Randomised controlled trial of a brief alcohol intervention in a general hospital setting

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1 Shiles et al. Trials 2013, 14:345 TRIALS RESEARCH Ope Access Radomised cotrolled trial of a brief alcohol itervetio i a geeral hospital settig Celia J Shiles 1, Ua P Caig 1, Sadra A Keell-Webb 1, Carolie M Gustoe 1, E Jae Marshall 2*, Timothy J Peters 3 ad Simo C Wessely 4 Abstract Backgroud: The evidece suggests that brief alcohol-focused itervetios, directed at hazardous ad harmful drikers i o-specialist settigs such as primary care are effective i reducig alcohol cosumptio. However, there is a eed for further research i the hospital settig. This is a radomised cotrolled trial to ivestigate the effectiveess of a 10-miute brief itervetio amogst at risk drikers admitted to geeral hospital wards. Ulike some previous trials, this trial is radomised, used blided assessors, icludes a itetio-to-treat aalysis, icluded female subjects ad excluded people with alcohol depedece. Methods: A total of 250 at risk drikers admitted to Kig s College Hospital were idetified usig the Alcohol Use Disorders Idetificatio Test (AUDIT). Some 154 subjects etered the study ad were radomly allocated to the cotrol ad itervetio groups. Subjects i the cotrol group received o advice about their drikig whilst subjects i the itervetio group received 10 miutes of simple advice o reducig alcohol cosumptio. Recruitmet took place betwee 1995 ad The primary outcome was the AUDIT questioaire at 12 moths. Secodary outcomes were a previous week s Driks Diary, questioaires (Geeral Health Questioaire, Alcohol Problems Questioaire ad the Severity of Alcohol Depedece Questioaire) ad laboratory blood tests (gamma glutamyl trasferase, mea cell volume ad haemoglobi). Results: At 3-moth ad 12-moth follow-up, all participats were icluded i the itetio-to-treat aalysis. At both time poits there was o evidece of a itervetio effect that could be attributed to the brief itervetio. Both the itervetio ad cotrol groups had a improved AUDIT score ad reduced levels of alcohol cosumptio as measured by a subjective Driks Diary at 3 moths which was maitaied at 12 moths. Coclusios: This study has added further evidece o brief itervetios i the hospital settig. I cotrast to the recet Cochrae review by McQuee et al., the results of this study do ot support the effectiveess of a brief alcohol itervetio i geeral hospital wards. However our study was uderpowered ad there were flaws i the statistical aalyses, ad these limitatios temper the stregth of our coclusios. Keywords: Brief alcohol itervetio, Geeral hospital, Alcohol problems, Cotrolled cliical trial Backgroud Brief itervetios are widely regarded as a effective strategy to reduce alcohol cosumptio i hazardous ad harmful drikers [1,2]. They are brief, ad typically delivered by o-specialists i o-specialist settigs. The majority of studies exclude idividuals with moderate to * Correspodece: jae.marshall@slam.hs.uk 2 Out-Patiet Departmet, Maudsley Hospital, South Lodo ad Maudsley, NHS Foudatio Trust, Alcohol Uit, C/O Room 40, Demark Hill, Lodo SE5 8AZ, UK Full list of author iformatio is available at the ed of the article severe alcohol depedece who should be referred to specialist treatmet services. Thereisgoodevidecefortheeffectiveessofbriefitervetios i primary care. The Cochrae meta-aalysis of 22 radomised cotrol trials foud that alcohol cosumptio was reduced i the itervetio group by a average of 38 g/week more tha i the cotrol group at 12-moth follow-up [1]. Therefore, Natioal Istitute for Health ad Cliical Excellece (NICE) guidelies recommed brief alcohol itervetios i the primary care settig [3]. The geeral hospital settig has also bee cosidered as a importat settig for brief itervetios as hazardous 2013 Shiles et al.; licesee BioMed Cetral Ltd. This is a ope access article distributed uder the terms of the Creative Commos Attributio Licese ( which permits urestricted use, distributio, ad reproductio i ay medium, provided the origial work is properly cited.

2 Shiles et al. Trials 2013, 14:345 Page 2 of 8 ad harmful drikers are frequetly admitted to hospital ad may have icreased levels of motivatio to reduce their alcohol cosumptio whilst recoverig from a illess [4]. However, the evidece for a brief itervetio i this settig is ot as strog as it is for primary care. A systematic review by Emme et al. i 2004 foud the evidece to be icoclusive for brief itervetios i a geeral hospital settig [5]. Cotrastigly i 2011, McQuee et al. s Cochrae meta-aalysis of 14 trials o brief itervetios i hospitals foud that alcohol cosumptio was reduced at 6 ad 9 moths i the itervetio group compared to the cotrol group [2]. However ulike i a primary health care settig, this alcohol reductio was ot maitaied at 12-moth followup. More recetly, a systematic review by Mdege et al. suggests that multiple sessio brief itervetios may be effective, but there was o clear beefit foud for sigle sessio brief itervetios [6]. These reviews demostrate the eed for further trials to add to the evidece base for brief itervetios i the hospital settig. Further research is also eeded to ivestigate whether brief itervetios are effective i females ad to determie their optimal cotet ad duratio. This study is a radomised cotrolled trial ivestigatig the effectiveess of a 10-miute brief itervetio amogst at risk drikers admitted to geeral hospital wards. It followed up participats at 3 ad 12 moths. Ulike some trials i the Cochrae review of brief itervetios i the hospital settig, this trial is radomised, used blided assessors, icluded a itetio-to-treat aalysis ad female subjects, ad excluded people with alcohol depedece [2]. Recruitmet took place betwee 1995 ad 1997 (Additioal file 1). A accompayig ote describes the backgroud to the late publicatio of the trial. Method Protocol Over a two-year period, cosecutive acute medical admissios to oe of the three geeral medical teams at Kig s College Hospital i South Lodo were asked (usually withi the first 24 hours of admissio) to complete a short (10 miute) Health ad Lifestyle Questioaire (HLQ) icorporatig questios o alcohol, smokig, diet, exercise, illegal drug use ad alterative medicie [7]. Patiets were excluded from the screeig process if they were too physically ill; showed evidece of serious eurological impairmet; had a severe psychiatric coditio ad/or had overdosed; were of o fixed abode, or refused. Patiets with multiple admissios were recorded oly oce. Recruitmet was exteded to a secod medical team i Jue 1996 whe the pool of ew patiets i the first medical team dimiished due to re-admissios. Iformed coset was obtaied from each patiet ad full ethical approval was received from Kig s College Hospital. The Alcohol Use Disorders Idetificatio Test (AUDIT), a 10-item questioaire desiged for the early detectio of hazardous ad harmful drikers, was embedded i the alcohol sectio of the HLQ, which also icluded questios o quatity ad frequecy of alcohol use. I lie with previous work, patiets scorig eight or above o the AUDIT were idetified as hazardous/harmful drikers, ad ivited to participate i a radomised cotrol trial of a brief itervetio. The AUDIT-positive patiets were further assessed usig validated questioaires to determie the umber of alcohol-related problems; the severity of alcohol depedece; ad psychological well-beig. The questioaires used were: the Alcohol Problems Questioaire (APQ) [8], the Severity of Alcohol Depedece Questioaire (SADQ), [9], ad the Geeral Health Questioaire (GHQ) [10] respectively. A Driks Diary was used to obtai the umber of uits of alcohol cosumed daily over the previous week (1 uit = 8 g ethaol). Medical otes were scrutiised maually to obtai the admissio diagosis ad diagoses were coded accordig to the Iteratioal Classificatio of Disease (ICD-10) (WHO, [11]). Each patiet was also asked to provide a blood sample for assays of serum to test gamma-glutamyl trasferase (GGT) ad for routie haematology idices icludig haemoglobi (Hb) ad erythrocyte mea cell volume (MCV) by stadard laboratory methods. The assessmet iterview took approximately 45 miutes to complete ad was carried out as privately as possible o the ward. Patiets were excluded from the trial if the iitial screeig process or the assessmet iterview foud that they met the ICD-10 criteria for alcohol depedece. A history of delirium, seizures, halluciatios, ad curret or previous treatmet for alcohol problems were also exclusio criteria. Assigmet At the ed of the assessmet iterview, patiets were radomly allocated to itervetio ad cotrol groups by the research urse (SKW) resposible for admiisterig the brief itervetio, usig sealed evelopes. The sealed evelopes were geerated by UPC ad SKW i cojuctio with the statisticia, Richard Hooper. A total of 250 patiets were eligible to joi the study of whom 154 gave their coset. The study desig ad subject losses are show i Figure 1. Itervetio Subjects i the cotrol group received o advice about their drikig except that which they may have received from medical or ursig staff o the ward. Subjects radomised to the brief itervetio group were give a

3 Shiles et al. Trials 2013, 14:345 Page 3 of 8 Figure 1 Flow chart of patiets radomisatio ad follow-up. *Some patiets lost to 3-moth follow-up were cotacted at 12 moths. BAI, brief alcohol itervetio. 10-miute advice sessio by the research urse (SKW). This sessio icorporated a assessmet of alcohol itake, ad simple advice to reduce their alcohol cosumptio to 21 uits per week or below if male, ad 14 uits per week or below if female. Advice was supplemeted with a umber of booklets icludig That s the Limit produced by the Health Educatio Authority [12]. Follow-up assessmets were carried out at 3 moths ad 12 moths by aother research worker (UC) who was blid as to whether subjects had bee assiged to the itervetio or cotrol groups. Subjects were cotacted by telephoe or ivited by letter ad give the choice of attedig a follow-up appoitmet at the hospital or beig see i their ow home. At the follow-up iterview, the AUDIT questioaire, ad the baselie assessmet iterview were admiistered ad a blood sample take for the estimatios oted above. Subjects uwillig to retur for follow-up were asked to complete

4 Shiles et al. Trials 2013, 14:345 Page 4 of 8 at least a AUDIT ad a Driks Diary, either via the telephoe or by post. Subjects respodig by post were offered up to 5 as a icetive. Maskig Documetatio relatig to patiet assigmet was logged by the research urse (SKW) i a book kept locked i a desk. I additio, patiets were give a umber whe etered oto the computer ad were ot assiged a radomisatio code util the last patiet had bee followed up at 12 moths. The research assistat (UC) who carried out the follow-up assessmet arm of the study remaied blid to patiet allocatio util the study had bee completed. Durig the course of the follow-up iterviews the blid research assistat accidetly discovered how two subjects had bee assiged. Outcome variables The primary outcome measure was the AUDIT score at 12 moths. The previous week s Driks Diary was take as a secodary outcome measure, ad chages i APQ, SADQ, GHQ ad laboratory tests were used as subsidiary measures. Statistical aalysis A power calculatio was based o the results of Chick et al. s (1985) study i which 156 problem drikers were assiged to a sigle sessio of cousellig or routie medical care [4]. At 12-moth follow-up both groups showed reduced levels of alcohol cosumptio, ad there was o betwee-group differece o this variable. There was, however, a 18% differece betwee the groups i percetage itervetio respose (52% versus 34%). This percetage chage may have bee a artefact of the pre-itervetio differeces betwee the groups, but it represeted a reasoable differece o which a power calculatio could be based. To detect this differece with 80% power ad 0.05 sigificace, 114 subjects were required for each group. I retrospect, basig the sample size o a previous study that foud o differece i the primary outcome was a serious limitatio. The umbers recruited were i the regio of 40% of the umbers required ad our study was uderpowered. Hospital data idicated that the medical team admitted 2,000 patiets each year. We estimated (coservatively) that 1,000 of these could be screeed (500 me ad 500 wome). Usig data from the Geeral Household Survey ad estimates from Prof. Joatha Chick, it was assumed that 25% of male admissios ad 8% of female admissios would be idetified as hazardous or harmful drikers ad it was thus estimated that 125 me ad 45 wome could be recruited each year ito the study. The study had three years fudig. It was, therefore, decided to scree all admissios for the first two years. Patiets eterig the trial i Years 1 ad 2 were followed up i Years 2 ad 3 respectively. Results were aalysed usig CONSORT guidelies, which ivolved aalysis both by protocol (icludig oly those who reached the primary ed poit who did adhere to the protocol) ad by itetio-to-treat (which icluded all participats who reached the primary ed poit irrespective of whether they adhered to the treatmet protocol or ot). Geder was etered ito the multivariate aalysis of variace (MANOVA) as a iteractio effect o the two mai outcome variables. Where there was a sigificat iteractio effect, the subjects were split ito male ad female groups ad the MANOVA repeated. The distributio of the AUDIT scores, Driks Diary, APQ, SADQ ad GHQ scores were markedly positively skewed, ad to reder them more ameable to statistical aalysis, chages i scores were calculated that is the differece betwee baselie ad 3 moths ad betwee 3 moths ad 12 moths. These differeces were the used i the aalysis. Percetage chage scores were calculated for the three blood tests. Multiple aalysis of variace was used to test for time ad itervetio effects with geder etered as a iteractio ito each aalysis. Results Participat flow A total of 250 patiets were eligible to eter the trial, of whom 154 gave iformed coset. Of these 154 at risk drikers who etered the trial, 75 were radomised to the cotrol group ad 79 to the itervetio group (Figure 1). Descriptive data at baselie for cotrol ad itervetio group is show i Table 1. Three-moth follow-up At 3-moth follow-up, 115 (75%) of the origial 154 subjects were re-assessed. Eight (5%) had died durig Table 1 Descriptive data at baselie for cotrol ad itervetio groups Cotrol ( = 75) Itervetio ( = 79) Demographic variables (rage) (rage) Age (years) 52 (1.9) (20-83) 50 (1.9) (21-78) No. (%) No. (%) Social class I-III 26 (35) 26 (33) Married 25 (33) 32 (41) Divorced/separated 14 (19) 12 (15) Lives with other 7 (9) 11 (14) Sigle 20 (27) 20 (25) Widowed 9 (12) 4 (5) Lives aloe 28 (37) 22 (28) Employed 28 (37) 33 (42)

5 Shiles et al. Trials 2013, 14:345 Page 5 of 8 the 3-moth period leavig a available sample of 146 of whom 115 (79%) were followed up i some way: 58 from the itervetio group ad 57 from the cotrol group. The uadjusted attedace rate was 73% for the itervetio group ad 76% from the cotrol group. Adjusted rates, excludig those who had died, were 77% ad 80% for the itervetio ad cotrol groups respectively. There was o differece i baselie AUDIT scores ad mea alcohol cosumptio betwee those who atteded for iterview at 3 moths ad those who did ot. Of the 115 patiets who were followed up, 105 (91%) successfully completed a face-to-face iterview, five (4%) agreed to a telephoe iterview, ad five (4%) retured postal questioaires. Iformatio o oe subject (1%) was obtaied from close relatives. Twelve-moth follow-up At 12-moth follow-up 106 (69%) subjects were reassessed. Of the origial 154 subjects who etered the study, 18 (12%) had died leavig a available sample of 136, of whom 106 (78%) were followed up: 54 from the itervetio group ad 52 from the cotrol group. The uadjusted follow-up rate was similar for both the itervetio (68%) ad the cotrol groups (69%) ad the adjusted rates were 75% ad 81% respectively. There were o differeces i 3-moth AUDIT scores ad mea alcohol cosumptio betwee those who atteded for iterview at 12 moths ad those who did ot. Of the 106 patiets followed up at 12 moths, 93 (88%) successfully completed a face-to-face iterview, seve (7%) agreed to a telephoe iterview, ad three (3%) retured postal questioaires. Iformatio o three subjects (3%) was obtaied from relatives. Aalysis accordig to itetio to treat Meas ad stadard deviatios of outcome variables at iitial assessmet ad follow-up for both groups are show i Table 2. There was a reductio i the mea AUDIT score for the whole group from baselie (mea = 14) to 3-moth follow-up (mea = 10) but o chage was recorded betwee 3 ad 12 moths (mea = 11). This was reflected i the sigificat mai effect of time i the aalysis (F = 37.36, df 1,89, P <0.001). There was also a reductio i the mea uit score for weekly alcohol cosumptio for the whole group from baselie (mea = 51 uits) to 3-moth follow-up (mea = 35 uits) ad a further reductio i the mea APQ score for the whole group from baselie (mea = 4) to 3-moth followup (mea = 3) ad further reductio betwee 3 ad 12 moths (mea = 3) (mai effect of time F = 19.68, df 1,78, P <0.001). No sigificat differeces were recorded betwee the percetage chage scores for GGT ad MCV but there was a sigificat time effect for Hb (F = 9.81, df 1,71, P = 0.003). No sigificat itervetio effects were recorded betwee the two groups o ay of the outcome variables. There was a sigificat iteractio effect for the weekly Driks Diary whe aalysed accordig to time*geder*radomisatio (F = 6.55, df 1,151, P = 0.011), but o sigificat itervetio effects whe geder was aalysed separately. Table 2 Data for baselie, 3- ad 12-moth follow-up by itetio-to-treat aalysis Baselie Three-moth follow-up Twelve-moth follow-up Cotrol Itervetio Cotrol Itervetio Cotrol Itervetio (rage) (rage) Cosumptio AUDIT + (0-40) 13 (0.6) (8-39) 15 (0.6) (8-31) 10 (0.7) (0.30) 11 (0.8) (0-33) 10 (0.7) (0-30) 11 (0.9) (0-31) Driks Diary 50 (4.7) (8-315) 52 (4.1) (9-200) 35 (4.3) (0-234) 36 (4.6) (0-204) 34 (4.3) (0-260) 32 (4.0) (0-124) Problem scores APQ (0-23) 4 (0.3) (0-14) 5 (0.4) (0-18) 3 (0.3) (0-12) 3 (0.5) (0-19) 3 (0.3) (0-14) 3 (0.5) (0-19) SADQ++ (0-12) 9 (0.3) (0-48) 9 (0.4) (0-48) 6 (0.8) (0-37) 7 (1.1) (3-48) 6 (0.8) (0-37) 7 (1.0) (0-40) GHQ (0-12) 4 (0.4) (0-12) 3 (0.4) (0-12) 3 (0.4) (0-12) 3 (0.4) (0-12) 3 (0.4) (0-12) 3 (0.4) (0-12) Blood results +++ GGT mmol/l* 135 (43.73) ( ) (52) MCV fl** 89.5 (1.29) (31-108) (91.3) Hb g%*** 13.6 (0.26) ( ) (13.7) 62 (14.32) (8-1060) (35) 91.2 (0.82) (70-122) (90.5) 13.4 (0.20) ( ) (13.7) 98.1 (17.50) (10-911) 53.3 (10.56) (8-799) (31.77) ( ) 50.7 (9.52) (7-707) 89.7 (1.16) (31-105) 91.2 (0.83) (74-122) 90.6 (1.28) (31-108) 91.6 (0.77) (79-122) 14.1 (0.18) ( ) 13.6 (0.20) ( ) 13.8 (0.21) ( ) 13.4 (0.77) ( ) *Excludes seve i the cotrol group ad two i the itervetio group for whom o results were obtaied; **excludes eight i the cotrol group ad two i the itervetio group for whom o results were obtaied; ***excludes six i the cotrol group ad oe i the itervetio group for whom o results were obtaied. + Score of 8 or more = hazardous driker; ++score greater tha 30 = severe depedece; +++ormal rage of GGT = 5 to 55; MCV = 76 to 97; Hb 13 to 18. GGT, glutamyl trasferase; Hb, haemoglobi; MCV, mea cell volume.

6 Shiles et al. Trials 2013, 14:345 Page 6 of 8 Aalysis accordig to protocol Meas ad stadard deviatios of all the outcome variables at iitial assessmet ad follow-up for both groups are show i Table 3. There was reductio i mea AUDIT score for the whole group from baselie (mea = 14) to 3-moth follow-up (mea = 9) but o chage was recorded betwee 3 ad 12 moths (mea = 10) ad this was reflected i the sigificat mai effect of time (F = 39.96, df 1,151, P <0.001). A reductio i mea uit score for weekly alcohol cosumptio for the whole group was recorded from baselie (mea = 51 uits) to 3-moth follow-up (mea = 31 uits) but o further reductio betwee 3 ad 12 moths (mea = 28 uits) (mai effect of time F = 18.11, df 1,151, P <0.002). There was a reductio i mea APQ score for the whole group from baselie (mea = 4) to 3-moth follow-up (mea = 3) but o further reductio betwee 3 ad 12 moths (mea = 3) (mai effect of time F = 18.11, df 1,151, P < 0.001). There were o sigificat differeces usig percetage chage scores for GGT ad MCV but there was a sigificat time effect for Hb (F = 9.17, df 1,144, P = 0.003). There was o sigificat itervetio effect recorded betwee the two groups for ay of the outcome variables. There was a sigificat iteractio effect for weekly Driks Diary whe aalysed accordig to time*geder*radomisatio (F = 5.53, df 1,91, P = 0.021), but o sigificat itervetio effects whe the geder was aalysed separately. Discussio The results of this study do ot support the effectiveess of a 10-miute brief itervetio i at risk drikers admitted to geeral hospital wards. This is i cotrast to the recet Cochrae meta-aalysis by McQuee et al., but cosistet with the recet systematic review by Mdege et al. [2,6]. However, both the itervetio ad cotrol groups had a improved AUDIT score ad reduced levels of alcohol cosumptio as measured by a subjective Driks Diary at 3 moths, which was maitaied at 12 moths. There are several possible reasos why this study did ot fid a sigificat result whereas other trials have. First, brief itervetios are ot stadardised therefore there is cosiderable heterogeeity across studies. The duratio of the itervetio i this trial was extremely short whe compared with the itervetios i other trials ad this may have lesseed the effect size. However, the review of brief itervetios i primary care did ot fid that loger itervetios were associated with a sigificatly greater reductio i alcohol cosumptio [1]. Kaer ad co-authors therefore cocluded that the Table 3 Data for baselie, 3- ad 12-moth follow-up by protocol Baselie Three-moth follow-up Twelve-moth follow-up Cotrol Itervetio Cotrol Itervetio Cotrol Itervetio (rage) N (rage) Cosumptio AUDIT + (0-40) 13 (0.6) (8-39) (0.6) (8-31) 79 9 (0.8) (0-30) 57 9 (1.0) (0-33) (0.9) (0-30) (1.1) (0-31) 51 Driks Diary 50 (4.7) (8-315) (4.1) (9-200) (5.5) (0-234) (5.1) (0-204) (5.9) (0-260) (4.5) (0-112) 53 Problem scores APQ (0-23) 4 (0.3) (0-14) 75 5 (0.4) (0-18) 79 3 (0.4) (0-12) 57 3 (0.6) (0-19) 55 3 (0.4) (0-14) 48 2 (0.5) (0-14) 40 SADQ++ (0-12) 9 (0.3) (0-48) 75 9 (0.4) (0-48) 79 6 (0.9) (0-37) 57 6 (1.4) (0-48) 55 6 (1.1) (0-37) 48 5 (1.3) (0-33) 40 GHQ (0-12) 4 (0.4) (0-12) 75 3 (0.4) (0-12) 79 3 (0.5) (0-12) 57 3 (0.5) (0-12) 54 3 (0.5) (0-260) 48 2 (0.5) (0-10) 38 Blood results +++ GGT mmol/l* 135 (43.73) ( ) (52) MCV fl** 89.5 (1.29) (31-108) (91.3) Hb g%*** 13.6 (0.26) ( ) (13.7) Weeks to follow-up (14.32) (8-1060) (35) (0.82) (70-122) (90.5) (0.20) ( ) (13.7) (19.33) (10-911) (0.99) ( ) (0.21) ( ) Mea (SD) N/A N/A 15.6 (2.84) (10-22) (16.34) (8-799) (0.93) ( ) (0.24) ( ) Mea (SD) 17.3 (6.34) (12-39) 48 3 (0.4) (0-14) (16.44) (7-707) 48 6 (1.1) (0-37) (0.91) ( ) 48 3 (0.5) (0-12) (0.28) ( ) Mea (SD) 62.1 (21.40) (47-148) Mea (SD) 58.1 (10.58) (41-98) *Excludes seve i the cotrol group ad two i the itervetio group for whom o results were obtaied; **excludes eight i the cotrol group ad two i the itervetio group for whom o results were obtaied; ***excludes six i the cotrol group ad oe i the itervetio group for whom o results were obtaied. +Score of 8 or more = hazardous driker; ++score greater tha 30 = severe depedece; +++ormal rage of GGT = 5 to 55; MCV = 76 to 97; Hb 13 to 18. GGT, glutamyl trasferase; Hb, haemoglobi; MCV, mea cell volume

7 Shiles et al. Trials 2013, 14:345 Page 7 of 8 cotet of the itervetio may be more importat tha the duratio of delivery. A further explaatio for the isigificat result may be the use of a sigle sessio brief itervetio i this trial. A recet systematic review suggests that multiple sessio brief itervetios may be effective, but o clear beefit was foud for sigle sessio brief itervetios [6]. The cotet of the itervetio i this trial was simple advice ad leaflets ad this may have cotributed to the isigificat result. Other studies have typically used motivatioal iterviewig techiques [1,2]. However, further research ito the most effective cotet of brief itervetios is eeded before ay firm coclusios ca be draw [13]. It might be the case that differet types of itervetio are more suitable for differet patiets. For example patiets who are ot ready to chage may beefit more from motivatioal iterviewig whereas patiets who are ready to chage may beefit more from advice o how to reduce alcohol cosumptio [14]. A readiess to chage assessmet was ot icluded i the trial so we were uable to test this. Aother possible reaso for the isigificat result i this study is the size ad compositio of the sample. The power calculatio was based o Chick et al. s study [4] ad this was a limitatio because that study foud o differece i the primary outcome ad was probably uderpowered. The umbers recruited i this study were, therefore, i the regio of 40% of the umbers required (that is 184 subjects were eeded i each group) ad the trial was uderpowered. For a radomised trial the aalysis udertake i this study was flawed. The primary outcome was skewed ad we used chage scores (the differece betwee baselie ad 3 moths ad the differece betwee 3 moths ad 12 moths) as the outcome, as these appeared to be ormally distributed. Furthermore, takig the AUDIT score as the sigle outcome, the mai ifluece o this score at 12 moths would have bee the AUDIT score at baselie. Eve if we used chages i AUDIT scores betwee baselie ad 12 moths, we should have adjusted the aalysis for this major cofoudig factor by icludig it i the aalysis as a covariate. The appropriate method for aalysis would have bee to employ a liear regressio approach, adjustig for baselie AUDIT score to establish the mea differece betwee the groups i AUDIT score at moth 12 ad the 95% cofidece itervals. Furthermore, the iclusio of wome i the trial may have diluted the effect. Four of the trials i the Cochrae meta-aalysis by McQuee et al. icluded me oly [2] ad the primary care settig review foud a sigificat differece for me but ot for wome [1]. Aother differece betwee the sample i this study ad the Cochrae review is that our trial did ot iclude alcohol-depedet idividuals whereas six of the trials i the Cochrae meta-aalysis did. This should icrease the likelihood of a sigificat result as brief itervetios are thought to be effective for harmful drikig [1,2]. This trial was rigorously coducted i compariso to some of the trials icluded i the Cochrae metaaalysis by McQuee et al. It was a radomised cotrol trial whereas half of the trials icluded i the metaaalysis were ot radomised [2]. Furthermore, the outcome assessors were blided, which was ot the case i three of the studies icluded i the meta-aalysis. Like may other trials o brief itervetios, this study foud a reductio i alcohol misuse i both the itervetio ad cotrol groups. It has bee suggested that this may be due to the iitial assessmet process, which i this trial was of 45 miutes duratio ad cosisted of four questioaires o alcohol use ad psychological well-beig [1,2]. This could oly be cofirmed, however, by recruitig a parallel cotrol group that had o iitial assessmet at all, probably via a Zele desig [15]. The improvemet i both groups could also be explaied by regressio to the mea ad the impact of beig admitted to hospital. Furthermore, Kig s College Hospital had a strog iterest i alcohol misuse both amogst the psychiatrists ad physicias ad thus ormal practice might have caused both groups to improve. Coclusios I coclusio, this study has added further to the evidece base o brief itervetios i the hospital settig. Ulike some previous trials icluded i the recet Cochrae review by McQuee et al., this trial is radomised, used blided assessors, icluded a itetioto-treat aalysis, icluded female subjects ad excluded people who are alcohol depedet [2]. The results of this study do ot support the effectiveess of a brief itervetio comprisig of 10 miutes advice i at risk drikers admitted to geeral hospital wards. This is i cotrast to the recet Cochrae metaaalysis result foud by McQuee et al. [2]. However, our study was uderpowered ad there were flaws i the statistical aalyses, ad these limitatios temper the stregth of our coclusios. Like may other trials, this trial foud a improvemet i both the itervetio ad cotrol groups for AUDIT scores ad a subjective Driks Diary measure of alcohol cosumptio. This may be due to the iitial assessmet process, regressio to the mea or the impact of beig admitted to hospital. Further research ito brief itervetios is eeded to clarify their effectiveess i the hospital settig. I additio, further ivestigatio is required to determie

8 Shiles et al. Trials 2013, 14:345 Page 8 of 8 whether the itervetio is effective i wome ad the optimum duratio ad cotet of the itervetio. Additioal file Additioal file 1: A ote from the authors, explaiig the history of this trial. Abbreviatios APQ: Alcohol problems questioaire; AUDIT: Alcohol use disorders idetificatio test; GGT: Gamma glutamyl trasferase; GHQ: Geeral health questioaire; Hb: Haemoglobi; HLQ: Health ad lifestyle questioaire; MANOVA: Multivariate aalysis of variace; MCV: Mea cell volume; NICE: Natioal istitute of cliical excellece; SADQ: Severity of depedece questioaire. Competig iterests The authors declare that they have o competig iterests. Authors cotributios CJS drafted the itroductio, discussio ad coclusios. UPC, SAK, CMG, EJM, TJP ad SCW coducted the trial ad drafted the mauscript. All authors read ad approved the fial mauscript. Authors iformatio CJS is a fourth year Kig s College Lodo medical studet. EJM is a Cosultat Psychiatrist ad Seior Lecturer i Addictios, South Lodo ad Maudsley NHS Foudatio Trust. SCW is the Vice Dea, Academic Psychiatry, Teachig ad Traiig: Istitute of Psychiatry. Editor s ote It is our policy that the trials described i articles i the joural must have bee registered. The trial reported i this article was completed some years before registratio was itroduced so we have waived the requiremet. 3. NICE public health guidace 24: Alcohol-use disorders: prevetig harmful drikig Chick J, Lloyd G, Crombie E: Cousellig problem drikers i medical wards: a cotrolled study. BMJ 1985, 290: Emme MJ, Schippers GM, Bleijeberg G, Wollersheim H: Effectiveess of opportuistic brief itervetios for problem drikig i a geeral hospital settig: systematic review. BMJ 2004, 328: Mdege ND, Fayter D, Watso JM, Stirk L, Sowde A, Godfrey C: Itervetios for reducig alcohol cosumptio amog geeral hospital ipatiet heavy alcohol users: a systematic review. Drug Alcohol Deped 2013, 131: Caig UP, Keell-Webb SA, Marshall EJ, Wessely SC, Peters TJ: Substace misuse i acute geeral medical admissios. QJM 1999, 92: Williams BTR, Drummod DC: The alcohol problems questioaire: reliability ad validity. Drug Alcohol Deped 1994, 35: Stockwell T, Murphy D, Hodgso R: The severity of alcohol depedece questioaire: its use ad reliability ad validity. Br J Addict 1983, 78: Goldberg D: Maual of the Geeral Health Questioaire. Widsor UK: NFER- Nelso; Iteratioal Classificatio of Disease (ICD-10): The ICD-10 classificatio of metal ad behavioural disorders: cliical descriptios ad diagostic guidelies. Geeva: World Health Orgaizatio; Health Educatio Authority: That s the limit. Lodo: Health Educatio Authority; McCambridge J: Brief itervetio cotet matters. Drug Alcohol Rev 2013, 32: Maisto SA, Coigliaro J, McNeil M, Kraemer K, Cogliaro RL, Kelley ME: Effects of two types of brief itervetios ad readiess to chage o alcohol use i hazardous drikers. J Stud Alcohol 2001, 62: Torgerso DJ, Rolad M: What is the Zele s desig? BMJ 1998, 316:606. doi: / Cite this article as: Shiles et al.: Radomised cotrolled trial of a brief alcohol itervetio i a geeral hospital settig. Trials :345. Ackowledgemets This research was fuded by Lambeth, Southwark ad Lewisham Health Authority. The authors thak Dr. I. Forjacs, Prof. A. McGregor ad staff for their cooperatio. We are also grateful to all hospital staff who supported the project ad to the patiets themselves without whom this research would ot have bee possible. We are idebted to Dr. Richard Hooper ad Dr. Matthew Hotopf for their statistical advice ad support. We also thak the two referees for their advice ad the South East Lodo Health Authority for fudig the project. Fudig Fuded by the South East Lodo Health Authority. Author details 1 Kig s College Lodo Medical School, Guy s Campus, Kig s College Lodo, Lodo SE1 1UL, UK. 2 Out-Patiet Departmet, Maudsley Hospital, South Lodo ad Maudsley, NHS Foudatio Trust, Alcohol Uit, C/O Room 40, Demark Hill, Lodo SE5 8AZ, UK. 3 Istitute of Archaeology ad Atiquity, Uiversity of Birmigham, Edgbasto, Birmigham B15 2TT, UK. 4 Istitute of Psychiatry, Westo Educatio Cetre, Cutcombe Road, Lodo SE5 9RJ, UK. Received: 21 December 2012 Accepted: 4 October 2013 Published: 22 October 2013 Refereces 1. Kaer EF, Dickiso HO, Beyer FR, Campbell F, Achlesiger C, Heather N, Sauders JB, Burad B, Pieaar ED: Effectiveess of brief alcohol itervetios i primary care populatios. Cochrae Database Syst Rev 2009:CD Review. 2. McQuee J, Howe TE, Alla L, Mais D, Hardy V: Brief itervetios for heavy alcohol users admitted to geeral hospital wards. Cochrae Database Syst Rev CD Submit your ext mauscript to BioMed Cetral ad take full advatage of: Coveiet olie submissio Thorough peer review No space costraits or color figure charges Immediate publicatio o acceptace Iclusio i PubMed, CAS, Scopus ad Google Scholar Research which is freely available for redistributio Submit your mauscript at