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1.  The Effectiveness of Alcohol Screening and Brief Intervention in Emergency Departments: A Multicentre Pragmatic Cluster Randomized Controlled Trial 
PLoS ONE  2014;9(6):e99463.
Background
Alcohol misuse is common in people attending emergency departments (EDs) and there is some evidence of efficacy of alcohol screening and brief interventions (SBI). This study investigated the effectiveness of SBI approaches of different intensities delivered by ED staff in nine typical EDs in England: the SIPS ED trial.
Methods and Findings
Pragmatic multicentre cluster randomized controlled trial of SBI for hazardous and harmful drinkers presenting to ED. Nine EDs were randomized to three conditions: a patient information leaflet (PIL), 5 minutes of brief advice (BA), and referral to an alcohol health worker who provided 20 minutes of brief lifestyle counseling (BLC). The primary outcome measure was the Alcohol Use Disorders Identification Test (AUDIT) status at 6 months. Of 5899 patients aged 18 or more presenting to EDs, 3737 (63·3%) were eligible to participate and 1497 (40·1%) screened positive for hazardous or harmful drinking, of whom 1204 (80·4%) gave consent to participate in the trial. Follow up rates were 72% (n = 863) at six, and 67% (n = 810) at 12 months. There was no evidence of any differences between intervention conditions for AUDIT status or any other outcome measures at months 6 or 12 in an intention to treat analysis. At month 6, compared to the PIL group, the odds ratio of being AUDIT negative for brief advice was 1·103 (95% CI 0·328 to 3·715). The odds ratio comparing BLC to PIL was 1·247 (95% CI 0·315 to 4·939). A per protocol analysis confirmed these findings.
Conclusions
SBI is difficult to implement in typical EDs. The results do not support widespread implementation of alcohol SBI in ED beyond screening followed by simple clinical feedback and alcohol information, which is likely to be easier and less expensive to implement than more complex interventions.
Trial Registration
Current Controlled Trials ISRCTN 93681536
doi:10.1371/journal.pone.0099463
PMCID: PMC4070907  PMID: 24963731
2.  Galvanic vestibular stimulation in hemi-spatial neglect 
Hemi-spatial neglect is an attentional disorder in which the sufferer fails to acknowledge or respond to stimuli appearing in contralesional space. In recent years, it has become clear that a measurable reduction in contralesional neglect can occur during galvanic vestibular stimulation, a technique by which transmastoid, small amplitude current induces lateral, attentional shifts via asymmetric modulation of the left and right vestibular nerves. However, it remains unclear whether this reduction persists after stimulation is stopped. To estimate longevity of effect, we therefore conducted a double-blind, randomized, dose-response trial involving a group of stroke patients suffering from left-sided neglect (n = 52, mean age = 66 years). To determine whether repeated sessions of galvanic vestibular stimulation more effectively induce lasting relief than a single session, participants received 1, 5, or 10 sessions, each lasting 25 min, of sub-sensory, left-anodal right-cathodal noisy direct current (mean amplitude = 1 mA). Ninety five percent confidence intervals indicated that all three treatment arms showed a statistically significant improvement between the pre-stimulation baseline and the final day of stimulation on the primary outcome measure, the conventional tests of the Behavioral Inattention Test. More remarkably, this change (mean change = 28%, SD = 18) was still evident 1 month later. Secondary analyses indicated an allied increase of 20% in median Barthel Index (BI) score, a measure of functional capacity, in the absence of any adverse events or instances of participant non-compliance. Together these data suggest that galvanic vestibular stimulation, a simple, cheap technique suitable for home-based administration, may produce lasting reductions in neglect that are clinically important. Further protocol optimization is now needed ahead of a larger effectiveness study.
doi:10.3389/fnint.2014.00004
PMCID: PMC3905204  PMID: 24523679
stroke; neuro-stimulation; clinical trial; hemi-inattention; rehabilitation
3.  Alcohol misuse 
Clinical Evidence  2011;2011:1017.
Introduction
Alcohol use is a leading cause of mortality and morbidity internationally, and is ranked by the World Health Organization (WHO) as one of the top 5 risk factors for disease burden. Without treatment, approximately 16% of hazardous or harmful alcohol users will progress to more dependent patterns of alcohol consumption. This review covers interventions in hazardous or harmful, but not dependent, alcohol users.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of interventions in hazardous or harmful drinkers in the primary-care setting? What are the effects of interventions in hazardous or harmful drinkers in the emergency-department setting? We searched: Medline, Embase, The Cochrane Library, and other important databases up to September 2010 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 21 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review, we present information relating to the effectiveness and safety of the following interventions in primary care and in emergency departments: brief intervention (single or multiple session), universal screening plus brief interventions, and targeted screening plus brief interventions.
Key Points
Alcohol use is a leading cause of mortality and morbidity internationally, and is ranked by the WHO as one of the top 5 risk factors for disease burden. Without treatment, approximately 16% of hazardous or harmful alcohol users will progress to more dependent patterns of alcohol consumption.
This review covers interventions in hazardous or harmful (but not dependent) alcohol users. Hazardous alcohol consumption is defined as a pattern of alcohol consumption that increases the individual's risk of alcohol-related harm, but is not currently causing alcohol-related harm.Harmful alcohol consumption is a pattern of consumption likely to have already led to alcohol-related harm.
Single- or multiple-session brief intervention reduces alcohol consumption over 1 year in hazardous drinkers treated in the primary-care setting, but we don't know how it affects mortality.
Brief intervention (single or multiple session) is also effective at reducing alcohol consumption in people treated in the emergency department, although the evidence is not as strong.
Adding universal screening to brief intervention enhances its benefits when given in primary care. We found insufficient RCT evidence to assess whether universal screening and brief intervention is any more effective than usual care in emergency departments.We don't know whether targeted screening is effective, as we found no RCT evidence assessing its use in primary or emergency care.
PMCID: PMC3275317  PMID: 21426592
4.  Brief intervention to prevent hazardous drinking in young people aged 14–15 in a high school setting (SIPS JR-HIGH): study protocol for a randomized controlled trial 
Trials  2012;13:166.
Background
Whilst the overall proportion of young people drinking alcohol in the United Kingdom has decreased in recent years, those who do drink appear to drink a larger amount, and more frequently. Early and heavy drinking by younger adolescents is a significant public health problem linked to intellectual impairment, increased risk of injuries, mental health issues, unprotected or regretted sexual experience, violence, and sometimes accidental death, which leads to high social and economic costs. This feasibility pilot trial aims to explore the feasibility of delivering brief alcohol intervention in a school setting with adolescents aged 14 and 15 and to examine the acceptability of study measures to school staff, young people and parents.
Methods and design
Seven schools across one geographical area in the North East of England will be recruited. Schools will be randomly allocated to one of three conditions: provision of an advice leaflet (control condition, n = 2 schools); a 30-minute brief interactive session, which combines structured advice and motivational interviewing techniques delivered by the school learning mentor (level 1 condition, n = 2 schools); and a 60-minute session involving family members delivered by the school learning mentor (level 2 condition, n = 3 schools). Participants will be year 10 school pupils (aged 14 and 15) who screen positively on a single alcohol screening question and who consent to take part in the trial. Year 10 pupils in all seven schools will be followed up at 6 and 12 months. Secondary outcome measures include the ten-question Alcohol-Use Disorders Identification Test. The EQ-5D-Y and a modified short service use questionnaire will inform the health and social resource costs for any future economic evaluation.
Young people recruited into the trial will also complete a 28-day timeline follow back questionnaire at 12-month follow-up. A qualitative evaluation (with young people, school staff, learning mentors, and parents) will examine facilitators and barriers to the use of screening and brief intervention approaches in the school setting in this age group.
Trial registration
Trial reference number ISRCTN07073105
doi:10.1186/1745-6215-13-166
PMCID: PMC3707809  PMID: 22974108
Alcohol; Screening and brief intervention; Feasibility pilot trial; Motivational interviewing; Young people
5.  Evaluation of a hospice rapid response community service: a controlled evaluation 
BMC Palliative Care  2012;11:11.
Background
While most people faced with a terminal illness would prefer to die at home, less than a third in England are enabled to do so with many dying in National Health Service hospitals. Patients are more likely to die at home if their carers receive professional support. Hospice rapid response teams, which provide specialist palliative care at home on a 24/7 on-call basis, are proposed as an effective way to help terminally ill patients die in their preferred place, usually at home. However, the effectiveness of rapid response teams has not been rigorously evaluated in terms of patient, carer and cost outcomes.
Methods/Design
The study is a pragmatic quasi-experimental controlled trial. The primary outcome for the quantitative evaluation for patients is dying in their preferred place of death. Carers’ quality of life will be evaluated using postal questionnaires sent at patient intake to the hospice service and eight months later. Carers’ perceptions of care received and the patient’s death will be assessed in one to one interviews at 6 to 8 months post bereavement. Service utilisation costs including the rapid response intervention will be compared to those of usual care.
Discussion
The study will contribute to the development of the evidence base on outcomes for patients and carers and costs of hospice rapid response teams operating in the community.
Trial registration: Current controlled trials ISRCTN32119670.
doi:10.1186/1472-684X-11-11
PMCID: PMC3441320  PMID: 22846107
Rapid response service; Hospice at home; Pragmatic trial; Preferred place of death; Palliative care
6.  Efficacy of Memantine for Agitation in Alzheimer’s Dementia: A Randomised Double-Blind Placebo Controlled Trial 
PLoS ONE  2012;7(5):e35185.
Background
Agitation in Alzheimer’s disease (AD) is common and associated with poor patient life-quality and carer distress. The best evidence-based pharmacological treatments are antipsychotics which have limited benefits with increased morbidity and mortality. There are no memantine trials in clinically significant agitation but post-hoc analyses in other populations found reduced agitation. We tested the primary hypothesis, memantine is superior to placebo for clinically significant agitation, in patients with moderate-to-severe AD.
Methods and Findings
We recruited 153 participants with AD and clinically significant agitation from care-homes or hospitals for a double-blind randomised-controlled trial and 149 people started the trial of memantine versus placebo. The primary outcome was 6 weeks mixed model autoregressive analysis of Cohen-Mansfield Agitation Inventory (CMAI). Secondary outcomes were: 12 weeks CMAI; 6 and 12 weeks Neuropsychiatric symptoms (NPI), Clinical Global Impression Change (CGI-C), Standardised Mini Mental State Examination, Severe Impairment Battery. Using a mixed effects model we found no significant differences in the primary outcome, 6 weeks CMAI, between memantine and placebo (memantine lower −3.0; −8.3 to 2.2, p = 0.26); or 12 weeks CMAI; or CGI-C or adverse events at 6 or 12 weeks. NPI mean difference favoured memantine at weeks 6 (−6.9; −12.2 to −1.6; p = 0.012) and 12 (−9.6; −15.0 to −4.3 p = 0.0005). Memantine was significantly better than placebo for cognition. The main study limitation is that it still remains to be determined whether memantine has a role in milder agitation in AD.
Conclusions
Memantine did not improve significant agitation in people with in moderate-to-severe AD. Future studies are urgently needed to test other pharmacological candidates in this group and memantine for neuropsychiatric symptoms.
Trial Registration
ClinicalTrials.gov NCT00371059
Trial Registration
International Standard Randomised Controlled Trial 24953404
doi:10.1371/journal.pone.0035185
PMCID: PMC3342281  PMID: 22567095
7.  Assertive Community Treatment for alcohol dependence (ACTAD): study protocol for a randomised controlled trial 
Trials  2012;13:19.
Background
Alcohol dependence is a significant and costly problem in the UK yet only 6% of people a year receive treatment. Current service provision based on the treatment of acute episodes of illness and emphasising personal choice and motivation results in a small proportion of these patients engaging with alcohol treatment. There is a need for interventions targeted at the population of alcohol dependent patients who are hard to engage in conventional treatment. Assertive Community Treatment (ACT), a model of care based on assertive outreach, has been used for treating patients with severe mental illnesses and presents a promising avenue for engaging patients with primary alcohol dependence. So far there has been little research on this.
Methods/Design
In this single blind exploratory randomised controlled trial, a total of 90 alcohol dependent participants will be recruited from community addiction services. After completing a baseline assessment, they will be assigned to one of two conditions: (1) ACT plus care as usual, or (2) care as usual. Those allocated to the ACT plus care as usual will receive the same treatment that is routinely provided by services, plus a trained key worker who will provide ACT. ACT comprises intensive and assertive contact at least once a week, over 50% of contacts in the participant's home or local community, and comprehensive case management across social and health care, for a period of one year. All participants will be followed up at 6 months and 12 months to assess outcome post randomisation. The primary outcome measures will be alcohol consumption: mean drinks per drinking day and percentage of days abstinent measured by the Time Line Follow Back interview. Secondary outcome measures will include severity of alcohol dependence, alcohol related problems, motivation to change, social network involvement, quality of life, therapeutic relationship and service use. Other outcome variables are treatment engagement including completion of assessment, detoxification and aftercare.
Discussion
Results of this trial will help clarify the potential beneficial effects of ACT for people with alcohol dependence and provide information to design a definitive trial.
Trial registration number
ISRCTN: ISRCTN22775534
doi:10.1186/1745-6215-13-19
PMCID: PMC3305428  PMID: 22348423
assertive outreach; alcohol dependence; case management; substance use treatment; assertive community treatment
13.  Alcohol misuse 
Clinical Evidence  2009;2009:1017.
Introduction
Alcohol use is a leading cause of mortality and morbidity internationally, and is ranked by the World Health Organization (WHO) as one of the top five risk factors for disease burden. Without treatment, approximately 16% of hazardous or harmful alcohol users will progress to more dependent patterns of alcohol consumption. This review covers interventions in hazardous or harmful, but not dependent, alcohol users.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of interventions in hazardous or harmful drinkers in the primary-care setting? What are the effects of interventions in hazardous or harmful drinkers in the emergency-department setting? We searched: Medline, Embase, The Cochrane Library, and other important databases up to February 2009 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 18 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review, we present information relating to the effectiveness and safety of the following interventions in primary care and in emergency departments: brief intervention (single- or multiple-session); universal screening plus brief interventions; and targeted screening plus brief interventions.
Key Points
Alcohol use is a leading cause of mortality and morbidity internationally, and is ranked by the WHO as one of the top five risk factors for disease burden. Without treatment, approximately 16% of hazardous or harmful alcohol users will progress to more dependent patterns of alcohol consumption.
This review covers interventions in hazardous or harmful (but not dependent) alcohol users. Hazardous alcohol consumption is defined as a pattern of alcohol consumption that increases the individual's risk of alcohol-related harm, but is not currently causing alcohol-related harm.Harmful alcohol consumption is a pattern of consumption likely to have already led to alcohol-related harm.
Single- or multiple-session brief intervention reduces alcohol consumption over 1 year in hazardous drinkers treated in the primary-care setting, but we don't know how it affects mortality.
Brief intervention (single- or multiple-session) is also effective at reducing alcohol consumption in people treated in the emergency department, although the evidence is not as strong.
Adding universal screening to brief intervention enhances its benefits when given in primary care. We don't know how effectiveuniversal screening in emergency departments is, as we found no data.We don't know whether targeted screening is effective, as we found no data assessing its use in primary or emergency care.
PMCID: PMC2907792  PMID: 21718573
14.  The effectiveness and cost-effectiveness of a participative community singing programme as a health promotion initiative for older people: protocol for a randomised controlled trial 
BMC Public Health  2011;11:142.
Background
The growth in numbers of older people represents a considerable cost to health and social care services in the United Kingdom. There is an acknowledged need to address issues of social exclusion and both the physical and mental health of this age group. In recent years there has been much interest in the potential contribution of the arts to the health of communities and individuals. There is some evidence that participative singing may be of benefit to older people, however studies to date are limited in number and have lacked rigour. There is therefore a need to build on this knowledge base to provide more quantifiable evidence of both effectiveness and cost effectiveness of singing as a health intervention for this population group.
Methods
The proposed study is a pragmatic randomised controlled trial with two parallel arms. The primary hypothesis is that singing groups for older people improve both physical and mental aspects of quality of life when compared to usual activities. Potential participants will be volunteers over 60 years living in the community and recruited through publicity. Eligible and consenting participants will be randomized to either a singing group or a control group. Singing groups will take part in a twelve week planned programme of singing and control groups will continue with usual activities. The primary outcome measure will be the York SF-12, a health related quality of life measure which will be administered at baseline, three and six months after baseline. The study will evaluate both effectiveness and cost-effectiveness.
Discussion
This study proposes to add to the existing body of evidence on the value of singing for older people by using a rigorous methodological design, which includes a power calculation, a standardised intervention and assessment of cost-effectiveness. It should be regarded as a stage in a progressive programme of studies in this area. If group singing is found to be effective and cost-effective it may offer an alternative means to maintaining the health of people in later life.
Trial Registration
ISRCTN62404401
doi:10.1186/1471-2458-11-142
PMCID: PMC3053252  PMID: 21356071
15.  Participants' preference for type of leaflet used to feed back the results of a randomised trial: a survey 
Trials  2010;11:116.
Background
Hundreds of thousands of volunteers take part in medical research, but many will never hear from researchers about what the study revealed. There is a growing demand for the results of randomised trials to be fed back to research participants both for ethical research practice and for ensuring their co-operation in a trial. This study aims to determine participants' preferences for type of leaflet (short versus long) used to summarise the findings of a randomised trial; and to test whether certain characteristics explained participants' preferences.
Methods
553 participants in a randomised trial about General Practitioners' access to Magnetic Resonance Imaging for patients presenting with suspected internal derangement of the knee were asked in the final follow-up questionnaire whether they would like to be fed back the results of the trial. Participants who agreed to this were included in a postal questionnaire survey asking about their preference, if any, between a short and a long leaflet and what it was about the leaflet that they preferred. Multinomial logistic regression was used to test whether certain demographics of responding participants along with treatment group explained whether a participant had a preference for type of leaflet or no preference.
Results
Of the participants who returned the final follow-up questionnaire, 416 (88%) agreed to receive the results of the trial. Subsequently 132 (32%) participants responded to the survey. Most participants preferred the longer leaflet (55%) and the main reasons for this were the use of technical information (94%) and diagrams (89%). There was weak evidence to suggest that gender might explain whether participants have a preference for type of leaflet or not (P = 0.084).
Conclusions
Trial participants want to receive feed back about the results and appear to prefer a longer leaflet. Males and females might require information to be communicated to them differently and should be the focus of further research.
Trial registration
The trial is registered with http://www.isrctn.org/ and ID is ISRCTN76616358.
doi:10.1186/1745-6215-11-116
PMCID: PMC3002349  PMID: 21122094
16.  Screening and brief interventions for hazardous and harmful alcohol use in probation services: a cluster randomised controlled trial protocol 
BMC Public Health  2009;9:418.
Background
A large number of randomised controlled trials in health settings have consistently reported positive effects of brief intervention in terms of reductions in alcohol use. However, although alcohol misuse is common amongst offenders, there is limited evidence of alcohol brief interventions in the criminal justice field. This factorial pragmatic cluster randomised controlled trial with Offender Managers (OMs) as the unit of randomisation will evaluate the effectiveness and cost-effectiveness of different models of screening to identify hazardous and harmful drinkers in probation and different intensities of brief intervention to reduce excessive drinking in probation clients.
Methods and design
Ninety-six OMs from 9 probation areas across 3 English regions (the North East Region (n = 4) and London and the South East Regions (n = 5)) will be recruited. OMs will be randomly allocated to one of three intervention conditions: a client information leaflet control condition (n = 32 OMs); 5-minute simple structured advice (n = 32 OMs) and 20-minute brief lifestyle counselling delivered by an Alcohol Health Worker (n = 32 OMs). Randomisation will be stratified by probation area. To test the relative effectiveness of different screening methods all OMs will be randomised to either the Modified Single Item Screening Questionnaire (M-SASQ) or the Fast Alcohol Screening Test (FAST). There will be a minimum of 480 clients recruited into the trial. There will be an intention to treat analysis of study outcomes at 6 and 12 months post intervention. Analysis will include client measures (screening result, weekly alcohol consumption, alcohol-related problems, re-offending, public service use and quality of life) and implementation measures from OMs (the extent of screening and brief intervention beyond the minimum recruitment threshold will provide data on acceptability and feasibility of different models of brief intervention). We will also examine the practitioner and organisational factors associated with successful implementation.
Discussion
The trial will evaluate the impact of screening and brief alcohol intervention in routine probation work and therefore its findings will be highly relevant to probation teams and thus the criminal justice system in the UK.
Ethical approval was given by Northern & Yorkshire REC
Trial Registration number
ISRCTN 19160244
doi:10.1186/1471-2458-9-418
PMCID: PMC2784463  PMID: 19922618
17.  Screening and brief interventions for hazardous and harmful alcohol use in primary care: a cluster randomised controlled trial protocol 
BMC Public Health  2009;9:287.
Background
There have been many randomized controlled trials of screening and brief alcohol intervention in primary care. Most trials have reported positive effects of brief intervention, in terms of reduced alcohol consumption in excessive drinkers. Despite this considerable evidence-base, key questions remain unanswered including: the applicability of the evidence to routine practice; the most efficient strategy for screening patients; and the required intensity of brief intervention in primary care. This pragmatic factorial trial, with cluster randomization of practices, will evaluate the effectiveness and cost-effectiveness of different models of screening to identify hazardous and harmful drinkers in primary care and different intensities of brief intervention to reduce excessive drinking in primary care patients.
Methods and design
GPs and nurses from 24 practices across the North East (n = 12), London and South East (n = 12) of England will be recruited. Practices will be randomly allocated to one of three intervention conditions: a leaflet-only control group (n = 8); brief structured advice (n = 8); and brief lifestyle counselling (n = 8). To test the relative effectiveness of different screening methods all practices will also be randomised to either a universal or targeted screening approach and to use either a modified single item (M-SASQ) or FAST screening tool. Screening randomisation will incorporate stratification by geographical area and intervention condition. During the intervention stage of the trial, practices in each of the three arms will recruit at least 31 hazardous or harmful drinkers who will receive a short baseline assessment followed by brief intervention. Thus there will be a minimum of 744 patients recruited into the trial.
Discussion
The trial will evaluate the impact of screening and brief alcohol intervention in routine practice; thus its findings will be highly relevant to clinicians working in primary care in the UK. There will be an intention to treat analysis of study outcomes at 6 and 12 months after intervention. Analyses will include patient measures (screening result, weekly alcohol consumption, alcohol-related problems, public service use and quality of life) and implementation measures from practice staff (the acceptability and feasibility of different models of brief intervention.) We will also examine organisational factors associated with successful implementation.
Trial registration
Current Controlled Trials ISRCTN06145674.
doi:10.1186/1471-2458-9-287
PMCID: PMC2734851  PMID: 19664255
18.  Screening and brief interventions for hazardous alcohol use in accident and emergency departments: a randomised controlled trial protocol 
Background
There is a wealth of evidence regarding the detrimental impact of excessive alcohol consumption on the physical, psychological and social health of the population. There also exists a substantial evidence base for the efficacy of brief interventions aimed at reducing alcohol consumption across a range of healthcare settings. Primary research conducted in emergency departments has reinforced the current evidence regarding the potential effectiveness and cost-effectiveness. Within this body of evidence there is marked variation in the intensity of brief intervention delivered, from very minimal interventions to more intensive behavioural or lifestyle counselling approaches. Further the majority of primary research has been conducted in single centre and there is little evidence of the wider issues of generalisability and implementation of brief interventions across emergency departments.
Methods/design
The study design is a prospective pragmatic factorial cluster randomised controlled trial. Individual Emergency Departments (ED) (n = 9) are randomised with equal probability to a combination of screening tool (M-SASQ vs FAST vs SIPS-PAT) and an intervention (Minimal intervention vs Brief advice vs Brief lifestyle counselling). The primary hypothesis is that brief lifestyle counselling delivered by an Alcohol Health Worker (AHW) is more effective than Brief Advice or a minimal intervention delivered by ED staff. Secondary hypotheses address whether short screening instruments are more acceptable and as efficient as longer screening instruments and the cost-effectiveness of screening and brief interventions in ED. Individual participants will be followed up at 6 and 12 months after consent. The primary outcome measure is performance using a gold-standard screening test (AUDIT). Secondary outcomes include; quantity and frequency of alcohol consumed, alcohol-related problems, motivation to change, health related quality of life and service utilisation.
Discussion
This paper presents a protocol for a large multi-centre pragmatic factorial cluster randomised trial to evaluate the effectiveness and cost-effectiveness of screening and brief interventions for hazardous alcohol users attending emergency departments.
Trial Registration
ISRCTN 93681536
doi:10.1186/1472-6963-9-114
PMCID: PMC2712466  PMID: 19575791
19.  Effectiveness of nurse delivered endoscopy: findings from randomised multi-institution nurse endoscopy trial (MINuET) 
Objective To compare the clinical effectiveness of doctors and nurses in undertaking upper and lower gastrointestinal endoscopy.
Design Pragmatic trial with Zelen’s randomisation before consent to minimise distortion of existing practice.
Setting 23 hospitals in the United Kingdom. In six hospitals, nurses undertook both upper and lower gastrointestinal endoscopy, yielding a total of 29 centres.
Participants 67 doctors and 30 nurses. Of 4964 potentially eligible patients, we randomised 4128 (83%) and recruited 1888 (38%) from July 2002 to June 2003.
Interventions Diagnostic upper gastrointestinal endoscopy and flexible sigmoidoscopy, undertaken with or without sedation, with the standard preparation, techniques, and protocols of participating hospitals. After referral for either procedure, patients were randomised between doctors and nurses.
Main outcome measures Gastrointestinal symptom rating questionnaire (primary outcome), gastrointestinal endoscopy satisfaction questionnaire and state-trait anxiety inventory (all analysed by intention to treat); immediate and delayed complications; quality of examination and corresponding report; patients’ preferences for operator; and new diagnoses at one year (all analysed according to who carried out the procedure).
Results There was no significant difference between groups in outcome at one day, one month, or one year after endoscopy, except that patients were more satisfied with nurses after one day. Nurses were also more thorough than doctors in examining the stomach and oesophagus. While quality of life scores were slightly better in patients the doctor group, this was not statistically significant.
Conclusions Diagnostic endoscopy can be undertaken safely and effectively by nurses.
Trial registration International standard RCT 82765705
doi:10.1136/bmj.b231
PMCID: PMC2643440  PMID: 19208714
20.  Cost effectiveness of nurse delivered endoscopy: findings from randomised multi-institution nurse endoscopy trial (MINuET) 
Objective To compare the cost effectiveness of nurses and doctors in performing upper gastrointestinal endoscopy and flexible sigmoidoscopy.
Design As part of a pragmatic randomised trial, the economic analysis calculated incremental cost effectiveness ratios, and generated cost effectiveness acceptability curves to address uncertainty.
Setting 23 hospitals in the United Kingdom.
Participants 67 doctors and 30 nurses, with a total of 1888 patients, from July 2002 to June 2003.
Intervention Diagnostic upper gastrointestinal endoscopy and flexible sigmoidoscopy carried out by doctors or nurses.
Main outcome measure Estimated health gains in QALYs measured with EQ-5D. Probability of cost effectiveness over a range of decision makers’ willingness to pay for an additional quality adjusted life year (QALY).
Results Although differences did not reach traditional levels of significance, patients in the doctor group gained 0.015 QALYs more than those in the nurse group, at an increased cost of about £56 (€59, $78) per patient. This yields an incremental cost effectiveness ratio of £3660 (€3876, $5097) per QALY. Though there is uncertainty around these results, doctors are probably more cost effective than nurses for plausible values of a QALY.
Conclusions Though upper gastrointestinal endoscopies and flexible sigmoidoscopies carried out by doctors cost slightly more than those by nurses and improved health outcomes only slightly, our analysis favours endoscopies by doctors. For plausible values of decision makers’ willingness to pay for an extra QALY, endoscopy delivered by nurses is unlikely to be cost effective compared with endoscopy delivered by doctors.
Trial registration International standard RCT 82765705
doi:10.1136/bmj.b270
PMCID: PMC2643438  PMID: 19208715
21.  The effectiveness and cost-effectiveness of opportunistic screening and stepped care interventions for older hazardous alcohol users in primary care (AESOPS) – A randomised control trial protocol 
Background
There is a wealth of evidence regarding the detrimental impact of excessive alcohol consumption. In older populations excessive alcohol consumption is associated with increased risk of coronary heart disease, hypertension, stroke and a range of cancers. Alcohol consumption is also associated with an increased risk of falls, early onset of dementia and other cognitive deficits. Physiological changes that occur as part of the ageing process mean that older people experience alcohol related problems at lower consumption levels. There is a strong evidence base for the effectiveness of brief psychosocial interventions in reducing alcohol consumption in populations identified opportunistically in primary care settings. Stepped care interventions involve the delivery of more intensive interventions only to those in the population who fail to respond to less intensive interventions and provide a potentially resource efficient means of meeting the needs of this population.
Methods/design
The study design is a pragmatic prospective multi-centre two arm randomised controlled trial. The primary hypothesis is that stepped care interventions for older hazardous alcohol users reduce alcohol consumption compared with a minimal intervention at 12 months post randomisation. Potential participants are identified using the AUDIT questionnaire. Eligible and consenting participants are randomised with equal probability to either a minimal intervention or a three step treatment approach. The step treatment approach incorporates as step 1 behavioural change counselling, step 2 three sessions of motivational enhancement therapy and step 3 referral to specialist services. The primary outcome is measured using average standard drinks per day and secondary outcome measures include the Drinking Problems Index, health related quality of life and health utility. The study incorporates a comprehensive economic analysis to assess the relative cost-effectiveness of the interventions.
Discussion
The paper presents a protocol for the first pragmatic randomised controlled trial evaluating the effectiveness and cost-effectiveness of stepped care interventions for older hazardous alcohol users in primary care.
Trial registration
ISRCTN52557360
doi:10.1186/1472-6963-8-129
PMCID: PMC2442836  PMID: 18549492
22.  Improving response rates using a monetary incentive for patient completion of questionnaires: an observational study 
Background
Poor response rates to postal questionnaires can introduce bias and reduce the statistical power of a study. To improve response rates in our trial in primary care we tested the effect of introducing an unconditional direct payment of £5 for the completion of postal questionnaires.
Methods
We recruited patients in general practice with knee problems from sites across the United Kingdom. An evidence-based strategy was used to follow-up patients at twelve months with postal questionnaires. This included an unconditional direct payment of £5 to patients for the completion and return of questionnaires. The first 105 patients did not receive the £5 incentive, but the subsequent 442 patients did. We used logistic regression to analyse the effect of introducing a monetary incentive to increase the response to postal questionnaires.
Results
The response rate following reminders for the historical controls was 78.1% (82 of 105) compared with 88.0% (389 of 442) for those patients who received the £5 payment (diff = 9.9%, 95% CI 2.3% to 19.1%). Direct payments significantly increased the odds of response (adjusted odds ratio = 2.2, 95% CI 1.2 to 4.0, P = 0.009) with only 12 of 442 patients declining the payment. The incentive did not save costs to the trial – the extra cost per additional respondent was almost £50.
Conclusion
The direct payment of £5 significantly increased the completion of postal questionnaires at negligible increase in cost for an adequately powered study.
doi:10.1186/1471-2288-7-12
PMCID: PMC1810307  PMID: 17326837
23.  The DAMASK trial protocol: a pragmatic randomised trial to evaluate whether GPs should have direct access to MRI for patients with suspected internal derangement of the knee 
Background
Though new technologies like Magnetic Resonance Imaging (MRI) may be accurate, they often diffuse into practice before thorough assessment of their value in diagnosis and management, and of their effects on patient outcome and costs. MRI of the knee is a common investigation despite concern that it is not always appropriate. There is wide variation in general practitioners (GPs) access to, and use of MRI, and in the associated costs. The objective of this study was to resolve uncertainty whether GPs should refer patients with suspected internal derangement of the knee for MRI or to an orthopaedic specialist in secondary care.
Methods/Design
The design consisted of a pragmatic multi-centre randomised trial with two parallel groups and concomitant economic evaluation. Patients presenting in general practice with suspected internal derangement of the knee and for whom their GP was considering referral to an orthopaedic specialist in secondary care were eligible for inclusion. Within practices, GPs or practice nurses randomised eligible and consenting participants to the local radiology department for an MRI examination, or for consultation with an orthopaedic specialist. To ensure that the waiting time from GP consultation to orthopaedic appointment was similar for both trial arms, GPs made a provisional referral to orthopaedics when requesting the MRI examination. Thus we evaluated the more appropriate sequence of events independent of variations in waiting times. Follow up of participants was by postal questionnaires at six, twelve and 24 months after randomisation. This was to ensure that the evaluation covered all events up to and including arthroscopy.
Discussion
The DAMASK trial should make a major contribution to the development of evidence-based partnerships between primary and secondary care professionals and inform the debate when MRI should enter the diagnostic pathway.
doi:10.1186/1472-6963-6-133
PMCID: PMC1621066  PMID: 17040558
24.  Opportunistic screening for alcohol use disorders in primary care: comparative study 
BMJ : British Medical Journal  2006;332(7540):511-517.
Objective To evaluate the efficacy and relative costs of different screening methods for the identification of alcohol use disorders in an opportunistic screening programme in primary care in the United Kingdom.
Design Comparative study.
Setting Six general practices in south Wales.
Participants 194 male primary care attendees aged 18 or over who completed an alcohol use disorders identification test (AUDIT) questionnaire.
Main outcome measures Scores on alcohol use disorders identification test and measures of γ-glutamyltransferase, aspartate aminotransferase, per cent carbohydrate deficient transferrin, and erythrocyte mean cell volume. Hazardous alcohol consumption, weekly binge consumption, and monthly binge consumption were ascertained using the time line follow back method over the previous 180 days. Alcohol dependence was determined using the Diagnostic and Statistical Manual of Mental Disorders, fourth edition. Unit costs were established from published resource references and from actual costs of analysing the biochemical tests.
Results A significant correlation was observed be alcohol consumption and score on the alcohol use disorders identification test (Pearson's correlation coefficient r = 0.74) and measures of γ-glutamyltransferase (r = 0.20) and per cent carbohydrate deficient transferrin (r = 0.36) but not aspartate aminotransferase (r = 0.08) or erythrocyte mean cell volume (r = 0.02). The alcohol use disorders identification test exhibited significantly higher sensitivity, specificity, and positive predictive value than all of the biochemical markers for hazardous consumption (69%, 98%, and 95%), weekly binge consumption (75%, 90%, and 71%), monthly binge consumption (66%, 97%, and 91%), and alcohol dependence (84%, 83%, and 41%). The questionnaire was also more cost efficient, with a lower cost per true positive for all consumption outcomes.
Conclusion The alcohol use disorders identification test questionnaire is an efficient and cost efficient diagnostic tool for routine screening for alcohol use disorders in primary care.
doi:10.1136/bmj.38743.421574.7C
PMCID: PMC1388125  PMID: 16488896
25.  Randomised trial of a brief physiotherapy intervention compared with usual physiotherapy for neck pain patients: outcomes and patients' preference 
BMJ : British Medical Journal  2005;330(7482):75.
Objectives Firstly, to compare the effectiveness of a brief physiotherapy intervention with “usual” physiotherapy for patients with neck pain. Secondly, to evaluate the effect of patients' preferences on outcome.
Design Non-inferiority randomised controlled trial eliciting preferences independently of randomisation.
Setting Physiotherapy departments in a community setting in Yorkshire and north Lincolnshire.
Participants 268 patients (mean age 48 years) with subacute and chronic neck pain, who were referred by their general practitioner and randomly assigned to a brief physiotherapy intervention (one to three sessions) using cognitive behaviour principles to encourage self management and return to normal function or usual physiotherapy, at the discretion of the physiotherapist concerned.
Main outcome measures The Northwick Park neck pain questionnaire (NPQ), a specific measure of functional disability resulting from neck pain. Also, the short form 36 (SF-36) questionnaire, a generic, health related, quality of life measure; and the Tampa scale for kinesophobia, a measure of fear and avoidance of movement.
Results At 12 months, patients allocated to usual physiotherapy had a small but significant improvement in NPQ scores compared with patients in the brief intervention group (mean difference 1.99, 95% confidence interval 0.45 to 3.52; P = 0.01). Although the result shows a significant inferiority of the intervention, the confidence interval shows that the effect could be in the non-inferiority range for the brief intervention (below 1.2 points of NPQ score). Patients who preferred the brief intervention and received this treatment had similar outcomes to patients receiving usual physiotherapy.
Conclusions Usual physiotherapy may be only marginally better than a brief physiotherapy intervention for neck pain. Patients with a preference for the brief intervention may do at least as well with this approach. Additional training for the physiotherapists in cognitive behaviour techniques might improve this approach further.
doi:10.1136/bmj.38286.493206.82
PMCID: PMC543869  PMID: 15585539

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