Search

In people with bone and soft tissue injuries of the wrist, hand and/or fingers, do feedback-guided exercises performed on a tablet touchscreen hasten return to work, reduce healthcare usage and improve clinical recovery more than a home exercise program prescribed on paper? Randomised, parallel-group trial with concealed allocation, assessor blinding and intention-to-treat analysis. Seventy-four workers with limited functional ability due to bone and soft tissue injuries of the wrist, hand and/or fingers. Participants in the experimental and control groups received the same in-patient physiotherapy and occupational therapy. Participants in the experimental group received a home exercise program using the ReHand tablet application, which guides exercises performed on a tablet touchscreen with feedback, monitoring and progression. Participants in the control group were prescribed an evidence-based home exercise program on paper. The primary outcome was the time taken to return to work. Secondary outcomes included: healthcare usage (number of clinical appointments); and functional ability, pain intensity, and grip and pinch strength 2 and 4 weeks after randomisation. Compared with the control group, the experimental group: returned to work sooner (MD –18 days, 95% CI –33 to –3); required fewer physiotherapy sessions (MD –7.4, 95% CI –13.1 to –1.6), rehabilitation consultations (MD –1.9, 95% CI –3.6 to 0.3) and plastic surgery consultations (MD –3.6, 95% CI –6.3 to –0.9); and had better short-term recovery of functional ability and pinch strength. In people with bone and soft-tissue injuries of the wrist, hand and/or fingers, prescribing a feedback-guided home exercise program using a tablet-based application instead of a conventional program on paper hastened return to work and improved the short-term recovery of functional ability and pinch strength, while reducing the number of required healthcare appointments. ACTRN12619000344190 [ABSTRACT FROM AUTHOR]

Background: The internet can provide evidence-based patient education to overcome time constraints of busy ambulatory practices. Health informationprescriptions (HIPs) can be effectivelyintegrated into clinic workflow, but compliance to visit health information sites such as Medline Plus is limited.Objective: Compare the efficacy of paper (pHIP)and email (eHIP) links to deliver HIPs; evaluate patient satisfaction with the HIP process and MedlinePlus information; assess reasons for noncompliance to HIPs.Method: Of 948 patients approached at two internal medicine clinics affiliated with an academic medical centre, 592 gave informed consent after meeting the inclusion criteria. In this randomised controlled trial, subjects were randomised to receive pHIP or eHIP for accessing an intermediate website that provided up to five MedlinePlus links for physician-selected HIP conditions. Patients accessing the intermediate website were surveyed by email to assess satisfaction with the health information.Survey non-responders were contacted by telephone to determine the reasons for no response.Results: One hundred and eighty-one patients accessed the website, with significantly more 'filling' eHIP than pHIP (38% vs 23%; P < 0.001). Most(82%) survey respondents found the website information useful, with 77% favouring email for future HIPs delivery. Lack of time, forgot, lost instructions or changed mind were reasons given for not accessing the websites.Conclusions: Delivery of MedlinePlus-based HIPs in clinic is more effective using email prescriptions than paper. Satisfaction with the HIP information was high, but overall response was low and deserves further investigation to improve compliance and related outcomes. [ABSTRACT FROM AUTHOR]

Objective: To determine whether implementing a Facebook training program improves the effectiveness of computerized cognitive training (CCT) in older adults. Design: Randomized, controlled, double single-blind trial with parallel groups. Setting: Community centers. Subjects: Eighty-six adults between 60 and 90 years old. Interventions: Nine face-to-face 60-min sessions of CCT with VIRTRAEL for all participants. The experimental group received an additional 30 min of Facebook training per session. Main measures: Attention (d2 Test of Attention); learning and verbal memory (Hopkins Verbal Learning Test-Revised); working memory (Letter-Number Sequencing test), semantic and abstract reasoning (Similarities and Matrix Reasoning tests); and planning (Key Search test). Results: There was a significant Group*Time interaction in the Hopkins Verbal Learning Test-Revised-Trial 3, Letter-Number sequencing, and Matrix tests. Between groups, post-hoc analyses showed a difference in Matrix reasoning (p <.001; d = 0.893) at post-intervention in favor of the experimental group. Significant main effects of time were found in the CCT group between baseline and 3-month follow-up for Concentration (F = 26.431, p ≤.001), Letters and Numbers (F = 30.549, p ≤.001), Learning (F = 38.678, p ≤.001), Similarities (F = 69.885, p ≤.001), Matrix (F = 90.342, p ≤.001), and Key Search (F = 7.904, p =.006) tests. Conclusions: The utilization of CCT with VIRTRAEL, a freely accessible tool with broad applicability, resulted in enhanced attention, verbal learning, working memory, abstract and semantic reasoning, and planning among older adults. These improvements were sustained for at least three months post-training. Additional training in Facebook did not enhance the effectiveness of CCT. [ABSTRACT FROM AUTHOR]

Background Despite harmful drinking causing a significant burden on global health, there is a large treatment gap, especially in low- and middle-income countries. A major barrier to care is the lack of adequately skilled human resources to deliver contextually appropriate treatments. This paper describes the systematic process used to develop Counselling for Alcohol Problems ( CAP), a brief psychological treatment (PT) for delivery by lay counselors in routine primary care settings to men with harmful drinking in India. Methods CAP was developed using a methodology involving 3 sequential steps: (i) identifying potential treatment strategies; (ii) developing a theoretical framework for the treatment; and (iii) evaluating the acceptability and feasibility of the treatment. Results CAP is a 3-phase treatment delivered over 1 to 4 sessions based on a motivational interviewing ( MI) stance and involves the following strategies: assessment and personalized feedback, family engagement, drink refusal skills, skills to address drinking urges, problem-solving skills and handling difficult emotions, and relapse prevention and management. Data from a case series were used to inform several adaptations to enhance the acceptability of CAP to the recipients and feasibility of delivery by lay counselors of the treatment, for example expansion of the target group to include alcohol-dependent patients and the extension of the delivery settings to include home-based delivery. There was preliminary evidence of the effectiveness of CAP. Conclusions CAP is an acceptable brief PT for harmful drinking delivered by lay counselors in primary care whose effectiveness is currently being tested in a randomized controlled trial based in primary care in Goa, India. [ABSTRACT FROM AUTHOR]

The negative impacts of parental mental health problems on children and adolescents are well known, but the relationship between a child's depression and their parents' health is not so well understood. Being a carer/parent of someone with mental illness can be associated with negative outcomes for the caregiver. This paper reports the associations between the mental health of adolescents with major depression and their parents, before and after treatment of the adolescent's depression. Data were collected as part of the Adolescent Depression Antidepressants and Psychotherapy Trial, a randomised controlled trial of selective serotonin reuptake inhibitors with and without cognitive behaviour therapy in 208 clinic-recruited adolescents with major depression. The baseline severity of depression in the adolescent was significantly associated with both maternal and paternal mental health (as rated by the General Health Questionnaire). This effect was not confounded by other psychiatric symptoms. The degree of improvement in parental and child mental health was positively correlated across time. Our results support the hypothesis that there is a significant association between parental mental health and adolescent depressive symptoms. This study was not able to establish the direction of this association. In clinical practice, the findings demonstrate the importance of considering the mental health of the parents when treating depressed adolescents. [ABSTRACT FROM AUTHOR]

Background: Multiple sclerosis (MS) is a complex autoimmune disease mediated by an immune response to central nervous system antigens. Modern immunomodulatory therapies, however, do not ameliorate many of the symptoms, such as pain and depression. Patients thus seek alternative treatments, such as acupuncture, although the benefits of such treatments have not been objectively evaluated. The present study was thus designed to evaluate the effect of the use of acupuncture in the alleviation of the symptoms of patients with MS. Methods: Thirty-one patients with Relapsing-Remitting Multiple Sclerosis undergoing treatment with immunomodulators were randomly distributed into sex-stratified experimental and placebo groups in a patient-and evaluator-blind design; they received either true or sham electroacupuncture during regular visits to the doctor in the university hospital outpatient clinic. Standardized questionnaires were used to evaluate the effect of electroacupuncture on the quality of life of these patients. Initial and follow-up assessment included the evaluation of clinical status (Expanded Disability Status Scale), pain (Visual Analogue Scale) and quality of life (Functional Assessment of multiple Sclerosis) to ascertain the impact of electroacupuncture on the quality of life of these patients. Results: Electroacupuncture improved various aspects of quality of life, including a reduction in pain and depression. The self-report scales were more sensitive to improvement than was the more objective clinical measure. Conclusion: This paper provides evidence that electroacupuncture can significantly improve the quality of life of such patients. The results suggest that the routine use of a self-report scale evaluating quality of life should be included in regular clinical evaluations in order to detect changes more rapidly. Trial Registration: RBR-58yq52 [ABSTRACT FROM AUTHOR]

Background: Despite high levels of clinically significant persistent cancer related fatigue in breast cancer survivors few treatments are currently available and most pose a significant burden on the part of the woman. Acupressure, a component of Traditional Chinese Medicine, has been shown to decrease fatigue levels by as much as 70% in cancer survivors while being inexpensive, non-toxic and an easy to use intervention. The primary aim of this study was to determine the efficacy of two types of self-administered acupressure (relaxation acupressure and stimulating acupressure), compared to standard of care on fatigue severity. Secondary aims were to evaluate the efficacy of two types of acupressure on sleep and kinetic parameters required for implementation of acupressure in a clinical setting; The purpose of this paper is to share the methodology used including challenges and insights. Methods/design: This study is a three group, randomized clinical trial. 375 breast cancer survivors at least 12 months after completion of cancer treatments, with moderate to severe persistent fatigue, are being randomized to one of 3 groups: self-administered relaxation acupressure; self-administered stimulating acupressure; or standard of care. Participants are assessed at baseline, 3 weeks, and 6 weeks followed by a 4-week follow-up period. The primary aim is to examine the effect of 6-weeks of relaxation acupressure compared to stimulatory acupressure or standard of care on fatigue as assessed by: weekly self-report using the Brief Fatigue Inventory; objective daytime physical activity on actigraph; or fatigue patterns assessed 4-times daily using a visual analog scale. Secondary endpoints include depression, anxiety, self-efficacy, and sleep quality. Discussion: This study has the potential to develop a low-cost, self-care intervention for the most troubling of late-term effects in breast cancer populations, fatigue. The methods used may lend constructive ideas to other investigators working with this population and/or intervention. Trial registration: ClinicalTrial.Gov Trials Register NCT01281904 [ABSTRACT FROM AUTHOR]

Context: Both balance training and selected interventions meant to target sensory structures (STARS) have been shown to be effective at restoring deficits associated with chronic ankle instability (CAI). Clinicians often use multiple treatment modalities in patients with CAI. However, evidence for combined intervention effectiveness in CAI patients remains limited. Objective: To determine if augmenting a balance-training protocol with STARS (BTS) results in greater improvements than balance training (BT) alone in those with CAI. Design: Randomized-controlled trial. Setting: Research laboratory. Patients: 24 CAI participants (age 21.3 ± 2.0 y; height 169.8 ± 12.9 cm; mass 72.5 ± 22.2 kg) were randomized into 2 groups: BT and BTS. Interventions: Participants completed a 4-week progression-based balance-training protocol consisting of 3 20-min sessions per week. The experimental group also received a 5-min set of STARS treatments consisting of calf stretching, plantar massage, ankle joint mobilizations, and ankle joint traction before each balance-training session. Main Outcome Measures: Outcomes included self-assessed disability, Star Excursion Balance Test reach distance, and time-to-boundary calculated from static balance trials. All outcomes were assessed before, and 24-hours and 1-week after protocol completion. Self-assessed disability was also captured 1-month after the intervention. Results: No significant group differences were identified (P > .10). Both groups demonstrated improvements in all outcome categories after the interventions (P < .10), many of which were retained at 1-week posttest (P < .10). Although 90% CIs include zero, effect sizes favor BTS. Similarly, only the BTS group exceeded the minimal detectable change for time-to-boundary outcomes. Conclusions: While statistically no more effective, exceeding minimal detectable change scores and favorable effect sizes suggest that a 4-week progressive BTS program may be more effective at improving self-assessed disability and postural control in CAI patients than balance training in isolation. [ABSTRACT FROM AUTHOR]

Sexual abuse is a crime with devastating health consequences. Accessible, acceptable and affordable treatment of PTSD after sexual abuse is important. In this pilot study, a one-session PTSD treatment and a modified perspective to PTSD treatment is introduced. The aim of the study was to test the efficacy of one session of Modified Lifespan Integration (MLI) on reduction of symptoms of PTSD in individuals with PTSD after one sexual assault. This was a single-center, individually randomized waitlist-controlled treatment study with 1:1 allocation, with the intervention of one 90 - 140 minutes session of MLI and with post-treatment follow-up at 3 weeks (time point two). All participants were females, mean age 24, with PTSD symptoms after one sexual assault during the past 5 years. Exclusion criteria were poor understanding of Swedish, multiple traumas, active substance abuse, active psychosis, ADHD, or autism spectrum disorder. Of 135 interested participants, 38 were finally included, 36 completed baseline measures and were included in the intent to treat analyses and 33 were analyzed per protocol. The primary outcome was the difference between the two trial arms in mean PTSD symptoms as measured by the Impact of Event Scale Revised (IES-R) at time point two. In the intervention arm, 72% no longer scored PTSD in per-protocol analysis, compared to 6% in the waiting list arm. IES-R scores were on average halved in the intervention arm (F=21.37, P<0.001), but were essentially unchanged in the waiting list arm. No adverse effects or drop-outs were seen. One session of Modified Lifespan Integration was an effective treatment with a low drop-out rate for females aged 15-65 with PTSD after one sexual assault. Provided that this result can be replicated, MLI should be offered to these patients in clinical settings. Registration number NCT03141047 was given 03/25/2016 at ClinicalTrials.gov (https://register.clinicaltrials.gov/). [ABSTRACT FROM AUTHOR]

The addition of 25 mmol·L-1 sodium to low alcohol (2.3% ABV) beer has been shown to enhance post exercise fluid retention compared with full strength (4.8% ABV) beer with and without electrolyte modification. This investigation explored the effect of further manipulations to the alcohol and sodium content of beer on fluid restoration following exercise. Twelve male volunteers lost 2.03 ± 0.19% body mass (mean ± SD) using cycling-based exercise. Participants were then randomly allocated a different beer to consume on four separate occasions. Drinks included low alcohol beer with 25 mmol· L-1 of added sodium [LightBeer+25], low alcohol beer with 50 mmol·L-1 of added sodium [LightBeer+50], midstrength beer (3.5% ABV) [Mid] or midstrength beer with 25 mmol·L-1 of added sodium [Mid+25]. Total drink volumes in each trial were equivalent to 150% of body mass loss during exercise, consumed over a 1h period. Body mass, urine samples and regulatory hormones were obtained before and 4 hr after beverage consumption. Total urine output was significantly lower in the LightBeer+50 trial (1450 ± 183 ml) compared with the LightBeer+25 (1796 ± 284 ml), Mid+25 (1786 ± 373 ml) and Mid (1986 ± 304 ml) trials (all p < .05). This resulted in significantly higher net body mass following the LightBeer+50 trial (-0.97 ± 0.17kg) compared with all other beverages (LightBeer+25 (-1.30 ± 0.24 kg), Mid+25 (-1.38 ± 0.33 kg) and Mid (-1.58 ± 0.29 kg), all p < .05). No significant changes to aldosterone or vasopressin were associated with different drink treatments. The electrolyte concentration of low alcohol beer appears to have more significant impact on post exercise fluid retention than small changes in alcohol content. [ABSTRACT FROM AUTHOR]

Objective: This study examined the influence of physicians' recommendations and gender on the decision‐making process in a preference‐sensitive situation. Methods: N = 201 participants were put in a hypothetical scenario in which they suffered from a rupture of the anterior cruciate ligament (ACL). They received general information on two equally successful treatment options for this injury (surgery vs physiotherapy) and answered questions regarding their treatment preference, certainty and satisfaction regarding their decision and attitude towards the treatment options. Then, participants watched a video that differed regarding physician's recommendation (surgery vs physiotherapy) and physician's gender (female vs male voice and picture). Afterwards, they indicated again their treatment preference, certainty, satisfaction and attitude, as well as the physician's professional and social competence. Results: Participants changed their treatment preferences in the direction of the physician's recommendation (P <.001). Decision certainty (P <.001) and satisfaction (P <.001) increased more strongly if the physician's recommendation was congruent with the participant's prior attitude than if the recommendation was contrary to the participant's prior attitude. Finally, participants' attitudes towards the recommended treatment became more positive (surgery recommendation: P <.001; physiotherapy recommendation: P <.001). We found no influence of the physician's gender on participants' decisions, attitudes, or competence assessments. Conclusion: This research indicates that physicians should be careful with recommendations when aiming for shared decisions, as they might influence patients even if the patients have been made aware that they should take their personal preferences into account. This could be particularly problematic if the recommendation is not in line with the patient's preferences. [ABSTRACT FROM AUTHOR]

Background: Pelargonium sidoides DC (Geraniaceae) root extract, EPs®7630 or "Kaloba®", is a widely used herbal remedy for respiratory infections, with some evidence of effectiveness for acute bronchitis. However, it is not yet widely recommended by medical professionals in the UK. There is a need to undertake appropriately designed randomised trials to test its use as an alternative to antibiotics. The aim was to assess the feasibility of conducting a double-blind randomised controlled trial of Pelargonium sidoides root extract for treatment of acute bronchitis in UK primary care, investigating intervention compliance, patient preference for dosage form and acceptability of patient diaries. Study design: Feasibility double-blind randomised placebo-controlled clinical trial. Methods: We aimed to recruit 160 patients with cough (≤ 21 days) caused by acute bronchitis from UK general practices. Practices were cluster-randomised to liquid or tablet preparations and patients were individually randomised to Kaloba® or placebo. We followed participants up for 28 days through self-reported patient diaries with telephone support and reviewed medical records at one month. Outcomes included recruitment, withdrawal, safety, reconsultation and symptom diary completion rates. We also assessed treatment adherence, antibiotic prescribing and consumption, mean symptom severity (at days 2–4 after randomisation) and time to symptom resolution. We interviewed 29 patients and 11 health professionals to identify barriers and facilitators to running such a randomised trial. Results: Of 543 patients screened, 261 were eligible, of whom 134 (51%) were recruited and 103 (77%) returned a completed diary. Overall, 41% (41/100) of patients took antibiotics (Kaloba® liquid group: 48% [15/31]; placebo liquid group: 23% [6/26]; Kaloba® tablet group: 48% [9/21]; placebo tablet group: 50% [11/22]). Most patients adhered to the study medication (median 19 out of 21 doses taken in week 1, IQR 18–21 - all arms combined). There were no serious adverse events relating to treatment. Most patients interviewed found study recruitment to be straightforward, but some found the diary too complex. Conclusions: It was feasible and acceptable to recruit patients from UK primary care to a double-blind placebo-controlled trial of herbal medicine (Kaloba®) for the treatment of acute bronchitis, with good retention and low data attrition. Trial registration: HATRIC was registered on the ISRCTN registry (ISRCTN17672884) on 16 August 2018, retrospectively registered. The record can be found at http://www.isrctn.com/ISRCTN17672884. [ABSTRACT FROM AUTHOR]

Objectives: Acute coronary syndrome (ACS) is an acute disease with high mortality. Although early percutaneous coronary intervention (PCI) is proved to be the practical approach in treating ACS, the incidence of cardiovascular events is still far from satisfactory. The combination of Suxiao Jiuxin Pill (SJP) and Western medicine is one conventional approach in the treatment of ACS. Many elementary and clinical trials have proved the efficacy and safety in the improvement of cardiocerebral vascular conditions. The aim of this project is to evaluate the safety and efficacy of SJP on ACS with early PCI patients. Trial Design: This is a multicenter randomized, double-blind placebo-controlled trial. Trial registration: ChiCTR-TRC-13003053. Settings: Hospitals. Subjects: A total of 200 ACS with early PCI patients were randomly divided into SJP group (n = 100) and placebo group (n = 100). Interventions: The SJP group was treated with routine treatment and SJP (taking eight SJP pills orally each time, three times per day). The placebo group was treated with routine treatment along with equal amounts of SJP placebo. The course of treatment was 6 months and a follow-up visit at 12 months. Outcome Measures: Assessments of major adverse cardiovascular events (MACE), safety assessments, adverse events, left ventricular systolic function (LVEF), Seattle angina questionnaire (SAQ), troponin C (cTNI), C-reactive protein (CRP), fibrinogen (Fib), and cystatin C (cysC). Results: The SJP group had a relatively low incidence of MACE than the placebo (p < 0.05, odds ratio: 1.916, 95% confidence interval [0.999–3.674]). LVEF was significantly higher in the SJP group than the placebo group on the 360-day follow-up (p < 0.01). SJP had a significant increase score in the SAQ subscale of physical limitation, angina frequency, and treatment satisfaction (p < 0.05). There is no significant difference in the cTNI and CRP level between the two groups. The serum concentration of Fib and cysC in the SJP was significantly decreased compared with the placebo (p < 0.05). The numbers of adverse events between the two groups were not statistically different (p > 0.05). Conclusions: SJP is associated with a reduction in MACE, and an improvement of heart function and quality of life in ACS patients with early PCI, and is probably safe to use. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness of acupuncture in patients with vascular cognitive impairment no dementia (VCIND) in comparison with citicoline, an agent for cognitive disturbances associated with chronic cerebral disorders. Design: A randomized controlled multicenter trial. Setting: In three hospitals in Beijing, China. Subjects: A total of 216 patients with VCIND were recruited. Interventions: Patients with VCIND (mean age of 65.4 years) were randomized to receive acupuncture (two sessions per week) or oral citicoline (100 mg three times daily) over three months. Main measures: The primary outcome was the change from baseline to three months in cognitive symptom, measured by Alzheimer's disease Assessment Scale, cognitive subscale (ADAS-cog). Secondary outcomes included changes from baseline to six months in ADAS-cog, executive function measured by the Clock Drawing Test (CDT), and functional disability measured by the Ability of Daily Living (ADL) scale at three and six months. Results: At three months, the acupuncture group had a greater decrease in mean ADAS-cog score (−2.33 ± 0.31) than the citicoline group (−1.38 ± 0.34) with a mean difference of −0.95 (95% CI, −1.84 to −0.07, P = 0.035). The mean change from baseline to six months in ADAS-cog also significantly favored acupuncture treatments (acupuncture change −2.61 vs citicoline −1.25, difference: −1.36 points; 95% CI, −2.20 to −0.51; P = 0.002). There was no difference between the two groups on CDT and ADL scores at either time point. Conclusion: Compared with citicoline, acupuncture has comparable and even superior efficacy with improved cognitive and daily living performance as a complementary and alternative medicine treatment for VCIND. [ABSTRACT FROM AUTHOR]

Objective: To examine the feasibility of a trial to evaluate web-based physiotherapy compared to a standard home exercise programme in people with multiple sclerosis. Design: Multi-centre, randomized controlled, feasibility study. Setting: Three multiple sclerosis out-patient centres. Participants: A total of 90 people with multiple sclerosis (Expanded Disability Status Scale 4–6.5). Interventions: Participants were randomized to a six-month individualized, home exercise programme delivered via web-based physiotherapy (n = 45; intervention) or a sheet of exercises (n = 45; active comparator). Outcome measures: Outcome measures (0, three, six and nine months) included adherence, two-minute walk test, 25 foot walk, Berg Balance Scale, physical activity and healthcare resource use. Interviews were undertaken with 24 participants and 3 physiotherapists. Results: Almost 25% of people approached agreed to take part. No intervention-related adverse events were recorded. Adherence was 40%–63% and 53%–71% in the intervention and comparator groups. There was no difference in the two-minute walk test between groups at baseline (Intervention-80.4(33.91)m, Comparator-70.6(31.20)m) and no change over time (at six-month Intervention-81.6(32.75)m, Comparator-74.8(36.16)m. There were no significant changes over time in other outcome measures except the EuroQol-5 Dimension at six months which decreased in the active comparator group. For a difference of 8(17.4)m in two-minute walk test between groups, 76 participants/group would be required (80% power, P > 0.05) for a future randomized controlled trial. Conclusion: No changes were found in the majority of outcome measures over time. This study was acceptable and feasible by participants and physiotherapists. An adequately powered study needs 160 participants. [ABSTRACT FROM AUTHOR]

Objective: To determine the short-term effects of supplying hospital inpatients with earplugs and eye masks, preparatory to a full-scale trial. Design: A single-centre, open-label, two-arm, parallel group, randomized-controlled trial. Setting: A total of 13 medical and surgical wards in a large teaching hospital in the United Kingdom. Participants: Everyone admitted to hospital aged 18 years or older, who stayed overnight and had the mental capacity and sufficient understanding of English to give consent, the ability to complete the study questionnaire and the ability to use earplugs and eye masks unaided was considered. Interventions: The intervention group was provided with earplugs and eye masks for use the following night, and the control group received standard care. Main measures: Sleep quality assessed using the SleepSure questionnaire after the first night of using the intervention, use of earplugs and eye masks, number of falls throughout their inpatient stay, use of zopiclone during inpatient stay, length of stay and recruitment rate. Results: A total of 1600 patients were admitted; out of which, 626 (39%) were eligible and 206 (13% total, 33% eligible) recruited (intervention group, 109). The intervention group's mean sleep quality score was 6.33 (95% confidence interval (CI): 5.89–6.77), compared with 5.09 (95% CI: 4.66–5.52) in the control group (p < 0.001). There were no differences in use of zopiclone, falls or length of stay between the groups. Of the intervention group, 91 (86%) reported using the earplugs and/or eye masks. Conclusions: The intervention seems feasible, and effective, but trial eligibility rate and rate of recruitment into the study were limited. [ABSTRACT FROM AUTHOR]

Objective: The UK's Initial Operational Response (IOR) is a new process for improving the survival of multiple casualties following a chemical, biological, radiological or nuclear incident. Whilst the introduction of IOR represents a patient-focused response for ambulant casualties, there is currently no provision for disrobe and dry decontamination of nonambulant casualties. Moreover, the current specialist operational response (SOR) protocol for nonambulant casualty decontamination (also referred to as "clinical decontamination") has not been subject to rigorous evaluation or development. Therefore, the aim of this study was to confirm the effectiveness of putatively optimized dry (IOR) and wet (SOR) protocols for nonambulant decontamination in human volunteers. Methods: Dry and wet decontamination protocols were objectively evaluated using human volunteers. Decontamination effectiveness was quantified by liquid chromatography-mass spectrometry analysis of the recovery of a chemical warfare agent simulant (methylsalicylate) from skin and hair of volunteers, with whole-body fluorescence imaging to quantify the skin distribution of residual simulant. Results: Both the dry and wet decontamination processes were rapid (3 and 4 min, respectively) and were effective in removing simulant from the hair and skin of volunteers, with no observable adverse effects related to skin surface spreading of contaminant. Conclusions: Further studies are required to assess the combined effectiveness of dry and wet decontamination under more realistic conditions and to develop appropriate operational procedures that ensure the safety of first responders. [ABSTRACT FROM AUTHOR]

ABSTRACT Background As many delirium manifestations (e.g., hallucinations or fears) are linked to patients' experiences and personality traits, it is suggested that interventions should be tailored to optimize its management. The inclusion of family members, as part of an intervention, has recently emerged as a solution to developing individualised patient care, but has never been assessed in post-cardiac surgery intensive care unit where almost half of patients will present with delirium. Aims To assess the feasibility, acceptability and preliminary efficacy of an nursing intervention involving family caregivers ( FC) in delirium management following cardiac surgery. Design A randomized pilot study. Methods A total of 30 patient/ FC dyads were recruited and randomized to usual care ( n = 14) or intervention ( n = 16). The intervention was based on the Human Caring Theory, a mentoring model, and sources informing self-efficacy. It comprised seven planned encounters spread over 3 days between an intervention nurse and the FC, each including a 30-min visit at the patient's bedside. During this bedside visit, the FC used delirium management strategies, e.g. reorient the person with delirium. The primary indicator of acceptability was to obtain consent from 75% of approached FCs. The preliminary effect of the intervention on patient outcomes was assessed on (1) delirium severity using the Delirium Index, (2) occurrence of complications, such as falls, (3) length of postoperative hospital stay and (4) psycho-functional recovery using the Sickness Impact Profile. The preliminary effect on FC outcomes was assessed on FC anxiety and self-efficacy. Data were analysed using descriptive statistics, ANCOVAs and logistic regressions. Results The primary indicator of obtaining consent from FC was achieved (77%). Of the 14 dyads, thirteen (93%) dyads received all seven encounters planned in the experimental intervention. Intervention group patients presented better psycho-functional recovery scores when compared with control group patients ( p = 0·01). Mean delirium severity scores showed similar trajectories on days 1, 2 and 3 in both groups. Conclusion The mentoring intervention was acceptable and feasible and shows promising results in improving patients and FC outcomes. Relevance to clinical practice Nurses should involve, if willing, FC to participate in activities that optimise patient well-being FC to use recognized delirium management strategies like reorientation and reassurance. [ABSTRACT FROM AUTHOR]

Aims: To describe correlations and agreement between salivary and serum B-type natriuretic peptide (BNP), C-reactive protein (CRP), interleukin (IL)-6, and IL-10 and determine which biomarkers predict worse functional class in patients with heart failure (HF). Methods: Serum and saliva were collected from 75 hospitalized patients with HF (57 ± 12 years, 43% female, New York Heart Association [NYHA] Classes I [4%], II [43%], and III [53%]). Oral inflammation was rated as good, fair, or poor. Spearman’s ρ and Bland–Altman were used to determine correlations and agreement of the salivary and serum forms of each biomarker. Logistic regressions were used to determine which biomarkers predicted worse NYHA functional class, controlling for depression, body mass index, smoking, and oral inflammation. Results: Median biomarker concentrations were as follows: BNP (serum 361 pg/ml, saliva 9 pg/ml), CRP (serum 13 ng/ml, saliva 25.6 ng/ml), IL-6 (serum 19.3 pg/ml, saliva 10.5 pg/ml), and IL-10 (serum 64.1 pg/ml, saliva 4.7 pg/ml). There was a moderate-to-strong correlation for serum–salivary CRP, weak correlation for serum–salivary IL-6, and no correlations for serum–salivary BNP and IL-10. The Bland–Altman test showed good salivary–serum agreement for all biomarkers, but as serum concentrations rose, salivary measures underestimated serum levels. Visible oral inflammation was the only predictor of worse NYHA class. [ABSTRACT FROM AUTHOR]

Background: Orlistat is a lipase inhibitor which reduced absorption of dietary fat by ~30% thereby inducing a weight loss; however, side effects occur as a consequence of increased colonic fat content. To test the hypothesis that most gastrointestinal side events induced by treatment with orlistat could be prevented/ameliorated by concomitant use of natural dietary components, flaxseed fiber (FF) and/or dairy calcium (Ca), binding liquid fats to more solid complexes. Methods: A randomized controlled dietary intervention study. Thirty-eight obese adults completed a 1-week run-in period, where all participants were treated with orlistat (60 mg t.i.d) and were hereafter randomized to 12 weeks dietary supplementation with/without 5 g FF (FF+/FF-) and/or 1200 mg dairy calcium (Ca+/Ca-) in conjunction with orlistat. All feces were collected for 3 days, and diet was recorded for 5 days, during run-in and week 4. The primary end-point, gastrointestinal symptoms, was assessed biweekly. At baseline and after 12 weeks, cardiometabolic risk markers and anthropometrics were evaluated as secondary end-points. Results: Both FF and Ca increased fecal fat excretion (P = 0.02 and P = 0.04, respectively). Although fecal fat excretion increased by ~100% in the FF+/Ca + group, and only by ~12% in the FF-/Ca + group, no interaction between FF and Ca was present, suggesting an additive effect. The fecal fat excretion was ~10 g/d higher with FF and Ca (~25 g/d) compared to fecal fat excretion with orlistat alone (~15 g/d). Mean ratings of severity of diarrhea tended to increase with Ca (P = 0.03) but not with FF. No other gastrointestinal symptoms, or a composite score of symptoms, were affected by the dietary supplements. Body weight was reduced in all groups but did not differ between groups, whereas waist circumference was most reduced in the FF+/Ca + group. No effects of dietary supplements on cardiometabolic risk factors were observed, except a slight increase in diastolic blood pressure (P = 0.03) with FF, but not Ca. Conclusions: Our results do not support an improvement in orlistat-induced gastrointestinal side effects by concomitant use of FF and Ca. However, fecal fat excretion was increased with both FF and Ca in the absence of a worsening of symptoms, warranting further studies powered to detect potential additive weight loss effects. Trial registration: Ethical Committee of the Capital Region of Denmark reg. no. H-1-2010-110, 02-11-2010 database no. NCT01320228, 21-03-2011. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives Our aim was to evaluate the effectiveness of a Post-it® note to increase response rates and shorten response times to a 4-month postal follow-up questionnaire sent to participants taking part in the Collaborative Care in Screen-Positive Elders (CASPER) trials. Method Our trial was a two-arm randomized controlled trial comparing response rates to questionnaires with a printed Post-it® note (intervention) and without (control), nested in multi centred randomized controlled trials of older people with varying levels of depressive symptoms; the CASPER+ and CASPER Self Help for those At Risk of Depression (SHARD) trials. A total of 611 participants were eligible and randomized. The primary outcome was response rates, secondary outcomes were time to response and need for a reminder. Results Of 297 participants, 266 (89.6%) returned their 4-month questionnaire in the post-it note arm, compared with 282 of 314 participants (89.8%) in the control arm (OR = 0.97, 95% CI: 0.57, 1.65, P = 0.913). There were no statistically significant differences in time to respond or the need to be sent a reminder. Patients with a major depressive episode were more likely to return questionnaires with post-it notes ( P of interaction = .019). Conclusion There was no significant difference in response rates, time to response, or the need for a reminder between the intervention and control at 4-month follow up for older people with depressive symptoms. However, there was a significant interaction between the Post-it® note group and level of depression. [ABSTRACT FROM AUTHOR]

Background/Objectives: Higher fibre intakes are associated with risk reduction for chronic diseases. However, many people find difficulty in consuming sufficient fibre through their diet. Supplements may be an effective alternative. We aimed to investigate the effects of PolyGlycopleX® (PGX®), a proprietary polysaccharide complex and a proprietary Psyllium product (PgxSyl™) (PSY) on diet, body weight and composition in overweight and obese individuals. Subjects/Methods: This was a double-blind 52 weeks study with 159 people randomized to 3 groups: control (rice flour); PGX (PGX) and proprietary psyllium (PSY). Participants did not change any of their usual habits or diet except they consumed 5 g of supplement taken with a total of 500 ml of water 5-10 min before meals. Results: Weight was significantly lower in the PGX group compared to control at 3 (-1.6 kg [0.57, 2.67, p = 0.003]), 6(-2.6 kg [1.01, 4.13, p = 0.001]) and 12 months (-2.6 kg [0.59, 4.64, p = 0.012]) and in the PSY group compared to control group at 3 (-1.1 kg [0.07, 2.12, = 0.037]) and 6 months (-2.4 kg [0.95, 3.93, p = 0.002]). This was a difference of - 2.8% for the PGX group and - 1.5% for the PSY group compared to control after 12 months supplementation. Body Fat was significantly lower in PGX compared to control at 6 (-1.8 kg [0.63, 2.95, p = 0.003]) and 12 months (-1.9 kg [0.43, 3.36, p = 0.012]) and in PSY compared to control at 6 (-1.9 kg [0.84, 3.04, p = 0.001]) and 12 months (-1.4 kg [0.08, 2.71, p = 0.038]). Conclusions: PGX was better than PSY at maintaining dietary changes and weight loss over the 12 month intervention period, with no change to exercise. A simple strategy of PGX supplementation may offer an effective solution to long-term weight-loss and then management without the need for other nutrient modification. [ABSTRACT FROM AUTHOR]

Objectives Mental ill-health has become a large health problem and it is important for caregivers to provide effective treatment alternatives. REGASSA is a randomized controlled study performed in primary care to study the effects of 12 weeks of Internet-based cognitive behaviour therapy ( ICBT) and physical exercise ( PE) compared with treatment as usual ( TAU) in patients with mild-to-moderate mental ill-health. The present study aimed to examine the results of these treatment alternatives on psychological functioning, stress, and sleep disturbances. Methods The study comprised 879 patients with mental ill-health taking part in the REGASSA study. Data were collected by Interactive Voice Response ( IVR), a computerized, automated telephone technique. The treatments were compared at baseline, twice during treatment, at the end of treatment and at three follow-ups after treatment. Measures used were the Outcome Questionnaire-45, the short versions of the Perceived Stress Scale, and the Karolinska Sleep Questionnaire. Results Linear mixed models showed that the patients in ICBT and PE had better results than in TAU on psychological functioning and sleep disturbances, p < .001 , with weak-to-moderate effect sizes. On stress there were no differences; all groups made improvements. Women had stronger effects than men. More patients recovered on psychological functioning ( OQ-45) in ICBT and PE than in TAU. Conclusions Internet-based cognitive behaviour therapy and PE proved to be effective treatment alternatives for patients with mild-to-moderate mental ill-health in improving psychological functioning, stress, and sleep disturbances and could be useful alternatives in primary care. Practitioner points Internet-based cognitive behaviour therapy and physical exercise proved to be effective treatment alternatives for mental ill-health patients in primary care., Automated techniques (Interactive Voice Response) could be useful for following treatment course in large groups of patients in the health care., It is important to use measures that capture different aspects of patients' health problems., The recruitment of participants was based on patients' interest and inclusion criteria which may have affect the generalizability. [ABSTRACT FROM AUTHOR]

Objectives To test a new cognitive behavioral therapy for insomnia ( CBT-I) program designed for use by nonclinicians. Design Randomized controlled trial. Setting Department of Veterans Affairs healthcare system. Participants Community-dwelling veterans aged 60 and older who met diagnostic criteria for insomnia of 3 months duration or longer (N = 159). Intervention Nonclinician 'sleep coaches' delivered a five-session manual-based CBT-I program including stimulus control, sleep restriction, sleep hygiene, and cognitive therapy (individually or in small groups), with weekly telephone behavioral sleep medicine supervision. Controls received five sessions of general sleep education. Measurements Primary outcomes, including self-reported (7-day sleep diary) sleep onset latency ( SOL-D), wake after sleep onset ( WASO-D), total wake time ( TWT-D), and sleep efficiency ( SE-D); Pittsburgh Sleep Quality Index ( PSQI); and objective sleep efficiency (7-day wrist actigraphy, SE-A) were measured at baseline, at the posttreatment assessment, and at 6- and 12-month follow-up. Additional measures included the Insomnia Severity Index ( ISI), depressive symptoms (Patient Health Questionnaire-9 ( PHQ-9)), and quality of life (Medical Outcomes Study 12-item Short-form Survey version 2 ( SF-12v2)). Results Intervention subjects had greater improvement than controls between the baseline and posttreatment assessments, the baseline and 6-month assessments, and the baseline and 12-month assessments in SOL-D (−23.4, −15.8, and −17.3 minutes, respectively), TWT-D (−68.4, −37.0, and −30.9 minutes, respectively), SE-D (10.5%, 6.7%, and 5.4%, respectively), PSQI (−3.4, −2.4, and −2.1 in total score, respectively), and ISI (−4.5, −3.9, and −2.8 in total score, respectively) (all P < .05). There were no significant differences in SE-A, PHQ-9, or SF-12v2. Conclusion Manual-based CBT-I delivered by nonclinician sleep coaches improves sleep in older adults with chronic insomnia. [ABSTRACT FROM AUTHOR]

Aim. To compare a gel made with chamomile (Chamomilla recutita) with a cream of urea as an intervention to delay the time to occurrence of radiation dermatitis. Background. Radiation dermatitis is one of the most common adverse effects of radiotherapy in patients with head and neck cancer. It is characterized by erythema, itching, pain, skin breakage and burning sensation, and there is no consensus on how to prevent it. Design. The study is a randomized controlled clinical trial. Methods. We will recruit 48 individuals with head and neck cancer who will be starting their radiotherapy and randomize them to receive either gel of chamomile or cream of urea, as an intervention for prevention of radiation dermatitis. Social-demographic data will be collected at baseline, and clinical data will be collected before the initiation of radiotherapy. Participants will be followed weekly to assess development of radiation dermatitis. The protocol is funded by Conselho Nacional de Pesquisa e Desenvolvimento Cientıfico (Brazil). The study was approved by a research ethics committee. Discussion. Given the clinical relevance of preventing radiation dermatitis and the lack of evidence supporting specific preventive interventions, it is important to study new products that might be efficacious to prevent this complication. This article presents the protocol of a randomized controlled trial comparing a gel made with chamomile (intervention) with a cream of urea (control) to prevent radiation dermatitis in patients with head and neck cancer undergoing radiotherapy. [ABSTRACT FROM AUTHOR]

Objectives. To determine the effect of sodium (Na) reduction on occurrence of headaches. Methods. In the Trial of Nonpharmacologic Interventions in the Elderly, 975 men and woman (aged 60-80 years) with hypertension were randomized to a Na-reduction intervention or control group and were followed for up to 36 months. The study was conducted between 1992 and 1995 at 4 clinical centers (Johns Hopkins University, Wake Forest University School of Medicine, Robert Wood Johnson Medical School, and the University of Tennessee). Results. Mean difference in Na excretion between the Na-reduction intervention and control group was significant at each follow-up visit (P < .001) with an average difference of 38.8 millimoles per 24 hours. The occurrence of headaches was significantly lower in the Na-reduction intervention group (10.5%) compared with control (14.3%) with a hazard ratio of 0.59 (95% confidence interval = 0.40, 0.88; P = .009). The risk of headaches was significantly associated with average level of Na excretion during follow-up, independent of most recent blood pressure. The relationship appeared to be nonlinear with a spline relationship and a knot at 150 millimoles per 24 hours. Conclusions. Reduced sodium intake, currently recommended for blood pressure control,may also reduce the occurrence of headaches in older persons with hypertension. [ABSTRACT FROM AUTHOR]

Objectives To compare the effects of 12 months of vitamin D3 supplementation with that placebo on lean mass, bone mineral density ( BMD), and muscle strength in overweight or obese postmenopausal women completing a structured weight-loss program. Design Double-blind, placebo-controlled randomized clinical trial. Setting Fred Hutchinson Cancer Research Center, Seattle, Washington. Participants Postmenopausal women aged 50 to 75 with a body mass index ( BMI) of 25 kg/m2 or greater and a serum 25-hydroxyvitamin D (25(OH)D) concentration between 10.0 and 32.0 ng/mL (insufficient) (N = 218). Intervention Oral vitamin D3 2,000 IU/d or placebo in combination with a lifestyle-based weight loss intervention consisting of a reduction of 500 kcal to 1,000 kcal per day and 225 min/wk of moderate- to vigorous-intensity aerobic exercise. Measurements Serum 25(OH)D, body composition, and muscle strength were measured before randomization (baseline) and at 12 months. Mean changes of the groups were compared (intention to treat) using generalized estimating equations. Results Change in 25(OH)D was significantly different between the vitamin D and placebo groups at 12 months (13.6 ng/mL vs −1.3 ng/mL, P < .001), but no differences in change in lean mass (−0.8 kg vs −1.1 kg, P = .53) or BMD of the spine (−0.01 g/cm2 vs 0.0 g/cm2, P = .82) or right femoral neck (both −0.01 g/cm2, P = .49) were detected between the groups. Leg strength decreased in the vitamin D group but not in the placebo group (−2.6 pounds vs 1.8 pounds, P = .03). In women randomized to vitamin D, achieving repletion (25(OH)D ≥ 32 ng/mL) did not alter results. Conclusion Vitamin D3 supplementation during weight-loss decreased leg strength but did not alter changes in lean mass or BMD in postmenopausal women with vitamin D insufficiency. [ABSTRACT FROM AUTHOR]

STUDY DESIGN: Randomized clinical trial. BACKGROUND: The recommended initial management strategy for patients with low back pain and signs of nerve root compression is conservative treatment, but there is little evidence to guide the most appropriate management strategy. Preliminary research suggests that a treatment protocol of mechanical traction and extension- oriented exercises may be effective, particularly in a specific subgroup of patients. OBJECTIVE: To examine the effectiveness of mechanical traction in patients with lumbar nerve root compression and within a predefined subgroup. METHODS: One hundred twenty patients with low back pain with nerve root compression were recruited from physical therapy clinics. Using predefined subgrouping criteria, patients were stratified at baseline and randomized to receive an extension-oriented treatment approach with or without the addition of mechanical traction. During a 6-week period, patients received up to 12 treatment visits. Primary outcomes of pain and disability were collected at 6 weeks, 6 months, and 1 year by assessors blinded to group allocation. Outcomes were examined using linear mixed- model analyses examining change over time by treatment and the interaction between treatment and subgrouping status. RESULTS: The mean ± SD age of participants was 41.1 ± 11.3 years, median duration of symptoms was 62 days, and 57% were male. No significant differences in disability or pain outcomes were noted between treatment groups at any time point, nor was any interaction found between subgroup status and treatment. CONCLUSION: Patients with lumbar nerve root compression presenting for physical therapy can expect significant changes in disability and pain over a 6-week treatment period. There is no evidence that mechanical lumbar traction in combination with an extension-oriented treatment is superior to extension-oriented exercises alone in the management of these patients or within a predefined subgroup of patients. The study protocol was registered with ClinicalTrials.gov (NCT00942227). [ABSTRACT FROM AUTHOR]

Objectives To evaluate the effect of structured physical activity on respiratory outcomes in community-dwelling elderly adults with mobility limitations. Design Multicenter, randomized trial of physical activity vs health education, with respiratory variables prespecified as tertiary outcomes over an intervention period of 24-42 months. Physical activity included walking (goal of 150 min/week) and strength, flexibility, and balance training. Health education included workshops on topics relevant to older adults and upper extremity stretching exercises. Setting Lifestyle Interventions and Independence in Elders ( LIFE) Study. Participants Community-dwelling persons aged 70-89 with Short Physical Performance Battery scores less than 10 (N = 1,635). Measurements Dyspnea severity (defined as moderate to severe according to a Borg index >2 immediately after a 400-m walk), forced expiratory volume in 1 second ( FEV1) (

The double-blind phase of the randomized ANRS IPERGAY trial, evaluating sexual activity-based oral HIV pre-exposure prophylaxis (PrEP), was conducted among high-risk men who have sex with men (MSM). Results showed an 86% (95% CI: 40–98) relative reduction in HIV incidence among participants with tenofovir disoproxil fumarate–emtricitabine vs. placebo. The present pooled analysis aimed to analyze (i) participants’ adherence to the prescribed treatment and/or condom use during sexual intercourse and (ii) sexual behavior during the double-blind phase of the study. Four hundred MSM were enrolled in the trial. Every 2 months they completed online questionnaires collecting sexual behavior and PrEP adherence data regarding their most recent sexual intercourse. A total of 2232 questionnaires (M0–M24) were analyzed. Changes over time were evaluated using a mixed model accounting for multiple measures. Irrespective of sexual partner and practice type, on average, 42.6% (min: 32.1–max: 45.8%) reported PrEP use only during their most recent episode of sexual intercourse; 29% (22.9–35.6%) reported both PrEP and condom use; 11.7% (7.2–18.9%) reported condom-use only, and 16.7% (10.8–29.6%) reported no PrEP or condom use with no significant change during the study. Scheduled (i.e., correct) PrEP use was reported on average by 59.0% (47.2–68.5%) of those reporting PrEP use during their most recent sexual intercourse. Overall, 70.3% (65.3–79.4%) and 69.3% (58.3–75.4%) of participants reported, respectively, condomless anal and condomless receptive anal intercourse during their most recent sexual encounter without significant change during follow-up. Overall, on average 83.3% (min: 70.4–max: 89.2%) of participants protected themselves by PrEP intake or condom use or both during the trial, and no increase in at-risk sexual practices was observed. None of these indicators showed significant trend during the follow-up, although we found a tendency toward decrease (p = .19) of the median number of sexual partners strengthening the absence of behavioral disinhibition. On-demand PrEP within a comprehensive HIV prevention package could improve prevention in MSM. [ABSTRACT FROM PUBLISHER]

Background: Fluid restriction (FR) in persons with heart failure (HF) is often prescribed, yet self-regulation and the troublesome symptom of thirst are difficult for patients to manage. Aims: The purpose of this pilot study was to test an educational and behavioral intervention (EBI) on adherence with prescribed FR and outcome measures of fluid congestion, symptom distress, and health related quality of life (HRQL). Secondary aims were to describe the relationships between self-reported and objectively measured determinants of fluid status and symptoms, and assess the psychometric properties of piloted instruments, and intervention effect sizes. Methods: NYHA Class II-IV (n=25, 44-83 years, 56% male, 20% minority, mean EF 23.0+11.7%) participants were randomized to the EBI or attention control (AC) and evaluated at baseline, 3 and 6 months. Results: EBI patients trended toward decreasing fluid ingestion (p=0.08), experienced less HF symptom frequency (p=0.13) and severity (p=0.06), and increased symptoms of thirst (p<0.01) across time. Whereas HRQL remained stable in the EBI group, it improved in the AC group over time (p=0.01). There were no significant differences in clinical measures of fluid congestion between groups. Conclusions: These outcomes suggest that patients receiving the EBI drank slightly less fluid, experienced less typical HF symptoms, greater thirst distress and stable HRQOL. Moderate to large effect sizes for the measures used were observed, and outcomes suggest that a randomized trial of various levels of FR would not potentiate fluid congestion but should specifically address preservation of HRQOL and thirst symptoms. [ABSTRACT FROM AUTHOR]

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

Objectives:Behavioral and psychological symptoms of dementia (BPSD) cause significant stress and distress to both aged-care residents and staff. This study evaluated a training program to assist staff to manage BPSD in residential care. Method:A randomised controlled trial (RCT) was employed. The study was included in the Australian and New Zealand Clinical Trial Register residential care facilities. Staff (n= 204) and residents (n= 187) were from 16 residential care facilities. Facilities were recruited and randomly assigned to four staff training conditions: (1) training in the use of a BPSD-structured clinical protocol, plus external clinical support, (2) a workshop on BPSD, plus external clinical support, (3) training in the use of the structured clinical protocol alone, and (4) care as usual. Staff and resident outcome measures were obtained pre-intervention, three months and six months post-intervention. The primary outcome was changes in BPSD, measured using the Cohen-Mansfield Agitation Inventory (CMAI) as well as frequency and duration of challenging behaviors. Secondary outcomes were changes in staff adjustment. Results:There were improvements in challenging behaviors for both intervention conditions that included training in the BPSD instrument, but these were not maintained in the condition without clinical support. The training/support condition resulted in sustained improvements in both staff and resident variables, whereas the other conditions only led to improvement in some of the measured variables. Conclusion:These results demonstrate the effectiveness of the BPSD protocol in reducing BPSD and improving staff self-efficacy and stress. [ABSTRACT FROM AUTHOR]

Background: Hypothyroidism is a common endocrine condition. There is evidence to suggest that, for a proportion of sufferers, the standard medical treatment does not completely reverse the constitutional and neuropsychiatric symptoms brought about by this condition. The management of hypothyroidism follows a biomedical model with little consideration given to alternative management approaches. There exists anecdotal evidence and case reports supporting the use of a biopsychosocial-based intervention called Neuro-Emotional Technique (NET) for this population. The aim of this study was to explore the potential short-medium term clinical efficacy and safety of NET for individuals with primary hypothyroidism. Design Placebo-controlled, blinded, parallel groups, randomized trial. Methods: Ninety adults with a diagnosis of primary hypothyroidism were recruited from Sydney, Australia. Blinded participants were randomized to either the NET or placebo group and received ten intervention sessions over a six week period. The primary outcome involved the measurement of states of depression using the DASS-42 questionnaire. Secondary outcomes included thyroid function, thyroid autoimmunity testing, SF-36v2 questionnaire, resting heart rate and temperature measurement. Outcomes were obtained at baseline, seven weeks and six months. Questionnaires were completed at the private clinics, and serum measures were obtained and analysed at commercial pathology company locations. Heart rate and temperature were also measured daily by participants. Linear mixed-effects models were used to analyse the continuous outcomes. Unadjusted odds ratios with 95% confidence intervals were calculated for the binary outcomes. Results: Participants were randomly allocated to the NET (n=44) and placebo (n=46) groups. A proportion of the sample displayed neuropsychiatric disturbances and alterations in quality of life measures at baseline. There were no statistically significant or clinically relevant changes in the primary or secondary outcomes between the NET and placebo groups at time seven weeks or six months. There were a few short-lived minor adverse events reported in both the NET and placebo groups that coincided with the application of the intervention. Conclusions: The application of the NET intervention appears to be safe, but did not confer any clinical benefit to the participants in this study and is unlikely to be of therapeutic use in a hypothyroid population. Clinical trials registration number: Australian and New Zealand Clinical Trials Registry Number: 12607000040460. [ABSTRACT FROM AUTHOR]

BackgroundAlthough both cognitive therapy (CT) and interpersonal psychotherapy (IPT) have been shown to be effective treatments for major depressive disorder (MDD), it is not clear yet whether one therapy outperforms the other with regard to severity and course of the disorder. This study examined the clinical effectiveness of CT v. IPT in a large sample of depressed patients seeking treatment in a Dutch outpatient mental health clinic. We tested whether one of the treatments was superior to the other at post-treatment and at 5 months follow-up. Furthermore, we tested whether active treatment was superior to no treatment. We also assessed whether initial depression severity moderated the effect of time and condition and tested for therapist differences.MethodDepressed adults (n = 182) were randomized to either CT (n = 76), IPT (n = 75) or a 2-month waiting list control (WLC) condition (n = 31). Main outcome was depression severity, measured with the Beck Depression Inventory – II (BDI-II), assessed at baseline, 2, 3, and 7 months (treatment phase) and monthly up to 5 months follow-up (8–12 months).ResultsNo differential effects between CT and IPT were found. Both treatments exceeded response in the WLC condition, and led to considerable improvement in depression severity that was sustained up to 1 year. Baseline depression severity did not moderate the effect of time and condition.ConclusionsWithin our power and time ranges, CT and IPT appeared not to differ in the treatment of depression in the acute phase and beyond. [ABSTRACT FROM PUBLISHER]

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

Background Lifestyle modification is recommended for management of prehypertension, yet finding effective interventions to reach rural women is a public health challenge. This community-based clinical trial compared the effectiveness of standard advice to two multi-component theory-based tailored interventions, using web-based or print-mailed delivery, in reducing blood pressure among rural women, ages 40–69, with prehypertension. Methods 289 women with prehypertension enrolled in the Wellness for Women: DASHing towards Health trial, a 12-month intervention with 12-month follow-up. Women were randomly assigned to groups using a 1:2:2 ratio, comparing standard advice (30-minute counseling session) to two interventions (two 2-hour counseling sessions, 5 phone goal-setting sessions, strength-training video, and 16 tailored newsletters, web-based or print-mailed). Linear mixed model methods were used to test planned pairwise comparisons of marginal mean change in blood pressure, healthy eating and activity, adjusted for age and baseline level. General estimating equations were used to examine the proportion of women achieving normotensive status and meeting health outcome criteria for eating and activity. Results Mean blood pressure reduction ranged from 3.8 (SD = 9.8) mm Hg to 8.1 (SD = 10.4) mm Hg. The 24-month estimated marginal proportions of women achieving normotensive status were 47% for web-based, and 39% for both print-mailed and standard advice groups, with no group differences (p = .11 and p = .09, respectively). Web-based and print-mailed groups improved more than standard advice group for waist circumference (p = .017 and p = .016, respectively); % daily calories from fat (p = .018 and p = .030) and saturated fat (p = .049 and p = .013); daily servings of fruit and vegetables (p = .008 and p < .005); and low fat dairy (p < .001 and p = .002). Greater improvements were observed in web-based versus standard advice groups in systolic blood pressure (p = .048) and estimated VO2max (p = .037). Dropout rates were 6% by 6-months, 11.4% by 24 months, with no differences across groups. Conclusions Rural women with prehypertension receiving distance-delivery theory-based lifestyle modifications can achieve a reduction of blood pressure and attainment of normotensive status. [ABSTRACT FROM AUTHOR]

Aims To assess the relations of menthol cigarette use with measures of cessation success in a large comparative effectiveness trial ( CET). Design Participants were randomized to one of six medication treatment conditions in a randomized double-blind, placebo-controlled clinical trial. All participants received six individual counseling sessions. Setting Community-based smokers in two communities in Wisconsin, USA. Participants A total of 1504 adult smokers who smoked at least 10 cigarettes per day during the past 6 months and reported being motivated to quit smoking. The analysis sample comprised 1439 participants: 814 white non-menthol smokers, 439 white menthol smokers and 186 African American ( AA) menthol smokers. There were too few AA non-menthol smokers ( n = 16) to be included in the analyses. Interventions Nicotine lozenge, nicotine patch, bupropion sustained release, nicotine patch + nicotine lozenge, bupropion + nicotine lozenge and placebo. Measurements Biochemically confirmed 7-day point-prevalence abstinence assessed at 4, 8 and 26 weeks post-quit. Findings In longitudinal abstinence analyses (generalized estimating equations) controlling for cessation treatment, menthol smoking was associated with reduced likelihood of smoking cessation success relative to non-menthol smoking [model-based estimates of abstinence = 31 versus 38%, respectively; odds ratio ( OR) = 0.71, 95% confidence interval ( CI) = 0.59, 0.86]. In addition, among menthol smokers, AA women were at especially high risk of cessation failure relative to white women (estimated abstinence = 17 versus 35%, respectively; OR = 2.63, 95% CI = 1.75, 3.96; estimated abstinence rates for AA males and white males were both 30%, OR = 1.06, 95% CI = 0.60, 1.66). Conclusion In the United States, smoking menthol cigarettes appears to be associated with reduced cessation success compared with non-menthol smoking, especially in African American females. [ABSTRACT FROM AUTHOR]

Background A substantial minority of adolescents suffer from depression and it is associated with increased risk of suicide, social and educational impairment, and mental health problems in adulthood. A recently conducted randomized controlled trial in England evaluated the effectiveness of a manualized universally delivered age-appropriate CBT programme in school classrooms. The cost-effectiveness of the programme for preventing low mood and depression for all participants from a health and social care sector perspective needs to be determined. Methods A trial-based cost-effectiveness analysis based on a cluster-randomized controlled trial (trial registration - ISRCTN 19083628) comparing classroom-based CBT with usual school provision of Personal Social and Health Education. Per-student cost of intervention was estimated from programme records. The study was undertaken in eight mixed-sex UK secondary schools, and included 3,357 school children aged 12 to 16 years (in the two trial arms evaluated in the cost-effectiveness analysis). The main outcome measures were individual self-reported data on care costs, Quality-Adjusted Life-Years ( QALYs, based on the EQ-5D health-related quality-of-life instrument) and symptoms of depression (Short Mood and Feelings Questionnaire) at baseline, 6 and 12 months. Results Although there was lower quality-adjusted life-years over 12 months (−.05 QALYs per person, 95% confidence interval −.09 to −.005, p = .03) with CBT, this is a 'clinically' negligible difference, which was not found in the complete case analyses. There was little evidence of any between-arm differences in SMFQ scores (0.19, 95% CI −0.57 to 0.95, p = .62), or costs (£142, 95% CI −£132 to £415, p = .31) per person for CBT versus usual school provision. Conclusions Our analysis suggests that the universal provision of classroom-based CBT is unlikely to be either more effective or less costly than usual school provision. [ABSTRACT FROM AUTHOR]

The article presents a study which examines the efficacy of local corticosteroid injection and low-level laser treatment in 135 patients with subacromial impingement syndrome. The study used a controlled clinical trial to assess the pre- and post- treatment of patients at a Physical Medicine and Rehabilitation outpatient clinic. Results show that low-level laser treatment and local corticosteroid injection are both effective in treating subacromial impingement syndrome.

Background. Plantar heel pain can be managed with dry needling of myofascial trigger points; however, there is only poor-quality evidence supporting its use. Objective. The purpose of this study was to evaluate the effectiveness of dry needling for plantar heel pain. Design. The study was a parallel-group, participant-blinded, randomized controlled trial. Setting. The study was conducted in a university health sciences clinic. Patients. Study participants were 84 patients with plantar heel pain of at least 1 month’s duration. Intervention. Participants were randomly assigned to receive real or sham trigger point dry needling. The intervention consisted of 1 treatment per week for 6 weeks. Participants were followed for 12 weeks. Measurements . Primary outcome measures included first-step pain, as measured with a visual analog scale (VAS), and foot pain, as measured with the pain subscale of the Foot Health Status Questionnaire (FHSQ). The primary end point for predicting the effectiveness of dry needling for plantar heel pain was 6 weeks. Results. At the primary end point, significant effects favored real dry needling over sham dry needling for pain (adjusted mean difference: VAS first-step pain= -14.4 mm, 95% confidence interval [95% CI] = -23.5 to -5.2; FHSQ foot pain= 10.0 points, 95% CI=1.0 to 19-1), although the between-group difference was lower than the minimal important difference. The number needed to treat at 6 weeks was 4 (95% CI=2 to 12). The frequency of minor transitory adverse events was significantly greater in the real dry needling group (70 real dry needling appointments [32%] compared with only 1 sham dry needling appointment [<1%]). Limitations. It was not possible to blind the therapist. Conclusion. Dry needling provided statistically significant reductions in plantar heel pain, but the magnitude of this effect should be considered against the frequency of minor transitory adverse events. [ABSTRACT FROM AUTHOR]

Aims: To evaluate the effectiveness of a prefabricated appliance and compare it to the effectiveness of a stabilization appliance in patients with temporomandibular joint (TMJ) pain. Methods: This randomized, controlled multicenter study comprised 48 patients diagnosed with TMJ arthralgia according to the Research Diagnostic Criteria for Temporomandibular Disorders. The effectiveness of a prefabricated appliance (Relax), worn by half of the patients (referred to as the R group), was compared to the effectiveness of a stabilization appliance, worn by the other half of patients (S group). Treatment outcome was assessed according to the recommendations by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) on an intent-to-treat basis. To analyze the differences between groups, the chi-square test and the Mann-Whitney U test were used, while the Friedman analysis of variance (ANOVA) on ranks was used for the analyses between baseline data and follow-up measurements, all with a significance level set at P < .05. Results: There were no differences between the groups at baseline. A 30% reduction of pain intensity was reported by 62.5% of the R group and 58.3% of the S group at the 10-week follow-up; 58% and 50.3%, respectively, at the 6-month follow-up; and 41.7% in both groups at 12 months. At the 12-month follow-up, pain intensity had decreased and physical function had improved in both groups (P < .005 and P < .016, respectively), without significant group differences. Emotional function (depression and nonspecific physical symptoms) did not change. Overall improvement of "better" to "symptom-free" was observed in 67% of the R group and 58% of the S group. No side effects occurred. Conclusion: The effectiveness of the prefabricated appliance seems to be similar to that of the stabilization appliance in alleviating TMJ pain. Since the prefabricated appliance requires only one visit for construction, it is convenient for both the general practitioner and for the patient. [ABSTRACT FROM AUTHOR]

The once daily, single-tablet regimen (STR) combining rilpivirine (RPV), emtricitabine (FTC), and tenofovir disoproxil fumarate (TDF) provides a simplified treatment option for antiretroviral therapy (ART)-naïve patients with baseline HIV-1 RNA (BLVL) of ≤100,000 copies/mL. The aim of this analysis is to compare long-term efficacy, safety, and tolerability of RPV+FTC/TDF vs. efavirenz (EFV)+FTC/TDF as individual components in subjects with BLVL ≤100,000 copies/mL. Week 96 efficacy and safety data from subjects with BLVL ≤100,000 copies/mL, who received daily RPV 25 mg or EFV 600 mg with FTC/TDF in the phase 3, randomized, double-blind, double-dummy, active-controlled, registrational trials ECHO and THRIVE, were analyzed. Virologic response was evaluated by intent-to-treat, time to loss of virological response (ITT-TLOVR), and Snapshot algorithms. Through Week 96, RPV+FTC/TDF demonstrated non-inferior efficacy to EFV+FTC/TDF (84% vs. 81%, respectively; ITT-TLOVR) in 543 subjects with BLVL ≤100,000 copies/mL, and overall rates of virologic failure (VF) were 5.9% vs. 2.4%, respectively. Resistance development was lower in Year 2 than Year 1. Subjects in both arms with suboptimal adherence (≤95%) had lower virologic responses (63% vs. 62%, respectively). Treatment with RPV+FTC/TDF was associated with significantly fewer treatment-related adverse events (AEs), grade 2-4 AEs, neurological and psychiatric AEs (including dizziness and abnormal dreams/nightmares), and rash. Additionally, grade 2-4 treatment-emergent laboratory abnormalities and grade 1-3 lipid abnormalities were significantly less common with RPV+FTC/TDF than EFV+FTC/TDF. RPV+FTC/TDF demonstrated non-inferior efficacy to EFV+FTC/TDF in ART-naïve subjects with BLVL ≤100,000 copies/mL and was associated with a higher rate of VF but a more favorable safety and tolerability profile through Week 96. [ABSTRACT FROM AUTHOR]

Background. Depression and anxiety are major causes of absence from work and underperformance in the workplace. Cognitive behavioural therapy (CBT) can be effective in treating such problems and online versions offer many practical advantages. The aim of the study was to investigate the effectiveness of a computerized CBT intervention (MoodGYM) in a workplace context. Method. The study was a phase III two-arm, parallel randomized controlled trial whose main outcome was total score on the Work and Social Adjustment Scale (WSAS). Depression, anxiety, psychological functioning, costs and acceptability of the online process were also measured. Most data were collected online for 637 participants at baseline, 359 at 6 weeks marking the end of the intervention and 251 participants at 12 weeks post-baseline. Results. In both experimental and control groups depression scores improved over 6 weeks but attrition was high. There was no evidence for a difference in the average treatment effect of MoodGYM on the WSAS, nor for a difference in any of the secondary outcomes. Conclusions. This study found no evidence that MoodGYM was superior to informational websites in terms of psychological outcomes or service use, although improvement to subthreshold levels of depression was seen in nearly half the patients in both groups. [ABSTRACT FROM AUTHOR]

Objective:This study investigated improvements in quality of life associated with eight weeks of montelukast and/or intranasal steroid treatment for moderate to severe allergic rhinitis.Methods:A single-centre, prospective, randomised, double-blind, placebo-controlled study was carried out. Assessments were made using the Rhinoconjunctivitis Quality of Life Questionnaire and symptom scales.Results:A total of 128 patients (aged 13–51 years) were randomly assigned to one of two groups. In the montelukast group, patients were treated with montelukast tablets and fluticasone propionate nasal spray (n = 64). In the placebo group, treatment comprised a placebo and fluticasone propionate. The results showed significant improvements in symptom scores and quality of life scores for both groups after one month and two months of treatment, compared with baseline values; these improvements were significantly greater for the montelukast group compared with the placebo group. The mean number of loratadine tablets taken by each patient during the study period was only 0.73 for the montelukast group compared with 9 for the placebo group.Conclusion:The combination of montelukast tablets and fluticasone propionate nasal spray improved symptom control and overall quality of life for moderate to severe allergic rhinitis patients. [ABSTRACT FROM PUBLISHER]

Background Little is known about interventions to help men and their partners cope with the after effects of prostate cancer treatment. The lack of in-depth descriptions of the intervention content is hindering the identification of which intervention (or component of an intervention) works. Aim To describe the development and evaluation of the content of a self-management psychosocial intervention for men with prostate cancer and their partners. Design A feasibility randomized controlled trial including structure, process, and outcome analysis. Methods This 9-week intervention commences on completion of treatment and consists of three group and two telephone sessions. The intervention focuses on symptom management, sexual dysfunction, uncertainty management, positive thinking and couple communication. Forty-eight couples will be assigned to either the intervention or a control group receiving usual care. Participants will be assessed at baseline, immediately postintervention and at 1 and 6 months postintervention. Outcome measures for patients and caregivers include self-efficacy, quality of life, symptom distress, uncertainty, benefits of illness, health behaviour, and measures of couple communication and support. An additional caregiver assessment will be completed by the partner. Discussion The main purpose of this feasibility study is to investigate the acceptability of the CONNECT programme to men with prostate cancer and their partners and to gain feedback from the participants and facilitators to make changes to and enhance the programme. Reasons why men do not want to participate will be collated to enhance recruitment in the future. We will also test recruitment strategies, randomization procedures, and the acceptability of the questionnaires. Ethical approval granted December 2010. [ABSTRACT FROM AUTHOR]

A Structured Observational Analog Procedure (SOAP), an analogue measure of parent-child interactions, was used to assess treatment outcome in children with Autism Spectrum Disorder and serious behavior problems. It served as a secondary outcome measure in a 24-week, randomized trial of risperidone (MED; N = 49) versus risperidone plus parent training (COMB; n = 75) (ages 4-13 years). At 24-weeks, there was 28 % reduction in child inappropriate behavior during a Demand Condition ( p = .0002) and 12 % increase in compliance to parental requests ( p = .004) for the two treatment conditions combined. Parents displayed 64 % greater use of positive reinforcement ( p = .001) and fewer repeated requests for compliance ( p < .0001). In the analysis of covariance (ANCOVA), COMB parents used significantly more positive reinforcement ( p = .01) and fewer restrictive statements ( p < .05) than MED parents. The SOAP is sensitive to change in child and parent behavior as a function of risperidone alone and in combination with PMT and can serve as a valuable complement to parent and clinician-based measures. [ABSTRACT FROM AUTHOR]

Background: Attention deficit hyperactivity disorder is increased in children with intellectual disability. Previous research has suggested stimulants are less effective than in typically developing children but no studies have titrated medication for individual optimal dosing or tested the effects for longer than 4 weeks. Method: One hundred and twenty two drug-free children aged 7-15 with hyperkinetic disorder and IQ 30-69 were recruited to a double-blind, placebo-controlled trial that randomized participants using minimization by probability, stratified by referral source and IQ level in a one to one ratio. Methylphenidate was compared with placebo. Dose titration comprised at least 1 week each of low (0.5 mg/kg/day), medium (1.0 mg/kg/day) and high dose (1.5 mg/kg/day). Parent and teacher Attention deficit hyperactivity disorder (ADHD) index of the Conners Rating Scale-Short Version at 16 weeks provided the primary outcome measures. Clinical response was determined with the Clinical Global Impressions scale (CGI-I). Adverse effects were evaluated by a parent-rated questionnaire, weight, pulse and blood pressure. Analyses were by intention to treat. Trial registration: ISRCTN 68384912. Results: Methylphenidate was superior to placebo with effect sizes of 0.39 [95% confidence intervals (CIs) 0.09, 0.70] and 0.52 (95% CIs 0.23, 0.82) for the parent and teacher Conners ADHD index. Four (7%) children on placebo versus 24 (40%) of those on methylphenidate were judged improved or much improved on the CGI. IQ and autistic symptoms did not affect treatment efficacy. Active medication was associated with sleep difficulty, loss of appetite and weight loss but there were no significant differences in pulse or blood pressure. Conclusions: Optimal dosing of methylphenidate is practical and effective in some children with hyperkinetic disorder and intellectual disability. Adverse effects typical of methylphenidate were seen and medication use may require close monitoring in this vulnerable group. [ABSTRACT FROM AUTHOR]

Objective To determine the feasibility and acceptability of acupuncture in managing fatigue and well-being in breast cancer survivors. Methods A randomised controlled trial compared acupuncture was with sham acupuncture and wait list controls was performed in Sydney, Australia. A total of 30 women with fatigue following breast cancer treatment participated in the trial. Women received six sessions of acupuncture over 8 weeks. Outcomes related to an assessment of interest to participate in the trial and identification of appropriate recruitment strategies, appropriateness of eligibility criteria and compliance with treatment attendance. Clinical outcomes assessed fatigue and well-being. In-depth interviews were undertaken with seven women, who described their experience of acupuncture. Results Our study demonstrated feasibility with appropriate trial entry criteria, good acceptability and treatment compliance with the study interventions, and with the completion of outcome forms. There was a significant reduction in fatigue for women receiving acupuncture compared with control after 2 weeks mean difference (MD) 5.3, 95% CI 4.5 to 6.2, p=0.05, and a significant improvement in well-being at 6 weeks for acupuncture compared with the sham and wait list control, MD 2.7, 95% CI 2.1 to 3.2, p=0.006. Women described their experience of acupuncture positively, and interview data may also offer explanations for the improved outcomes of well-being, with women reporting an improvement in sleep, mood and relaxation. Conclusions Fatigue is a common symptom experienced by people recovering from treatment, and an appropriately powered trial to evaluate the effect of acupuncture is needed. [ABSTRACT FROM AUTHOR]

Introduction: Minimally displaced metaphyseal both-bone fractures of the distal forearm in children are often treated with an above-elbow cast (AEC). Treatment with a below-elbow cast (BEC) could give more comfort, but might lead to fracture displacement reducing pronation and supination. Because this has not been systematically investigated, we set up a randomized multicentre study. The purpose of this study was to find out whether BEC causes equal limitation of pronation and supination but with higher comfort level compared with AEC. Patients and methods: In four hospitals, consecutive children aged < 16 (mean 7.1) years with a minimally displaced metaphyseal both-bone fracture of the distal forearm were randomized to four weeks BEC (n = 35) or four weeks AEC (n = 31). Primary outcome was limitation of pronation and supination six months after initial trauma. The secondary outcomes were cast comfort, limitation of flexion/extension of wrist/elbow, complications, cosmetics, complaints, and radiological assessment. Results: A group of 34 children received BEC and 31 children received AEC. All children attended for the final examination at a mean follow-up of 7.0 months (range 5.0-11.6 months). Limitation of pronation and supination six months after initial trauma showed no significant difference between the two groups [4.4° (±5.8) for BEC and 5.8° (±9.8) for AEC]. Children treated with BEC had significantly higher cast comfort on a visual analogue scale [5.6 (±2.7) versus 8.4 (±1.4)] and needed significantly less help with dressing (8.2 days versus 15.1 days). Six complications occurred in the BEC group and 14 in the AEC group. Other secondary outcomes were similar between the two groups. Conclusions: Children with minimally displaced metaphyseal both-bone fractures of the distal forearm should be treated with a below-elbow cast. [ABSTRACT FROM AUTHOR]