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Effects of Integrated Brain, Body, and Social (IBBS) intervention on ERP measures of attentional control in children with ADHD
© 2019 A primary goal of this study was to examine the impact of an Integrated Brain, Body, and Social (IBBS) intervention (multi-faceted treatment consisting of computerized cognitive training, physical exercise, and behavior management) on ERPs of attentional control (P3 & N2) in children with ADHD. The secondary goal was to test the differences between children with and without ADHD on ERP and Go/No-Go behavioral measures. A total of twenty-nine participants (M age = 7.14 years; 52% male; 41.4% white) recruited from the IBBS efficacy study comparing IBBS to Treatment-As-Usual (TAU) completed a Go/No-Go task before and after treatment as brain activity was recorded using EEG. Thirty-four matched healthy controls (HC) completed the same EEG procedures at a single time point. Following treatment, the Go P3 latency was significantly earlier for the IBBS group relative to the TAU group. No treatment effects were found on any behavioral measures. Prior to treatment, there was a significant difference between the ADHD group and HC group for the N2 difference wave. Children with ADHD also showed slower reaction times on behavioral measures. Although this pilot study did not reveal robust treatment effects, it suggests that IBBS may prevent the worsening of attentional systems in the brain and larger studies are needed for replication purposes.
Author Correction: Adaptive platform trials: definition, design, conduct and reporting considerations (Nature Reviews Drug Discovery, (2019), 10.1038/s41573-019-0034-3)
© 2019, Springer Nature Limited. The name of an author, Alex John London, has been corrected.
Citizen and staff involvement in health service decision-making: Have National Health Service foundation trusts in England given stakeholders a louder voice?
Objectives: National Health Service (NHS) foundation trusts have been created to decentralize the management of NHS provider organizations through the substitution of central government control with local accountability to citizens and employed staff. Our aim was to explore the roles adopted by elected and appointed governors of a first wave NHS foundation trust and the extent to which governors shared power with trust directors and influenced the management of the trust. Methods: A one-year case study of a single NHS foundation trust (Homerton Hospital in East London) was conducted. Data were collected using face-to-face interviews with a sample of governors and directors, as well as through non-participant observation of public and private meetings of governors and documentary analysis. Results: Governors and directors found the new role of foundation trust governor ambiguous and difficult to define. This lack of clarity impeded the development of the new governance function. Governors perceived that they had made little impact on the decisions of the Trust during the year of study. However, evidence was found of an increased involvement of governors and the public in the activities of the Trust. Conclusions: Government plans to decentralize accountability of public hospitals to local communities appear problematic, at least in the short term. Unless the effectiveness of the new local governance arrangements is addressed, an accountability 'gap' may emerge as prior mechanisms for public accountability to the centre are dismantled. In diese circumstances, decentralization may lead in practice to a loss of public accountability. © The Royal Society of Medicine Press Ltd 2008.
How do GPs and patients share the responsibility for cancer safety netting follow-up actions? A qualitative interview study of GPs and patients in Oxfordshire, UK.
OBJECTIVE: To explore patients' and General Practitioners' (GPs) accounts of how responsibility for follow-up was perceived and shared in their experiences of cancer safety netting occurring within the past 6 months. DESIGN: In-depth interviews were recorded and transcribed verbatim. Data were analysed through an abductive process, exploring anticipated and emergent themes. Conceptualisations of 'responsibility' were explored by drawing on a transactional to interdependent continuum drawing from the shared decision-making literature. SETTINGS AND PARTICIPANTS: A purposive sample of 25 qualified GPs and 23 adult patients in Oxfordshire, UK. RESULTS: The transactional sharing approach involves responsibility being passed from GP to patient. Patients expected and were willing to accept responsibility in this way as long as they received clear guidance from their GP and had capacity. In interdependent sharing, GPs principally aimed to reach consensus and share responsibility with the patient by explaining their rationale, uncertainty or by stressing the potential seriousness of the situation. Patients sharing this responsibility could be put at risk if no follow-up or timeframe was suggested, they had inadequate information, were falsely reassured or their concerns were not addressed at re-consultation. CONCLUSION: GPs and patients exchange and share responsibility using a combination of transactional and interdependent styles, tailoring information based on patient characteristics and each party's level of concern. Clear action plans (written where necessary) at the end of every consultation would help patients decide when to re-consult. Further research should investigate how responsibility is shared within and outside the consultation, within primary care teams and with specialist services.
Current understanding and implementation of 'care navigation' across England: a cross-sectional study of NHS clinical commissioning groups.
BACKGROUND: Care navigation is an avenue to link patients to activities or organisations that can help address non-medical needs affecting health and wellbeing. An understanding of how care navigation is being implemented across primary care is lacking. AIM: To determine how 'care navigation' is interpreted and currently implemented by clinical commissioning groups (CCGs). DESIGN AND SETTING: A cross-sectional study involving CCGs in England. METHOD: A questionnaire was sent to all CCGs inviting them to comment on who provided care navigation, the type of patients for whom care navigation was provided, how individuals were referred, and whether services were being evaluated. Responses were summarised using descriptive statistics. RESULTS: The authors received usable responses from 83% of CCGs (n = 162), and of these >90% (n = 147) had some form of care navigation running in their area. A total of 75 different titles were used to describe the role. Most services were open to all adult patients, though particular groups may have been targeted; for example, people who are older and those with long-term conditions. Referrals tended to be made by a professional, or people were identified by a receptionist when they presented to a surgery. Evaluation of care navigation services was limited. CONCLUSION: There is a policy steer to engaging patients in social prescribing, using some form of care navigator to help with this. Results from this study highlight that, although this type of role is being provided, its implementation is heterogeneous. This could make comparison and the pooling of data on care navigation difficult. It may also leave patients unsure about what care navigation is about and how it could help them.
© 2019 The Cochrane Collaboration. Background Motivational Interviewing (MI) is a directive patient-centred style of counselling, designed to help people to explore and resolve ambivalence about behaviour change. It was developed as a treatment for alcohol abuse, but may help people to a make a successful attempt to stop smoking. Objectives To evaluate the efficacy of MI for smoking cessation compared with no treatment, in addition to another form of smoking cessation treatment, and compared with other types of smoking cessation treatment. We also investigated whether more intensive MI is more effective than less intensive MI for smoking cessation. Search methods We searched the Cochrane Tobacco Addiction Group Specialised Register for studies using the term motivat* NEAR2 (interview* OR enhanc* OR session* OR counsel* OR practi* OR behav*) in the title or abstract, or motivation* as a keyword. We also searched trial registries to identify unpublished studies. Date of the most recent search: August 2018. Selection criteria Randomised controlled trials in which MI or its variants were offered to smokers to assist smoking cessation. We excluded trials that did not assess cessation as an outcome, with follow-up less than six months, and with additional non-MI intervention components not matched between arms. We excluded trials in pregnant women as these are covered elsewhere. Data collection and analysis We followed standard Cochrane methods. Smoking cessation was measured after at least six months, using the most rigorous definition available, on an intention-to-treat basis. We calculated risk ratios (RR) and 95% confidence intervals (CI) for smoking cessation for each study, where possible. We grouped eligible studies according to the type of comparison. We carried out meta-analyses where appropriate, using Mantel-Haenszel random-effects models. We extracted data on mental health outcomes and quality of life and summarised these narratively. Main results We identified 37 eligible studies involving over 15,000 participants who smoked tobacco. The majority of studies recruited participants with particular characteristics, often from groups of people who are less likely to seek support to stop smoking than the general population. Although a few studies recruited participants who intended to stop smoking soon or had no intentions to quit, most recruited a population without regard to their intention to quit. MI was conducted in one to 12 sessions, with the total duration of MI ranging from five to 315 minutes across studies. We judged four of the 37 studies to be at low risk of bias, and 11 to be at high risk, but restricting the analysis only to those studies at low or unclear risk did not significantly alter results, apart from in one case-our analysis comparing higher to lower intensity MI. We found low-certainty evidence, limited by risk of bias and imprecision, comparing the effect of MI to no treatment for smoking cessation (RR = 0.84, 95% CI 0.63 to 1.12; I2 = 0%; adjusted N = 684). One study was excluded from this analysis as the participants recruited (incarcerated men) were not comparable to the other participants included in the analysis, resulting in substantial statistical heterogeneity when all studies were pooled (I2 = 87%). Enhancing existing smoking cessation support with additional MI, compared with existing support alone, gave an RR of 1.07 (95% CI 0.85 to 1.36; adjusted N = 4167; I2 = 47%), and MI compared with other forms of smoking cessation support gave an RR of 1.24 (95% CI 0.91 to 1.69; I2 = 54%; N = 5192). We judged both of these estimates to be of low certainty due to heterogeneity and imprecision. Low-certainty evidence detected a benefit of higher intensity MI when compared with lower intensity MI (RR 1.23, 95% CI 1.11 to 1.37; adjusted N = 5620; I2 = 0%). The evidence was limited because three of the five studies in this comparison were at risk of bias. Excluding them gave an RR of 1.00 (95% CI 0.65 to 1.54; I2 = n/a; N = 482), changing the interpretation of the results. Mental health and quality of life outcomes were reported in only one study, providing little evidence on whether MI improves mental well-being. Authors’ conclusions There is insufficient evidence to show whether or not MI helps people to stop smoking compared with no intervention, as an addition to other types of behavioural support for smoking cessation, or compared with other types of behavioural support for smoking cessation. It is also unclear whether more intensive MI is more effective than less intensive MI. All estimates of treatment effect were of low certainty because of concerns about bias in the trials, imprecision and inconsistency. Consequently, future trials are likely to change these conclusions. There is almost no evidence on whether MI for smoking cessation improves mental well-being.
Ursodeoxycholic acid versus placebo in women with intrahepatic cholestasis of pregnancy (PITCHES): a randomised controlled trial
© 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license Background: Intrahepatic cholestasis of pregnancy, characterised by maternal pruritus and increased serum bile acid concentrations, is associated with increased rates of stillbirth, preterm birth, and neonatal unit admission. Ursodeoxycholic acid is widely used as a treatment without an adequate evidence base. We aimed to evaluate whether ursodeoxycholic acid reduces adverse perinatal outcomes in women with intrahepatic cholestasis of pregnancy. Methods: We did a double-blind, multicentre, randomised placebo-controlled trial at 33 hospital maternity units in England and Wales. We recruited women with intrahepatic cholestasis of pregnancy, who were aged 18 years or older and with a gestational age between 20 weeks and 40 weeks and 6 days, with a singleton or twin pregnancy and no known lethal fetal anomaly. Participants were randomly assigned 1:1 to ursodeoxycholic acid or placebo, given as two oral tablets a day at an equivalent dose of 500 mg twice a day. The dose could be increased or decreased at the clinician's discretion, to a maximum of four tablets and a minimum of one tablet a day. We recommended that treatment should be continued from enrolment until the infant's birth. The primary outcome was a composite of perinatal death (in-utero fetal death after randomisation or known neonatal death up to 7 days after birth), preterm delivery (<37 weeks' gestation), or neonatal unit admission for at least 4 h (from birth until hospital discharge). Each infant was counted once within this composite. All analyses were done according to the intention-to-treat principle. The trial was prospectively registered with the ISRCTN registry, number 91918806. Findings: Between Dec 23, 2015, and Aug 7, 2018, 605 women were enrolled and randomly allocated to receive ursodeoxycholic acid (n=305) or placebo (n=300). The primary outcome analysis included 304 women and 322 infants in the ursodeoxycholic acid group, and 300 women and 318 infants in the placebo group (consent to use data was withdrawn for 1 woman and 2 infants). The primary composite outcome occurred in 74 (23%) of 322 infants in the ursodeoxycholic acid group and 85 (27%) of 318 infants in the placebo group (adjusted risk ratio 0·85 [95% CI 0·62–1·15]). Two serious adverse events were reported in the ursodeoxycholic acid group and six serious adverse events were reported in the placebo group; no serious adverse events were regarded as being related to treatment. Interpretation: Treatment with ursodeoxycholic acid does not reduce adverse perinatal outcomes in women with intrahepatic cholestasis of pregnancy. Therefore, its routine use for this condition should be reconsidered. Funding: National Institute for Health Research Efficacy and Mechanism Evaluation Programme.
BACKGROUND:Poorly described placebo/sham controls inhibit appraisal of active intervention benefits and harms. The 12-item Template for Intervention Description and Replication (TIDieR) checklist was developed to improve the reporting of active intervention components. The extent to which TIDieR is used to guide description of placebo or sham control is not known. MATERIALS AND METHODS:We examined all placebo/sham-controlled randomised trials published in 2018 in the top six general medical journals. We reported how many of the TIDieR checklist items they used to describe the placebo/sham control(s). We supplemented this with a sample of 100 placebo/sham-controlled trials from any journal, and searched Google Scholar to identify placebo/sham-controlled trials citing TIDieR. RESULTS:We identified 94 placebo/sham-controlled trials published in the top journals in 2018; none reported using TIDieR. On average 8 items were addressed, with placebo/sham control name (100%) and when and how much was administered (97.9%) most commonly reported. Some items (rationale, 8.5%, whether there were modifications, 25.5%) were less often reported. In our sample of less well cited journals, reporting was poorer (average of 6 items) and followed a similar pattern. Since TIDieR's first publication, six placebo-controlled trials have cited it according to Google Scholar; two of these used the checklist to describe placebo controls. CONCLUSIONS:Placebo and sham controls are poorly described within randomised trials, and TIDieR is rarely used to guide these descriptions. We recommend developing guidelines to promote better descriptions of placebo/sham control components within clinical trials.
Long-term effects of functional appliances in treated versus untreated patients with Class II malocclusion: A systematic review and meta-analysis.
OBJECTIVE: To assess the cephalometric skeletal and soft-tissue of functional appliances in treated versus untreated Class II subjects in the long-term (primarily at the end of growth, secondarily at least 3 years after retention). SEARCH METHODS: Unrestricted electronic search of 24 databases and additional manual searches up to March 2018. SELECTION CRITERIA: Randomised and non-randomised controlled trials reporting on cephalometric skeletal and soft-tissue measurements of Class II patients (aged 16 years or under) treated with functional appliances, worn alone or in combination with multi-bracket therapy, compared to untreated Class II subjects. DATA COLLECTION AND ANALYSIS: Mean differences (MDs) and 95% confidence intervals (95% CIs) were calculated with the random-effects model. Data were analysed at 2 primary time points (above 18 years of age, at the end of growth according to the Cervical Vertebral Maturation method) and a secondary time point (at least 3 years after retention). The risk of bias and quality of evidence were assessed according to the ROBINS tool and GRADE system, respectively. RESULTS: Eight non-randomised studies published in 12 papers were included. Functional appliances produced a significant improvement of the maxillo-mandibular relationship, at almost all time points (Wits appraisal at the end of growth, MD -3.52 mm, 95% CI -5.11 to -1.93, P < 0.0001). The greatest increase in mandibular length was recorded in patients aged 18 years and above (Co-Gn, MD 3.20 mm, 95% CI 1.32 to 5.08, P = 0.0009), although the improvement of the mandibular projection was negligible or not significant. The quality of evidence was 'very low' for most of the outcomes at both primary time points. CONCLUSIONS: Functional appliances may be effective in correcting skeletal Class II malocclusion in the long-term, however the quality of the evidence was very low and the clinical significance was limited. SYSTEMATIC REVIEW REGISTRATION: CRD42018092139.
Potential impact on prevalence of obesity in the UK of a 20% price increase in high sugar snacks: modelling study.
OBJECTIVE: To estimate the potential impact on body mass index (BMI) and prevalence of obesity of a 20% price increase in high sugar snacks. DESIGN: Modelling study. SETTING: General adult population of the United Kingdom. PARTICIPANTS: 36 324 households with data on product level household expenditure from UK Kantar FMCG (fast moving consumer goods) panel for January 2012 to December 2013. Data were used to estimate changes in energy (kcal, 1 kcal=4.18 kJ=0.00418 MJ) purchase associated with a 20% price increase in high sugar snacks. Data for 2544 adults from waves 5 to 8 of the National Diet and Nutrition Survey (2012-16) were used to estimate resulting changes in BMI and prevalence of obesity. MAIN OUTCOME MEASURES: The effect on per person take home energy purchases of a 20% price increase for three categories of high sugar snacks: confectionery (including chocolate), biscuits, and cakes. Health outcomes resulting from the price increase were measured as changes in weight, BMI (not overweight (BMI <25), overweight (BMI ≥25 and <30), and obese (BMI ≥30)), and prevalence of obesity. Results were stratified by household income and BMI. RESULTS: For income groups combined, the average reduction in energy consumption for a 20% price increase in high sugar snacks was estimated to be 8.9×103 kcal (95% confidence interval -13.1×103 to -4.2×103 kcal). Using a static weight loss model, BMI was estimated to decrease by 0.53 (95% confidence interval -1.01 to -0.06) on average across all categories and income groups. This change could reduce the UK prevalence of obesity by 2.7 percentage points (95% confidence interval -3.7 to -1.7 percentage points) after one year. The impact of a 20% price increase in high sugar snacks on energy purchase was largest in low income households classified as obese and smallest in high income households classified as not overweight. CONCLUSIONS: Increasing the price of high sugar snacks by 20% could reduce energy intake, BMI, and prevalence of obesity. This finding was in a UK context and was double that modelled for a similar price increase in sugar sweetened beverages.