Search

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Aim: To examine the efficacy of Hand-Arm Bimanual Intensive Therapy (HABIT) on daily functioning, unimanual dexterity, and bimanual performance of children with bilateral cerebral palsy (CP) compared with customary care.Method: Forty-one children with bilateral CP, aged 4 to 16 years, classified in levels I to III of the Manual Ability Classification System, were randomly assigned to HABIT (90h) (n=21) or to customary care (4.5h) (n=20). Participants' daily functioning (Pediatric Evaluation of Disability Inventory [PEDI], Canadian Occupational Performance Measure [COPM]), unimanual dexterity (Jebsen-Taylor Test of Hand Function, Box and Blocks Test [BBT]), and bimanual performance (Both Hands Assessment) were assessed pre-, post-, and 6 months after the intervention. Linear mixed-effects models were used for inferential analysis.Results: Children participating in HABIT showed greater improvements in daily functioning (COPMperformance : χ12 =9.50, p<0.01; COPMsatisfaction : χ12 =5.07, p<0.05; PEDIfunctional skills : χ12 =6.81, p<0.01; PEDIcaregiver assistance : χ12 =6.23, p<0.05) and in the dexterity of the dominant hand (BBT: χ12 =3.99, p<0.05) compared with children maintaining customary care. Group or time effects did not explain any variance in bimanual performance or in the dexterity of the non-dominant hand.Interpretation: HABIT may be beneficial for children with bilateral CP, with benefits evidenced for daily functioning outcomes.What This Paper Adds: Hand-Arm Bimanual Intensive Therapy (HABIT) improved daily functioning of children with bilateral cerebral palsy (CP). Bimanual performance, measured by the Both Hands Assessment, did not change after HABIT in children with bilateral CP. Children with asymmetric and symmetric hand use exhibited similar improvements after HABIT. [ABSTRACT FROM AUTHOR]

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Micrographia occurs in approximately 60% of people with Parkinson's disease (PD). Although handwriting is an important task in daily life, it is not clear whether relearning and consolidation (ie the solid storage in motor memory) of this skill is possible in PD. The objective was to conduct for the first time a controlled study into the effects of intensive motor learning to improve micrographia in PD.Methods: In this placebo-controlled study, 38 right-handed people with PD were randomized into 2 groups, receiving 1 of 2 equally time-intensive training programs (30 min/day, 5 days/week for 6 weeks). The experimental group (n = 18) performed amplitude training focused at improving writing size. The placebo group (n = 20) received stretch and relaxation exercises. Participants' writing skills were assessed using a touch-sensitive writing tablet and a pen-and-paper test, pre- and posttraining, and after a 6-week retention period. The primary outcome was change in amplitude during several tests of consolidation: (1) transfer, using trained and untrained sequences performed with and without target zones; and (2) automatization, using single- and dual-task sequences.Results: The group receiving amplitude training significantly improved in amplitude and variability of amplitude on the transfer and automatization task. Effect sizes varied between 7% and 17%, and these benefits were maintained after the 6-week retention period. Moreover, there was transfer to daily life writing.Conclusions: These results show automatization, transfer, and retention of increased writing size (diminished micrographia) after intensive amplitude training, indicating that consolidation of motor learning is possible in PD. © 2016 International Parkinson and Movement Disorder Society. [ABSTRACT FROM AUTHOR]

Buprenorphine was registered in Australia as a maintenance and detoxification agent for the management of opioid dependence in November, 2000, and became widely available in August, 2001. This paper provides an overview of key developments in the introduction of buprenorphine treatment in Australia, with an emphasis upon the delivery of services in community-based (primary care) settings. A central study in this work was the Buprenorphine Implementation Trial (BIT), a randomized, controlled trial comparing buprenorphine and methadone maintenance treatment delivered under naturalistic conditions by specialist and community-based service providers (general practitioners and community pharmacists) in 139 subjects across nineteen treatment sites. In addition to conventional patient outcome measures (treatment retention, drug use, psychosocial functioning, and cost effectiveness), the BIT study also involved the development and evaluation of clinical guidelines, training programs for clinicians, and client literature, which are described here. Integration of treatment systems (methadone with buprenorphine, specialist and primary-care programs) and factors thought to be important in the uptake of buprenorphine treatment in Australia since registration are discussed. [ABSTRACT FROM AUTHOR]

This study aimed to investigate the chronic effects of green tea (GT) extract and resistance training (RT) on ambulatory and office blood pressure (BP), heart rate (HR), and rate-pressure product (RPP) in a sample of Iranian women with high-normal/stage 1 hypertension. Forty-four middle-aged sedentary women participated in this randomized, double-blind, placebo-controlled study. They were randomly assigned to one of four groups: GT and RT (GR, n = 11), RT (n = 10), GT (n = 10), or control (n = 13). Three weeks of GT consumption were followed by six weeks of the interaction with RT. GR and RT groups performed two circuits of RT at %50 of 1RM two days per week. RT and control groups also received placebo (maltodextrin) with the same timing. The changes of each variable from baseline to post-intervention were compared between the groups using the ANOVA test, and effect size (ES) statistic was also calculated. In comparison with the control group, significant reductions were found for office systolic BP (SBP, 8%, ES = 1.22), and 24 h-SBP (5%, ES = 1.2) in the RT group. However, GR group showed significant decreases in office SBP (10.5%, ES = 1.45), mean BP (8%, ES = 1.11), RPP (13%, ES = 1.47), 24 h-SBP (5%, ES = 1.21), and 24 h-RPP (10%, ES = 1.15). The interaction of regular RT and GT consumption seems to induce more beneficial effects on some important parameters including MBP and RPP when compared to RT or GT alone. [ABSTRACT FROM AUTHOR]

Background: This study was conducted to assess the clinical, immunological, and patient-centered outcomes of microcurrent electrotherapy on palatal wound healing.Methods: This was a parallel, double-masked randomized clinical trial, in which 53 patients with ridge preservation indications were selected and randomly assigned to one of two groups. In the control (sham) group (n = 27), palatal wounds, after free gingival grafts (FGG) harvest, received sham application of electrotherapy. In the test (electrotherapy treatment [EE]) group (n = 26), palatal wounds, after FGG harvest, received application of microcurrent electrotherapy protocol. Clinical parameters, patient-centered outcomes, and inflammatory markers were evaluated, up to 90 days postoperatively.Results: The EE group achieved earlier wound closure (P <0.001) and epithelialization (P <0.05; P = 0.03) at 7 and 14 days after harvest when compared with the sham group. Painful symptomatology was reported less frequently in the EE group than in the sham group at 3-day follow-up (P = 0.008). Likewise, an improvement in Oral Health Impact Profile was reported 2 days after the procedure by the EE group (P = 0.04). In addition, favorable modulation of inflammatory wound healing markers occurred when electrotherapy was applied.Conclusion: Within the limits of the present study, it can be concluded that the use of a low-intensity electrotherapy protocol may accelerate palatal wound healing and decrease patient discomfort after FGG harvest. [ABSTRACT FROM AUTHOR]

The rapid emergence of expensive anticancer therapies is leading to exponential growth in healthcare expenses. In clinical trials, most investigational drugs are provided free of charge by industrial and academic sponsors. This results in drug cost savings for healthcare payers, who are no longer charged with the cost of the standard-of-care treatment, which would have been administered outside the trial. This study aims to estimate drug cost savings resulting from patient enrolment in hematological oncology clinical trials, from a public payer perspective. Retrospective screening identified all patients with hematological malignancies included from 2011 to 2016 in a phase III trial and having received at least one sponsor-provided cycle. Drug cost savings were defined as the standard treatment costs not charged to the payer due to sponsor provision of treatment. For each patient, cost savings were determined by the number of cycles received in the trial and the cost of standard (control arm) treatment. Of the 345 patients included in eligible trials during study period, 272 received sponsor-provided drugs. Drug cost savings could be estimated for 177 patients (65.1%) included in 27 trials. Total cost savings were €5218 million (US$ 6804 million) for 1720 sponsor-provided cycles. Mean cost saving per patient was €19 182.7 ± 29 865.7 ($25 015.24 ± 39 478.25). Most cost-saving trials were industry-sponsored (77.8%), although academic trials generated 40.15% of total cost savings. Enrolling patients in clinical trials, whether industry-sponsored or academic, leads to substantial drug cost savings for payers. Implications are significant for public payers facing increasing financial constraints, as savings can be reallocated to patient care. [ABSTRACT FROM AUTHOR]

Objective: Troublesome hot flushes and night sweats (HFNS) are experienced by many women after treatment for breast cancer, impacting significantly on sleep and quality of life. Cognitive behavioural therapy (CBT) is known to be effective for the alleviation of HFNS. However, it is not known if it can effectively be delivered by specialist nurses. We investigated whether group CBT, delivered by breast care nurses (BCNs), can reduce the impact of HFNS.Methods: We recruited women with primary breast cancer following primary treatment with seven or more HFNS/week (including 4/10 or above on the HFNS problem rating scale), from six UK hospitals to an open, randomised, phase 3 effectiveness trial. Participants were randomised to Group CBT or usual care (UC). The primary endpoint was HFNS problem rating at 26 weeks after randomisation. Secondary outcomes included sleep, depression, anxiety and quality of life.Results: Between 2017 and 2018, 130 participants were recruited (CBT:63, control:67). We found a 46% (6.9-3.7) reduction in the mean HFNS problem rating score from randomisation to 26 weeks in the CBT arm and a 15% (6.5-5.5) reduction in the UC arm (adjusted mean difference -1.96, CI -3.68 to -0.23, P = .039). Secondary outcomes, including frequency of HFNS, sleep, anxiety and depression all improved significantly.Conclusion: Our results suggest that specialist nurses can be trained to deliver CBT effectively to alleviate troublesome menopausal hot flushes in women following breast cancer in the NHS setting. [ABSTRACT FROM AUTHOR]

Background: Lateral elbow pain (LEP) due to tendinosis is one of the most common musculoskeletal pains of the upper limbs, yet there is no satisfactory treatment. This study was an international, prospective, multi-centre, randomized, controlled, clinical trial to evaluate the efficacy of acupuncture compared to sham laser in the treatment of LEP.Methods: The study used a parallel and stratified design (1:1 allocation using a computer-generated sequence) and was participant-, outcome assessor- and statistician-blinded. Subjects from 18 to 80 years with unilateral chronic LEP (minimum three months) were recruited at four centres in Australia, China, Hong Kong and Italy. The treatment group received manual acupuncture at acupoints LI 10 and LI 11 on the affected side whereas the control group received sham laser acupuncture at the same acupoints. The primary endpoint was disabilities of the arm, shoulder, and hand (DASH) questionnaire score at the three-week post-treatment follow-up visit. Three VAS scales (pain at rest, pain on motion and pain during exertion) were secondary outcomes measures. Ninety-six subjects were allocated to either the treatment group (n = 47) or control group (n = 49) and were all included in the analysis.Results: At the follow-up visit, we found significant differences in DASH score between the two groups (p = .015). The median change to baseline for the treatment group was -11.7 (interval: -50.83 to 23.33), and for the control group -7.50 (interval: -36.67 to 29.10). The estimated effect size was 0.47, indicating a medium effect. Significant differences were also found for secondary outcome measures for VAS of pain. There were no severe adverse events. Our findings suggest that acupuncture has a moderate efficacy in the treatment of LEP.Conclusions: Acupuncture was shown to be efficacious in improving the function of the arm associated with lateral elbow tendinosis. Both the DASH score and the pain VAS on two occasions (at rest and during motion) showed a significant change over time indicating acupuncture as a potential treatment for LEP due to tendinosis. [ABSTRACT FROM AUTHOR]

Background: The objective of this trial is to optimize the transmuscular quadratus lumborum (TQL) block, by investigating the minimal effective volume (MEV90 ) of ropivacaine 0.75% for single-shot TQL block in percutaneous nephrolithotomy (PNL) patients.Methods: This double-blind, randomized and controlled dose-finding trial is based on a biased coin up-and-down sequential design, where the volume of local anaesthetic administered to each patient depends on the response from the previous one. Investigating the TQL block, the first patient recruited receives 20 ml ropivacaine 0.75% preoperatively. In case of block failure, the next patient will receive the same volume with an increment of 2 ml. Given a successful block for the first patient, the next patient will be randomized to either a lower volume (previous volume with a reduction of 2 ml), or the same volume as the previous patient. The respective probabilities being b = 0.11 for a reduced volume and 1-b = 0.89 for the same volume. Block success is defined as patient reported pain score numeric rated scale (NRS) ≤3 (0-10/10) 30 minutes after arrival in the post anaesthesia care unit (PACU). The NRS pain score is our primary and only outcome for block success. A minimum of 25 eligible patients are needed to achieve precise estimation of MEV90 with narrow 95% confidence intervals derived by bootstrapping.Discussion: Recruiting will begin June 2020 and is expected to finish November 2020. Data analysis will be performed at interims during and after the study. Results will be published in an international peer-reviewed medical journal. [ABSTRACT FROM AUTHOR]

Objective: The aim of this article is to describe the incidence and characteristics of pregnancy-related death in low- and middle-resource settings, in relation to the availability of key obstetric resources.Design: This is a secondary analysis of a stepped-wedge cluster randomised controlled trial.Setting: This trial was undertaken at ten sites across eight low- and middle-income countries in sub-Saharan Africa, India and Haiti.Population: Institutional-level consent was obtained and all women presenting for maternity care were eligible for inclusion.Methods: Pregnancy-related deaths were collected prospectively from routine data sources and active case searching.Main Outcome Measures: Pregnancy-related death, place, timing and age of maternal death, and neonatal outcomes in women with this outcome.Results: Over 20 months, in 536 233 deliveries there were 998 maternal deaths (18.6/10 000, range 28/10 000-630/10 000). The leading causes of death were obstetric haemorrhage (36.0%, n = 359), hypertensive disorders of pregnancy (20.6%, n = 206), sepsis (14.1%, n = 141) and other (26.5%, n = 264). Approximately a quarter of deaths occurred prior to delivery (28.4%, n = 283), 35.7% (n = 356) occurred on the day of delivery and 35.9% (n = 359) occurred after delivery. Half of maternal deaths (50.6%; n = 505) occurred in women aged 20-29 years, 10.3% (n = 103) occurred in women aged under 20 years, 34.5% (n = 344) occurred in women aged 30-39 years and 4.6% (n = 46) occurred in women aged ≥40 years. There was no measured association between the availability of key obstetric resources and the rate of pregnancy-related death.Conclusions: The large variation in the rate of pregnancy-related death, irrespective of resource availability, emphasises that inequality and inequity in health care persists.Tweetable Abstract: Inequality and inequity in pregnancy-related death persists globally, irrespective of resource availability. [ABSTRACT FROM AUTHOR]

Aims: This trial was conducted to explore the protective effect on β-cell function of adding vitamin D3 to DPP-4 inhibitors to treat patients with latent autoimmune diabetes in adults (LADA).Methods: 60 LADA patients were randomized to group A (n = 21) - conventional therapy with metformin (1-1.7 g/day) and/or insulin treatment; group B (n = 20) - saxagliptin (5 mg/day) plus conventional therapy; and group C (n = 19) - vitamin D3 (2000 IU/day) plus saxagliptin and conventional therapy for 12 months. Fasting and 2-hour postprandial blood samples were collected to measure blood glucose, glycosylated hemoglobin and C-peptide levels at baseline and after 3, 6 and 12 months of treatment.Results: During the 12 months of follow-up, the levels of fasting C-peptide (FCP), 2-hour postprandial C-peptide (PCP) and the C-peptide index (CPI, serum C-peptide-to-plasma glucose level ratio) were maintained in group C. In contrast to those in group A and group B, FCP levels decreased significantly in group B, and CPI levels declined significantly in group A during the 1-year treatment (P < .05). Additionally, the levels of GADA titers in group C significantly decreased compared with those at baseline (P < .05), but no significant differences in GADA titers levels were detected in group A and group B. No significant differences were found among the three groups in the levels of FCP, PCP, the CPI or GADA titers.Conclusions: The data suggested that adding 2000 IU/day vitamin D3 to saxagliptin might preserve β-cell function in patients with LADA. [ABSTRACT FROM AUTHOR]

Background: IRL752 is a novel small-molecule compound that acts to regioselectively enhance norepinephrine, dopamine, and acetylcholine neurotransmission in the cerebral cortex.Objective: The primary objective of the trial was to investigate the safety and tolerability of IRL752 in patients with Parkinson's disease and dementia.Methods: Patients with Parkinson's disease and dementia were randomized to IRL752 or placebo treatment (3:1 ratio) for 28 days. The study drug was given as an adjunct treatment to the patients' regular stable antiparkinsonian medication. Dosing was individually titrated for 14 days after which the dose was kept stable for an additional 14 days.Results: A total of 32 patients were randomized to treatment, and 29 patients completed the 4-week treatment. Adverse events were generally mild and transient and were mostly reported during the dose titration phase. There were 2 serious adverse events, and none of them were related to the experimental treatment. The average dose achieved in the stable dose phase was 600 mg daily, yielding a 2-hour postdose plasma concentration of about 4 μM on day 28. Exploratory assessment of secondary outcomes indicated efficacy for symptoms and signs known to be poorly responsive to levodopa.Conclusions: IRL752 appears to be safe and well tolerated for a 4-week treatment in patients with Parkinson's disease and dementia. © 2020 International Parkinson and Movement Disorder Society. [ABSTRACT FROM AUTHOR]

Understanding genetic factors that contribute to cannabis use disorder (CUD) is important, but to date, findings have been equivocal. Single-nucleotide polymorphisms (SNPs) in the cannabinoid receptor 1 gene (CNR1; rs1049353 and rs806378) and fatty acid amide hydrolase (FAAH) gene (rs324420) have been implicated in CUD. Their relationship to addiction endophenotypes such as cannabis-related state satiety, the salience of appetitive cues, and craving after acute cannabinoid administration has not been investigated. Forty-eight cannabis users participated in a double-blind, placebo-controlled, four-way crossover experiment where they were administered treatments in a randomized order via vaporization: placebo, Δ9 -tetrahydrocannabinol (THC) (8 mg), THC + cannabidiol (THC + CBD) (8 + 16 mg), and CBD (16 mg). Cannabis-related state satiety, appetitive cue salience (cannabis and food), and cannabis craving were assessed each day. Participants were genotyped for rs1049353, rs806378, and rs324420. Results indicated that CNR1 rs1049353 GG carriers showed increased state satiety after THC/THC + CBD administration in comparison with placebo and reduced the salience of appetitive cues after THC in comparison with CBD administration; A carriers did not vary on either of these measures indicative of a vulnerability to CUD. CNR1 rs806378 CC carriers showed greater salience to appetitive cues in comparison with T carriers, but there was no evidence for changes in state satiety. FAAH rs324420 A carriers showed greater bias to appetitive cues after THC, in comparison with CC carriers. FAAH CC carriers showed reduced bias after THC in comparison with CBD. No SNPs modulated craving. These findings identify candidate neurocognitive mechanisms through which endocannabinoid system genetics may influence vulnerability to CUD. [ABSTRACT FROM AUTHOR]

Background: This study compared clinical and patient-centered outcomes of subepithelial connective tissue graft (CTG) with and without enamel matrix derivative (EMD) in the treatment of multiple Class III-IV Miller periodontal recession (REC) defects on mandibular anterior teeth.Methods: This randomized clinical study evaluated 41 patients at 3 years follow-up. One hundred and fifty-six teeth were divided into two groups: test (CTG-EMD, 79 teeth) and control (CTG only, 77 teeth). Clinical REC, keratinized tissue (KT) width, percentage of root coverage, patient-centered outcomes were compared between the two groups.Results: At 36 months follow-up, patient level analysis showed that REC in the test group reduced significantly (5.71 ± 0.58 mm to 1.57 ± 0.85 mm) compared with the control group (5.94 ± 0.46 mm to 2.51 ± 0.62 mm) (P < 0.001), while KT width increased in the test group (1.51 ± 0.26 mm to 4.18 ± 0.34 mm) and was significantly greater than the control group (1.65 ± 0.21 mm to 2.90 ± 0.20 mm) (P < 0.001). At 36 months, tooth level analysis (Class III and Class IV groups) found less residual REC and increased KT in the test group compared with the control group (P < 0.01). Significantly less pain was reported at 2, 7, and 14 days follow-up post-surgery in the test group (P < 0.001).Conclusions: The addition of EMD to CTG results in improved root coverage outcomes and higher amounts of KT width 36 months after treatment of Class III-IV REC on mandibular anterior teeth. The adjunctive use of EMD also resulted in significantly reduced pain 14 days post-surgery. [ABSTRACT FROM AUTHOR]

Background: A reliable central venous access device is a cornerstone in the treatment of cancer. Both peripherally inserted central catheters (PICC) and totally implanted chest ports (PORT) are commonly used for the delivery of chemotherapy. Both types of catheter can cause adverse events such as catheter-related deep venous thrombosis (CR-DVT), infection and mechanical complications.Method: We conducted a randomized controlled trial including 399 patients with cancer and performed a health economic evaluation investigating the cost related to PICCs and PORTs using several clinically relevant dimensions from a healthcare perspective. The cost was determined using process and cost estimate models.Result: PICCs are associated with a higher total cost when compared with PORTs. Combining the costs of all categories, the prize per inserted device was 824.58 EUR for PICC and 662.34 EUR for PORT. When adjusting for total catheter dwell time the price was 6.58 EUR/day for PICC and 3.01 EUR/day for PORT. The difference in CR-DVT was the main contributor to the difference in cost. The daily cost of PICC is approximately twice to that of PORT.Conclusion: We have demonstrated that the cost from a healthcare perspective is higher in cancer patients receiving a PICC than to those with a PORT. The difference is driven mainly by the cost related to the management of adverse events. Our findings are relevant to anaesthetists, oncologists and vascular access clinicians and should be considered when choosing vascular access device prior to chemotherapy. [ABSTRACT FROM AUTHOR]

Objective: Unselected population-based BRCA testing provides the opportunity to apply genomics on a population-scale to maximise primary prevention for breast-and-ovarian cancer. We compare long-term outcomes of population-based and family-history (FH)/clinical-criteria-based BRCA testing on psychological health and quality of life.Design: Randomised controlled trial (RCT) (ISRCTN73338115) GCaPPS, with two-arms: (i) population-screening (PS); (ii) FH/clinical-criteria-based testing.Setting: North London Ashkenazi-Jewish (AJ) population.Population/sample: AJ women/men.Methods: Population-based RCT (1:1). Participants were recruited through self-referral, following pre-test genetic counselling from the North London AJ population.Inclusion Criteria: AJ women/men >18 years old; exclusion-criteria: prior BRCA testing or first-degree relatives of BRCA-carriers.Interventions: Genetic testing for three Jewish BRCA founder-mutations: 185delAG (c.68_69delAG), 5382insC (c.5266dupC) and 6174delT (c.5946delT), for (i) all participants in PS arm; (ii) those fulfilling FH/clinical criteria in FH arm. Linear mixed models and appropriate contrast tests were used to analyse the impact of BRCA testing on psychological and quality-of-life outcomes over 3 years.Main Outcome Measures: Validated questionnaires (HADS/MICRA/HAI/SF12) used to analyse psychological wellbeing/quality-of-life outcomes at baseline/1-year/2-year/3-year follow up.Results: In all, 1034 individuals (691 women, 343 men) were randomised to PS (n = 530) or FH (n = 504) arms. There was a statistically significant decrease in anxiety (P = 0.046) and total anxiety-&-depression scores (P = 0.0.012) in the PS arm compared with the FH arm over 3 years. No significant difference was observed between the FH and PS arms for depression, health-anxiety, distress, uncertainty, quality-of-life or experience scores associated with BRCA testing. Contrast tests showed a decrease in anxiety (P = 0.018), health-anxiety (P < 0.0005) and quality-of-life (P = 0.004) scores in both PS and FH groups over time. Eighteen of 30 (60%) BRCA carriers identified did not fulfil clinical criteria for BRCA testing. Total BRCA prevalence was 2.9% (95% CI 1.97-4.12%), BRCA1 prevalence was 1.55% (95% CI 0.89-2.5%) and BRCA2 prevalence was 1.35% (95% CI 0.74-2.26%).Conclusion: Population-based AJ BRCA testing does not adversely affect long-term psychological wellbeing or quality-of-life, decreases anxiety and could identify up to 150% additional BRCA carriers.Tweetable Abstract: Population BRCA testing in Ashkenazi Jews reduces anxiety and does not adversely affect psychological health or quality of life. [ABSTRACT FROM AUTHOR]

Given the importance of heavy menstrual bleeding (HMB), we investigated the effect of plantain syrup on HMB. This randomized clinical trial was performed on 68 women with HMB who were referred to the traditional medicine clinics of Mashhad University of Medical Sciences. The intervention group received placebo capsule and plantain syrup, whereas the control group received mefenamic acid capsule and placebo syrup in the first 5 days of menstruation for three menstruation cycles. Patients were asked to complete pictorial blood assessment chart one cycle before the intervention and three intervention cycles. Hemoglobin was measured at the beginning and at the end of the study. The results showed that the bleeding duration and severity diminished in both groups. No significant difference was observed between two groups in severity of bleeding after intervention (Cohen's d = .24), but duration of bleeding in mefenamic acid group was reduced significantly in comparison with plantain group (Cohen's d = .57). Although mean hemoglobin alterations in mefenamic acid group had a significant difference before and after the intervention, there was no significant difference between the two groups in mean hemoglobin alterations postintervention. Plantain syrup could be suggested as a complementary treatment for HMB, but further studies are required. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to evaluate the efficacy of a problem-solving intervention for the prevention of suicidal risk in Brazilian adolescents with elevated suicidal potential and depressive symptoms.Methods: A randomized controlled trial was conducted involving 100 participants (mean age 17.2 years, 60% women, 46% mixed race), allocated to the problem-solving intervention (n = 50) or the usual care control group (n = 50). Blinded interviewers conducted assessments at pretreatment, posttreatment, 1, 3, and 6 months of follow-up. The main outcome was suicidal orientation; secondary outcomes were suicidal risk, suicidal plans and attempts, depressive symptoms, and problem-solving skills.Results: At posttreatment and up to 6-month follow-up, there was lower suicidal orientation and suicidal risk in the problem-solving group compared to the control group. There were lower suicidal plans and attempts (0.0% participants vs 2.2% with a suicide plan and 2.2% with both suicide plan and attempt); risk difference was 0.04 (95% CI: 0.01-0.09) and the number needed to treat was 25 (95% CI: 11-70). Significant effects of the intervention on depressive symptoms were found at posttreatment and maintained for 6 months. The change in global and functional problem-solving skills mediated the reduction in suicide orientation.Conclusions: Thus, suicidal risk can be successfully prevented in adolescents. [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: This study aimed to investigate whether the intake of the 1975 Japanese diet (JD) could reduce the amount of abdominal fat in people with overweight.Methods: Using a single-blind randomized controlled trial, the modern diet (MD) was compared with the 1975-type JD, which is based on the MD but includes five characteristics of the 1975 JD in an enhanced form. Overweight people were randomly assigned to an MD group (n = 30) and a JD group (n = 30). The participants consumed test diets that were provided three times a day for 28 days. Body composition measurements and blood biochemical examinations were performed before and after the test diet intake, and the proportions of change were compared.Results: Those in the JD group had significantly decreased BMI, fat mass, and levels of low-density lipoprotein cholesterol, glycated hemoglobin, and C-reactive protein (P = 0.002, 0.015, 0.014, 0.012, and 0.039, respectively) and significantly increased high-density lipoprotein cholesterol levels compared with those in the MD group (P = 0.020).Conclusions: The intake of a diet with the characteristics of the 1975 JD may have beneficial effects on lipid metabolism in people with overweight and reduce the onset risk of metabolism-related disorders, such as obesity and diabetes. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to determine the effects of sustained morning fasting or breakfast consumption on metabolism, energy intake, and appetite in healthy adults with obesity.Methods: An independent-measures randomized controlled trial with baseline and follow-up laboratory assessment days separated by a 6-week intervention of either morning fasting (0 kcal until 12:00 pm) or daily breakfast (> 700 kcal by 11:00 am) was performed. Measures included metabolic outcomes (glucose, insulin, nonesterified fatty acids), hormones regulating appetite (total/acylated ghrelin, peptide YY, leptin), and energy expenditure (diet-induced thermogenesis) parameters throughout a laboratory test day and ad libitum intake following a fixed breakfast.Results: Allocation to fasting versus breakfast resulted in minimal adaptation as reflected by the metabolic outcomes or the majority of appetite regulatory outcomes for either area under curve or time-course-based measures (P > 0.05). Ad libitum lunch intake was not different (P = 0.13), nor was diet-induced thermogenesis or a composite appetite score (both P > 0.10). However, there was a reduced total area under the curve for peptide YY (P = 0.05) and increased postprandial hunger ratings (P = 0.05) in the breakfast group.Conclusions: There was little evidence of metabolic adaptation to acute feeding or negative consequences from sustained morning fasting. This indicates that previously observed differences between breakfast consumers and skippers may be acute effects of feeding or may have resulted from other lifestyle factors. [ABSTRACT FROM AUTHOR]

Objective: To explore physiotherapists' perceptions before and after delivering exercise advice via telephone to patients with knee osteoarthritis (OA).Methods: We performed a descriptive qualitative study (based on interpretivist methodology) embedded within a randomized controlled trial. Before and after providing exercise therapy to patients with knee OA, all 8 physiotherapists who were involved in the trial participated in semi-structured interviews via telephone. Interviews were audio recorded, transcribed verbatim, and thematically analyzed.Results: Prior to delivering the intervention, physiotherapists thought that the telephone should be used only for follow-up rather than as the primary mode of providing care. They believed that telephone-delivered care would be convenient and cost-saving for patients, would provide increased opportunity for patient education, and also increase access to services, but that the lack of visual and physical contact with patients would be problematic. After delivering the intervention, physiotherapists reflected that telephone-delivered care exceeded their expectations, noting positive patient outcomes including improved pain, function, and confidence. The focus on communication allowed more personal conversations with patients and shifted patient expectations of care away from manual therapies and toward self-management. Numerous implementation considerations were identified, including the need for clinician training in communication skills, written resources for patients to supplement telephone calls, and careful deliberation of how to schedule telephone consultations during the usual in-person consultations in the clinic.Conclusion: Although physiotherapists were initially skeptical about the effectiveness of telephone-delivered service models to patients with knee OA, perceptions shifted once they experienced delivery of care via this nontraditional method. Our findings suggest that firsthand experience may be necessary for physiotherapists to embrace new models of service delivery. [ABSTRACT FROM AUTHOR]

Background and Objectives: Neuroactive steroids (NAS) may play a role in addiction, with observed increases in response to acute stress and drug use, but decreases with chronic substance use, suggesting that NAS neuroadaptations may occur with chronic substance use. However, levels of NAS in addicted individuals have not been systematically examined. Here, we evaluated a panel of NAS in men and women with cocaine use disorder (CUD) who participated in a clinical laboratory study of progesterone.Methods: Forty six CUD individuals were enrolled in a randomized placebo-controlled laboratory study to evaluate progesterone effects on levels of various NAS. On day 5 of a 7-day inpatient treatment regimen of 400 mg/day progesterone (15M/8F) or placebo (14M/9F), plasma levels of NAS known to be downstream of progesterone (allopregnanolone, pregnanolone), and NAS not in the progesterone synthesis pathway (androstanediol, testosterone, dehydroepiandrosterone [DHEA] and the NAS precursor, pregnenolone) were analyzed using highly sensitive gas chromatography/mass spectrometry (GC/MS). The relationship between each of the NAS and chronicity of cocaine use was also assessed.Results: Progesterone versus placebo significantly increased the GABAergic NAS allopregnanolone and pregnanolone in both CUD men and women. Levels of pregnenolone, testosterone, its GABAergic metabolite androstanediol, and the non-GABAergic DHEA were unaffected by progesterone treatment, and testosterone and androstanediol levels were significantly higher in men than women. Importantly, lower pregnenolone and androstanediol levels were associated with greater years of cocaine use.Scientific Significance: GABAergic NAS that are upstream from the progesterone synthesis pathway appear susceptible to chronic effects of cocaine use. (Am J Addict 2019;28:16-21). [ABSTRACT FROM AUTHOR]

Although weight loss improves blood pressure (BP), its association with mortality remains unclear. In the Trials of Hypertension Prevention (TOHP), individuals aged 30-54 years with high normal BP were randomized to weight loss, usual care or other intervention over 18 months (TOHP I) or 3-4 years (TOHP II), with average 23-year mortality follow-up. We examined mortality and (a) randomized weight loss and (b) observed weight change among all with high baseline weight. Among 2964 randomized participants, 227 deaths occurred, with no intervention difference (hazard ratio (HR) = 0.97, 95% confidence interval (CI) = 0.75-1.26, P = 0.84). Among 3828 high-weight participants, weight change was directly related to mortality (HR = 1.14 per 5% change, 95% CI = 1.02-1.28, P = 0.019). During the trial 15% lost >5% (HR = 0.82), 29% lost 0-<=5% (HR = 0.94), 41% gained 0-<5% (reference), and 16% gained >5% (HR = 1.29) (P-trend = 0.046). This is consistent with a long-term beneficial effect of presumed intentional weight loss on mortality. [ABSTRACT FROM AUTHOR]

Objective: To test the hypothesis that patient-initiated follow up reduces the fear of cancer recurrence (FCR) and healthcare use when compared with traditional hospital-based follow up.Design: Pragmatic, multicentre randomised trial.Setting: Four Danish departments of gynaecology between May 2013 and May 2016.Population: One hundred and fifty-six women diagnosed with International Federation of Gynecology and Obstetrics (FIGO) stage I low-intermediate risk endometrial carcinoma.Methods: Women allocated to the control group attended hospital-based follow up consisting of regular outpatient visits for 3 years after primary treatment. Women in the intervention group were instructed in patient-initiated follow up, which included careful instruction in alarm symptoms and options for self-referral rather than a schedule of examinations.Main Outcome Measures: The primary end point was FCR as measured by the Fear of Cancer Recurrence Inventory (FCRI) after 10 months of follow up. Secondary end points included cancer-related use of primary and secondary health care during the first 10 months after treatment.Results: In the primary analysis, FCR decreased significantly more in the control group from baseline to 10 months of follow up (difference -5.9, 95% CI -10.9 to -0.9). The majority of this improvement happened after only 3 months of follow up. Women receiving the intervention had fewer examinations at the department compared with the control group (0 versus 2 median visits, P < 0.01) and 58% of these examinations were scheduled because of vaginal bleeding.Conclusions: Hospital-based follow up alleviates FCR significantly more than patient-initiated follow up, though the estimated difference was small. Patient-initiated follow up is a feasible, potentially cost-reducing follow-up approach in a population of endometrial cancer survivors with low risk of recurrence. The decision to use patient-initiated follow up should balance these benefits and harms.Tweetable Abstract: Patient-initiated follow up reduces healthcare use but maintains fear of recurrence in endometrial cancer.Plain Language Summary: Why and how was the study carried out? Follow up of women with endometrial cancer is resource consuming and previous research suggests that it is not effective. Even though the women benefit from reassurance at follow up, routine examinations may also remind the women of the disease and induce fear of cancer recurrence. Furthermore, routine follow up may delay recurrence diagnosis, because the women do not report their symptoms until the next scheduled visit. In the research explained in this article, patient-initiated follow up was evaluated as an alternative to traditional follow up. The women were randomly assigned to one of two follow-up programmes: regular gynaecological examinations at the department of gynaecology or self-referral with careful instruction in alarm symptoms, that is, patient-initiated follow up. The level of fear of cancer recurrence in the two groups was obtained by questionnaires. Information on healthcare use was obtained by questionnaires and a chart review. What were the main findings? Regular examinations at the department of gynaecology reduced the fear of cancer recurrence significantly more than patient-initiated follow up, though the difference was small. Women who were instructed in alarm symptoms, under self-referral, were able to monitor their symptoms, and this approach significantly reduced the number of examinations at the department of gynaecology. What are the limitations of the work? Participants in the self-referral group knew that they were examined less than other women, and this may have induced fear of cancer recurrence. Similarly, the regular completion of questionnaires regarding fear of cancer recurrence may have reminded the women of the disease and diminished the difference between the two groups. What are the implications for patients Patient-initiated follow up reduced healthcare use but maintained fear of cancer recurrence in women who had survived early-stage endometrial cancer. Future analyses on quality of life and cost-effectiveness are needed to balance the benefits and harms of patient-initiated follow up. [ABSTRACT FROM AUTHOR]

Objective: To determine whether oral clindamycin reduces the risk of preterm birth (PTB) in women with abnormal vaginal microflora as evidenced by a vaginal pH ≥5.0.Design: Randomised double-blind placebo-controlled trial.Setting: Rural southern India.Population: Pregnant women with a singleton fetus between 13+0/7 weeks and 20+6/7 weeks.Methods: Pregnant women were recruited during prenatal visits in Karnataka, India, from October 2013 to July 2015. Women were required to have a singleton fetus between 13+0/7 weeks and 20+6/7 weeks and an elevated vaginal pH (≥5.0) by colorimetric assessment. Participants were randomised to either oral clindamycin 300 mg twice daily for 5 days or an identical-appearing placebo.Main Outcome Measures: The primary outcome was the incidence of PTB, defined as delivery before 37+0/7 weeks.Results: Of the 6476 screened women, 1727 women were randomised (block randomised in groups of six; clindamycin n = 866, placebo n = 861). The demographic, reproductive, and anthropomorphometric characteristics of the study groups were similar. Compliance was high, with over 94% of capsules being taken. The rate of PTB before 37 weeks was comparable between the two groups [clindamycin 115/826 (13.9%) versus placebo 111/806 (13.8%), between-group difference 0.2% (95% CI -3.2 to 3.5%, P = 0.93)], as was PTB at less than 34 weeks [clindamycin 40/826 (4.8%) versus placebo group 37/806 (4.6%), between-group difference 0.3% (95% CI -1.8 to 2.3%, P = 0.81)]. No differences were detected in the incidence of birthweight of<2500 g, <1500 g, miscarriage, stillbirth or neonatal death.Conclusion: In this setting, oral clindamycin did not decrease PTB among women with vaginal pH ≥5.0.Tweetable Abstract: Oral clindamycin between 13+0/7 and 20+6/7 weeks does not prevent preterm birth in women with a vaginal pH ≥5.0. [ABSTRACT FROM AUTHOR]

Results of the SPRINT study have been disputed, based on the assumption that unattended BP measurements do not correlate with usual BP measurements. In this study, the authors investigated the correlation of unattended SPRINT-like measurements with other conventional measurements. All BP measurements were taken with the patient seated in a comfortable chair with the legs uncrossed and not speaking during the procedure. For the purpose of this study, sixty-five patients, mostly male (93%), were recruited from our hypertension clinic and all were on antihypertensive medication (av 3.0 ± 1.1). Patients were at high cardiovascular risk with high rates of comorbidities, av age 68 ± 12 years, 49% with diabetes, 34% with mild CKD (CKD 1-3, average eGFR 55.0 ± 13 mL/min/1.73 m2 ), and 20% with history of stable coronary artery disease. All BP measurements were similar with no statistically significant difference (one-way ANOVA, P = 0.621). Compared to unattended SPRINT BP values (139.77 ± 19.22/75.42 ± 11.72 mm Hg), the clinic BP measurements were numerically slightly higher but with a NS P value (P = 0.163). Similarly, unattended BP measurements were similar to values taken by the clinic physician. In a smaller cohort of 11 patients, the authors compared unobserved vs observed SPRINT-like BP measurements, and in 13 patients, the authors compared unobserved SPRINT-like BP measurements to average home BP measurements (Table 3). There were no significant differences between any of the subgroups (one-way ANOVA, P = 0.816 for systolic and P = 0.803 for diastolic). The authors conclude that unattended BP measurements taken (the SPRINT way) are similar to other conventional office blood pressure measurements. [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]

Objective: To assess whether a combination of Internet-based and postal survey methods (mixed-mode) compared to postal-only survey methods (postal-only) leads to improved response rates in a physician survey, and to compare the cost implications of the different recruitment strategies.Data Sources/study Setting: All primary care gynecologists in Bremen and Lower Saxony, Germany, were invited to participate in a cross-sectional survey from January to July 2014.Study Design: The sample was divided into two strata (A; B) depending on availability of an email address. Within each stratum, potential participants were randomly assigned to mixed-mode or postal-only group.Principal Findings: In Stratum A, the mixed-mode group had a lower response rate compared to the postal-only group (12.5 vs. 20.2 percent; RR = 0.61, 95 percent CI: 0.44-0.87). In stratum B, no significant differences were found (15.6 vs. 16.2 percent; RR = 0.95, 95 percent CI: 0.62-1.44). Total costs (in €) per valid questionnaire returned (Stratum A: 399.72 vs. 248.85; Stratum B: 496.37 vs. 455.15) and per percentage point of response (Stratum A: 1,379.02 vs. 861.02; Stratum B 1,116.82 vs. 1,024.09) were higher, whereas variable costs were lower in mixed-mode compared to the respective postal-only groups (Stratum A cost ratio: 0.47, Stratum B cost ratio: 0.71).Conclusions: In this study, primary care gynecologists were more likely to participate by traditional postal-only than by mixed-mode survey methods that first offered an Internet option. However, the lower response rate for the mixed-mode method may be partly due to the older age structure of the responding gynecologists. Variable costs per returned questionnaire were substantially lower in mixed-mode groups and indicate the potential for cost savings if the sample population is sufficiently large. [ABSTRACT FROM AUTHOR]

Aim: Sudden unexpected death in infancy (SUDI) rates for Māori and Pacific infants remain higher than for other ethnic groups in New Zealand and bed-sharing is a major risk factor when there is smoking exposure in pregnancy. Sleep space programmes of education and Pēpi-Pod baby beds require evaluation.Methods: Two hundred and forty Māori and Pacific women and infants were randomised 1:1, to the Pēpi-Pod sleep space programme, or to a control group with 'usual care'. When infants were under 2 weeks of age, baseline interviews occurred, followed up by interviews at 2 and 4 months of age to assess safe sleep knowledge, infant care practices and Pēpi-Pod use and acceptability. All participants were offered a New Zealand Standard approved portable cot.Results: At baseline, 25% of babies did not have a baby bed. Knowledge of smoking and bed-sharing as SUDI risks improved at follow-up in both groups. One quarter regularly bed-shared at follow-up in both groups. Intention to bed-share was a strong predictor of subsequent behaviour. Pēpi-Pods were regularly used by 46% at 2 months and 16% at 4 months follow-up.Conclusions: Bed-sharing and knowledge improvement were similar irrespective of group. It is likely that the impact of the intervention was reduced because the control group received better support than 'usual care' and all participants had a baby bed. New Zealand SUDI rates have declined since sleep space programmes have been available. Sleep space programmes should be prioritised for those with modifiable SUDI risk. [ABSTRACT FROM AUTHOR]

Copyright of Tropical Medicine & International Health is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

A randomised control trial was conducted to determine changes in the food and drink choices of adolescents following their participation in a 50-min nutrition workshop. The experiment was conducted at 104 schools in Barcelona (126 classes, 3,291 adolescents). Schools were randomly selected and stratified by district and by public or private status. The students were given three types of vouchers with different options regarding the type of food for which the vouchers could be exchanged (standard for healthy food and drink, two for one for unhealthy food, and two for one for unhealthy drink). Difference-in-differences linear models that control for individual, family, school or neighbourhood characteristics, and the influence of peers were applied. The probability of students' choosing unhealthy food and drink fell by 7.1% and 4.4%, respectively, following participation in the nutrition workshop. The promotion of unhealthy beverages counteracted the positive impact of the workshop on beverage choice. [ABSTRACT FROM AUTHOR]

Objective: Improving the maintenance of lost weight remains a critical challenge, which can be addressed by long-term behavioral and/or pharmacological interventions.Methods: This study investigated the efficacy of combined behavioral and pharmacological treatment in facilitating weight loss maintenance (WLM) in 137 adults (86.1% female; 68.6% black; BMI = 37.0 ± 5.6 kg/m2 ) who had lost ≥ 5% of initial weight during a 14-week low-calorie diet (LCD) program (mean = 9.3 ± 2.9%). Participants were randomly assigned to lorcaserin (10 mg twice a day) or placebo and were provided 16 group WLM counseling sessions over 52 weeks.Results: At 24 weeks post randomization, more lorcaserin-treated than placebo-treated participants maintained a ≥ 5% loss (73.9% vs. 57.4%; P = 0.033), and the lorcaserin-treated participants lost an additional 2.4 ± 0.8 kg versus a 0.6 ± 0.8 kg gain for placebo (P = 0.010). However, at week 52, groups did not differ on either co-primary outcome; 55.1% and 42.6%, respectively, maintained ≥ 5% loss (P = 0.110), with gains from randomization of 2.0 ± 0.8 kg and 2.5 ± 0.8 kg (P = 0.630), respectively. From the start of the LCD, groups maintained reductions of 7.8% and 6.6%, respectively (P = 0.318).Conclusions: Combined behavioral and pharmacological treatment produced clinically meaningful long-term weight loss in this group of predominantly black participants. Lorcaserin initially improved upon weight loss achieved with WLM counseling, but this advantage was not maintained at 1 year. [ABSTRACT FROM AUTHOR]

Objective: The ketones d-β-hydroxybutyrate (BHB) and acetoacetate are elevated during prolonged fasting or during a "ketogenic" diet. Although weight loss on a ketogenic diet may be associated with decreased appetite and altered gut hormone levels, it is unknown whether such changes are caused by elevated blood ketones. This study investigated the effects of an exogenous ketone ester (KE) on appetite.Methods: Following an overnight fast, subjects with normal weight (n = 15) consumed 1.9 kcal/kg of KE, or isocaloric dextrose (DEXT), in drinks matched for volume, taste, tonicity, and color. Blood samples were analyzed for BHB, glucose, insulin, ghrelin, glucagon-like peptide 1 (GLP-1), and peptide tyrosine tyrosine (PYY), and a three-measure visual analogue scale was used to measure hunger, fullness, and desire to eat.Results: KE consumption increased blood BHB levels from 0.2 to 3.3 mM after 60 minutes. DEXT consumption increased plasma glucose levels between 30 and 60 minutes. Postprandial plasma insulin, ghrelin, GLP-1, and PYY levels were significantly lower 2 to 4 hours after KE consumption, compared with DEXT consumption. Temporally related to the observed suppression of ghrelin, reported hunger and desire to eat were also significantly suppressed 1.5 hours after consumption of KE, compared with consumption of DEXT.Conclusions: Increased blood ketone levels may directly suppress appetite, as KE drinks lowered plasma ghrelin levels, perceived hunger, and desire to eat. [ABSTRACT FROM AUTHOR]

While continuing care for substance use treatment has been associated with reduced involvement in the criminal justice system, much of this research lacks random assignment to continuing care and so is limited by self-selection bias. This study sought to determine the impact of adding telephone-based continuing care to intensive outpatient programs on criminal justice outcomes for people with cocaine dependence. In three continuing care studies, spanning 1998-2008, participants were randomly assigned to an intensive outpatient program or an intensive outpatient program plus a telephone-based continuing care intervention. Cocaine-dependent participants from these three studies were included in the analyses, with outcomes derived from a dataset of jurisdiction-wide criminal sentences from a state sentencing agency. Multiple logistic regression was employed to examine the odds of a criminal conviction occurring in the 4 years after enrollment in a continuing care study. The results showed that, controlling for a criminal sentence in the previous year, gender, age, and continuing care study, people with cocaine dependence randomized to an intensive outpatient program plus a telephone-based continuing care intervention had 54% lower odds (p = 0.05, odds ratio = 0.46, 95% CI: 0.20-1.02) of a criminal sentence in the 4 years after enrollment in the continuing care study, compared with those randomized to an intensive outpatient program alone. We can conclude that adding telephone monitoring and counseling to intensive outpatient programs is associated with fewer criminal convictions over a 4-year follow-up period compared with intensive outpatient programs alone. [ABSTRACT FROM AUTHOR]

Aim: A previous maternal and infant nutrition intervention in rural Matlab, Bangladesh, showed that prenatal nutrient supplements improved child survival, but had no effect on size at birth. This secondary analysis examined whether prenatal multiple micronutrient supplements (MMS), on their own or combined with an early invitation to receive prenatal food supplements, affected child morbidity.Methods: This randomised trial enrolled 4436 pregnant women from November 2001 to October 2003 and allocated them to early or standard invitations to food supplements, in the ninth and 20th weeks of pregnancy, respectively, and supplements of either the standard 60 mg iron with 400 μg folic acid, 30 mg iron with 400 μg folic acid or MMS. Quasi-Poisson regression was used to analyse morbidity.Results: There were 3560 single live births and 3516 had morbidity data. The incidence rates of fever, diarrhoea and acute lower respiratory tract infection were 15.3, 3.6 and 2.3 episodes per person-year, respectively. The separate or combined interventions had no effect on morbidity up to 24 months.Conclusion: Early invitations to prenatal food supplements or prenatal MMS had no effect on common infections in rural Bangladesh, suggesting that earlier findings on improved child survival were not mediated by an effect on child morbidity. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effect of a community-based lifestyle behavioral intervention on intakes of fat, fruits, vegetables, fast foods, and beverages in low-income young mothers with overweight or obesity.Methods: Participants were randomly assigned to an intervention (watching video lessons at home plus peer support group teleconferences) or a comparison group. General linear mixed model analyses were utilized to determine mean differences between the groups (212 intervention, 126 comparison) immediately following and 3 months (196 intervention, 115 comparison) after the intervention.Results: Immediately after the intervention, the intervention group had significantly lower mean scores in intakes of fat (effect size [d] = 0.24), fast foods (d = 0.33), and non-sugar-sweetened beverages (d = 0.27) than the comparison group. No significant group differences were observed for intakes of fruits, vegetables, or sugar-sweetened beverages. Three months after the intervention, no significant group differences were observed for intakes of fat, fruits, vegetables, fast foods, and both sugar- and non-sugar-sweetened beverages.Conclusions: The intervention group improved dietary intakes of fat and fast foods but not fruits, vegetables, or beverages over the short term. Our intervention had no long-term effect on dietary intake behaviors. [ABSTRACT FROM AUTHOR]

Objective: This study aims to assess whether an intensive lifestyle intervention (ILI) for weight reduction precipitates binge eating (BE) and whether BE attenuates 4-year weight loss among participants with type 2 diabetes and overweight or obesity.Methods: Participants (N = 4,901) were from Look AHEAD, a randomized controlled trial that compared ILI to diabetes support and education (DSE). Annual assessments of measured weight and self-reported BE were used. By using the yearly time points when a person endorsed BE, participants were classified as no BE, remitted BE, incident BE, inconsistent BE (2-3 years, including baseline), and consistent BE (≥ 4 years, including baseline). Cox regression and mixed-effects models were used for analyses.Results: ILI participants were marginally more likely to report incident BE at year 4 than those in DSE (P = 0.06). At year 4, ILI participants with remitted BE lost more weight (4.7 ± 0.8%) than those with consistent BE (1.9 ± 1.0%; P = 0.03). ILI participants with no BE lost more weight (4.6 ± 0.2%) than those with incident BE (3.1 ± 0.6%; P = 0.02) and consistent BE (P = 0.01). DSE participants with remitted BE lost more weight than those with incident and consistent BE.Conclusions: Preexisting BE did not seem to be a contraindication for ILI, although persistent BE attenuated weight loss. Patients who report new or ongoing BE may need additional treatment. [ABSTRACT FROM AUTHOR]

This study aimed to examine the effects of hesperidin supplement on the glycemic parameters, oxidative DNA damage, and lipid peroxidation in patients with type 2 diabetes. Sixty-four patients were randomly allocated to receive 500 mg/day hesperidin or placebo capsules for 6 weeks. Data on glycemic parameters, total antioxidant capacity (TAC), 8-hydroxydeoxyguanosine (8-OHDG), and malondialdehyde (MDA) were collected at the baseline and at the end of the study. In hesperidin group, TAC increased (0.74 ± 0.16 vs. 0.82 ± 0.18), while serum froctoseamin (5.79 ± 5.86 vs. 5.01 ± 4.95; p = 0.001), 8-OHDG (14.32 ± 6.4 vs. 11.00 ± 7.0; p = 0.000), and MDA (5.78 ± 1.76 vs. 4.60 ± 0.75; p = 0.000) decreased in comparison with the baseline values. There was a significant difference in percent change of TAC (13.35 ± 19.21 vs. 3.13 ± 10.02; p = 0.043), froctoseamin (-10.10 ± 16.84 vs. 4.27 ± 34.646), 8-OHDG (-25.11 ± 28.23 vs. 8.69 ± 35.41; p = 0.000), and MDA (-16.46 ± 18.04 vs. -1.82 ± 22.63; p = 0.007) between hesperidin and control groups following intervention in adjusted models. These results suggest that hesperidin may improve TAC and alleviate serum froctoseamin, 8-OHDG, and MDA levels in type 2 diabetes. Copyright © 2017 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Objective: Taste blindness to 6-n-propylthiouracil (PROP) associates with increased fat preference and intake. No studies have matched a diet to a woman's PROP phenotype to improve weight loss. This study investigated (1) whether PROP nontaster (NT) women would lose more weight following a low-carbohydrate (LC) diet than a low-fat (LF) diet, and (2) whether PROP supertaster (ST) women would lose more weight following a LF diet than a LC diet.Methods: One hundred seven women (BMI = 34.8 ± 0.5 kg/m2 ), classified as PROP NTs (n = 47) and STs (n = 60), were randomized to a LC or LF diet within a 6-month lifestyle intervention. Assessments included 4-day dietary recalls and biobehavioral and psychosocial questionnaires.Results: At 6 months, NTs lost more weight following the LC than the LF diet (-8.5 ± 0.5 kg vs. -6.6 ± 0.5 kg, P = 0.008); there was no difference between STs following either diet (-8.8 ± 0.4 vs. -8.9 ± 0.5, P = 0.35). Dietary self-reports were unrelated to weight loss, and prescription of a LC diet associated with greater self-efficacy.Conclusions: NT women lost more weight following the LC diet compared to the LF diet. Screening for PROP phenotype may help personalize diet therapy for NT women to optimize their short-term weight loss. [ABSTRACT FROM AUTHOR]

Objective: To examine the safety and efficacy of a high-intensity (HI) progressive rehabilitation protocol beginning 4 days after total knee arthroplasty (TKA) compared to a low-intensity (LI) rehabilitation protocol.Methods: A total of 162 participants (mean ± SD ages 63 ± 7 years; 89 women) were randomized to either the HI group or LI group after TKA. Key components of the HI intervention were the use of progressive resistance exercises and a rapid progression to weight-bearing exercises and activities. Both groups were treated in an outpatient setting 2 to 3 times per week for 11 weeks (26 total sessions). Outcomes included the stair climbing test (SCT; primary outcome), timed-up-and-go (TUG) test, 6-minute walk (6MW) test, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), 12-item Short Form health survey (SF-12), knee range of motion (ROM), quadriceps and hamstring strength, and quadriceps activation. Outcomes were assessed preoperatively and at 1, 2, 3 (primary end point), 6, and 12 months postoperatively.Results: There were no significant differences between groups at 3 or 12 months in SCT, TUG, 6MW, WOMAC scores, knee ROM, quadriceps and hamstrings strength, quadriceps activation, or adverse event rates. By 12 months, outcomes on the 6MW, TUG, WOMAC, SF-12, quadriceps and hamstring strength, and quadriceps activation had improved beyond baseline performance in both groups.Conclusion: Both the HI and LI interventions were effective in improving strength and function after TKA. HI progressive rehabilitation is safe for individuals after TKA. However, its effectiveness may be limited by arthrogenic muscular inhibition in the early postoperative period. [ABSTRACT FROM AUTHOR]

Objective: To conduct an economic evaluation of the use of trans-obturator tape (TOT) compared with tension-free vaginal tape (TVT) in the surgical treatment of stress urinary incontinence in women.Design: Cost-utility and cost-effectiveness analyses from a public-payer perspective, conducted alongside a randomised clinical trial.Setting: Health services provided in Alberta, Canada.Sample: A total of 195 women participated in the randomised clinical trial, followed to 5 years postsurgery.Methods: Comparisons were undertaken between study groups for cost and two health-outcome measures. Multiple imputation was used to estimate the 14% of missing data. Bootstrapping was used to account for sampling uncertainty. Sensitivity analyses were based on complete case analyses and the removal of a TVT patient with extreme health service cost.Main Outcome Measures: The 15D instrument was used to calculate quality-adjusted life-years (QALYs) for the primary analysis. Absence of serious adverse events was also analysed. Costs were based on inpatient and outpatient hospital use data and practitioner fee-for-service claims data.Results: The TOT group had a nonsignificant average saving of $2368 (95% CI -$7166 to $2548) and incremental gain of 0.04 QALYs (95% CI -0.06 to 0.14) compared with TVT. TOT was dominant in over 71% of bootstrap replications and cost-effective over a wide range of willingness-to-pay. Cost-effectiveness analysis using the absence of an serious adverse events provided similar results.Conclusion: The results suggest that TOT is cost-effective compared with TVT in the treatment of stress urinary incontinence.Tweetable Abstract: The results of a 5-year cost-effectiveness analysis suggest that trans-obturator tape is cost-effective compared with tension-free vaginal tape in the treatment of stress urinary incontinence. [ABSTRACT FROM AUTHOR]

Background: To examine whether SMOFlipid prevents progression of intestinal failure-associated liver disease (IFALD) in parenteral nutrition (PN)-dependent infants with early IFALD (conjugated bilirubin 17-50 µmol/L, 1-3 mg/dL).Study Design: Pilot multicenter blinded randomized controlled trial comparing SMOFlipid with Intralipid. Patients received the trial lipid for up to 12 weeks, unless they achieved full enteral tolerance sooner. The primary clinical outcome was the serum conjugated bilirubin.Results: Twenty-four infants (mean age, 6 weeks) participated in the trial (13 Intralipid and 11 SMOFlipid). At the time of trial enrollment, patients in both groups were receiving 90% of their calories by PN. Mean duration on trial was 8 weeks and did not differ according to treatment ( P = .99). At trial conclusion, patients who received SMOFlipid had a lower conjugated bilirubin than those who received Intralipid (mean difference, -59 µmol/L; P = .03). Patients receiving SMOFlipid were also more likely to have a decrease in serum conjugated bilirubin to 0 µmol/L than those in the Intralipid group over the entire observation period (hazard ratio, 10.6; 95%; P = .03). The time to achievement of full enteral tolerance did not differ statistically (hazard ratio, 1.3; P = .59) between the groups. There was no significant difference in safety outcomes between the groups.Conclusions: Compared with Intralipid, SMOFlipid reduces the risk of progressive IFALD in children with intestinal failure. This trial was registered at clinicaltrials.gov as NCT00793195. [ABSTRACT FROM AUTHOR]

Aim: Optimal duration of parenteral antibiotics for treating neonatal sepsis ranges from 7-14 days. We compared the efficacy of 7 versus 10 days duration of intravenous antibiotics for neonatal septicaemia.Methods: We randomised blood culture-proven septic neonates (≥32 weeks and birth weight ≥1.5 kg) to receive either 7 or 10 days duration of intravenous antibiotics. We followed up neonates upto 28 days after stopping antibiotics for treatment failure defined by reappearance of clinical sepsis with a blood culture growing the same organism as cultured earlier, or in the absence of a positive culture, the presence of C-reactive protein and as adjudicated by an expert committee.Results: A total of 132 neonates were randomised to receive either 7 (n = 66) or 10 (n = 66) days duration of antibiotic therapy. Out of 128 neonates (64 per group) followed up, two (one per group) were regarded as 'treatment failure', and two were labelled as fresh episodes of sepsis (both in 10-day group). The risk (95% confidence interval) for treatment failure in the 7-day group was (1.0 (0.064-15.644) was not significantly higher. Neonates in both groups had comparable need for oxygen, inotropic support and blood products, duration of oxygen therapy and time to attainment of full feeds. The duration of hospitalisation was significantly longer in the 10-day group.Conclusion: A 7-day course of intravenous antibiotics may be sufficient to treat neonatal sepsis with the advantage of shorter hospital stay, but a larger meta-analysis would be required to state this with a degree of certainty. [ABSTRACT FROM AUTHOR]