Search

Background and aims: Offering financial incentives is effective for smoking cessation during pregnancy. We tested the effectiveness of financial incentives for maintaining postpartum cessation, comparing 12-month and 3-month incentives with each other and with usual care (UC). Design, setting and participants: This study was a pragmatic, multi-centre, three-arm randomized controlled trial involving four English, National Health Service, stop smoking services. A total of 462 postpartum women (aged ≥ 16 years) took part, who stopped smoking during pregnancy with financial incentives, validated as abstinent from smoking at end of pregnancy or early postpartum. Interventions: Interventions comprised (i) UC; (ii) UC plus up to £60 of financial voucher incentives offered to participants and £60 offered to an optional significant-other supporter, over 3 months postpartum, contingent upon validated abstinence ('3-month incentives'); or (iii) UC plus '3-month incentives' plus £180 of vouchers offered to participants over 9 months postpartum, contingent upon abstinence ('12-month incentives'). Measurements: Primary outcome: biochemically validated abstinence at 1 year postpartum. To adjust for testing all comparisons between groups with equal precision, P < 0.017 was necessary for significance. Secondary outcomes: self-reported and validated abstinence at 3 months postpartum; self-reported abstinence at 1 year postpartum. Findings: Primary outcome ascertainment: abstinence was 39.6% (63/159) 12 months incentives, 21.4% (33/154) 3 months incentives and 28.2% (42/149) UC. Adjusted odds ratios [95% confidence interval (CI)] = 12-month versus 3-month incentives OR = 2.41 (95% CI = 1.46-3.96), P = 0.001; 12 months versus UC 1.67 (1.04-2.70), P = 0.035; 3 months versus UC 0.69 (0.41-1.17), P = 0.174. Bayes factors indicated that for 12- month versus 3-month incentives and 12 months versus UC there was good evidence for the alternative hypothesis, and for 3 months versus UC there was good evidence for the null hypothesis. Conclusions: This randomized controlled trial provides weak evidence that up to £300 of voucher incentives over 12 months is effective for maintaining smoking abstinence postpartum compared with usual care. There was good evidence that 12-month incentives are superior to those over only 3 months, for which there was no evidence of effectiveness relative to usual care. [ABSTRACT FROM AUTHOR]

Background: Rural family caregivers (FCGs) in the United States often experience high economic costs. This randomized controlled trial compared a transitional palliative care intervention (TPC) to support FCGs of seriously ill care recipients (CRs) to an attention control condition. We evaluated the TPC's effect on healthcare use and out‐of‐pocket spending for both FCGs and CRs. Methods: TPC FCGs received teaching, guidance, and counseling via video calls for 8 weeks following CR discharge from the hospital. After discharge, a research assistant called all FCGs once a month for up to 6 months or CR death to collect self‐reported healthcare utilization (e.g., outpatient, emergency department, and hospital), out‐of‐pocket healthcare spending (e.g., deductibles and coinsurance), and health‐related travel costs (e.g., transportation, lodging, food) for FCGs and CRs. Incidence rate ratios (IRRs) were estimated using negative binomial regressions. Results: The study included 282 FCG–CR dyads across three U.S. states. Follow‐up over the 6‐month period was shortened by high CR mortality rates across both arms (29%), but was similar across arms. TPC reduced nights in the hospital for CR (IRR = 0.75; 95% confidence interval [CI] = 0.56–0. 99). Total out‐of‐pocket spending was not significantly different for TPC versus control. Across both groups, mean out‐of‐pocket spending for dyads was $1401.85, with healthcare payments contributing $1048.58 and transportation expenses contributing $136.79. TPC dyads reported lower lodging costs (IRR = 0.71; 95% CI = 0.56–0.89). Conclusions: This study contributes to evidence that palliative care interventions reduce the number of nights in the hospital for seriously ill patients. Yet, overall rural FCGs and seriously ill CRs experience substantial out‐of‐pocket economic costs in the 6 months following hospitalization. Transitional care intervention design should consider impacts on patient and caregiver spending. Clinicaltrials.gov # is NCT03339271. [ABSTRACT FROM AUTHOR]

Objectives: Patients with traumatic brain injury (TBI) often suffer memory and cognitive impairments, and oxiracetam‐like drugs are considered to have a positive impact on these symptoms potentially. However, the efficacy and safety of L‐oxiracetam and oxiracetam in TBI patients have not been sufficiently investigated. Methods: The study adopts a multicenter, randomized, double‐blind, parallel‐group, phase 3 clinical trial design in 74 centers across 51 hospitals in China. A total of 590 TBI patients meeting criteria will be randomly allocated into three groups in a 2:2:1 ratio: L‐oxiracetam group, oxiracetam group, and placebo group. The treatment period is 14 days, with a follow‐up period of 90 days. The primary outcome measure is the change in the Loewenstein Occupational Therapy Cognitive Assessment score at 90 days after treatment. Secondary outcomes include changes in other cognitive assessments, neurological function, activities of daily living, and safety assessments. Discussion: There is no robust evidence to suggest that L‐oxiracetam and oxiracetam can enhance memory and cognitive function in patients with mild to moderate TBI. This study has the potential to answer this crucial clinical question. Trial registration: chinadrugtrials.org.cn, identifier CTR20192539; ClinicalTrials.gov, identifier NCT04205565. [ABSTRACT FROM AUTHOR]

Objective: Although inpatient treatment is highly effective for patients with bulimia nervosa (BN), some patients show a resurgence of symptoms and relapse after discharge. Therefore, the aim of this study is to evaluate the efficacy of a guided smartphone‐based aftercare intervention following inpatient treatment to support recovery. Method: 172 female patients with BN (DSM‐5: 307.51) will be randomized to receive a 16‐week smartphone‐based aftercare intervention (German version of 'Recovery Record') with therapist feedback as an add‐on element to treatment as usual (TAU) or TAU alone. Assessments will take place at baseline (discharge, T0), during the intervention (after 4 weeks, T1), post‐intervention (after 16 weeks, T2) and at 6‐month follow‐up (T3). Primary outcome will be remission at T2. Moderator and mediator analyses will investigate for whom the aftercare intervention suits best and how it works. Conclusions: This is the first randomized controlled trial to examine a guided smartphone‐based aftercare intervention following inpatient treatment of patients with BN. We expect that this innovative aftercare intervention is highly accepted by the patients and that it has the potential to support recovery after inpatient treatment and thereby could contribute to improving aftercare for patients with BN. Highlights: There are several studies reporting relapse rates for patients with bulimia nervosa (BN) after having received remission or abstinence at the end of treatment.This is the first randomized controlled trial (RCT) to investigate the effects of a guided smartphone‐based aftercare following inpatient treatment of patients with BN.If this innovative aftercare intervention is accepted by the patients and supports recovery after inpatient treatment for patients with BN, it could contribute to improving aftercare for patients with BN. [ABSTRACT FROM AUTHOR]

A novel autologous heterogeneous skin construct (AHSC) was previously shown to be effective versus standard of care (SOC) treatment in facilitating complete wound healing of Wagner 1 diabetic foot ulcers in an interim analysis of 50 patients previously published. We now report the final analysis of 100 patients (50 per group), which further supports the interim analysis findings. Forty‐five subjects in the AHSC treatment group received only one application of the autologous heterogeneous skin construct, and five received two applications. For the primary endpoint at 12 weeks, there were significantly more diabetic wounds closed in the AHSC treatment group (35/50, 70%) than in the SOC control group (17/50, 34%) (p = 0.00032). A significant difference in percentage area reduction between groups was also demonstrated over 8 weeks (p = 0.009). Forty‐nine subjects experienced 148 adverse events: 66 occurred in 21 subjects (42%) in the AHSC treatment group versus 82 in 28 SOC control group subjects (56.0%). Eight subjects were withdrawn due to serious adverse events. Autologous heterogeneous skin construct was shown to be an effective adjunctive therapy for healing Wagner 1 diabetic foot ulcers. [ABSTRACT FROM AUTHOR]

Objectives: Assess (a) the variability of behaviour problems in children with Hyperkinetic Disorder/Attention‐DeficitHyperactivity Disorder (HKD/ADHD) across a range of family situations and (b) the degree to which behaviour in each situation can be modified through a cognitive behavioural parent training (CBPT). Furthermore (c), compare the effectiveness of training in two different formats and (d) test the proposition that group treatment benefits behaviour in a wider range of situations than individual treatment. Method: A registered multicentre randomized controlled trial comparing individual and group parent training to treatment‐as‐usual (TAU) for N = 237 children with HKD/ADHD. A German version of the Home Situations Questionnaire (HSQ) was employed to examine behaviour problems across a range of family situations, treatment‐related changes post‐treatment and at 6‐month follow‐up, while controlling for medication status. Results: Parents reported considerable variance in severity of behaviour problems across situations. All groups improved with time, but individual and group CBPT led to significantly greater improvement than TAU in many family situations. Results present situation‐specific treatment trajectories and demonstrate somewhat greater impact of individual compared with group training in certain situations post‐training and 6 months later. Conclusions: CBPT clearly adds to TAU (with effect sizes in the small to moderate range depending on situation). Individual was somewhat more successful than group format (which did not succeed in a wider range of situations). HSQ situations reveal a differentiated picture of child behaviour and treatment results. Situation‐specific assessment with an instrument like the HSQ offers promising perspectives that invite further development. [ABSTRACT FROM AUTHOR]

Background: 5%–10% children and young people (CYP) experience specific phobias that impact daily functioning. Cognitive Behaviour Therapy (CBT) is recommended but has limitations. One Session Treatment (OST), a briefer alternative incorporating CBT principles, has demonstrated efficacy. The Alleviating Specific Phobias Experienced by Children Trial (ASPECT) investigated the non‐inferiority of OST compared to multi‐session CBT for treating specific phobias in CYP. Methods: ASPECT was a pragmatic, multi‐center, non‐inferiority randomized controlled trial in 26 CAMHS sites, three voluntary agency services, and one university‐based CYP well‐being service. CYP aged 7–16 years with specific phobia were randomized to receive OST or CBT. Clinical non‐inferiority and a nested cost‐effectiveness evaluation was assessed 6‐months post‐randomization using the Behavioural Avoidance Task (BAT). Secondary outcome measures included the Anxiety Disorder Interview Schedule, Child Anxiety Impact Scale, Revised Children's Anxiety Depression Scale, goal‐based outcome measure, and EQ‐5DY and CHU‐9D, collected blind at baseline and six‐months. Results: 268 CYPs were randomized to OST (n = 134) or CBT (n = 134). Mean BAT scores at 6 months were similar across groups in both intention‐to‐treat (ITT) and per‐protocol (PP) populations (CBT: 7.1 (ITT, n = 76), 7.4 (PP, n = 57), OST: 7.4 (ITT, n = 73), 7.6 (PP, n = 56), on the standardized scale‐adjusted mean difference for CBT compared to OST ‐0.123, 95% CI −0.449 to 0.202 (ITT), mean difference −0.204, 95% CI −0.579 to 0.171 (PP)). These findings were wholly below the standardized non‐inferiority limit of 0.4, suggesting that OST is non‐inferior to CBT. No between‐group differences were found on secondary outcomes. OST marginally decreased mean service use costs and maintained similar mean Quality Adjusted Life Years compared to CBT. Conclusions: One Session Treatment has similar clinical effectiveness to CBT for specific phobias in CYP and may be a cost‐saving alternative. [ABSTRACT FROM AUTHOR]

Background: This study aimed to explore the efficacy of Nd:YAG laser-assisted periodontal therapy for management of patients with stage II-IV periodontitis.Methods: Patients who presented with residual periodontal pockets were enrolled. After non-surgical periodontal therapy (NSPT), test sites received Nd:YAG laser (first entrance to pocket: 3 W, 100 μs, 20 Hz; second entrance: 4 W, 600 μs, 20 Hz) and control sites received placebo (laser off). Periodontal probing depth (PPD), clinical attachment level (CAL), gingival recession (GR), bleeding on probing (BOP), and plaque index (PI) were recorded at baseline and 1, 2, 3, 4 and 6-month visits.Results: Twenty patients completed the 6-month period. Significant reductions in PPD, CAL, BOP, and PI values and a significant increase in GR at all follow-up visits compared to the baseline (all P < 0.001) were revealed in both groups. Test sites showed significantly greater improvement in PPD (P = 0.0002) and greater increase in GR (P < 0.0001) compared to the control sites at 6-month visit. There was no difference between two groups regarding CAL gain through the study period (P = 0.23).Conclusion: NSPT+Nd:YAG laser with the current protocol results in greater PPD reduction compared to NSPT alone. However, this reduction is likely because of greater GR rather than attachment gain. Therefore, the adjunction of Nd:YAG laser (with the current setting) to the NSPT for the treatment of residual periodontal pockets did not ameliorate the clinical outcomes (ClinicalTrials.gov ID: NCT03365167). [ABSTRACT FROM AUTHOR]

Background: This randomized, controlled clinical trial aimed to compare the differences in periodontal clinical outcomes, duration of the procedure, and patient's experience between conventional scaling and root planing and erbium-doped: yttrium-aluminum-garnet (Er:YAG) in the treatment of generalized moderate to severe chronic periodontitis or generalized Stages II or III, and Grade B periodontitis based on the Centers for Disease Control (CDC), American Academy of Periodontology (AAP), and European Federation of Periodontology (EFP) definitions.Methods: Thirty subjects were initially recruited. In a split-mouth fashion, right and left sides were randomly allocated into two treatment arms: conventional scaling and root planing (C-SRP) versus laser-assisted scaling and root planing (L-SRP). A blinded examiner recorded clinical measurements at baseline and 3 months. Duration of the procedure was also recorded for each visit, and the patient's experience was assessed with a questionnaire at baseline, 1, and 3 months.Results: The final sample consisted of 26 subjects. Both treatments resulted in overall improvement, but no significant differences were found between modalities for clinical attachment gain or probing depth reduction. The duration of the procedure was approximately half for L-SRP, and postoperative sensitivity was greater in C-SRP.Conclusions: The low-energy protocol with Er:YAG (50 mJ) used for the non-surgical treatment of moderate-severe chronic or Stage II-III, Grade B periodontitis performed in this study population was a treatment modality that yielded similar clinical improvements when compared to conventional scaling and root planing. [ABSTRACT FROM AUTHOR]

Literature suggests that acceptance and commitment therapy (ACT) is effective in improving well‐being and in reducing psychopathological symptoms commonly experienced by people with chronic illness (CI). Compassion‐focused therapy (CFT) reduces psychological distress, especially in individuals with high levels of shame and self‐criticism, but few studies have explored CFT in CI. Additionally, studies almost exclusively compared ACT and CFT with inactive controls (wait‐list; treatment as usual). Also, there is an interest in developing cost‐effective mental health solutions, such as low‐intensity online psychological interventions. This randomized controlled trial (RCT) aimed to assess the acceptability and compare the efficacy of four‐session online ACT (n = 25) and CFT (n = 24) interventions in a sample of people with CI. Results showed both interventions were acceptable, with attrition rates at post‐intervention comparable to those found in similar studies (around 50%). Intention‐to‐treat analyses showed that participants presented significantly less illness‐related shame, less uncompassionate self‐responding and more valued living after the intervention, although no difference was found between conditions. Results were sustained at 3‐ and 6‐month follow‐up. Results did not find statistical differences between conditions through reliable change index (RCI). Correlation between demographics and RCI showed that, at post‐intervention, younger participants presented more behavioural awareness, men presented more valued action, and participants with CI for shorter periods presented less uncompassionate self‐responding and less anxiety. Results suggest that low‐intensity (four sessions) online ACT and CFT are cost‐effective approaches to promote mental health of individuals with CI. Results and limitations are thoroughly discussed. [ABSTRACT FROM AUTHOR]

Background: Spinal cord stimulation (SCS) is a well‐established treatment for chronic intractable pain of the trunk and/or limbs; however, low back pain (LBP) is difficult to treat using traditional SCS. Differential Target Multiplexed spinal cord stimulation (DTM SCS) is an advanced approach inspired from animal studies demonstrating improved pain‐related behavior and pain‐relevant biological processes. Objective: The purpose of this study was to compare the effectiveness of DTM SCS and traditional SCS in treating chronic LBP and leg pain (LP). Methods: This prospective, postmarket randomized controlled trial compared DTM SCS to traditional SCS in patients with chronic LBP and LP. Primary end point was LBP responder rate (percentage of subjects with ≥ 50% relief) at 3 months. Noninferiority and superiority were assessed. Other outcomes included mean change in back and leg pain, responder rates, disability, global health, satisfaction, and safety profile throughout the 12‐month follow‐up. Results: One hundred twenty‐eight subjects were randomized across 12 centers (67 DTM SCS and 61 traditional SCS). Of the 94 patients implanted, 46 subjects in each group completed the 3‐month assessment. LBP responder rate of 80.1% with DTM SCS was superior to 51.2% with traditional SCS (p = 0.0010). Mean LBP reduction (5.36 cm) with DTM SCS was greater than reduction (3.37 cm) with traditional SCS (p < 0.0001). These results were sustained at 6 months and 12 months. Safety profiles were similar between treatment groups. Conclusion: Superiority of DTM SCS compared with traditional SCS for chronic LBP was demonstrated. Clinical improvements provided by DTM SCS were sustained over 12 months and are expected to significantly impact the management of chronic LBP. [ABSTRACT FROM AUTHOR]

Background: Growing evidence shows the efficacy of platelet concentrates in periodontal therapy. This study aimed to demonstrate that an inorganic bovine bone graft (IBB) in combination with a leukocyte and platelet rich fibrin (L-PRF) is non-inferior to a combination with a collagen membrane (CM) when managing unfavorable infrabony defects (IBDs).Methods: All patients exhibited at least one unfavorable IBD; they were randomly assigned to two groups, 31 treated with L-PRF+IBB and 31 with CM+IBB. A clinical and radiographic examination was performed at baseline and 12 months later. Clinical attachment level (CAL), gingival recession (GR), probing depth (PD), and radiographic defect bone level (DBL) post-therapy changes were compared between the two treatments. A non-inferiority margin = 1 mm was set to determine the efficacy of the test treatment (-1 mm for GR); a second non-inferiority margin = 0.5 mm (-0.5 mm for GR) was chosen for clinical relevance.Results: Twelve months after surgery a significant improvement of clinical and radiographic parameters was observed at both experimental sites. The 90% confidence intervals of the CM+IBB-L-PRF+IBB mean difference for CAL gain (-0.810 mm [-1.300 to -0.319]) and DBL gain (-0.648 mm [-1.244 to -0.052]) were below the 0.5 mm non-inferiority margin; GR increase (1.284 mm [0.764 to 1.804]) remained above the -0.5 mm, while PD reduction (0.499 mm [0.145 to 0.853]) crossed its 0.5-mm margin.Conclusions: The L-PRF+IBB treatment of unfavorable IBDs offers non-inferior efficacy for CAL gain, showing less GR and more DBL gain too, while for PD reduction it is inferior to the CM+IBB treatment. [ABSTRACT FROM AUTHOR]

Background: This split-mouth randomized clinical trial compared two different types of subepithelial connective tissue grafts (SCTG) considering clinical parameters and patient-centered outcomes in patients with bilateral recession type 1 multiple gingival recessions after 6 months postoperatively.Methods: A total of 21 patients were surgically treated with coronally advanced flap (CAF) associated with SCTG harvested by: double blade scalpel (DBS) and de-epithelialized (DE) SCTG. Periodontal clinical parameters and esthetics were evaluated by a calibrated periodontist at baseline and after 6 months. Patient-centered outcomes related to pain/discomfort and esthetics were assessed with visual analogue scale after 7 days and 6 months, respectively.Results: All clinical parameters, with the exception of probing depth, demonstrated differences in intragroup evaluation, comparing baseline to 6-month evaluation (P <0.05). Both groups presented reduction of recession depth and recession width and gain of keratinized tissue thickness, keratinized tissue width, and clinical attachment level (P <0.05). Intergroup comparison (DBS × DE) demonstrated no significant differences considering clinical parameters and periods. Both techniques improved esthetics evaluated by patients, without a difference between groups in patients and professional analysis. However, DBS group presented inferior pain/discomfort compared with DE (P <0.05).Conclusion: DBS and DE associated with CAF presented satisfactory clinical outcomes. However, DBS presented inferior morbidity, an important fact for decision-making process. [ABSTRACT FROM AUTHOR]

This randomized controlled trial (RCT) aimed to pilot the newly developed manualized and monitored systemic therapy (ST) for social anxiety disorder (SAD), as compared to manualized and monitored cognitive behavioral therapy (CBT). We conducted a prospective multicenter, assessor‐blind pilot RCT on 38 outpatients (ICD F40.1; Structured Clinical Interview for DSM (SCID); Liebowitz Social Anxiety Scale, LSAS‐SR >30). The primary outcome was level of social anxiety (LSAS‐SR) at the end of treatment. A total of 252 persons were screened, and 38 patients were randomized and started therapy (CBT: 20 patients; ST: 18 patients; age: M = 36 years, SD = 14). Within‐group, simple‐effect intent‐to‐treat analyses (ITT) showed significant reduction in LSAS‐SR (CBT:d = 1.04; ST:d = 1.67), while ITT mixed‐design ANOVA demonstrated the advantage of ST (d = 0.81). Per‐protocol analyses supported these results. Remission based on reliable change indices also demonstrated significant difference (LSAS‐SR: 15% in CBT; 39% in ST;h: 0.550), supported by blind diagnosticians' ratings of those who completed therapy (SCID; 45% in CBT, 78% in ST,p =.083). No adverse events were reported. CBT and ST both reduced social anxiety, supporting patient improvement with the newly developed ST for SAD; this has yet to be verified in a subsequent confirmatory RCT. [ABSTRACT FROM AUTHOR]

Background: Although a large number of adults with intellectual disabilities have depressive symptoms, non‐pharmacological treatments are scarce. The present authors investigated whether bright light therapy (BLT) is effective in decreasing depressive symptoms compared to care as usual. Methods: This multicentre randomized controlled trial consisted of three study groups (10,000 lux BLT, dim light BLT and a no‐BLT group). Participants received BLT for 30 min in the morning (14 consecutive days), additional to their regular care. Primary outcome was as follows: depressive symptoms measured with the ADAMS Depressive Mood subscale 1 week after the end of BLT (same time period in the no‐BLT group). Results: Forty‐one participants were included in our trial. In both BLT groups, a significant decrease in depressive symptoms was seen. No significant differences were found between 10,000 lux BLT and no‐BLT (p =.199) and no significant differences between dim light BLT and no‐BLT (p =.451). A minimum amount of side effects and no adverse events were reported. Conclusions: In both BLT interventions, a decrease in depressive symptoms was seen. With 10,000 lux BLT, depressive symptoms decreased even below the clinical cut‐off point, which makes BLT a promising intervention for clinical practice. [ABSTRACT FROM AUTHOR]

Objective: To assess the efficacy and safety of outpatient administration of oral hyoscine for cervical ripening.Methods: In a randomized controlled trial at a university hospital in Tehran between September 2017 and December 2018, 100 primiparous women with singleton pregnancy at 380 -400 gestational weeks and Bishop score of 5 or less were randomized to either routine expectant management (control group) or 10 mg of oral hyoscine twice daily for 1 week, followed by once daily for 1 week (hyoscine group).Results: Mean ± SD Bishop score in the hyoscine and control groups was, respectively, 1.19 ± 1.38 and 1.08 ± 1.70 at baseline, and 4.56 ± 2.87 and 2.76 ± 2.14 on admission for delivery (P=0.001). Duration of the first stage was 4.10 ± 5.49 hours in the hyoscine and 5.29 ± 6.48 hours in the control group (P=0.03). Duration of the second and third stages was, respectively, 0.52 ± 0.53 and 0.14 ± 0.25 hours in the hyoscine, and 0.59 ± 1.08 and 0.12 ± 0.15 hours in the control group. No adverse effects were reported.Conclusion: Administration of oral hyoscine in an outpatient setting was found to ripen the cervix with no clinically significant adverse drug reaction. IRANIAN REGISTRY OF CLINICAL TRIALS (IRCT20180819040830N1). [ABSTRACT FROM AUTHOR]

Background: A current recommendation for the treatment of patients with locoregionally advanced nasopharyngeal carcinoma (NPC) is conventional fractionated radiotherapy (RT) with concurrent cisplatin followed by adjuvant cisplatin and 5-fluorouracil (PF). This randomized NPC-0501 trial evaluated the therapeutic effect of changing to an induction-concurrent sequence or accelerated-fractionation sequence, and/or replacing 5-fluorouracil with capecitabine (X).Methods: Patients with American Joint Committee on Cancer/International Union Against Cancer stage III to stage IVB NPC initially were randomly allocated to 1 of 6 treatment arms (6-arm full-randomization cohort). The protocol was amended in 2009 to permit centers to opt out of randomization regarding fractionation (3-arm chemotherapy cohort).Results: A total of 803 patients were accrued (1 of whom was nonevaluable) from 2006 to 2012. Based on the overall comparisons, neither changing the chemotherapy sequence nor accelerated fractionation improved treatment outcome. However, secondary analyses demonstrated that when adjusted for RT parameters and other significant factors, the induction-concurrent sequence, especially the induction-PX regimen, achieved significant improvements in progression-free survival (PFS) and overall survival. Efficacy varied among different RT groups: although no impact was observed in the accelerated-fractionation group and the 3-arm chemotherapy cohort, a comparison of the induction-concurrent versus concurrent-adjuvant sequence in the conventional-fractionation group demonstrated a significant benefit in PFS (78% vs 62% at 5 years; P = .015) and a marginal benefit in overall survival (84% vs 72%; P = .042) after adjusting for multiple comparisons. Comparison of the induction-PX versus the adjuvant-PF regimen demonstrated better PFS (78% vs 62%; P = .027) without an increase in overall late toxicity.Conclusions: For patients irradiated using conventional fractionation, changing the chemotherapy sequence from a concurrent-adjuvant to an induction-concurrent sequence, particularly using induction cisplatin and capecitabine, potentially could improve efficacy without an adverse impact on late toxicity. However, further validation is needed for confirmation of these findings. [ABSTRACT FROM AUTHOR]

Objective: The current multicentre randomized controlled trial assessed the clinical efficacy of a combined mHealth intervention for eating disorders (EDs) based on cognitive behavioral therapy (CBT). Method: A total of 106 ED patients from eight different public and private mental health services in Spain were randomly assigned to two parallel groups. Patients of the experimental group (N = 53) received standard face‐to‐face CBT plus a mobile intervention through an application called "TCApp," which provides self‐monitoring and an online chat with the therapist. The control group (N = 53) received standard face‐to‐face CBT only. Patients completed self‐report questionnaires on ED symptomatology, anxiety, depression, and quality of life, before and after treatment. Results: Significant reductions in primary and secondary outcomes were observed for participants of both groups, with no differences between groups. Results also suggested that the frequency with which patients attended their referral mental health institution after the intervention was lower for patients in the experimental group than for those in the control group. Discussion The current study showed that CBT can help to reduce symptoms relating to ED, regardless of whether its delivery includes online components in addition to traditional face‐to‐face treatment. Besides, the additional component offered by the TCApp does not appear to be promising from a purely therapeutic perspective but perhaps as a cost‐effective tool, reducing thus the costs and time burden associated with weekly visits to health professionals. [ABSTRACT FROM AUTHOR]

Background: The purpose of this study was to evaluate the potential advantages of adjunctive use of enamel matrix protein derivative (EMD) in combination with demineralized porcine bone matrix (DPBM) for the treatment of one-wall intrabony defects in the molar regions, in comparison with the use of DPBM alone, through a randomized controlled clinical trial.Methods: Forty-two participants were randomly assigned to two groups: one where DPBM with the adjunctive use of EMD (test group, n = 20) was applied and the other without EMD (control group, n = 22). Changes in the clinical and radiographic parameters from baseline at 6, 12, and 24 months were measured (probing pocket depth, clinical attachment loss, defect depth, and defect width). Postoperative discomfort (severity/duration of pain and swelling) and early soft tissue wound healing (dehiscence/fenestration, persistent swelling, spontaneous bleeding, and ulceration) were also assessed.Results: Both treatment modalities, with and without EMD, resulted in significant improvement of clinical and radiographic outcomes without any severe adverse events. However, no statistically significant differences in any of the measured parameters were found when the two groups were compared. Early wound healing outcomes and the severity of swelling did not differ between the groups, but the severity of pain (P = 0.046), duration (P = 0.033), and swelling (P = 0.022) were significantly lower in the test group.Conclusions: DPBM has been verified for biocompatibility and can be used as a scaffold to enhance the clinical and radiographic outcomes of periodontal regeneration of one-wall intrabony defects. In particular, the adjunctive use of EMD significantly reduced the postoperative discomfort. [ABSTRACT FROM AUTHOR]

Aims: Patients with advanced heart failure (AdHF) who are ineligible for heart transplantation (HTx) can become candidates for treatment with a left ventricular assist device (LVAD) in some countries, but not others. This reflects the lack of a systematic analysis of the usefulness of LVAD systems in this context, and of their benefits, limitations and cost-effectiveness. The SWEdish evaluation of left Ventricular Assist Device (SweVAD) study is a Phase IV, prospective, 1:1 randomized, non-blinded, multicentre trial that will examine the impact of assignment to mechanical circulatory support with guideline-directed LVAD destination therapy (GD-LVAD-DT) using the HeartMate 3 (HM3) continuous flow pump vs. guideline-directed medical therapy (GDMT) on survival in a population of AdHF patients ineligible for HTx.Methods: A total of 80 patients will be recruited to SweVAD at the seven university hospitals in Sweden. The study population will comprise patients with AdHF (New York Heart Association class IIIB-IV, INTERMACS profile 2-6) who display signs of poor prognosis despite GDMT and who are not considered eligible for HTx. Participants will be followed for 2 years or until death occurs. Other endpoints will be determined by blinded adjudication. Patients who remain on study-assigned interventions beyond 2 years will be asked to continue follow-up for outcomes and adverse events for up to 5 years.Conclusion: The SweVAD study will compare survival, medium-term benefits, costs and potential hazards between GD-LVAD-DT and GDMT and will provide a valuable reference point to guide destination therapy strategies for patients with AdHF ineligible for HTx. [ABSTRACT FROM AUTHOR]

Introduction: Vitamin D deficiency is common in pregnancy, especially in obese women. Lifestyle intervention could potentially result in higher levels of vitamin D. We therefore aimed to study the effect of lifestyle intervention during pregnancy on serum levels of 25-hydroxyvitamin D (25(OH)D).Material and Methods: A total of 360 obese women were randomized before gestational age 14 weeks to lifestyle intervention (diet and exercise) or routine clinical follow up (controls). Clinical outcomes and levels of 25(OH)D were determined three times: At gestational age 12-15 weeks (baseline), gestational age 28-30 weeks and 6 months postpartum.Results: A total of 304 (84%) women completed the intervention study and 238 (66%) attended postpartum follow up. Vitamin D levels were similar in the two groups at baseline. At gestational age 28-30 weeks and 6 months postpartum, 25(OH)D levels were significantly higher in the intervention group than in controls (75.6 vs 66.8 nmol/L, P = 0.009) and (54.8 vs 43.1 nmol/L, P = 0.013), respectively. Concurrently, vitamin D deficiency (25-hydroxyvitamin D <50 nmol/L) was less frequent in the intervention group than in controls: 15 vs 25% (P = 0.038) at gestational age 28-30 and 45 vs 63% (P = 0.011) 6 months postpartum, respectively.Conclusions: Lifestyle intervention during pregnancy was associated with significantly increased vitamin D levels in late pregnancy and postpartum compared with controls. [ABSTRACT FROM AUTHOR]

Background: Melatonin may reduce REM-sleep behavior disorder (RBD) symptoms in Parkinson's disease (PD), though robust clinical trials are lacking.Objective: To assess the efficacy of prolonged-release (PR) melatonin for RBD in PD.Methods: Randomized, double-blind, placebo-controlled, parallel-group trial with an 8-week intervention and 4-week observation pre- and postintervention (ACTRN12613000648729). Thirty PD patients with rapid eye movement sleep behavior disorder were randomized to 4 mg of prolonged-release melatonin (Circadin) or matched placebo, ingested orally once-daily before bedtime. Primary outcome was the aggregate of rapid eye movement sleep behavior disorder incidents averaged over weeks 5 to 8 of treatment captured by a weekly diary. Data were included in a mixed-model analysis of variance (n = 15 per group).Results: No differences between groups at the primary endpoint (3.4 events/week melatonin vs. 3.6 placebo; difference, 0.2; 95% confidence interval = -3.2 to 3.6; P = 0.92). Adverse events included mild headaches, fatigue, and morning sleepiness (n = 4 melatonin; n = 5 placebo).Conclusion: Prolonged-release melatonin 4 mg did not reduce rapid eye movement sleep behavior disorder in PD. © 2019 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society. [ABSTRACT FROM AUTHOR]

Objective: To explore pregnant women's views of participation in a clinical research trial while pregnant. Design: Prospective nested qualitative cohort study embedded within a national, multi‐site randomized controlled trial of a diagnostic test for preeclampsia: Placental Growth Factor. One‐to‐one in‐depth semi‐structured interviews were undertaken with 19 women who had recently participated in the trial at a single recruiting site. The interviews were conducted in private, recorded digitally and transcribed verbatim. Setting: Single tertiary maternity hospital currently recruiting eligible women onto an on‐going randomized controlled trial (NCT 02881073). Participants: Women who had participated in the PARROT Ireland randomized controlled trial during their recent pregnancy. Methods: Thematic analysis was utilized. Each line of the transcribed interviews was coded into a category by two researchers. The resultant categories were reviewed, and those with similarities were pooled allowing the development of themes. Main Outcome Measures: Women's opinions and experience of participation in a randomized controlled trial of an interventional diagnostic test during their pregnancy. Results: Four major themes were identified as follows: (a) Understanding of preeclampsia, (b) Motivators for clinical trial participation, (c) Barriers to decision making and (d) Influence of PARROT Ireland on pregnancy experience. Conclusions: Women are generally interested and positively inclined to participate in research during pregnancy. The potential of risk is an important consideration for eligible pregnant woman. Information and support by both researchers and clinicians are paramount in aiding women's understanding of a research trial. [ABSTRACT FROM AUTHOR]

Background: Fatigue is a common and disabling side effect of targeted therapies such as tyrosine kinase inhibitors (TKIs) used to treat chronic myeloid leukemia (CML). The goal of the current study was to conduct a pilot randomized trial of the first cognitive behavioral intervention developed for fatigue due to targeted therapy.Methods: Patients with CML treated with a TKI who were reporting moderate to severe fatigue were recruited and randomized 2:1 to cognitive behavioral therapy for targeted therapy-related fatigue (CBT-TTF) delivered via FaceTime for the iPad or to a waitlist control (WLC) group. The outcomes were acceptability, feasibility, and preliminary efficacy for fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue; primary outcome) and quality of life (Functional Assessment of Cancer Therapy-General; secondary outcome). Participants were assessed before randomization and after treatment (ie, approximately 18 weeks later).Results: A total of 44 patients (mean age, 55 years; 48% female) were assigned to CBT-TTF (n = 29) or WLC (n = 15). The study participation rate was 59%. Among the patients assigned to CBT-TTF, 79% completed the intervention. Intent-to-treat analyses indicated that patients assigned to CBT-TTF demonstrated greater improvements in fatigue (d = 1.06; P < .001) and overall quality of life (d = 1.15; P = .005) than those assigned to WLC. More patients randomized to CBT-TTF than WLC demonstrated clinically significant improvements in fatigue (85% vs 29%) and quality of life (88% vs 54%; P values ≤ .016).Conclusions: CBT-TTF displays preliminary efficacy in improving fatigue and quality of life among fatigued patients with CML treated with TKIs. The findings suggest that a larger randomized study is warranted. [ABSTRACT FROM AUTHOR]

Objective: To compare the effect of gonadotropin-releasing hormone (GnRH) agonist microdose flare-up and GnRH agonist flare-up protocols among women with poor ovarian reserve undergoing intracytoplasmic sperm injection (ICSI) cycles.Methods: Randomized controlled trial study among 131 women with poor ovarian reserve who underwent ICSI cycles at a single center in Tehran, Iran, between September 2008 and May 2014. Eligible women were randomly assigned to either the microdose flare-up (n=66) or flare-up (n=65) protocol. The primary outcome measure was live birth rate.Results: Both groups were comparable in cycle cancellation, mean number of dominant follicles, retrieved oocytes, and metaphase II oocytes. Number of stimulation days (P=032) and endometrial thickness (P=0.001) were significantly higher, and gonadotropin dose was non-significantly higher (P=0.075) in the microdose flare-up group than in the flare-up group. No difference in clinical pregnancy, implantation, or abortion rate was observed between the two protocols. Live birth was higher in the microdose flare-up group than in the flare-up group (P=0.036).Conclusion: The microdose flare-up protocol seemed to be superior to the flare-up protocol, but it required a higher dose of gonadotropins and a longer duration of stimulation. Further prospective clinical trials of the microdose flare-up protocol are recommended. CLINICALTRIALS.GOV: NCT01006954. [ABSTRACT FROM AUTHOR]

Background: Photoactivated disinfection (PAD) could support the periodontal treatment outcome. The effect of the light emitting diode (LED) as an innovative light source in PAD is under discussion. The aim of this study was to evaluate the clinical and microbiological effect of adjunctive PAD in the treatment of periodontitis with a red LED as light source.Methods: Twenty patients with periodontitis completed this split-mouth study. The left and right side of the jaws were randomly assigned to either test or control group. After conservative periodontal treatment in both groups, the test group received two sessions of adjunctive PAD (red LED, 635 nm, photosensitive dye, 0.01% tolonium chloride), whereas the control group received no adjunctive PAD. The parameters of clinical periodontal examination-including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP) and microbiological assays (PCR) were evaluated before and after treatment.Results: After 3 months, both treatment groups showed significant improvements regarding BOP, PD, and CAL compared to baseline, with no significant difference between control and treatment group. The recolonization of Porphyromonas gingivalis and Treponema denticola was reduced after adjuvant treatment, but not significantly.Conclusions: The positive effect of adjunctive PAD regarding clinical parameters was reported in recent trials. In this study and with the current settings, both treatment groups showed similar clinical results after initial periodontal treatment, without beneficial effect of adjunctive PAD. [ABSTRACT FROM AUTHOR]

Objective: To assess the safety and efficacy of preoperative rectal misoprostol for the prevention of intraoperative and postoperative blood loss in women undergoing elective cesarean delivery.Methods: A single-blind randomized controlled trial of 200 full-term pregnant women scheduled for elective cesarean delivery. Computer-generated randomization allocated women to receive 400 μg rectal misoprostol at urinary catheter insertion plus 400 μg rectally after abdominal closure (preoperative group, n=100) or 800 μg of rectal misoprostol after abdominal closure (postoperative group, n=100). Primary outcome was intraoperative blood loss.Results: Intraoperative blood loss was significantly lower in the preoperative misoprostol group compared with the postoperative group (528.7 ± 114.8 mL vs 788.6 ± 165.8 mL; P<0.001). Blood loss during the first 24 hours after delivery was also lower in the preoperative group (199.3 ± 84.5 mL vs 302.9 ± 125.6 mL; P<0.001). Fewer women in the preoperative group needed additional uterotonics (7 vs 21; P<0.001). After delivery, the decrease in both hemoglobin and hematocrit levels was significantly less in the preoperative group (-6.8 vs -12.8% and -6.05 vs -17.8%, respectively; P<0.001).Conclusion: Preoperative rectal administration of misoprostol significantly reduced intraoperative and postoperative blood loss during and after elective cesarean delivery. ClinicalTrial.gov ID: NCT03680339. Date of registration 9/2018. [ABSTRACT FROM AUTHOR]

Background: The measurement and interpretation of patient experience is a distinct dimension of health care quality. The Midwives @ New Group practice Options (M@NGO) randomized control trial of caseload midwifery compared with standard care among women regardless of risk reported both clinical and cost benefits. This study reports participants' perceptions of the quality of antenatal care within caseload midwifery, compared with standard care for women of any risk within that trial. Methods: A trial conducted at two Australian tertiary hospitals randomly assigned participants (1:1) to caseload midwifery or standard care regardless of risk. Women were sent an 89‐question survey at 6 weeks postpartum that included 12 questions relating to pregnancy care. Ten survey questions (including 7‐point Likert scales) were analyzed by intention to treat and illustrated by participant quotes from two free‐text open‐response items. Results: From the 1748 women recruited to the trial, 58% (n = 1017) completed the 6‐week survey. Of those allocated to caseload midwifery, 66% (n = 573) responded, compared with 51% (n = 444) of those allocated to standard care. The survey found women allocated to caseload midwifery perceived a higher level of quality care across every antenatal measure. Notably, those women with identified risk factors reported higher levels of emotional support (aOR 2.52 [95% CI 1.87‐3.39]), quality care (2.94 [2.28‐3.79]), and feeling actively involved in decision‐making (3.21 [2.35‐4.37]). Conclusions: Results from the study show that in addition to the benefits to clinical care and cost demonstrated in the M@NGO trial, caseload midwifery outperforms standard care in perceived quality of pregnancy care regardless of risk. [ABSTRACT FROM AUTHOR]

Background: Peripherally inserted central catheters (PICCs) are used to administer parenteral nutrition (PN) in very low birth weight infants (VLBW; <1500 g). Clinicians try to optimize early nutrition but also minimize the risks associated with intravascular devices. The objective of this study was to examine the early nutrition impact of discontinuing PN at different enteral feed volumes in VLBW infants.Methods: In this unmasked, multicenter, randomized controlled trial, patients were randomly assigned to PICC removal and PN discontinuation at an enteral feed volume of 100 mL/kg/day (intervention) or 140 mL/kg/day (control). Clinically stable VLBW infants with a PICC in situ who were receiving PN were eligible for inclusion. Infants with major congenital anomalies were excluded. A total of 139 patients were enrolled; 69 and 70 patients were randomized to the intervention and control groups, respectively. The primary outcome measure was the mean difference in time (days) to regain birth weight.Results: The groups were well matched at study entry. Patients in the intervention group regained birth weight more slowly (mean difference 1.5 days CI: 0.3-2.7 days, P = 0.01). The mean difference in time to regain birth weight for infants <1000 g was 2.8 days (95% CI: 0.8-4.8 days, P = 0.008).Conclusions: In VLBW infants, early PICC removal at an enteral feed volume of 100 mL/kg/day compared with later removal at 140 mL/kg/day resulted in a significant delay in time to regain birth weight, and this delay was more pronounced in infants <1000 g. [ABSTRACT FROM AUTHOR]

Background: In a prior open-label study, the combination of dalantercept, a novel antiangiogenic targeting activin receptor-like kinase 1 (ALK1), plus axitinib was deemed safe and tolerable with a promising efficacy signal in patients with advanced renal cell carcinoma (RCC).Methods: In the current phase 2, randomized, double-blind, placebo-controlled study, patients with clear cell RCC previously treated with 1 prior angiogenesis inhibitor were randomized 1:1 to receive axitinib plus dalantercept versus axitinib plus placebo. Randomization was stratified by the type of prior therapy. The primary endpoint was progression-free survival (PFS). Secondary endpoints were PFS in patients with ≥2 prior lines of anticancer therapy, overall survival, and the objective response rate.Results: Between June 10, 2014, and February 23, 2017, a total of 124 patients were randomly assigned to receive axitinib plus dalantercept (59 patients) or placebo (65 patients). The median PFS was not found to be significantly different between the treatment groups (median, 6.8 months vs 5.6 months; hazard ratio, 1.11 [95% CI, 0.71-1.73; P = .670]). Neither group reached the median overall survival (hazard ratio, 1.39 [95% CI, 0.70-2.77; P = .349]). The objective response rate was 19.0% (11 of 58 patients; 95% CI, 9.9%-31.4%) in the dalantercept plus axitinib group and 24.6% (15 of 61 patients; 95% CI, 14.5%-37.3%) in the placebo plus axitinib group. At least 1 treatment-emergent adverse event of ≥grade 3 was observed in 59% of patients (34 of 58 patients) in the dalantercept group and 64% of patients (39 of 61 patients) in the placebo group. One treatment-related death occurred in the placebo plus axitinib group.Conclusions: Although well tolerated, the addition of dalantercept to axitinib did not appear to improve treatment-related outcomes in previously treated patients with advanced RCC. [ABSTRACT FROM AUTHOR]

Background: It remains unclear whether deep neuromuscular blockade results in better postoperative recovery than does moderate neuromuscular blockade. Therefore, in this study, we aimed to compare the effects of deep neuromuscular blockade and moderate neuromuscular blockade on the quality of postoperative recovery in patients undergoing robotic gastrectomy.Methods: In this prospective, double-blind, single-center randomized controlled superiority trial with two parallel groups, 56 adult patients (19-80 years) scheduled for elective robotic gastrectomy were randomly assigned to a moderate neuromuscular blockade group or a deep neuromuscular blockade group in a 1:1 ratio. In the deep and moderate neuromuscular blockade groups, the infusion rate for rocuronium was adjusted to maintain a post-tetanic count of 1-2 or a train-of-four count of 1-2, respectively. The primary outcome was the Quality of Recovery-40 (QoR-40) score on postoperative day 1. Secondary outcomes included the QoR-40 score on postoperative day 2, intraoperative hemodynamic data, intraoperative respiratory data, visual analog scale score for pain, postoperative incidences of nausea and vomiting, postoperative rescue analgesic use, and postoperative rescue antiemetic use.Results: The postoperative QoR-40 score was similar between the two groups on postoperative days 1 and 2. Moreover, the two groups showed no differences in intraoperative hemodynamic and respiratory data or postoperative pain, nausea and vomiting, and rescue medication use.Conclusion: Our findings suggest that the quality of recovery after robotic gastrectomy is similar for deep and moderate neuromuscular blockade. Therefore, deep neuromuscular blockade during robotic gastrectomy may be unnecessary, at least in patients with normal body mass index. [ABSTRACT FROM AUTHOR]

Introduction: The role of the radioprotector amifostine in ameliorating radiotherapy side effects in head and neck squamous cell carcinoma (HNSCC) is controversial. This trial aimed to determine whether pretreatment with amifostine reduced the incidence of Radiation Therapy Oncology Group grade ≥2 acute and late xerostomia in patients receiving definitive or adjuvant radiotherapy for HNSCC, without reducing tumour control or survival.Methods: Between 14 September 2001 and 8 November 2004, 44 Royal Adelaide Hospital patients were randomized double-blind to receive amifostine (200 mg/m2 IV) or placebo (normal saline IV) 5 days/week, prior to standard radiotherapy (60-70 Gy), each having ≥75% of the parotids treated to ≥40 Gy. Side effects were assessed weekly during treatment, at 3 and 5 months after radiotherapy, then every 6 months until disease progression or death.Results: The accrual target was 200 patients over 4-5 years, but the trial closed prematurely when only 44 patients had been randomized after 3 years. Of 41 evaluable patients, 80% (16/20) in the amifostine arm had grade ≥2 acute radiation salivary toxicity versus 76% (16/21) in the placebo arm (P = 1.00). The rate of grade ≥2 late radiation salivary toxicity at 12 months was 66% in the amifostine arm and 82% in the placebo arm (estimated hazard ratio 1.61, 95% confidence interval 0.74-3.49, P = 0.22). Other toxicities tended to be worse in the amifostine arm: acute grade 3-4 skin 35% vs 5% and mucous membrane 40% vs 5%; grade ≥2 vomiting 35% vs 5%, hypocalcaemia 25% vs 5% and fatigue 85% vs 33%, with only the latter retaining statistical significance after adjusting for multiple comparisons. There were no significant differences in failure-free (P = 0.70) or overall survival (P = 0.86), with estimated 4-year rates of 48% vs 54% and 49% vs 59% for the amifostine vs placebo arms respectively.Conclusion: There was no clear evidence that pretreatment with amifostine made any difference to the incidence of grade ≥2 acute or late xerostomia. Other toxicity tended to be more severe with amifostine. There was no effect on failure-free or overall survival. Acknowledging the low statistical power, these results do not support the use of IV amifostine pre-radiotherapy in HNSCC. [ABSTRACT FROM AUTHOR]

Histologically node negative esophageal squamous cell carcinoma (pN0 ESCC) after radical resection still carries a significant risk of recurrence, especially in high‐risk patients. Our previous study showed that the risk of recurrence was associated with tumor location and cell differentiation, as well as the presence of lymphovascular invasion. Most recurrence occurs within two years after surgery. There is still a lack of knowledge on the risks or potential benefits of postoperative adjuvant therapies for high‐risk pN0 ESCC patients. This study was designed to evaluate the efficacy and toxicity of adjuvant therapies after radical surgery in high‐risk patients with pN0 ESCC. This study is a multicenter, prospective, controlled randomized trial, which will compare the differences between either adjuvant chemotherapy or adjuvant radiotherapy and surgery alone for high‐risk pN0 ESCC. Patients in group A will receive three cycles of adjuvant chemotherapy with paclitaxel and cisplatin, patients in group B will receive adjuvant radiotherapy with intensity‐modulated radiation of 50 Gy, and patients in group C (the control) will receive surgery alone. The primary endpoint is three‐year disease‐free survival. Secondary endpoints include toxicity of adjuvant therapies and five‐year overall survival. One hundred and sixty‐two patients in each group are required and a total of 486 patients will finally be enrolled into the study. This will be the first randomized trial to investigate the necessity or potential benefit of postoperative adjuvant therapies for high‐risk pN0 ESCC patients. [ABSTRACT FROM AUTHOR]

We report the rationale and design of a community PHARMacy-based prospective randomized controlled interdisciplinary study for ambulatory patients with Chronic Heart Failure (PHARM-CHF) and results of its pilot study. The pilot study randomized 50 patients to a pharmacy-based intervention or usual care for 12 months. It demonstrated the feasibility of the design and showed reduced systolic blood pressure in the intervention group as indicator for improved medication adherence. The main study will randomize patients ≥60 years on stable pharmacotherapy including at least one diuretic and a history of heart failure hospitalization within 12 months. The intervention group will receive a medication review at baseline followed by regular dose dispensing of the medication, counselling regarding medication use and symptoms of heart failure. The control patients are unknown to the pharmacy and receive usual care. The primary efficacy endpoint is medication adherence, pre-specified as a significant difference of the proportion of days covered between the intervention and control group within 365 days following randomization using pharmacy claims data for three CHF medications (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, beta-blockers, and mineralocorticoid receptor antagonists). The primary composite safety endpoint is days lost due to blindly adjudicated unplanned cardiovascular hospitalizations or death. Overall, 248 patients shall be randomized. The minimum follow-up is 12 months with an expected mean of 24 months. Based on the feasibility demonstrated in the pilot study, the randomized PHARM-CHF trial will test whether an interdisciplinary pharmacy-based intervention can safely improve medication adherence and will estimate the potential impact on clinical endpoints. ClinicalTrials.gov Identifier: NCT01692119. [ABSTRACT FROM AUTHOR]

Objectives: To determine whether intervention‐induced physical activity (PA) changes in sedentary older adults differed according to dopamine‐related genotype. Design: Randomized clinical trial (Lifestyle Interventions and Independence for Elders Trial (2010–13)). Setting: Multicenter study, 8 U.S. locations. Participants: Volunteer sample of sedentary adults aged 70 to 89 at risk of disability (N=1635). Interventions: Structured PA versus health education (HE) for an average of 2.6 years. Measurements: Single‐nucleotide polymorphisms of dopamine‐related genes (dopamine receptor (DR) D1, DRD2, DRD3, and catechol‐O‐methyltransferase (COMT)) were assessed. Average moderate to vigorous PA (MVPA) was calculated using accelerometry (min/d) at baseline and 6, 12, and 24 months. Between‐arm MVPA differences according to genotype and genotype with square root–transformed MVPA separately according to arm were tested, stratified according to race, and adjusted for multiple comparisons. Results: White participants in the PA arm (n=513) had higher average square root transformed MVPA (4.91±1.91)than those in the HE arm (n=538) (4.51±1.82) (p=.001). Between‐arm differences were greater for DRD2 Met/Met (high dopamine; HE: 4.76±1.80, PA: 5.53±1.60, p=.03) than Val/Val (low dopamine; HE: 4.58±1.92, PA: 4.81±1.83, p=.16); results were similar for COMT. In the PA arm, DRD2 Met/Met was associated with higher average MVPA (5.39±2.00) than Met/Val (4.46±2.51) (p=.01) and Val/Val (4.65±2.71) (p=.01). There were no associations for other genes. Associations were not significant in blacks but followed similar trends. Conclusion: Higher dopamine signaling may support changes in PA during an intervention. The role of dopamine‐related pathways in promoting PA participation and enhancing response to interventions in sedentary older adults should be studied. Trial Registration: clinicaltrials.gov Identifier: NCT01072500 [ABSTRACT FROM AUTHOR]

Background: Cachexia, described as weight loss (mainly in lean body mass [LBM]) and anorexia, is common in patients with advanced cancer. This study examined the efficacy and safety of anamorelin (ONO-7643), a novel selective ghrelin receptor agonist, in Japanese cancer patients with cachexia.Methods: This double-blind clinical trial (ONO-7643-04) enrolled 174 patients with unresectable stage III/IV non-small cell lung cancer (NSCLC) and cachexia in Japan. Patients were randomized to daily oral anamorelin (100 mg) or a placebo for 12 weeks. The primary endpoint was the change from the baseline LBM (measured with dual-energy x-ray absorptiometry) over 12 weeks. The secondary endpoints were changes in appetite, body weight, quality of life, handgrip strength (HGS), and 6-minute walk test (6MWT) results.Results: The least squares mean change (plus or minus the standard error) in LBM from the baseline over 12 weeks was 1.38 ± 0.18 and -0.17 ± 0.17 kg in the anamorelin and placebo groups, respectively (P < .0001). Changes from the baseline in LBM, body weight, and anorexia symptoms showed significant differences between the 2 treatment groups at all time points. Anamorelin increased prealbumin at weeks 3 and 9. No changes in HGS or 6MWT were detected between the groups. Twelve weeks' treatment with anamorelin was safe and well tolerated in NSCLC patients.Conclusions: Anamorelin significantly increased LBM and improved anorexia symptoms and the nutritional state, but not motor function, in Japanese patients with advanced NSCLC. Because no effective treatment for cancer cachexia is currently available, anamorelin can be a beneficial treatment option. Cancer 2018;124:606-16. © 2017 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made. [ABSTRACT FROM AUTHOR]

Abstract: Background and purpose: Pneumonia is the most important respiratory problem in low‐to‐middle income countries. Airway clearance therapy continues to be used in children with pneumonia and secretion retention; however, there is lack of evidence to support or reject this treatment. This study aimed to investigate the feasibility of a randomized controlled trial (RCT) on the efficacy and safety of assisted autogenic drainage (AAD) compared to standard nursing care in children hospitalized with uncomplicated pneumonia. Methods: A single‐blinded pilot RCT was conducted on 29 children (median age 3.5 months, IQR 1.5–9.4) hospitalized with uncomplicated pneumonia. The intervention group received standard nursing care with additional bi‐daily AAD, for 10 to 30 min. The control group only received standard nursing care, unless otherwise deemed necessary by the physician or physiotherapist. The primary outcome measure was duration of hospitalization. The secondary outcome measures included days of fever and supplemental oxygen support; respiratory rate (RR) and heart rate adjusted for age; RR and oxygen saturation pre‐, post‐, and 1‐hr post‐treatment; oxygen saturation; adverse events; and mortality. Results: No difference was found for duration of hospitalization (median 7.5 and 7.0 days for the control and intervention groups, respectively); however, Kaplan–Meier analysis revealed a strong tendency towards a shorter time to discharge in the intervention group (p = .06). No significant differences were found for the other outcome measures at time of discharge. No adverse events were reported. Within the intervention group, a significant reduction in RR adjusted for age was found. Discussion: As no adverse events were reported, and AAD did not prolong hospitalization; AAD might be considered as safe and effective in young children with uncomplicated pneumonia. However, a larger multicentred RCT is warranted to determine the efficacy of AAD compared to standard nursing care. [ABSTRACT FROM AUTHOR]

Abstract: Aim: We aimed to assess the use of metformin (MTF) in the prevention of gestational diabetes mellitus (GDM) in patients with pregestational insulin resistance (PIR). Methods: A double blind, multicenter, randomized trial was carried out in patients with a history of PIR and pregestational MTF treatment. Groups were allocated either to MTF 1700 mg/day or placebo. Patients were recruited between 12+0 and 15+6 gestational weeks, and treatment was extended until week 36. A multiple logistic regression analysis was applied to determine the relation between the use of metformin and the development of GDM. Results: One hundred and forty one patients were randomized (68 patients in the MTF group and 73 in the placebo group). A total of 30 patients withdrew from the study during follow‐up. Administration of MTF was not associated with a decrease in the incidence of GDM as compared to placebo (37.5% vs 25.4%, respectively; P = 0.2). Moreover, MTF administration was associated with a significant increase in drug intolerance as compared to placebo (14.3% vs 1.8%, respectively; P = 0.02). Conclusion: The use of MTF is not effective in prevention of GDM in populations with PIR. The use of MTF shows a significantly higher frequency of drug intolerance than placebo. [ABSTRACT FROM AUTHOR]

Objective: To compare vaginal misoprostol treatment with expectant management in early non-viable pregnancy with vaginal bleeding with regard to complete evacuation of the uterine cavity within 10 days after randomization.Methods: This was a parallel randomized controlled, open-label trial conducted in Skåne University Hospital, Sweden. Patients with anembryonic pregnancy or early fetal demise (crown-rump length ≤ 33 mm) and vaginal bleeding were randomly allocated to either expectant management or treatment with a single dose of 800 μg misoprostol administered vaginally. Patients were evaluated clinically and by ultrasound until complete evacuation of the uterus was achieved (no gestational sac in the uterine cavity and maximum anteroposterior diameter of the intracavitary contents < 15 mm as measured by transvaginal ultrasound on midsagittal view). Follow-up visits were planned at 10, 17, 24 and 31 days. Dilatation and evacuation (D&E) was recommended if miscarriage was not complete within 31 days, but was performed earlier at patient's request, or if there was excessive bleeding as judged clinically. Analysis was by intention to treat. The main outcome measure was number of patients with complete miscarriage without D&E ≤ 10 days.Results: Ninety-four patients were randomized to misoprostol treatment and 95 to expectant management. After exclusion of three patients and withdrawal of consent by two patients in the expectant management group, 90 women were included in this group. Miscarriage was complete ≤ 10 days in 62/94 (66%) of the patients in the misoprostol group and in 39/90 (43%) of those in the group managed expectantly (risk difference (RD) = 23%; 95% CI, 8-37%). At 31 days, the corresponding figures were 81/94 (86%) and 55/90 (61%) (RD = 25%; 95% CI, 12-38%). Two patients from each group underwent emergency D&E because of excessive bleeding and one of these in each group received blood transfusion. The number of patients undergoing D&E at their own request was higher in the expectantly managed group, 15/90 (17%) vs 3/94 (3%) in the misoprostol group (RD = 14%; 95% CI, 4-23%), as was the number of patients making out-of-protocol visits, 50/90 (56%) vs 27/94 (29%) (RD = 27%; 95% CI, 12-40%). Compared with the expectant management group, more patients in the misoprostol group experienced pain (71/77 (92%) vs 91/91 (100%); RD = 8%; 95% CI, 1-17%) and used painkillers (59/77 (77%) vs 85/91 (93%); RD = 17%; 95% CI, 5-29%). No major side effect was reported in any group.Conclusions: In women with early non-viable pregnancy and vaginal bleeding, misoprostol treatment is more effective than is expectant management for complete evacuation of the uterus. Both methods are safe but misoprostol treatment is associated with more pain than is expectant management. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]

Background: 13-Cis retinoic acid (13-CRA) is a synthetic vitamin A derivative. High-dose 13-CRA in patients with squamous cell cancers of the head and neck (SCCHNs) reduces the incidence of second primary tumors (SPTs). The authors report long-term results from a phase 3 randomized trial that compared treatment with low-dose 13-CRA versus placebo for patients who had early stage SCCHN, with a focus on the development of SPTs and overall survival (OS).Methods: In total, 176 patients who received treatment for stage I/II SCCHN were randomized to receive either low-dose 13-CRA (weight-based dose of 7.5 mg or 10 mg) or placebo for 2 years. A competing-risk approach and the log-rank test were used to compare the time to SPT and OS, respectively, between groups.Results: 13-CRA neither significantly reduced the cumulative incidence of SPT (P = .61) nor improved the time to SPT (hazard ratio [HR] for 13-CRA/placebo; 0.86; P = .61). Despite limited power, there was a trend toward improved OS for the 13-CRA arm (HR, 0.75; P = .14), particularly among patients whose index tumor was surgically excised (N = 26; HR, 0.50; P = .057) and among women (N = 39; HR, 0.44; P = .065) and never/former smokers (N = 129; HR, 0.61; P = .055), with a median follow-up of 16 years. The main 13-CRA related toxicities were dry skin and cheilitis.Conclusions: Treatment with low-dose 13-CRA for 2 years did not decrease the incidence of SPT; subset analysis indicates a potential survival advantage among patients who are women and never/former smokers. More targeted interventions based on clinical risk factors and molecular characterization of tumors may yield greater success in future prevention trials. Cancer 2017;123:4653-4662. © 2017 American Cancer Society. [ABSTRACT FROM AUTHOR]

Objective: Lung cancer patients report among the highest distress rates of all cancer patients. Partners report similar distress rates. The present study examined the effectiveness of additional mindfulness-based stress reduction (care as usual [CAU] + MBSR) versus solely CAU to reduce psychological distress in lung cancer patients and/or their partners.Methods: We performed a multicentre, parallel-group, randomized controlled trial. Mindfulness-based stress reduction is an 8-week group-based intervention, including mindfulness practice and teachings on stress. Care as usual included anticancer treatment, medical consultations, and supportive care. The primary outcome was psychological distress. Secondary outcomes included quality of life, caregiver burden, relationship satisfaction, mindfulness skills, self-compassion, rumination, and posttraumatic stress symptoms. Outcomes were assessed at baseline, post-intervention, and 3-month follow-up. Linear mixed modeling was conducted on an intention-to-treat sample. Moderation (gender, disease stage, baseline distress, participation with/without partner) and mediation analyses were performed.Results: A total of 31 patients and 21 partners were randomized to CAU + MBSR and 32 patients and 23 partners to CAU. After CAU + MBSR patients reported significantly less psychological distress (p = .008, d = .69) than after CAU. Baseline distress moderated outcome: those with more distress benefitted most from MBSR. Additionally, after CAU + MBSR patients showed more improvements in quality of life, mindfulness skills, self-compassion, and rumination than after CAU. In partners, no differences were found between groups.Conclusion: Our findings suggest that psychological distress in lung cancer patients can be effectively treated with MBSR. No effect was found in partners, possibly because they were more focused on patients' well-being rather than their own. [ABSTRACT FROM AUTHOR]

Introduction: Progesterone is becoming universally accepted for preventing recurrent spontaneous preterm delivery. There is, however, poor consensus on the effective types and doses of progesterone to be used. Despite the encouraging available research, the role of oral micronized progesterone has not yet been thoroughly investigated.Material and Methods: We randomized 212 singleton pregnancies with past history of spontaneous preterm delivery at <37 weeks, into a progesterone group (receiving 100 mg oral micronized progesterone, six-hourly, starting at 14-18 weeks until 37 weeks or delivery) and an identical placebo group. The rate of spontaneous preterm delivery was the primary outcome. Secondary outcomes included gestational age at birth and admission to neonatal intensive care units.Results: The progesterone group delivered at a later gestational age, and needed longer tocolysis-to-delivery intervals (35.4 weeks vs. 33.9 weeks, p = 0.01, and 87 days vs. 36 days, p < 0.001, respectively). The relative risk of spontaneous preterm delivery was 0.7 (95% confidence interval 0.54-0.92, p = 0.01), and the number needed-to-treat to prevent one case of spontaneous preterm delivery was 5 (95% confidence interval 3-20). The two groups had similar rates of operative delivery and postpartum complications. Progesterone was associated with mild maternal dizziness (29.1% vs. 9.8%, p = 0.002), somnolence (41.6% vs. 19.7%, p = 0.002), and vaginal dryness (20.8% vs. 8.7%, p = 0.03), lower neonatal mortality rates (7.3% vs. 25.2%, p < 0.001), and shorter neonatal intensive care unit admissions (p = 0.008).Conclusion: Oral micronized progesterone is effective in preventing spontaneous preterm delivery. The additional advantages of oral administration, affordability, and high safety profile make it worth recommending, at least for further research. [ABSTRACT FROM AUTHOR]

Background and Aims Premises licensed for the sale and consumption of alcohol can contribute to levels of assault-related injury through poor operational practices that, if addressed, could reduce violence. We tested the real-world effectiveness of an intervention designed to change premises operation, whether any intervention effect changed over time, and the effect of intervention dose. Design A parallel randomized controlled trial with the unit of allocation and outcomes measured at the level of individual premises. Setting All premises (public houses, nightclubs or hotels with a public bar) in Wales, UK. Participants A randomly selected subsample ( n = 600) of eligible premises (that had one or more violent incidents recorded in police-recorded crime data; n = 837) were randomized into control and intervention groups. Intervention and comparator Intervention premises were audited by Environmental Health Practitioners who identified risks for violence and provided feedback by varying dose (informal, through written advice, follow-up visits) on how risks could be addressed. Control premises received usual practice. Measurements Police data were used to derive a binary variable describing whether, on each day premises were open, one or more violent incidents were evident over a 455-day period following randomization. Findings Due to premises being unavailable at the time of intervention delivery 208 received the intervention and 245 were subject to usual practice in an intention-to-treat analysis. The intervention was associated with an increase in police recorded violence compared to normal practice (hazard ratio = 1.34, 95% confidence interval = 1.20-1.51). Exploratory analyses suggested that reduced violence was associated with greater intervention dose (follow-up visits). Conclusion An Environmental Health Practitioner-led intervention in premises licensed for the sale and on-site consumption of alcohol resulted in an increase in police recorded violence. [ABSTRACT FROM AUTHOR]

Background: Concurrent-adjuvant chemoradiotherapy (CRT) became a recommended treatment for locoregionally advanced nasopharyngeal carcinoma (NPC) with the first report of a significant survival benefit from the Intergroup 0099 study. However, data on late toxicities are lacking. Previous reports from the current NPC-9901 trial have raised concerns about a failure to improve overall survival (OS) because of an inadequate impact on distant control and increases in toxicities/noncancer deaths. Validation of the long-term therapeutic ratio is needed.Methods: In this phase 3, randomized trial, patients with nonkeratinizing NPC (stage T1-4/N2-3/M0) were randomly assigned to radiotherapy alone (176 patients) or to CRT (172 patients) with concurrent cisplatin followed by adjuvant cisplatin plus fluorouracil.Results: The early findings of significant improvements in tumor control were maintained: the CRT group achieved significantly higher 10-year overall failure-free (62% vs 50%; P = .01) and progression-free survival rates (56% vs 42%; P = .006) because of superior locoregional control (87% vs 74%; P = .003), whereas the impact on distant control remained insignificant (68% vs 65%; P = .24). The initial differences in toxicities diminished with longer follow-up: 52% versus 47% at 10 years for late toxicities (P = .20), 4.1% versus 2.8% for deaths due to treatment toxicity, and 15.1% versus 13.1% for deaths due to incidental/unknown causes. The OS rate for the CRT group reached statistical superiority at 10 years (62% vs 49%; P = .047).Conclusions: Long-term results have confirmed that CRT can significantly improve OS without excessive late toxicities for patients with regionally advanced NPC. However, more potent therapy is needed for improving distant control, especially for patients with stage IVA/B disease. Cancer 2017;123:4147-4157. © 2017 American Cancer Society. [ABSTRACT FROM AUTHOR]

Background: Severe fatigue is a common and distressing symptom affecting approximately one in four survivors of breast cancer. The current study examined the efficacy of Internet-based cognitive behavioral therapy (ICBT) for severe fatigue in survivors of breast cancer compared with care as usual (CAU).Methods: The authors conducted a parallel-group randomized controlled trial. Severely fatigued, disease-free survivors of breast cancer who had completed cancer treatment at least 3 months previously were eligible. Participants were randomly allocated to ICBT or CAU using computer-generated stratified block randomization. The primary outcome of fatigue severity was assessed at baseline and after 6 months, as were the secondary outcomes of functional impairment, psychological distress, and quality of life. Statistical effects were tested with analyses of covariance (intention-to-treat analysis).Results: Participants were recruited between January 2014 and March 2016 and assigned to ICBT (66 patients) or CAU (66 patients). Compared with the participants who had received CAU, those who had received ICBT reported lower fatigue scores at 6 months (mean difference [Δ], 11.5; 95% confidence interval [95% CI], 7.7-15.3) and a large effect size (Cohen d = 1.0), with the majority of patients (73%) demonstrating clinically significant improvement. ICBT also was found to lead to lower functional impairment (Δ, 297.8; 95% CI, 145.5-450.1) and psychological distress scores (Δ, 5.7; 95% CI, 3.4-7.9) and higher quality-of-life scores (Δ, 11.7; 95% CI, 5.8-17.7) compared with CAU, with medium to large effect sizes (Cohen d = 0.6-0.8).Conclusions: ICBT appears to be effective in reducing severe fatigue and related symptoms and meets the current need for easy accessible and more efficient evidence-based treatment options for severely fatigued survivors of breast cancer. Cancer 2017;123:3825-34. © 2017 American Cancer Society. [ABSTRACT FROM AUTHOR]

Objective: Emotional distress in cancer patients often goes unnoticed in daily routine; therefore, distress screening is now recommended in many national guidelines. However, screening alone does not necessarily translate into better well-being. We examined whether stepped psychooncological care improves referral to consultation-liaison (CL) services and improves well-being.Methods: In a cluster-randomized trial, wards were randomly allocated to stepped versus standard care. Stepped care comprised screening for distress, consultation between doctor and patient about the patient's need for CL services, and provision of CL service. Primary outcomes were referral to psychosocial services and emotional well-being half a year after baseline, measured with the Hospital Anxiety and Depression Scale. A secondary endpoint was uptake of outpatient health care. Analysis employed mixed-effects multivariate regression modeling.Results: Thirteen wards were randomized; 1012 patients participated. With stepped care (N = 570; 7 wards), 22% of the patients were referred to CL services and 3% with standard care (N = 442; 6 wards; odds ratio [OR] 10.0; P < .001). Well-being 6 months after baseline was 9.5 after stepped care (N = 341) and 9.4 after standard care (N = 234, β -0.3; P = .71). After stepped care, patients with psychiatric comorbidity went more often to psychotherapists (OR 4.0, P = .05) and to psychiatrists (OR 2.3, P = .12), whereas patients without comorbidity used psychiatrists less often (OR 0.4, P = .04) than in standard care.Conclusions: Stepped care resulted in better referral to CL services. The patients' emotional well-being was not improved, but uptake of outpatient psychiatric help was increased in patients with psychiatric comorbidity and decreased in patients without. [ABSTRACT FROM AUTHOR]

The aim of this randomized controlled trial was to analyze inexperienced dental students' perceptions of the difficulty and applicability of digital and conventional implant impressions and their preferences including performance. Fifty undergraduate dental students at a dental school in Switzerland were randomly divided into two groups (2×25). Group A first took digital impressions in a standardized phantom model and then conventional impressions, while the procedures were reversed for Group B. Participants were asked to complete a VAS questionnaire (0-100) on the level of difficulty and applicability (user/patient-friendliness) of both techniques. They were asked which technique they preferred and perceived to be more efficient. A quotient of "effective scan time per software-recorded time" (TRIOS) was calculated as an objective quality indicator for intraoral optical scanning (IOS). The majority of students perceived IOS as easier than the conventional technique. Most (72%) preferred the digital approach using IOS to take the implant impression to the conventional method (12%) or had no preference (12%). Although total work was similar for males and females, the TRIOS quotient indicated that male students tended to use their time more efficiently. In this study, dental students with no clinical experience were very capable of acquiring digital tools, indicating that digital impression techniques can be included early in the dental curriculum to help them catch up with ongoing development in computer-assisted technologies used in oral rehabilitation. [ABSTRACT FROM AUTHOR]

Objectives To assess the effects of bimagrumab on skeletal muscle mass and function in older adults with sarcopenia and mobility limitations. Design A 24-week, randomized, double-blind, placebo-controlled, parallel-arm, proof-of-concept study. Setting Five centers in the United States. Participants Community-dwelling adults (N = 40) aged 65 and older with gait speed between 0.4 and 1.0 m/s over 4 m and an appendicular skeletal muscle index of 7.25 kg/m2 or less for men and 5.67 kg/m2 or less for women. Intervention Intravenous bimagrumab 30 mg/kg (n = 19) or placebo (n = 21). Measurements Change from baseline in thigh muscle volume (TMV), subcutaneous and intermuscular fat, appendicular and total lean body mass, grip strength, gait speed, and 6-minute walk distance (6MWD). Results Thirty-two (80%) participants completed the study. TMV increased by Week 2, was sustained throughout the treatment period, and remained above baseline at the end of study in bimagrumab-treated participants, whereas there was no change with placebo treatment (Week 2: 5.15 ± 2.19% vs −0.34 ± 2.59%, P < .001; Week 4: 6.12 ± 2.56% vs 0.16 ± 3.42%, P < .001; Week 8: 8.01 ± 3.70% vs 0.35 ± 3.32%, P < .001; Week 16: 7.72 ± 5.31% vs 0.42 ± 5.14%, P < .001; Week 24: 4.80 ± 5.81% vs −1.01 ± 4.43%, P = .002). Participants with slower walking speed at baseline receiving bimagrumab had clinically meaningful and statistically significantly greater improvements in gait speed (mean 0.15 m/s, P = .009) and 6MWD (mean 82 m, P = .022) than those receiving placebo at Week 16. Adverse events in the bimagrumab group included muscle-related symptoms, acne, and diarrhea, most of which were mild in severity and resolved by the end of study. Conclusion Treatment with bimagrumab over 16 weeks increased muscle mass and strength in older adults with sarcopenia and improved mobility in those with slow walking speed. [ABSTRACT FROM AUTHOR]

Aim To study the effectiveness of a brief intervention (BI) associated with the ASSIST (Alcohol Smoking and Substance Involvement Screening Test) for alcohol and illicit drug use as part of a systematic screening program implemented in primary care. Design A multi-center randomized open-label trial stratified using the ASSIST-specific substance involvement score (for alcohol, scores ranged from 11 to 15 and 16 to 20; and for the other substances from 4 to 12 and 13 to 20). Setting A total of 19 primary care centers ( n = 520), eight emergency rooms ( n = 195) and five police stations ( n = 91) were evaluated. Participants A total of 12 217 people aged between 19 and 55 years were screened for moderate alcohol and drug use risk as defined by the ASSIST Chilean version. A total of 806 non-treatment-seekers were randomized. Intervention and comparison ASSIST-linked BI ( n = 400) compared with an informational pamphlet on risk associated with substance use ( n = 406). Measurements Total ASSIST alcohol and illicit involvement score (ASSIST-AI), and ASSIST-specific score for alcohol, cannabis and cocaine at baseline and at 3-month follow-up. Findings Sixty-two per cent of participants completed follow-up. An intention-to-treat analysis showed no difference between the two groups for the ASSIST-AI score [mean difference (MD) = − 0.17, confidence interval (CI) = −1.87, 2.20], either for specific scores alcohol (MD = 0.18, CI = −1.45, 1.10), cannabis (MD = -0.62, CI = −0.89, 2.14) or cocaine (MD = -0.79, CI = −2.89, 4.47). Conclusion It is not clear whether a brief intervention associated with the Alcohol Smoking and Substance Involvement Screening Test is more effective than an informational pamphlet in reducing alcohol and illicit substance consumption in non-treatment-seeking, primary care users with moderate risk. [ABSTRACT FROM AUTHOR]

Aims To estimate the effectiveness of pregnancy smoking cessation support delivered by short message service (SMS) text message and key parameters needed to plan a definitive trial. Design Multi-centre, parallel-group, single-blinded, individual randomized controlled trial. Setting Sixteen antenatal clinics in England. Participants Four hundred and seven participants were randomized to the intervention ( n = 203) or usual care ( n = 204). Eligible women were < 25 weeks gestation, smoked at least one daily cigarette (> 5 pre-pregnancy), were able to receive and understand English SMS texts and were not already using text-based cessation support. Intervention All participants received a smoking cessation leaflet; intervention participants also received a 12-week programme of individually tailored, automated, interactive, self-help smoking cessation text messages (MiQuit). Outcome measurements Seven smoking outcomes, including validated continuous abstinence from 4 weeks post-randomization until 36 weeks gestation, design parameters for a future trial and cost-per-quitter. Findings Using the validated, continuous abstinence outcome, 5.4% (11 of 203) of MiQuit participants were abstinent versus 2.0% (four of 204) of usual care participants [odds ratio (OR) = 2.7, 95% confidence interval (CI) = 0.93-9.35]. The Bayes factor for this outcome was 2.23. Completeness of follow-up at 36 weeks gestation was similar in both groups; provision of self-report smoking data was 64% (MiQuit) and 65% (usual care) and abstinence validation rates were 56% (MiQuit) and 61% (usual care). The incremental cost-per-quitter was £133.53 (95% CI = -£395.78 to 843.62). Conclusions There was some evidence, although not conclusive, that a text-messaging programme may increase cessation rates in pregnant smokers when provided alongside routine NHS cessation care. [ABSTRACT FROM AUTHOR]