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
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
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
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
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.
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
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
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
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
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
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
2
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
3
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).
4
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
5
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
6
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
7
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].
8
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
9
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
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
11
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
12
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
13
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)
14
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
15
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
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
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
18
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
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
20
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
21
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
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%)
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)
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)
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)
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
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)
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%)
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)
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%
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%)
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)
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)
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)
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)
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)
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
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
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
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
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