Search

Background: A total of 68% of pre‐school children with cleft palate have speech problems requiring speech therapy. There is a lack of access to regular targeted therapy. Parent training leads to positive outcomes in early communication skills in cleft palate and non‐cleft speech disorders. Connected health has been used to address inadequate access to therapy, providing intervention to those who would not otherwise receive therapy. Aims: To evaluate the speech, activity and participation outcomes of Parent Led, Therapist Supervised, Articulation Therapy (PLAT) compared with routine speech therapy intervention in parent–child dyads. Methods & Procedures: A total of 44 children, aged 2.9–7.5 years, were included in a two‐centre, two‐phase randomized controlled trial. Informed consent and assent were obtained. Participants and speech and language therapists (SLTs) were unblinded to the groups. Parents, in the parent‐trained group (n = 23), attended 2 days' training, received a detailed speech therapy programme, and undertook intervention over 12 weeks supported by the cleft specialist SLT using FaceTime and one face‐to‐face session. In the control arm (n = 21), parent–child dyads received six therapy sessions over 12 weeks with a research SLT, comparable with usual care. Speech recordings were undertaken pre‐ and post‐intervention. Percent consonant correct (PCC) was analysed by external SLTs blinded to the time and group. Activity and participation were measured using the Intelligibility in Context Scale (ICS) and Focus on Outcomes for Children Under Six (FOCUS) questionnaire. Outcomes & Results: There was no evidence of an interaction between Time and Group or an overall statistical difference between groups for PCC scores. There was a statistically significant difference over time for both groups (words: p < 0.002; confidence interval (CI) = 9.38–16.27; d = 0.57; sentences: p < 0.002; CI = 16.04–25.97; d = 0.23). Effect sizes were medium for words and small for sentences. For intelligibility and participation, there was no evidence of an interaction between Time and Group or an overall statistical difference between groups. A statistically significant difference over time was found for intelligibility (F = 29.97, d.f. = 1, 42, p < 0.001, 95 % CI = 1.45–3.15 d = 0.46) and for participation (F = 14.19, d.f. = 1, 41, p < 0.001 95% CI = 7.63–25.03; d = 0.36) with FOCUS results indicating clinically meaningful (parent‐led group) and significant (control group) change in participation. Conclusions & Implications: PLAT can be as effective as routine care in changing speech, activity and participation outcomes for children with cleft palate, when supported by a specialist cleft SLT using connected health. What this paper addsWhat is already known on this subjectOver 50% of children with cleft palate require speech therapy. However, there is a lack of timely, accessible speech therapy services in the UK and Ireland. Previous studies have shown that parents can deliver therapy effectively, and that connected health can support the delivery of speech therapy. This study aims to provide evidence that parent‐led therapy with the supervision of a specialist cleft therapist using FaceTime is effective.What this paper adds to existing knowledgeThis randomized controlled trial indicates that parents can be trained to deliver therapy for children with cleft palate speech disorders, under the supervision of an SLT. This approach results in improved speech, activity and participation outcomes similar to routine care.What are the potential or actual clinical implications of this work?This study indicates that both parent‐led articulation therapy and routine care showed meaningful gains in speech, activity and participation, and that parent‐led articulation therapy when supported by a cleft SLT using connected health could be an additional service delivery model for children with cleft palate speech disorders. [ABSTRACT FROM AUTHOR]

Background Previous studies have reported that obese people with trisomy 21 suffer from lowgrade systemic inflammation. A recent study has found that aerobic training reduced inflammation in obese women with Down syndrome. To the best of our knowledge, the study reported in this paper is the first to determine for how long these effects were maintained after completion of the programme. Methods Twenty premenopausal obese women (18-30 years old) with Down syndrome volunteered for this study. Eleven were randomly assigned to the intervention group and performed a 10-week aerobic training programme, 3 sessions per week, consisting of warming-up followed by treadmill exercise (30-40 min) at a work intensity of 55-65% of peak heart rate and a cooling-down period. The control group included 9, age, sex and BMI matched women with Down syndrome that did not perform any training programme. Fat mass percentage and distribution were measured. Plasma level of IL-6 and high-sensitive C-reactive protein (hs-CRP) were monitored. Time-course changes for these outcomes were assessed at pre- and post-intervention. Further, they were re-evaluated at 1, 3 and 6 months after completion of the programme. Results Three months after completion of the programme, plasma levels of IL-6 and hs-CRP were significantly increased. Up to 6 months later, both fat mass percentage and waist circumference (WC) were significantly increased. Furthermore, physical fitness was also impaired in the intervention group. No changes were observed in the control group. Conclusion A 3-month detraining period significantly impaired chronic inflammation in obese women with DS. [ABSTRACT FROM AUTHOR]

Background The effectiveness of two treatment approaches (phonological therapy and articulation therapy) for treatment of 14 children, aged 4;0-6;7 years, with phonologically based speech-sound disorder (SSD) has been previously analysed with severity outcome measures (percentage of consonants correct score, percentage occurrence of phonological processes and phonetic inventory). Considering that the ultimate goal of intervention for children with phonologically based SSD is to improve intelligibility, it is curious that intervention studies focusing on children's phonology do not routinely use intelligibility as an outcome measure. It is therefore important that the impact of interventions on speech intelligibility is explored. Aims This paper investigates the effectiveness of the two treatment approaches (phonological therapy and articulation therapy) using intelligibility measures, both in single words and in continuous speech, as the primary outcome. Methods & Procedures Fourteen children with phonologically based SSD participated in the intervention. The children were randomly assigned to phonological therapy or articulation therapy (seven children in each group). Two assessment methods were used for measuring intelligibility: a word identification task (for single words) and a rating scale (for continuous speech). Twenty-one unfamiliar adults listened and judged the children's intelligibility. Reliability analyses showed overall high agreement between listeners across both methods. Outcomes & Results Significant improvements were noted in intelligibility in both single words (paired t(6) = 4.409, p = 0.005) and continuous speech (asymptotic Z = 2.371, p = 0.018) for the group receiving phonology therapy pre- to post-treatment, but no differences in intelligibility were found for those receiving the articulation therapy pre- to post-treatment, either for single words (paired t(6) = 1.763, p = 0.128) or continuous speech (asymptotic Z = 1.442, p = 0.149). Conclusions & Implications Intelligibility measures were sensitive enough to show changes in the phonological therapy group but not in the articulation therapy group. These findings emphasize the importance of using intelligibility as an outcome measure to complement the results obtained with other severity measures when exploring the effectiveness of speech interventions. This study presents new evidence for the effectiveness of phonological therapy in improving intelligibility with children with SSD. [ABSTRACT FROM AUTHOR]

Objectives Lipoatrophy is a long-term adverse effect of some antiretrovirals that affects quality of life, compromises adherence and may limit the clinical impact of HIV treatments. This paper explores the effect of tenofovir/emtricitabine ( TDF/ FTC) on the amount of limb fat in patients with virological suppression. Methods A randomized, prospective clinical trial was performed to compare continuation on a zidovudine/lamivudine ( ZDV/3TC)-based regimen with switching to a TDF/ FTC-based regimen in terms of the effect on limb fat mass as assessed by DEXA over a 72-week period. Results Eighty patients were included (39 in the TDF/ FTC arm and 41 in the ZDV/3 TC arm) and 73 completed the study (37 and 36, respectively). In the switch arm, limb fat increased by a median of 540 g from baseline ( P = 0.022), while in the ZDV/3TC arm it decreased by a median of 379 g ( P = 0.112; p between groups = 0.007). Subjects with baseline limb fat ≤ 7200 g, previous time on ZDV > 5 years or a body mass index > 25 kg/m2 experienced higher limb fat gains than other subjects, and these differences were statistically significant. Haemoglobin increased by a median of 1.0 g/d L in the TDF/ FTC arm ( P < 0.001) and remained unchanged in the ZDV/3TC arm (p between groups = 0.0002). There were no significant differences between groups in other secondary endpoints (body weight, total body and trunk fat content, total body bone mineral density, laboratory parameters, CD4 cell count and viral load). Conclusions Switching from a ZDV/3TC-based to a TDF/ FTC-based regimen led to a statistically significant improvement in limb fat, in contrast to the progressive loss of limb fat in subjects continuing ZDV/3TC. [ABSTRACT FROM AUTHOR]

Aims This study examines the preliminary outcomes of an intervention targeting service providers in methadone maintenance therapy ( MMT) clinics in China. The intervention effects on both service providers and clients are reported. Design The MMT CARE intervention pilot was developed and implemented collaboratively with local health educators. After three group intervention sessions, trained providers in intervention clinics delivered two individual motivational interviewing sessions with their clients. Settings Six clinics in Sichuan, China, were randomized to either the MMT CARE intervention condition or a standard care condition. Participants A total of 41 providers and 179 clients were sampled from the six clinics. Measurements At baseline and three-, six-, and nine-month assessments, providers completed self-administrated paper/pencil questionnaires regarding provider-client interaction, MMT knowledge, perceived job-related stigma and clinic support. Clients completed a face-to-face survey about their concurrent drug use and drug avoidance self-efficacy. Mixed-effects regression models with clinic-level random effect were used to assess the intervention effects. Findings Significant intervention effects for providers were found in improved MMT knowledge, provider-client interaction and perceived clinic support. For clients, better improvements in drug avoidance self-efficacy and reduced concurrent drug use were observed for the intervention compared with the standard care group. Conclusions The MMT CARE intervention targeting providers in methadone maintenance clinics can improve providers' treatment knowledge and their interaction with clients. The intervention can also reduce clients' drug-using behavior through motivational interviewing sessions conducted by trained providers. [ABSTRACT FROM AUTHOR]

Background: Sensitive responsiveness is an important aspect in affect‐regulation of people with severe to profound intellectual disabilities. Aim: This randomized controlled trial evaluated the Attune & Stimulate‐checklist, a tool for detecting subtle and idiosyncratic communicative behaviours and responding adequately. Methods: Effects on the sensitive responsiveness of professional caregivers and the arousal and valence of adults with severe to profound intellectual disabilities were investigated. Video recordings of 102 interactions were analysed with several observation instruments. Results: Although no significant effect was found on the checklist‐suggestions of responsive behaviours (d = 0.33, p =.052), the intervention increased caregivers' sensitive responsive and affective behaviour (d = 0.94 – 1.10, p <.001) and clients' optimal arousal (d = 0.48, p =.019) and interactive engagement (d = 0.40 – 0.48, p =.018 ‐.050). Conclusion: This low‐intensity intervention had a medium to large immediate effect on the interaction. Future research should investigate medium‐ and long‐term effects. [ABSTRACT FROM AUTHOR]

Background: Children's pain in dentistry has undesirable short‐ and long‐term consequences; therefore, less invasive treatments merit consideration. Aim: To investigate procedural pain scores for two treatments for carious primary molars in New Zealand primary care. Design: This study was a split‐mouth randomised control trial, with secondary outcome analysis. Children (4–8 years) with proximal carious lesions on matched primary molars had one tooth treated with the Hall technique (HT) and one treated with a conventional stainless steel crown (CT); treatment type and order of treatment were randomly allocated (allocation concealment). The Wong–Baker self‐report pain scale measured pretreatment dental pain, procedural pain at each treatment and post‐operative pain. Results: Data were analysed for 103 children: 49 children had the HT first and 54 children had the CT first. Procedural pain scores did not differ by treatment type, with 71.8% and 76.7% of children reporting low pain for the HT and the CT, respectively. Fewer children reported low procedural pain for the second treatment than the first (p =.047). Most children reported low procedural pain for both treatments (58.3%), although 41.7% experienced moderate–high procedural pain with at least one treatment. Conclusions: The HT caused pain for as many children as the CT. There is an opportunity for better dental pain management in this setting. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to develop an objective method to assess the degree of bristle splaying of used manual toothbrushes and to investigate their plaque removal efficacy. Methods: A randomized controlled trial targeting Hiroshima University students was performed to assess the plaque removal efficacy of polybutylene terephthalate (PBT) manual toothbrushes. Participants were randomly assigned to the soft toothbrush group (n = 40) or the medium toothbrush group (n = 40). A small number of participants discontinued the intervention for personal reasons in both the medium (n = 6) and soft (n = 2) toothbrush groups. Toothbrushes were collected immediately after first use (T0: baseline), after 1 month of use (T1: month 1), after 2 months of use (T2: month 3) and after 3 months of use (T3: month 6), following the allocation of a new toothbrush. The bristle surface area was measured using digital software. Results: The surface area of the bristles was significantly greater at T1, T2 and T3 than at T0 in the medium toothbrush group (n = 34) and soft toothbrush group (n = 38) (P <.001). Importantly, plaque removal efficacy, calculated from a modified plaque control record score and modified patient hygiene performance score, was significantly lower at T2 than at T0 in both groups. Conclusions: Our method for evaluation of bristle splaying is considered to be reliable and reproducible. PBT toothbrushes may become less effective after two months of use. [ABSTRACT FROM AUTHOR]

Introduction: Intravenous (IV) fluid is a key intervention in the management of septic shock. The benefits and harms of lower versus higher fluid volumes are unknown and thus clinical equipoise exists. We describe the protocol and detailed statistical analysis plan for the conservative versus liberal approach to fluid therapy of septic shock in the Intensive Care (CLASSIC) trial. The aim of the CLASSIC trial is to assess benefits and harms of IV fluid restriction versus standard care in adult intensive care unit (ICU) patients with septic shock.Methods: CLASSIC trial is an investigator-initiated, international, randomised, stratified, and analyst-blinded trial. We will allocate 1554 adult patients with septic shock, who are planned to be or are admitted to an ICU, to IV fluid restriction versus standard care. The primary outcome is mortality at day 90. Secondary outcomes are serious adverse events (SAEs), serious adverse reactions (SARs), days alive at day 90 without life support, days alive and out of the hospital at day 90 and mortality, health-related quality of life (HRQoL), and cognitive function at 1 year. We will conduct the statistical analyses according to a pre-defined statistical analysis plan, including three interim analyses. For the primary analysis, we will use logistic regression adjusted for the stratification variables comparing the two interventions in the intention-to-treat (ITT) population.Discussion: The CLASSIC trial results will provide important evidence to guide clinicians' choice regarding the IV fluid therapy in adults with septic shock. [ABSTRACT FROM AUTHOR]

Background: Effortful swallowing training (EST) is a remedial method for the training of swallowing‐related muscles in the oropharyngeal phase. However, clinical evidence of its effectiveness is insufficient. Aims: To investigate the effects of EST on tongue strength and swallowing function in patients with stroke. Methods & Procedures: Stroke patients with dysphagia were randomly assigned to one of two groups: an experimental group (n = 12) and a control group (n = 12). The experimental group underwent EST, while the control group performed saliva swallowing. Training was conducted 5 days per week for 4 weeks. Both groups underwent conventional dysphagia treatment for 30 min/day, 5 days/week for 4 weeks. Outcomes & Results: Tongue strength was assessed using the Iowa Oral Performance Instrument. The Videofluoroscopic Dysphagia Scale (VDS), based on a videofluoroscopic swallowing study, was used to analyze oropharyngeal swallowing function. The experimental group showed greater improvements in anterior and posterior tongue strength compared with the control group (p = 0.046 and 0.042, respectively), and greater improvement in the oral phases of the VDS (p = 0.017). Conclusions & Implications: We recommend EST as a remedial strategy for improving tongue strength and oral swallowing function in patients with stroke. [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]

Studies suggest that stimulation of the left dorsolateral prefrontal cortex (DLPFC) reduces food craving in bulimic patients, but evidence supporting repetitive transcranial magnetic stimulation (rTMS) as a therapeutic tool is lacking. We investigated the safety and therapeutic efficacy of an adjunct high-frequency rTMS programme targeting the left DLPFC. Forty-seven women with bulimia nervosa were randomised to a real or sham stimulation group. The real group underwent 10 rTMS sessions, each consisting of 20 trains of 5 seconds with 55-second intervals between trains, at a frequency of 10 Hz. The main outcome was the number of binge episodes in the 15 days following the end of stimulation. Overall, no significant improvement in bingeing and purging symptoms was noted after the programme. rTMS was well tolerated. This suggests that 10 sessions of high-frequency rTMS to the left DLPFC provide no greater benefit than placebo. Future studies should consider methodological issues as well as alternative targets. Copyright © 2016 John Wiley & Sons, Ltd and Eating Disorders Association. [ABSTRACT FROM AUTHOR]

Aims To examine the safety and effectiveness of buprenorphine + naloxone sublingual tablets (BUP, as Suboxone®) provided after administration of extended-release injectable naltrexone (XR-NTX, as Vivitrol®) to reduce cocaine use in participants who met DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse. Methods This multi-centered, double-blind, placebo-controlled study, conducted under the auspices of the National Drug Abuse Treatment Clinical Trials Network, randomly assigned 302 participants at sites in California, Oregon, Washington, Colorado, Texas, Georgia, Ohio, New York and Washington DC, USA to one of three conditions provided with XR-NTX: 4 mg/day BUP (BUP4, n = 100), 16 mg/day BUP (BUP16, n = 100, or no buprenorphine (placebo; PLB, n = 102). Participants received pharmacotherapy for 8 weeks, with three clinic visits per week. Cognitive behavioral therapy was provided weekly. Follow-up assessments occurred at 1 and 3 months post-intervention. The planned primary outcome was urine drug screen (UDS)-corrected, self-reported cocaine use during the last 4 weeks of treatment. Planned secondary analyses assessed cocaine use by UDS, medication adherence, retention and adverse events. Results No group differences were found between groups for the primary outcome (BUP4 versus PLB, P = 0.262; BUP16 versus PLB, P = 0.185). Longitudinal analysis of UDS data during the evaluation period using generalized linear mixed equations found a statistically significant difference between BUP16 and PLB [ P = 0.022, odds ratio (OR) = 1.71] but not for BUP4 ( P = 0.105, OR = 1.05). No secondary outcome differences across groups were found for adherence, retention or adverse events. Conclusions Buprenorphine + naloxone, used in combination with naltrexone, may be associated with reductions in cocaine use among people who meet DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse. [ABSTRACT FROM AUTHOR]

Objective The primary objective of the TEENZ Study (NCT01211145) was to assess the efficacy of zolmitriptan nasal spray in the acute treatment of adolescent migraine patients (ages 12 to 17 years), as measured by the primary outcome variable of pain-free status at 2 hours post-treatment. Methods This randomized, double-blind, placebo-controlled, four-arm parallel group study compared zolmitriptan nasal spray with placebo in the treatment of a single episode of adolescent migraine. Patients completed a 30-day run-in period to treat a single migraine attack with single-blind placebo nasal spray. Eligible patients, who had not responded to placebo, were randomized to one of three zolmitriptan nasal spray doses (5, 2.5, or 0.5 mg) or placebo in a ratio of 5:3:3:5 according to a computer-generated randomization scheme. Patients completed diaries for 24 hours after treatment, recording headache pain scores, adverse events (AEs), and medications taken. Results In an interim futility analysis, zolmitriptan nasal spray doses of 0.5 and 2.5 mg were declared futile relative to placebo and further randomization to these treatment arms was discontinued. Of 1653 patients enrolled into the study, 855 patients failed to meet study eligibility criteria and were considered screen failures. The most common reason for screen failure was response to placebo challenge (325 patients [38.0%]). Of the 798 patients who were randomized to treatment, 721 (90.4%) completed the study period. Of these, 657 (82.3%) treated a migraine within the study period and contributed data for analysis. Zolmitriptan nasal spray 5 mg was significantly more effective than placebo in achieving pain-free status at 2 hours after treatment ( P < .001), with 30% of patients achieving pain-free status at 2 hours vs 17% of placebo-treated patients (OR 2.18; 95% CI 1.40, 3.39). Zolmitriptan nasal spray 5 mg was also more effective than placebo in achieving pain-free status at 3 and 4 hours post-treatment (45 vs 24%, and 56 vs 39%; both P < .001). Zolmitriptan nasal spray 5 mg was also more effective than placebo in achieving headache response at 2, 3, and 4 hours after treatment (51 vs 39%, 61 vs 48%, and 69 vs 57%, respectively; all P ≤ .011). Zolmitriptan nasal spray was well-tolerated at all doses. Dysgeusia was the most frequently reported AE, with greater frequencies reported in active treatment groups versus placebo. No serious AEs or AEs leading to discontinuation were reported. Most AEs were mild or moderate in severity, and consistent with the known profile of zolmitriptan in adult and adolescent populations. Conclusion Zolmitriptan nasal spray was well-tolerated in the acute treatment of adolescent (ages 12 to 17 years) migraine. Zolmitriptan 5 mg nasal spray demonstrated superior efficacy compared with placebo for the primary efficacy endpoint of pain-free status 2 hours after treatment and the efficacy of the 5 mg dose was supported by the majority of secondary efficacy endpoints. [ABSTRACT FROM AUTHOR]

The aim of this study was to investigate the effects of vitamin C and E supplementation on changes in muscle mass (lean mass and muscle thickness) and strength during 12 weeks of strength training in elderly men. Thirty-four elderly males (60-81 years) were randomized to either an antioxidant group (500 mg of vitamin C and 117.5 mg vitamin E before and after training) or a placebo group following the same strength training program (three sessions per week). Body composition was assessed with dual-energy X-ray absorptiometry and muscle thickness by ultrasound imaging. Muscle strength was measured as one-repetition maximum (1 RM). Total lean mass increased by 3.9% (95% confidence intervals: 3.0, 5.2) and 1.4% (0, 5.4) in the placebo and antioxidant groups, respectively, revealing larger gains in the placebo group ( P = 0.04). Similarly, the thickness of m. rectus femoris increased more in the placebo group [16.2% (12.8, 24.1)] than in the antioxidant group [10.9% (9.8, 13.5); P = 0.01]. Increases of lean mass in trunk and arms, and muscle thickness of elbow flexors, did not differ significantly between groups. With no group differences, 1RM improved in the range of 15-21% ( P < 0.001). In conclusion, high-dosage vitamin C and E supplementation blunted certain muscular adaptations to strength training in elderly men. [ABSTRACT FROM AUTHOR]

Background and Aims A broadly mandated reduction of the nicotine content (RNC) of cigarettes has been proposed in the United States to reduce the addictiveness of cigarettes, to prevent new smokers from becoming addicted and to facilitate quitting in established smokers. The primary aim of this study was to determine whether following 7 months of smoking very low nicotine content cigarettes (VLNC), and then returning to their own cigarettes, smokers would demonstrate persistently reduced nicotine intake compared with baseline or quit smoking. Methods In a community-based clinic 135 smokers not interested in quitting were randomized to one of two groups. A research group smoked their usual brand of cigarettes, followed by five types of research cigarettes with progressively lower nicotine content, each for 1 month, followed by 6 months at the lowest nicotine level (0.5 mg/cigarette) (53 subjects) and then 12 months with no intervention (30 subjects completed). A control group smoked their usual brand for the same period of time (50 subjects at 6 months, 38 completed). Smoking behavior, biomarkers of nicotine intake and smoke toxicant exposure were measured. Results After 7 months smoking VLNC, nicotine intake remained below baseline (plasma cotinine 149 versus 250 ng/ml, P<0.005) with no significant change in cigarettes per day or expired carbon monoxide (CO). During the 12-month follow-up, cotinine levels in RNC smokers rose to baseline levels and to those of control smokers. Quit rates among RNC smokers were very low [7.5 versus 2% in controls, not significant). Conclusions In smokers not interested in quitting, reducing the nicotine content in cigarettes over 12 months does not appear to result in extinction of nicotine dependence, assessed by persistently reduced nicotine intake or quitting smoking over the subsequent 12 months. [ABSTRACT FROM AUTHOR]

Aim To evaluate the clinical treatment effects of a glycine powder air-polishing or ultrasonic device on peri-implant mucositis. Materials and methods Thirty-seven patients with one implant diagnosed with peri-implant mucositis (probing depth ≥4 mm (0.2N) and bleeding on probing ( BOP) (primary outcome)) were randomly assigned to treatment with either glycine powder air-polishing ( GPAP) or ultrasonic ( US) debridement. Treatment was performed at baseline and at 3 and 6 months. Professional supra gingival cleaning was performed at 9 and 12 months. Oral hygiene instructions were reinforced at each visit. Results At 12 months there was a statistically significant reduction in mean plaque score, bleeding on probing and number of periodontal pockets ≥4 mm within the treatment groups compared to baseline. The percentages of diseased sites were significantly reduced for both groups. Conclusions Treatment with a glycine powder air-polishing or an ultrasonic device is effective in non-surgical treatment of peri-implant mucositis. [ABSTRACT FROM AUTHOR]

Background This study examined the effects of atomoxetine ( ATX) and OROS methylphenidate ( MPH) on laboratory measures of inhibitory control and attention in youth with attention-deficit/hyperactivity disorder ( ADHD). It was hypothesized that performance would be improved by both treatments, but response profiles would differ because the medications work via different mechanisms. Methods One hundred and two youth (77 male; mean age = 10.5 ± 2.7 years) with ADHD received ATX (1.4 ± 0.5 mg/kg) and MPH (52.4 ± 16.6 mg) in a randomized, double-blind, crossover design. Medication was titrated in 4-6-week blocks separated by a 2-week placebo washout. Inhibitory control and attention measures were obtained at baseline, following washout, and at the end of each treatment using Conners' Continuous Performance Test II ( CPT- II), which provided age-adjusted T-scores for reaction time ( RT), reaction time variability ( RT variability), and errors. Repeated-measures analyses of variance were performed, with Time (premedication, postmedication) and Treatment type ( ATX, MPH) entered as within-subject factors. Data from the two treatment blocks were checked for order effects and combined if order effects were not present. Clinical trial registration: Clinicaltrials.gov: NCT00183391. Results Main effects for Time on RT ( p = .03), RTSD ( p = .001), and omission errors ( p = .01) were significant. A significant Drug × Time interaction indicated that MPH improved RT, RTSD, and omission errors more than ATX ( p < .05). Changes in performance with treatment did not correlate with changes in ADHD symptoms. Conclusions MPH has greater effects than ATX on CPT measures of sustained attention in youth with ADHD. However, the dissociation of cognitive and behavioral change with treatment indicates that CPT measures cannot be considered proxies for symptomatic improvement. Further research on the dissociation of cognitive and behavioral endpoints for ADHD is indicated. [ABSTRACT FROM AUTHOR]

ABSTRACT Benign prostatic hyperplasia ( BPH) is a common problem of the elderly population. This study was conducted to investigate the effect of Urtica dioica on the clinical symptoms of BPH. This double-blind clinical trial included 248 patients with symptomatic BPH in Shohada Ashayer Hospital of Khorramabad. The patients were randomly divided into four groups of treatment with U. dioica 3 g, U. dioica 5 g, U. dioica 7 g and treatment with prazosin 1 mg alone as the control group. The clinical symptoms, patients' quality of life and level of serum prostate-specific antigen ( PSA) were measured before and 2 months after the intervention. The results of the study showed significant differences between the four groups after the intervention for the scores of clinical symptoms and patients' quality of life, while no significant differences were found for serum PSA levels. Sheffe post hoc comparisons showed significant improvements in the scores of the patients' clinical symptom in the U. dioica 5 g/d and U. dioica 7 g/d groups. The results of the study showed that simultaneous consumption of higher doses of U. dioica, up to 7 g/d, plus prazosin, compared with the consumption of prazosin alone, resulted in significant improvements in the clinical symptoms of BPH. [ABSTRACT FROM AUTHOR]

Objective This is a secondary analysis of a randomized clinical trial which aims to examine changes in cognitive and behavioral responses to migraine with cognitive behavioral treatment for migraine, preventive medication for migraine, and their combination, and the relationship between these changes and reductions in migraine-related disability. Background Cognitive behavioral treatment is thought to reduce migraine-related disability through modifying maladaptive cognitive and behavioral responses to migraine. Methods Two hundred thirty-two people with migraine who did not respond to 5 weeks of optimized acute therapy were randomized into a 2 (beta-blocker vs placebo) X 2 (behavioral migraine management [ BMM] vs no BMM) treatment design. Participants received BMM and/or beta-blocker dose adjustment for 4 months, and were followed for an additional 12 months. Participants completed measures of catastrophizing, behavioral coping, and migraine-related disability throughout the study. Results Compared to drug therapy only, BMM demonstrated larger decreases in catastrophizing scores (19.16 to 9.89 vs 16.78 to 11.84, P < .001) and increases in number of positive coping strategies (proactive: 1.09 to 1.90 vs 1.16 to 1.09, P < .001; anticipatory: 0.19 to 0.69 vs 0.10 to 0.08, P < .001; migraine management: 0.14 to 0.36 vs 0.04 to 0.04, P < .001) at the end of the follow-up period. Decreases in catastrophizing were associated with a larger BMM effect on migraine-related disability ( P = .036). Conclusions This study demonstrated that BMM modified important cognitive and behavioral factors postulated to be mechanisms of cognitive behavioral treatments for migraine. [ABSTRACT FROM AUTHOR]

Aim To analyse change in selected bone markers in peri-implant sulcus fluid ( PISF) sampled before treatment and after 12 months and test correlation with change in disease progression. Materials and Methods Peri-implant sulcus fluid was sampled from 32 patients in a randomized, clinical study comparing peri-implant defect re-construction with or without porous titanium granules. Matrix metalloproteinase 8 levels were measured using the Quantikine Human Total MMP-8 ( DMP800) ELISA. Multianalyte profiling of the level of bone markers [interleukin-6, osteprotegerin (OPG), osteocalcin, leptin, osteopontin, parathyroid hormone, tumour necrosis factor-α, adiponectin and insulin] was performed by Luminex using Human Bone Panel IB. Changes in bone marker levels were compared and correlation with clinical findings was tested. Results No differences in clinical parameter or bone marker levels between test and control group were found. When comparing bone marker levels irrespective of treatment allocation between baseline and 12 months, a significant reduction in total protein, matrix metalloproteinase -8, interleukin-6, OPG, leptin and adiponectin were demonstrated. Positive correlations were found between the reduction in interleukin-6 ( r = 0.43), insulin ( r = 0.38) and matrix metalloproteinase-8 ( r = 0.47) concentration, and probing pocket depth reduction. Conclusion Peri-implantitis surgical treatment induced some reduction of the studied bone markers. Conclusive evidence for correlation between change in bone marker concentrations with disease resolution was not found. [ABSTRACT FROM AUTHOR]

Objectives Low-dose stavudine therapy may have a lower toxicity profile compared with standard dose. A randomized controlled trial comparing these two doses of stavudine with tenofovir disoproxil fumarate (tenofovir DF) was performed to assess the effects on anthropometry, markers of inflammation, and lipid and glucose metabolism in Black South African patients. Methods Sixty patients were randomized 1:1:1 to either standard-dose (30-40 mg) or low-dose (20-30 mg) stavudine or tenofovir DF (300 mg), each combined with lamivudine and efavirenz, for 48 weeks. Anthropometry, markers of inflammation, and lipid and glucose metabolism were assessed using standard techniques. Results In all three treatment arms, there was a significant increase in lipid levels over the study period. At 48 weeks, fasting glucose level ( P < 0.005) and homeostasis model assessment ( HOMA) score ( P < 0.05) increased significantly in the standard-dose stavudine arm, as did insulin and C-peptide levels in both the standard- and low-dose stavudine arms. At week 48, a significant decrease ( P < 0.05) in adiponectin was noted in the standard-dose stavudine arm, but there was an increase ( P < 0.005) in the tenofovir DF arm. In both the stavudine arms, significant increases in anthropometric measures occurred at 24 weeks but these decreased by week 48. Mitochondrial toxicities occurred in both the stavudine arms. Immunological and virological outcomes were similar for all three arms. Conclusions This study highlights the occurrence of metabolic abnormalities with both stavudine and tenofovir DF treatment. Awareness of the potential increased cardiovascular risk should be of concern with the use of both these therapies. [ABSTRACT FROM AUTHOR]

Aim To assess the efficacy of a 0.07% cetylpyridinium chloride ( CPC) mouth rinse in the control of plaque and gingival inflammation during a 6-month period. Material and Methods Adult subjects with moderate gingivitis were selected [≥40% bleeding on marginal probing ( BOMP)]. After retrieving microbiological samples and evaluating the clinical parameters (plaque, BOMP and stain indexes), a professional prophylaxis was performed and subjects were randomly assigned to the test ( CPC mouth rinse) or to the placebo group. Subjects were re-assessed after 3 and 6 months. Results A total of 67 patients (35 test, 32 placebo) were included in the analysis. At 6 months, intra-group significant plaque reductions were observed in the test group (0.691, p < 0.001), but not in the placebo (0.181, p = 0.653). At 6 months, the mean BOMP values were lower in the test group ( p = 0.052). Changes between baseline and 6 months were significantly higher in the test group both for plaque ( p = 0.002) and BOMP ( p = 0.037) when compared with the placebo. A microbiological impact was observed in the test group, especially for Prevotella intermedia. Conclusion The evaluated 0.07% CPC-based mouth rinse, used three times per day adjunctively to mechanical tooth cleaning, prevents plaque accumulation and gingival inflammation, as compared to the placebo, for at least 6 months. [ABSTRACT FROM AUTHOR]

Aim To investigate the effect of photodynamic therapy (PDT) as adjunct to mechanical therapy in furcations. Materials and Methods A double-blind, parallel, randomized controlled clinical trial was conducted in subjects presenting class II furcations. The subjects were randomly allocated to a test (PDT; n = 16) or control group (non-activated laser/only photosensitizer; n = 21). At baseline, 3 and 6 months, clinical, microbiological and cytokine pattern evaluation was performed. Clinical attachment level was defined as the primary outcome variable. Results Clinical parameters improved after both therapies ( p < 0.05) with no differences between groups at any time point ( p > 0.05). At 6 months, real-time PCR evaluation showed a decrease in Porphyromonas gingivalis and Tannerella forsythia only in the PDT group ( p < 0.05) with no inter-group differences. Regarding cytokines, IL-4 and IL-10 levels increased in both groups at 6 months. GM-CSF, IL-8, IL-1β and IL-6 levels decreased only in the PDT group after 3 months ( p < 0.05). At 3 months, inter-group analyses showed that GM-CSF, IFN-γ, IL-6 and IL-8 levels were lower in the PDT group. At 6 months, lower IL-1β levels were also observed in the PDT group ( p < 0.05). Conclusion Photodynamic therapy did not promote clinical benefits for class II furcations; however, advantages in local levels of cytokines and a reduction in periodontopathogens were demonstrated. [ABSTRACT FROM AUTHOR]

Aim To examine the 2-year post-therapy kinetics of change in the composition of subgingival biofilms. Material and Methods In this study, 178 chronic periodontitis subjects were recruited and clinically monitored at baseline, 3, 6, 12, 18 and 24 months after therapy. All subjects received scaling and root planing and 156 one or more of periodontal surgery, systemically administered amoxicillin + metronidazole or local tetracycline at pockets ≥5 mm. Subgingival biofilm samples taken from each subject at each time point were analysed for their content of 40 bacterial species using checkerboard DNA-DNA hybridization. The significance of changes in median species counts over time was sought using the Wilcoxon or Friedman tests and adjusted for multiple comparisons. Results Mean counts were significantly reduced from baseline to 2 years for 30 of the 40 taxa. Marked reductions were observed for periodontal pathogens including Tannerella forsythia, Treponema denticola and Eubacterium nodatum. The kinetics of change differed from species to species. When data were subset according to baseline PD, patterns of change in the microbial profiles were generally similar. Conclusion Periodontal therapy leads to a rapid reduction in periodontal pathogens, followed by a slower reduction in other taxa that can be sustained for at least 2 years. [ABSTRACT FROM AUTHOR]

Aims To test aripiprazole for efficacy in decreasing use in methamphetamine-dependent adults, compared to placebo. Design Participants were randomized to receive 12 weeks of aripiprazole or placebo, with a 3-month follow-up and a platform of weekly 30-minute substance abuse counseling. Setting The trial was conducted from January 2009 to March 2012 at the San Francisco Department of Public Health. Participants Ninety actively using, methamphetamine-dependent, sexually active adults were recruited from community venues. Measurements The primary outcome was regression estimated reductions in weekly methamphetamine-positive urines. Secondary outcomes were study medication adherence [by self-report and medication event monitoring systems ( MEMS)], sexual risk behavior and abstinence from methamphetamine. Findings Participant mean age was 38.7 years, 87.8% were male, 50.0% white, 18.9% African American, and 16.7% Latino. Eighty-three per cent of follow-up visits and final visits were completed. By intent-to-treat, participants assigned to aripiprazole had similar reductions in methamphetamine-positive urines as participants assigned to placebo [risk ratio ( RR) 0.88, 95% confidence interval ( CI): 0.66-1.19, P = 0.41]. Urine positivity declined from 73% (33 of 45 participants) to 45% (18 of 40) in the placebo arm and from 77% (34 of 44) to 44% (20 of 35) in the aripiprazole arm. Adherence by MEMS and self-report was 42 and 74%, respectively, with no significant difference between arms ( MEMS P = 0.31; self-report P = 0.17). Most sexual risk behaviors declined similarly among participants in both arms (all P > 0.05). There were no serious adverse events related to study drug, although participants randomized to aripiprazole reported more akathisia, fatigue and drowsiness ( P < 0.05). Conclusion Compared with placebo, aripiprazole did not reduce methamphetamine use significantly among actively using, dependent adults. [ABSTRACT FROM AUTHOR]

Aims Like many indigenous peoples, New Zealand Māori bear a heavy burden of alcohol-related harm relative to their non-indigenous compatriots, and disparities are greatest among young adults. We tested the effectiveness of web-based alcohol screening and brief intervention (e- SBI) for reducing hazardous drinking among Māori university students. Design Parallel, double-blind, multi-site, randomized controlled trial. Setting Seven of New Zealand's eight universities. Participants In April 2010, we sent e-mail invitations to all 6697 17-24-year-old Māori students to complete a brief web questionnaire including the Alcohol Use Disorders Identification Test ( AUDIT)- C, a screening tool for hazardous and harmful drinking. Those screening positive were computer randomized to: <10 minutes of web-based alcohol assessment and personalized feedback (intervention) or screening alone (control). Measurements We conducted a fully automated 5-month follow-up assessment with observers and participants blinded to study hypotheses, design and intervention delivery. Pre-determined primary outcomes were: (i) frequency of drinking, (ii) amount consumed per typical drinking occasion, (iii) overall volume of alcohol consumed and (iv) academic problems. Findings Of the participants, 1789 were hazardous or harmful drinkers ( AUDIT- C ≥ 4) and were randomized: 850 to control, 939 to intervention. Follow-up assessments were completed by 682 controls (80%) and 733 intervention group members (78%). Relative to controls, participants receiving intervention drank less often [ RR = 0.89; 95% confidence interval (CI): 0.82-0.97], less per drinking occasion ( RR = 0.92; 95% CI: 0.84-1.00), less overall ( RR = 0.78; 95% CI: 0.69-0.89) and had fewer academic problems ( RR = 0.81; 95% CI: 0.69-0.95). Conclusions Web-based screening and brief intervention reduced hazardous and harmful drinking among non-help-seeking Māori students in a large-scale pragmatic trial. The study has wider implications for behavioural intervention in the important but neglected area of indigenous health. [ABSTRACT FROM AUTHOR]

Aims To determine whether web-based tailored cessation advice, based on social cognitive theory and the perspectives on change model, was more effective in aiding a quit attempt than broadly similar web-based advice that was not tailored. Design Participants were allocated randomly to one of two groups, to receive either a cessation advice report and progress report that were tailored to individual-level characteristics or a cessation advice report that presented standardized (non-tailored) content. Tailoring was based on smoking-related beliefs, personal characteristics and smoking patterns, self-efficacy and outcome expectations. Setting Participant enrolment and baseline assessments were conducted remotely online via the study website, with the advice reports presented by the same website. Participants Participants ( n = 1758) were visitors to the QUIT website who were based in the United Kingdom, aged 18 years or over and who smoked cigarettes or hand-rolled tobacco. Measurements Follow-up assessments were made at 6 months by telephone interview. The primary outcome measure was self-reported 3 months prolonged abstinence, and secondary outcomes were 1 month prolonged abstinence, 7-day and 24-hour point prevalence abstinence. Findings The intervention group did not differ from the control group on the primary outcome (9.1% versus 9.3%; odds ratio = 1.02 95% confidence interval 0.73-1.42) or on any of the secondary outcomes. Intervention participants gave more positive evaluations of the materials than control participants. Conclusions A web-based intervention that tailored content according to smoking-related beliefs, personal characteristics and smoking patterns, self-efficacy and outcome expectations, was not more effective than web-based materials presenting broadly similar non-tailored information. [ABSTRACT FROM AUTHOR]

Epidermal sheets spread centrifugally postinjury from the hair follicle infundibulum to reepithelialize the wound bed. Healing progresses faster in skin areas rich in terminal hair follicles. These observations are consistent with the role of the hair follicle as a major reservoir for progenitor cells. To evaluate the feasibility and potential healing capacity of autologous scalp follicular grafts transplanted into the wound bed of chronic leg ulcers, 10 patients with ulcers of an average 36.8 cm2 size and a 10.5-year duration were included in this pilot study. Within each ulcer we randomly assigned a 2 × 2 cm 'experimental' square to receive 20 hair grafts and a nongrafted 'control' square of equal size. The procedure seemed to be safe, although major unrelated complications occurred in two patients. At the 18-week end point, we observed a 27.1% ulcer area reduction in the experimental square as compared with 6.5% in the control square ( p = 0.046) with a maximum 33.5% vs. 9.7% reduction at week 4 ( p = 0.007). Histological analyses showed enhanced epithelialization, neovascularization, and dermal reorganization. We conclude that terminal hair follicle grafting into wound beds is feasible in an outpatient setting and represents a promising therapeutic alternative for nonhealing chronic leg ulcers. [ABSTRACT FROM AUTHOR]

Previous research has shown clinical effectiveness of dermal substitution; however, in burn wounds, only limited effect has been shown. A problem in burn wounds is the reduced take of the autograft, when the substitute and graft are applied in one procedure. Recently, application of topical negative pressure ( TNP) was shown to improve graft take. The aim of this study was to investigate if application of a dermal substitute in combination with TNP improves scar quality after burns. In a four-armed multicenter randomized controlled trial, a split-skin graft with or without a dermal substitute and with or without TNP was compared in patients with deep dermal or full-thickness burns requiring skin transplantation. Graft take and rate of wound epithelialization were evaluated. Three and 12 months postoperatively, scar parameters were measured. The results of 86 patients showed that graft take and epithelialization did not reveal significant differences. Significantly fewer wounds in the TNP group showed postoperative contamination, compared to other groups. Highest elasticity was measured in scars treated with the substitute and TNP, which was significantly better compared to scars treated with the substitute alone. Concluding, this randomized controlled trial shows the effectiveness of dermal substitution combined with TNP in burns, based on extensive wound and scar measurements. [ABSTRACT FROM AUTHOR]

Aim To determine pre- and post-dosing effects of prenatal methadone compared to buprenorphine on fetal wellbeing. Design A secondary analysis of data derived from the Maternal Opioid Treatment: Human Experimental Research ( MOTHER) study, a double-blind, double-dummy, randomized clinical trial. Setting Six United States sites and one European site that provided comprehensive opioid-dependence treatment to pregnant women. Participants Eighty-one of the 131 opioid-dependent pregnant women completing the MOTHER clinical trial, assessed between 31 and 33 weeks of gestation. Measurements Two fetal assessments were conducted, once before and once after study medication dosing. Measures included mean fetal heart rate ( FHR), number of FHR accelerations, FHR reactivity in the fetal non-stress test ( NST) and biophysical profile ( BPP) score. Findings Significant group differences were found for number of FHR accelerations, non-reactive NST and BPP scores (all Ps < 0.05). There were no significant group differences before time of dosing. Significant decreases (all Ps < 0.05) occurred from pre- to post-dose assessment for mean FHR, FHR accelerations, reactive NST and fetal movement. The decrease in accelerations and reactive NST were significant only for fetuses in the methadone group, and this resulted in a significantly lower likelihood of a reactive NST compared to fetuses in the buprenorphine group. Conclusion Buprenorphine compared with methadone appears to result in less suppression of mean fetal heart rate, fetal heart rate reactivity and the biophysical profile score after medication dosing and these findings provide support for the relative safety of buprenorphine when fetal indices are considered as part of the complete risk-benefit ratio. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims To determine whether collaborative behavioral management (CBM) reduces substance use, crime and re-arrest among drug-involved parolees. Design Step'n Out was a randomized behavioral trial of CBM versus standard parole (SP) during 2004-08. CBM adapted evidence-based role induction, behavioral contracting and contingent reinforcement to provide parole officer/treatment counselor dyads with positive tools in addition to sanctions to manage parolees' behavior over 12 weeks. Setting Six parole offices in five states in the USA. Participants Parolee volunteers with a mandate for addiction treatment and a minimum of 3 months of parole ( n = 476). Follow-up was 94% at 3 months and 86% at 9 months. Measurements Drug use and crime in a given month from calendar interviews 3 and 9 months after parole initiation, and re-arrests from criminal justice administrative data. Findings The CBM group had fewer months in which they used their primary drug [adjusted risk ratio (ARR) 0.20, 95% confidence interval (CI): 0.05, 0.78, P = 0.02] and alcohol (ARR 0.38, 95% CI: 0.22, 0.66, P = 0.006) over follow-up. CBM had its greatest effects among parolees who reported marijuana or another 'non-hard' drug as their primary drug; parolees who preferred stimulants or opiates did not benefit. No differences were seen in total crime, re-arrests or parole revocations. Conclusions Collaborative behavioral management may reduce substance use among primary marijuana or other 'non-hard' drug-using parolees without increasing revocations. Because the majority of drug violation arrests in the United States are for marijuana, these findings have important implications for the management of a substantial proportion of the US community correctional population. [ABSTRACT FROM AUTHOR]

Celivarone in Atrial Fibrillation/Atrial Flutter. Introduction: Celivarone, a new noniodinated benzofuran derivative pharmacologically related to dronedarone and amiodarone, has been shown to have antiarrhythmic properties at a molecular level. The purpose of the 2 trials presented here (MAIA and CORYFEE) was to assess celivarone efficacy in the maintenance of sinus rhythm postcardioversion and for the conversion of atrial fibrillation (AF)/atrial flutter (AFL). Methods and Results: In the MAIA trial, 673 patients with AF/AFL recently converted to sinus rhythm were randomly assigned to receive 50, 100, 200, or 300 mg once-daily dosing of celivarone; 200 mg daily of amiodarone preceded by a loading dose of 600 mg for 10 days; or placebo. At 3 months' follow up, no significant difference was observed in time to AF/AFL relapse among the various celivarone groups and placebo. However, fewer symptomatic AF/AFL recurrences were observed in the lower-dose celivarone groups (26.6% for celivarone 50 mg [P = 0.022] and 25.2% for celivarone 100 mg [P = 0.018] vs 40.5% for placebo at 90 days). Fewer adverse events were observed with the use of celivarone and placebo than amiodarone. In the CORYFEE study, 150 patients with AF/AFL were randomly assigned to once-daily celivarone dosing of 300 or 600 mg, or placebo, for a 2-day treatment period. There was no significant difference in the rate of spontaneous conversion to sinus rhythm between the treatment and control groups. Conclusions: In these studies, celivarone does not appear to be efficacious in the maintenance of sinus rhythm in AF/AFL patients or for the conversion of AF/AFL patients. (J Cardiovasc Electrophysiol, Vol. 23, pp. 462-472, May 2012) [ABSTRACT FROM AUTHOR]

Malignant wounds ( MWs) occur in 5-10% of all cancer patients. Malodor and exudation are the most common side effects. The aim was to determine the influence of honey-coated compared with silver-coated bandages on treatment of MWs. Patients were randomly selected to enter either group A (honey-coated bandages) or group B (silver-coated bandages). Parameters were the following: wound size, cleanliness, malodor, exudation, and wound pain. Digital photographs, visual analog scales ( VAS), and wound morphology registration were used for measurement at baseline and following the 4-week intervention. Sixty-nine patients with MWs and advanced cancer, aged 47-90 (median 65.6), were included. No statistically significant difference was noted between the groups with respect to wound size, degree of cleanliness, exudation, malodor, and wound pain. There was a median decrease in wound size of 15 cm2 and 8 cm2 in group A and B, respectively ( p = 0.63). Based on post-intervention pooled data from the groups, improvement was seen in 62% of the participants with respect to wound size and in 58% ( n = 69) with respect to cleanliness. The VAS score for malodor ( p = 0.007) and exudation ( p < 0.0001) improved significantly post-intervention. Patients with reduced wound size had a median survival time of 387 days compared with 134 days in patients with no wound reduction ( p = 0.003). The use of honey-coated and silver-coated bandages improved the outcome of MWs. No differences were found between the two regimens. Both types of bandages are recommended for use by patients with MWs containing tumor debris and necrosis. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims To determine whether 18 months of telephone continuing care improves 24-month outcomes for patients with alcohol dependence. Subgroup analyses were performed to identify patients who would benefit most from continuing care. Design Comparative effectiveness trial of continuing care that consisted of monitoring and feedback only (TM) or monitoring and feedback plus counseling (TMC). Patients were randomized to treatment as usual (TAU), TAU plus TM or TAU plus TMC, and followed quarterly for 24 months. Setting Publicly funded intensive out-patient programs (IOP). Participants A total of 252 alcohol-dependent patients (49% with current cocaine dependence) who completed 3 weeks of IOP. Measurements Percentage of days drinking, any heavy drinking and a composite good clinical outcome. Findings In the intent-to-treat sample, group differences in alcohol outcomes out to 18 months favoring TMC over TAU were no longer present in months 19-24. There was also a non-significant trend for TMC to perform better than usual care on the good clinical outcome measure (60% vs. 46% good clinical outcome in months 19-24). Overall significant effects favoring TMC and TM over TAU were seen for women; and TMC was also superior to TAU for participants with social support for drinking, low readiness to change and prior alcohol treatments. Most of these effects were obtained on at least two of three outcomes. However, no effects remained significant at 24 months. Conclusions The benefits of an extended telephone-based continuing care programme to treat alcohol dependence did not persist after the end of the intervention. A post-hoc analysis suggested that women and individuals with social support for drinking, low readiness to change or prior alcohol treatments may benefit from the intervention. [ABSTRACT FROM AUTHOR]

To determine the effect of offering smokers who want to quit easy access to nicotine replacement therapy (NRT), a period of familiarization and choice of product on smoking abstinence at 6 months. Single-blind, randomized controlled trial. New Zealand. A total of 1410 adult smokers who called the national Quitline for quitting support were randomized to usual Quitline care or a box containing different NRT products (patch, gum, inhaler, sublingual tablet, oral pouch) to try for a week prior to quitting, and then to choose one or two of these products for 8 weeks' use. The primary outcome was 7-day point prevalence smoking abstinence 6 months after quit day. Secondary outcomes included continuous abstinence, cigarette consumption, withdrawal, NRT choice and serious adverse events at 1 and 3 weeks and 3 and 6 months. No differences in 6-month quit rates (7-day point prevalence or continuous abstinence) were observed between the groups. However, smokers allocated to the intervention group were more likely to have quit smoking at 3 months [self-reported point prevalence, relative risk (RR) = 1.17, 95% confidence interval (CI): 1.02, 1.35, P = 0.03], had a longer time to relapse (median 70 days versus 28 days, P < 0.01) and used significantly more NRT. The selection box concept was highly acceptable to users, with the patch and inhaler combination the most popular choice (34%). In terms of smoking abstinence at 6 months, offering smokers who want to quit free access to a wide range of nicotine replacement therapy, including a 1-week period of familiarization and choice of up to two products, appears no different to offering reduced cost and choice of nicotine replacement therapy, with no familiarization period. [ABSTRACT FROM AUTHOR]

The ultimate goal of alcohol treatment research is to develop interventions that help individuals reduce their alcohol use. To determine whether a treatment is effective, researchers must then evaluate whether a particular treatment affects changes in drinking behavior after treatment. Importantly, drinking following treatment tends to be highly variable between individuals and within individuals across time. Using data from the COMBINE study (), the current study compared 3 commonly used and novel methods for analyzing changes in drinking over time: latent growth curve (LGC) analysis, growth mixture models, and latent Markov models. Specifically, using self-reported drinking data from all participants ( n = 1,383, 69% male), we were interested in examining how well the 3 estimated models were able to explain observed changes in percent heavy drinking days during the 52 weeks following treatment. The results from all 3 models indicated that the majority of individuals were either abstinent or reported few heavy drinking days during the 52-week follow-up and only a minority of individuals (10% or fewer) reported consistently frequent heavy drinking following treatment. All 3 models provided a reasonably good fit to the observed data with the latent Markov models providing the closest fit. The observed drinking trajectories evinced discontinuity, whereby individuals seem to transition between drinking and nondrinking across adjacent follow-up assessment points. The LGC and growth mixture models both assumed continuous change and could not explain this discontinuity in the observed drinking trajectories, whereas the latent Markov approach explicitly modeled transitions between drinking states. The 3 models tested in the current study provided a unique look at the observed drinking among individuals who received treatment for alcohol dependence. Latent Markov modeling may be a highly desirable methodology for gaining a better sense of transitions between positive and negative drinking outcomes. [ABSTRACT FROM AUTHOR]