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Background: Very young children from lower socioeconomic status (SES) backgrounds often show poorer language development. Whilst there have been attempts to provide early intervention programmes, these sometimes miss the most disadvantaged groups. Aims: This report presents preliminary feasibility and effectiveness data for a novel language intervention designed for parents of toddlers in the United Kingdom. Methods and Procedures: In total, 43 UK families of 2–4‐year‐olds were recruited to the study, half of whom completed an 8‐week course (Tots Talking) focussed on parent interaction, and half of whom acted as wait‐list controls. Results and Outcomes: Results suggest that such programmes are feasible for families with 86% staying in the intervention. In addition, greater changes in underlying communication skills such as joint attention and gesture were evident compared to wait‐list controls. Conclusions and Implications: We conclude that pre‐verbal skills may be more important to measure as initial outcomes than language or vocabulary change in this population. What This Paper Adds: What is already known on the subject: Children from lower socioeconomic status (SES) backgrounds are at higher risk of communication difficulties and there is a need for community intervention programmes for very young children. What this study adds: This study suggests that such programmes can be feasible and effective, but that very early/basic communicative skills (such as joint attention) may be boosted first rather than language or vocabulary. What are the clinical implications of this work?: Children's centres and other community services could feasibly run short parent facing courses emphasising contingent communication in low SES families and other diverse groups. These may be more successful run with younger preschoolers. Joint attention may be a better focus of intervention before expecting vocabulary or language change. Community health professionals may find this information useful in referring and supporting families in need. [ABSTRACT FROM AUTHOR]

Restorative home-care services, or re-ablement home-care services as they are now known in the UK, aim to assist older individuals who are experiencing difficulties in everyday living to optimise their functioning and reduce their need for ongoing home care. Until recently, the effectiveness of restorative home-care services had only been investigated in terms of singular outcomes such as length of home-care episode, admission to hospital and quality of life. This paper reports on a more complex and perhaps more significant measure - the use and cost of the home-care and healthcare services received over the 2-year period following service commencement. Seven hundred and fifty older individuals referred for government-funded home care were randomly assigned to a restorative or standard service between June 2005 and August 2007. Health and aged care service data were sourced and linked via the Western Australian Data Linkage System. Restorative clients used fewer home-care hours (mean [ SD], 117.3 [129.4] vs. 191.2 [230.4]), had lower total home-care costs ( AU$5570 vs. AU$8541) and were less likely to be approved for a higher level of aged care ( N [%], 171 [55.2] vs. 249 [63.0]) during follow-up. They were also less likely to have presented at an emergency department ( OR = 0.69, 95% CI = 0.50-0.94) or have had an unplanned hospital admission [ OR (95% CI), 0.69 (0.50-0.95)]. Additionally, the aggregated health and home-care costs of the restorative clients were lower by a factor of 0.83 (95% CI 0.72-0.96) over the 2-year follow-up ( AU$19,090 vs. AU$23,428). These results indicate that at a time when Australia is facing the challenges of population ageing and an expected increase in demand for health and aged care services, the provision of a restorative service when an older person is referred for home care is potentially a more cost-effective option than providing conventional home care. [ABSTRACT FROM AUTHOR]

Objective: we estimated the cost-effectiveness of a community falls prevention service compared with usual care from a National Health Service and personal social services perspective over the 12 month trial period.Design: a cost-effectiveness and cost utility analysis alongside a randomised controlled trialSetting: community.Participants: people over 60 years of age living at home or in residential care who had fallen and called an emergency ambulance but were not taken to hospital.Interventions: referral to community fall prevention services or usual health and social care.Measurements: incremental cost per fall prevented and incremental cost per Quality-Adjusted Life Years (QALYs)Results: a total of 157 participants (82 interventions and 75 controls) were used to perform the economic evaluation. The mean difference in NHS and personal social service costs between the groups was £-1,551 per patient over 1 year (95% CI: £-5,932 to £2,829) comparing the intervention and control groups. The intervention patients experienced on average 5.34 fewer falls over 12 months (95% CI: −7.06 to −3.62). The mean difference in QALYs was 0.070 (95% CI: −0.010 to 0.150) in favour of the intervention group.Conclusion: the community falls prevention service was estimated to be cost-effective in this high-risk group. Current Controlled Trials ISRCTN67535605. (controlled-trials.com) [ABSTRACT FROM AUTHOR]

Aim: To determine the feasibility of a nurse‐led, primary care‐based comprehensive geriatric assessment (CGA) intervention. Design: A feasibility cluster randomized controlled trial. Methods: The trial was conducted in six general practices in the United Kingdom from May 2018 to April 2020. Participants were moderately/severely frail people aged 65 years and older living at home. Clusters were randomly assigned to the intervention arm control arms. A CGA was delivered to the intervention participants, with control participants receiving usual care. Study outcomes related to feasibility of the intervention and of conducting the trial including recruitment and retention. A range of outcome measures of quality of life, function, loneliness, self‐determination, mortality, hospital admission/readmission and number of prescribed medications were evaluated. Results: All pre‐specified feasibility criteria relating to recruitment and retention were met with 56 participants recruited in total (30 intervention and 26 control). Retention was high with 94.6% of participants completing 13‐week follow‐up and 87.5% (n = 49) completing 26‐week follow‐up. All outcome measures instruments met feasibility criteria relating to completeness and responsiveness over time. Quality of life was recommended as the primary outcome for a definitive trial with numbers of prescribed medications as a secondary outcome measure. Conclusion: It is feasible to implement and conduct a randomized controlled trial of a nurse‐led, primary care‐based CGA intervention. Impact: The study provided evidence on the feasibility of a CGA intervention for older people delivered in primary care. It provides information to maximize the success of a definitive trial of the clinical effectiveness of the intervention. Patient or Public Contribution: Patient and public representatives were involved in the study design including intervention development and production of participant‐facing documentation. Representatives served on the trial management and steering committees and, as part of this role, interpreted feasibility data. ISRCTN Number: 74345449. [ABSTRACT FROM AUTHOR]

Aims: Assess effectiveness of a hybrid intervention targeting physical activity in women with prior gestational diabetes. Methods: Randomised controlled trial with parallel arms. 293 women (35.1 ± 5.1 years; 40% ethnic minority) recruited from two hospitals and randomised to routine care or hybrid lifestyle intervention comprising two group sessions and access to a mobile web app. Primary outcome was a change in objectively measured physical activity at 12 months. Secondary outcomes included self‐efficacy for exercise, quality of life and anxiety and depression. Linear regression compared outcome measures between groups. Results: 83% of intervention participants attended at least one group session, of who 66% registered to use the app. There was a non‐significant increase in physical activity at 12 months (between‐group difference of 0.95 mg [95% CI: −0.46 to 2.37]), equivalent to approximately 500 steps per day. Intervention participants reported higher self‐efficacy for exercise (0.54, 95% CI: 0.05 to 1.102; p = 0.029), lower anxiety (−0.91, 95% CI: −1.74 to −0.09; p = 0.031), and higher quality of life (0.05, 95% CI: 0.004 to 0.09; p = 0.032), compared to controls. Conclusions: The intervention improved confidence in exercise and quality of life. Further research is needed to improve participant engagement with physical activity interventions in multi‐ethnic populations with a history of gestational diabetes. [ABSTRACT FROM AUTHOR]

Background The Early CDT®-Lung antibody blood test plus serial computed tomography scans for test-positives (TPGs) reduces late-stage lung cancer presentation. This study assessed the psychological outcomes of this approach. Methods Randomized controlled trial (n  = 12 208) comparing psychological outcomes 1–12 months post-recruitment in a subsample (n  = 1032) of TPG, test-negative (TNG) and control groups (CG). Results Compared to TNG, TPG had lower positive affect (difference between means (DBM), 3 months (3m: −1.49 (−2.65, − 0.33)), greater impact of worries (DBM 1m: 0.26 (0.05, 0.47); 3m: 0.28 (0.07, 0.50)), screening distress (DBM 1m: 3.59 (2.28, 4.90); 3m: 2.29 (0.97, 3.61); 6m: 1.94 (0.61, 3.27)), worry about tests (odds ratio (OR) 1m: 5.79 (2.66, 12.63) and more frequent lung cancer worry (OR 1m: 2.52 (1.31, 4.83); 3m: 2.43 (1.26, 4.68); 6m: 2.87 (1.48, 5.60)). Compared to CG, TPG had greater worry about tests (OR 1m: 3.40 (1.69, 6.84)). TNG had lower negative affect (log-transformed DBM 3m: −0.08 (−0.13, −0.02)), higher positive affect (DBM 1m: 1.52 (0.43, 2.61); 3m: 1.43 (0.33, 2.53); 6m: 1.27 (0.17, 2.37)), less impact of worries (DBM 3m: −0.27 (−0.48, −0.07)) and less-frequent lung cancer worry (OR 3m: 0.49 (0.26, 0.92)). Conclusions Negative psychological effects in TPG and positive effects in TNG were short-lived and most differences were small. [ABSTRACT FROM AUTHOR]

To assess the benefits of the Ida Institute's Why improve my hearing? Telecare Tool used before the initial hearing assessment appointment. A prospective, single-blind randomised clinical trial with two arms: (i) Why improve my hearing? Telecare Tool intervention, and (ii) standard care control. Adults with hearing loss were recruited from two Audiology Services within the United Kingdom's publicly-funded National Health Service. Of 461 individuals assessed for eligibility, 57 were eligible to participate. Measure of Audiologic Rehabilitation Self-efficacy for Hearing Aids (primary outcome) scores did not differ between groups from baseline to post-assessment (Mean change [Δ]= −2.28; 95% confidence interval [CI]= −6.70, 2.15, p=.307) and 10-weeks follow-up (Mean Δ= −2.69; 95% CI= −9.52, 4.15, p =.434). However, Short Form Patient Activation Measure scores significantly improved in the intervention group compared to the control group from baseline to post-assessment (Mean Δ= −6.06, 95% CI= −11.31, −0.82, p =.024, ES=.61) and 10-weeks follow-up (Mean Δ= −9.87, 95% CI= −15.34, −4.40, p =.001, ES= −.97). This study demonstrates that while a patient-centred telecare intervention completed before management decisions may not improve an individual's self-efficacy to manage their hearing loss, it can lead to improvements in readiness. [ABSTRACT FROM AUTHOR]

Little is known about the economic impact of military mental health screening. To investigate (a) whether post-deployment screening of military personnel affects use and cost of services and (b) the impact of psychiatric morbidity on costs. Participants were recruited from UK Royal Marine and Army platoons and randomised to an intervention group (which received tailored advice predicated upon mental health status) or a control group (which received general advice following assessment of mental health status). The intervention costs were calculated while service use and associated costs were assessed at 12-month follow-up. Data were available for 6323 participants. Mean screening cost was £34. Service costs were slightly higher in the control group compared to the intervention group (£1197 vs. £1147) which was not statistically significant (bootstrapped 95%CI, −£363 to £434. In both groups, screening and control, costs were significantly higher for those who screened positive for mental health problems. Costs were not affected by screening. In countries that have already implemented post-deployment screening, the political cost of disinvestment needs careful consideration. Those who develop psychiatric morbidity have substantially higher care costs than those who do not. [ABSTRACT FROM AUTHOR]

Objective: To test the feasibility of a telephone delivered intervention, informed by cognitive behavioural principles, for post-stroke fatigue, and estimated its effect on fatigue and other outcomes. Design: Randomised controlled parallel group trial. Setting: Three Scottish stroke services. Subjects: Stroke survivors with fatigue three months to two years post-stroke onset. Interventions: Seven telephone calls (fortnightly then a 'booster session' at 16 weeks) of a manualised intervention, plus information about fatigue, versus information only. Main measures: Feasibility of trial methods, and collected outcome measures (fatigue, mood, anxiety, social participation, quality of life, return to work) just before randomisation, at the end of treatment (four months after randomisation) and at six months after randomisation. Results: Between October 2018 and January 2020, we invited 886 stroke survivors to participate in postal screening: 188/886 (21%) returned questionnaires and consented, of whom 76/188 (40%) were eligible and returned baseline forms; 64/76 (84%) returned six month follow-up questionnaires. Of the 39 allocated the intervention, 23 (59%) attended at least four sessions. At six months, there were no significant differences between the groups (adjusted mean differences in Fatigue Assessment Scale −0.619 (95% CI −4.9631, 3.694; p = 0.768), the Generalised Anxiety Disorder 7 −0.178 (95% CI −3.823, 3.467, p = 0.92), and the Patient Health Questionnaire −0.247 (95% CI −2.935, 2.442, p = 0.851). There were no between-group differences in quality of life, social participation or return to work. Conclusion: Patients can be recruited to a trial of this design. These data will inform the design of further trials in post-stroke fatigue. [ABSTRACT FROM AUTHOR]

Aims: Debate continues as to the optimal orientation of the acetabular component in total hip arthroplasty (THA) and how to reliably achieve this. The primary objective of this study was to compare functional CT-based planning and patient-specific instruments with conventional THA using 2D templating. Methods: A pragmatic single-center, patient-assessor blinded, randomized control trial of patients undergoing THA was performed. 54 patients (aged 18–70) were recruited to either Corin Optimized Positioning System (OPS) or conventional THA. All patients received a cementless acetabular component. All patients underwent pre- and postoperative CT scans, and four functional X-rays. Patients in the OPS group had a 3D surgical plan and bespoke guides made. Patients in the conventional group had a surgical plan based on 2D templating X-rays. The primary outcome measure was the mean error in acetabular anteversion as determined by postoperative CT scan. Results: There was no statistically significant difference in the mean error in angle of acetabular anteversion when comparing OPS and conventional THA. In the OPS group, the achieved acetabular anteversion was within 10° of the planned anteversion in 96% of cases, compared with only 76% in the conventional group. The clinical outcomes were comparable between the groups. Conclusion: Large errors in acetabular orientation appear to be reduced when CT-based planning and patient-specific instruments are used compared to the standard technique but no significant differences were seen in the mean error. [ABSTRACT FROM AUTHOR]

Abstract: Background: The rise in the number of patients with arthritis coupled with understaffing of medical services has seen the deployment of Clinical Nurse Specialists in running nurse-led clinics alongside the rheumatologist clinics. There are no systematic reviews of nurse-led care effectiveness in rheumatoid arthritis. Few published RCTs exist and they have shown positive results for nurse-led care but they have several limitations and there has been no economic assessment of rheumatology nurse-led care in the UK. Objective: This paper outlines the study protocol and methodology currently being used to evaluate the outcomes and cost effectiveness for patients attending rheumatology nurse-led clinics. Design and methods: A multi-centred, pragmatic randomised controlled trial with a non-inferiority design; the null hypothesis being that of ‘inferiority’ of nurse-led clinics compared to physician-led clinics. The primary outcome is rheumatoid arthritis disease activity (measured by DAS28 score) and secondary outcomes are quality of life, self-efficacy, disability, psychological well-being, satisfaction, pain, fatigue and stiffness. Cost effectiveness will be measured using the EQ-5D, DAS28 and cost profile for each centre. Power calculations: In this trial, a DAS28 change of 0.6 is considered to be the threshold for clinical distinction of ‘inferiority’. A sample size of 180 participants (90 per treatment arm) is needed to reject the null hypothesis of ‘inferiority’, given 90% power. Primary analysis will focus on 2-sided 95% confidence interval evaluation of between-group differences in DAS28 change scores averaged over 4 equidistant follow up time points (13, 26, 39 and 52 weeks). Cost effectiveness will be evaluated assessing the joint parameterisation of costs and effects. Results: The study started in July 2007 and the results are expected after July 2011. Trial registration: The International Standard Randomised Controlled Trial Number ISRCTN29803766. [Copyright &y& Elsevier]

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]

Background User-testing and subsequent modification of clinical guidelines increases health professionals' information retrieval and comprehension. No study has investigated whether this results in safer care. Objective To compare the frequency of medication errors when administering an intravenous medicine using the current National Health Service Injectable Medicines Guide (IMG) versus an IMG version revised with user-testing. Method Single-blind, randomised parallel group in situ simulation. Participants were on-duty nurses/midwives who regularly prepared intravenous medicines. Using a training manikin in their clinical area, participants administered a voriconazole infusion, a high-risk medicine requiring several steps to prepare. They were randomised to use current IMG guidelines or IMG guidelines revised with user-testing. Direct observation was used to time the simulation and identify errors. Participant confidence was measured using a validated instrument. The primary outcome was the percentage of simulations with at least one moderate-severe IMG-related error, with error severity classified by an expert panel. Results In total, 133 participants were randomised to current guidelines and 140 to user-tested guidelines. Fewer moderate-severe IMG-related errors occurred with the user-tested guidelines (n=68, 49%) compared with current guidelines (n=79, 59%), but this difference was not statistically significant (risk ratio: 0.82; 95% CI 0.66 to 1.02). Significantly more simulations were completed without any IMG-related errors with the user-tested guidelines (n=67, 48%) compared with current guidelines (n=26, 20%) (risk ratio: 2.46; 95% CI 1.68 to 3.60). Median simulation completion time was 1.6 min (95% CI 0.2 to 3.0) less with the user-tested guidelines. Participants who used user-tested guidelines reported greater confidence. Conclusion User-testing injectable medicines guidelines reduces the number of errors and the time taken to prepare and administer intravenous medicines, while increasing staff confidence. [ABSTRACT FROM AUTHOR]

Background: Technological progress has enabled the provision of personalised feedback across multiple dimensions of physical activity that are important for health. Whether this multidimensional approach supports physical activity behaviour change has not yet been examined. Our objective was to examine the effectiveness of a novel digital system and app that provided multidimensional physical activity feedback combined with health trainer support in primary care patients identified as at risk of chronic disease. Methods: MIPACT was a parallel-group, randomised controlled trial that recruited patients at medium (≥10 and < 20%) or high (≥20%) risk of cardiovascular disease and/or type II diabetes from six primary care practices in the United Kingdom. Intervention group participants (n = 120) received personal multidimensional physical activity feedback using a customised digital system and web-app for 3 months plus five health trainer-led sessions. All participants received standardised information regarding physical activity. Control group participants (n = 84) received no further intervention. The primary outcome was device-based assessment of physical activity at 12 months. Results: Mean intervention effects were: moderate-vigorous physical activity: -1.1 (95% CI, − 17.9 to 15.7) min/day; moderate-vigorous physical activity in ≥10-min bouts: 0.2 (− 14.2 to 14.6) min/day; Physical Activity Level (PAL): 0.00 (− 0.036 to 0.054); vigorous physical activity: 1.8 (− 0.8 to 4.2) min/day; and sedentary time: 10 (− 19.3 to 39.3) min/day. For all of these outcomes, the results showed that the groups were practically equivalent and statistically ruled out meaningful positive or negative effects (>minimum clinically important difference, MCID). However, there was profound physical activity multidimensionality, and only a small proportion (5%) of patients had consistently low physical activity across all dimensions. Conclusion: In patients at risk of cardiovascular disease and/or type II diabetes, MIPACT did not increase mean physical activity. Using a sophisticated multidimensional digital approach revealed enormous heterogeneity in baseline physical activity in primary care patients, and practitioners may need to screen for low physical activity across dimensions rather than rely on disease-risk algorithms that are heavily influenced by age. Trial registration: This trial is registered with the ISRCTN registry (ISRCTN18008011; registration date 31 July 2013). [ABSTRACT FROM AUTHOR]

Background: Caregivers frequently provide support to people living with long-term conditions. However, there is paucity of evidence of interventions that support caregivers in their role. Rehabilitation EnAblement in Chronic Heart Failure (REACH-HF) is a novel home-based, health-professional-facilitated, self-management programme for patients with heart failure (HF) and their caregivers. Methods: Based on the random allocation of individual adult patients with reduced ejection fraction (HFrEF) and left ventricular ejection fraction <45% within the past five years, the caregiver of patients was allocated to receive the REACH-HF intervention over 12 weeks (REACH-HF group) or not (control group). Caregiver outcomes were generic health-related quality of life (EQ-5D-5L), Family Caregiver Quality of Life Scale questionnaire (FamQol), Caregiver Burden Questionnaire HF (CBQ-HF), Caregiver Contribution to Self-care of HF Index questionnaire (CC-SCHFI) and Hospital Anxiety and Depression Scale (HADS). Outcomes were compared between groups at 4, 6 and 12 months follow-up. Twenty caregivers receiving REACH-HF were purposively selected for qualitative interviews at 4 and 12 months. Results: Compared with controls (44 caregivers), the REACH-HF group (53 caregivers) had a higher mean CC-SCHFI confidence score at 12 months (57.5 vs 62.8, adjusted mean difference: 9.3, 95% confidence interval: 1.8–16.8, p = 0.016). No significant between group differences were seen in other caregiver outcomes. Qualitative interviews showed that most caregivers who received the REACH-HF intervention made positive changes to how they supported the HF patient they were caring for, and perceived that they had increased their confidence in the caregiver role over time. Conclusion: Provision of the REACH-HF intervention for caregivers of HF patients improved their confidence of self-management and was perceived for some to be helpful in supporting their caregiver role. [ABSTRACT FROM AUTHOR]

Objective: To assess the costs, effects, and cost-utility of an accelerated physiotherapy programme versus a standard physiotherapy programme following resurfacing hip arthroplasty. Design: A cost-utility analysis alongside a randomized controlled trial. Setting: A UK National Health Service hospital and patients' homes. Subjects: A total of 80 male resurfacing hip arthroplasty patients randomized post procedure to one of the two programmes. Interventions: The accelerated physiotherapy programme commenced in hospital with patients being fully weight bearing, without hip precautions, and following a range of exercises facilitating gait re-education, balance, and lower limb strength. Standard physiotherapy commenced in hospital, but hip precautions were used and exercises were only partially weight bearing. In both groups, patients continued with their exercises at home for an eight-week period. Main measures: Data on healthcare contacts were collected from patients to 12 months and costed using unit costs from national sources. Information was also collected on patients' costs. Health-related quality of life was measured using the EuroQol EQ-5D questionnaire and used to estimate quality-adjusted life years (QALYs) to 12 months. Mean costs and QALYs for each trial arm were compared. Results: On average, the accelerated physiotherapy programme was less expensive (mean cost difference −£200; 95% confidence interval: −£656 to £255) and more effective (mean QALY difference 0.13; 95% confidence interval: 0.05 to 0.21) than standard physiotherapy and had a high probability of being cost-effective. Conclusion: From the National Health Service perspective, an accelerated physiotherapy programme for male patients undergoing revision of total hip arthroplasty (RHA) is very likely to be cost-effective when compared to a standard physiotherapy programme. [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: To evaluate the feasibility of a multicentre randomized controlled trial of ReaDySpeech, an online speech therapy programme for people with dysarthria. Design: Feasibility randomized controlled trial, 2:1 minimization procedure. Setting: Four UK NHS services across hospital and community. Participants: Forty participants with dysarthria at least one week post-stroke. Interventions/comparator: ReaDySpeech with usual care (n = 26) versus usual care only (n = 14). Main outcomes: Feasibility measures included the following: recruitment and retention rate, time taken to carry out assessments, success of outcome assessor blinding, fidelity and adherence. Participant baseline and outcome measures collected before and after 8-10 weeks of intervention were the Frenchay Dysarthria Assessment II, Therapy Outcome Measure, Communication Outcomes After Stroke Scale, EQ-5D-5L and Dysarthria Impact Profile. Results: Recruited 40 participants out of 74 eligible people, 1-13 weeks post stroke and mean age 69 years (37-99). Retention was very high (92%). Assessor blinding was not achieved with intervention allocation correctly guessed for 70% of participants (26/37). Time to carry out assessments was acceptable to participants. ReaDySpeech was delivered to 16 of 26 allocated participants, who completed 55% of prescribed activities, but both interventions were delivered at low intensity (mean 6.6 face-to-face sessions of 40-minute duration). Conclusion: Recruitment and retention in this randomized controlled trial of computerized therapy for dysarthria is feasible for acute stroke. However, further feasibility work is needed to evaluate whether it is possible to recruit chronic stroke; increase intervention delivery, intensity and adherence; achieve outcome assessor blinding by video-recording and to determine sample size for a larger trial of effectiveness. [ABSTRACT FROM AUTHOR]

Abstract: Background: Dysphagia is common after stroke, affecting up to 50% of patients initially. It can lead to post‐stroke pneumonia, which causes 30% of stroke‐related deaths, a longer hospital stay and poorer health outcomes. Dysphagia care post‐stroke generally focuses on the management of symptoms, via modified oral intake textures and adapted posture, rather than direct physical rehabilitation of the swallowing function. Transcutaneous neuromuscular electrical stimulation (NMES) is a promising rehabilitation technology that can be used to stimulate swallowing; however, findings regarding efficacy have been conflicting. Aims: This pilot randomized controlled study involving three UK sites compared the efficacy of the Ampcare Effective Swallowing Protocol (ESP), combining NMES with swallow‐strengthening exercises, with usual care in order to clarify evidence on NMES in the treatment of dysphagia post‐stroke. A further objective was to pilot recruitment procedures and outcome measures in order to inform the design of a full‐scale trial. Methods & Procedures: Thirty patients were recruited and randomized into either (1) usual speech and language therapy dysphagia care; or (2) Ampcare ESP, receiving treatment 5 days/week for 4 weeks. Outcome measures included: the Functional Oral Intake Scale (FOIS), the Rosenbek Penetration‐Aspiration Scale (PAS) and patient‐reported outcomes (Swallow Related Quality of Life—SWAL‐QOL). Outcomes & Results: Thirty patients were recruited; 15 were randomized to the Ampcare ESP intervention arm and 15 to usual care. A greater proportion (75%, or 9/12) of patients receiving Ampcare ESP improved compared with 57% (or 8/14) of the usual‐care group. Patients receiving Ampcare ESP also made clinically meaningful change (a comparative benefit of 1.5 on the FOIS, and on the PAS: 1.35 for diet and 0.3 for fluids) compared with usual care. The intervention group also reported much better outcome satisfaction. Conclusions & Implications: The pilot demonstrated successful recruitment, treatment safety and tolerability and clinically meaningful outcome improvements, justifying progression to a fully powered study. It also showed clinically meaningful treatment trends for the Ampcare ESP intervention. [ABSTRACT FROM AUTHOR]

Background and Aims Naloxone is an opioid antagonist used for emergency resuscitation following opioid overdose. Prisoners with a history of heroin injection have a high risk of drug-related death soon after release from prison. The NALoxone InVEstigation (N-ALIVE) pilot trial (ISRCTN34044390) tested feasibility measures for randomized provision of naloxone-on-release (NOR) to eligible prisoners in England. Design. Parallel-group randomized controlled pilot trial. Setting English prisons. Participants A total of 1685 adult heroin injectors, incarcerated for at least 7 days pre-randomization, release due within 3 months and more than 6 months since previous N-ALIVE release. Intervention Using 1 : 1 minimization, prisoners were randomized to receive on release a pack containing either a single 'rescue' injection of naloxone or a control pack with no syringe. Measurements Key feasibility outcomes were tested against prior expectations: on participation (14 English prisons; 2800 prisoners), consent (75% for randomization), returned prisoner self-questionnaires (RPSQs: 207), NOR-carriage (75% in first 4 weeks) and overdose presence (80%). Findings Prisons (16) and prisoners (1685) were willing to participate [consent rate, 95% confidence interval (CI) = 70-74%]; 218 RPSQs were received; NOR-carriage (95% CI = 63-79%) and overdose presence (95% CI = 75-84%) were as expected. We randomized 842 to NOR and 843 to control during 30 months but stopped early, because only one-third of NOR administrations were to the ex-prisoner. Nine deaths within 12 weeks of release were registered for 1557 randomized participants released before 9 December 2014. Conclusions Large randomized trials are feasible with prison populations. Provision of take-home emergency naloxone prior to prison release may be a life-saving interim measure to prevent heroin overdose deaths among ex-prisoners and the wider population. [ABSTRACT FROM AUTHOR]

Objectives To design and evaluate the effectiveness of a pre-notification leaflet about research to increase recruitment to a randomized controlled trial (RCT). Methods A methodological, two-arm, RCT was conducted, embedded within an existing cohort RCT (REFORM). Participants were randomized for the embedded trial, using a 1:2 ratio (intervention : control) before being randomized for REFORM. Controls received a trial recruitment pack. The intervention group received an additional pre-notification leaflet 2-3 weeks before the recruitment pack. Primary and secondary analyses were conducted using relative risk, the Cox proportional hazards model and incremental cost-effectiveness ratios. Results Of the 1436 intervention group participants, 73 (5.1%) were randomized into the REFORM trial compared with 126 (4.4%) of the 2878 control group participants. The associated relative risk (1.16) was not statistically significant [95% confidence interval (CI) 0.88-1.56]. Return rate was not significantly increased (relative risk 1.10, 95% CI 0.92-1.28) nor time to return decreased (hazard ratio: 1.11, 95% CI 0.93-1.33). Incremental cost-effectiveness ratios indicated the intervention may be cost-effective if the true estimate of effect was close to the upper bound of the associated 95% CI. Conclusion Pre-notification for potential trial participants demonstrated a small difference to randomization (0.7% difference) and return rates (1.1% difference) in favour of the intervention. Results should however be interpreted with caution as CIs for these estimates cross the point of no effect. Nevertheless, this research enhances existing evidence for pre-notification to increase recruitment rates, with further development and assessment of this potentially cost-effective intervention being recommended. [ABSTRACT FROM AUTHOR]

Background Opioid substitution treatment (OST) reduces the harm of injecting and opioid dependence. The SCID feasibility trial explored the processes of conducting a randomized control trial (RCT) with people who inject drugs (PWID) in a low-threshold agency. Feasibility of the intervention investigated whether offering PWID immediate access to OST via specialist primary care increased numbers in OSTat 3 months, compared with offering advice and case management. Methods Un-blinded RCTwas conducted at Bristol Drugs Project needle exchange. A total of 311 individuals were eligible and 100 consented to participate. Trial process outcomes involved exploring OST status at 3 months; secondary outcomes were substance use and health-related quality of life measures. Results Follow-up was 86%. At 3 months, 51% intervention and 47% of control participants were in OST (OR of success of intervention 1.17 (0.54-2.57)). Opioid use reduced by 79 and 73%, respectively (OR of intervention success 1.38 (0.5-3.7)). Physical and mental health improved but there was little differences between groups. Conclusions The feasibility of conducting the trial was a success, but there was insufficient evidence of an effect compared with intensive case management. Further development and evaluation of case management approaches in low-threshold agencies is warranted. [ABSTRACT FROM AUTHOR]

Aims To determine whether the provision of contingencymanagement using financial incentives to improve hepatitis B vaccine completion in people who inject drugs entering community treatment represents a cost-effective use of healthcare resources. Design A probabilistic cost-effectiveness analysis was conducted, using a decision-tree to estimate the short-term clinical and health-care cost impact of the vaccination strategies, followed by a Markov process to evaluate the long-term clinical consequences and costs associated with hepatitis B infection. Settings and participants Data on attendance to vaccination from a UK cluster randomized trial. Intervention Two contingency management options were examined in the trial: fixed versus escalating schedule financial incentives. Measurement Life-time health-care costs and quality-adjusted life years discounted at 3.5% annually; incremental cost-effectiveness ratios. Findings The resulting estimate for the incremental life-time health-care cost of the contingency management strategy versus usual care was £21.86 [95% confidence interval (CI) = -£12.20 to 39.86] per person offered the incentive. For 1000 people offered the incentive, the incremental reduction in numbers of hepatitis B infections avoided over their lifetime was estimated at 19 (95% CI = 8-30). The probabilistic incremental cost per quality adjusted life-year gained of the contingency management programmewas estimated to be £6738 (95% CI = £6297-7172),with an 89% probability of being considered cost-effective at a threshold of £20 000 per quality-adjusted life years gained (97.60% at £30 000). Conclusions Using financial incentives to increase hepatitis B vaccination completion in people who inject drugs could be a cost-effective use of health-care resources in the UK as long as the incidence remains above 1.2%. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to determine whether combining potential biomarkers of fruit and vegetables is better at predicting FV intake within FV intervention studies than single biomarkers. Design: Data from a tightly controlled randomised FV intervention study (BIOFAV; all food provided and two meals/day on weekdays consumed under supervision) were used. A total of 30 participants were randomised to either 2, 5 or 8 portions FV/day for 4 weeks, and blood samples were collected at baseline and 4 weeks for plasma vitamin C and serum carotenoid analysis. The combined biomarker approach was also tested in three further FV intervention studies conducted by the same research team, with less strict dietary control (FV provided and no supervised meals). Results: The combined model containing all carotenoids and vitamin C was a better fit than either the vitamin C only ( P < 0.001) model or the lutein only ( P = 0.006) model in the BIOFAV study. The C-statistic was slightly lower in the lutein only model (0.85) and in the model based upon factor analysis (0.88), and much lower in the vitamin C model (0.68) compared with the full model (0.95). Results for the other studies were similar, although the differences between the models were less marked. Conclusions: Although there was some variation between studies, which may relate to the level of dietary control or participant characteristics, a combined biomarker approach to assess overall FV consumption may more accurately predict FV intake within intervention studies than the use of a single biomarker. The generalisability of these findings to other populations and study designs remains to be tested. Clinical trial Registration Number NCT01591057 (). [ABSTRACT FROM AUTHOR]

Background Heavy alcohol use during pregnancy can cause considerable developmental problems for children, but effects of light-moderate drinking are uncertain. This study examined possible effects of moderate drinking in pregnancy on children's conduct problems using a Mendelian randomisation design to improve causal inference. Methods A prospective cohort study ( ALSPAC) followed children from their mother's pregnancy to age 13 years. Analyses were based on 3,544 children whose mothers self-reported either not drinking alcohol during pregnancy or drinking up to six units per week without binge drinking. Children's conduct problem trajectories were classified as low risk, childhood-limited, adolescence-onset or early-onset-persistent, using six repeated measures of the Strengths and Difficulties Questionnaire between ages 4-13 years. Variants of alcohol-metabolising genes in children were used to create an instrumental variable for Mendelian randomisation analysis. Results Children's genotype scores were associated with early-onset-persistent conduct problems ( OR = 1.29, 95% CI = 1.04-1.60, p = .020) if mothers drank moderately in pregnancy, but not if mothers abstained from drinking ( OR = 0.94, CI = 0.72-1.25, p = .688). Children's genotype scores did not predict childhood-limited or adolescence-onset conduct problems. Conclusions This quasi-experimental study suggests that moderate alcohol drinking in pregnancy contributes to increased risk for children's early-onset-persistent conduct problems, but not childhood-limited or adolescence-onset conduct problems. [ABSTRACT FROM AUTHOR]

Purpose: Selenium is an essential trace mineral and a component of selenoproteins that are involved in the production of thyroid hormones and in regulating the immune response. We aimed to explore the effect of low-dose selenium supplementation on thyroid peroxidase antibody (TPO-Ab) concentration and thyroid function in pregnant women from a mild-to-moderate iodine-deficient population. Methods: Samples and data were from a secondary analysis of Selenium in PRegnancy INTervention (SPRINT), a double-blind, randomized, placebo-controlled study that recruited 230 women with singleton pregnancies from a UK antenatal clinic at 12 weeks of gestation. Women were randomized to receive 60 µg/day selenium or placebo until delivery. Serum thyroid peroxidase antibodies (TPO-Ab), thyrotropin (TSH) and free thyroxine (FT4) were measured at 12, 20 and 35 weeks and thyroglobulin antibodies (Tg-Ab) at 12 weeks. Results: 93.5 % of participants completed the study. Se supplementation had no more effect than placebo in decreasing TPO-Ab concentration or the prevalence of TPO-Ab positivity during the course of pregnancy. In women who were either TPO-Ab or Tg-Ab negative at baseline (Thy-Ab), TSH increased and FT4 decreased significantly throughout gestation ( P < 0.001), with no difference between treatment groups. In women who were Thy-Ab at baseline, TSH tended to decrease and was lower than placebo at 35 weeks ( P = 0.050). FT4 fell more on Se than placebo supplementation and was significantly lower at 35 weeks ( P = 0.029). Conclusions: Low-dose selenium supplementation in pregnant women with mild-to-moderate deficiency had no effect on TPO-Ab concentration, but tended to change thyroid function in Thy-Ab women. [ABSTRACT FROM AUTHOR]

The article discusses research which compared effectiveness of ciclosporin and prednisolone in treating pyoderma gangrenosum. Topics explored include the speed of ulcer healing associated with these drugs, the daily drug dosage administered to research participants, and the adverse reactions recorded in both treatment groups such as acute kidney injury and infection.

The article presents a study on the occupational therapy intervention for residents with stroke related conditions in care homes in Great Britain. Topics covered include the Barthel index of activities of daily living, an individualized course of occupational therapy targeting stroke related disabilities, and cognitive impairment.

Background: The BeWEL (BodyWEight and physicaL activity) randomised controlled trial demonstrated that a weight management programme offered in the colorectal cancer screening setting was effective. However, the differential responses of participants to the programme were notable. This study aimed to explore the factors associated with success and to identify implications for future programme design. Methods: Analyses were conducted of quantitative data (n= 148) from the BeWEL intervention group to compare demographic and psychosocial characteristics and lifestyle changes in those who met and exceeded the target 7 % weight loss ('super-achievers') with those who achieved only 'moderate' or low' amounts of weight loss (2-7 % loss, or <2 % loss, respectively). In-depth qualitative interviews (n = 24) explored in detail the motivations, actions, pathways to weight loss and circumstances of study participants. Results: Over the 12 month intervention period, mean percentage weight loss of super-achievers (n = 33) was 11.5 %, compared with moderate-achievers (n = 58) who lost 4.2 %, and low-achievers (n = 57) who gained 0.8 %. Compared to other groups, super- achievers increased their fruit and vegetable intake (p < 0.01) and physical activity (step count, p < 0.01). 'Super-achievers' did not differ in baseline demographic characteristics from other participants. However, significantly fewer reported that their activities were limited by physical and emotional health and they were more likely to perceive their current diet as harmful. Qualitative analyses found no consistent patterns among super-achievers in relation to some factors identified as important in previous studies, such as social support. However, super-achievers shared several characteristics such as determination and consistency in their engagement with the intervention, receptivity to new information and prompts, previous positive experience of changing health behaviours, being motivated by early success, making changes routine, and an ability to devise and apply strategies for dealing with setback and 'relapse' triggers. Conclusions: Successful lifestyle change depends on active engagement as well as effective intervention ingredients. Weight loss interventions are likely to be more effective where they can adapt to participants' differing characteristics and needs, while also providing core elements likely to build success. [ABSTRACT FROM AUTHOR]

BackgroundThere is an increasing interest in cognitive–behavioural therapy (CBT) interventions targeting negative symptoms in schizophrenia. To date, CBT trials primarily focused on positive symptoms and investigated change in negative symptoms only as a secondary outcome. To enhance insight into factors contributing to improvement of negative symptoms, and to identify subgroups of patients that may benefit most from CBT directed at ameliorating negative symptoms, we reviewed all available evidence on these outcomes.MethodA systematic search of the literature was conducted in PsychInfo, PubMed and the Cochrane register to identify randomized controlled trials reporting on the impact of CBT interventions on negative symptoms in schizophrenia. Random-effects meta-analyses were performed on end-of-treatment, short-term and long-term changes in negative symptoms.ResultsA total of 35 publications covering 30 trials in 2312 patients, published between 1993 and 2013, were included. Our results showed studies’ pooled effect on symptom alleviation to be small [Hedges’ g = 0.093, 95% confidence interval (CI) −0.028 to 0.214, p = 0.130] and heterogeneous (Q = 73.067, degrees of freedom = 29, p < 0.001, τ2 = 0.081, I2 = 60.31) in studies with negative symptoms as a secondary outcome. Similar results were found for studies focused on negative symptom reduction (Hedges’ g = 0.157, 95% CI −0.10 to 0.409, p = 0.225). Meta-regression revealed that stronger treatment effects were associated with earlier year of publication, lower study quality and with CBT provided individually (as compared with group-based).ConclusionsThe co-occurring beneficial effect of conventional CBT on negative symptoms found in older studies was not supported by more recent studies. It is now necessary to further disentangle effective treatment ingredients of older studies in order to guide the development of future CBT interventions aimed at negative symptom reduction. [ABSTRACT FROM PUBLISHER]

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 discusses a study which examined whether operative or non-operative treatment leads to better outcomes in patients with typical displaced intra-articular calcaneal fractures. Topics covered include the allocation of patients to open reduction and internal fixation with a plate and screws, the similarity of Kerr-Atkins scores for calcaneal fracture between the operative and non-operative groups and the complications experienced by patients in the operative group.

The article discusses research which examined the cost effectiveness of STrAtegies for RelaTives (START) manual based coping intervention for family carers of people with dementia. The differences between START intervention and usual treatment groups in treatment and cost impacts and effectiveness are presented. Findings include lower Hospital Anxiety and Depression Scale total (HADS-T) in the intervention group.

The article presents information on the effect of using high facilitation while implementing the Gold Standards Framework in Care Homes programme in Great Britain. It was hypothesised that implementing the programme will help in reducing hospital deaths for residents. It is concluded that without national guidelines, facilitation of the programme will vary and its implementation.

Background. Extracurricular programmes could provide a mechanism to increase the physical activity (PA) of primary-school-aged children. The aim of this feasibility study was to examine whether the Action 3:30 intervention, which is delivered by teaching assistants, holds promise as a means of increasing the PA of Year 5 and 6 children. Methods. A cluster randomised feasibility trial was conducted in 20 primary schools. Ten schools received the Action 3:30 intervention and 10 schools were allocated to the control arm. The intervention was 40 one-hour sessions, delivered twice a week by teaching assistants. The proportion of participants recruited per school was calculated. Session delivery and session attendance was calculated for intervention schools. Weekday and after-school (3.30 to 8.30 pm) moderate to vigorous intensity physical (MVPA) was assessed by accelerometer at baseline (T0), during the last few weeks of the intervention (T1) and four months after the intervention had ended (T2). The costs of delivering the intervention were estimated. Results. Five intervention schools ran all 40 of the intended sessions. Of the remaining five, three ran 39, one ran 38 and one ran 29 sessions. Mean attendance was 53%. The adjusted difference in weekday MVPA at T1 was 4.3 minutes (95% CI −2.6 to 11.3). Sex-stratified analyses indicated that boys obtained 8.6 more minutes of weekday MVPA than the control group (95% CI 2.8 to 14.5) at T1 with no effect for girls (0.15 minutes, 95% CI −9.7 to 10.0). There was no evidence that participation in the programme increased MVPA once the club sessions ceased (T2). The indicative average cost of this intervention was £2,425 per school or £81 per participating child during its first year and £1,461 per school or £49 per participating child thereafter. Conclusions. The effect of the Action 3:30 interventions was comparable to previous physical activity interventions but further analysis indicated that there was a marked sex difference with a positive impact on boys and no evidence of an effect on girls. The Action 3:30 intervention holds considerable promise but more work is needed to enhance the effectiveness of the intervention, particularly for girls. [ABSTRACT FROM AUTHOR]

Background Current academic literature suggests that school gardening programmes can provide an interactive environment with the potential to change children’s fruit and vegetable intake. This is the first cluster randomised controlled trial (RCT) designed to evaluate whether a school gardening programme can have an effect on children’s fruit and vegetable intake. Methods The trial included children from 23 schools; these schools were randomised into two groups, one to receive the Royal Horticultural Society (RHS)-led intervention and the other to receive the less involved Teacher-led intervention. A 24-hour food diary (CADET) was used to collect baseline and follow-up dietary intake 18 months apart. Questionnaires were also administered to evaluate the intervention implementation. Results A total of 641 children completed the trial with a mean age of 8.1 years (95%CI: 8.0, 8.4). The unadjusted results from multilevel regression analysis revealed that for combined daily fruit and vegetable intake the Teacher-led group had a higher daily mean change of 8 g (95%CI: −19, 36) compared to the RHS-led group -32 g (95%CI: −60, −3). However, after adjusting for possible confounders this difference was not significant (intervention effect: −40 g, 95%CI: −88, 1; p = 0.06). The adjusted analysis of process measures identified that if schools improved their gardening score by 3 levels (a measure of school gardening involvement - the scale has 6 levels from 0 ‘no garden’ to 5 ‘community involvement’), irrespective of group allocation, children had, on average, a daily increase of 81 g of fruit and vegetable intake (95%CI: 0, 163; p = 0.05) compared to schools that had no change in gardening score. Conclusions This study is the first cluster randomised controlled trial designed to evaluate a school gardening intervention. The results have found very little evidence to support the claims that school gardening alone can improve children’s daily fruit and vegetable intake. However, when a gardening intervention is implemented at a high level within the school it may improve children’s daily fruit and vegetable intake by a portion. Improving children’s fruit and vegetable intake remains a challenging task. [ABSTRACT FROM AUTHOR]

Pre-eclampsia is a serious hypertensive condition of pregnancy associated with high maternal and fetal morbidity and mortality. Se intake or status has been linked to the occurrence of pre-eclampsia by our own work and that of others. We hypothesised that a small increase in the Se intake of UK pregnant women of inadequate Se status would protect against the risk of pre-eclampsia, as assessed by biomarkers of pre-eclampsia. In a double-blind, placebo-controlled, pilot trial, we randomised 230 primiparous pregnant women to Se (60 μg/d, as Se-enriched yeast) or placebo treatment from 12 to 14 weeks of gestation until delivery. Whole-blood Se concentration was measured at baseline and 35 weeks, and plasma selenoprotein P (SEPP1) concentration at 35 weeks. The primary outcome measure of the present study was serum soluble vascular endothelial growth factor receptor-1 (sFlt-1), an anti-angiogenic factor linked with the risk of pre-eclampsia. Other serum/plasma components related to the risk of pre-eclampsia were also measured. Between 12 and 35 weeks, whole-blood Se concentration increased significantly in the Se-treated group but decreased significantly in the placebo group. At 35 weeks, significantly higher concentrations of whole-blood Se and plasma SEPP1 were observed in the Se-treated group than in the placebo group. In line with our hypothesis, the concentration of sFlt-1 was significantly lower at 35 weeks in the Se-treated group than in the placebo group in participants in the lowest quartile of Se status at baseline (P= 0·039). None of the secondary outcome measures was significantly affected by treatment. The present finding that Se supplementation has the potential to reduce the risk of pre-eclampsia in pregnant women of low Se status needs to be validated in an adequately powered trial. [ABSTRACT FROM PUBLISHER]

BackgroundCognitive remediation (CR) preceding cognitive–behavioural therapy for psychosis (CBTp) was trialled within routine clinical services, with the hypothesis that following first-episode non-affective psychosis CR would enhance CBTp efficacy by improving neuropsychological performance.MethodA total of 61 patients with DSM-IV non-affective psychoses waiting for routine CBTp were randomized to computerized CR over 12 weeks, supported by a trained support worker, or time-matched social contact (SC). Primary outcome was the blind-rated Psychotic Symptoms Rating Scale (PSYRATS). Secondary outcomes included measures of CBTp progress, cognition, symptoms, insight and self-esteem: all at baseline, after CR (12 weeks) and after CBTp (42 weeks). PSYRATS and global neuropsychological efficacy were tested using mixed-effects models with a group × time interaction term. Measures of CBTp progress and some neuropsychological measures were modelled by regression.ResultsThere was no significant difference between the CR and SC groups in PSYRATS (group × time coefficient 0.3, 95% confidence interval −0.4 to 1.1, p = 0.39). However, after CR CBTp was shorter [median 7 sessions, interquartile range (IQR) 2–12 after CR; median 13, IQR 4–18 after SC; model p = 0.011] and linked to better insight (p = 0.02). Global cognition did not improve significantly more after CR (p = 0.20) but executive function did (Wisconsin Card Sort, p = 0.012).ConclusionsCBTp courses preceded by CR were far shorter but achieved the same outcome as CBTp preceded by an active control, consistent with neuropsychological improvement enhancing CBTp. CR was delivered by staff with minimal training, offering the potential to reduce the costs of CBTp considerably. [ABSTRACT FROM AUTHOR]

Background: home-based telecare (TC) is utilised to manage risks of independent living and provide prompt emergency responses. This study examined the effect of TC on health-related quality of life (HRQoL), anxiety and depressive symptoms over 12 months in patients receiving social care.Design: a study of participant-reported outcomes [the Whole Systems Demonstrator (WSD) Telecare Questionnaire Study; baseline n = 1,189] was nested in a pragmatic cluster-randomised trial of TC (the WSD Telecare trial), held across three English Local Authorities. General practice (GP) was the unit of randomisation and TC was compared with usual care (UC).Methods: participant-reported outcome measures were collected at baseline, short-term (4 months) and long-term (12 months) follow-up, assessing generic HRQoL, anxiety and depressive symptoms. Primary intention-to-treat analyses tested treatment effectiveness and were conducted using multilevel models to control for GP clustering and covariates for participants who completed questionnaire measures at baseline assessment plus at least one other assessment (n = 873).Results: analyses found significant differences between TC and UC on Short Form-12 mental component scores (P < 0.05), with parameter estimates indicating being a member of the TC trial-arm increases mental component scores (UC-adjusted mean = 40.52; TC-adjusted mean = 43.69). Additional significant analyses revealed, time effects on EQ5D (decreasing over time) and depressive symptoms (increasing over time).Conclusions: TC potentially contributes to the amelioration in the decline in users’ mental HRQoL over a 12-month period. TC may not transform the lives of its users, but it may afford small relative benefits on some psychological and HRQOL outcomes relative to users who only receive UC.International Standard Randomised Controlled Trial Number Register: ISRCTN 43002091. [ABSTRACT FROM AUTHOR]

Background: Unintentional injury is the leading cause of preventable death in children in the UK, and 0-4- year-olds frequently attend emergency departments following injuries in the home. Parenting programmes designed to support parents, promote behaviour change and enhance parent-child relationships have been shown to improve health outcomes in children. It is not known whether group-based parenting programmes have the potential to prevent unintentional injuries in preschool children. Methods: A study to develop a group-based parenting programme to prevent unintentional home injuries in preschool children, and assess the feasibility of evaluation through a cluster-randomised controlled trial. The intervention, designed for parents of children who have sustained a medically attended injury, will be developed with two voluntary sector organisations. The feasibility study will assess ability to recruit parents, deliver the programme and follow-up participants. Participants will complete questionnaires at baseline, 3 months and 6 months, and report injuries in their preschool children using a tool designed and validated for this study. Qualitative methods will assess user and deliverer perceptions of the programme. Discussion: This study will develop the first group-based parenting programme to prevent injuries in preschool children, and design tools for parent-reported injury outcomes. A key challenge will be to recruit parents to participate in a manner that is nonstigmatising, and does not result in feelings of guilt or belief that they are perceived to be a bad parent. The findings will be used to prepare a trial to assess the effectiveness and cost-effectiveness of the intervention. [ABSTRACT FROM AUTHOR]

Summary: Evidence suggests that increased fruit and vegetable (FV) intake may be associated with improved bone health, but there is limited evidence from intervention trials to support this. This 16-week study showed that increased FV consumption (five or more portions per day) does not have any effect on the markers of bone health in older adults. Introduction: Observational evidence suggests that increased FV consumption may be associated with improved bone health. However, there is lack of evidence from intervention trials to support this. This study examined the effect of increased FV consumption on bone markers among healthy, free-living older adults. Methods: A randomised controlled trial was undertaken. Eighty-three participants aged 65-85 years, habitually consuming less than or equal to two portions of FV per day, were randomised to continue their normal diet or to consume five or more portions of FV per day for 16 weeks. FV were delivered to all participants each week, free of charge. Compliance was assessed at baseline and at 6, 12 and 16 weeks by diet histories and biomarkers of micronutrient status. Fasting serum bone markers (osteocalcin (OC) and C-terminal telopeptide of type 1 collagen (CTX)) were measured using enzyme-linked immunosorbent assay. Results: Eighty-two participants completed the intervention. The five portions per day group showed a significantly greater change in daily FV consumption compared to the two portions per day group ( p < 0.001), and this was reflected in significant increases in micronutrient status. No significant differences were evident in change in bone markers between the two portions per day group and the five portions per day group over the 16 weeks (geometric mean of week 16 to baseline ratio (95% confidence interval): OC-0.95 (0.89-1.02) and 1.04 (0.91-1.18), respectively, p = 0.25; CTX-1.06 (0.95-1.19) and 0.98 (0.90-1.06) respectively, p = 0.20). Conclusions: Increased FV consumption had no effect on bone markers in older adults. Larger intervention studies of longer duration are warranted to establish whether long-term FV consumption can benefit bone health. [ABSTRACT FROM AUTHOR]

In this article, the authors focus on the multicentre randomised controlled trial (ROSSINI Trial) related to the impact of a wound edge protection device (WEPD) on surgical site infection in patients after laparotomy. According to the trial, WEPDs are not useful in reducing the rate of surgical site infection and patients diagnosed with an infection experienced longer hospital stay. They also mention that they carried out secondary analyses on the basis of contamination during operation.

The article focuses on a study to investigate the role of a specialist medical and mental health unit (MMHU) in improving outcomes, experience, and satisfaction for older people with dementia or delirium admitted to an acute hospital as compared to standard care. A randomised controlled trial was compared with a specialist medical and mental health unit providing best practice care with standard hospital wards. The study took place in a single centre in Great Britain which provided sole acute hospital medical services for its population.

Objectives We investigated the treatment effects reported from a high-quality randomized controlled trial of cognitive behavioural therapy ( CBT) for 106 people with borderline personality disorder attending community-based clinics in the UK National Health Service - the BOSCOT trial. Specifically, we examined whether the amount of therapy and therapist competence had an impact on our primary outcome, the number of suicidal acts, using instrumental variables regression modelling. Design Randomized controlled trial. Participants from across three sites ( London, Glasgow, and Ayrshire/ Arran) were randomized equally to CBT for personality disorders ( CBTpd) plus Treatment as Usual or to Treatment as Usual. Treatment as Usual varied between sites and individuals, but was consistent with routine treatment in the UK National Health Service at the time. CBTpd comprised an average 16 sessions (range 0-35) over 12 months. Method We used instrumental variable regression modelling to estimate the impact of quantity and quality of therapy received (recording activities and behaviours that took place after randomization) on number of suicidal acts and inpatient psychiatric hospitalization. Results A total of 101 participants provided full outcome data at 2 years post randomization. The previously reported intention-to-treat ( ITT) results showed on average a reduction of 0.91 (95% confidence interval 0.15-1.67) suicidal acts over 2 years for those randomized to CBT. By incorporating the influence of quantity of therapy and therapist competence, we show that this estimate of the effect of CBTpd could be approximately two to three times greater for those receiving the right amount of therapy from a competent therapist. Conclusions Trials should routinely control for and collect data on both quantity of therapy and therapist competence, which can be used, via instrumental variable regression modelling, to estimate treatment effects for optimal delivery of therapy. Such estimates complement rather than replace the ITT results, which are properly the principal analysis results from such trials. Practitioner points Assessing the impact of the quantity and quality of therapy (competence of therapists) is complex., More competent therapists, trained in CBTpd, may significantly reduce the number of suicidal act in patients with borderline personality disorder. [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]

Background: Many children spend too much time screen-viewing (watching TV, surfing the internet and playing video games) and do not meet physical activity (PA) guidelines. Parents are important influences on children's PA and screen-viewing (SV). There is a shortage of parent-focused interventions to change children's PA and SV. Methods: Teamplay was a two arm individualized randomized controlled feasibility trial. Participants were parents of 6-8 year old children. Intervention participants were invited to attend an eight week parenting program with each session lasting 2 hours. Children and parents wore an accelerometer for seven days and minutes of moderate-to- vigorous intensity PA (MVPA) were derived. Parents were also asked to report the average number of hours per day that both they and the target child spent watching TV. Measures were assessed at baseline (time 0) at the end of the intervention (week 8) and 2 months after the intervention had ended (week 16). Results: There were 75 participants who provided consent and were randomized but 27 participants withdrew post-randomization. Children in the intervention group engaged in 2.6 fewer minutes of weekday MVPA at Time 1 but engaged in 11 more minutes of weekend MVPA. At Time 1 the intervention parents engaged in 9 more minutes of weekday MVPA and 13 more minutes of weekend MVPA. The proportion of children in the intervention group watching ? 2 hours per day of TV on weekend days decreased after the intervention (time 0 = 76%, time 1 = 39%, time 2 = 50%), while the control group proportion increased slightly (79%, 86% and 87%). Parental weekday TV watching decreased in both groups. In post-study interviews many mothers reported problems associated with wearing the accelerometers. In terms of a future full-scale trial, a sample of between 80 and 340 families would be needed to detect a mean difference of 10-minutes of weekend MVPA. Conclusions: Teamplay is a promising parenting program in an under-researched area. The intervention was acceptable to parents, and all elements of the study protocol were successfully completed. Simple changes to the trial protocol could result in more complete data collection and study engagement. [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]