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1.  The Effectiveness of Community Action in Reducing Risky Alcohol Consumption and Harm: A Cluster Randomised Controlled Trial 
PLoS Medicine  2014;11(3):e1001617.
In a cluster randomized controlled trial, Anthony Shakeshaft and colleagues measure the effectiveness of a multi-component community-based intervention for reducing alcohol-related harm.
Background
The World Health Organization, governments, and communities agree that community action is likely to reduce risky alcohol consumption and harm. Despite this agreement, there is little rigorous evidence that community action is effective: of the six randomised trials of community action published to date, all were US-based and focused on young people (rather than the whole community), and their outcomes were limited to self-report or alcohol purchase attempts. The objective of this study was to conduct the first non-US randomised controlled trial (RCT) of community action to quantify the effectiveness of this approach in reducing risky alcohol consumption and harms measured using both self-report and routinely collected data.
Methods and Findings
We conducted a cluster RCT comprising 20 communities in Australia that had populations of 5,000–20,000, were at least 100 km from an urban centre (population ≥ 100,000), and were not involved in another community alcohol project. Communities were pair-matched, and one member of each pair was randomly allocated to the experimental group. Thirteen interventions were implemented in the experimental communities from 2005 to 2009: community engagement; general practitioner training in alcohol screening and brief intervention (SBI); feedback to key stakeholders; media campaign; workplace policies/practices training; school-based intervention; general practitioner feedback on their prescribing of alcohol medications; community pharmacy-based SBI; web-based SBI; Aboriginal Community Controlled Health Services support for SBI; Good Sports program for sports clubs; identifying and targeting high-risk weekends; and hospital emergency department–based SBI. Primary outcomes based on routinely collected data were alcohol-related crime, traffic crashes, and hospital inpatient admissions. Routinely collected data for the entire study period (2001–2009) were obtained in 2010. Secondary outcomes based on pre- and post-intervention surveys (n = 2,977 and 2,255, respectively) were the following: long-term risky drinking, short-term high-risk drinking, short-term risky drinking, weekly consumption, hazardous/harmful alcohol use, and experience of alcohol harm. At the 5% level of statistical significance, there was insufficient evidence to conclude that the interventions were effective in the experimental, relative to control, communities for alcohol-related crime, traffic crashes, and hospital inpatient admissions, and for rates of risky alcohol consumption and hazardous/harmful alcohol use. Although respondents in the experimental communities reported statistically significantly lower average weekly consumption (1.90 fewer standard drinks per week, 95% CI = −3.37 to −0.43, p = 0.01) and less alcohol-related verbal abuse (odds ratio = 0.58, 95% CI = 0.35 to 0.96, p = 0.04) post-intervention, the low survey response rates (40% and 24% for the pre- and post-intervention surveys, respectively) require conservative interpretation. The main limitations of this study are as follows: (1) that the study may have been under-powered to detect differences in routinely collected data outcomes as statistically significant, and (2) the low survey response rates.
Conclusions
This RCT provides little evidence that community action significantly reduces risky alcohol consumption and alcohol-related harms, other than potential reductions in self-reported average weekly consumption and experience of alcohol-related verbal abuse. Complementary legislative action may be required to more effectively reduce alcohol harms.
Trial registration
Australian New Zealand Clinical Trials Registry ACTRN12607000123448
Please see later in the article for the Editors' Summary
Editors' Summary
Background
People have consumed alcoholic beverages throughout history, but alcohol use is now an increasing global public health problem. According to the World Health Organization's 2010 Global Burden of Disease Study, alcohol use is the fifth leading risk factor (after high blood pressure and smoking) for disease and is responsible for 3.9% of the global disease burden. Alcohol use contributes to heart disease, liver disease, depression, some cancers, and many other health conditions. Alcohol also affects the well-being and health of people around those who drink, through alcohol-related crimes and road traffic crashes. The impact of alcohol use on disease and injury depends on the amount of alcohol consumed and the pattern of drinking. Most guidelines define long-term risky drinking as more than four drinks per day on average for men or more than two drinks per day for women (a “drink” is, roughly speaking, a can of beer or a small glass of wine), and short-term risky drinking (also called binge drinking) as seven or more drinks on a single occasion for men or five or more drinks on a single occasion for women. However, recent changes to the Australian guidelines acknowledge that a lower level of alcohol consumption is considered risky (with lifetime risky drinking defined as more than two drinks a day and binge drinking defined as more than four drinks on one occasion).
Why Was This Study Done?
In 2010, the World Health Assembly endorsed a global strategy to reduce the harmful use of alcohol. This strategy emphasizes the importance of community action–a process in which a community defines its own needs and determines the actions that are required to meet these needs. Although community action is highly acceptable to community members, few studies have looked at the effectiveness of community action in reducing risky alcohol consumption and alcohol-related harm. Here, the researchers undertake a cluster randomized controlled trial (the Alcohol Action in Rural Communities [AARC] project) to quantify the effectiveness of community action in reducing risky alcohol consumption and harms in rural communities in Australia. A cluster randomized trial compares outcomes in clusters of people (here, communities) who receive alternative interventions assigned through the play of chance.
What Did the Researchers Do and Find?
The researchers pair-matched 20 rural Australian communities according to the proportion of their population that was Aboriginal (rates of alcohol-related harm are disproportionately higher among Aboriginal individuals than among non-Aboriginal individuals in Australia; they are also higher among young people and males, but the proportions of these two groups across communities was comparable). They randomly assigned one member of each pair to the experimental group and implemented 13 interventions in these communities by negotiating with key individuals in each community to define and implement each intervention. Examples of interventions included general practitioner training in screening for alcohol use disorders and in implementing a brief intervention, and a school-based interactive session designed to reduce alcohol harm among young people. The researchers quantified the effectiveness of the interventions using routinely collected data on alcohol-related crime and road traffic crashes, and on hospital inpatient admissions for alcohol dependence or abuse (which were expected to increase in the experimental group if the intervention was effective because of more people seeking or being referred for treatment). They also examined drinking habits and experiences of alcohol-related harm, such as verbal abuse, among community members using pre- and post-intervention surveys. After implementation of the interventions, the rates of alcohol-related crime, road traffic crashes, and hospital admissions, and of risky and hazardous/harmful alcohol consumption (measured using a validated tool called the Alcohol Use Disorders Identification Test) were not statistically significantly different in the experimental and control communities (a difference in outcomes that is not statistically significantly different can occur by chance). However, the reported average weekly consumption of alcohol was 20% lower in the experimental communities after the intervention than in the control communities (equivalent to 1.9 fewer standard drinks per week per respondent) and there was less alcohol-related verbal abuse post-intervention in the experimental communities than in the control communities.
What Do These Findings Mean?
These findings provide little evidence that community action reduced risky alcohol consumption and alcohol-related harms in rural Australian communities. Although there was some evidence of significant reductions in self-reported weekly alcohol consumption and in experiences of alcohol-related verbal abuse, these findings must be interpreted cautiously because they are based on surveys with very low response rates. A larger or differently designed study might provide statistically significant evidence for the effectiveness of community action in reducing risky alcohol consumption. However, given their findings, the researchers suggest that legislative approaches that are beyond the control of individual communities, such as alcohol taxation and restrictions on alcohol availability, may be required to effectively reduce alcohol harms. In other words, community action alone may not be the most effective way to reduce alcohol-related harm.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001617.
The World Health Organization provides detailed information about alcohol; its fact sheet on alcohol includes information about the global strategy to reduce the harmful use of alcohol; the Global Information System on Alcohol and Health provides further information about alcohol, including information on control policies around the world
The US National Institute on Alcohol Abuse and Alcoholism has information about alcohol and its effects on health
The US Centers for Disease Control and Prevention has a website on alcohol and public health that includes information on the health risks of excessive drinking
The UK National Health Service Choices website provides detailed information about drinking and alcohol, including information on the risks of drinking too much, tools for calculating alcohol consumption, and personal stories about alcohol use problems
MedlinePlus provides links to many other resources on alcohol
More information about the Alcohol Action in Rural Communities project is available
doi:10.1371/journal.pmed.1001617
PMCID: PMC3949675  PMID: 24618831
2.  Comparative Analysis of Alcohol Control Policies in 30 Countries 
PLoS Medicine  2007;4(4):e151.
Background
Alcohol consumption causes an estimated 4% of the global disease burden, prompting goverments to impose regulations to mitigate the adverse effects of alcohol. To assist public health leaders and policymakers, the authors developed a composite indicator—the Alcohol Policy Index—to gauge the strength of a country's alcohol control policies.
Methods and Findings
The Index generates a score based on policies from five regulatory domains—physical availability of alcohol, drinking context, alcohol prices, alcohol advertising, and operation of motor vehicles. The Index was applied to the 30 countries that compose the Organization for Economic Cooperation and Development and regression analysis was used to examine the relationship between policy score and per capita alcohol consumption. Countries attained a median score of 42.4 of a possible 100 points, ranging from 14.5 (Luxembourg) to 67.3 (Norway). The analysis revealed a strong negative correlation between score and consumption (r = −0.57; p = 0.001): a 10-point increase in the score was associated with a one-liter decrease in absolute alcohol consumption per person per year (95% confidence interval, 0.4–1.5 l). A sensitivity analysis demonstrated the robustness of the Index by showing that countries' scores and ranks remained relatively stable in response to variations in methodological assumptions.
Conclusions
The strength of alcohol control policies, as estimated by the Alcohol Policy Index, varied widely among 30 countries located in Europe, Asia, North America, and Australia. The study revealed a clear inverse relationship between policy strength and alcohol consumption. The Index provides a straightforward tool for facilitating international comparisons. In addition, it can help policymakers review and strengthen existing regulations aimed at minimizing alcohol-related harm and estimate the likely impact of policy changes.
Using an index that gauges the strength of national alcohol policies, a clear inverse relationship was found between policy strength and alcohol consumption.
Editors' Summary
Background.
Alcohol drinking is now recognized as one of the most important risks to human health. Previous research studies (see the research article by Rodgers et al., linked below) have predicted that around 4% of the burden of disease worldwide comes about as a result of drinking alcohol, which can be a factor in a wide range of health problems. These include chronic diseases such as cirrhosis of the liver and certain cancers, as well as poor health resulting from trauma, violence, and accidental injuries. For these reasons, most governments try to control the consumption of alcohol through laws, although very few countries ban alcohol entirely.
Why Was This Study Done?
Although bodies such as the World Health Assembly have recommended that its member countries develop national control policies to prevent excessive alcohol use, there is a huge variation between national policies. It is also very unclear whether there is any link between the strictness of legislation regarding alcohol control in any given country and how much people in that country actually drink.
What Did the Researchers Do and Find?
The researchers carrying out this study had two broad goals. First, they wanted to develop an index (or scoring system) that would allow them and others to rate the strength of any given country's alcohol control policy. Second, they wanted to see whether there is any link between the strength of control policies on this index and the amount of alcohol that is drunk by people on average in each country. In order to develop the alcohol control index, the researchers chose five main areas relating to alcohol control. These five areas related to the availability of alcohol, the “drinking context,” pricing, advertising, and vehicles. Within each policy area, specific policy topics relating to prevention of alcohol consumption and harm were identified. Then, each of 30 countries within the OECD (Organization for Economic Cooperation and Development) were rated on this index using recent data from public reports and databases. The researchers also collected data on alcohol consumption within each country from the World Health Organization and used this to estimate the average amount drunk per person in a year. When the researchers plotted scores on their index against the average amount drunk per person per year, they saw a negative correlation. That is, the stronger the alcohol control policy in any given country, the less people seemed to drink. This worked out at around roughly a 10-point increase on the index equating to a one-liter drop in alcohol consumption per person per year. However, some countries did not seem to fit these predictions very well.
What Do These Findings Mean?
The finding that there is a link between the strength of alcohol control policies and amount of alcohol drinking does not necessarily mean that greater government control causes lower drinking rates. The relationship might just mean that some other variable (e.g., some cultural factor) plays a role in determining the amount that people drink as well as affecting national policies for alcohol control. However, the index developed here is a useful method for researchers and policy makers to measure changes in alcohol controls and therefore understand more clearly the factors that affect drinking rates. This study looked only at the connection between control measures and extent of alcohol consumption, and did not examine alcohol-related harm. Future research might focus on the links between controls and the harms caused by alcohol.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0040151.
A Perspective in PLoS Medicine by Alison Ritter accompanies this article: “Comparing alcohol policies between countries: Science or silliness?”
Facts and figures on alcohol are available from the World Health Organization, including information about the burden of disease worldwide as a result of alcohol
Information from the US Centers for Disease Control and Prevention is available about alcohol and public health
A 2004 PLoS Medicine research article includes discussion of the health burdens of alcohol: Rodgers A, Ezzati M, Vander Hoorn S, Lopez AD, Lin RB, et al. (2004) Distribution of major health risks: Findings from the global burden of disease study. PLoS Medicine 1(1): e27. doi:10.1371/journal.pmed.0010027
Current information about research on alcohol and alcoholism is available from the National Institute on Alcohol Abuse and Alcoholism
doi:10.1371/journal.pmed.0040151
PMCID: PMC1876414  PMID: 17455992
3.  “…Keep mobile, I think that’s half the battle.” A qualitative study of prevention of knee pain in symptomless older adults 
BMC Public Health  2012;12:753.
Background
The emphasis on prevention in English health policy continues to centre predominantly on major diseases such as coronary heart disease and diabetes. A number of key documents detailing self-management techniques and prevention of osteoarthritis (OA) are currently available, including the NICE guidelines and the Arthritis Foundation’s National Public Health Agenda for Osteoarthritis. However, few investigations have explored preventative knowledge of knee OA amongst the population. In particular, asymptomatic members of the population may use further information in considering how to prevent knee pain. This study considers perceptions around the prevention of knee pain amongst an asymptomatic population; this target population may provide alternative insights by which to stimulate preventative behaviours.
Methods
A sample of thirteen patients with no current knee pain was selected from responders to a population survey. Each interview was tape recorded and fully transcribed. Qualitative computer software package NVivo8 was used to manage the data. Thematic analysis was conducted using the constant comparative method.
Results
The definition and causes of knee pain were interpreted in a multitude of ways. The importance of prevention was recognised by a sub-set, while a small proportion of participants negated the role of prevention. A range of social factors, including early adoption of actions, influenced the implementation and continuation of preventative behaviours. Individual responsibility for prevention was a key theme, although the role of society was also considered. Exercise was cited as a principal preventative strategy, although some participants viewed exercise as a destructive activity. A number of participants deemed pharmacotherapy to be harmful and at odds with normal physiology, instead preferring to adopt preventative behaviour over medication usage.
Conclusions
This asymptomatic population exhibit considerable breadth and variation in knowledge of preventative strategies for knee pain. Similarities in perceptions of prevention exist when comparing to the symptomatic population. These range from emphasis on individual responsibility, through to observations on the role of exercise and pharmacotherapy in knee pain. In general individuals are agreeable to act upon recommended treatments in line with NICE guidance. This receptiveness demands a greater consideration of preventative strategies in consultations, as well as wider availability and promotion of preventative strategies in order to improve the musculoskeletal health of the general population.
doi:10.1186/1471-2458-12-753
PMCID: PMC3584728  PMID: 22958420
4.  What is the optimal level of population alcohol consumption for chronic disease prevention in England? Modelling the impact of changes in average consumption levels 
BMJ Open  2012;2(3):e000957.
Objective
To estimate the impact of achieving alternative average population alcohol consumption levels on chronic disease mortality in England.
Design
A macro-simulation model was built to simultaneously estimate the number of deaths from coronary heart disease, stroke, hypertensive disease, diabetes, liver cirrhosis, epilepsy and five cancers that would be averted or delayed annually as a result of changes in alcohol consumption among English adults. Counterfactual scenarios assessed the impact on alcohol-related mortalities of changing (1) the median alcohol consumption of drinkers and (2) the percentage of non-drinkers.
Data sources
Risk relationships were drawn from published meta-analyses. Age- and sex-specific distributions of alcohol consumption (grams per day) for the English population in 2006 were drawn from the General Household Survey 2006, and age-, sex- and cause-specific mortality data for 2006 were provided by the Office for National Statistics.
Results
The optimum median consumption level for drinkers in the model was 5 g/day (about half a unit), which would avert or delay 4579 (2544 to 6590) deaths per year. Approximately equal numbers of deaths from cancers and liver disease would be delayed or averted (∼2800 for each), while there was a small increase in cardiovascular mortality. The model showed no benefit in terms of reduced mortality when the proportion of non-drinkers in the population was increased.
Conclusions
Current government recommendations for alcohol consumption are well above the level likely to minimise chronic disease. Public health targets should aim for a reduction in population alcohol consumption in order to reduce chronic disease mortality.
Article summary
Article focus
Alcohol consumption is a risk factor for many chronic diseases, while providing modest protection from others. Assessments of the impact of alcohol on individual chronic diseases can therefore result in contradictory advice about the level of alcohol consumption that is optimal for health.
The UK Government currently recommends that men should consume no more than three to four units per day (24–32 g/day of pure alcohol) and women should drink no more than two to three units per day (16–24 g/day). However the net impact of this level of consumption on chronic disease mortality is unclear.
The aim of this study was to estimate the impact of achieving alternative population alcohol consumption levels on chronic disease mortality in England.
Key messages
Results suggest that the optimum population level of alcohol consumption for minimising chronic disease mortality in England is just 5 g (approximately half a unit) per day.
Current recommendations for alcohol consumption are well above this level and may not be compatible with optimum protection of public health. Substantial reductions in recommendations and in population alcohol consumption levels would be needed to minimise the chronic disease burden associated with alcohol consumption in England.
Community beliefs in the protective role of alcohol in cardiovascular disease are widespread; however, our modelling shows that when multiple conditions are considered simultaneously, the levels of alcohol that would actually be likely to be associated with reduced risk of chronic disease are much lower than is generally accepted or recommended by government.
Strengths and limitations of this study
The study used a detailed modelling approach to synthesise the best available evidence from meta-analysis of prospective cohort studies and provide for the first time an estimate of the level of alcohol associated with theoretical minimum risk of a range of chronic diseases, considering both harmful and protective effects simultaneously.
The model is dependent on the meta-analyses selected to define the parameters. Results may vary significantly in other contexts with varying levels of disease, alcohol consumption and other risk factors. Furthermore, results depend on the quality of the available epidemiological evidence, which remains contested in some areas.
The approach used also relies on chronic (average) consumption of alcohol and is not able to take account of to take account of patterns of drinking (eg, binge drinking). Furthermore, the results are based on the assumption of a steady-state relationship between alcohol consumption patterns and RR of disease and cannot estimate the time required between changes in population alcohol consumption levels occurring and the achievement of changes in mortality rates.
doi:10.1136/bmjopen-2012-000957
PMCID: PMC3367150  PMID: 22649178
5.  Enduring Effects of Prenatal and Infancy Home Visiting by Nurses on Maternal Life Course and Government Spending 
Objective
To test, among an urban primarily African American sample, the effects of prenatal and infancy home visiting by nurses on mothers’ fertility, partner relationships, and economic self-sufficiency and on government spending through age 12 years of their firstborn child.
Design
Randomized controlled trial.
Setting
Public system of obstetric and pediatric care in Memphis, Tennessee.
Participants
A total of 594 urban primarily African American economically disadvantaged mothers (among 743 who registered during pregnancy).
Intervention
Prenatal and infancy home visiting by nurses.
Main Outcome Measures
Mothers’ cohabitation with and marriage to the child’s biological father, intimate partner violence, duration (stability) of partner relationships, role impairment due to alcohol and other drug use, use and cost of welfare benefits, arrests, mastery, child foster care placements, and cumulative subsequent births.
Results
By the time the firstborn child was 12 years old, nurse-visited mothers compared with control subjects reported less role impairment owing to alcohol and other drug use (0.0% vs 2.5%, P = .04), longer partner relationships (59.58 vs 52.67 months, P = .02), and greater sense of mastery (101.04 vs 99.60, P = .005). During this 12-year period, government spent less per year on food stamps, Medicaid, and Aid to Families with Dependent Children and Temporary Assistance for Needy Families for nurse-visited than control families ($8772 vs $9797, P = .02); this represents $12 300 in discounted savings compared with a program cost of $11 511, both expressed in 2006 US dollars. No statistically significant program effects were noted on mothers’ marriage, partnership with the child’s biological father, intimate partner violence, alcohol and other drug use, arrests, incarceration, psychological distress, or reports of child foster care placements.
Conclusion
The program improved maternal life course and reduced government spending among children through age 12 years.
doi:10.1001/archpediatrics.2010.49
PMCID: PMC3249758  PMID: 20439792
6.  The effectiveness of schemes that refine referrals between primary and secondary care—the UK experience with glaucoma referrals: the Health Innovation & Education Cluster (HIEC) Glaucoma Pathways Project 
BMJ Open  2013;3(7):e002715.
Objectives
A comparison of glaucoma referral refinement schemes (GRRS) in the UK during a time period of considerable change in national policy and guidance.
Design
Retrospective multisite review.
Setting
The outcomes of clinical examinations by optometrists with a specialist interest in glaucoma (OSIs) were compared with optometrists with no specialist interest in glaucoma (non-OSIs). Data from Huntingdon and Nottingham assessed non-OSI findings, while Manchester and Gloucestershire reviewed OSI findings.
Participants
1086 patients. 434 patients were from Huntingdon, 179 from Manchester, 204 from Gloucestershire and 269 from Nottingham.
Results
The first-visit discharge rate (FVDR) for all time periods for OSIs was 14.1% compared with 36.1% from non-OSIs (difference 22%, CI 16.9% to 26.7%; p<0.001). The FVDR increased after the April 2009 National Institute for Health and Clinical Excellence (NICE) glaucoma guidelines compared with pre-NICE, which was particularly evident when pre-NICE was compared with the current practice time period (OSIs 6.2–17.2%, difference 11%, CI −24.7% to 4.3%; p=0.18, non-OSIs 29.2–43.9%, difference 14.7%, CI −27.8% to −0.30%; p=0.03). Elevated intraocular pressure (IOP) was the commonest reason for referral for OSIs and non-OSIs, 28.7% and 36.1%, respectively, of total referrals. The proportion of referrals for elevated IOP increased from 10.9% pre-NICE to 28.0% post-NICE for OSIs, and from 19% to 45.1% for non-OSIs.
Conclusions
In terms of ‘demand management’, OSIs can reduce FVDR of patients reviewed in secondary care; however, in terms of ‘patient safety’ this study also shows that overemphasis on IOP as a criterion for referral is having an adverse effect on both the non-OSIs and indeed the OSIs ability to detect glaucomatous optic nerve features. It is recommended that referral letters from non-OSIs be stratified for risk, directing high-risk patients straight to secondary care, and low-risk patients to OSIs.
doi:10.1136/bmjopen-2013-002715
PMCID: PMC3717451  PMID: 23878172
7.  Alcohol Sales and Risk of Serious Assault 
PLoS Medicine  2008;5(5):e104.
Background
Alcohol is a contributing cause of unintentional injuries, such as motor vehicle crashes. Prior research on the association between alcohol use and violent injury was limited to survey-based data, and the inclusion of cases from a single trauma centre, without adequate controls. Beyond these limitations was the inability of prior researchers to comprehensively capture most alcohol sales. In Ontario, most alcohol is sold through retail outlets run by the provincial government, and hospitals are financed under a provincial health care system. We assessed the risk of being hospitalized due to assault in association with retail alcohol sales across Ontario.
Methods and Findings
We performed a population-based case-crossover analysis of all persons aged 13 years and older hospitalized for assault in Ontario from 1 April 2002 to 1 December 2004. On the day prior to each assault case's hospitalization, the volume of alcohol sold at the store in closest proximity to the victim's home was compared to the volume of alcohol sold at the same store 7 d earlier. Conditional logistic regression analysis was used to determine the associated relative risk (RR) of assault per 1,000 l higher daily sales of alcohol. Of the 3,212 persons admitted to hospital for assault, nearly 25% were between the ages of 13 and 20 y, and 83% were male. A total of 1,150 assaults (36%) involved the use of a sharp or blunt weapon, and 1,532 (48%) arose during an unarmed brawl or fight. For every 1,000 l more of alcohol sold per store per day, the relative risk of being hospitalized for assault was 1.13 (95% confidence interval [CI] 1.02–1.26). The risk was accentuated for males (1.18, 95% CI 1.05–1.33), youth aged 13 to 20 y (1.21, 95% CI 0.99–1.46), and those in urban areas (1.19, 95% CI 1.06–1.35).
Conclusions
The risk of being a victim of serious assault increases with alcohol sales, especially among young urban men. Akin to reducing the risk of driving while impaired, consideration should be given to novel methods of preventing alcohol-related violence.
In a population-based case-crossover analysis, Joel Ray and colleagues find that the risk of being a victim of serious assault increases with retail alcohol sales, especially among young urban men.
Editors' Summary
Background.
Alcohol has been produced and consumed around the world since prehistoric times. In the Western world it is now the most commonly consumed psychoactive drug (a substance that changes mood, behavior, and thought processes). The World Health Organization reports that there are 76.3 million persons with alcohol use disorders worldwide. Alcohol consumption is an important factor in unintentional injuries, such as motor vehicle crashes, and in violent criminal behavior. In the United Kingdom, for example, a higher proportion of heavy drinkers than light drinkers cause violent criminal offenses. Other figures suggest that people (in particular, young men) have an increased risk of committing a criminally violent offense within 24 h of drinking alcohol. There is also some evidence that suggests that the victims as well as the perpetrators of assaults have often been drinking recently, possibly because alcohol impairs the victim's ability to judge potentially explosive situations.
Why Was This Study Done?
The researchers wanted to know more about the relationship between alcohol and intentional violence. The recognition of a clear link between driving when impaired by alcohol and motor vehicle crashes has led many countries to introduce public awareness programs that stigmatize drunk driving. If a clear link between alcohol consumption by the people involved in violent crime could also be established, similar programs might reduce alcohol-related assaults. The researchers tested the hypothesis that the risk of being hospitalized due to a violent assault increases when there are increased alcohol sales in the immediate vicinity of the victim's place of residence.
What Did the Researchers Do and Find?
The researchers did their study in Ontario, Canada for three reasons. First, Ontario is Canada's largest province. Second, the province keeps detailed computerized medical records, including records of people hospitalized from being violently assaulted. Third, most alcohol is sold in government-run shops, and the district has the infrastructure to allow daily alcohol sales to be tracked. The researchers identified more than 3,000 people over the age of 13 y who were hospitalized in the province because of a serious assault during a 32-mo period. They compared the volume of alcohol sold at the liquor store nearest to the victim's home the day before the assault with the volume sold at the same store a week earlier (this type of study is called a “case-crossover” study). For every extra 1,000 l of alcohol sold per store per day (a doubling of alcohol sales), the overall risk of being hospitalized for assault increased by 13%. The risk was highest in three subgroups of people: men (18% increased risk), youths aged 13 to 20 y (21% increased risk), and those living in urban areas (19% increased risk). At peak times of alcohol sales, the risk of assault was 41% higher than at times when alcohol sales were lowest.
What Do These Findings Mean?
These findings indicate that the risk of being seriously assaulted increases with the amount of alcohol sold locally the day before the assault and show that the individuals most at risk are young men living in urban areas. Because the study considers only serious assaults and alcohol sold in shops (i.e., not including alcohol sold in bars), it probably underestimates the association between alcohol and assault. It also does not indicate whether the victim or perpetrator of the assault (or both) had been drinking, and its findings may not apply to countries with different drinking habits. Nevertheless, these findings support the idea that the consumption of alcohol contributes to the occurrence of medical injuries from intentional violence. Increasing the price of alcohol or making alcohol harder to obtain might help to reduce the occurrence of alcohol-related assaults. The researchers suggest that a particularly effective approach may be to stigmatize alcohol-related brawling, analogous to the way that driving under the influence of alcohol has been made socially unacceptable.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0050104.
This study is further discussed in a PLoS Medicine Perspective by Bennetts and Seabrook
The US National Institute on Alcohol Abuse and Alcoholism provides information on all aspects of alcohol abuse, including an article on alcohol use and violence among young adults
Alcohol-related assault is examined in the British Crime Survey
Alcohol Concern, the UK national agency on alcohol misuse, provides fact sheets on the health impacts of alcohol, young people's drinking, and alcohol and crime
The Canadian Centre for Addiction and Mental Health in Toronto provides information about alcohol addiction (in English and French)
doi:10.1371/journal.pmed.0050104
PMCID: PMC2375945  PMID: 18479181
8.  NICE guidance: a comparative study of the introduction of the single technology appraisal process and comparison with guidance from Scottish Medicines Consortium 
BMJ Open  2012;2(1):e000671.
Objectives
To compare the timelines and recommendations of the Scottish Medicines Consortium (SMC) and National Institute of Health and Clinical Excellence (NICE), in particular since the single technology assessment (STA) process was introduced in 2005.
Design
Comparative study of drug appraisals published by NICE and SMC.
Setting
NICE and SMC.
Participants
All drugs appraised by SMC and NICE, from establishment of each organisation until August 2010, were included. Data were gathered from published reports on the NICE website, SMC annual reports and European Medicines Agency website.
Primary and secondary outcome measures
Primary outcome was time from marketing authorisation until publication of first guidance. The final outcome for each drug was documented. Drug appraisals by NICE (before and after the introduction of the STA process) and SMC were compared.
Results
NICE and SMC appraised 140 drugs, 415 were appraised by SMC alone and 102 by NICE alone. NICE recommended, with or without restriction, 90% of drugs and SMC 80%. SMC published guidance more quickly than NICE (median 7.4 compared with 21.4 months). Overall, the STA process reduced the average time to publication compared with multiple technology assessments (median 16.1 compared with 22.8 months). However, for cancer medications, the STA process took longer than multiple technology assessment (25.2 compared with 20.0 months).
Conclusions
Proportions of drugs recommended for NHS use by SMC and NICE are similar. SMC publishes guidance more quickly than NICE. The STA process has improved the time to publication but not for cancer drugs. The lengthier time for NICE guidance is partly due to measures to provide transparency and the widespread consultation during the NICE process.
Article summary
Article focus
Has the STA process resulted in speedier guidance for NICE?
What are the differences in recommendation and timelines between SMC and NICE?
Key messages
The STA system has resulted in speedier guidance for some drugs but not for cancer drugs.
SMC publishes speedier guidance than NICE.
SMC and NICE recommend a similar proportion of drugs.
Strength and limitations of this study
Although some differences by SMC and NICE are shown, it is not possible in this study to say which is correct.
Accuracy of outcome data taken from NICE website and SMC annual reports is unclear.
doi:10.1136/bmjopen-2011-000671
PMCID: PMC3269048  PMID: 22290398
9.  Insights into the Management of Emerging Infections: Regulating Variant Creutzfeldt-Jakob Disease Transfusion Risk in the UK and the US 
PLoS Medicine  2006;3(10):e342.
Background
Variant Creutzfeldt-Jakob disease (vCJD) is a human prion disease caused by infection with the agent of bovine spongiform encephalopathy. After the recognition of vCJD in the UK in 1996, many nations implemented policies intended to reduce the hypothetical risk of transfusion transmission of vCJD. This was despite the fact that no cases of transfusion transmission had yet been identified. In December 2003, however, the first case of vCJD in a recipient of blood from a vCJD-infected donor was announced. The aim of this study is to ascertain and compare the factors that influenced the motivation for and the design of regulations to prevent transfusion transmission of vCJD in the UK and US prior to the recognition of this case.
Methods and Findings
A document search was conducted to identify US and UK governmental policy statements and guidance, transcripts (or minutes when transcripts were not available) of scientific advisory committee meetings, research articles, and editorials published in medical and scientific journals on the topic of vCJD and blood transfusion transmission between March 1996 and December 2003. In addition, 40 interviews were conducted with individuals familiar with the decision-making process and/or the science involved. All documents and transcripts were coded and analyzed according to the methods and principles of grounded theory. Data showed that while resulting policies were based on the available science, social and historical factors played a major role in the motivation for and the design of regulations to protect against transfusion transmission of vCJD. First, recent experience with and collective guilt resulting from the transfusion-transmitted epidemics of HIV/AIDS in both countries served as a major, historically specific impetus for such policies. This history was brought to bear both by hemophilia activists and those charged with regulating blood products in the US and UK. Second, local specificities, such as the recall of blood products for possible vCJD contamination in the UK, contributed to a greater sense of urgency and a speedier implementation of regulations in that country. Third, while the results of scientific studies played a prominent role in the construction of regulations in both nations, this role was shaped by existing social and professional networks. In the UK, early focus on a European study implicating B-lymphocytes as the carrier of prion infectivity in blood led to the introduction of a policy that requires universal leukoreduction of blood components. In the US, early focus on an American study highlighting the ability of plasma to serve as a reservoir of prion infectivity led the FDA and its advisory panel to eschew similar measures.
Conclusions
The results of this study yield three important theoretical insights that pertain to the global management of emerging infectious diseases. First, because the perception and management of disease may be shaped by previous experience with disease, especially catastrophic experience, there is always the possibility for over-management of some possible routes of transmission and relative neglect of others. Second, local specificities within a given nation may influence the temporality of decision making, which in turn may influence the choice of disease management policies. Third, a preference for science-based risk management among nations will not necessarily lead to homogeneous policies. This is because the exposure to and interpretation of scientific results depends on the existing social and professional networks within a given nation. Together, these theoretical insights provide a framework for analyzing and anticipating potential conflicts in the international management of emerging infectious diseases. In addition, this study illustrates the utility of qualitative methods in investigating research questions that are difficult to assess through quantitative means.
A qualitative study of US and UK governmental policy statements on the topic of vCJD and blood transfusion transmission identified factors responsible for differences in the policies adopted.
Editors' Summary
Background.
In 1996 in the UK, a new type of human prion disease was seen for the first time. This is now known as variant Creutzfeldt-Jakob disease (vCJD). Prion diseases are rare brain diseases passed from individual to individual (or between animals) by a particular type of wrongly folded protein, and they are fatal. It was suspected that vCJD had passed to humans from cattle, and that the agent causing vCJD was the same as that causing bovine spongiform encephalopathy (or “mad cow disease”). Shortly after vCJD was recognized, authorities in many countries became concerned about the possibility that it could be transmitted from one person to another through contaminated blood supplies used for transfusion in hospitals. Even though there wasn't any evidence of actual transmission of the disease through blood before December 2003, authorities in the UK, US, and elsewhere set up regulations designed to reduce the chance of that happening. At this early stage in the epidemic, there was little in the way of scientific information about the transmission properties of the disease. Both the UK and US, however, sought to make decisions in a scientific manner. They made use of evidence as it was being produced, often before it had been published. Despite this, the UK and US decided on very different changes to their respective regulations on blood donation. Both countries chose to prevent certain people (who they thought would be at greater risk of having vCJD) from donating blood. In the UK, however, the decision was made to remove white blood cells from donated blood to reduce the risk of transmitting vCJD, while the US decided that such a step was not merited by the evidence.
Why Was This Study Done?
This researcher wanted to understand more clearly why the UK and US ended up with different policies: what role was played by science, and what role was played by non-scientific factors? She hoped that insights from this investigation would also be relevant to similar challenges in the future—for example, as many countries try to work out how to control the threat of avian flu.
What Did the Researcher Do and Find?
The researcher searched for all relevant official government documents from the US and UK, as well as scientific papers, published between the time vCJD was first identified (March 1996) and the first instance of vCJD carried through blood (December 2003). She also interviewed people who knew about vCJD management in the US and UK—for example, members of government agencies and the relevant advisory committees. From the documents and interviews, the researcher picked out and grouped shared ideas. Although these documents and interviews suggested that policy making was rooted in scientific evidence, many non-scientific factors were also important. The researcher found substantial uncertainty in the scientific evidence available at the time. The document search and interviews showed that policy makers felt guilty about a previous experience in which people had become infected with HIV/AIDS through contaminated blood and were concerned about repeating this experience. Finally, in the UK, the possibility of blood contamination was seen as a much more urgent problem than in the US, because BSE and vCJD were found there first and there were far more cases. This meant that when the UK made its decision about whether to remove white blood cells from donated blood, there was less scientific evidence available. In fact, the main study that was relied on at the time would later be questioned.
What Do These Findings Mean?
These findings show that for this particular case, science was not the only factor affecting government policies. Historical and social factors such as previous experience, sense of urgency, public pressure, and the relative importance of different scientific networks were also very important. The study predicts that in the future, infectious disease–related policy decisions are unlikely to be the same across different countries because the interpretation of scientific evidence depends, to a large extent, on social factors.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0030342.
National Creutzfeldt-Jakob Disease Surveillance Unit, Edinburgh, UK
US Centers for Disease Control and Prevention pages about prion diseases
World Health Organization variant Creutzfeldt-Jakob disease fact sheet
US National Institute of Neurological Disorders and Stroke information about prion diseases
doi:10.1371/journal.pmed.0030342
PMCID: PMC1621089  PMID: 17076547
10.  What's the evidence that NICE guidance has been implemented? Results from a national evaluation using time series analysis, audit of patients' notes, and interviews 
BMJ : British Medical Journal  2004;329(7473):999.
Objectives To assess the extent and pattern of implementation of guidance issued by the National Institute for Clinical Excellence (NICE).
Design Interrupted time series analysis, review of case notes, survey, and interviews.
Setting Acute and primary care trusts in England and Wales.
Participants All primary care prescribing, hospital pharmacies; a random sample of 20 acute trusts, 17 mental health trusts, and 21 primary care trusts; and senior clinicians and managers from five acute trusts.
Main outcome measures Rates of prescribing and use of procedures and medical devices relative to evidence based guidance.
Results 6308 usable patient audit forms were returned. Implementation of NICE guidance varied by trust and by topic. Prescribing of some taxanes for cancer (P < 0.002) and orlistat for obesity (P < 0.001) significantly increased in line with guidance. Prescribing of drugs for Alzheimer's disease and prophylactic extraction of wisdom teeth showed trends consistent with, but not obviously a consequence of, the guidance. Prescribing practice often did not accord with the details of the guidance. No change was apparent in the use of hearing aids, hip prostheses, implantable cardioverter defibrillators, laparoscopic hernia repair, and laparoscopic colorectal cancer surgery after NICE guidance had been issued.
Conclusions Implementation of NICE guidance has been variable. Guidance seems more likely to be adopted when there is strong professional support, a stable and convincing evidence base, and no increased or unfunded costs, in organisations that have established good systems for tracking guidance implementation and where the professionals involved are not isolated. Guidance needs to be clear and reflect the clinical context.
PMCID: PMC524545  PMID: 15514342
11.  Alcohol interventions, alcohol policy and intimate partner violence: a systematic review 
BMC Public Health  2014;14(1):881.
Background
Intimate partner violence (IPV) is a significant global public health issue. The consistent evidence that alcohol use by one or both partners contributes to the risk and severity of IPV suggests that interventions that reduce alcohol consumption may also reduce IPV. This study sought to review the evidence for effects on IPV of alcohol interventions at the population, community, relationship and individual levels using the World Health Organization ecological framework for violence.
Methods
Eleven databases including Medline, PsycINFO, CINAHL and EMBASE were searched for English-language studies and grey literature published 1 January 1992 – 1 March 2013 investigating whether alcohol interventions/policies were associated with IPV reduction within adult (≥18) intimate relationships. Eleven studies meeting design criteria for attributing effects to the intervention and ten studies showing mediation of alcohol consumption were included in the review. The heterogeneity of study designs precluded quantitative meta analysis; therefore, a critical narrative approach was used.
Results
Population-level pricing and taxation studies found weak or no evidence for alcohol price changes influencing IPV. Studies of community-level policies or interventions (e.g., hours of sale, alcohol outlet density) showed weak evidence of an association with IPV. Couples-based and individual alcohol treatment studies found a relationship between reductions in alcohol consumption and reductions in IPV but their designs precluded attributing changes to treatment. Randomized controlled trials of combined alcohol and violence treatment programs found some positive effects of brief alcohol intervention as an adjunct to batterer treatment for hazardous drinking IPV perpetrators, and of brief interventions with non-dependent younger populations, but effects were often not sustained.
Conclusions
Despite evidence associating problematic alcohol use with IPV, the potential for alcohol interventions to reduce IPV has not been adequately tested, possibly because studies have not focused on those most at risk of alcohol-related IPV. Research using rigorous designs should target young adult populations among whom IPV and drinking is highly prevalent. Combining alcohol and IPV intervention/policy approaches at the population, community, relationship and individual-level may provide the best opportunity for effective intervention.
Electronic supplementary material
The online version of this article (doi:10.1186/1471-2458-14-881) contains supplementary material, which is available to authorized users.
doi:10.1186/1471-2458-14-881
PMCID: PMC4159554  PMID: 25160510
12.  Impact of the National Institute for Health and Care Excellence (NICE) guidance on medical technology uptake: analysis of the uptake of spinal cord stimulation in England 2008–2012 
BMJ Open  2014;4(1):e004182.
Background
The National Institute for Health and Care Excellence (NICE) Technology Appraisal Guidance on spinal cord stimulation (SCS) was published in 2008 and updated in 2012 with no change. This guidance recommends SCS as a cost-effective treatment for patients with neuropathic pain.
Objective
To assess the impact of NICE guidance by comparing SCS uptake in England pre-NICE (2008–2009) and post-NICE (2009–2012) guidance. We also compared the English SCS uptake rate with that of Belgium, the Netherlands, France and Germany.
Design
SCS implant data for England was obtained from the Hospital Episode Statistics (HES) database and compared with other European countries where comparable data were available.
Results
The HES data showed small increases in SCS implantation and replacement/revision procedures, and a large increase in SCS trials between 2008 and 2012. The increase in the total number of SCS procedures per million of population in England is driven primarily by revision/replacements and increased trial activity. Marked variability in SCS uptake at both health regions and primary care trust level was observed.
Conclusions
Despite the positive NICE recommendation for the routine use of SCS, we found no evidence of a significant impact on SCS uptake in England. Rates of SCS implantation in England are lower than many other European countries.
doi:10.1136/bmjopen-2013-004182
PMCID: PMC3902463  PMID: 24398364
PAIN MANAGEMENT
13.  Intervention against Excessive Alcohol Consumption in Primary Health Care: A Survey of GPs' Attitudes and Practices in England 10 Years On 
Aims: To ascertain the views of general practitioners (GPs) regarding the prevention and management of alcohol-related problems in practice, together with perceived barriers and incentives for this work; to compare our findings with a comparable survey conducted 10 years earlier. Methods: In total, 282 (73%) of 419 GPs surveyed in East Midlands, UK, completed a postal questionnaire, measuring practices and attitudes, including the Shortened Alcohol and Alcohol Problems Perception Questionnaire (SAAPPQ). Results: GPs reported lower levels of post-graduate education or training on alcohol-related issues (<4 h for the majority) than in 1999 but not significantly so (P = 0.031). In the last year, GPs had most commonly requested more than 12 blood tests and managed 1–6 patients for alcohol. Reports of these preventive practices were significantly increased from 1999 (P < 0.001). Most felt that problem or dependent drinkers' alcohol issues could be legitimately (88%, 87%) and adequately (78%, 69%) addressed by GPs. However, they had low levels of motivation (42%, 35%), task-related self-esteem (53%, 49%) and job satisfaction (15%, 12%) for this. Busyness (63%) and lack of training (57%) or contractual incentives (48%) were key barriers. Endorsement for government policies on alcohol was very low. Conclusion: Among GPs, there still appears to be a gap between actual practice and potential for preventive work relating to alcohol problems; they report little specific training and a lack of support. Translational work on understanding the evidence-base supporting screening and brief intervention could incentivize intervention against excessive drinking and embedding it into everyday primary care practice.
doi:10.1093/alcalc/agr067
PMCID: PMC3156887  PMID: 21690169
14.  Toward a Global View of Alcohol, Tobacco, Cannabis, and Cocaine Use: Findings from the WHO World Mental Health Surveys 
PLoS Medicine  2008;5(7):e141.
Background
Alcohol, tobacco, and illegal drug use cause considerable morbidity and mortality, but good cross-national epidemiological data are limited. This paper describes such data from the first 17 countries participating in the World Health Organization's (WHO's) World Mental Health (WMH) Survey Initiative.
Methods and Findings
Household surveys with a combined sample size of 85,052 were carried out in the Americas (Colombia, Mexico, United States), Europe (Belgium, France, Germany, Italy, Netherlands, Spain, Ukraine), Middle East and Africa (Israel, Lebanon, Nigeria, South Africa), Asia (Japan, People's Republic of China), and Oceania (New Zealand). The WHO Composite International Diagnostic Interview (CIDI) was used to assess the prevalence and correlates of a wide variety of mental and substance disorders. This paper focuses on lifetime use and age of initiation of tobacco, alcohol, cannabis, and cocaine. Alcohol had been used by most in the Americas, Europe, Japan, and New Zealand, with smaller proportions in the Middle East, Africa, and China. Cannabis use in the US and New Zealand (both 42%) was far higher than in any other country. The US was also an outlier in cocaine use (16%). Males were more likely than females to have used drugs; and a sex–cohort interaction was observed, whereby not only were younger cohorts more likely to use all drugs, but the male–female gap was closing in more recent cohorts. The period of risk for drug initiation also appears to be lengthening longer into adulthood among more recent cohorts. Associations with sociodemographic variables were consistent across countries, as were the curves of incidence of lifetime use.
Conclusions
Globally, drug use is not distributed evenly and is not simply related to drug policy, since countries with stringent user-level illegal drug policies did not have lower levels of use than countries with liberal ones. Sex differences were consistently documented, but are decreasing in more recent cohorts, who also have higher levels of illegal drug use and extensions in the period of risk for initiation.
Louisa Degenhardt and colleagues report an international survey of 17 countries that finds clear differences in drug use across different regions of the world.
Editors' Summary
Background.
Understanding how much disability and death a particular disease causes (known as the “burden of disease”) is important. Knowing the burden of a disease in a country contributes to the development of healthier nations by directing strategies and policies against the disease. Researchers' understanding of the burden of diseases across different countries was piecemeal until the 1990 launch of a special World Health Organization (WHO) project, the Global Burden of Disease Project. In 2002, on the basis of updated information from this ongoing project, the WHO estimated that 91 million people were affected by alcohol use disorders and 15 million by drug use disorders.
Why Was This Study Done?
It is widely accepted that alcohol, tobacco, and illegal drug use are linked with a considerable amount of illness, disability, and death. However, there are few high-quality data quantifying the amount across different countries, especially in less-developed countries. The researchers therefore set out to collect basic patterns of alcohol, tobacco, cannabis, and cocaine use in different countries. They documented lifetime use of these substances in each county, focusing on young adults. They also wanted to examine the age of onset of use and whether the type of drugs used was affected by one's social and economic status.
What Did the Researchers Do and Find?
Data on drug use were available from 54,069 survey participants in 17 countries. The 17 countries were determined by the availability of collaborators and on funding for the survey. Trained lay interviewers carried out face-to-face interviews (except in France where the interviews were done over the telephone) using a standardized, structured diagnostic interview for psychiatric conditions. Participants were asked if they had ever used (a) alcohol, (b) tobacco (cigarettes, cigars or pipes), (c) cannabis (marijuana, hashish), or (d) cocaine. If they had used any of these drugs, they were asked about the age they started using each type of drug. The age of first tobacco smoking was not assessed in New Zealand, Japan, France, Germany, Belgium, The Netherlands, Italy, or Spain. The interviewers also recorded the participants' sex, age, years of education, marital status, employment, and household income.
The researchers found that in the Americas, Europe, Japan, and New Zealand, alcohol had been used by the vast majority of survey participants, compared to smaller proportions in the Middle East, Africa, and China. The global distribution of drug use is unevenly distributed with the US having the highest levels of both legal and illegal drug use among all countries surveyed. There are differences in both legal and illegal drug use among different socioeconomic groups. For example, males were more likely than females to have used all drug types; younger adults were more likely than older adults to have used all drugs examined; and higher income was related to drug use of all kinds. Marital status was found to be linked only to illegal drug use—the use of cocaine and cannabis is more likely in people who have never been married or were previously married. Drug use does not appear to be related to drug policy, as countries with more stringent policies (e.g., the US) did not have lower levels of illegal drug use than countries with more liberal policies (e.g., The Netherlands).
What Do These Findings Mean?
These findings present comprehensive and useful data on the patterns of drug use from national samples representing all regions of the world. The data will add to the understanding of the global burden of disease and should be useful to government and health organizations in developing policies to combat these problems. The study does have its limitations—for example, it surveyed only 17 of the world's countries, within these countries there were different rates of participation, and it is unclear whether people accurately report their drug use when interviewed. Nevertheless, the study did find clear differences in drug use across different regions of the world, with the US having among the highest levels of legal and illegal drug use of all the countries surveyed.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0050141.
Facts and figures on alcohol are available from the World Health Organization, including information about the burden of disease worldwide as a result of alcohol
Information on the management of substance abuse is available from WHO
Information on the Global Burden of Disease Project is also available from WHO
Researchers from the University of New South Wales, Australia and the University of Queensland co-chair, sponsors the Global Burden of Disease Mental Disorders and Illicit Drug Use Expert Group, which examines illicit drug use and disorders
The UN World Drug Report is available from the UN Office on Drugs and Crime
The University of New South Wales also runs the Secretariat for the Reference Group to the United Nations on HIV and Injecting Drug Use
doi:10.1371/journal.pmed.0050141
PMCID: PMC2443200  PMID: 18597549
15.  Factors Affecting the Delivery, Access, and Use of Interventions to Prevent Malaria in Pregnancy in Sub-Saharan Africa: A Systematic Review and Meta-Analysis 
PLoS Medicine  2013;10(7):e1001488.
Jenny Hill and colleagues conduct a systematic review and meta-analysis of qualitative, quantitative, and mixed methods studies to explore the factors that affect the delivery, access, and use of interventions to prevent malaria in pregnant women in sub-Saharan Africa.
Please see later in the article for the Editors' Summary
Background
Malaria in pregnancy has important consequences for mother and baby. Coverage with the World Health Organization–recommended prevention strategy for pregnant women in sub-Saharan Africa of intermittent preventive treatment in pregnancy (IPTp) and insecticide-treated nets (ITNs) is low. We conducted a systematic review to explore factors affecting delivery, access, and use of IPTp and ITNs among healthcare providers and women.
Methods and Results
We searched the Malaria in Pregnancy Library and Global Health Database from 1 January 1990 to 23 April 2013, without language restriction. Data extraction was performed by two investigators independently, and data was appraised for quality and content. Data on barriers and facilitators, and the effect of interventions, were explored using content analysis and narrative synthesis. We conducted a meta-analysis of determinants of IPTp and ITN uptake using random effects models, and performed subgroup analysis to evaluate consistency across interventions and study populations, countries, and enrolment sites. We did not perform a meta-ethnography of qualitative data.
Ninety-eight articles were included, of which 20 were intervention studies. Key barriers to the provision of IPTp and ITNs were unclear policy and guidance on IPTp; general healthcare system issues, such as stockouts and user fees; health facility issues stemming from poor organisation, leading to poor quality of care; poor healthcare provider performance, including confusion over the timing of each IPTp dose; and women's poor antenatal attendance, affecting IPTp uptake. Key determinants of IPTp coverage were education, knowledge about malaria/IPTp, socio-economic status, parity, and number and timing of antenatal clinic visits. Key determinants of ITN coverage were employment status, education, knowledge about malaria/ITNs, age, and marital status. Predictors showed regional variations.
Conclusions
Delivery of ITNs through antenatal clinics presents fewer problems than delivery of IPTp. Many obstacles to IPTp delivery are relatively simple barriers that could be resolved in the short term. Other barriers are more entrenched within the overall healthcare system or socio-economic/cultural contexts, and will require medium- to long-term strategies.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Half the world's population is at risk of malaria, a mosquito-borne parasite that kills a million people every year. Most of these deaths occur among young children in sub-Saharan Africa, but pregnant women and their unborn babies are also vulnerable to malaria. Infection with malaria during pregnancy can cause maternal death, severe maternal anemia, miscarriages, and pre-term and low-birth-weight babies. Malaria in pregnancy is responsible for about 100,000 babies and 10,000 women dying every year but is preventable by simple, inexpensive interventions that have been available for many years. The World Health Organization recommends a three-pronged approach to the prevention of malaria in pregnancy in areas with stable malaria transmission in Africa—delivery of the antimalarial drug sulfadoxine-pyrimethamine to pregnant women during antenatal clinic visits (intermittent preventative treatment in pregnancy; IPTp), the use of insecticide-treated bed nets (ITNs) to protect pregnant women from the bites of infected mosquitoes, and effective diagnosis and case management of pregnant women with malarial illness.
Why Was This Study Done?
Coverage with this prevention strategy is currently very low. Recent survey data from sub-Saharan African countries suggest that only about a quarter of pregnant women receive two doses of IPTp and only about a third use ITNs. To improve coverage, public health experts need to understand why coverage is so low, and they need to know the factors (determinants) that are associated with the uptake of IPTp and ITNs. In this systematic review and meta-analysis of qualitative, quantitative, and mixed methods studies, the researchers explore the factors that affect delivery, access, and use of IPTp and ITNs among pregnant women in sub-Saharan Africa. A systematic review uses predefined criteria to identify all the research on a given topic. Meta-analysis is a statistical method for combining the results of several studies. Qualitative studies collect non-quantitative data such as reasons for not accepting an intervention, whereas quantitative studies collect numerical data such as the proportion of a population accepting an intervention.
What Did the Researchers Do and Find?
The researchers' search of the Malaria in Pregnancy Library (a resource maintained by the Malaria in Pregnancy Consortium) and the Global Health Database identified 98 studies that provided data on barriers to and determinants of IPTp and ITN uptake and/or data on interventions designed to increase IPTp and ITN uptake. The researchers explored these data using content analysis (a research methodology that examines words and phrases within texts) and narrative synthesis (a method for summarizing results drawn from several qualitative studies). Key barriers to the provision and uptake of IPTp and ITNs included unclear policy and guidance on IPTp, general healthcare system issues such as drug shortages, healthcare facility issues such as unavailability of water for the provision of IPTp by directly observed therapy, poor healthcare provider performance such as confusion about the timing of IPTp doses, and the delayed antenatal care-seeking practices of pregnant women. The researchers' meta-analysis identified education, knowledge about malaria, socio-economic status, number and timing of antenatal clinic visits, and number of pregnancies as key determinants of IPTp uptake, and employment status, education, knowledge, age, and marital status as key determinants of coverage of ITN use. So, for example, highly educated women were more likely to receive IPTp or ITNs than poorly educated women.
What Do These Findings Mean?
These findings identify key interacting barriers to access, delivery, and use of IPTp and ITNs in sub-Saharan Africa and show that these barriers are relatively consistent across countries. Moreover, they suggest that there are fewer barriers to the delivery of ITNs through antenatal clinics than to the delivery of IPTp. Importantly, some of the barriers to IPTp uptake can be resolved in the short term (for example, simplification of country policies and guidance on IPTp might increase its uptake), but barriers to uptake that are entrenched within the overall healthcare system will only be resolved with medium- to long-term strategies that aim to improve the quality of antenatal services and to encourage antenatal clinic use among women. Overall, this analysis provides a checklist of factors that policy-makers involved in national malaria programs may be able to use to help them decide which interventions to prioritize. However, the researchers warn, multi-country studies are nevertheless urgently needed to evaluate targeted or multifaceted interventions designed to increase delivery and uptake of IPTp and ITNs, to reduce the adverse consequences of malaria in pregnancy.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001488.
Information is available from the World Health Organization on malaria (in several languages) and on IPTp; the World Malaria Report 2012 provides details of the current global malaria situation
The US Centers for Disease Control and Prevention also provides information on malaria and on IPTp; a personal story about malaria in pregnancy is available
Information is available from the Roll Back Malaria Partnership on all aspects of global malaria control, including information on malaria in pregnancy
The Malaria in Pregnancy Consortium is undertaking research into the prevention and treatment of malaria in pregnancy
MedlinePlus provides links to additional information on malaria (in English and Spanish)
doi:10.1371/journal.pmed.1001488
PMCID: PMC3720261  PMID: 23935459
16.  The Demise of Oregon’s Medically Needy Program: Effects of Losing Prescription Drug Coverage 
BACKGROUND
In January 2003, people covered by Oregon’s Medically Needy program lost benefits owing to state budget shortfalls. The Medically Needy program is a federally matched optional Medicaid program. In Oregon, this program mainly provided prescription drug benefits.
OBJECTIVE
To describe the Medically Needy population and determine how benefit loss affected this population’s health and prescription use.
DESIGN
A 49-question telephone survey instrument created by the research team and administered by a research contractor.
PARTICIPANTS
A random sample of 1,269 eligible enrollees in Oregon’s Medically Needy Program. Response rate was 35% with 439 individuals, ages 21–91 and 64% women, completing the survey.
MEASUREMENTS
Demographics, health information, and medicatication use at the time of the survey obtained from the interview. Medication use during the program obtained from administrative data.
RESULTS
In the 6 months after the Medically Needy program ended, 75% had skipped or stopped medications. Sixty percent of the respondents had cut back on their food budget, 47% had borrowed money, and 49% had skipped paying other bills to pay for medications. By self-report, there was no significant difference in emergency department visits, but a significant decrease in hospitalizations comparing 6 months before and after losing the program. Two-thirds of respondents rated their current health as poor or fair.
CONCLUSIONS
The Medically Needy program provided coverage for a low-income, chronically ill population. Since its termination, enrollees have decreased prescription drug use and increased financial burden. As states make program changes and Medicare Part D evolves, effects on vulnerable populations must be considered.
doi:10.1007/s11606-007-0178-4
PMCID: PMC2219861  PMID: 17380369
prescription drugs; vulnerable populations; survey research
17.  Managing wildlife populations with uncertainty: cormorants Phalacrocorax carbo 
The Journal of Applied Ecology  2008;45(6):1675-1682.
Managing wildlife populations for conservation, control or harvesting involves uncertainty. Nevertheless, decisions need to be made based on the available evidence. The two main sources of uncertainty in population modelling are parameter estimates and structural uncertainty. Structural uncertainty in models is not included as often as parameter uncertainty.We present an approach where parameter and structural uncertainty (strength of density dependence) is included within a model, using the over-wintering English population of cormorants Phalacrocorax carbo L. Because of the damage caused to inland fishery interests by cormorants, there was a change in UK government policy in autumn 2004, increasing the numbers of birds that can be shot under licence.A stochastic Monte Carlo annual population model was produced to examine the effect of changes to the numbers of birds shot each year. Indices of annual population size were converted to population estimates and used to determine annual growth rates and strength of density dependence.There is strong evidence for density dependence in the data, which suggests the population is currently slightly above carrying capacity, with a mean growth rate of 4–6% per annum. The 1300 birds shot under licence in 2004/05 represent about 4·5% of the English population, and if this level of culling continues, the population would be expected to decline by 9% by 2007, compared to the long-term average. The a priori preferred model, which included all uncertainty, gave predictions for 2004/05 and 2005/06 in close agreement with field data.The model was used to produce short-term population projections, with the understanding that Adaptive Resource Management (ARM) will be adopted to iteratively update the parameters and model each year, feeding back into the numbers of available licences.Synthesis and applications. We recommend the approach used in this study of including parameter and structural uncertainty within a single model, where possible, with the proportion of iterations that utilize a particular structure dependent on the weight of evidence for that structure. This will produce results with wider confidence intervals, but ensures that the evidence for any particular model is not over-interpreted.
doi:10.1111/j.1365-2664.2008.01380.x
PMCID: PMC2695860  PMID: 19536342
density dependence; model structure; Monte Carlo model; population; population growth; population model; population index
18.  Adult Mortality Attributable to Preventable Risk Factors for Non-Communicable Diseases and Injuries in Japan: A Comparative Risk Assessment 
PLoS Medicine  2012;9(1):e1001160.
Using a combination of published data and modeling, Nayu Ikeda and colleagues identify tobacco smoking and high blood pressure as major risk factors for death from noncommunicable diseases among adults in Japan.
Background
The population of Japan has achieved the longest life expectancy in the world. To further improve population health, consistent and comparative evidence on mortality attributable to preventable risk factors is necessary for setting priorities for health policies and programs. Although several past studies have quantified the impact of individual risk factors in Japan, to our knowledge no study has assessed and compared the effects of multiple modifiable risk factors for non-communicable diseases and injuries using a standard framework. We estimated the effects of 16 risk factors on cause-specific deaths and life expectancy in Japan.
Methods and Findings
We obtained data on risk factor exposures from the National Health and Nutrition Survey and epidemiological studies, data on the number of cause-specific deaths from vital records adjusted for ill-defined codes, and data on relative risks from epidemiological studies and meta-analyses. We applied a comparative risk assessment framework to estimate effects of excess risks on deaths and life expectancy at age 40 y. In 2007, tobacco smoking and high blood pressure accounted for 129,000 deaths (95% CI: 115,000–154,000) and 104,000 deaths (95% CI: 86,000–119,000), respectively, followed by physical inactivity (52,000 deaths, 95% CI: 47,000–58,000), high blood glucose (34,000 deaths, 95% CI: 26,000–43,000), high dietary salt intake (34,000 deaths, 95% CI: 27,000–39,000), and alcohol use (31,000 deaths, 95% CI: 28,000–35,000). In recent decades, cancer mortality attributable to tobacco smoking has increased in the elderly, while stroke mortality attributable to high blood pressure has declined. Life expectancy at age 40 y in 2007 would have been extended by 1.4 y for both sexes (men, 95% CI: 1.3–1.6; women, 95% CI: 1.2–1.7) if exposures to multiple cardiovascular risk factors had been reduced to their optimal levels as determined by a theoretical-minimum-risk exposure distribution.
Conclusions
Tobacco smoking and high blood pressure are the two major risk factors for adult mortality from non-communicable diseases and injuries in Japan. There is a large potential population health gain if multiple risk factors are jointly controlled.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Worldwide, a small number of modifiable risk factors are responsible for many premature or preventable deaths. For example, having high blood pressure (hypertension) increases a person's risk of developing life-threatening heart problems and stroke (cardiovascular disease). Similarly, having a high blood sugar level increases the risk of developing diabetes, a chronic (long-term) disease that can lead to cardiovascular problems and kidney failure, and half of all long-term tobacco smokers in Western populations will die prematurely from diseases related to smoking, such as lung cancer. Importantly, the five major risk factors for death globally—high blood pressure, tobacco use, high blood sugar, physical inactivity, and overweight and obesity—are all modifiable. That is, lifestyle changes and dietary changes such as exercising more, reducing salt intake, and increasing fruit and vegetable intake can reduce an individual's exposure to these risk factors and one's chances of premature death. Moreover, public health programs designed to reduce a population's exposure to modifiable risk factors should reduce preventable deaths in that population.
Why Was This Study Done?
In 2000, the Japanese government initiated Health Japan 21, a ten-year national health promotion campaign designed to prevent premature death from non-communicable (noninfectious) diseases and injuries. This campaign set 59 goals to monitor and improve risk factor management in the Japanese population, which has one of the longest life expectancies at birth in the world (the life expectancy of a person born in Japan in 2009 was 83.1 years). Because the campaign's final evaluation revealed deterioration or no improvement on some of these goals, the Japanese government recently released new guidelines that stress the importance of simultaneously controlling multiple risk factors for chronic diseases. However, although several studies have quantified the impacts on life expectancy and cause-specific death of individual modifiable risk factors in Japan, the effects of multiple risk factors have not been assessed. In this study, the researchers use a “comparative risk assessment” framework to estimate the effects of 16 risk factors on cause-specific deaths and life expectancy in Japan. Comparative risk assessment estimates the number of deaths that would be prevented if current distributions of risk factor exposures were changed to hypothetical optimal distributions.
What Did the Researchers Do and Find?
The researchers obtained data on exposure to the selected risk factors from the 2007 Japanese National Health and Nutrition Survey and from epidemiological studies, and information on the number of deaths in 2007 from different diseases from official records. They used published studies to estimate how much each factor increases the risk of death from each disease and then used a mathematical formula to estimate the effects of the risk factors on the number of deaths in Japan and on life expectancy at age 40. In 2007, tobacco smoking and high blood pressure accounted for 129,000 and 104,000 deaths, respectively, in Japan. Physical inactivity accounted for 52,000 deaths, high blood glucose and high dietary salt intake accounted for 34,000 deaths each, and alcohol use for 31,000 deaths. Life expectancy at age 40 in 2007 would have been extended by 1.4 years for both sexes, the researchers estimate, if exposure to multiple cardiovascular risk factors had been reduced to calculated optimal distributions, or by 0.7 years if these risk factors had been reduced to the distributions defined by national guidelines and goals.
What Do These Findings Mean?
These findings identify tobacco smoking and high blood pressure as the major risk factors for death from non-communicable diseases among adults in Japan, a result consistent with previous findings from the US. They also indicate that simultaneous control of multiple risk factors has great potential for producing health gains among the Japanese population. Although the researchers focused on estimating the effect of these risk factors on mortality and did not include illness and disability in this study, these findings nevertheless identify two areas of public health policy that need to be strengthened to improve health, reduce death rates, and increase life expectancy among the Japanese population. First, they highlight the need to reduce tobacco smoking, particularly among men. Second and most importantly, these findings emphasize the need to improve ongoing programs designed to help people manage multiple cardiovascular risk factors, including high blood pressure.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001160.
The US Centers for Disease Control and Prevention provides information on all aspects of healthy living
The World Health Report 2002—Reducing Risks, Promoting Healthy Life provides a global analysis of how healthy life expectancy could be increased
The American Heart Association and the American Cancer Society provide information on many important risk factors for noncommunicable diseases and include some personal stories about keeping healthy
Details about Health Japan 21 are provided by the Japanese Ministry of Health, Labour and Welfare. Further details about this campaign are available from the World Health Organization
MedlinePlus provides links to further resources on healthy living and on healthy aging (in English and Spanish)
doi:10.1371/journal.pmed.1001160
PMCID: PMC3265534  PMID: 22291576
19.  Alcohol Intake and Blood Pressure: A Systematic Review Implementing a Mendelian Randomization Approach 
PLoS Medicine  2008;5(3):e52.
Background
Alcohol has been reported to be a common and modifiable risk factor for hypertension. However, observational studies are subject to confounding by other behavioural and sociodemographic factors, while clinical trials are difficult to implement and have limited follow-up time. Mendelian randomization can provide robust evidence on the nature of this association by use of a common polymorphism in aldehyde dehydrogenase 2 (ALDH2) as a surrogate for measuring alcohol consumption. ALDH2 encodes a major enzyme involved in alcohol metabolism. Individuals homozygous for the null variant (*2*2) experience adverse symptoms when drinking alcohol and consequently drink considerably less alcohol than wild-type homozygotes (*1*1) or heterozygotes. We hypothesise that this polymorphism may influence the risk of hypertension by affecting alcohol drinking behaviour.
Methods and Findings
We carried out fixed effect meta-analyses of the ALDH2 genotype with blood pressure (five studies, n = 7,658) and hypertension (three studies, n = 4,219) using studies identified via systematic review. In males, we obtained an overall odds ratio of 2.42 (95% confidence interval [CI] 1.66–3.55, p = 4.8 × 10−6) for hypertension comparing *1*1 with *2*2 homozygotes and an odds ratio of 1.72 (95% CI 1.17–2.52, p = 0.006) comparing heterozygotes (surrogate for moderate drinkers) with *2*2 homozygotes. Systolic blood pressure was 7.44 mmHg (95% CI 5.39–9.49, p = 1.1 × 10−12) greater among *1*1 than among *2*2 homozygotes, and 4.24 mmHg (95% CI 2.18–6.31, p = 0.00005) greater among heterozygotes than among *2*2 homozygotes.
Conclusions
These findings support the hypothesis that alcohol intake has a marked effect on blood pressure and the risk of hypertension.
Using a mendelian randomization approach Sarah Lewis and colleagues find strong support for the hypothesis that alcohol intake has a marked effect on blood pressure and the risk of hypertension.
Editors' Summary
Background.
High blood pressure (hypertension) is a common medical condition that affects nearly a third of US and UK adults. Hypertension has no symptoms but can lead to heart attacks or strokes. It is diagnosed by measuring blood pressure—the force that blood moving around the body exerts on the inside of large blood vessels. Blood pressure is highest when the heart is pumping out blood (systolic pressure) and lowest when it is filling up with blood (diastolic pressure). Normal blood pressure is defined as a systolic pressure of less than 130 millimeters of mercury (mmHg) and a diastolic pressure of less than 85 mmHg (a blood pressure of 130/85). A reading of more than 140/90 indicates hypertension. Many factors affect blood pressure, but overweight people and individuals who eat too much salty or fatty foods are at high risk of developing hypertension. Mild hypertension can often be corrected by lifestyle changes, but many people also take antihypertensive drugs to reduce their blood pressure.
Why Was This Study Done?
Another modifiable lifestyle factor thought to affect blood pressure is alcohol intake. Observational studies that ask people about their drinking habits and measure their blood pressure suggest that alcohol intake correlates with blood pressure, but they cannot prove a causal link because of “confounding”—other risk factors associated with alcohol drinking, such as diet, might also affect the study participant's blood pressures. A trial that randomly assigns people to different alcohol intakes could provide this proof of causality, but such a trial is impractical. In this study, therefore, the researchers have used “Mendelian randomization” to investigate whether alcohol intake affects blood pressure. An inactive variant of aldehyde dehydrogenase 2 (ALDH2; the enzyme that removes alcohol from the body) has been identified. People who inherit the variant form of this gene from both parents have an ALDH2 *2*2 genotype (genetic makeup) and become flushed and nauseated after drinking. Consequently, they drink less than people with a *1*2 genotype and much less than those with a *1*1 genotype. Because inheritance of these genetic variants does not affect lifestyle factors other than alcohol intake, an association between ALDH2 genotypes and blood pressure would indicate that alcohol intake has an effect on blood pressure without any confounding.
What Did the Researchers Do and Find?
The researchers identified ten published studies (mainly done in Japan where the ALDH2 gene variant is common) on associations between ALDH2 genotype and blood pressure or hypertension using a detailed search protocol (a “systematic review”). A meta-analysis (a statistical method for combining the results of independent studies) of the studies that had investigated the association between ALDH2 genotype and hypertension showed that men with the *1*1 genotype (highest alcohol intake) and those with the *1*2 genotype (intermediate alcohol intake) were 2.42 and 1.72 times more likely, respectively, to have hypertension than those with the *2*2 genotype (lowest alcohol intake). There was no association between ALDH2 genotype and hypertension among the women in these studies because they drank very little. Systolic and diastolic blood pressures showed a similar relationship to ALDH2 genotype in a second meta-analysis of relevant studies. Finally, the researchers estimated that for men the lifetime effect of drinking 1 g of alcohol a day (one unit of alcohol contains 8 g of alcohol in the UK and 14 g in the US; recommended daily limits in these countries are 3–4 and 1–2 units, respectively) would be an increase in systolic blood pressure of 0.24 mmHg.
What Do These Findings Mean?
These findings support the suggestion that alcohol has a marked effect on blood pressure and hypertension. Consequently, some cases of hypertension could be prevented by encouraging people to reduce their daily alcohol intake. Although the Mendelian randomization approach avoids most of the confounding intrinsic to observational studies, it is possible that a gene near ALDH2 that has no effect on alcohol intake affects blood pressure, since genes are often inherited in blocks. Alternatively, ALDH2 could affect blood pressure independent of alcohol intake. The possibility that ALDH2 could effect blood pressure independently of alcohol is intake made unlikely by the fact that no effect of genotype on blood pressure is seen among women who drink very little. Additional large-scale studies are needed to address these possibilities, to confirm the current finding in more people, and to improve the estimates of the effect that alcohol intake has on blood pressure.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0050052.
The MedlinePlus encyclopedia has a page on hypertension (in English and Spanish)
The American Heart Association provides information for patients and health professionals about hypertension
The UK Blood Pressure Association provides information for patients and health professionals on all aspects of hypertension, including information about alcohol affects blood pressure
The Explore@Bristol science center (a UK charity) provides an alcohol unit calculator and information on the effects of alcohol
The International Center for Alcohol Policies provides drinking guidelines for countries around the world
doi:10.1371/journal.pmed.0050052
PMCID: PMC2265305  PMID: 18318597
20.  Patient outcomes and experiences of an acupuncture and self-care service for persistent low back pain in the NHS: a mixed methods approach 
Background
Supported self-management, acupuncture and information can help reduce the symptoms of low back pain. These approaches are currently recommended by NICE guidance as treatment options for patients with persistent low back pain. However, there has been no previous evaluation of a service providing them together for this common problem. The purpose of this service evaluation was to report patient outcomes and experiences of the Beating Back Pain Service (BBPS), a pilot service based in a primary and community care setting, delivering acupuncture, self-management and information to patients with chronic low back pain.
Methods
Patients completed a questionnaire at three time points: pre-BBPS, immediately post-BBPS and three months post-BBPS. Outcome measures included the Bournemouth Questionnaire (measuring musculoskeletal, MSK, problems), EuroQoL-5D (measuring quality of life), Pain and Self-efficacy Questionnaire, and additional questions on medication use, physical activity, understanding of pain and positive well-being. Additionally, the STarT Back (measuring risk of developing chronic pain) was collected at BBPS information sessions. Non-parametric tests were used to evaluate pre- and post- variables. Questionnaires also collected qualitative data (open-text responses) regarding patient views and experiences of the BBPS, which were analysed using thematic analysis.
Results
80 (out of 108) patients who attended the initial BBPS information session agreed to participate in the service evaluation (mean age 47 years, 65% female). 65 patients attended subsequent BBPS acupuncture and/or self-management sessions and were asked to complete post-treatment questionnaires; complete datasets were available for 61 patients.
There were statistically significant improvements over time for pain (p <0.0001), quality of life (p = 0.006), understanding of pain (p <0.001), physical activity (p = 0.047) and relaxation (p = 0.012). Post-hoc analysis revealed that scores improved between baseline and post-treatment, these improvements were maintained at 3-month follow-up (except relaxation). Patients receiving a combination of acupuncture and self-management sessions produced the most positive results. Patient satisfaction with the BBPS was high.
Conclusions
The BBPS provided a MSK pain management service that many patients found effective and valuable. Combining self-management with acupuncture was found to be particularly effective, although further consideration is required regarding how best to engage patients in self-management.
doi:10.1186/1472-6882-13-300
PMCID: PMC3827006  PMID: 24180515
Beating back pain; Self-management; Acupuncture; Information; Evaluation
21.  Health on the web: randomised trial of work-based online screening and brief intervention for hazardous and harmful drinking 
BMC Public Health  2013;13:505.
Background
Alcohol misuse is a significant international public health problem. Screening and brief intervention (SBI) in primary care reduces alcohol consumption by about 15 – 30%, sustained over 12 months in hazardous or harmful drinkers but implementation has proved difficult leading to growing interest in exploring the effectiveness of SBI in other settings, including the workplace. Computerised interventions for alcohol misuse can be as effective as traditional face-to-face interventions and may have advantages, including anonymity, convenience and availability.
Methods/design
Individually randomised controlled trial to determine the effectiveness and cost-effectiveness of offering online screening and brief intervention for alcohol misuse in a workplace. Participants: adults (aged 18 or over) employed by participating employers scoring 5 or more on a three item screen for alcohol misuse (the AUDIT-C) indicating possible hazardous or harmful alcohol consumption, recruited through the offer of an online health check providing screening for a range of health behaviours with personalised feedback. Participants who accept the health check and score 5 or more on the alcohol screen will be randomised to receiving immediate feedback on their alcohol consumption and access to an online intervention offering support in reducing alcohol consumption (Down Your Drink) or delayed feedback and access to Down Your Drink after completion of follow-up data at three months. All employees who take the online health check will receive personalised feedback on other screened health behaviours including diet, physical activity, smoking, and body mass index. The primary outcome is alcohol consumption in the past week at three months; secondary outcomes are the AUDIT, EQ-5D, days off work, number and duration of hospital admissions, costs and use of the intervention. A sample size of 1,472 participants (736 in each arm) provides 90% power with 5% significance to determine a 20% reduction in alcohol consumption. Outcomes between groups at three months will be compared following the intention to treat principle and economic analyses will follow NICE guidance.
Discussion
This innovative design avoids recruitment bias by not mentioning alcohol in the invitation and avoids reactivity of assessment by not collecting baseline data on alcohol consumption.
doi:10.1186/1471-2458-13-505
PMCID: PMC3671166  PMID: 23706155
Alcohol-related disorders; Alcohol; Screening and brief intervention; Internet; Randomised; Controlled trial; Workplace; Health promotion
22.  Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration 
PLoS Medicine  2008;5(2):e45.
Background
Meta-analyses of antidepressant medications have reported only modest benefits over placebo treatment, and when unpublished trial data are included, the benefit falls below accepted criteria for clinical significance. Yet, the efficacy of the antidepressants may also depend on the severity of initial depression scores. The purpose of this analysis is to establish the relation of baseline severity and antidepressant efficacy using a relevant dataset of published and unpublished clinical trials.
Methods and Findings
We obtained data on all clinical trials submitted to the US Food and Drug Administration (FDA) for the licensing of the four new-generation antidepressants for which full datasets were available. We then used meta-analytic techniques to assess linear and quadratic effects of initial severity on improvement scores for drug and placebo groups and on drug–placebo difference scores. Drug–placebo differences increased as a function of initial severity, rising from virtually no difference at moderate levels of initial depression to a relatively small difference for patients with very severe depression, reaching conventional criteria for clinical significance only for patients at the upper end of the very severely depressed category. Meta-regression analyses indicated that the relation of baseline severity and improvement was curvilinear in drug groups and showed a strong, negative linear component in placebo groups.
Conclusions
Drug–placebo differences in antidepressant efficacy increase as a function of baseline severity, but are relatively small even for severely depressed patients. The relationship between initial severity and antidepressant efficacy is attributable to decreased responsiveness to placebo among very severely depressed patients, rather than to increased responsiveness to medication.
Kirsch and colleagues show that, in antidepressant trials, there is a greater difference in efficacy between drug and placebo amongst more severely depressed patients. However, this difference seems to result from a poorer response to placebo amongst more depressed patients.
Editors' Summary
Background.
Everyone feels miserable occasionally. But for some people—those with depression—these sad feelings last for months or years and interfere with daily life. Depression is a serious medical illness caused by imbalances in the brain chemicals that regulate mood. It affects one in six people at some time during their life, making them feel hopeless, worthless, unmotivated, even suicidal. Doctors measure the severity of depression using the “Hamilton Rating Scale of Depression” (HRSD), a 17–21 item questionnaire. The answers to each question are given a score and a total score for the questionnaire of more than 18 indicates severe depression. Mild depression is often treated with psychotherapy or talk therapy (for example, cognitive–behavioral therapy helps people to change negative ways of thinking and behaving). For more severe depression, current treatment is usually a combination of psychotherapy and an antidepressant drug, which is hypothesized to normalize the brain chemicals that affect mood. Antidepressants include “tricyclics,” “monoamine oxidases,” and “selective serotonin reuptake inhibitors” (SSRIs). SSRIs are the newest antidepressants and include fluoxetine, venlafaxine, nefazodone, and paroxetine.
Why Was This Study Done?
Although the US Food and Drug Administration (FDA), the UK National Institute for Health and Clinical Excellence (NICE), and other licensing authorities have approved SSRIs for the treatment of depression, some doubts remain about their clinical efficacy. Before an antidepressant is approved for use in patients, it must undergo clinical trials that compare its ability to improve the HRSD scores of patients with that of a placebo, a dummy tablet that contains no drug. Each individual trial provides some information about the new drug's effectiveness but additional information can be gained by combining the results of all the trials in a “meta-analysis,” a statistical method for combining the results of many studies. A previously published meta-analysis of the published and unpublished trials on SSRIs submitted to the FDA during licensing has indicated that these drugs have only a marginal clinical benefit. On average, the SSRIs improved the HRSD score of patients by 1.8 points more than the placebo, whereas NICE has defined a significant clinical benefit for antidepressants as a drug–placebo difference in the improvement of the HRSD score of 3 points. However, average improvement scores may obscure beneficial effects between different groups of patient, so in the meta-analysis in this paper, the researchers investigated whether the baseline severity of depression affects antidepressant efficacy.
What Did the Researchers Do and Find?
The researchers obtained data on all the clinical trials submitted to the FDA for the licensing of fluoxetine, venlafaxine, nefazodone, and paroxetine. They then used meta-analytic techniques to investigate whether the initial severity of depression affected the HRSD improvement scores for the drug and placebo groups in these trials. They confirmed first that the overall effect of these new generation of antidepressants was below the recommended criteria for clinical significance. Then they showed that there was virtually no difference in the improvement scores for drug and placebo in patients with moderate depression and only a small and clinically insignificant difference among patients with very severe depression. The difference in improvement between the antidepressant and placebo reached clinical significance, however, in patients with initial HRSD scores of more than 28—that is, in the most severely depressed patients. Additional analyses indicated that the apparent clinical effectiveness of the antidepressants among these most severely depressed patients reflected a decreased responsiveness to placebo rather than an increased responsiveness to antidepressants.
What Do These Findings Mean?
These findings suggest that, compared with placebo, the new-generation antidepressants do not produce clinically significant improvements in depression in patients who initially have moderate or even very severe depression, but show significant effects only in the most severely depressed patients. The findings also show that the effect for these patients seems to be due to decreased responsiveness to placebo, rather than increased responsiveness to medication. Given these results, the researchers conclude that there is little reason to prescribe new-generation antidepressant medications to any but the most severely depressed patients unless alternative treatments have been ineffective. In addition, the finding that extremely depressed patients are less responsive to placebo than less severely depressed patients but have similar responses to antidepressants is a potentially important insight into how patients with depression respond to antidepressants and placebos that should be investigated further.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0050045.
The MedlinePlus encyclopedia contains a page on depression (in English and Spanish)
Detailed information for patients and caregivers is available on all aspects of depression (including symptoms and treatment) from the US National Institute of Medical Health and from the UK National Health Service Direct Health Encyclopedia
MedlinePlus provides a list of links to further information on depression
Clinical Guidance for professionals, patients, caregivers and the public is provided by the UK National Institute for Health and Clinical Excellence
doi:10.1371/journal.pmed.0050045
PMCID: PMC2253608  PMID: 18303940
23.  Evaluation of coagulation parameters and liver enzymes among alcohol drinkers in Port Harcourt, Nigeria 
Alcohol is a major contributor to the global burden of disease, disability, and death in high, middle, and low-income countries. Harmful use of alcohol is one of the main factors contributing to premature deaths and avoidable disease burden worldwide and has a major impact on public health. The aim of this present cross-sectional study was to investigate the effect of alcohol consumption on coagulation parameters and liver enzymes of subjects in Port Harcourt, Nigeria. Two hundred adults consisting of 120 alcohol dependent subjects and 80 age, gender-matched nondrinkers aged 25–65 years (mean age 45.25 ± 11.50 years) were enrolled in this study. Of the 120 chronic alcohol drinkers, 37 were dependent on local dry gin, while 83 were dependent on other alcoholic beverages. The mean values of the liver enzymes, aspartate aminotransferase and gamma glutamyl transferase, were significantly higher (P = 0.002 and P = 0.02 respectively) among the chronic alcohol consumers compared with their nondrinker counterparts. Although the value of alanine aminotransferase was higher in the chronic drinkers, it did not reveal any significant difference (P = 0.11). The coagulation parameters, prothrombin time and activated partial thromboplastin time were investigated among chronic drinkers and nondrinkers. The mean value of prothrombin time and activated partial thromboplastin time was significantly higher in the chronic alcohol drinkers compared to the nondrinkers (P = 0.04 and P = 0.02 respectively). We observed a positive and significant correlation between values of liver enzymes, serum gamma glutamyl transferase and aspartate aminotransferase, and values of prothrombin time among alcohol consumers (r = 0.72 and r = 0.68 respectively). The implementation of policies to target harm reduction strategies among alcoholics is urgently needed, alongside the building of a strong base of public awareness and community support required for the continuity and sustainability of alcohol policies. There is also the need for the Nigerian government to enforce tighter regulations and restrictions on the production and distribution of alcoholic beverages to reduce harmful use, and protect young people and other vulnerable groups.
doi:10.2147/IJGM.S43472
PMCID: PMC3685397  PMID: 23807858
coagulation parameters; liver enzymes; chronic alcoholics; Port Harcourt; Nigeria
24.  Pipeline™ Embolization Device for the Treatment of Complex Intracranial Aneurysms 
As part of its Medical Technologies Evaluation Programme, the National Institute of Health and Clinical Excellence (NICE) invited the manufacturer, Covidien, to provide clinical and economic evidence for the evaluation of the Pipeline™ embolization device (PED) for the treatment of complex intracranial aneurysms. Cedar; a consortium between Cardiff and Vale University Health Board and Cardiff University, was commissioned to act as an External Assessment Centre (EAC) for NICE to independently critique the manufacturers’ submissions. This article gives an overview of the evidence provided, the findings of the EAC and the final guidance published by NICE.
The scope issued by NICE considered PED as the intervention in a patient population with complex unruptured intracranial aneurysms (IAs), specifically large/giant, wide-necked and fusiform aneurysms. The comparator treatments identified were stent-assisted coiling, parent vessel occlusion, neurosurgical techniques and conservative management. The manufacturer claimed that PED fulfils a currently unmet clinical need in the treatment of large or giant, wide-necked or fusiform IAs.
Thirteen studies were identified by the manufacturer as being relevant to the decision problem, with two of these included for data extraction. The EAC identified 16 studies as relevant, three of which had been published after the manufacturer’s search. Data extraction was carried out on these studies as, although many were low level research comprising of case reports and case series, they provided useful, pertinent safety and outcome data.
No relevant economic studies of the device were identified; therefore, a new economic model was designed by the manufacturer. The base-case scenario provided recognized the costs of PED to be higher than the costs for endovascular parent vessel occlusion, neurosurgical parent vessel occlusion, neurosurgical clipping and conservative management. However, PED was found to be cost saving compared with stent-assisted coiling, with a saving of £13,110 per patient.
Analysis of the clinical data suggested that treatment with PED has high rates of clinical success with high rates of aneurysm occlusion and acceptable adverse events for the patient population. Economic evidence suggested that the costs in the base-case for PED may have been underestimated, meaning that PED would only become cost saving in patients who would otherwise require treatment with 32 coils or more. NICE Medical Technologies Guidance MTG10, issued in May 2012, recommends the adoption of PED in selected patients within the UK National Health Service (NHS).
doi:10.1007/s40258-012-0005-x
PMCID: PMC3563954  PMID: 23341264
25.  Adult Consequences of Late Adolescent Alcohol Consumption: A Systematic Review of Cohort Studies 
PLoS Medicine  2011;8(2):e1000413.
In a systematic review of cohort studies of adolescent drinking and later outcomes, Jim McCambridge and colleagues show that although studies suggest links to worse adult physical and mental health and social consequences, existing evidence is of poor quality.
Background
Although important to public policy, there have been no rigorous evidence syntheses of the long-term consequences of late adolescent drinking.
Methods and Findings
This systematic review summarises evidence from general population cohort studies of drinking between 15–19 years old and any subsequent outcomes aged 20 or greater, with at least 3 years of follow-up study. Fifty-four studies were included, of which 35 were assessed to be vulnerable to bias and/or confounding. The principal findings are: (1) There is consistent evidence that higher alcohol consumption in late adolescence continues into adulthood and is also associated with alcohol problems including dependence; (2) Although a number of studies suggest links to adult physical and mental health and social consequences, existing evidence is of insufficient quality to warrant causal inferences at this stage.
Conclusions
There is an urgent need for high quality long-term prospective cohort studies in order to better understand the public health burden that is consequent on late adolescent drinking, both in relation to adult drinking and more broadly. Reducing drinking during late adolescence is likely to be important for preventing long-term adverse consequences as well as protecting against more immediate harms.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
The effects of alcohol intoxication (drunkenness), dependence (habitual, compulsive, and long-term drinking), and the associated biochemical changes, have wide-ranging health and social consequences, some of which can be lethal. Worldwide, alcohol causes 2.5 million deaths (3.8% of total) and 69.4 million (4.5% of total) of disability-adjusted life years (DALYs). Unintentional injuries alone account for about one-third of the 2.5 million deaths, whereas neuro-psychiatric conditions account for almost 40%. There is also a causal relationship between alcohol consumption and more than 60 types of disease and injury; worldwide, alcohol is estimated to cause about 20%–30% cases of esophageal cancer, liver cancer, cirrhosis of the liver, homicide, epilepsy, and motor vehicle crashes. There is increasing evidence that, in addition to the volume of alcohol consumed, the pattern of drinking has an effect on health outcomes, with binge drinking found to be particularly harmful. As the majority of people who binge drink are teenagers, this group may be particularly vulnerable to the damaging health effects of alcohol, leading to global concern about the drinking trends and patterns among young people.
Why Was This Study Done?
Although there have been many published cohort studies reporting the longer term harms associated with adolescent drinking, the strength of this evidence remains unclear, which has implications for the objectives of interventions. For example, if adolescent drinking does not cause later difficulties, early intervention on, and management of, the acute consequences of alcohol consumption, such as antisocial behaviour and unintentional injuries, may be the most appropriate community safety and public health responses. However, if there is a causal relationship, there needs to be an additional approach that addresses the cumulative harmful effects of alcohol. The researchers conducted this systematic review of cohort studies, as this method provides the strongest observational study design to evaluate evidence of causality.
What Did the Researchers Do and Find?
The researchers conducted a comprehensive literature review to identify relevant studies that met their inclusion criteria, which were: (1) data collection from at least two points in time, at least 3 years apart, from the same cohort; (2) data collection regarding alcohol consumption between the ages of 15 and 19 years old; and (3) inclusion of a report of at least one quantitative measure of effect, such as an odds ratio, between alcohol involvement and any later outcome assessed at age 20 or greater. The majority of these studies were multiple reports from ten cohorts and approximately half were from the US. The researchers then evaluated the strength of causal inference possible in these studies by assessing whether all possible contributing factors(confounders) had been taken into account, identifying studies that had follow-up rates of 80% or greater, and which had sample sizes of 1,000 participants or more.
Using these methods, the researchers found that, overall, there is consistent evidence that higher alcohol consumption in late adolescence continues into adulthood and is also associated with alcohol problems, including dependence. For example, one population-based cohort showed that late adolescent drinking can cause early death among men, mainly through car crashes and suicides, and there was a large evidence base supporting the ongoing impacts of late adolescent drinking on adult drinking behaviours—although most of these studies could not strongly support causal inferences because of their weak designs. The researchers also concluded that although a number of studies suggested links with late adolescent drinking to adult physical and mental health and social consequences, this evidence is generally of poor quality and insufficient to infer causality.
What Do These Findings Mean?
The results of this study show that that the evidence-base on the long-term consequences of late adolescent drinking is not as extensive or compelling as it needs to be. The researchers stress that there is an urgent need for high quality long-term prospective cohort studies in order to better understand the public health burden associated with adolescent drinking in general and in relation to adult drinking. However, there is sufficient evidence to suggest that reducing drinking during late adolescence is likely to be important for preventing long-term adverse consequences as well as protecting against more immediate harmful consequences harms.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000413.
The World Health Organization has information about the global incidence of alcohol consumption
The US-based Marin Institute has information about alcohol and young people
The BBC also has a site on late adolescent drinking
doi:10.1371/journal.pmed.1000413
PMCID: PMC3035611  PMID: 21346802

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