 12 months. Concordant participants with high perceived and measured balance walked fastest and had fewer falls. Conclusions: Discordance existed between perceived and measured balance in one-third of individuals at two and 12 months post-stroke. Perceived balance impacted gait speed but not fall incidence. [ABSTRACT FROM AUTHOR]

Background Whether 10-day or 14-day sequential therapy is superior to 14-day triple therapy in the first-line treatment of Helicobacter pylori remains controversial. Aim To compare the efficacy of 10-day or 14-day sequential therapy vs. 14-day triple therapy. Methods Randomised controlled trials ( RCTs) comparing 10-day or 14-day sequential therapy and 14-day triple therapy as first-line treatment in adults were searched from the PubMed and Cochrane databases from 2000 to October 2015. Abstracts from international annual conferences were also searched. The primary and secondary outcomes were the eradication rate according to the intention-to-treat analysis and adverse effects, respectively. Results Of the 109 articles identified, 13 RCTs including 2749 patients in the sequential therapy group and 2424 patients in the 14-day triple therapy group were eligible. Overall, sequential therapy for 10 or 14 days was not significantly superior to 14-day triple therapy [Risk ratio ( RR) 1.04, 95% confidence interval ( CI) 0.99-1.08, P = 0.145]. However, there was significant heterogeneity ( I2 = 57.6%, P = 0.005). In the subgroup analysis of four trials, we found that 14-day sequential therapy was significantly more effective than 14-day triple therapy ( RR: 1.09, 95% CI: 1.04-1.16, P = 0.002), and there was no significant heterogeneity ( I2 = 0%, P = 0.624) in this comparison. Sequential therapy given for 10 days was not superior to 14-day triple therapy ( RR: 1.03, 95% CI: 0.98-1.09, P = 0.207). There was no significant difference in the risk of adverse effects. Conclusion Sequential therapy given for 14 days, but not 10 days, was more effective than 14-day triple therapy as first-line treatment. [ABSTRACT FROM AUTHOR]

BackgroundWhile oral antidepressants reach efficacy after weeks, single-dose intravenous (i.v.) ketamine has rapid, yet time-limited antidepressant effects. We aimed to determine the efficacy and safety of single-dose i.v. ketamine augmentation of escitalopram in major depressive disorder (MDD).MethodThirty outpatients with severe MDD (17-item Hamilton Rating Scale for Depression total score ⩾24) were randomized to 4 weeks double-blind treatment with escitalopram 10 mg/day+single-dose i.v. ketamine (0.5 mg/kg over 40 min) or escitalopram 10 mg/day + placebo (0.9% i.v. saline). Depressive symptoms were measured using the Montgomery–Asberg Depression Rating Scale (MADRS) and the Quick Inventory of Depressive Symptomatology – Self-Report (QIDS-SR). Suicidal ideation was evaluated with the QIDS-SR item 12. Adverse psychopathological effects were measured with the Brief Psychiatric Rating Scale (BPRS)-positive symptoms, Young Mania Rating Scale (YMRS) and Clinician Administered Dissociative States Scale (CADSS). Patients were assessed at baseline, 1, 2, 4, 24 and 72 h and 7, 14, 21 and 28 days. Time to response (⩾50% MADRS score reduction) was the primary outcome.ResultsBy 4 weeks, more escitalopram + ketamine-treated than escitalopram + placebo-treated patients responded (92.3% v. 57.1%, p = 0.04) and remitted (76.9% v. 14.3%, p = 0.001), with significantly shorter time to response [hazard ratio (HR) 0.04, 95% confidence interval (CI) 0.01–0.22, p < 0.001] and remission (HR 0.11, 95% CI 0.02–0.63, p = 0.01). Compared to escitalopram + placebo, escitalopram + ketamine was associated with significantly lower MADRS scores from 2 h to 2 weeks [(peak = 3 days–2 weeks; effect size (ES) = 1.08–1.18)], QIDS-SR scores from 2 h to 2 weeks (maximum ES = 1.27), and QIDS-SR suicidality from 2 to 72 h (maximum ES = 2.24). Only YMRS scores increased significantly with ketamine augmentation (1 and 2 h), without significant BPRS or CADSS elevation.ConclusionsSingle-dose i.v. ketamine augmentation of escitalopram was safe and effective in severe MDD, holding promise for speeding up early oral antidepressant efficacy. [ABSTRACT FROM PUBLISHER]

Background: Pain flare occurs after palliative radiotherapy, and dexamethasone has shown potential for prevention of such flare. We aimed to compare the efficacy of dexamethasone with that of placebo in terms of reduction of incidence of pain flare.Methods: In this double-blind, randomised, placebo-controlled phase 3 trial, patients from 23 Canadian centres were randomly allocated (1:1) with a web-based system and minimisation algorithm to receive either two 4 mg dexamethasone tablets or two placebo tablets taken orally at least 1 h before the start of radiation treatment (a single 8 Gy dose to bone metastases; day 0) and then every day for 4 days after radiotherapy (days 1-4). Patients were eligible if they had a non-haematological malignancy and bone metastasis (or metastases) corresponding to the clinically painful area or areas. Patients reported their worst pain scores and opioid analgesic intake before treatment and daily for 10 days after radiation treatment. They completed the European Organisation for Research and Treatment of Cancer (EORTC) quality of life QLQ-C15-PAL, the bone metastases module (EORTC QLQ-BM22), and the Dexamethasone Symptom Questionnaire at baseline, and at days 10 and 42 after radiation treatment. Pain flare was defined as at least a two-point increase on a scale of 0-10 in the worst pain score with no decrease in analgesic intake, or a 25% or greater increase in analgesic intake with no decrease in the worst pain score from days 0-10, followed by a return to baseline levels or below. Primary analysis of incidence of pain flare was by intention-to-treat (patients with missing primary data were classified as having pain flare). This study is registered with ClinicalTrials.gov, number NCT01248585, and is completed.Findings: Between May 30, 2011, and Dec 11, 2014, 298 patients were enrolled. 39 (26%) of 148 patients randomly allocated to the dexamethasone group and 53 (35%) of 150 patients in the placebo group had a pain flare (difference 8·9%, lower 95% confidence bound 0·0, one-sided p=0·05). Two grade 3 and one grade 4 biochemical hyperglycaemic events occurred in the dexamethasone group (without known clinical effects) compared with none in the placebo group. The most common adverse events were bone pain (61 [41%] of 147 vs 68 [48%] of 143), fatigue (58 [39%] of 147 vs 49 [34%] of 143), constipation (47 [32%] of 147 vs 37 [26%] of 143), and nausea (34 [23%] of 147 vs 34 [24%] of 143), most of which were mild grade 1 or 2.Interpretation: Dexamethasone reduces radiation-induced pain flare in the treatment of painful bone metastases.Funding: The NCIC CTG's programmatic grant from the Canadian Cancer Society Research Institute. [ABSTRACT FROM AUTHOR]

As the U.S. population ages, efficacious interventions are needed to manage pain and maintain physical function among older adults with osteoarthritis (OA). Skeletal muscle weakness is a primary contributory factor to pain and functional decline among persons with OA, thus interventions are needed that improve muscle strength. High-load resistance exercise is the best-known method of improving muscle strength; however high-compressive loads commonly induce significant joint pain among persons with OA. Thus interventions with low-compressive loads are needed which improve muscle strength while limiting joint stress. This study is investigating the potential of an innovative training paradigm, known as Kaatsu, for this purpose. Kaatsu involves performing low-load exercise while externally-applied compression partially restricts blood flow to the active skeletal muscle. The objective of this randomized, single-masked pilot trial is to evaluate the efficacy and feasibility of chronic Kaatsu training for improving skeletal muscle strength and physical function among older adults. Participants aged ≥ 60 years with physical limitations and symptomatic knee OA will be randomly assigned to engage in a 3-month intervention of either (1) center-based, moderate-load resistance training, or (2) Kaatsu training matched for overall workload. Study dependent outcomes include the change in 1) knee extensor strength, 2) objective measures of physical function, and 3) subjective measures of physical function and pain. This study will provide novel information regarding the therapeutic potential of Kaatsu training while also informing about the long-term clinical viability of the paradigm by evaluating participant safety, discomfort, and willingness to continually engage in the intervention. [ABSTRACT FROM AUTHOR]

Summary: Background: Although repeat radiation treatment has been shown to palliate pain in patients with bone metastases from multiple primary origin sites, data for the best possible dose fractionation schedules are lacking. We aimed to assess two dose fractionation schedules in patients with painful bone metastases needing repeat radiation therapy. Methods: We did a multicentre, non-blinded, randomised, controlled trial in nine countries worldwide. We enrolled patients 18 years or older who had radiologically confirmed, painful (ie, pain measured as ≥2 points using the Brief Pain Inventory) bone metastases, had received previous radiation therapy, and were taking a stable dose and schedule of pain-relieving drugs (if prescribed). Patients were randomly assigned (1:1) to receive either 8 Gy in a single fraction or 20 Gy in multiple fractions by a central computer-generated allocation sequence using dynamic minimisation to conceal assignment, stratified by previous radiation fraction schedule, response to initial radiation, and treatment centre. Patients, caregivers, and investigators were not masked to treatment allocation. The primary endpoint was overall pain response at 2 months, which was defined as the sum of complete and partial pain responses to treatment, assessed using both Brief Pain Inventory scores and changes in analgesic consumption. Analysis was done by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00080912. Findings: Between Jan 7, 2004, and May 24, 2012, we randomly assigned 425 patients to each treatment group. 19 (4%) patients in the 8 Gy group and 12 (3%) in the 20 Gy group were found to be ineligible after randomisation, and 140 (33%) and 132 (31%) patients, respectively, were not assessable at 2 months and were counted as missing data in the intention-to-treat analysis. In the intention-to-treat population, 118 (28%) patients allocated to 8 Gy treatment and 135 (32%) allocated to 20 Gy treatment had an overall pain response to treatment (p=0·21; response difference of 4·00% [upper limit of the 95% CI 9·2, less than the prespecified non-inferiority margin of 10%]). In the per-protocol population, 116 (45%) of 258 patients and 134 (51%) of 263 patients, respectively, had an overall pain response to treatment (p=0·17; response difference 6·00% [upper limit of the 95% CI 13·2, greater than the prespecified non-inferiority margin of 10%]). The most frequently reported acute radiation-related toxicities at 14 days were lack of appetite (201 [56%] of 358 assessable patients who received 8 Gy vs 229 [66%] of 349 assessable patients who received 20 Gy; p=0·011) and diarrhoea (81 [23%] of 357 vs 108 [31%] of 349; p=0·018). Pathological fractures occurred in 30 (7%) of 425 patients assigned to 8 Gy and 20 (5%) of 425 assigned to 20 Gy (odds ratio [OR] 1·54, 95% CI 0·85–2·75; p=0·15), and spinal cord or cauda equina compressions were reported in seven (2%) of 425 versus two (<1%) of 425, respectively (OR 3·54, 95% CI 0·73–17·15; p=0·094). Interpretation: In patients with painful bone metastases requiring repeat radiation therapy, treatment with 8 Gy in a single fraction seems to be non-inferior and less toxic than 20 Gy in multiple fractions; however, as findings were not robust in a per-protocol analysis, trade-offs between efficacy and toxicity might exist. Funding: Canadian Cancer Society Research Institute, US National Cancer Institute, Cancer Council Australia, Royal Adelaide Hospital, Dutch Cancer Society, and Assistance Publique-Hôpitaux de Paris. [ABSTRACT FROM AUTHOR]

The Locomotor Experience Applied Post Stroke rehabilitation trial found equivalent walking outcomes for body weight-supported treadmill plus overground walking practice versus home-based exercise that did not emphasize walking. From this large database, we examined several clinically important questions that provide insights into recovery of walking that may affect future trial designs. Using logistic regression analyses, we examined predictors of response based on a variety of walking speed-related outcomes and measures that captured disability, physical impairment, and quality of life. The most robust predictor was being closer at baseline to the primary outcome measure, which was the functional walking speed thresholds of 0.4 m/s (household walking) and 0.8 m/s (community walking). Regardless of baseline walking speed, a younger age and higher Berg Balance Scale score were relative predictors of responding, whether operationally defined by transitioning beyond each speed boundary or by a continuous change or a greater than median increase in walking speed. Of note, the cutoff values of 0.4 and 0.8 m/s had no particular significance compared with other walking speed changes despite their general use as descriptors of functional levels of walking. No evidence was found for any difference in predictors based on treatment group. [ABSTRACT FROM AUTHOR]

Background. Limited evidence exists on how strength and endurance exercises commonly used to prevent low back pain affect muscle morphometry and endurance. Objective. The purpose of this study was to analyze the effects of 2 exercise regimens on the morphometry and endurance of key trunk musculature in a healthy population. Design. The study was designed as a randomized controlled trial. Setting. The study was conducted in a military training setting. Participants. A random subsample (n=340; 72% men, 28% women; mean [±SD] age = 21.9±4.2 years; mean [±SD] body mass index=24.8±2.8 kg/m2) from the larger Prevention of Low Back Pain in the Military trial (N=4,325) was included. Intervention. The core stabilization exercise program (CSEP) included low-load/ low-repetition motor control exercises, whereas the traditional exercise program (TEP) included exercises conducted at a fast pace, with the use of high-load, high- repetition trunk strengthening exercises. Measurements. Baseline and follow-up examinations included ultrasound imaging of the trunk muscles and endurance tests. Linear mixed models were fitted to study the group and time effect and their interactions, accounting for the clustering effect. Results. Symmetry generally improved in the rest and contracted states, but there were no differences suggestive of muscle hypertrophy or improved ability to contract the trunk muscles between soldiers receiving the CSEP or the TEP. Total trunk endurance time decreased over the 12-week period, but endurance performance favored soldiers in the CSEP group. Endurance time was not associated with future episodes of low back pain. Limitations. The lack of morphological changes may not be detectable in an already-active cohort, or a more intensive dose was needed. Conclusions. Although improved symmetry was noted, neither the CSEP nor the TEP resulted in muscle hypertrophy. Longer endurance times were noted in individuals who completed the CSEP but were not strongly predictive of future low back pain episodes. [ABSTRACT FROM AUTHOR]

Introduction: Diverticular disease is very common in Western societies. However, there is a trend towards reducing indications for the surgical management of diverticulitis. Minimally invasive surgery offers many potential advantages to patients in the treatment of diverticulitis and may optimise surgical indications. Methods: A systematic literature review of minimally invasive techniques was carried out for the treatment of diverticulitis. The following techniques were reviewed: laparoscopic, single-port, natural orifice specimen extraction, natural orifice transluminal endoscopic surgery and laparoscopic lavage for the treatment of diverticulitis. Results: In total, 2,050 minimally invasive cases were reviewed. Of all the different minimally invasive techniques published regarding the management of diverticular disease, laparoscopic surgery is the only technique that has undergone the rigours of randomised controlled trials. The documented benefits are less blood loss, less pain and analgesic requirements, a reduction in major complications, a reduction in the frequency of drain usage, a reduction in the duration of postoperative ileus and shorter hospital stay. However, operative time does appear to be longer. It has also been demonstrated that elective laparoscopic surgery results in improved quality of life and social functioning. Conclusion: Minimally invasive surgery for the treatment of diverticular disease appears feasible and safe. The result of future randomised trials will more clearly define the role each minimally invasive technique will play in the future. [ABSTRACT FROM AUTHOR]

Background. The US Army has traditionally utilized bent-knee sit-ups as part of physical training and testing. It is unknown whether the short-term effects of a core stabilization exercise program without sit-up training may result in decreased musculoskeletal injury incidence and work restriction compared with traditional training. Objective. The objective of this study was to explore the short-term effects of a core stabilization exercise program (CSEP) without sit-up training and a traditional exercise program (TEP) on musculoskeletal injury incidence and work restriction. Design. The study was designed as a cluster randomized trial. Setting. The setting was a 16-week training program at Fort Sam Houston (San Antonio, Texas). Participants. The study participants were soldiers with a mean age of 22.9 years (SD=4,7, range= 18-35) for whom complete injury data were available for analysis (n=1,141). Intervention. Twenty companies of soldiers were cluster randomized to complete the CSEP (10 companies of 542 soldiers) or the TEP (10 companies of 599 soldiers). The CSEP included exercises targeting the transversus abdominus and multifidus musculature. The TEP comprised exercises targeting the rectus abdominus, oblique abdominal, and hip flexor musculature. Measurements. Research staff recorded all injuries resulting in the inability to complete full duty responsibilities. Differences in the percentages of musculoskeletal injuries were examined with chi-square analysis; independent sample t tests were used to examine differences in the numbers of days of work restriction. Results. Of the 1,141 soldiers for whom complete injury data were available for analysis, 511 (44.8%) experienced musculoskeletal injuries during training that resulted in work restrictions. There were no differences in the percentages of soldiers with musculoskeletal injuries. There also were no differences in the numbers of days of work restriction for musculoskeletal injuries overall or specific to the upper extremity. However, soldiers who completed the TEP and experienced a low back injury had more days of work restriction: 8.3 days (SD= 14.5) for the TEP group and 4.2 days (SD=8.0) for the CSEP group. Limitations. A limitation of this study was the inconsistent reporting of injuries during training. However, the rates of reporting were similar between the groups. Conclusions. The incidence of musculoskeletal injuries was similar between the groups. There was marginal evidence that the CSEP resulted in fewer days of work restriction for low back injuries. INSET: The Bottom Line. [ABSTRACT FROM AUTHOR]

Knee osteoarthritis (OA) is a leading cause of late life pain and disability, and non-Hispanic black (NHB) adults experience greater OA-related pain and disability than non-Hispanic whites (NHWs). Recent evidence implicates psychosocial stress, cognitive-attentional processes, and altered central pain processing as contributors to greater OA-related pain and disability among NHBs. To address these ethnic/race disparities, this clinical trial will test whether a mindfulness intervention (Breathing and Attention Training, BAT) combined with transcranial direct current stimulation (tDCS) will enhance pain modulatory balance and pain-related brain function, reduce clinical pain, and attenuate ethnic differences therein, among NHBs and NHWs with knee OA. Participants will complete assessments of clinical pain, function, psychosocial measures, and quantitative sensory testing (QST), including mechanical temporal summation and conditioned pain modulation. Neuroimaging will be performed to examine pain-related brain structure and function. Then, participants will be randomized to one of four groups created by crossing two BAT conditions (Real vs. Sham) with two tDCS conditions (Real vs. Sham). Participants will then undergo five treatment sessions during which the assigned BAT and tDCS interventions will be delivered concurrently for 20 min over one week. After the fifth intervention session, participants will undergo assessments of clinical pain and function, QST and neuroimaging identical to the pretreatment measures, and monthly follow-up assessments of pain will be conducted for three months. This will be the first study to determine whether mindfulness and tDCS treatments will show additive or synergistic effects when combined, and whether treatment effects differ across ethnic/race groups. [ABSTRACT FROM AUTHOR]