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Title Physician and nurse-led brief intervention for alcohol drinking inthe primary care setting : a systematic review

Author(s) Chan, Ching-han, Helen; 陳靜嫻

Citation

Issued Date 2013

URL http://hdl.handle.net/10722/193834

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Abstract of project entitled

“Physician and nurse-led brief intervention for alcohol drinking in the primary care setting: a systematic review”

Submitted by

Chan Ching Han, Helen

for the degree of Master of Public Health at The University of Hong Kong

in August 2013

Background: With the increasing public health concern over the alcohol related health burden and mortality globally, the World Health Organization (WHO) has

listed alcohol use as the top three risk factors in Non-Communicable Disease (NCD)

and the alcohol related mortality and morbidity could be avoided through early

intervention and prevention. The Department of Health (DH) of Hong Kong Special

Administration Region (HKSAR) has declared the alcohol epidemic was alarming

with the increasing in prevalence of alcohol use and binge drinking especially among

young people with the westernization of Hong Kong society.

In combating local alcohol use epidemic, DH has put priority to reform health

care sector system and to ensure that the local health care system is responsive to the

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with at-risk alcohol use especially in primary health care settings in the various past

systematic reviews. However, most reviews mainly focus on physician-led BI while

the role of nurse in BI delivery in alcohol drinking had not been under great attention.

The effectiveness of nurse-led BI to at-risk drinking has not been fully examined as

compared with physician-led interventions in the past reviews. Evaluation of

treatment components in terms of intensity, treatment components and service settings

may also shed light to public health policy makers in development of local model of

BI in dealing with drinking problem in the Chinese population.

Objective: To investigate the effectiveness of physician-led or nurse-led BI on quantity of alcohol consumption, number of drinking days, number of binge drinking

episode and health care utilization. The potentially effective treatment intensity,

treatments components and setting of intervention were also investigated.

Methods: All the studies published from 1990 to 2012 in MEDLINE, would be evaluated on the effectiveness of BI delivered by physicians and/or nurses to adult

at-risk drinkers in primary health care settings, were searched and identified using a

combination of keywords.

Results: A total of 13 randomized controlled trials out of 134 articles from MEDLINE were included in this systematic review. The included studies used

different outcome measurements to compare the effectiveness of BI by physicians

and/or nurses in treating at-risk drinking. Similar demographics and clinical

characteristics of the subjects between the intervention and control groups were

reported. The studies were from 5 countries. The age range of subjects was from 14 to

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Alcohol Abuse and Alcoholism (NIAA), United State (US). Through there were

discrepancies among the results generated in the included studies on the effectiveness

of physician-led and/ or nurse-led BI, the benefits of nurse-led BI in treatment of

at-risk drinking cannot be dispelled and could be considered as an alternative or

supplement to the physician-led BI in busy primary health care setting today. BI with

at least two 5-15 minute sessions was found to be more effective than very BI with

one 5-minute session only. High quality BI with all five essential treatment

components (information giving, advice, goal setting, assistance and follow up) were

found to be more effective than partially included treatment. BI were found effective

in dealing at risk alcohol use in all General Out Patient Clinic (GOPC) while the

effectiveness of BI on alcohol drinking in Special Out Patient Clinic (SOPC) needs

further research to warrant the result.

Conclusion: Based on this systematic review, the potential effects of nurse-led BI remain unclear in comparison with physician-led BI for at-risk drinkers. More

researches on the effectiveness of BI by nurse and its cost-effectiveness as well as BI

delivered by different primary health care personnel in treating at-risk alcohol

drinking with long study period, especially in the Chinese population, is needed to

provide further evidence on the development of local BI in local primary health care

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Physician and nurse-led brief intervention for alcohol

drinking in the primary care setting:

a systematic review

by

Chan Ching Han, Helen

B.S.W. HKU, M Soc. Sc. HKU

A project submitted in partial fulfillment of the requirements for

the Degree of Master of Public Health

at The University of Hong Kong

August 2013.

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i

Declaration

I declare that this project and the research work thereof represents my

own work, except where due acknowledgement is made, and that is has

not been previously include in a thesis, dissertation, or reported submitted

to this University or to any other institutions for a degree, a diploma or

other qualifications.

Signed: __________________________________

Chan Ching Han, Helen

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ii

Acknowledgements

I would like to give my sincere gratitude to my supervisor, Dr. Yang Lin, for her

valuable guidance and support. Without her patience and continuous feedback, the

project would not be completed possible.

I am indebted to my family including my beloved dog, Gordon, for their endless

encouragement, motivations and support through all my years. Without their love and

support, I would not be where I am today.

Finally, I would like to thank all my beloved friends, especially Gary Pau for giving

me strength to get back on my feet and to move forward. I feel blessed to have all the

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iii Contents

Declaration ………i

Acknowledgments ……….ii

Table of Contents ……….iii

Abbreviations ………v

Chapter 1 Introduction

1.1 Overview of alcohol drinking and its global burden……….P.1 1.2 Classification of alcohol drinking problems & related health risk…..P.2 1.3 Screening and identification of alcohol use….….……….…….………P.4 1.4 Local Alcohol Use Prevalence….….……….……….……. P.5 1.5 High Risk Group at-risk alcohol drinking.………..….…….…P.7 1.6 Local alcohol related disease burden.……….………….……..…….…P.7 1.7 Intervention to alcohol drinking problems in health settings……….P.8 1.8 Research objective….……….……….…..….……. P.9

Chapter 2 Methods

2.1 Search Strategies….……….………..….……. P.10 2.2 Selection Strategy….……….………..………. P.10 2.3 Outcome measures….……….………. P.11 2.4 Identification and Selection of articles….……….……….…….P.14 2.5 Quality Assessment….……….……….……..….……. P.16 2.6 Data Extraction and Synthesis….………..….……. P.20

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iv Chapter 3 Results

3.1 Overview ………P.38 3.2 Summary of the Studies Included ….……….………….…..….……. P.39 3.3. Results of review ….……….………..….……. P.40

Chapter 4 Discussion

4.1 Summary of research findings ………..P.46 4.2 Possible explanation of discrepancy….……….………..……. P.47 4.3 Limitations ….……….………..……. P.48 4.4 Implications and Future Directions ………. P.50

Chapter 5 Conclusion……….P.52

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v Abbreviations

AA Alcohol Anonymous

ADUIT Alcohol Use Identification Test

BI Brief intervention

BRFS Behavioral Risk Factor Survey

CAGE Cut down, Annoyed, Guilty, Eye-opener

CD Communicable Disease

CONSORT Consolidated Standard of Reporting Trials DALYS Disability-adjusted Life Years

DPI Drinking Problem Index

GDP Gross Domestic Product

GGT Gamma-glutamyl transferase

GOPC General Outpatient Clinic

HA Hospital Authority

HIV/AIDS Human Immunodeficiency Virus Infection / Acquired Immunodeficiency Syndrome

HKSAR Hong Kong Special Administrative Region

HKU University of Hong Kong

IARC International Agency for Research on Cancer

NCD Non Communicable Disease

NIAA National Institute of Alcohol Abuse and Alcoholism

PHS Population Health Survey

PRISMA Preferred Reporting Items for Systematic Reviews and Meta-Analyses

RAPI Rutgers Alcohol Problem Index

RCT Randomized Controlled Trial

SBIRT Screening, Brief intervention, Referral to Treatment

SF-12 Short Form 12

SGOPC Special General Outpatient Clinic

SAC Substance Abuse Clinic

TWGHs Tung Wah Group of Hospitals

UK United Kingdom

US United States

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1 Chapter 1 Introduction

1.1 Overview of Alcohol drinking and its global burden

Alcohol drinking is common in social drinking and celebration worldwide which

different socioeconomic and cultural impacts in different societies. Alcohol

consumption on different occasion serves different socio-cultural functions e.g.

celebration, socialization and relaxation. Some evidence even suggested low to

moderate alcohol could have protective effect on cardiovascular disease in specified

population [1-4]. However, alcohol use was estimated to cause 5.5% of global

deaths and 4% of Disability-adjusted Life Years (DALYS) in 2010 [5]. Alcohol

drinking has been identified by WHO as the third leading risk factor for premature

death and disability while harmful alcohol use caused an estimation of 2.5 million of

premature death globally every year with a significant proportion happening in the

young and male. [6]. Given the modest protective effect on health, harmful alcohol

use was considered as one of the four most common modifiable and preventable risk

factors causing NCD [6]. Moreover there has been emerging evidence shown that

harmful use of alcohol is associating with Communicable Disease (CD) such as

tuberculosis and HIV/AIDS [7]. Alcohol epidemic has become a major global public

health concern and reducing alcohol related harm has been accorded as one of the

priorities for prevention and control of NCD [7,8].

Alcohol is associated with many disease conditions including alcoholic hepatitis,

cirrhosis, fatty liver, hypertension, coronary heart disease, heart failure and alcohol

dependence [9-12]. Moreover, alcohol is related with profound social harms with

externalities such as traffic accidents, violence, crimes, unprotected sex and economic

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addition, the adverse effect of alcohol use was estimated to cause a substantial Gross

Domestic Product (GDP) loss in developed countries [14].

1.2 Classification and of alcohol drinking problems and related health risk

Alcohol related harm on disease and injury is related to two linked dimensions of

drinking: volume of alcohol consumption and pattern of drinking in acute and

cumulative chronic effect through toxic and negative effect on organs and tissue,

intoxication and dependence. [6]. There was no scientific evidence of a threshold

effect in the relationship between the risk and level of alcohol consumption for some

disease e.g cancer and tuberculosis. The NIAA ,US has published a guideline for

maximum limits on drinking in 1995, with one standard drink defined as 12-gram

beer or wine cooler, one 5-gram of distilled spirits [14]. NIAA has also defined and

quantified different level of drinking problem with different level of severity and

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List 1: Classification of alcohol drinking by NIAA, US (1995)

*CAGE=Cut down, Annoyed, Guilty, Eye-opener questionnaire, a 4-item validated screening tool for alcohol abuse or dependence

Moderate or low-risk drinking: consumption of not more than two standard drinks for men and no more than one standard drink for women and people aged over 65

Harmful/Problem drinking: drinking behavior that causes substantial health and social consequences for drinkers and related people as well as the society; positive response to CAGE* and evidence of alcohol related medical or behavioral problems

At-risk drinking: excessive drinking and/or binge drinking, are defined as consumption of more than 14 drinks per week or more than 4 drinks per occasion for men and consumption of more than 7 drinks per week or more than 3 drinks per occasion for women; positive response to one or more questions on the CAGE*.

Binge drinking: consumption of 5 or more drinks on one or more occasions in the past month for men and consumption of 4 or more drinks on one or more occasion in the past month for women.

Alcohol dependence: evidence of one of the followings symptoms of alcohol dependence (i.e. lost control over drinking, compulsion to drink, withdrawal symptoms, drink to relieve) and /or either three or above positive response to CAGE and/or withdrawal and increase tolerance to alcohol).

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The risk of alcohol use varies with age, sex, biological characteristics of drinkers,

pattern, volume, context as well as environment of drinking. Some vulnerable groups

and individual e.g. children or pregnant women are highly susceptible to the toxicity

and psychoactive and dependence properties of ethanol. A great volume of alcohol

consumption within short time in a single episode might also cause alcohol

intoxication [6]. Alcohol has been classified as Group 1 carcinogen by the

International Agency for Research on Cancer (IARC) of WHO in 2006 that all

alcoholic beverages are definitely carcinogenic to human [15]. Causal relationship has

been established alcohol drinking and cancers of the oral cavity, pharynx, larynx,

esophagus, liver, colon, rectum, and, in women, breast. An association is suspected for

cancers of the pancreas and lung [16].

1.3 Screening and Identification of alcohol use

Alcohol Use Identification Test (AUDIT), a 10-question validated screening tool,

developed by WHO in 1989, is widespread used in identifying persons with hazardous

and harmful pattern of alcohol consumption that the person can benefit from reducing

or ceasing drinking through by self-administration or interview [53] .The AUDIT can help the health care practitioners to identify the person with hazardous drinking (or

at-risk drinking), harmful drinking or alcohol dependence in a range of health settings

where majority of excessive drinking are undiagnosed. With each response scoring

from 0 to 4, a total score of 8 or more are considered as indicators of hazardous and

harmful drinking as well as possible alcohol dependence. The cutoff point of 7 was

established for women and men over age 65 in considerations of effects of alcohol

change with average body weight and difference in metabolism. Four level of risk

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List 2.

List 2 Risk level and interventions suggested by AUDIT Score, WHO

Score Risk level Interventions

0-7 Zone I Alcohol education

8-15 Zone II Simple advice

16-19 Zone III Simple advice, brief counseling & continuous monitoring

20 – 40 Zone IV Referral for specialist for further diagnostic evaluation &

treatment

Nevertheless, the AUDIT cut off score may adjust slightly according the country‘s

drinking pattern, alcohol content of standard drinks and nature of screening program

and the is applicable for screening majority of patients population. However, the

AUDIT score should be considered to be tentative and subject to clinical judgment

taking into account of patient’s medical condition, family history of alcoholism and

perceived honesty of patients in response. Clinical screening procedure, physical

examination and laboratory tests is required for resistant, uncooperative and unable to

respond clients or to further confirm possible alcohol dependence.

1.4 Local Alcohol Use Prevalence

The local alcohol use has reached an alarming level and described as “problematic”

according to the Public Health and Epidemiology Bulletin published by the DH,

HKSAR in 2007 [17]. A working group on alcohol and health has been set up in

dealing with prevention and control of local alcohol related harm and death [18] with

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sectors, health sector plays a leading role in the prevention and control of alcohol

related harm and burden by education and early intervention.

With the increasing westernized lifestyle, rapid economic growth of local

community, highly accessibility of retails points, exemption of duties on a significant

portion of alcoholic beverages and the removal of relevant legislation on

administrative control in 2008, alcohol drinking has increased its popularity among

the local population together with aggressive promotion as entertainment and tourist

attraction [19]. The alcohol related disease burden on local public health is expected

on the rise.

The estimated per capita alcohol consumption among local adult has been raised

from 2.57 to 2.64 liters per capita from 2004 to 2010 [18]. The alcohol consumption

per capita among adult in local was estimated to be 2.64 liters in 2010 which is lower

than neighbor countries like South Korea, Japan and China. Nevertheless, among

different kind of alcohol beverages, Hong Kong consumed 3.5 liters per wine per

capita in 2008 which ranked the highest and was significantly ahead of other

neighboring countries [19].

According to the Population Health Survey (PHS) in 2002/2004, 23.7% of the

respondents (aged 15 years and above) drank alcohol occasionally (drink less than

once a month or drink 1-3 days a month). 9.4% were regular alcohol drinkers drank at

least once a week. More male respondents (53.2%) than were female respondents

(26.2%) were drinkers with a ratio of 2:1 [20]. Besides, Behavioral Risk Factor

Survey (BRFS) in 2012 reported 30.8% of the respondents were alcohol drinkers with

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alcohol drinkers, 6.2% responders were daily drinkers and 44.9% of drank less than

one day per week. 68.9% of these drinkers consumed less than 3 standard drinks per

day with a consumption of 2.5 standard drinkers per day in the past 30 days [21].

1.5 High risk group of at-risk alcohol drinking

According to the BRFS (2012), the drinkers were more prevalent among males,

group aged 18-24, never married, those with tertiary education or above, service

workers, those living in private housing and those with higher monthly household

income[21]. Among those who drank alcohol in the past 30 days, 20.4% of them

reported having engaged in binge drinking (drinking 5 or more glasses or cans of

alcohol on one occasions) at least once in the past 30 days and were with prevalent

among those without completion of secondary education and with monthly income of

$8,000. 12% of the drinkers reported with signs of drunkenness and were more

prevalent in male, 18-24 and were never married. [21]. Nevertheless, only a small

percentage of respondents reported that they had encountered alcohol related problem

(including self or someone’ else drinking) in physical or work-related aspects.

1.6 Local alcohol related disease burden

In 2009, alcohol related illness or injuries accounted for a total of 2,433

admissions into both private and public hospitals. Mental and behavioral disorders

due to use of alcohol (73.6%) and alcoholic liver disease account for the majority of

these admissions [18]. In 2009, 58 alcohol related death was recorded which

contributed to 0.14% of locally registered deaths in H K (58 out of 41,047) [18].

About 10.3% of all motor vehicle deaths were associated with alcohol in 2001 [18].

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alcohol-related domestic violence and sexual assault which was another paramount

concern to evaluate the burden of alcohol related harms accurately.

1.7 Intervention to alcohol drinking problems in health settings

In Hong Kong, the Tuen Mun Alcohol Clinic under Hospital Authority (HA)

provides comprehensive treatment to alcoholic dependence including comprehensive

assessment, detoxification, and treatment of comorbidity, marital counseling and

self-help group to alcohol related problem [22]. Six Substance Abuse Clinics (SAC)

under HA provide specialized treatment to alcohol dependent drinkers in Hong Kong

upon referral. “Stay sober, stay free” project by the Tung Wah Group of Hospitals (TWGHs) provides counseling and social work intervention for alcoholic dependence

and abuse [23]. A few supportive group of Alcoholic Anonymous (AA) available in

Hong Kong also provide supportive services to alcohol drinkers [24]. Nevertheless,

the existing resources allocated for alcohol treatment served alcohol dependent

drinkers and problematic alcohol drinkers only in a very limited number of patients

and could not help in reducing overall adverse effect of alcohol epidemic in the long

run. As many problematic drinkers could only be identified during hospital admission

due to poor health conditions, injuries or accidents, local drinking problem may be

fairly well entrenched. There is still much room for in early identification and

secondary prevention at primary health care level for pre-symptomatic high risk

alcohol users in order to reduce preventable life loss and disease burden at early stage.

In the“Action Plan to reduce alcohol related harm in Hong Kong,” by DH, HKSAR has determined to improve the health care system and ensure the health care sector is

responsive to alcohol related harm through early identification and management of

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Primary care providers are important in promoting health to at-risk drinkers as

the first point of contact for patients at community level during consultation visits or

health check by screening, brief intervention, referral to treatment (SBIRT). BI was

evident to be efficacious in many trials in reduction of alcohol consumption in many

countries for at-risk or heavy drinkers especially in primary health care system in

many countries [25-29]. However, not much research emphasis was put in evaluating

the effectiveness of BI delivered by different primary care clinicians while most of the

emphasis was put on physician-led BI in the past. Before we step into the public

health policy in dealing with local alcohol problem, it is the research interest in

knowing the effectiveness of BI delivery by different personnel, treatment intensity,

effective components and setting for delivery in reduction of alcohol related harm and

health care burden to shed more light on the development of local alcohol BI model in

combating the drinking epidemic in H K..

1.8 Research Objective

The objective of this study is to systematically review the articles on the

effectiveness of BI for at-risk alcohol drinkers that were led by physicians and/or

nurses. The treatment intensity, potential effective treatment components and services

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10 Chapter Two – Methods

2.1 Search Strategies

There were a number of reviews on the effectiveness BI for at-risk drinkers in

primary care settings in the past several years and was published in 1996, 1999,

2006 ,2009,2011 respectively [25-29]. This review was conducted to gather the most

updated evidence, in order to help make the recommendation to the local model of BI

for at-risk drinkers in primary health care settings. This systematic review followed

the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2009 checklist [30].

The database MEDLINE were searched by using the keyword combination

(“alcohol” AND “brief intervention”, AND “primary care”, AND “physician”) or

(“alcohol” AND “brief intervention” AND “primary care” AND “nurse”). Same keywords search was conducted at Google scholar for comprehensive search. The

final literature search was conducted on 1st June 2013.

2.2 Selection Strategy 2.2.1 Inclusion Criteria

The studies that fulfilled the following the PICO criteria were included in this

review [31]:

1) Patient/Population: patients seeking treatment for at primary care settings with at risk drinking (drinking beyond recommended limits and/ or with binge drinking )

2) Intervention: brief intervention

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4) Outcome: self-report drinking quantity, drinking frequency, drinking pattern, health care utilization, alcohol related harms to drinkers or others,

test results of biological markers

(See Table 3 Summary of Results of 13 included articles in the

systematic review )

2. 2.2 Exclusion Criteria

Only studies published in English after 1990s were included. Articles without

access to full papers were also excluded since details of abstract per se would not be

as comprehensive as full articles. Studies in language other than English were

excluded. For relevance, studies with non- human or non-adult subjects were excluded.

For scientific vigorous about the effectiveness of BI, studies other than RCT were

excluded. For relevance and applicability to local primary health care settings, non

face-to-face BI (e.g. web-based or telephone-based intervention) and alcohol

dependence or alcoholism were excluded as most of the primary care services are

rendered to general patients through regular health visits at GOPC, SGOPC and

clinics of private practitioners. Finally, studies without any outcome measures about

alcohol consumption (alcohol during specified period) would be excluded as it is the

most common outcome measures among alcohol related studies and it is difficult to

do the comparison between studies without the common outcome measures.

2.3 Outcome measures

The outcome measures listed of included studies were classified in three aspects

including alcohol consumption and pattern (in quantity, frequency, percentage of safe

drinking limit, behavior change), health related outcomes (in alcohol use problem

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biological markers of alcohol reduction (Table 1 Primary Outcomes measure for

included studies ). Original articles must have included at least the measurement of

alcohol consumption (mean number of drink per week or month) as one of the

primary outcome measures in order to facilitate critical evaluation between studies.

The listed outcomes appeared to be comprehensive but they were by no means

exhaustive. Three commonly reported outcomes including, 1) mean number of drink

per week or month, 2) mean number. of binge drinking episode, 3) mean number of

drinking days would be evaluated.

In the review, the levels of intensity of BI would be classified into “very brief BI”

with one 5-15 minute session only, and “Brief BI” with multi-contacts of at least two

5-15 minute sessions with or without telephone follow up. Five key components

including feedback, advice, goal-setting, assistance and follow up were identified

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Table 1 Primary Outcomes measure for included studies

Alcohol Consumption and pattern Standard drinks (within specified period)

Drinking days

Heavy drinking days

Binge drinking episode

Percentage of safe drinking

Percentage of excessive drinking

Percentage of binge drinkers

Percentage of chronic drinking

New quit

Relapse Rate

Health related outcomes

Alcohol Use Problem Score

Score of CAGE Questionnaire*

Score of Alcohol Use Identification Test (AUDIT) *

Drinking Problem Index (DPI) *

Rutgers Alcohol Problem Index (RAPI)

Life style improvement

SF-12 (Physical & Mental Health) *

Health Care Utilization

Hospital days

Emergency visits

Allowance for sick day or social services

Alcohol related harm

Drink driving

Traffic accidents involved

Arrest for controlled substance or for liquor violation

Biological markers Gamma-glutamyl transferase (GGT)

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Abbreviations: AUDIT=Alcohol Use Disorder Identification Test, an 10 items screening tools for harmful and hazardous alcohol consumption, DPI=drinking problem index, a 17-item tools in assessing the frequency of alcohol-related problems, RAPI= an inventory in assessing the negative consequence of alcohol use in three dimension (abuse/dependence, personal consequence, social consequence), GGT= an enzyme that serves an indicator of excessive long-term consumption., SF-12=Short Form-12,a simplified 12 item tools of SF-36, for measurement general health in physical and mental health being,

2.4 Identification and Selection of articles

After keywords searching using the electronic resources of University of Hong

Kong (HKU), a total of 134 articles from MEDLINE were retried. A sum of 98

articles was excluded for irrelevance after screening of title and abstracts.

Subsequently, 41 papers were then remained after first elimination process. After

second round of elimination, 5 papers were excluded due to duplication. Eventually,

36 papers were left after second elimination process. After third round of elimination,

22 papers was excluded after the candidate articles were then further screened in

details according to the inclusion and exclusion criteria mentioned. Eventually, one

paper was further excluded after quality assessment due to poor quality. After a final

version of the remaining studies, a total of thirteen randomized controlled trials were

included in this systematic review. An overview of the search process is illustrated

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Figure 1 Flow diagram of article selection process

MEDLINE preliminary Keyword Search

(n=134)

MEDLINE Studies remaining after Setting Limits

(n=41) Studies Excluded based on

Inclusion and Exclusion Criteria

(n=98)

Studies Excluded for duplication

(n=5)

MEDLINE Studies remaining After removal duplication

(n=36) Studies Excluded for

screening titles and abstracts for relevance

(n=22)

Relevant Primary studies included in review

(n=14) Studies Excluded after

reviewing the study quality

(n=1) Relevant Primary studies

included in summary of evidence

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16 2.5 Quality Assessment

Fourteen candidate studies were included for critically evaluation for quality

assessment in the final round. The quality indicators from Consolidated Standard of

Reporting Trials (CONSORT) 2010 checklist [33] were adopted and applied for the

appraisal of all relevant Randomized Controlled Trial (RCT) in this systematic review

(See List 3). After examination of articles with caution, a grading system (A: Good, B:

Average, C: Unsatisfactory, and D: Not mentioned in article) for each quality indicator

of individual article was determined. A metrics of A=3, B=2, C=1, D=0 was used to

calculate the overall score for each article. The highest possible score is 27. The

quality assessment of this studies being analyzed is shown in Table 2 (Summary of

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17 List 3: Quality Indicators

1. Sample size: Was the sample representative of the population?

2. Randomization: Was the trial randomized (on individual or cluster level)? 3. Allocation concealment: Did the investigators know which group the potential

subjects would be assigned before enrollment?

4. Blinding: Were the subjects, clinicians and assessors masked to the group assignment?

5. Baseline characteristics: Were the baseline demographic and clinics characteristics similar between the intervention and the control group?

6. Primary outcomes: were the primary outcomes clearly stated? 7. Follow up: Were the follow up of the subjects completed?

8. Intention to treat analysis : were all the subjects analyzed in the groups which they were randomized

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Table 2. Summary of scoring of quality indicators by CONSORT statement

Author/ Year/ Project Name Sample Size Randomization Allocation concealment Blinding Baseline Characteristic Primary outcome Follow up Intention to treat

Applicability Total Score

Fleming MF et. al (2010)

A A A A A A A A B 26

Rubio et al (2010);

A A A C B A A B B 22

Fleming MF et al.(2009) Health Moms Trial

C A A B A A A A C 23 Ockene JK et al(2009) Project Health II A D D D B B A D B 12 Lock CA et al. (2006); B B A C A A C B B 19 Reiff-Hekking S et al (2005) Project Health I A B D D A A B D B 15 Grossberg PM et al. (2004) Project TrEAT B C D B A C A D B 14 Curry et al. (2003) B A D B A A B C B 18 Fleming et al. (1999) Project GOAL B A D A B A A D B 18

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19 Author/ Year/ Project Name Sample Size Randomization Allocation

concealment Blinding Baseline Characteristic Primary outcome Follow up Intention to treat

Applicability Total Score

Ockene et al. (1999) Project Health A C D D B A A D B 15 Tomson et. al (1998) B B D C B A B D B 14 Córdoba R et al (1998) C D D D A B C D C 9 Fleming MF et al (1997) Project TrEAT A A A A B A A D B 22 McIntosh MC et al. (1997) A D D D A A A D B 14 Remark:

1) Range of total scoring for 9 quality indicators for RCT is from 0-27

(A: Good with 3 points, B: Fair with 2 points, C: unsatisfactory with 1 point, D: Not mentioned in article with 0 point). 2) Studies of Córdoba R et al (1998) was deleted after quality evaluation due to the unsatisfactory quality of study

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The fourteen candidate articles were assessed for their quality using the criteria

listed. One studies resulted in overall unsatisfactory rating was excluded from the

systematic review [34]. At the final stage of selection process, thirteen studies were

included for systematic review [35-46]. The quality of included studies was quite

diverse. Five studies were assessed with good quality (with overall scores of 18 or

above) while eight studies were with fair quality (with overall score above 9 and

below 18). None of studies with a rating of good in applicability as all studies were

conducted in western countries with majority of subjects were mainly Hispanic white.

For representativeness of sample size, one study of Fleming MF et al (2009) was

ranked “C” (unsatisfactory) due to the fact that subjects were with female only. For randomization, two studies did not mentioned about the randomization process were

ranked “D” and two studies only highlighted randomization in abstract were ranked “C”. For allocation concealment, eight studies did not mention particulars about the process allocation concealment and were ranked “D”. For blinding, four studies did

not provide any information about the blinding and were ranked “D”. All thirteen

studies scored “B: Satisfactory” or “A: Good” in baseline characteristics as the control and intervention groups were not statistically different in characteristics. The

author considered the overall quality the thirteen included studies was adequate. A

summary of the quality assessment of the fourteen studies was illustrated in Table 2

(Summary of scoring of quality indicators by CONSORT statement).

2.6 Data Extraction and Synthesis

Clinical trials were identified using the keywords search mentioned in literature

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were further analyzed for relevance. The candidate articles were further reviewed and

analyzed in details using the quality assessment indicators mentioned above.

The main findings reported 13 RCT were analyzed into two different table (Table

3) with the following: author, published year, country, sample size, subjects

characteristics, population, clinicians , settings , inclusion criteria, intervention

intensity, intervention components, study duration, number of subjects completed

(32)

22

Table 3 Summary of results of 13 included articles in the systematic review

Author /Year/ Country Sex (Men%)/ Mean Age ± SD/ Population / Personnel/ Setting Sample Size (ExpVs Cont) Inclusion Criteria as At- Risk Drinking Intervention Vs Control Intervention components Study Duration /Follow up rate Result

Baseline Vs Follow up Outcome Measure

Fleming MF (2010) ; US 51%, 21 yrs, College students Physician /College clinics N=986 Exp: 493 Cont: 493 Men: ≥50 drinks or ≥ 8 heavy drinking episodes (≥ 5 standard drinks) in previous 28 days / Women: ≥40 drinks or ≥ 6 more heavy drinking episodes in the last 28 days † (*standard higher than NIAAA recommended limit)

IG: two 15 mins

counsellings & two follow up phone calls using motivational interviewing, contracting, diary cards& take home exercise CONT: health booklet on general health issues 1) Feedback about current health behavior 2) Review of prevalence of high risk drinking 3) List of alcohol adverse consequences 4) Lists of personal likes

and disks about

drinking

5) Worksheet on drinking cues

6) Blood alcohol level calculator

7) Life goal and alcohol affect

12 months/

88%

1) No. of drink (past 28 days)

Exp: 71.0±35.4 Vs 51.7±40.1 (27.2%) Cont:69.2±31.9 Vs54.7±40.3(21%)

*(p=0.018)

2) No. of heavy drinking days

Exp: 7.2±3.7Vs5.3±4.3(1.9) Cont:7.1±3.3Vs5.5±3.7(1.6) (p=0.148)

3) No. of drinking days

( past 28 days) Exp:11.7±5.0 Vs:9.9±5.8(1.8) Cont:11.8±4.9Vs10.3±5.5(1.5) *(p=0.053) 4) Hospitalization/r emergency department visit Exp: 29.2% Vs 18.5% (10.7%) Cont: 29.6% Vs 18.3% ( 11.3%)

(33)

23 Author /Year/ Country Sex (Men%)/ Mean Age ± SD/ Population / Personnel/ Setting Sample Size (ExpVs Cont) Inclusion Criteria as At- Risk Drinking Intervention Vs Control Intervention components Study Duration /Follow up rate Result

Baseline Vs Follow up Outcome Measure

8) Agreement as a form of prescription Drinking diary cards 5) RAPI Exp: 15.2±10.4 Vs 7.8±7.5(7.4) Cont: 15.9±10.7Vs 9.1±8.8(6.8) (p=0.33) Rubio et al (2010); Spain 65.3% Median: 31-40yrs Adult patients (18-65 ) Primary care physician /Primary care centres N=752 Exp: 371 Cont:381 Binge Drinking *and AUDIT score ≤ 14 IG: 2 sessions of 10-15 mins of counseling sessions with 4 weeks apart using a scripted workbook with 2 phone follow up by nurse CH: Booklet on general health issues 1) Review of alcohol related health effects 2) Prevalence of at risk drinks 3) Methods for cutting down 4) Treatment contract 5) Cognitive behavioural exercise 2 follow up phone call at 12 months/ 89.6%

1) No. of drinks ( past 7 days ) Exp:27.42±9.43 Vs 19.20±9.10(30%) Cont:26.90±9.76 Vs22.24±9.11(21%)

*(P<0.001)

2) No. of binge drinking episodes Exp: 2.95±2.33 Vs1.14±1.43 (62%) Cont: 2.95±2.27Vs1.56±1.68 (47.1%) *(P<0.001)

3) Binge drinking (past 30 days) Exp: 371(100%) Vs 194(52.29%) (47.1%)

Cont: 381(100%) Vs 256(67.19%) (32.9%) *(P<0.001)

(34)

24 Author /Year/ Country Sex (Men%)/ Mean Age ± SD/ Population / Personnel/ Setting Sample Size (ExpVs Cont) Inclusion Criteria as At- Risk Drinking Intervention Vs Control Intervention components Study Duration /Follow up rate Result

Baseline Vs Follow up Outcome Measure

2th and 8 th

weeks after

initial sessions

4) Excessive drinking (past 7 days) n(%) Exp: 371(100%) Vs 178 (47.97%) (52.03%) Cont: 381(100%) Vs 254 (66.66%) (33.34%) *(P<0.001) Fleming MF (2009); US Healthy Moms Trial 0 (0%) 28yrs Women (18+) seeking postpartum care Outpatient Obstetrical nurses & research staff/ 34 obstetrical practice mater clinics N=235 Exp:122 Cont:113 Prior to pregnancy: ≥3 drinking days/week or ≥ 5 drinks/day or ≥7 more drinks per week

Pregnant: standard drinks in past 28 days / ≥4 more drinks on ≥ 4 occasions in the past 28 days/ ≥20 or more drinking

days in the past

Exp: Two 15-minute visits of a brief intervention and a reinforcement session & 2 follow-up phone calls (motivational interviewing and CBT) Cont: Usual Care with general health booklet on general health 1) Feedback regarding current health behaviours 2) Review of prevalence of problem drinking 3) List of adverse effects of alcohol focused on women and pregnancy 4) Worksheet on drinking cues 5) A drinking agreement in a 6 months/ 87%

1) No. of standard drink, (past 28 days): Exp: 34.0±22.8 Vs 19.8±19.2 (41.8%) Cont: 32.2±16.2 Vs 27.1 ±22.1 (15.8%) *(p=0.013)

2) No. of Drinking Days (past 28 days) Exp: 10.3±6.8 Vs6.9±6.3(3.4)

Cont:10.4±7.2 Vs 9.2±22.1(1.2) *(P=0.024)

3) No. of Heavy Drinking Days (past 28 days)

Exp: 3.5±3.8 Vs1.7±2.2(1.8) Cont:3.1±3.3 Vs2.6 ±3.1(0.5) *(p=0.019)

(35)

25 Author /Year/ Country Sex (Men%)/ Mean Age ± SD/ Population / Personnel/ Setting Sample Size (ExpVs Cont) Inclusion Criteria as At- Risk Drinking Intervention Vs Control Intervention components Study Duration /Follow up rate Result

Baseline Vs Follow up Outcome Measure

28 days (*standard below NIAAA recommended limit) issues form of prescription 6) Drinking diary cars 7) Follow up calls between sessions (based on motivational interviewing and cognitive behavioral therapy) Ockene JK et al (2009); US Exp: 70.4% Cont:59.8% Exp: 44.2±13.9 Cont:43.5±14.0 Adult High risk drinkers Physicians & nurse practitioners /Routine Primary care N=530 Exp: 274 Cont: 256 Excessive drinking* & binge drinking* Exp: 10-15 brief patient centered counseling intervention Cont: Usual Care 1) Personalized feedback about alcohol consumption and adverse effect 2) Patient centered counseling 48 months/not specified

1) Drinks per week Exp:18.47±12.71 Vs No data Cont:16.90±13.19 Vs No data (p=0.27)

2) Binge per month Exp:4.83±6.55 Vs No data Cont: 4.01±6.09 Vs No data (p=0.23)

(36)

26 Author /Year/ Country Sex (Men%)/ Mean Age ± SD/ Population / Personnel/ Setting Sample Size (ExpVs Cont) Inclusion Criteria as At- Risk Drinking Intervention Vs Control Intervention components Study Duration /Follow up rate Result

Baseline Vs Follow up Outcome Measure

3) Increase positive self-efficacy 4) Negotiate change goals 5) Collaborate on change plan

3) Percentage of low risk drinking :

Exp: no data Vs 64%

Cont: no data Vs 63%

4) Relapse rate: no data

(P>0.05)

5) New quit: no data

(P=0.46) Lock CA et al. (2006); UK 63 (50%) 44.1±13.5 Patients (16+) Nurse /40 general practice cluster N=127 Exp: 67; Cont: 60 AUDIT (cut off points: >8

for men; > 7 for

women) Exp: 5-10 minutes with a “drink less protocol” Cont: standard treatment on cutting down drinking and a leaflet 1) Information on standard drink units 2) Recommend low risk consumption 3) Benefits of cutting down drinking 4) Tips on reducing 12 months/ 61.4% 1) AUDIT Exp: 10.58 6.42 Vs 7.50±3.01 Cont:10.31±9.64Vs 10.6±9.83 (p=0.24) 2) Unit/Week Exp: 23.00±20.7 Vs 16.08±22.84 (27%) Cont: 26.48±29.77 Vs 19.60±23.57 (25.9%) (p=0.65) 3) DPI Exp: 5.44±5.08 Vs2.05±3.40

(37)

27 Author /Year/ Country Sex (Men%)/ Mean Age ± SD/ Population / Personnel/ Setting Sample Size (ExpVs Cont) Inclusion Criteria as At- Risk Drinking Intervention Vs Control Intervention components Study Duration /Follow up rate Result

Baseline Vs Follow up Outcome Measure

consumption 5) Advice on goal setting and action planning 6) Follow up Self-help booklet/diary Cont: 5.17±15.01Vs16.05±15.70 (p=0.33) 4) SF-12 Physical Health Exp: 49.15±8.76 Vs 47.00±9.31 Cont: 50.56±13.80 Vs 51.38±7.01 (p=0.99) 5) SF-12 Mental Health Exp: 50.53±8.85 Vs 53.84±6.55 Cont: 51.86±12.26 Vs 53.03±5.58 (p=0.67) Reiff-Hekking S et al (2005); US Exp: 59% Cont: 41% Exp: 43.8±13.8 Cont 44.4 ± 14.1: primary care patient (21-70) Physician & nurse/ primary care practices centres N=445 Exp:235 Cont:210 Excessive drinking* & binge drinking * Exp: 5-10 mins patient centered alcohol counseling sequence at the time of a regular interview Cont: health booklet on 1) Patient centered counseling 2) Feedback on consumption and pattern 3) Goal setting Follow up visit 12 months/ Exp:85.8% Cont:82.8 % 1) Unit /week Exp: 18.3±12.2 Vs12.6±14.9(31.1%) Cont:16.3±12.1 Vs13.3±13.1(18.4%) *(P=0.03)

2) Binge drinking episodes Exp: 4.8±6.2 Vs 2.6±5.4(45.8%) Cont: 3.8±5.8 Vs 2.4±5.3 (36.8%) (P=0.36)

(38)

28 Author /Year/ Country Sex (Men%)/ Mean Age ± SD/ Population / Personnel/ Setting Sample Size (ExpVs Cont) Inclusion Criteria as At- Risk Drinking Intervention Vs Control Intervention components Study Duration /Follow up rate Result

Baseline Vs Follow up Outcome Measure

general health

issue 3) Safe drinking

Exp: 48(20%) Vs 128 (54%) (34%) Cont: 55(26%) Vs 103 (49%) (23%)

*(p=0.05)

4) No. binge drinking

Exp: 51 (22%) Vs 130 (55%) (33%) Cont: 57 (27%) Vs 103 (49%) (22%) (P=0.18) Grossberg PM et al. (2004); US Sex : no data Mean age: no data Young adults (18-30) Primary care physician/ Primary care centres N=226 Exp: 114 Cont: 114 Male: ≥14 drinks /week in the previous days ; Female: ≥11 drinks /week in the previous 90 days Health Screening Survey Exp: brief motivational message form their primary care provider ; self- help manual ; written personalize feedback and 3 outreach telephone 1) Motivational message 2) Self-help manual 3) Written personalized feedback 4) 3 outreach telephone calls (1-2 weeks after first appointment, 12 months/ Exp: 66% Cont: 78%

1) Consume≥3 drinks per day (past 7 days )

Exp: 45 (39%) Vs 17 (15%) (24%) Cont: 51 (46%) Vs 22 (20%) (26%)

*(P<0.001)

2) Drinks consumed (past 7 days) Exp: 16.2±11.2 Vs 8.6±10.2 (47%) Cont: 18.3±12.1 Vs 11.6±12.7 (36.6%)

(39)

29 Author /Year/ Country Sex (Men%)/ Mean Age ± SD/ Population / Personnel/ Setting Sample Size (ExpVs Cont) Inclusion Criteria as At- Risk Drinking Intervention Vs Control Intervention components Study Duration /Follow up rate Result

Baseline Vs Follow up Outcome Measure

indicated high alcohol indicated at-risk alcohol use Cont: No intervention within 4 weeks

after the 1st call,

within 3 weeks

after the 2nd call.

3) Binge drinking (past 30 days ) Exp: 96±110 Vs 66±75

Cont: 96±107 Vs 81±91

* (P<0.01)

4) Episodes of binge (past 30 days) Exp: 5.9±4.0 Vs 3.6±4.7 (39%) Cont: 6.3±4.3 Vs 4.8±5.5 (23.8%) *(P<0.01) 5) Emergency Visit: Exp: No data Vs 103 (48%) Cont: No data Vs 177 (63%) *(P<0.01)

6) Motor vehicle crash Exp: No data Vs 9

Cont: No data Vs 20

*(P<0.05)

(40)

30 Author /Year/ Country Sex (Men%)/ Mean Age ± SD/ Population / Personnel/ Setting Sample Size (ExpVs Cont) Inclusion Criteria as At- Risk Drinking Intervention Vs Control Intervention components Study Duration /Follow up rate Result

Baseline Vs Follow up Outcome Measure

Exp: No data Vs 114 (55%)

Cont: No data Vs 149 (67%)

*(P<0.05)

8) Arrests for controlled substance for liquor violation No data

Exp: No data Vs 0 Cont: No data Vs 8 *(P<0.01) Curry (2003); US 65% 47yrs Adult patients for primary health care services Primary care center; N=333 Exp: 166 Cont:167 At least one of the three drinking pattern as 1) AUDIT score of 15 or below; 2) Chronic drinking (≥2 drinks per day

in the past month); 3) binge drinking Exp: two 10-15 min physician delivered intervention Cont: Usual care 1) Workbook feeding patient’s health behaviours 2) Review of problem drinking prevalence and reason behind 3) Adverse effects of alcohol 4) Drinking cues 12 months/ 92.4% 1) Drink/ week Exp: 14.93±0.82 Vs 9.3 (37.75%) Cont: 13.56±0.83 Vs 9.5 (29.9%) (p=0.42)

2) At risk drinking pattern: Exp: No data Vs 42%

Cont: No data Vs 61%

*(p=0.003)

3) Chronic drinking Exp: 45% Vs 25%

(41)

31 Author /Year/ Country Sex (Men%)/ Mean Age ± SD/ Population / Personnel/ Setting Sample Size (ExpVs Cont) Inclusion Criteria as At- Risk Drinking Intervention Vs Control Intervention components Study Duration /Follow up rate Result

Baseline Vs Follow up Outcome Measure

(≥5 drinks per occasion at least

twice in the past

month), 4) drinking and driving* 5) Drinking agreement in a form of prescription Drinking diary cards Cont: 40% Vs 28% (p=0.13) 4) Binge Drinking Exp: 34% Vs 12% Cont: 32% Vs 17% (p=0.10)

5) Drinking & driving Exp: 51% Vs 18% Cont: 60% Vs 34% *(P=0.02) Fleming et al. (1999), US 66.4% Majority: 65-75 patients(≥65) Physicians /Community primary care practice N=158 Exp:71 Cont:87 Excessive drinking, 2 or more positive response to CAGE, binge drinking Exp: One 5-10 min brief intervention Cont: health booklet on general health issue 1) Patient centre counseling 2) Feedback to drinking pattern and frequency 3) Improve self-efficacy 4) Negotiate 6 months/ 91%

1) No. of drinks (past 7 days)

Exp: 15.54±7.65 Vs 9.92.±6.97 (36.2%) Cont: 16.58±11.49 Vs 16.27±12.17 (1.9%)

*(P<0.001)

2) No. of binge drinking episodes (past 30 days)

Exp: 3.38±7.05 Vs 1.83±5.94 (45.9%) Cont: 4.15±8.47 Vs 5.36±9.25 (29.2%)

(42)

32 Author /Year/ Country Sex (Men%)/ Mean Age ± SD/ Population / Personnel/ Setting Sample Size (ExpVs Cont) Inclusion Criteria as At- Risk Drinking Intervention Vs Control Intervention components Study Duration /Follow up rate Result

Baseline Vs Follow up Outcome Measure

change goals

5) Collaborate on change plan

6) Follow up visit

*(P<0.005)

3) Binge drinking (past 30 days) Exp: 48.72% Vs 30.77% (17.95%) Cont: 40.30% Vs 49.25% (8.95%)

*(P<0.025)

4) Drinking excessively ( past 7 days) Exp: 29.49% Vs 15.38 % (14.11%) Cont: 29.85% Vs 34.33 % (4.48%) *(P<0.005) Ockene et al. (1999); US 64.7% Exp: 43.5±14.0 Cont: 44.2±13.9 Patients (21-70) Physicians an nurse practitioners /Academic medical centre- affiliated primary care practice site N=530 Exp: 274 Cont: 256 Excessive drinking & binge dinking Exp: 2 or more consultation in brief intervention general lifestyle especially on alcohol Cont: appointment with GP about 1) Consultation in lifestyle in general and alcohol in particular 2) Discussion over facilitators and barriers of controlled drinking in 24 months Exp: 33.3% Cont: 36.9%

1) Weekly alcohol consumption Exp: 18.7±14.6 Vs 12.6±14.2 (32.6%) Cont: 16.4±12.1 Vs 13.3±12.7 (18.9%)

*(P=0.003)

2) Excessive weekly drinking to safe drinking

OR: 1.83 (1.20-2.78)

(43)

33 Author /Year/ Country Sex (Men%)/ Mean Age ± SD/ Population / Personnel/ Setting Sample Size (ExpVs Cont) Inclusion Criteria as At- Risk Drinking Intervention Vs Control Intervention components Study Duration /Follow up rate Result

Baseline Vs Follow up Outcome Measure

the reason about

the elevated GGT empathetic way 3) Biochemical feedback by GGT 4) Follow up

3) Binge drinking to non-binge drinking OR: 1.24 (0.81-1.90)

(p=0.32)

4) Excessive weekly drinking or binge drinking to safe drinking and

non-binge drinking OR:1.60 (1.09-2.34) *(P=0.02) Tomson et al (1998); Sweden 59 (81.3%) Exp: 47 Cont: 44 Patient (25-45) Nurse /Community Health Centre N=222 Exp: 100 Cont: 122 GGT above 0.89µat/I Exp: two 10-15 brief counseling wit 4 weeks apart and a booster session

Cont: usual care

1) Review of alcohol related health effects, 2) Information on frequency of different types of at risk drinkers 3) List of methods to cut down drinking 4) Treatment 48 months/ 88% 1) CAGE ≥2 Exp: 60% Vs 46% (14%) Cont: No data Vs 53% 2) weekly consumption Exp: 337g Vs 228g (32.3%) (*p=0.02) Cont: No data Vs 196g 3) GGT: Exp: 1.52 Vs 1.21* (p=0.02) Cont: 1.75 Vs 2.16 (p=0.34)

(44)

34 Author /Year/ Country Sex (Men%)/ Mean Age ± SD/ Population / Personnel/ Setting Sample Size (ExpVs Cont) Inclusion Criteria as At- Risk Drinking Intervention Vs Control Intervention components Study Duration /Follow up rate Result

Baseline Vs Follow up Outcome Measure

contract 5) Cognitive behavioral exercise Follow up calls at at 2nd and 8th week

4) Sickness allowance and records in social services

Exp: 27% Vs 20% (7%) Cont: 13% Vs 18% (5%)

5) No. of sick day (1 year before & after) Exp: 38.2±70.8 Vs 34.2±73 (10.5%) Cont: 27.8±58.7 Vs 24.9±37.4 (10.4%) (P≥0.05)

6) Hospitalization (3 years before & after) IG: 23% Vs 30% (7%) Cont: 18% Vs 25% (7%) (P≥0.05) Fleming MF et al (1997); US 62.3^% Mean age: no data patients (18-65)/ Family physicians / Community based primary care practices N=774 Exp: 392 Cont: 382 Men: ≥14 drinks /week (168 g of alcohol); Women: ≥11 drinks /week (132g of alcohol) Exp: two 10-15 minute counseling including advice, education and contracting 1) Prevalence of problem drinking 2) Adverse effects of alcohol 3) Drinking cues worksheet 12 months/ 93.4%

1) No. of drinks (past 7 days)

Exp: 19.14±12.26 Vs 11.48±11.31 (40%) Cont: 18.94±11.84 Vs 15.46±12.93 (18.4%)

*(P<0.001)

2) No. Binge drinking episode (past 30days)

(45)

35 Author /Year/ Country Sex (Men%)/ Mean Age ± SD/ Population / Personnel/ Setting Sample Size (ExpVs Cont) Inclusion Criteria as At- Risk Drinking Intervention Vs Control Intervention components Study Duration /Follow up rate Result

Baseline Vs Follow up Outcome Measure

information and 2 follow up telephone Cont: a booklet on general health issue 4) A drinking agreement as prescription 5) Drinking daily cards A follow up telephone call

2weeks after each

meeting

Exp: 5.65±5.95 Vs 5.34±5.03

Cont: 3.07±5.23 Vs 4.21±5.52

*(P<0.005)

3) Binge drinking (past 30 days) Exp: 288 (85.46%) Vs 188 (55.79.%)

(29.67%)

Cont: 317 (86.61%) Vs 261(71.31%)

(15.3%)

*(P<.001)

4) Drinking excessively (past 7 days) Exp: 160 (47.48%) Vs 60 (17.80%)

(29.68%)

Cont: 176 (48.09%) Vs 119 (32.51%)

(15.58%)

*(P<0.001)

5) No. of Hospitals day (past 6 month) (No. of patient)

(46)

36 Author /Year/ Country Sex (Men%)/ Mean Age ± SD/ Population / Personnel/ Setting Sample Size (ExpVs Cont) Inclusion Criteria as At- Risk Drinking Intervention Vs Control Intervention components Study Duration /Follow up rate Result

Baseline Vs Follow up Outcome Measure

Cont: 42 (17) Vs 146 (17)

*(P<0.001)

6) No. of emergency department visits (no. of patient) Exp: 75 (58) Vs 60 (47) Cont: 80 (65) Vs 62(50) (P>0.10) McIntosh MC et al. (1997); Canada Exp(P):56.1% Exp(N):43.4% Cont:57.5% Exp(P):31.8 Exp(N):30.6 Cont: 30.7 patients (≥15) physician or nurse/Famil y practice clinic/ N=159 Exp (P): 40 Exp(N) :66 Cont: 53 CAGE score ≥1; ≥4 standard drink on any

one day in the

past 28 days Cont: 5 minute advice by physician intervention Exp(P) : two 30 mins brief intervention with a physician using CBT Exp(N): two 30 mins brief intervention by nurse Not mentioned in details

12 months 1) Monthly quantify Frequency of drinking at baseline Men Cont: 46.2Vs 27.7.(40%) Exp(P): 51.0Vs22.9(55%) Exp(N): 51.3Vs 27.5 (46%) Women Cont: 11.6Vs8.2 (30%) Exp(P): 24.2Vs10.6(56%) Exp(N): 9.4Vs6.0(26%) (P>0.05)

(47)

37 Author /Year/ Country Sex (Men%)/ Mean Age ± SD/ Population / Personnel/ Setting Sample Size (ExpVs Cont) Inclusion Criteria as At- Risk Drinking Intervention Vs Control Intervention components Study Duration /Follow up rate Result

Baseline Vs Follow up Outcome Measure

practitioner

using CBT

2) Monthly quantify frequency reports for clients reporting ≥1 hazardous drinking day Men Cont: 56.2Vs26.6.(59%) Exp(P): 47.4Vs12.7(73%) Exp(N): 56.1Vs20.4(64%) Women Cont: 11.1Vs 2.3(79%) Exp(P): 25.3Vs 6.6(74%) Exp(N): 11.8 Vs3.9(66%) (P>0.05)

Exp=experimental group , Cont=control group Exp(P)=experimental group by physician, Exp(N)=experimental group by nurse1 standard drinks=12.8 g of alcohol per drink

Binge Drinking= ≥ 5 or standard drinks per occasion on 1 or more occasion in the past month(Men) ;≥ 4 standard drink(women)

Excessing drinking= ≥12 standard drinks /week (men); ≥ 9 standard drinks/week (women), drinking beyond NIAA recommended limits

(48)

38 Chapter 3 Result

3.1 Overview

In this systematic review, an extensive literature search and careful screening of

the potential articles matching the eligibility were performed. A total of thirteen RCT

were identified for further evaluation in comparing the effectiveness of BI delivered

by physician and/or nurse to risk drinkers. The data were compiled by the

characteristics of the subject including year of study, country, sex ratio, mean age and

were further synthesized from the sample size, study duration, interventions offered,

number of subjects completed follow up, outcome measures (primary baseline and

follow up measure) for all included studies.

The thirteen included studies in the systematic review were from the period 1997

to 2010. Four articles were excluded during the search selection process as the full

papers could not be retrieved. One study, Project Health II (Ockene JK et al, 2009)

was the extension of Project Health I (Reiff-Hekking S et al , 2005 & Ockene et

al.,1999) in which subjects from the two studies were asked for re-consent to join

Project Health II. Participants in the included studies were at-risk, non-dependent

alcohol drinkers patients (aged 14 or above) seeking consultation in primary care

services for non-alcohol problems. One study included moms seeking postpartum care

in obstetrics practice clinic (Fleming et. al., 2009) and one study included elderly aged

65 or above only (Fleming et. al. 1999) in community settings. Nine studies were

from United States (US), one study was from Spain, one study was from Sweden, one

study was from United Kingdom (UK) and one study was from Canada. Twelve

studies covered both gender while one studies included female subjects only (Fleming

(49)

39

The average age of subjects in all studies combined was about 37.4 years. All subjects’

alcohol consumption was defined at-risk drinking according to the inclusion criteria

except the study of by Tomson et. Al (1998) which the inclusion criterion was

subject’s GGT (over 0.89µat/I) [45] . Demographic and clinical characteristics of the subjects between the intervention and control group were similar. An overview of the

subjects’ characteristic of the studies included in the systematic review was presented at Table 3.

3.2 Summary of the Studies Included

The study duration of RCT included for the critical appraisal were ranged from 6

months to 48 months. A total of 5,460 subjects were recruited in the thirteen included

RCT. Eleven studies compared BI with usual care, no intervention and/or booklet on

general health care issue. One study (McIntosh Mc et al, 1997) compared BI by

physician or nurse to traditional physician advice and it was only one study which

compared the effectiveness of BI to men and women. Six studies were about

physician-led BI, three studies were about nurse-led and four studies were about

both-led (both physician and nurse-led) BI.

About 20% of the participants have lost the follow up while only study (Ockene

et al, 1999) reported a great lost the follow up rate up to 70% [44]. The number of

participants lost to follow up due to adverse events was generally acceptable by author.

The only primary and secondary outcome measures were very varied across thirteen

included studies. Alcohol consumption in quantity (mean standard drink during

specific time) was the only commonly used primary outcome measurement among

studies. For the list of outcome measurement, the results were displayed at Table 2

(50)

40 3.3. Results of review

The outcome measurements were reported in mean value with standard deviation

(See Table 2 Summary of scoring of quality indicators by CONSORT statement). The

effect of intervention in intervention group and control group was evaluated according

the statistical significance level between intervention group and control group at the

follow up measurement. If P value equaled less than 0.05 (P≤0.05), there were less

than 5% chance that observed difference between intervention and control group were

due to chance and it was statistically significant. On the other hand, if the P value was

greater than 0.05 (P≥0.05), there was more than 5% chance that the observed difference between intervention and control group were due to chance and it was

statistically insignificant. The change in outcome measurement at follow up would be

reported as compared to baseline measurement.

3.3.1 Physician-led and nurse-led BI

The effectiveness of physician-led or nurse-led intervention would be evaluated

according to four major primary outcomes that were commonly reported in the

included studies would be discussed after data synthesis including 1) alcohol

consumption 2) no. of binge drinking episode 3) no. of drinking days 4) health care

utilization . Moreover, the effectiveness of BI components in intensity, components

and settings would be further studied.

3.3.1.1 Effectiveness on alcohol consumption

In order to give comprehensive pictures about the effectiveness of brief

intervention by individual studies, different outcome measurement was summarized in

(51)

41

Decrease in alcohol consumption during specified period for at risk drinkers was

associated with decrease in quantity of toxin exposure in alcohol use with less harmful

effects. Alcohol consumption was the most common outcome measurement among

the included studies. Three physician-led BI studies showed a reduction in drink

consumption for intervention group from 27%-47% in intervention group at follow up

as compared to baseline and the result was statistically (P≤0.05) between intervention

and control.. The two other physician-led BI studies with statistically insignificant

results between intervention and controls reported a 37.7% and 40% (both at 12

months) in intervention group respectively.

Only one nurse-led BI study(Fleming et al 2009) reported 41.8% reduction in

alcohol consumption for control group at 6-months follow up and the result was

statistically significant between intervention and control groups. One study (Lock CA

et al, 2006) indicated in 27% reduction in alcohol consumption at 12-months follow

up but the result were not statistically significant between intervention and control

group. Another study (Tom son et al, 1998) showed 32% reduction in alcohol

consumption at 48 months follow up for intervention group and the result was

statistically significant

Two both led BI studies reported 32.6% reduction in alcohol consumption at

6-months follow up and 31.1% reduction in alcohol consumption at 12 months follow

up for intervention group and the results were statistically significant between

intervention and control. Two studies with both led BI reported statistically

insignificant results between intervention and control group while one study

(McIntosh MC et al, 1997) reported a 45% reduction in alcohol consumption at 12

Figure

Table 1 Primary Outcomes measure for included studies
Figure 1 Flow diagram of article selection process
Table 2. Summary of scoring of quality indicators by CONSORT statement
Table 3 Summary of results of 13 included articles in the systematic review

References

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