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.

A brief cognitive behavioural preimplantation and rehabilitation programme for patients receiving an implantable cardioverter-defibrillator improves physical health and reduces psychological morbidity and unplanned readmissions.

OBJECTIVE: To assess the clinical and cost effectiveness of a brief home-based cognitive behavioural rehabilitation programme (the ICD Plan) for patients undergoing implantation of a cardiac defibrillator. DESIGN: A prospective multicentred, intention-to-treat, cluster-randomised controlled trial. SETTING: Eight implantable cardioverter-defibrillator (ICD) implantation centres in the UK. PATIENTS: Consecutive series of patients undergoing implantation with an ICD. INTERVENTIONS: The control group received usual care and advice from an experienced healthcare professional. The intervention group received usual care plus the ICD Plan. The plan was introduced before implantation, with three further brief telephone contacts with the nurse over the next 12 weeks. MAIN OUTCOME MEASURES: Health-related quality of life (Short Form Health Survey (SF-12)), anxiety and depression (Hospital Anxiety and Depression Scale (HADS)), activity limitations (subscale from the Seattle Angina Questionnaire (SAQ)), unplanned admissions and other economic data using a questionnaire developed for the study. RESULTS: 192 patients were recruited to the study (71 intervention, 121 control). At 6 months after surgery the intervention group had better physical health (37.83 vs 34.24; p<0.01), fewer limitations in physical activity (34.02 vs 31.72; p = 0.04), a greater reduction in the proportion of patients with a borderline diagnosis of anxiety (21% vs 13%; p = 0.60) and depression (13% vs 2%; p = 0.30), more planned ECGs (89% vs 66%; p = 0.04) and 50% fewer unplanned admissions (11% vs 22%; p<0.01). CONCLUSIONS: The ICD Plan improved health-related quality of life, reduced the incidence of clinically significant psychological distress and significantly reduced unplanned readmissions. It is a cost effective and easily implemented method for delivering rehabilitation and psychological care to patients undergoing ICD implantation. TRIAL REGISTRATION NUMBER: ISRCTN70212111.

Randomized trial of two physiotherapy interventions for primary care neck and back pain patients: 'McKenzie' vs brief physiotherapy pain management.

OBJECTIVES: Interventions that take psychosocial factors into account are recommended for patients with persistent back or neck pain. We compared the effectiveness of a brief physiotherapy pain management approach using cognitive-behavioural principles (Solution-Finding Approach-SFA) with a commonly used method of physical therapy (McKenzie Approach-McK). METHODS: Eligible patients referred by GPs to physiotherapy departments with neck or back pain lasting at least 2 weeks were randomized to McK (n= 161) or to SFA (n= 154). They were further randomized to receive an educational booklet or not. The primary outcome was the Tampa Scale of Kinesiophobia (TSK) (Activity-Avoidance scale used as a proxy for coping) at 6 weeks, and 6 and 12 months. RESULTS: Of 649 patients assessed for eligibility, 315 were recruited (219 with back pain, 96 with neck pain). There were no statistically significant differences in outcomes between the groups, except that at any time point SFA patients supported by a booklet reported less reliance on health professionals (Multidimensional Health Locus of Control Powerful Others Scale), while at 6 months McK patients showed slightly more improvement on activity-avoidance (TSK). At 6 weeks, patient satisfaction was greater for McK (median 90% compared with 70% for SFA). Both interventions resulted in modest but clinically important improvements over time on the Roland Disability Questionnaire Scores and Northwick Park Neck Pain Scores. CONCLUSIONS: The McK approach resulted in higher patient satisfaction overall but the SFA could be more cost-effective, as fewer (three vs four) sessions were needed.

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.

Dry tap at myringotomy: a three-year study of 1688 children undergoing myringotomy.

One thousand six hundred and eighty-eight children undergoing myringotomy were studied to determine the rate of 'dry taps' and factors associated with a dry middle ear at operation. The percentage of bilateral dry taps was 16%. The dry tap rate was significantly higher in the following groups: older children, those with an A, C1 or C2 tympanogram at the time of listing, milder hearing loss, a preceding history of recurrent acute otitis media and operation performed during the summer or autumn. There was no significant relationship between the dry tap rate and the time on the waiting list, the gender of the child or the order in which right or left myringotomies were performed. Careful preoperative reassessment of any child with a type A, C1 or C2 tympanogram should be made to prevent unnecessary surgery. Separating those listed for treatment of recurrent acute otitis media from those with OME would prevent these being included in the overall dry tap rate.