Assertive outreach treatment versus care as usual for the treatment of high-need, high-cost alcohol related frequent attenders: study protocol for a randomised controlled trial.

BACKGROUND: Alcohol-related hospital admissions have doubled in the last ten years to > 1.2 m per year in England. High-need, high-cost (HNHC) alcohol-related frequent attenders (ARFA) are a relatively small subgroup of patients, having multiple admissions or attendances from alcohol during a short time period. This trial aims to test the effectiveness of an assertive outreach treatment (AOT) approach in improving clinical outcomes for ARFA, and reducing resource use in the acute setting. METHODS: One hundred and sixty ARFA patients will be recruited and following baseline assessment, randomly assigned to AOT plus care as usual (CAU) or CAU alone in equal numbers. Baseline assessment includes alcohol consumption and related problems, physical and mental health comorbidity and health and social care service use in the previous 6 months using standard validated tools, plus a measure of resource use. Follow-up assessments at 6 and 12 months after randomization includes the same tools as baseline plus standard measure of patient satisfaction. Outcomes for CAU + AOT and CAU at 6 and 12 months will be compared, controlling for pre-specified baseline measures. Primary outcome will be percentage of days abstinent at 12 months. Secondary outcomes include emergency department (ED) attendance, number and length of hospital admissions, alcohol consumption, alcohol-related problems, other health service use, mental and physical comorbidity 6 and 12 months post intervention. Health economic analysis will estimate the economic impact of AOT from health, social care and societal perspectives and explore cost-effectiveness in terms of quality adjusted life years and alcohol consumption at 12-month follow-up. DISCUSSION: AOT models piloted with alcohol dependent patients have demonstrated significant reductions in alcohol consumption and use of unplanned National Health Service (NHS) care, with increased engagement with alcohol treatment services, compared with patients receiving CAU. While AOT interventions are costlier per case than current standard care in the UK, the rationale for targeting HNHC ARFAs is because of their disproportionate contribution to overall alcohol burden on the NHS. No previous studies have evaluated the clinical and cost-effectiveness of AOT for HNHC ARFAs: this randomized controlled trial (RCT) targeting ARFAs across five South London NHS Trusts is the first. TRIAL REGISTRATION: International standard randomized controlled trial number (ISRCTN) registry: ISRCTN67000214, retrospectively registered 26/11/2016.

Finding the Right Assessment Measures for Young People with Intellectual Disabilities Who Display Harmful Sexual Behaviour.

BACKGROUND: Previous studies and national reports have all noted that a significant proportion of the young people who display harmful sexual behaviours have intellectual disabilities. However, research on the topic has been scarce. This study presents a systematic review of the literature relating to clinical instruments specifically developed or adapted for adolescents with intellectual disabilities who display harmful sexual behaviours. METHOD: An electronic search of databases was completed for published articles in English from the earliest possible date to the end of 2013. RESULTS: No published articles met the full search criteria. This confirmed the lack of published clinical measures, apart from two risk assessment instruments. CONCLUSIONS: Given the lack of measures, it is recommended that the focus of future research needs to be on developing or adapting instruments that will offer researchers' and clinicians' empirical as well as clinical data on this all-too-often-overlooked population of vulnerable youth.

The implementation and evaluation of a mentoring program for Bachelor of Midwifery students in the clinical practice environment.

AIM: To describe the implementation and evaluation of a midwife/midwifery student-mentoring program in one Local Health District in Sydney NSW Australia. BACKGROUND: Evidence suggests well designed and supported midwife/midwifery student mentorship programs can make a difference to the clinical placement experiences and attrition rates of midwifery students. DESIGN: In the evaluation of the mentoring program, we used surveys, focus groups and individual interviews. METHODS: Eighty-six participants, including midwife mentors, midwifery students, non-mentor midwives and midwifery managers participated in the evaluation. Quantitative data were analysed using descriptive statistics and qualitative data, content analysis. RESULTS: The mentoring program increased midwives' mentoring skills and was beneficial to their professional growth and leadership skills. Students reported positive outcomes including someone to talk to, emotional support and a sense of belonging. Mentoring programs require structure, mentor training, organisational support and transparency. CONCLUSION: The mentoring program provided benefits to both midwifery mentors and students and demonstrated the value of a structured and supported mentoring program for midwifery students.

The potential of case management for people with dementia: a commentary.

BACKGROUND: A recent review of studies of case management in dementia argues that lack of evidence of cost-effectiveness should discourage the use of this approach to care. We argue that that this is too conservative a stance, given the urgent need throughout the world to improve the quality of care for people with dementia and their caregivers. We propose a research agenda on case management for people with dementia. METHOD: A critical comparison was made of the studies identified in two systematic reviews of trials of case management for dementia, with selective inclusion of non-trial studies and economic evaluations. RESULTS: Our interpretation of the literature leads us to four provisional conclusions. First, studies with long follow-up periods tend to show delayed relocation of people with dementia to care homes. Second, the quality of life of people with dementia and their caregivers may also influence the likelihood of relocation. Third, different understandings of what constitutes case management make interpretation of studies difficult. Fourth, we agree that the population most likely to benefit from case management needs to be characterised. Earlier intervention may be more beneficial than intervening when the condition has progressed and the individual's situation is highly complex. However, this runs counter to some definitions of case management as an administrative, professional, and systemic focus on people with high needs and where expensive support is accessed or in prospect. CONCLUSIONS: More work needs to be carried out in a more focused way in order to establish the value of case management for people with dementia. Since care home residence is such a sizeable contributor to the costs of dementia care, studies need to be long enough to capture possible postponed relocation. However, case management studies with shorter follow-up periods can still contribute to our understanding, since they can demonstrate improved quality of life. Future research should be built around a common, agreed definition of types of case management.

The midwife-student mentor relationship: Creating the virtuous circle.

BACKGROUND: Good mentoring is important for students to support their adjustment to and learning in the clinical environment. The quality of the mentoring relationship is key for students but there is a lack of evidence explaining how a good mentor/mentee relationship establishes and develops over time. AIM: To explore the developing relationship between mentors and mentees participating in a structured midwifery mentoring program in one Local Health District in Sydney, Australia. METHODS: A qualitative interpretive descriptive research design was utilised. Data were collected using 10 focus groups with midwife mentors (n = 31) and seven focus groups and four interviews with Bachelor of Midwifery student mentees (n = 24), over a 12-month period. Thematic analysis using an inductive approach was applied incorporating constant comparison to identify themes and sub-themes. FINDINGS: Three overarching themes and three sub-themes were identified. The first theme was 'The great unknown'. Within the second theme 'Building the relationship' were three subthemes: trying to connect; becoming known; and an insider on your side. The final theme 'the virtuous circle' described the reciprocal relationship and benefits that developed between mentor and mentee. DISCUSSION: The mentor/mentee relationship took time to develop and went through a number of phases. A positive mentor/ mentee relationship flattened hierarchical differences, increased student confidence and capacity for learning, and reflected the midwifery continuity of care relationship between midwife and woman built on respect and partnership. CONCLUSION: Developing a successful midwifery mentoring relationship takes persistence, reassurance, and mutual disclosure ultimately resulting in a recurring cycle of encouragement and support.

Exploring treatment attendance and its relationship to outcome in a randomized controlled trial of treatment for alcohol problems: secondary analysis of the UK Alcohol Treatment Trial (UKATT).

AIMS: To identify client characteristics that predict attendance at treatment sessions and to investigate the effect of attendance on outcomes using data from the UK Alcohol Treatment Trial. METHODS: Logistic regression was used to determine whether there were characteristics that could predict attendance and then continuation in treatment. Linear regression was used to explore the effects of treatment attendance on outcomes. RESULTS: There were significant positive relationships between treatment attendance and outcomes at Month 3. At Month 12, these relationships were only significant for dependence and alcohol problems for those randomized to motivational enhancement therapy (MET). There were significant differences between groups in attendance, with MET clients more likely to attend than clients allocated to social behaviour and network therapy (SBNT). MET clients were also more likely to attend all sessions (three sessions) compared with SBNT (eight sessions). MET clients with larger social networks and those with confidence in their ability not to drink excessively were more likely to attend. SBNT clients with greater motivation to change and those with more negative short-term alcohol outcome expectancies were more likely to attend. No significant predictors were found for retention in treatment for MET. For those receiving SBNT, fewer alcohol problems were associated with continuation in treatment. CONCLUSION: Attending more sessions was associated with better outcomes. An interpretation of these findings is that, to improve outcomes, methods should be developed and used to increase attendance rates. Different characteristics were identified that predicted attendance and continuation in treatment for MET and SBNT.

Predicting drinking outcomes: Evidence from the United Kingdom Alcohol Treatment Trial (UKATT).

AIMS: To explore client characteristics that predict drinking outcomes using data from the UK Alcohol Treatment Trial (UKATT). METHODS: Multiple linear regression was used to determine if there were any characteristics, measured before the start of treatment, that could predict drinking outcomes at three and 12months, as measured by percent day abstinent (PDA) and drinks per drinking day (DDD) over the preceding 90days. RESULTS: Lower baseline DDD score and greater confidence to resist drinking predicted lower DDD at both three and twelve months following entry to treatment. In addition to baseline PDA and having greater confidence to resist heavy drinking, female gender, aiming for abstinence, more satisfaction with family life and a social network that included less support for drinking were predictors of percent days abstinent. CONCLUSIONS: Overall the strongest and most consistent predictors of outcome were confidence to avoid heavy drinking and social support for drinking. More predictors were identified for percent of days abstinent than for drinks per drinking day. For percent of days abstinent, a number of client characteristics at baseline consistently predicted outcome at both month three and month twelve.

Obesity and disability - a short review.

The prevalence of both obesity and disability is increasing globally and there is now growing evidence to suggest that these two health priorities may be linked. This paper explores the evidence linking obesity to muscular-skeletal conditions, mental health disorders and learning disabilities in both adult and child populations. The impact of obesity on the four most prevalent disabling conditions in the UK (arthritis, mental health disorders, learning disabilities and back ailments) has been examined through novel data analysis of the 2001 Health Survey for England and UK Back Exercise And Manipulation trial data. Together these analyses strongly suggest that whether the cause or result of disability, obesity is undeniably implicated, thus presenting a serious public health priority. Future research efforts are required to strengthen the evidence base examining obesity in back disorders, mental health and learning disabilities, in order to improve current clinical management.

What are the clinical outcome and cost-effectiveness of endoscopy undertaken by nurses when compared with doctors? A Multi-Institution Nurse Endoscopy Trial (MINuET).

OBJECTIVES: To compare the clinical outcome and cost-effectiveness of doctors and nurses undertaking upper and lower gastrointestinal endoscopy. DESIGN: The study was a pragmatic randomised controlled trial. Zelen's randomisation before consent was used to minimise distortion of existing practice in the participating sites. An economic evaluation was conducted alongside the trial, assessing the relative cost-effectiveness of nurses and doctors. SETTING: The study was undertaken in 23 hospitals in England, Scotland and Wales. In six hospitals nurses undertook both upper and lower gastrointestinal endoscopy, yielding a total of 29 'centres'. The study was coordinated and managed from Swansea. Randomisation, data management and analysis were undertaken at York. Analysis was by intention-to-scope. PARTICIPANTS: Sixty-seven doctors and 30 nurses took part in the study. Of 4964 potentially eligible patients, 4128 (83%) were randomised. Of these, 1888 (45%) were recruited to the study from 29 July 2002 to 30 June 2003. INTERVENTIONS: The procedures under study were diagnostic upper gastrointestinal endoscopy and flexible sigmoidoscopy undertaken by nurses or doctors, with or without sedation, using the preparation, techniques and protocols of participating hospitals. MAIN OUTCOME MEASURES: Primary outcome measure was the Gastrointestinal Symptom Rating Questionnaire (GSRQ). The secondary outcome measures were EuroQol (EQ5D), Gastrointestinal Endoscopy Satisfaction Questionnaire (GESQ), State-Trait Anxiety Inventory (STAI), cost-effectiveness, immediate and delayed complications, quality of examination by blinded assessment of endoscopic video recordings, quality of procedure reports, patients' preferences for operator 1 year after endoscopy, and new diagnoses at 1 year. RESULTS: The two groups were well matched at baseline for demographic and clinical characteristics. Significantly more patients changed from a planned endoscopy by a doctor to a nurse than vice versa, mainly for staffing reasons. There was no significant difference between the two groups in the primary or secondary outcome measures at 1 day, 1 month or 1 year after endoscopy, with the exception of patient satisfaction at 1 day, which favoured nurses. Nurses were significantly more thorough in the examination of stomach and oesophagus, but no different from doctors in the examination of duodenum and colon. There was no significant difference in costs to the NHS or patients, although doctors cost slightly more. Although quality of life measures showed improvement in some scores in the doctor group, this did not reach traditional levels of statistical significance. Even so, the economic evaluation, taking account of uncertainty in both costs and quality of life, suggests that endoscopy by doctors has an 87% chance of being more cost-effective than endoscopy by nurses. CONCLUSIONS: There is no statistically significant difference between doctors and nurses in their clinical effectiveness in diagnostic endoscopy. However, nurses are significantly more thorough in the examination of oesophagus and stomach, and patients are significantly more satisfied after endoscopy by a nurse. Endoscopy by doctors is associated with better outcome at 1 year at higher cost, but overall is likely to be cost-effective. Further research is needed to evaluate the clinical outcome and cost-effectiveness of nurses undertaking a greater role in other settings, to monitor the cost-effectiveness of nurse endoscopists as they become more experienced and to assess, the effect of increasing the number of nurse endoscopists on waiting times for patients, and the career implications and opportunities for nurses who become trained endoscopists. Evaluation of the clinical outcome and cost-effectiveness of diagnostic endoscopy for all current indications is also needed.

Interventions for drug-using offenders in the courts, secure establishments and the community.

BACKGROUND: Drug strategies internationally recognize link between drug use and crime. This review consider interventions for drug-using offenders under the care of the criminal justice system. OBJECTIVES: To assess the effectiveness of interventions for drug-using offenders in reducing criminal activity and drug use in the courts, secure establishments and community-based settings. SEARCH STRATEGY: Twenty two electronic databases were searched (1980 to 2004). Internet sites and experts in the field were contacted for further information. SELECTION CRITERIA: Randomised Controlled Trials designed to reduce, eliminate or prevent relapse in drug using offenders DATA COLLECTION AND ANALYSIS: Two authors independently assessed trials for inclusion. Data were extracted by one author and double checked. MAIN RESULTS: Twenty four studies, 8936 participants, met the inclusion criteria. Results show that comparing a court-based community pre-trial release with drugs testing and sanctions versus routine pre-trial, for arrest at 90 days results favoured the comparison group OR 1.33 (95% CI 1.04 to 1.70). Comparing therapeutic community with aftercare with a mental health programme with a waiting list control, considering incarceration at 12 months OR 0.37 (95% CI 0.16 to 0.87), results in favour of the treatment Comparing intensive supervision with routine parole/probation, for recidivism OR 1.98 (95% CI 1.01 to 3.87) results in favour of comparison group, no statistically significant difference between the groups for arrest OR 1.49 (95% CI 0.88 to 2.51), drug arrest OR 1.10 (95% CI 0.50 to 2.39), conviction OR 0.93 (95% CI 0.55 to 1.58 ) and incarceration at one year OR 0.88 (95% CI 0.50, 1.54). Comparing intensive supervision and increased surveillance with intensive supervision alone, no statistically significant difference between the groups for recidivism OR 2.09 (95% CI, 0.86 to 5.07), arrest OR 1.22 (95% CI 0.51 to 2.88]), drug arrest, OR 1.29 (95% CI 0.35 to 4.85), conviction OR0.1.14 (95% CI, 0.22, to 5.91) and incarceration OR 1.30 (95% CI 0.39, to 4.30]) at one year. AUTHORS' CONCLUSIONS: Limited conclusions can be drawn about the effectiveness of drug treatment programmes for drug-using offenders in the courts or the community. This is partly due to the broad range of studies and the heterogenity of the different outcome measures presented. Therapeutic communities with aftercare show promising results for the reduction of drug use and criminal activity in drug using offenders. Standardisation of outcome measures and costing methodology would help improve the quality of research conducted in the area.

Pharmacological assessment of the role of the glycine transporter GlyT-1 in mediating high-affinity glycine uptake by rat cerebral cortex and cerebellum synaptosomes.

Two distinct types of glycine transporter, GlyT-1 and GlyT-2, have been characterised. GlyT-1 and GlyT-2 are known to be differentially expressed amongst CNS areas, but direct functional evidence for their relative contributions to high-affinity glycine uptake by brain tissues is lacking. In the present study, we have used the selective GlyT-1 inhibitor N[3-(4"-fluorophenyl)-3-(4"-phenylphenoxy)propyl]sarcosine (NFPS) to investigate the role of GlyT-1 in mediating glycine uptake. HEK293 cells expressing human GlyT-1c or GlyT-2 showed high levels of Na(+)-dependent glycine uptake, with K(m) values of 117+/-13 and 200+/-22 microM, respectively. NFPS potently inhibited uptake in GlyT-1c cells (IC(50) value 0.22+/-0.03 microM), being around 500-fold more potent than glycine or sarcosine, but had no effect on uptake in GlyT-2 cells (IC(50) >10 microM). Efflux of pre-loaded [3H]-glycine from GlyT-1c cells was increased by glycine or sarcosine, whereas NFPS had no effect on its own but blocked the effects of glycine or sarcosine. These results confirm that NFPS is a potent, selective and non-transportable GlyT-1 inhibitor. Rat cortex and cerebellum synaptosomes also showed a high-affinity Na(+)-dependent component of glycine uptake, with affinities similar to those observed for uptake in GlyT-1c or GlyT-2 cells. In cortex synaptosomes, NFPS and sarcosine produced the same maximal inhibition of uptake as glycine itself. However, in cerebellum synaptosomes, the maximal inhibition produced by NFPS and sarcosine was only half that produced by glycine. In both tissues NFPS was around 1000-fold more potent than glycine or sarcosine. Overall, our findings indicate that high-affinity glycine uptake in cerebral cortex occurs predominantly via GlyT-1. However, in cerebellum, only a part of the high-affinity uptake is mediated by GlyT-1, with the remaining NFPS-insensitive component most likely mediated by GlyT-2.

Recent advances in the chemistry and biology of carbapenem antibiotics.

The discovery of the olivanic acids and thienamycin aroused considerable interest amongst medicinal chemists and microbiologists around the world. The susceptibility of these agents to metabolic degradation has, however, been a major obstacle in their development. For many years the only notable success from such intensive research was the combination of imipenem with cilastatin, an inhibitor of the renal dipeptidase enzyme DHP-1. The enormous success of Primaxin for the treatment of a range of life-threatening bacterial infections provided the impetus for the discovery of totally synthetic, non-natural carbapenem derivatives that combine the broad spectrum of antimicrobial activity with stability to enzymatic degradation. This has indeed been realised in the development of meropenem; it possesses the broad spectrum of activity and resistance to beta-lactamases that are embodied in imipenem as well as displaying increased stability to human dehydropeptidases. Most recent research has focused upon the development of carbapenem antibiotics which combine broad spectrum antimicrobial activity and metabolic stability with oral absorption, for the treatment of community-acquired infections. Indeed, the pro-drug esters of the tricyclic carbapenems represent the first significant advance in this respect. However, the increased use of carbapenem antibiotics would undoubtedly accelerate the emergence of carbapenem-hydrolysing enzymes. The ultimate challenge could therefore be the design and synthesis of carbapenem derivatives that are resistant to these metallo-beta-lactamases. Due to the enormous problems encountered in the development of the carbapenem antibiotics, this area of research has, in the past, been described as a battlefield that did not bode well for the future [181]. Primaxin and meropenem proved however that these problems were not insurmountable, and are therefore a testimony to the persistence and dedication of those scientists in their war against bacterial infection.

Mutual pro-drugs of the olivanic acids and renal dipeptidase inhibitors.

The carbapenem antibiotics, which include the olivanic acids and thienamycin, possess potent broad spectrum antibacterial activity. They are however extensively metabolized by the renal dipeptidase enzyme, dehydropeptidase I. As a result of this degradation, only low urinary recoveries of antibiotic are obtained in vivo. The preparation of mutual pro-drugs of the olivanic acids and an inhibitor of the renal dipeptidase enzyme is described. MM 22382 and MM 13902 have been combined with Z-2-isovaleramidobut-2-enoic acid as double esters of formaldehyde hydrate. Administration of these linked esters to mice results in improved urinary recoveries of antibiotic.

Synthesis and antibacterial activity of C-2 alkenylthio-carbapenem derivatives.

A number of C-2 aminoalkenylthio-carbapenem derivatives possessing both the (5R,6R, 8S)- and the (5R,6S,8R)-stereochemistries have been prepared from the olivanic acids MM 22382 and MM 22383, respectively. Certain members of this new class of compounds displayed potent, broad spectrum antibacterial activity as well as improved stability to human kidney homogenate.

Synthesis and antibacterial activity of C-2 carboxyethenylthio-carbapenem derivatives.

A number of C-2 carboxyethenylthio-carbapenem derivatives possessing either the (5R,6R,8S)- or the (5R,6S,8R)-stereochemistries have been prepared from the olivanic acids MM 22382 (1) and MM 22383 (4), respectively. Their in vitro antibacterial activities and stabilities to human kidney homogenate are superior to those of the parent compounds, particularly in the latter series.

6-(substituted methylene)penems, potent broad spectrum inhibitors of bacterial beta-lactamase. IV. Kidney stability, serum binding and additional biological evaluation of racemic derivatives.

Sodium (5RS)-Z-6-(substituted methylene)penem-3-carboxylates (3) are extremely potent inhibitors of bacterial beta-lactamases, but some members of this group of compounds are highly bound to human serum, while others are readily degraded by renal dehydropeptidase I enzyme. Consequently, the stability of a variety of 6-(substituted methylene)penems (3) to human kidney homogenate, their binding to human serum and their activity in a mouse infection model was investigated at an early stage, and were instrumental in the selection of the 1,2,3-triazolylmethylene derivatives (e.g. 3k) as a class of compounds worthy of further evaluation.

Novel C-2 substituted carbapenem derivatives. Part IV. Synthesis and biological activity of five membered heteroaromatic derivatives.

The synthesis, antibacterial activity, and stability to human dehydropeptidase-1 (DHP-1) of a novel series of (5R,6S)-6-[(1R)-1-hydroxyethyl]-2-heterocyclylcarbapen-2-em-3-carb oxylates are described. Of the compounds investigated 1,5-disubstituted pyrazol-3-yl and 3-substituted isoxazol-5-yl derivatives have the best combination of antibacterial activity and stability to DHP-1. They are particularly active against community-acquired respiratory tract pathogens and have stabilities to DHP-1 superior to that of meropenem.

Pharmaceutical care for elderly patients shared between community pharmacists and general practitioners: a randomised evaluation. RESPECT (Randomised Evaluation of Shared Prescribing for Elderly people in the Community over Time) [ISRCTN16932128].

BACKGROUND: This trial aims to investigate the effectiveness and cost implications of 'pharmaceutical care' provided by community pharmacists to elderly patients in the community. As the UK government has proposed that by 2004 pharmaceutical care services should extend nationwide, this provides an opportunity to evaluate the effect of pharmaceutical care for the elderly. DESIGN: The trial design is a randomised multiple interrupted time series. We aim to recruit 700 patients from about 20 general practices, each associated with about three community pharmacies, from each of the five Primary Care Trusts in North and East Yorkshire. We shall randomise the five resulting groups of practices, pharmacies and patients to begin pharmaceutical care in five successive phases. All five will act as controls until they receive the intervention in a random sequence. Until they receive training community pharmacists will provide their usual dispensing services and so act as controls. The community pharmacists and general practitioners will receive training in pharmaceutical care for the elderly. Once trained, community pharmacists will meet recruited patients, either in their pharmacies (in a consultation room or dispensary to preserve confidentiality) or at home. They will identify drug-related issues/problems, and design a pharmaceutical care plan in conjunction with both the GP and the patient. They will implement, monitor, and update this plan monthly. The primary outcome measure is the 'Medication Appropriateness Index'. Secondary measures include adverse events, quality of life, and patient knowledge and compliance. We shall also investigate the cost of pharmaceutical care to the NHS, to patients and to society as a whole.

UK Back pain Exercise And Manipulation (UK BEAM) trial--national randomised trial of physical treatments for back pain in primary care: objectives, design and interventions [ISRCTN32683578].

BACKGROUND: Low back pain has major health and social implications. Although there have been many randomised controlled trials of manipulation and exercise for the management of low back pain, the role of these two treatments in its routine management remains unclear. A previous trial comparing private chiropractic treatment with National Health Service (NHS) outpatient treatment, which found a benefit from chiropractic treatment, has been criticised because it did not take treatment location into account. There are data to suggest that general exercise programmes may have beneficial effects on low back pain. The UK Medical Research Council (MRC) has funded this major trial of physical treatments for back pain, based in primary care. It aims to establish if, when added to best care in general practice, a defined package of spinal manipulation and a defined programme of exercise classes (Back to Fitness) improve participant-assessed outcomes. Additionally the trial compares outcomes between participants receiving the spinal manipulation in NHS premises and in private premises. DESIGN: Randomised controlled trial using a 3 x 2 factorial design. METHODS: We sought to randomise 1350 participants with simple low back pain of at least one month's duration. These came from 14 locations across the UK, each with a cluster of 10-15 general practices that were members of the MRC General Practice Research Framework (GPRF). All practices were trained in the active management of low back pain. Participants were randomised to this form of general practice care only, or this general practice care plus manipulation, or this general practice care plus exercise, or this general practice care plus manipulation followed by exercise. Those randomised to manipulation were further randomised to receive treatment in either NHS or private premises. Follow up was by postal questionnaire one, three and 12 months after randomisation. The primary analysis will consider the main treatment effects before interactions between the two treatment packages. Economic analysis will estimate the cost per unit of health utility gained by adding either or both of the treatment packages to general practice care.

AESOPS: a randomised controlled trial of the clinical effectiveness and cost-effectiveness of opportunistic screening and stepped care interventions for older hazardous alcohol users in primary care.

BACKGROUND: There is clear evidence of the detrimental impact of hazardous alcohol consumption on the physical and mental health of the population. Estimates suggest that hazardous alcohol consumption annually accounts for 150,000 hospital admissions and between 15,000 and 22,000 deaths in the UK. In the older population, hazardous alcohol consumption is associated with a wide range of physical, psychological and social problems. There is evidence of an association between increased alcohol consumption and increased risk of coronary heart disease, hypertension and haemorrhagic and ischaemic stroke, increased rates of alcohol-related liver disease and increased risk of a range of cancers. Alcohol is identified as one of the three main risk factors for falls. Excessive alcohol consumption in older age can also contribute to the onset of dementia and other age-related cognitive deficits and is implicated in one-third of all suicides in the older population. OBJECTIVE: To compare the clinical effectiveness and cost-effectiveness of a stepped care intervention against a minimal intervention in the treatment of older hazardous alcohol users in primary care. DESIGN: A multicentre, pragmatic, two-armed randomised controlled trial with an economic evaluation. SETTING: General practices in primary care in England and Scotland between April 2008 and October 2010. PARTICIPANTS: Adults aged ≥ 55 years scoring ≥ 8 on the Alcohol Use Disorders Identification Test (10-item) (AUDIT) were eligible. In total, 529 patients were randomised in the study. INTERVENTIONS: The minimal intervention group received a 5-minute brief advice intervention with the practice or research nurse involving feedback of the screening results and discussion regarding the health consequences of continued hazardous alcohol consumption. Those in the stepped care arm initially received a 20-minute session of behavioural change counselling, with referral to step 2 (motivational enhancement therapy) and step 3 (local specialist alcohol services) if indicated. Sessions were recorded and rated to ensure treatment fidelity. MAIN OUTCOME MEASURES: The primary outcome was average drinks per day (ADD) derived from extended AUDIT--Consumption (3-item) (AUDIT-C) at 12 months. Secondary outcomes were AUDIT-C score at 6 and 12 months; alcohol-related problems assessed using the Drinking Problems Index (DPI) at 6 and 12 months; health-related quality of life assessed using the Short Form Questionnaire-12 items (SF-12) at 6 and 12 months; ADD at 6 months; quality-adjusted life-years (QALYs) (for cost-utility analysis derived from European Quality of Life-5 Dimensions); and health and social care resource use associated with the two groups. RESULTS: Both groups reduced alcohol consumption between baseline and 12 months. The difference between groups in log-transformed ADD at 12 months was very small, at 0.025 [95% confidence interval (CI)--0.060 to 0.119], and not statistically significant. At month 6 the stepped care group had a lower ADD, but again the difference was not statistically significant. At months 6 and 12, the stepped care group had a lower DPI score, but this difference was not statistically significant at the 5% level. The stepped care group had a lower SF-12 mental component score and lower physical component score at month 6 and month 12, but these differences were not statistically significant at the 5% level. The overall average cost per patient, taking into account health and social care resource use, was £488 [standard deviation (SD) £826] in the stepped care group and £482 (SD £826) in the minimal intervention group at month 6. The mean QALY gains were slightly greater in the stepped care group than in the minimal intervention group, with a mean difference of 0.0058 (95% CI -0.0018 to 0.0133), generating an incremental cost-effectiveness ratio (ICER) of £1100 per QALY gained. At month 12, participants in the stepped care group incurred fewer costs, with a mean difference of -£194 (95% CI -£585 to £198), and had gained 0.0117 more QALYs (95% CI -0.0084 to 0.0318) than the control group. Therefore, from an economic perspective the minimal intervention was dominated by stepped care but, as would be expected given the effectiveness results, the difference was small and not statistically significant. CONCLUSIONS: Stepped care does not confer an advantage over minimal intervention in terms of reduction in alcohol consumption at 12 months post intervention when compared with a 5-minute brief (minimal) intervention. TRIAL REGISTRATION: This trial is registered as ISRCTN52557360. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 17, No. 25. See the HTA programme website for further project information.