Waking Up in Pain: a prospective unselected cohort study of pain in 3702 patients immediately after surgery in the Danish Realm.

BACKGROUND: Acute and persistent pain after surgery is well described. However, no large-scale studies on immediate postoperative pain in the operating room (OR) exist, hindering potential areas of research to improve clinical outcomes. Thus, we aimed to describe the occurrence and severity of immediate postoperative pain in a large, unselected cohort. METHODS: This was a prospective cohort study, encompassing all procedures in 31 public hospitals in the Danish Realm, during a 5-day period including the weekend. Data on procedures and anesthesia were collected and the main outcome was occurrence of moderate or severe pain in the OR. Secondary outcomes included pain, sedation and nausea in the OR or during the first 15 min in the postanesthesia care unit (PACU) including relevant risk factors. Descriptive and logistic regression statistics were used. RESULTS: A total of 3675 procedures were included for analysis (87% inclusion rate). Moderate or severe pain occurred in 7.4% (95% CI 6.5% to 8.3%) of cases in the OR immediately after awakening, rising to 20.2% in the OR and/or PACU. Large intraprocedure and interprocedure variations occurred (0.0%-37.5%), and in 20% of cases with epidural-general anesthesia patients experienced moderate or severe pain. Independent risk factors were female sex, younger age, preoperative pain, daily opioid use and major surgical procedures. CONCLUSION: Moderate or severe pain in the immediate postoperative phase occurred in 20% of all cases with procedure and anesthesiological technique variations, suggesting a need for identification of relevant procedure-specific risk factors and development of preventive treatments. TRIAL REGISTRATION NUMBER: RoPR ID 43191.

Intraoperative clonidine for prevention of postoperative agitation in children anaesthetised with sevoflurane (PREVENT AGITATION): a randomised, placebo-controlled, double-blind trial.

BACKGROUND: Postoperative agitation is a frequent and stressful condition for a child, their family, and their health-care providers, and prevention would be of benefit. We aimed to assess the effects of intravenous clonidine administered intraoperatively on the incidence of postoperative agitation, pain, and adverse events. METHODS: We did this randomised, placebo-controlled, double-blind trial (PREVENT AGITATION) at one tertiary-level hospital and two urban-district hospitals in Denmark. Children aged 1-5 years, with an American Society of Anesthesiologists physical classification score of 1-2, who were scheduled for anaesthesia with sevoflurane and fentanyl were randomly assigned (1:1) in blocks of ten by computer-generated centralised randomisation, stratified by age (<2 years or ≥2 years) and site, to receive either intravenous clonidine 3 µg/kg or an equal quantity of isotonic saline in identical vials, administered around 20 min before the completion of surgery. Data were collected from the postoperative care unit (24 h) and at follow-up (30 days). Our primary outcome was the proportion of patients with one or more episodes of postoperative agitation, measured every 15 min in the postoperative care unit (POCU) with the four-point Watcha scale (ie, Watcha >2). We analysed by intention to treat. The trial is registered with ClinicalTrials.gov (number NCT02361476). FINDINGS: Between January and December, 2015, of the 379 eligible children, we randomly assigned 191 to receive clonidine treatment and 188 to receive placebo; 75 were girls (20%). Nine were excluded from the primary outcome analysis because of missing data points. 46 (25%) of 187 clonidine participants compared with 86 (47%) of 183 placebo participants had one or more episodes of postoperative agitation (Watcha score >2; relative risk 0·56, 95% CI 0·43-0·73; p<0·0001). 30 (20%) of 150 boys in the clonidine group were agitated compared with 69 (47%) of 147 boys in the placebo group (0·43, 0·30-0·61; p<0·0001). The observed effect was not significant in girls. Incidence of adverse events was similar in the clonidine and placebo groups. INTERPRETATION: On the basis of our results, clonidine might be used to safely prevent postoperative agitation in boys anaesthetised with sevoflurane. FUNDING: Danish Society of Anaesthesia and Intensive Care.

Cluster randomised controlled trial of a theory-based multiple behaviour change intervention aimed at healthcare professionals to improve their management of type 2 diabetes in primary care.

BACKGROUND: National diabetes audits in the UK show room for improvement in the quality of care delivered to people with type 2 diabetes in primary care. Systematic reviews of quality improvement interventions show that such approaches can be effective but there is wide variability between trials and little understanding concerning what explains this variability. A national cohort study of primary care across 99 UK practices identified modifiable predictors of healthcare professionals' prescribing, advising and foot examination. Our objective was to evaluate the effectiveness of an implementation intervention to improve six guideline-recommended health professional behaviours in managing type 2 diabetes in primary care: prescribing for blood pressure and glycaemic control, providing physical activity and nutrition advice and providing updated diabetes education and foot examination. METHODS: Two-armed cluster randomised trial involving 44 general practices. Primary outcomes (at 12 months follow-up): from electronic medical records, the proportion of patients receiving additional prescriptions for blood pressure and insulin initiation for glycaemic control and having a foot examination; and from a patient survey of a random sample of 100 patients per practice, reported receipt of updated diabetes education and physical activity and nutrition advice. RESULTS: The implementation intervention did not lead to statistically significant improvement on any of the six clinical behaviours. 1,138,105 prescriptions were assessed. Intervention (29% to 37% patients) and control arms (31% to 35%) increased insulin initiation relative to baseline but were not statistically significantly different at follow-up (IRR 1.18, 95%CI 0.95-1.48). Intervention (45% to 53%) and control practices (45% to 50%) increased blood pressure prescription from baseline to follow-up but were not statistically significantly different at follow-up (IRR 1.05, 95%CI 0.96 to 1.16). Intervention (75 to 78%) and control practices (74 to 79%) increased foot examination relative to baseline; control practices increased statistically significantly more (OR 0.84, 95%CI 0.75-0.94). Fewer patients in intervention (33%) than control practices (40%) reported receiving updated diabetes education (OR = 0.74, 95%CI 0.57-0.97). No statistically significant differences were observed in patient reports of having had a discussion about nutrition (intervention = 73%; control = 72%; OR = 0.98, 95%CI 0.59-1.64) or physical activity (intervention = 57%; control = 62%; OR = 0.79, 95%CI 0.56-1.11). Development and delivery of the intervention cost £1191 per practice. CONCLUSIONS: There was no measurable benefit to practices' participation in this intervention. Despite widespread use of outreach interventions worldwide, there is a need to better understand which techniques at which intensity are optimally suited to address the multiple clinical behaviours involved in improving care for type 2 diabetes. TRIAL REGISTRATION: ISRCTN, ISRCTN66498413 . Registered April 4, 2013.

Acoustic changes in the speech of children with cerebral palsy following an intensive program of dysarthria therapy.

BACKGROUND: The speech intelligibility of children with dysarthria and cerebral palsy has been observed to increase following therapy focusing on respiration and phonation. AIMS: To determine if speech intelligibility change following intervention is associated with change in acoustic measures of voice. METHODS & PROCEDURES: We recorded 16 young people with cerebral palsy and dysarthria (nine girls; mean age 14 years, SD = 2; nine spastic type, two dyskinetic, four mixed; one Worster-Drought) producing speech in two conditions (single words, connected speech) twice before and twice after therapy focusing on respiration, phonation and rate. In both single-word and connected speech we measured vocal intensity (root mean square-RMS), period-to-period variability (Shimmer APQ, Jitter RAP and PPQ) and harmonics-to-noise ratio (HNR). In connected speech we also measured mean fundamental frequency, utterance duration in seconds and speech and articulation rate (syllables/s with and without pauses respectively). All acoustic measures were made using Praat. Intelligibility was calculated in previous research. OUTCOMES & RESULTS: In single words statistically significant but very small reductions were observed in period-to-period variability following therapy: Shimmer APQ -0.15 (95% CI = -0.21 to -0.09); Jitter RAP -0.08 (95% CI = -0.14 to -0.01); Jitter PPQ -0.08 (95% CI = -0.15 to -0.01). No changes in period-to-period perturbation across phrases in connected speech were detected. However, changes in connected speech were observed in phrase length, rate and intensity. Following therapy, mean utterance duration increased by 1.11 s (95% CI = 0.37-1.86) when measured with pauses and by 1.13 s (95% CI = 0.40-1.85) when measured without pauses. Articulation rate increased by 0.07 syllables/s (95% CI = 0.02-0.13); speech rate increased by 0.06 syllables/s (95% CI = < 0.01-0.12); and intensity increased by 0.03 Pascals (95% CI = 0.02-0.04). There was a gradual reduction in mean fundamental frequency across all time points (-11.85 Hz, 95% CI = -19.84 to -3.86). Only increases in the intensity of single words (0.37 Pascals, 95% CI = 0.10-0.65) and reductions in fundamental frequency (-0.11 Hz, 95% CI = -0.21 to -0.02) in connected speech were associated with gains in intelligibility. CONCLUSIONS & IMPLICATIONS: Mean reductions in impairment in vocal function following therapy observed were small and most are unlikely to be clinically significant. Changes in vocal control did not explain improved intelligibility.

A randomised controlled trial of losartan as an anti-fibrotic agent in non-alcoholic steatohepatitis.

INTRODUCTION: Non-alcoholic fatty liver disease (NAFLD) is a common liver disease worldwide. Experimental and small clinical trials have demonstrated that angiotensin II blockers (ARB) may be anti-fibrotic in the liver. The aim of this randomised controlled trial was to assess whether treatment with Losartan for 96 weeks slowed, halted or reversed the progression of fibrosis in patients with non-alcoholic steatohepatitis (NASH). METHODS: Double-blind randomised-controlled trial of Losartan 50 mg once a day versus placebo for 96 weeks in patients with histological evidence of NASH. The primary outcome for the study was change in histological fibrosis stage from pre-treatment to end-of-treatment. RESULTS: The study planned to recruit 214 patients. However, recruitment was slower than expected, and after 45 patients were randomised (median age 55; 56% male; 60% diabetic; median fibrosis stage 2), enrolment was suspended. Thirty-two patients (15 losartan and 17 placebo) completed follow up period: one patient (6.7%) treated with losartan and 4 patients (23.5%) in the placebo group were "responders" (lower fibrosis stage at follow up compared with baseline). The major reason for slow recruitment was that 39% of potentially eligible patients were already taking an ARB or angiotensin converting enzyme inhibitor (ACEI), and 15% were taking other prohibited medications. CONCLUSIONS: Due to the widespread use of ACEI and ARB in patients with NASH this trial failed to recruit sufficient patients to determine whether losartan has anti-fibrotic effects in the liver. TRIAL REGISTRATION: ISRCTN 57849521.

[Lactic acidosis in a 24-year-old woman with status asthmaticus].

A 24-year-old woman with asthma presented with symptoms of upper airway infection and tachypnoea and wheezes. She had a history of admissions to intensive care units (ICU) due to respiratory insufficiency. The initial lactate concentration was 2.1 mmol/l. The treatment consisted of inhaled and intravenous ß ² agonists. Hereafter, the lactate concentration rose to 9.8 mmol/l, and the patient was admitted to the ICU due to severe asthma exacerbation. The elevation of lactate concentration cleared after discontinuation of ß ² agonist therapy. Although lactic acidosis is a rare side effect to ß ² agonist treatment, it is important to recog-nize it when present.

Effect of clonidine to prevent agitation in children after sevoflurane anaesthesia: a randomised placebo controlled multicentre trial.

INTRODUCTION: Post-operative agitation (PA) is a common problem (20-70%) in children anaesthetised with sevoflur-ane. Clonidine is widely used off-label in children for several indications, including PA, but the current level of evidence is limited. Our aim is to investigate the impact of prophylactic intravenous (IV) clonidine administered at the end of surgery on the incidence and degree of PA. Furthermore, the pharmacokinetic profile of IV clonidine in children is not well established and our aim is to obtain pharmacokinetic data relating hereto. METHODS: This is a multicentre, randomised and blinded clinical trial in which we will be enrolling 380 children aged 1-5 years who are planned for anaesthesia with sevoflurane and fentanyl. Inclusion is based on computer-generated randomisation (1:1) and stratified by age and site. The study drug is administered IV approximately 20 min. before the expected completion of surgery (intervention: clonidine 3 µg per kg; placebo: equal quantity of saline). CONCLUSION: The primary outcome is PA measured on the Watcha scale. The secondary outcomes include post-operative pain relief and adverse effects, including a 30-day follow-up. In total, 40 children will be allocated to drug assay sampling, enabling a compartmental pharmacokinetic analysis. FUNDING: Funded by the participating departments and by two unrestricted scientific grants from the Danish Society of Anaesthesia and Intensive. TRIAL REGISTRATION: This study was approved by the Danish Health and Medicines Authority (EudraCT number 2014-001466-10), the Ethics Committee of the Capital Region of Denmark (H-2-2014-072) and registered with Clinicaltrials.gov (NCT02361476).

Antidepressant augmentation with metyrapone for treatment-resistant depression (the ADD study): a double-blind, randomised, placebo-controlled trial.

BACKGROUND: Many patients with major depressive disorder have treatment-resistant depression, defined as no adequate response to two consecutive courses of antidepressants. Some evidence suggests that antiglucocorticoid augmentation of antidepressants might be efficacious in patients with major depressive disorder. We aimed to test the proof of concept of metyrapone for the augmentation of serotonergic antidepressants in the clinically relevant population of patients with treatment-resistant depression. METHODS: This double-blind, randomised, placebo-controlled trial recruited patients from seven UK National Health Service (NHS) Mental Health Trusts from three areas (northeast England, northwest England, and the Leeds and Bradford area). Eligible patients were aged 18-65 years with treatment-resistant depression (Hamilton Depression Rating Scale 17-item score of ≥18 and a Massachusetts General Hospital Treatment-Resistant Depression staging score of 2-10) and taking a single-agent or combination antidepressant treatment that included a serotonergic drug. Patients were randomly assigned (1:1) through a centralised web-based system to metyrapone (500 mg twice daily) or placebo, in addition to their existing antidepressant regimen, for 21 days. Permuted block randomisation was done with a block size of two or four, stratified by centre and primary or secondary care setting. The primary outcome was improvement in Montgomery-Åsberg Depression Rating Scale (MADRS) score 5 weeks after randomisation, analysed in the modified intention-to-treat population of all randomly assigned patients that completed the MADRS assessment at week 5. The study has an International Standard Randomised Controlled Trial Number (ISRCTN45338259) and is registered with the EU Clinical Trial register, number 2009-015165-31. FINDINGS: Between Feb 8, 2011, and Dec 10, 2012, 165 patients were recruited and randomly assigned (83 to metyrapone and 82 to placebo), with 143 (87%) completing the primary outcome assessment (69 [83%] in the metyrapone and 74 [90%] in the placebo group). At 5 weeks, MADRS score did not significantly differ between groups (21·7 points [95% CI 19·2-24·4] in the metyrapone group vs 22·6 points [20·1-24·8] in the placebo group; adjusted mean difference of -0·51 points [95% CI -3·48 to 2·46]; p=0·74). 12 serious adverse events were reported in four (5%) of 83 patients in the metyrapone group and six (7%) of 82 patients in the placebo group, none of which were related to study treatment. 134 adverse events occurred in 58 (70%) patients in the metyrapone group compared with 95 events in 45 (55%) patients in the placebo group, of which 11 (8%) events in the metyrapone group and four (4%) in the placebo group were judged by principle investigators at the time of occurrence to be probably related to the study drug. INTERPRETATION: Metyrapone augmentation of antidepressants is not efficacious in a broadly representative population of patients with treatment-resistant depression within the NHS and therefore is not an option for patients with treatment-resistant depression in routine clinical practice at this time. Further research is needed to clarify if such augmentation might benefit subpopulations with demonstrable hypothalamic-pituitary-adrenal axis abnormalities. FUNDING: Efficacy and Mechanism Evaluation (EME) programme, a UK Medical Research Council and National Institute for Health Research partnership.

OHIP-TMDs: a patient-reported outcome measure for temporomandibular disorders.

OBJECTIVES: This research aims to assess the test-retest reliability, the face, content and known groups validity, and responsiveness to change, of OHIP-TMDs, a 22-item TMDs-specific version of the Oral Health Impact Profile (OHIP). METHODS: Test-retest reliability - A group of patients with TMDs (n = 20) was administered OHIP-TMDs twice before initial consultation with a 2-week interval. Face and content validity - Content validity index assessments were undertaken with professionals and patients. Known groups validity - Participants (n = 76) with confirmed Axis 1 RDC/TMD diagnoses completed OHIP-TMDs prior to TMDs treatment. Their responses were compared, using inferential statistics, with those of age- and gender-matched controls. Responsiveness to change - Using the same 76 participants, a comparison was made of OHIP-TMDs with OHIP-49 (order of administration randomized) both at baseline and 3 months after starting treatment. RESULTS: OHIP-TMDs showed good test-retest reliability ICC [2,1] 0.805 (95% CI: 0.565, 0.918); good face and content validity; significant differences (P < 0.001) between controls and participants demonstrating known groups validity. Its responsiveness to change was similar to OHIP-49. CONCLUSIONS: OHIP-TMDs is an appropriate biopsychosocial, patient-centred, outcome measure for assessing QOL in patients with TMDs. It is less than half the length of OHIP-49 and contains proportionately more items relevant to TMDs.

The NAtional randomised controlled Trial of Tonsillectomy IN Adults (NATTINA): a clinical and cost-effectiveness study: study protocol for a randomised control trial.

BACKGROUND: The role of tonsillectomy in the management of adult tonsillitis remains uncertain and UK regional variation in tonsillectomy rates persists. Patients, doctors and health policy makers wish to know the costs and benefits of tonsillectomy against conservative management and whether therapy can be better targeted to maximise benefits and minimise risks of surgery, hence maximising cost-effective use of resources. NATTINA incorporates the first attempt to map current NHS referral criteria against other metrics of tonsil disease severity. METHODS/DESIGN: A UK multi-centre, randomised, controlled trial for adults with recurrent tonsillitis to compare the clinical and cost-effectiveness of tonsillectomy versus conservative management. An initial feasibility study comprises qualitative interviews to investigate the practicality of the protocol, including willingness to randomise and be randomised. Approximately 20 otolaryngology staff, 10 GPs and 15 ENT patients will be recruited over 5 months in all 9 proposed main trial participating sites. A 6-month internal pilot will then recruit 72 patients across 6 of the 9 sites. Participants will be adults with recurrent acute tonsillitis referred by a GP to secondary care. Randomisation between tonsillectomy and conservative management will be according to a blocked allocation method in a 1:1 ratio stratified by centre and baseline disease severity. If the pilot is successful, the main trial will recruit a further 528 patients over 18 months in all 9 participating sites. All participants will be followed up for a total of 24 months, throughout which both primary and secondary outcome data will be collected. The primary outcome is the number of sore throat days experienced over the 24-month follow-up. The pilot and main trials include an embedded qualitative process evaluation. DISCUSSION: NATTINA is designed to evaluate the relative effectiveness and efficiency of tonsillectomy versus conservative management in patients with recurrent sore throat who are eligible for surgery. Most adult tonsil disease and surgery has an impact on economically active age groups, with individual and societal costs through loss of earnings and productivity. Avoidance of unnecessary operations and prioritisation of those individuals likely to gain most from tonsillectomy would reduce costs to the NHS and society. TRIAL REGISTRATION: ISRCTN55284102, Date of Registration: 4 August 2014.

Managing repetitive behaviours in young children with autism spectrum disorder (ASD): pilot randomised controlled trial of a new parent group intervention.

Early intervention for autism spectrum disorder (ASD) tends to focus on enhancing social-communication skills. We report the acceptability, feasibility and impact on child functioning of a new 8 weeks parent-group intervention to manage restricted and repetitive behaviours (RRB) in young children with ASD aged 3-7 years. Forty-five families took part in the pilot RCT. A range of primary and secondary outcome measures were collected on four occasions (baseline, 10, 18 and 24 weeks) to capture both independent ratings and parent-reported changes in RRB. This pilot established that parents were willing to be recruited and randomised, and the format and content of the intervention was feasible. Fidelity of delivery was high, and attendance was 90 %. A fully powered trial is now planned.

An external pilot study to test the feasibility of a randomised controlled trial comparing eye muscle surgery against active monitoring for childhood intermittent exotropia [X(T)].

INTRODUCTION: The evidence base for the treatment of strabismus (squint) is poor. Our main aim is to improve this evidence base for the treatment of a common type of childhood squint {intermittent exotropia, [X(T)]}. We conducted an external pilot study in order to inform the design and conduct of a future full randomised controlled trial (RCT). METHODS: Children of between 6 months and 16 years with a recent diagnosis of X(T) were eligible for recruitment. Participants were recruited from secondary care at the ophthalmology departments at four UK NHS foundation trusts. Participants were randomised to either active monitoring or surgery. This report describes the findings of the Pilot Rehearsal Trial and Qualitative Study, and assesses the success against the objectives proposed. RECRUITMENT AND RETENTION: The experience gained during the Pilot Rehearsal Trial demonstrates the ability to recruit and retain sites that are willing to randomise children to both trial arms, and for parents to agree to randomisation of their children to such a study. One child declined the group allocation. A total of 231 children were screened (expected 240), of whom 138 (60%) were eligible (expected 228: 95%) and 49 (35% of eligible) children were recruited (expected 144: 63% of eligible). Strategies that improved recruitment over the course of the trial are discussed, together with the reasons why fewer children were eligible for recruitment than initially anticipated. Attrition was low. Outcome data were obtained for 47 of 49 randomised children. TRIAL PROCESSES AND DATA COLLECTION: The Trial Management processes proved effective. There were high levels of completion on all of the data collection forms. However, the feedback from the treatment orthoptists revealed that some modifications should be made to the length and frequency of the health service assessment and travel assessment questionnaires, thus reducing the burden on participants in the main trial. Modifications to the wording of the questions also need to be made. MONITORING OF BIAS: Children who recruited to the trial were older and had more severe strabismus than those children eligible but declining participation. Strategies to account for this in a full trial are proposed. REASONS FOR PARTICIPATION OR DECLINING STUDY: These were identified using qualitative interviews. The principal reasons for declining entry into the study were strong preferences for and against surgical treatment. HARMS: There were no serious unexpected adverse events. Two children had overcorrection of their X(T) with reduction in binocular vision following surgery, which is in line with previous studies. No children in the active monitoring arm developed a constant strabismus although two showed some reduction in control. CONCLUSIONS: The SamExo study has demonstrated that it is possible to recruit and retain participants to a randomised trial of surgery compared with active monitoring for X(T). For longer-term full RCTs, in order to maximise the generalisability of future studies, consideration needs to be given to planning more time and clinic appointments to assess eligibility and to allow consideration of participation; the greater use of research nurses for recruitment; and accommodating the strong preferences of some parents both for and against surgical intervention. TRIAL REGISTRATION: Current Controlled Trials ISRCTN44114892. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 39. See the NIHR Journals Library website for further project information.

Demonstration of an intrinsic relationship between endogenous C-peptide concentration and determinants of glycemic control in type 1 diabetes following islet transplantation.

OBJECTIVE: Maintenance of endogenous pancreatic ß-cell function could be an important goal in the management of type 1 diabetes. However, the impact of stimulated C-peptide level on overall glycemic control is unknown. The relationship between C-peptide and parameters of glucose control was therefore characterized in a cohort with rapidly changing ß-cell function following islet transplantation. RESEARCH DESIGN AND METHODS: Standardized mixed-meal tolerance test was undertaken in 12 consecutive islet recipients at 1-6-month intervals, with graft function determined by 90-min stimulated C-peptide. Continuous glucose monitoring was undertaken in the week preceding each assessment and the relationship between C-peptide and glucose control evaluated by mixed Poisson regression. RESULTS: Recipients completed 5 (1-14) [median (range)] clinical assessments over 18 (1-51) months posttransplant encompassing a wide range of stimulated C-peptide levels (7-2,622 pmol/L). Increasing ß-cell function across predefined C-peptide groups was associated with reduced insulin dose, HbA1c, mean glucose (low [<200 pmol/L] 10.7 vs. excellent [>1,000 pmol/L] 7.5 mmol/L), and glucose SD (low, 4.4 vs. excellent, 1.4 mmol/L). Highly statistically significant continuous associations between stimulated C-peptide and mean interstitial glucose (lower by 2.5% [95% CI 1.5-3.5%] per 100 pmol/L higher C-peptide), glucose SD, time outside glucose target range, and measures of hyper-/hypoglycemia risk were confirmed. CONCLUSIONS: Repeated assessment of islet transplant recipients has enabled modeling of the relationship between endogenous ß-cell function and measures of glycemic control providing quantitative estimates of likely impact of an acute change in ß-cell function in individuals with type 1 diabetes.

A time series evaluation of the FAST National Stroke Awareness Campaign in England.

OBJECTIVE: In February 2009, the Department of Health in England launched the Face, Arm, Speech, and Time (FAST) mass media campaign, to raise public awareness of stroke symptoms and the need for an emergency response. We aimed to evaluate the impact of three consecutive phases of FAST using population-level measures of behaviour in England. METHODS: Interrupted time series (May 2007 to February 2011) assessed the impact of the campaign on: access to a national stroke charity's information resources (Stroke Association [SA]); emergency hospital admissions with a primary diagnosis of stroke (Hospital Episode Statistics for England); and thrombolysis activity from centres in England contributing data to the Safe Implementation of Thrombolysis in Stroke UK database. RESULTS: Before the campaign, emergency admissions (and patients admitted via accident and emergency [A&E]) and thrombolysis activity was increasing significantly over time, whereas emergency admissions via general practitioners (GPs) were decreasing significantly. SA webpage views, calls to their helpline and information materials dispatched increased significantly after phase one. Website hits/views, and information materials dispatched decreased after phase one; these outcomes increased significantly during phases two and three. After phase one there were significant increases in overall emergency admissions (505, 95% CI = 75 to 935) and patients admitted via A&E (451, 95% CI = 26 to 875). Significantly fewer monthly emergency admissions via GPs were reported after phase three (-19, 95% CI =  -29 to -9). Thrombolysis activity per month significantly increased after phases one (3, 95% CI = 1 to 6), and three (3, 95% CI = 1 to 4). CONCLUSIONS: Phase one had a statistically significant impact on information seeking behaviour and emergency admissions, with additional impact that may be attributable to subsequent phases on information seeking behaviour, emergency admissions via GPs, and thrombolysis activity. Future campaigns should be accompanied by evaluation of impact on clinical outcomes such as reduced stroke-related morbidity and mortality.

The effectiveness of collaborative care for people with memory problems in primary care: results of the CAREDEM case management modelling and feasibility study.

BACKGROUND: People with dementia and their families need support in different forms, but currently services are often fragmented with variable quality of care. Case management offers a way of co-ordinating services along the care pathway and therefore could provide individualised support; however, evidence of the effectiveness of case management for dementia is inconclusive. OBJECTIVE: To adapt the intervention used in a promising case management project in the USA and test its feasibility and acceptability in English general practice. DESIGN: In work package 1, a design group of varied professionals, with a carer and staff from the voluntary sector, met six times over a year to identify the skills and personal characteristics required for case management; protocols from the US study were adapted for use in the UK. The feasibility of recruiting general practices and patient-carer dyads and of delivering case management were tested in a pilot study (work package 2). An embedded qualitative study explored stakeholder views on study procedures and case management. SETTING: Four general practices, two in the north-east of England (Newcastle) one in London and one in Norfolk, took part in a feasibility pilot study of case management. PARTICIPANTS: Community-dwelling people with dementia and their carers who were not already being case managed by other services. INTERVENTION: A social worker shared by the two practices in the north-east and practice nurses in the other two practices were trained to deliver case management. We aimed to recruit 11 people with dementia from each practice who were not already being case managed. MAIN OUTCOME MEASURES: Numbers of people with dementia and their carers recruited, numbers and content of contacts, needs identified and perceptions of case management among stakeholders. RESULTS: Recruitment of practices and patients was slow and none of the practices achieved its recruitment target. It took more than 6 months to recruit a total of 28 people with dementia. Practice Quality and Outcome Framework registers for dementia contained only 60% of the expected number of people, most living in care homes. All stakeholders were positive about the potential of case management; however, only one of the four practices achieved a level of case management activity that might have influenced patient and carer outcomes. Case managers' activity levels were not related solely to time available for case management. Delivery of case management was hindered by limited clarity about the role, poor integration with existing services and a lack of embeddedness within primary care. There were discrepancies between case manager and researcher judgements about need, and evidence of a high threshold for acting on unmet need. The practice nurses experienced difficulties in ring-fencing case management time. CONCLUSIONS: The model of case management developed and evaluated in this feasibility study is unlikely to be sustainable in general practice under current conditions and in our view it would not be appropriate to attempt a definitive trial of this model. This study could inform the development of a case management role with a greater likelihood of impact. Different approaches to recruiting and training case managers, and identifying people with dementia who might benefit from case management, are needed, as is exploration of the scale of need for this type of working. TRIAL REGISTRATION: Current Controlled Trials ISRCTN74015152. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 52. See the NIHR Journals Library website for further project information.

Association between objective measurement of the speech intelligibility of young people with dysarthria and listener ratings of ease of understanding.

PURPOSE: This study aimed to investigate the association between listeners' ratings of how much effort it took to understand the speech of young people with cerebral palsy and the percentage of words listeners actually understood. METHOD: Thirty-one young people with dysarthria and cerebral palsy (16 males, 15 females; mean age = 11 years, SD = 3) were audio recorded repeating single words and producing speech. Objective measures of intelligibility were calculated for multiple familiar and unfamiliar listeners using a forced choice paradigm for single words and verbatim orthographic transcriptions for connected speech. Listeners rated how much effort it took to understand speech in each condition using a 5-point ordinal ease of listening (EOL) scale. RESULTS: Agreement on EOL within rater groups was high (ICC > 0.71). An effect of listener was observed for familiar listeners, but not for unfamiliar listeners. EOL agreement between familiar and unfamiliar listeners was weak-moderate (ICC = 0.46). EOL predicted the percentage of speech actually understood by familiar and unfamiliar listeners (r > 0.56, p < 0.001 for all predictions). Strongest associations between EOL and intelligibility were observed for speakers with mild and profound impairments. CONCLUSIONS: The findings of this study demonstrate that listeners can judge how well they have understood dysarthric speech. EOL is associated with listener familiarity, speech task and speech impairment severity. EOL is appropriate for use in clinical practice as a measure of communication activity.

Improving Diabetes care through Examining, Advising, and prescribing (IDEA): protocol for a theory-based cluster randomised controlled trial of a multiple behaviour change intervention aimed at primary healthcare professionals.

BACKGROUND: New clinical research findings may require clinicians to change their behaviour to provide high-quality care to people with type 2 diabetes, likely requiring them to change multiple different clinical behaviours. The present study builds on findings from a UK-wide study of theory-based behavioural and organisational factors associated with prescribing, advising, and examining consistent with high-quality diabetes care. AIM: To develop and evaluate the effectiveness and cost of an intervention to improve multiple behaviours in clinicians involved in delivering high-quality care for type 2 diabetes. DESIGN/METHODS: We will conduct a two-armed cluster randomised controlled trial in 44 general practices in the North East of England to evaluate a theory-based behaviour change intervention. We will target improvement in six underperformed clinical behaviours highlighted in quality standards for type 2 diabetes: prescribing for hypertension; prescribing for glycaemic control; providing physical activity advice; providing nutrition advice; providing on-going education; and ensuring that feet have been examined. The primary outcome will be the proportion of patients appropriately prescribed and examined (using anonymised computer records), and advised (using anonymous patient surveys) at 12 months. We will use behaviour change techniques targeting motivational, volitional, and impulsive factors that we have previously demonstrated to be predictive of multiple health professional behaviours involved in high-quality type 2 diabetes care. We will also investigate whether the intervention was delivered as designed (fidelity) by coding audiotaped workshops and interventionist delivery reports, and operated as hypothesised (process evaluation) by analysing responses to theory-based postal questionnaires. In addition, we will conduct post-trial qualitative interviews with practice teams to further inform the process evaluation, and a post-trial economic analysis to estimate the costs of the intervention and cost of service use. DISCUSSION: Consistent with UK Medical Research Council guidance and building on previous development research, this pragmatic cluster randomised trial will evaluate the effectiveness of a theory-based complex intervention focusing on changing multiple clinical behaviours to improve quality of diabetes care. TRIAL REGISTRATION: ISRCTN66498413.

The STRIDE (Strategies to Increase confidence, InDependence and Energy) study: cognitive behavioural therapy-based intervention to reduce fear of falling in older fallers living in the community - study protocol for a randomised controlled trial.

BACKGROUND: Around 30% to 62% of older individuals fall each year, with adverse consequences of falls being by no means limited to physical injury and escalating levels of dependence. Many older individuals suffer from a variety of adverse psychosocial difficulties related to falling including fear, anxiety, loss of confidence and subsequent increasing activity avoidance, social isolation and frailty. Such 'fear of falling' is common and disabling, but definitive studies examining the effective management of the syndrome are lacking. Cognitive behavioural therapy has been trialed with some success in a group setting, but there is no adequately powered randomised controlled study of an individually based cognitive behavioural therapy intervention, and none using non-mental health professionals to deliver the intervention. METHODS/DESIGN: We are conducting a two-phase study examining the role of individual cognitive behavioural therapy delivered by healthcare assistants in improving fear of falling in older adults. In Phase I, the intervention was developed and taught to healthcare assistants, while Phase II is the pragmatic randomised controlled study examining the efficacy of the intervention in improving fear of falling in community-dwelling elders attending falls services. A qualitative process evaluation study informed by Normalization Process Theory is being conducted throughout to examine the potential promoters and inhibitors of introducing such an intervention into routine clinical practice, while a health economic sub-study running alongside the trial is examining the costs and benefits of such an approach to the wider health economy. TRIAL REGISTRATION: Current Controlled Trials ISRCTN78396615.

Reflective and automatic processes in health care professional behaviour: a dual process model tested across multiple behaviours.

BACKGROUND: Clinicians' behaviours require deliberate decision-making in complex contexts and may involve both impulsive (automatic) and reflective (motivational and volitional) processes. PURPOSE: The purpose of this study was to test a dual process model applied to clinician behaviours in their management of type 2 diabetes. METHODS: The design used six nested prospective correlational studies. Questionnaires were sent to general practitioners and nurses in 99 UK primary care practices, measuring reflective (intention, action planning and coping planning) and impulsive (automaticity) predictors for six guideline-recommended behaviours: blood pressure prescribing (N = 335), prescribing for glycemic control (N = 288), providing diabetes-related education (N = 346), providing weight advice (N = 417), providing self-management advice (N = 332) and examining the feet (N = 218). RESULTS: Respondent retention was high. A dual process model was supported for prescribing behaviours, weight advice, and examining the feet. A sequential reflective process was supported for blood pressure prescribing, self-management and weight advice, and diabetes-related education. CONCLUSIONS: Reflective and impulsive processes predict behaviour. Quality improvement interventions should consider both reflective and impulsive approaches to behaviour change.

Movement as Medicine for Type 2 Diabetes: protocol for an open pilot study and external pilot clustered randomised controlled trial to assess acceptability, feasibility and fidelity of a multifaceted behavioural intervention targeting physical activity in primary care.

BACKGROUND: Physical activity (PA) and nutrition are the cornerstones of diabetes management. Several reviews and meta-analyses report that PA independently produces clinically important improvements in glucose control in people with Type 2 diabetes. However, it remains unclear what the optimal strategies are to increase PA behaviour in people with Type 2 diabetes in routine primary care. METHODS: This study will determine whether an evidence-informed multifaceted behaviour change intervention (Movement as Medicine for Type 2 Diabetes) targeting both consultation behaviour of primary healthcare professionals and PA behaviour in adults with Type 2 diabetes is both acceptable and feasible in the primary care setting. An open pilot study conducted in two primary care practices (phase one) will assess acceptability, feasibility and fidelity. Ongoing feedback from participating primary healthcare professionals and patients will provide opportunities for systematic adaptation and refinement of the intervention and study procedures. A two-arm parallel group clustered pilot randomised controlled trial with patients from participating primary care practices in North East England will assess acceptability, feasibility, and fidelity of the intervention (versus usual clinical care) and trial processes over a 12-month period. Consultation behaviour involving fidelity of intervention delivery, diabetes and PA related knowledge, attitudes/beliefs, intentions and self-efficacy for delivering a behaviour change intervention targeting PA behaviour will be assessed in primary healthcare professionals. We will rehearse the collection of outcome data (with the focus on data yield and quality) for a future definitive trial, through outcome assessment at baseline, one, six and twelve months. An embedded qualitative process evaluation and treatment fidelity assessment will explore issues around intervention implementation and assess whether intervention components can be reliably and faithfully delivered in routine primary care. DISCUSSION: Movement as Medicine for Type 2 Diabetes will address an important gap in the evidence-base, that is, the need for interventions to increase free-living PA behaviour in adults with Type 2 diabetes. The multifaceted intervention incorporates an online accredited training programme for primary healthcare professionals and represents, to the best of our knowledge, the first of its kind in the United Kingdom. This study will establish whether the multifaceted behavioural intervention is acceptable and feasible in routine primary care. TRIAL REGISTRATION: Movement as Medicine for Type 2 Diabetes (MaMT2D) was registered with Current Controlled Trials on the 14th January 2012: ISRCTN67997502. The first primary care practice was randomised on the 5th October 2012.