Lynn Owens

Brief interventions in dependent drinkers: a comparative prospective analysis in two hospitals.

AIMS To investigate whether brief interventions (BIs) delivered by a dedicated Alcohol Specialist Nurse (ASN) to non-treatment-seeking alcohol-dependent patients in an acute hospital setting are effective in reducing alcohol consumption and dependence. METHODS A prospective cohort control study in two acute NHS Hospital Trusts in the North West England, one of which provided BI (university teaching hospital-test site) while the other did not (district general hospital-control site), including follow-up BIs. Subjects were alcohol-dependent patients aged ≥18 years. RESULTS A total of 100 patients were recruited at each site. No differences were found between the groups in the baseline demographic parameters or medical co-morbidities. At the test site, further sessions were sometimes offered, and 46 patients received more than one intervention (median 4, mean 6.3 and maximum 20). At 6 months, alcohol consumption (P < 0.0001), Alcohol Use Disorders Identification Tool (AUDIT) score (P < 0.0001) and Severity of Alcohol Dependence Questionnaire score (P = 0.0001) were significantly lower at the test site than the control site. Outcomes were found to be independent of both the baseline level of dependence and medical co-morbidity. CONCLUSION BI delivered by a dedicated ASN for non-treatment-seeking alcohol-dependent individuals, who often have significant medical co-morbidities, seem to be effective in an acute hospital setting. This study provides a framework to inform the design of a future randomized controlled trial.

An Investigation of Disagreement in Causality Assessment of Adverse Drug Reactions

AbstractBackground: Causality assessment is used to determine the likelihood that a drug caused a particular adverse event. There are multiple methods for assessing the causality of suspected adverse drug reactions (ADRs). Undertaking some form of causality assessment of suspected ADRs is part of pharmacovigilance practice, but potentially without value if reproducibility of the results is consistently poor, and may vary with the background and experience of the assessor. Objective: The aim of this study was to compare inter-assessor agreements for causality assessment of epidemiological study data from an individual perspective and between individuals from different healthcare backgrounds. Study Methods: Six assessors (two pharmacists, two physicians and two nurses), assessed 200 ADR reports for causality using the Naranjo ADR Probability Scale, the Venulet algorithm and the WHO causality term assessment criteria. Agreement between assessors using the same algorithms was examined, and agreement between the algorithms for the same assessor was also measured. Results: For all methods, the majority of the causality assessments resulted in ‘probable’ or ‘possible’ categorization. Physician and pharmacist assessment was more likely to result in ‘definite’ or ‘certain’ causality assessments than nurse assessment, when using the Naranjo and WHO algorithms. Use of the Venulet algorithm resulted in a higher number of ‘unlikely’ or ‘unrelated’ assessments than the other two methods. The inter-assessor agreement measured was no greater than ‘fair’ (weighted kappa [κw] = 0.31) for any comparison between raters, and for three comparisons, inter-assessor agreement was less than that expected by chance. Conversely, the weighted observed proportion of agreement, Po (w), was good (>0.6) for all assessments. Intra-assessor agreement between scales was highest for the Naranjo algorithm versus the WHO algorithm, with ‘substantial’ (κw = 0.61) agreement between assessments made by pharmacist 1.The lowest level of agreement within assessors came from nurse 2 when comparing the Naranjo and Venulet algorithms, where agreement was ‘slight’ (κw = 0.19), though the mean Po (w) for intra-assessor agreement was 0.81. Conclusions: Comparability between assessors was found to be ‘fair’ or less for the ADR causality assessment methods examined in this study. The most consistent results were produced by the application of the Naranjo algorithm and the least consistent was the Venulet algorithm. It is likely that the clinical experience of the assessor influences how the assessment methods are applied. The high level of disagreement in the results produced using the assessment scales in this study question the robustness of causality assessments.

Drug therapy for alcohol dependence in primary care in the UK: A Clinical Practice Research Datalink study

Aim To evaluate drug therapy for alcohol dependence in the 12 months after first diagnosis in UK primary care. Design Open cohort study. Setting General practices contributing data to the UK Clinical Practice Research Database. Participants 39,980 people with an incident diagnosis of alcohol dependence aged 16 years or older between 1 January 1990 and 31 December 2013. Main outcome measure Use of pharmacotherapy (acamprosate, disulfiram, naltrexone, baclofen and topiramate) to promote abstinence from alcohol or reduce drinking to safe levels in the first 12 months after a recorded diagnosis of alcohol dependence. Findings Only 4,677 (11.7%) of the cohort received relevant pharmacotherapy in the 12 months following diagnosis. Of the 35,303 that did not receive pharmacotherapy, 3,255 (9.2%) received psychosocial support. The remaining 32,048 (80.2%) did not receive either mode of treatment in the first 12 months. Factors that independently reduced the likelihood of receiving pharmacotherapy included: being male (Odds Ratio [OR] 0.74; 95% CI 0.69 to 0.78); older (65-74 years: OR 0.61; 95% CI 0.49 to 0.77); being from a practice based in the most deprived quintile (OR 0.58; 95% CI 0.53 to 0.64); and being located in Northern Ireland (OR 0.78; 95% CI 0.67 to 0.91). The median duration to initiation of pharmacotherapy was 0.80 months (95% CI 0.70 to 1.00) for acamprosate and 0.60 months (95% CI 0.43 to 0.73) for disulfiram. Persistence analysis for those receiving acamprosate and disulfiram revealed that many patients never received a repeat prescription; persistence at 6 months was 27.7% for acomprosate and 33.2% for disulfiram. The median duration of therapy was 2.10 months (95% CI 1.87 to 2.53) for acamprosate and 3.13 months (95% CI 2.77 to 3.36) for disulfiram. Conclusion Drug therapy to promote abstinence in alcohol dependent patients was low, with the majority of patients receiving no therapy, either psychological or pharmacological. When drug therapy was prescribed, persistence was low with most patients receiving only one prescription. Our data show that treatment for alcohol dependence is haphazard, and there is an urgent need to explore strategies for improving clinical management of this patient group.

Pharmacotherapy for alcohol dependence: A stratified approach

Alcohol dependence is a common disorder in many societies worldwide, and remains difficult to identify and treat. It is also a risk factor for many secondary non-communicable diseases. Pharmacotherapy is one available treatment option, but appears to be underutilised in practice. Major barriers to use of medications in this area include lack of clinical guidance and questionable efficacy. However, for each medication there appears to be a subpopulation that responds positively, and understanding the moderating factors to treatment efficacy is an important research goal. Thus, this review provides a narrative regarding potential stratification techniques in pharmacological treatment of alcohol dependence, with a specific focus on typologies and pharmacogenetics. In addition, we discuss the basic background of stratified medicine and recent studies on genetic predisposition to alcohol dependence. A growing repository of data exists for both approved and non-approved pharmacotherapies, but failure to replicate findings, inadequate sample sizes, and insufficient funding has resulted in a translational gap. Implementing evidence-based stratified/personalised therapy and identifying new therapeutic agents may lead to improved clinical outcomes and reduced financial burden. Despite some promising findings to date, much work is still required.

Systematic review: Baclofen dosing protocols for alcohol use disorders used in observational studies

The popularity of baclofen as an anti-craving agent in the treatment of alcohol use disorders (AUDs) has increased, especially in patients with established liver disease. However, evidence-based guidelines to inform practice are lacking. The aim of this systematic review is explore the prescribing practices of baclofen in AUD treatment. Electronic databases were searched for relevant articles from 2002. Assessment of eligibility criteria for inclusion was performed independently by two investigators. The main outcomes of interest were maximum dose, starting dose, titration regimen, effectiveness, and tolerability. Twenty-five studies reporting outcomes in 613 patients treated with baclofen for an AUD were identified. Starting doses ranged between 5 and 50mg/d. Titration was study-dependent, and doses were increased until either therapeutic target (abstinence or study-defined low risk drinking) was achieved or adverse events resulted in a dose reduction or discontinuation. The maximum dose for individual patients ranged between 20 and 630mg/d. Seven studies reported at least one patient using >300mg/d. In studies with 10 or more patients, we found a negative correlation between dose and proportion of patients achieving the therapeutic goal. However, this was skewed by one study. A range of serious adverse events were reported. Most were reported at doses over 100mg/d, but others presented at lower doses. Baclofen is a promising therapeutic in this area. Evidence is required, however, to support practitioners in prescribing doses that optimise outcomes and reduce adverse events.

A six month follow-up study to determine the clinical utility and patient acceptability of fibroelastography in detection and treatment of alcohol-related liver disease

FRI-001 A six month follow-up study to determine the clinical utility and patient acceptability of fibroelastography in detection and treatment of alcohol-related liver disease L. Owens, A. Thompson, C. Siju, P. Richardson. Royal Liverpool University Hospital, Hepatology, Liverpool, United Kingdom; University of Liverpool, Wolfson Centre for Personalised Medicine, Liverpool, United Kingdom; University of Liverpool, Medical School, Liverpool, United Kingdom Email: lynno@liv.ac.uk

Health-related quality of life in alcohol dependence: Similar cross-cultural impact beyond specific drinking habits

ABSTRACT This study explores sociocultural differences in alcohol-related impact on quality of life between France and United Kingdom. We included 38 alcohol-dependent patients in France and United Kingdom in 10 focus groups. We used a text-mining approach. Three classes of each corpus regarded identical themes across the countries: (a) core impact on quality of life, (b) drinking habits, (c) sources of help. Core impact was similar between the two countries. Main differences were in drinking habits and referral to sources of help. Despite differences in drinking habits, the domains of life impacted by alcohol were non–country specific.

Baclofen : Maintenance of Abstinence in Alcohol Dependent Patients Attending a Joint Liver and Alcohol Treatment Clinic

Introduction Alcohol induced liver disease (ALD) is the predominant cause of alcohol-related mortality in the UK. Therefore helping patients with ALD to quit is a primary treatment goal. Aims/Objectives The primary aim of this study was to measure the effectiveness and tolerability of Baclofen in maintaining abstinence, and to determine if this resulted in a reduction in standard measures of liver damage. Methods An observational prospective clinical audit was performed. Patients with ALD were commenced on Baclofen titrated according to tolerability and response up to 30 mg TDS. Primary outcome measures were severity of physical dependence (SADQ score) and biochemical markers of liver damage GGT, ALT, Bilirubin fibroelastography. These were compared at baseline, and 1 year. Results Of the 243 patients commenced on Baclofen, 151 (85 female 66 male) have completed 1 year follow-up (F/U) of which 130 (86%) have remained engaged. 10 have died. Comparison of baseline (B/L) and 1 year biochemical markers showed a reduction in GGT (c2= 66.8 P Conclusion Baclofen is well tolerated in this very difficult to treat, high risk patient group. It has a positive impact on alcohol consumption, and overall measures of liver function and harm. A RCT is needed to confirm the benefit of Baclofen in this patient group.

PTH-045 Integrated Alcohol And Hepatology Mdt: Reducing Alcohol-related Hospital Admission And Attendance

Introduction In 2010 a joint position paper on behalf of British Society of Gastroenterology, the Alcohol Health Alliance UK, and the British Association for Study of the Liver highlighted that the most deprived lifestyle groups have up-to 15 times greater alcohol‐specific mortality and up to 10 times greater alcohol‐specific admissions to hospital. It therefore recommended that each acute hospital should develop a multidisciplinary approach to the care and management of people attending or admitted to hospital with an alcohol-related cause.1 Methods We conducted a notes review of all patients attending or admitted to the hospital on more than 6 occasions in the previous 6 months. We also complied 3 in-depth case studies of our most frequent attenders. We investigated the reason for admission including medical and social confounders. We then looked at the range and number of medical and social disciplines involved in their care, discharge planning and aftercare. We spoke to our patients about why they had chosen to attend hospital and what they felt could be provided as an alternative. We developed an electronic early warning system to inform the Alcohol Team when a patient was admitted. This triggered referral to our integrated alcohol and hepatology consultant led MDT Results Our investigations showed that the majority of patients had a range of support including key workers from a variety of voluntary agencies, housing agencies, GP’s, primary care alcohol specialist nurses, social workers, homeless outreach, and specialist medical consultants from psychiatry to hepatology. However, much of this work was happening in isolation and was at times conflicting with no one organisation or professionals supporting or mapping out the patients journey. Importantl, y, the patients were unclear where to go for what, and were often utilising the ED as a failsafe when they were unsure or troubled. The MDT is a vehicle to ensure that the patient gets the right treatment at the right time by the right person; which has helped our patients better understand their care pathways and their aims. This has resulted in a significant reduction in hospital attendance and admission for this small but significant patient group. Conclusion An MDT for alcohol-related admissions augments and centralises the expertise of health and social care partners in the development of truly patient centred shared plans of care. This leads to hospital admission only when appropriate and necessary Reference 1 Moriarty K. A Joint Position Paper on behalf of the British Society of Gastroenterology, Alcohol Health Alliance UK, British Association for Study of the Liver – ALCOHOL-RELATED DISEASE Meeting the challenge of improved quality of care and better use of resources. 2010 Disclosure of Interest None Declared.

PTU-118 Baclofen As An Adjunct Pharmacotherapy For The Maintenance Of Abstinence In Alcohol Dependent Patients With Liver Disease

Introduction Alcohol induced liver disease is the predominant cause of alcohol-related mortality in the UK. Therefore abstinence-based treatments are essential. Upto 70% of patients receiving alcohol treatment relapse within 6 months,1 NICE attribute much of this failure of treatment to underutilisation of pharmacotherapy and recommend this be made available.2 However, current licensed pharmacotherapies are contraindicated for patients with ALD. Baclofen has shown efficacy in the promotion of abstinence in patients with severe alcohol dependence3,4 including those with ALD,5 without exhibiting any of the complications or side effects elicited by current pharmacotherapies. Therefore the primary aim of this study was to measure the effectiveness of Baclofen in maintaining abstinence in this difficult to treat group. Methods An observational prospective clinical audit was performed. Patients with liver disease and concomitant alcohol use were commenced on Baclofen at 10 mg three times daily (TDS), and titrated according to tolerability and response up to 30 mg TDS. Primary outcome measures were severity of physical dependence, as determined by SADQ score, and weekly alcohol consumption. These were compared at baseline, and 6 months. Setting Acute Hospital Trust Participants 149 patients referred to Hepatology for investigation of abnormal liver function and heavy drinking Results Of the 149 patients commenced on Baclofen 100 (67.1%) remained engaged in treatment for 6 months. There was a significant reduction in alcohol consumption (P < 0.0001 95% CI for difference 18 to 20) with 81 of the 149 patients (54.3%) maintaining total abstinence, 20 (13.4%) continued to drink and 48 (32.2%) were lost to follow-up and assumed to have returned to drinking. There was a significant reduction in the presence of physical dependence (c2 = 77.4 P < 0.0001) as categorised by SADQ, and a non-significant improvement of liver biochemistry. Conclusion Baclofen has a positive impact on alcohol consumption in this very difficult to treat, high risk patient group. A RCT is needed to confirm the benefit of baclofen in this patient group. References Raistrick, D. 2006, NTA NICE, Alcohol Use Disorders: CG115, 2011 Addolorato, G. 2012 Muzyk, A. 2012 Leggio, L. 2010 Disclosure of Interest None Declared.