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1.  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
2.  Representation and Misrepresentation of Scientific Evidence in Contemporary Tobacco Regulation: A Review of Tobacco Industry Submissions to the UK Government Consultation on Standardised Packaging 
PLoS Medicine  2014;11(3):e1001629.
Selda Ulucanlar and colleagues analyze submissions by two tobacco companies to the UK government consultation on standardized packaging.
Please see later in the article for the Editors' Summary
Background
Standardised packaging (SP) of tobacco products is an innovative tobacco control measure opposed by transnational tobacco companies (TTCs) whose responses to the UK government's public consultation on SP argued that evidence was inadequate to support implementing the measure. The government's initial decision, announced 11 months after the consultation closed, was to wait for ‘more evidence’, but four months later a second ‘independent review’ was launched. In view of the centrality of evidence to debates over SP and TTCs' history of denying harms and manufacturing uncertainty about scientific evidence, we analysed their submissions to examine how they used evidence to oppose SP.
Methods and Findings
We purposively selected and analysed two TTC submissions using a verification-oriented cross-documentary method to ascertain how published studies were used and interpretive analysis with a constructivist grounded theory approach to examine the conceptual significance of TTC critiques. The companies' overall argument was that the SP evidence base was seriously flawed and did not warrant the introduction of SP. However, this argument was underpinned by three complementary techniques that misrepresented the evidence base. First, published studies were repeatedly misquoted, distorting the main messages. Second, ‘mimicked scientific critique’ was used to undermine evidence; this form of critique insisted on methodological perfection, rejected methodological pluralism, adopted a litigation (not scientific) model, and was not rigorous. Third, TTCs engaged in ‘evidential landscaping’, promoting a parallel evidence base to deflect attention from SP and excluding company-held evidence relevant to SP. The study's sample was limited to sub-sections of two out of four submissions, but leaked industry documents suggest at least one other company used a similar approach.
Conclusions
The TTCs' claim that SP will not lead to public health benefits is largely without foundation. The tools of Better Regulation, particularly stakeholder consultation, provide an opportunity for highly resourced corporations to slow, weaken, or prevent public health policies.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Every year, about 6 million people die from tobacco-related diseases and, if current trends continue, annual tobacco-related deaths will increase to more than 8 million by 2030. To reduce this loss of life, national and international bodies have drawn up various conventions and directives designed to implement tobacco control measures such as the adoption of taxation policies aimed at reducing tobacco consumption and bans on tobacco advertising, promotion, and sponsorship. One innovative but largely unused tobacco control measure is standardised packaging of tobacco products. Standardised packaging aims to prevent the use of packaging as a marketing tool by removing all brand imagery and text (other than name) and by introducing packs of a standard shape and colour that include prominent pictorial health warnings. Standardised packaging was first suggested as a tobacco control measure in 1986 but has been consistently opposed by the tobacco industry.
Why Was This Study Done?
The UK is currently considering standardised packaging of tobacco products. In the UK, Better Regulation guidance obliges officials to seek the views of stakeholders, including corporations, on the government's cost and benefit estimates of regulatory measures such as standardised packaging and on the evidence underlying these estimates. In response to a public consultation about standardised packaging in July 2013, which considered submissions from several transnational tobacco companies (TTCs), the UK government announced that it would wait for the results of the standardised packaging legislation that Australia adopted in December 2012 before making its final decision about this tobacco control measure. Parliamentary debates and media statements have suggested that doubt over the adequacy of the evidence was the main reason for this ‘wait and see’ decision. Notably, TTCs have a history of manufacturing uncertainty about the scientific evidence related to the harms of tobacco. Given the centrality of evidence to the debate about standardised packaging, in this study, the researchers analyse submissions made by two TTCs, British American Tobacco (BAT) and Japan Tobacco International (JTI), to the first UK consultation on standardised packaging (a second review is currently underway and will report shortly) to examine how TTCs used evidence to oppose standardised packaging.
What Did the Researchers Do and Find?
The researchers analysed sub-sections of two of the four TTC submissions (those submitted by BAT and JTI) made to the public consultation using verification-oriented cross-documentary analysis, which compared references made to published sources with the original sources to ascertain how these sources had been used, and interpretative analysis to examine the conceptual significance of TTC critiques of the evidence on standardised packaging. The researchers report that the companies' overall argument was that the evidence base in support of standardised packaging was seriously flawed and did not warrant the introduction of such packaging. The researchers identified three ways in which the TTC reports misrepresented the evidence base. First, the TTCs misquoted published studies, thereby distorting the main messages of these studies. For example, the TTCs sometimes omitted important qualifying information when quoting from published studies. Second, the TTCs undermined evidence by employing experts to review published studies for methodological rigor and value in ways that did not conform to normal scientific critique approaches (‘mimicked scientific critique’). So, for example, the experts considered each piece of evidence in isolation for its ability to support standardised packaging rather than considering the cumulative weight of the evidence. Finally, the TTCs engaged in ‘evidential landscaping’. That is, they promoted research that deflected attention from standardised packaging (for example, research into social explanations of smoking behaviour) and omitted internal industry research on the role of packaging in marketing.
What Do These Findings Mean?
These findings suggest that the TTC critique of the evidence in favour of standardised packaging that was presented to the UK public consultation on this tobacco control measure is highly misleading. However, because the researchers' analysis only considered subsections of the submissions from two TTCs, these findings may not be applicable to the other submissions or to other TTCs. Moreover, their analysis only considered the efforts made by TTCs to influence public health policy and not the effectiveness of these efforts. Nevertheless, these findings suggest that the claim of TTCs that standardised packaging will not lead to public health benefits is largely without foundation. More generally, these findings highlight the possibility that the tools of Better Regulation, particularly stakeholder consultation, provide an opportunity for wealthy corporations to slow, weaken, or prevent the implementation of public health policies.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001629.
The World Health Organization provides information about the dangers of tobacco (in several languages) and an article about first experiences with Australia's tobacco plain packaging law; for information about the tobacco industry's influence on policy, see the 2009 World Health Organization report ‘Tobacco industry interference with tobacco control’
A UK parliamentary briefing on standardised packaging of tobacco products, a press release about the consultation, and a summary report of the consultation are available; the ideas behind the UK's Better Regulation guidance are described in a leaflet produced by the Better Regulation Task Force
Cancer Research UK (CRUK) has a web page with information on standardised packaging and includes videos
Wikipedia has a page on standardised packaging of tobacco products (note: Wikipedia is a free online encyclopaedia that anyone can edit; available in several languages)
The UK Centre for Tobacco Control Studies is a network of UK universities that undertakes original research, policy development, advocacy, and teaching and training in the field of tobacco control
TobaccoTactics.org, an online resource managed by the University of Bath, provides up-to-date information on the tobacco industry and the tactics it uses to influence tobacco regulation
SmokeFree, a website provided by the UK National Health Service, offers advice on quitting smoking and includes personal stories from people who have stopped smoking
Smokefree.gov, from the US National Cancer Institute, offers online tools and resources to help people quit smoking
doi:10.1371/journal.pmed.1001629
PMCID: PMC3965396  PMID: 24667150
3.  The rise and fall of Australian physical activity policy 1996 – 2006: a national review framed in an international context 
Background
This paper provides an historical review of physical activity policy development in Australia for a period spanning a decade since the release of the US Surgeon General's Report on Physical Activity and Health in 1996 and including the 2004 WHO Global Strategy on Diet, Physical Activity and Health. Using our definition of 'HARDWIRED' policy criteria, this Australian review is compared with an international perspective of countries with established national physical activity policies and strategies (New Zealand, Canada, Brazil, Scotland, Switzerland, the Netherlands and Finland). Methods comprised a literature and policy review, audit of relevant web sites, document searches and surveys of international stakeholders.
Results
All these selected countries embraced multi-strategic policies and undertook monitoring of physical activity through national surveys. Few committed to policy of more than three years duration and none undertook systematic evaluation of national policy implementation. This Australian review highlights phases of innovation and leadership in physical activity-related policy, as well as periods of stagnation and decline; early efforts were amongst the best in the world but by the mid-point of this review (the year 2000), promising attempts towards development of a national intersectoral policy framework were thwarted by reforms in the Federal Sport and Recreation sector. Several well received reviews of evidence on good practices in physical activity and public health were produced in the period but leadership and resources were lacking to implement the policies and programs indicated. Latterly, widespread publicity and greatly increased public and political interest in chronic disease prevention, (especially in obesity and type 2 diabetes) have dominated the framework within which Australian policy deliberations have occurred. Finally, a national physical activity policy framework for the Health sector emerged, but not as a policy vision that was inclusive of the other essential sectors such as Education, Transport, Urban Planning as well as Sport and Recreation.
Conclusion
Despite some progression of physical activity policy in the decade since 1995/6, this review found inconsistent policy development, both in Australia and elsewhere. Arguably, Australia has done no worse than other countries, but more effective responses to physical inactivity in populations can be built only on sustainable multi-sectoral public health policy partnerships that are well informed by evidence of effectiveness and good practice. In Australia and elsewhere prerequisites for success are political support, long-term investment and commitment to program implementation and evaluation. An urgent priority is media and political advocacy for physical activity focussed on these factors.
doi:10.1186/1743-8462-5-18
PMCID: PMC2525635  PMID: 18667088
4.  A qualitative evaluation of general practitioners' perceptions regarding access to medicines in New Zealand 
BMJ Open  2012;2(2):e000518.
Objective
The objective of this study was to evaluate general practitioners' (GPs) perceptions regarding access to medicines in New Zealand.
Design
Qualitative.
Setting
Primary care.
Participants
GPs.
Main outcome measures
GPs' views and perceptions.
Results
GPs were of the view that the current range of medicines available in New Zealand was reasonable; however, it was acknowledged that there were some drugs that patients were missing out on. When considering the range of subsidised medicines available in New Zealand, some GPs felt that there had been an improvement over recent years. It was highlighted that unexpected funding changes could create financial barriers for some patients and that administrative procedures and other complexities created barriers in receiving a subsidy for restricted medicines. GPs also reported problems with the availability and sole supply of certain medicines and claimed that switching from a branded medicine to its generic counterpart could be disruptive for patients.
Conclusions
The research concluded that although there were some issues with the availability of certain drugs, most GPs were satisfied with the broader access to medicines situation in New Zealand. This view is to contrary to the situation presented by the pharmaceutical industry. The issues around sole supply, the use of generic medicines and the administrative barriers regarding funding of medicines could be improved with better systems. The current work provides a solid account of what GPs see as the advantages and disadvantages of the current system and how they balance these demands in practice.
Article summary
Article focus
To evaluate GPs' perceptions regarding access to medicines in New Zealand.
To identify GPs' views and perceptions regarding the role of PHARMAC within the New Zealand healthcare system.
Key messages
GPs were of the view that the current range of medicines available in New Zealand was reasonable; however, it was acknowledged that there were some drugs that patients were missing out on.
When considering the range of subsidised medicines available in New Zealand, some GPs felt that there had been an improvement over recent years.
It was highlighted that unexpected funding changes could create financial barriers for some patients and that administrative procedures and other complexities created barriers in receiving a subsidy for restricted medicines.
Strengths and limitations of this study
This is the first independent objective study covering GPs' perceptions regarding access to medicines issues in New Zealand.
Findings from this study will form an essential component of any future research, which reviews New Zealand's current medicines policy.
It will also help in developing strategies to better inform patients' access to medicines, with GPs being a large group of health professionals likely to positively affect patient knowledge and views.
All GPs were working in a large metropolitan city in New Zealand—it is not known whether their views and experiences differ from colleagues working and living in small towns and rural locales.
Also, only 19 of 150 contacted were interested in participating so this could be another source of bias in the study.
doi:10.1136/bmjopen-2011-000518
PMCID: PMC3317137  PMID: 22457477
5.  Event Rates, Hospital Utilization, and Costs Associated with Major Complications of Diabetes: A Multicountry Comparative Analysis 
PLoS Medicine  2010;7(2):e1000236.
Philip Clarke and colleagues examined patient-level data for over 11,000 participants with type 2 diabetes from 20 countries and find that major complications of diabetes significantly increased hospital use and costs across settings.
Background
Diabetes imposes a substantial burden globally in terms of premature mortality, morbidity, and health care costs. Estimates of economic outcomes associated with diabetes are essential inputs to policy analyses aimed at prevention and treatment of diabetes. Our objective was to estimate and compare event rates, hospital utilization, and costs associated with major diabetes-related complications in high-, middle-, and low-income countries.
Methods and Findings
Incidence and history of diabetes-related complications, hospital admissions, and length of stay were recorded in 11,140 patients with type 2 diabetes participating in the Action in Diabetes and Vascular Disease (ADVANCE) study (mean age at entry 66 y). The probability of hospital utilization and number of days in hospital for major events associated with coronary disease, cerebrovascular disease, congestive heart failure, peripheral vascular disease, and nephropathy were estimated for three regions (Asia, Eastern Europe, and Established Market Economies) using multiple regression analysis. The resulting estimates of days spent in hospital were multiplied by regional estimates of the costs per hospital bed-day from the World Health Organization to compute annual acute and long-term costs associated with the different types of complications. To assist, comparability, costs are reported in international dollars (Int$), which represent a hypothetical currency that allows for the same quantities of goods or services to be purchased regardless of country, standardized on purchasing power in the United States. A cost calculator accompanying this paper enables the estimation of costs for individual countries and translation of these costs into local currency units. The probability of attending a hospital following an event was highest for heart failure (93%–96% across regions) and lowest for nephropathy (15%–26%). The average numbers of days in hospital given at least one admission were greatest for stroke (17–32 d across region) and heart failure (16–31 d) and lowest for nephropathy (12–23 d). Considering regional differences, probabilities of hospitalization were lowest in Asia and highest in Established Market Economies; on the other hand, lengths of stay were highest in Asia and lowest in Established Market Economies. Overall estimated annual hospital costs for patients with none of the specified events or event histories ranged from Int$76 in Asia to Int$296 in Established Market Economies. All complications included in this analysis led to significant increases in hospital costs; coronary events, cerebrovascular events, and heart failure were the most costly, at more than Int$1,800, Int$3,000, and Int$4,000 in Asia, Eastern Europe, and Established Market Economies, respectively.
Conclusions
Major complications of diabetes significantly increase hospital use and costs across various settings and are likely to impose a high economic burden on health care systems.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Worldwide, nearly 250 million people have diabetes, and this number is increasing rapidly. Diabetes is characterized by dangerous amounts of sugar (glucose) in the blood. Blood sugar levels are normally controlled by insulin, a hormone produced by the pancreas. Blood sugar control fails in people with diabetes because they make no insulin (type 1 diabetes) or, more commonly, because the fat and muscle cells that usually respond to insulin by removing excess sugar from the blood have become insulin insensitive (type 2 diabetes). Type 2 diabetes can be prevented and controlled by eating a healthy diet and exercising regularly. It can also be treated with drugs that help the pancreas make more insulin or that increase insulin sensitivity. Major long-term complications of diabetes include kidney failure and an increased risk of cardiovascular problems such as heart attacks, heart failure, stroke, and problems with the blood vessels in the arms and legs. Because of these complications, the life expectancy of people with diabetes is about ten years shorter than that of people without diabetes.
Why Was This Study Done?
Diabetes imposes considerable demands on health care systems but little is known about the direct medical costs associated with treating this chronic disease in low- and middle-income countries where more than three-quarters of affected people live. In particular, although estimates have been made of the overall resources devoted to the treatment of diabetes, very little is known about how the different long-term complications of diabetes contribute to health care costs in different countries. Public-health experts and governments need this information to help them design effective and sustainable policies for the prevention and treatment of diabetes. In this study, the researchers estimate the resource use associated with diabetes-related complications in three economic regions using information collected in the Action in Diabetes and Vascular Disease (ADVANCE) study. This multinational clinical trial is investigating how drugs that control blood pressure and blood sugar levels affect the long-term complications of diabetes.
What Did the Researchers Do and Find?
The researchers recorded diabetes-related complications, hospital admissions for these complications, and length of hospital stays in 11,140 patients with severe diabetes from 20 countries who participated in the ADVANCE study. They used “multiple regression analysis” to estimate the number of days spent in hospital for diabetes-related complications in Asia, Eastern Europe, and the Established Market Economies (Canada, Australia, New Zealand, and several Western European countries). Finally, they calculated the economic costs of each complication using regional estimates of the costs per bed-day from the World Health Organization's CHOICE project (CHOosing Interventions that are Cost Effective). Nearly everyone in the study who developed heart failure attended a hospital, but only 15%–26% of people attended a hospital for kidney problems. The chances of hospitalization for any complication were lowest in Asia and highest in the Established Market Economies; conversely, lengths of stay were longest in Asia and shortest in the Established Market Economies. Finally, the estimated annual hospital costs for patients who had a coronary event, stroke, or heart failure were more than Int$1,800, Int$3,000, and Int$4,000 in Asia, Eastern Europe, and the Established Market Economies, respectively (the international dollar, Int$, is a hypothetical currency that has the same purchasing power in all countries), compared to Int$76, Int$156, and Int$296 for patients who experienced none of these events.
What Do These Findings Mean?
Because the ADVANCE trial had strict entry criteria, the findings of this study may not be generalizable to the broader population of people with diabetes. Nevertheless, given the lack of information about the costs associated with diabetes-related complications in low- and middle-income countries, these findings provide important new information about the patterns of hospital resource use and costs in these countries. Specifically, these findings show that the major complications of diabetes greatly increase hospital use and costs in all three economic regions considered and impose a high economic burden on health care systems that is likely to increase as the diabetes epidemic develops. Importantly, these findings should help policy makers anticipate the future health care costs associated with diabetes and should help them evaluate which therapies aimed at preventing diabetes-related complications will reduce these costs most effectively.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000236.
The International Diabetes Federation provides information about all aspects of diabetes
The US National Diabetes Information Clearinghouse provides detailed information about diabetes for patients, health care professionals, and the general public (in English and Spanish)
The UK National Health Service also provides information for patients and caregivers about type 2 diabetes (in several languages)
Information about the ADVANCE study is available
The World Health Organization's CHOICE Web site provides information about the analysis of the cost effectiveness of health care interventions
doi:10.1371/journal.pmed.1000236
PMCID: PMC2826379  PMID: 20186272
6.  The process and costs of publishing medical journals in Sri Lanka: an economic evaluation 
BMJ Open  2011;1(1):e000057.
Objectives
Medical journals have contributed to the advancement of medicine by helping to disseminate scientific knowledge and providing a forum for medical communities to debate issues in depth. To the authors' knowledge, there are no studies examining the process of medical journal publication in developing Asian countries. The authors analysed the process and costs of publishing medical journals in Sri Lanka, a developing country in South Asia.
Methods
Data were collected by interviewing the editors and perusing the records at the editorial offices of the respective medical journals. Articles published in 2009 (or 2008 for journals not published in 2009) were analysed by perusing the respective journals.
Results
A total of 44 medical journals were published in Sri Lanka's history, of which only 28 journals remained in publication after 2007. A majority (54%) of the journals published after 2007 were published once per year. Seventeen journals in publication after 2007 were published in paper version only, and 11 journals were also available online. The mean cost of printing one issue was Sri Lankan Rupees (LKR) 97 720 (US$888) (range LKR 28 000–270 000). The cost of distribution ranged from LKR 2000 to 140 000 (US$18–1273). The mean cost of publishing one article was LKR 6646 (US$60). A total of 456 articles were published in 2009 (/2008). The total number of pages published was 1723.
Conclusion
The infrastructure for medical journal publishing in Sri Lanka has many good qualities such as free access, minimum charges for authors and potential for online availability. The journals are solely academic (non-profit), but the costs remain high.
Article summary
Article focus
To analyse the process and costs of publishing medical journals in a developing country.
To identify a list of medical journals published in the country.
To analyse the number and types of articles published in recent Sri Lankan medical journals.
Key messages
Sri Lankan medical journals are freely accessible with minimum charges for authors.
Sri Lankan medical journals are solely academic (non-commercial) and non-profit in nature.
The publication costs remain high.
Strengths and limitations of this study
There is a lack of a comprehensive list of medical journals in the country.
The limited number of publications from the fields of allied health sciences (nursing, pharmacy and physiotherapy) were not included.
doi:10.1136/bmjopen-2011-000057
PMCID: PMC3191407  PMID: 22021741
7.  Transnational Tobacco Company Interests in Smokeless Tobacco in Europe: Analysis of Internal Industry Documents and Contemporary Industry Materials 
PLoS Medicine  2013;10(9):e1001506.
In light lobbying by transnational tobacco companies to remove the European Union ban on the sale of snus (a smokeless tobacco product), Silvy Peeters and Anna Gilmore explore the motivation behind tobacco companies' interests in smokeless tobacco products in Europe.
Please see later in the article for the Editors' Summary
Background
European Union (EU) legislation bans the sale of snus, a smokeless tobacco (SLT) which is considerably less harmful than smoking, in all EU countries other than Sweden. To inform the current review of this legislation, this paper aims to explore transnational tobacco company (TTC) interests in SLT and pure nicotine in Europe from the 1970s to the present, comparing them with TTCs' public claims of support for harm reduction.
Methods and Results
Internal tobacco industry documents (in total 416 documents dating from 1971 to 2009), obtained via searching the online Legacy Tobacco Documents Library, were analysed using a hermeneutic approach. This library comprises documents obtained via litigation in the US and does not include documents from Imperial Tobacco, Japan Tobacco International, or Swedish Match. To help overcome this limitation and provide more recent data, we triangulated our documentary findings with contemporary documentation including TTC investor presentations. The analysis demonstrates that British American Tobacco explored SLT opportunities in Europe from 1971 driven by regulatory threats and health concerns, both likely to impact cigarette sales negatively, and the potential to create a new form of tobacco use among those no longer interested in taking up smoking. Young people were a key target. TTCs did not, however, make SLT investments until 2002, a time when EU cigarette volumes started declining, smoke-free legislation was being introduced, and public health became interested in harm reduction. All TTCs have now invested in snus (and recently in pure nicotine), yet both early and recent snus test markets appear to have failed, and little evidence was found in TTCs' corporate materials that snus is central to their business strategy.
Conclusions
There is clear evidence that BAT's early interest in introducing SLT in Europe was based on the potential for creating an alternative form of tobacco use in light of declining cigarette sales and social restrictions on smoking, with young people a key target. We conclude that by investing in snus, and recently nicotine, TTCs have eliminated competition between cigarettes and lower-risk products, thus helping maintain the current market balance in favour of (highly profitable) cigarettes while ensuring TTCs' long-term future should cigarette sales decline further and profit margins be eroded.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Every year, about 5 million people die from cancer, heart disease, and other tobacco-related diseases. In recent years, to reduce this growing loss of life, international and national bodies have drawn up various tobacco control conventions and directives. For example, the European Union (EU) Directives on tobacco control call for member states to ban tobacco advertising, promotion, and sponsorship and to adopt taxation policies aimed at reducing tobacco consumption. The 2001 EU Tobacco Products Directive also bans the sale of snus, a form of smokeless tobacco (SLT), in all EU countries except Sweden. Snus, which originated in Sweden in the early 19th century, is a moist tobacco product that is placed under the upper lip. Although snus is considerably less harmful than smoking, the sale of snus was banned in the EU in 1992 because of fears that it might cause cancer and was being marketed to young people. When Sweden joined the EU in 1994, exemption from the ban was made a condition of the membership treaty.
Why Was This Study Done?
Transnational tobacco companies (TTCs) have been investing in European snus manufacturers since 2002 and more recently in pure nicotine products, and it has been suggested that, faced with declining cigarette markets in Europe and elsewhere, TTCs are preparing for a “post-cigarette era”. Since 2008, TTCs have been lobbying EU member states and the European Commission to remove the ban on snus sales, arguing that public health would be improved if governments allowed potentially reduced-harm products like snus onto the market. At the end of 2012, however, the European Commission proposed that the ban on snus sales should be continued. Here, to help inform this controversial policy debate, the researchers explore the interest of TTCs in SLT and pure nicotine in Europe from the 1970s to the present by examining internal tobacco documents and compare these interests with public claims of support for harm reduction made by TTCs.
What Did the Researchers Do and Find?
By searching the Legacy Tobacco Documents Library (internal tobacco industry documents released following US litigation cases), the researchers identified 416 documents that detail the historical interest of TTCs in SLT and pure nicotine and their efforts to enter European markets, and to influence national and EU public-health policy. The researchers analyzed these documents using a “hermeneutic” approach—methodical reading and re-reading of the documents to identify themes and sub-themes. Finally, they used TTC investor presentations and other documents to confirm these themes and to provide recent data on TTC investment in SLT. British American Tobacco (BAT) explored the opportunities for marketing SLT products in Europe from 1971 onwards. This exploration was driven by regulatory threats and health concerns, both of which were likely to impact tobacco sales, and by the potential to create a new form of tobacco use among people no longer interested in taking up smoking. TTCs did not begin to invest in SLT, however, until 2002, a time when EU cigarette sale volumes started to decline, smoke-free legislation was being introduced, and tobacco harm reduction first became a major public-health issue. All the TTCs have now invested in snus even though snus test markets appear to have failed and even though there is little evidence in corporate materials that snus is central to the business strategy of TTCs.
What Do These Findings Mean?
These findings suggest that BAT's early interest in SLT in Europe was driven by business concerns and was based on the potential for creating an alternative form of tobacco use among people—particularly young people—who would no longer take up smoking because of health concerns. They also suggest that TTC investments in snus were defensive—by buying up snus manufacturers and more recently nicotine producers, TTCs have eliminated competition between cigarettes and lower-risk products, thereby helping to maintain the current market balance in favor of cigarettes while ensuring the long-term future of TTCs should cigarette sales decline further. Although these findings are limited by the possibility that some relevant documents may have been omitted from this analysis, they nevertheless raise the concern that, if TTC investment in SLT continues, competition between cigarettes and SLT will reduce the potential for harm reduction to benefit public health. Legalization of snus sales in the European Union may therefore have considerably less benefit than envisaged.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001506.
The World Health Organization provides information about the dangers of tobacco (in several languages) and about the Framework Convention on Tobacco Control, an international treaty for tobacco control; for information about the tobacco industry's influence on policy, see the 2009 World Health Organization report Tobacco interference with tobacco control
Details of European Union legislation on the manufacture, presentation, and sale of tobacco products is available (in several languages)
Wikipedia has pages on tobacco harm reduction and on snus (note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The Legacy Tobacco Documents Library is a searchable public database of tobacco company internal documents detailing their advertising, manufacturing, marketing, sales, and scientific activities
The UK Centre for Tobacco Control Studies is a network of UK universities that undertakes original research, policy development, advocacy, and teaching and training in the field of tobacco control
SmokeFree, a website provided by the UK National Health Service, offers advice on quitting smoking and includes personal stories from people who have stopped smoking
Smokefree.gov, from the US National Cancer Institute, offers online tools and resources to help people quit smoking
TobaccoTactics.org, an online resource managed by the University of Bath, provides up-to-date information on the tobacco industry and their tactics to influence tobacco regulation
doi:10.1371/journal.pmed.1001506
PMCID: PMC3769209  PMID: 24058299
8.  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
9.  Hand Sanitiser Provision for Reducing Illness Absences in Primary School Children: A Cluster Randomised Trial 
PLoS Medicine  2014;11(8):e1001700.
In a cluster randomized trial, Patricia Priest and colleagues find that providing hand sanitizer along with hand hygiene education in primary school classrooms, compared with hand hygiene alone, does not reduce school absences.
Please see later in the article for the Editors' Summary
Background
The potential for transmission of infectious diseases offered by the school environment are likely to be an important contributor to the rates of infectious disease experienced by children. This study aimed to test whether the addition of hand sanitiser in primary school classrooms compared with usual hand hygiene would reduce illness absences in primary school children in New Zealand.
Methods and Findings
This parallel-group cluster randomised trial took place in 68 primary schools, where schools were allocated using restricted randomisation (1∶1 ratio) to the intervention or control group. All children (aged 5 to 11 y) in attendance at participating schools received an in-class hand hygiene education session. Schools in the intervention group were provided with alcohol-based hand sanitiser dispensers in classrooms for the winter school terms (27 April to 25 September 2009). Control schools received only the hand hygiene education session. The primary outcome was the number of absence episodes due to any illness among 2,443 follow-up children whose caregivers were telephoned after each absence from school. Secondary outcomes measured among follow-up children were the number of absence episodes due to specific illness (respiratory or gastrointestinal), length of illness and illness absence episodes, and number of episodes where at least one other member of the household became ill subsequently (child or adult). We also examined whether provision of sanitiser was associated with experience of a skin reaction. The number of absences for any reason and the length of the absence episode were measured in all primary school children enrolled at the schools. Children, school administrative staff, and the school liaison research assistants were not blind to group allocation. Outcome assessors of follow-up children were blind to group allocation. Of the 1,301 and 1,142 follow-up children in the hand sanitiser and control groups, respectively, the rate of absence episodes due to illness per 100 child-days was similar (1.21 and 1.16, respectively, incidence rate ratio 1.06, 95% CI 0.94 to 1.18). The provision of an alcohol-based hand sanitiser dispenser in classrooms was not effective in reducing rates of absence episodes due to respiratory or gastrointestinal illness, the length of illness or illness absence episodes, or the rate of subsequent infection for other members of the household in these children. The percentage of children experiencing a skin reaction was similar (10.4% hand sanitiser versus 10.3% control, risk ratio 1.01, 95% CI 0.78 to 1.30). The rate or length of absence episodes for any reason measured for all children also did not differ between groups. Limitations of the study include that the study was conducted during an influenza pandemic, with associated public health messaging about hand hygiene, which may have increased hand hygiene among all children and thereby reduced any additional effectiveness of sanitiser provision. We did not quite achieve the planned sample size of 1,350 follow-up children per group, although we still obtained precise estimates of the intervention effects. Also, it is possible that follow-up children were healthier than non-participating eligible children, with therefore less to gain from improved hand hygiene. However, lack of effectiveness of hand sanitiser provision on the rate of absences among all children suggests that this may not be the explanation.
Conclusions
The provision of hand sanitiser in addition to usual hand hygiene in primary schools in New Zealand did not prevent disease of severity sufficient to cause school absence.
Trial registration
Australian New Zealand Clinical Trials Registry ACTRN12609000478213
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Throughout human history, infectious diseases have been major killers. In the 1300 s, for example, the black death killed a third of the European population. Other diseases such as smallpox and cholera have also devastated human populations. Now, though, a better understanding of the bacteria, viruses, and other microbes that cause infectious diseases and the availability of effective vaccines and antibiotics mean that, for the first time in human history, non-communicable (chronic) diseases such as heart attacks and strokes are killing and disabling more people around the world than infectious diseases. But this does not mean that we can be complacent about infectious diseases. The control of infectious diseases remains important, even in high-income countries, because of the contribution of infectious diseases to ill-health and because we need to manage the risk of epidemics and pandemics (disease outbreaks that affect a large proportion of the population of a country or the world, respectively) of influenza and other diseases.
Why Was This Study Done?
The control of infectious disease transmission in children is a particularly important component of disease control because children tend to have high rates of infectious disease and to have more physical contact with peers and with adults than other age groups, particularly in the school environment. It might be possible, therefore, to reduce the occurrence of many infectious respiratory and gastrointestinal diseases in communities by interrupting the transmission of infectious diseases between children at school, but how can this be achieved? In health care settings, good hand hygiene is a key component of infectious disease control, so, here, the researchers undertake a cluster randomized trial among primary school children in New Zealand to investigate whether the promotion of extra hand cleaning through the provision of alcohol-based hand sanitizer in classrooms can reduce illness absences among school children compared with normal hand hygiene (washing with soap and water, mainly in school bathrooms). A cluster randomized trial compares the outcomes of groups of participants (in this case, schools) chosen randomly to receive different interventions.
What Did the Researchers Do and Find?
The researchers randomly assigned 68 city primary schools to the intervention or control group. All the children (aged 5–11 years) attending the participating schools received a thirty-minute in-class hand hygiene education session. Alcohol-based hand sanitizer dispensers were installed in the classrooms of the intervention schools during the winter term, and the children were asked to use the dispensers after coughing or sneezing and on the way out of the classroom for morning break and lunch. The researchers report that the trial's primary outcome—the rate of absence episodes per 100 child-days due to any illness among “follow-up” children, individuals whose caregivers agreed to be asked about the reason for any absence—was similar in the intervention and control groups. Moreover, among the follow-up children, the provision of hand sanitizer did not reduce the number of absences due to a specific illness (respiratory or gastrointestinal), the length of illness and length of absence from school, or the number of episodes in which at least one other family member became ill. Finally, the number of absences for any reason, and length of absence episodes, in all the children enrolled at the participating schools did not differ between the intervention and control groups.
What Do These Findings Mean?
These findings suggest that the provision of hand sanitizer in addition to usual hand hygiene in primary schools in New Zealand did not prevent any infectious diseases severe enough to warrant school absence. Because the trial was undertaken during an influenza epidemic, influenza-related public health messages about good hand hygiene may have increased hand hygiene among all the children in the study and lessened the intervention's effectiveness. Other study limitations—including that only a third of caregivers agreed to be contacted about their child's absences, and these may have been caregivers who had already taught their children good hand hygiene—may also affect the accuracy of these findings and their generalizability to other high-income countries. However, these findings suggest that, in high-income countries where clean water for hand washing is readily available, putting resources into extra hand hygiene by providing hand sanitizer in classrooms may not be an effective way to break the child-to-child transmission of infectious diseases.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001700.
The US Centers for Disease Control and Prevention has information about hand-washing, when and how to wash your hands and use sanitizer, and hand-washing as a family activity; it also provides information about the importance of hand hygiene in health care settings
Public Health England provides information about hand-washing; its webpage about hand-washing in primary schools contains links to lesson plans about hand-washing for children aged 5–7 years and to e-Bug, a web-based student resource about infectious diseases and their prevention for children aged 7–14 years
Kidshealth, a US-based not-for-profit organization, also provides information about the importance of hand-washing for parents, kids, and teens (in English and Spanish)
doi:10.1371/journal.pmed.1001700
PMCID: PMC4130492  PMID: 25117155
10.  Risk Factors for Severe Outcomes following 2009 Influenza A (H1N1) Infection: A Global Pooled Analysis 
PLoS Medicine  2011;8(7):e1001053.
This study analyzes data from 19 countries (from April 2009 to Jan 2010), comprising some 70,000 hospitalized patients with severe H1N1 infection, to reveal risk factors for severe pandemic influenza, which include chronic illness, cardiac disease, chronic respiratory disease, and diabetes.
Background
Since the start of the 2009 influenza A pandemic (H1N1pdm), the World Health Organization and its member states have gathered information to characterize the clinical severity of H1N1pdm infection and to assist policy makers to determine risk groups for targeted control measures.
Methods and Findings
Data were collected on approximately 70,000 laboratory-confirmed hospitalized H1N1pdm patients, 9,700 patients admitted to intensive care units (ICUs), and 2,500 deaths reported between 1 April 2009 and 1 January 2010 from 19 countries or administrative regions—Argentina, Australia, Canada, Chile, China, France, Germany, Hong Kong SAR, Japan, Madagascar, Mexico, the Netherlands, New Zealand, Singapore, South Africa, Spain, Thailand, the United States, and the United Kingdom—to characterize and compare the distribution of risk factors among H1N1pdm patients at three levels of severity: hospitalizations, ICU admissions, and deaths. The median age of patients increased with severity of disease. The highest per capita risk of hospitalization was among patients <5 y and 5–14 y (relative risk [RR] = 3.3 and 3.2, respectively, compared to the general population), whereas the highest risk of death per capita was in the age groups 50–64 y and ≥65 y (RR = 1.5 and 1.6, respectively, compared to the general population). Similarly, the ratio of H1N1pdm deaths to hospitalizations increased with age and was the highest in the ≥65-y-old age group, indicating that while infection rates have been observed to be very low in the oldest age group, risk of death in those over the age of 64 y who became infected was higher than in younger groups. The proportion of H1N1pdm patients with one or more reported chronic conditions increased with severity (median = 31.1%, 52.3%, and 61.8% of hospitalized, ICU-admitted, and fatal H1N1pdm cases, respectively). With the exception of the risk factors asthma, pregnancy, and obesity, the proportion of patients with each risk factor increased with severity level. For all levels of severity, pregnant women in their third trimester consistently accounted for the majority of the total of pregnant women. Our findings suggest that morbid obesity might be a risk factor for ICU admission and fatal outcome (RR = 36.3).
Conclusions
Our results demonstrate that risk factors for severe H1N1pdm infection are similar to those for seasonal influenza, with some notable differences, such as younger age groups and obesity, and reinforce the need to identify and protect groups at highest risk of severe outcomes.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
In April 2009, a new strain of influenza A H1N1 was first identified in Mexico and the United States and subsequently spread around the world. In June 2009, the World Health Organization (WHO) declared a pandemic alert phase 6, which continued until August 2010. Throughout the pandemic, WHO and member states gathered information to characterize the patterns of risk associated with the new influenza A H1N1 virus infection and to assess the clinical picture. Although risk factors for severe disease following seasonal influenza infection have been well documented in many countries (for example, pregnancy; chronic medical conditions such as pulmonary, cardiovascular, renal, hepatic, neuromuscular, hematologic, and metabolic disorders; some cognitive conditions; and immunodeficiency), risk factors for severe disease following infection early in the 2009 H1N1 pandemic were largely unknown.
Why Was This Study Done?
Many countries have recently reported data on the association between severe H1N1 influenza and a variety of underlying risk factors, but because these data are presented in different formats, making direct comparisons across countries is difficult, with no clear consensus for some conditions. Therefore, to assess the frequency and distribution of known and new potential risk factors for severe H1N1 infection, this study was conducted to collect data (from 1 April 2009 to 1 January 2010) from surveillance programs of the Ministries of Health or National Public Health Institutes in 19 countries―Argentina, Australia, Canada, Chile, China, France, Germany, Hong Kong (special administrative region), Japan, Madagascar, Mexico, the Netherlands, New Zealand, Singapore, South Africa, Spain, Thailand, the United States, and the United Kingdom.
What Did the Researchers Do and Find?
As part of routine surveillance, countries were asked to provide risk factor data on laboratory-confirmed H1N1 in patients who were admitted to hospital, admitted to the intensive care unit (ICU), or had died because of their infection, using a standardized format. The researchers grouped potential risk conditions into four categories: age, chronic medical illnesses, pregnancy (by trimester), and other conditions that were not previously considered as risk conditions for severe influenza outcomes, such as obesity. For each risk factor (except pregnancy), the researchers calculated the percentage of each group of patients using the total number of cases reported in each severity category (hospitalization, admission to ICU, and death). To evaluate the risk associated with pregnancy, the researchers used the ratio of pregnant women to all women of childbearing age (age 15–49 years) at each level of severity to describe the differences between levels.
The researchers were able to collect data on approximately 70,000 patients requiring hospitalization, 9,700 patients admitted to the ICU, and 2,500 patients who died from H1N1 infection. The proportion of patients with H1N1 with one or more reported chronic conditions increased with severity—the median was 31.1% of hospitalized patients, 52.3% of patients admitted to the ICU, and 61.8% of patients who died. For all levels of severity, pregnant women in their third trimester consistently accounted for the majority of the total of pregnant women. The proportion of patients with obesity increased with increasing disease severity—median of 6% of hospitalized patients, 11.3% of patients admitted to the ICU, and 12.0% of all deaths from H1N1.
What Do These Findings Mean?
These findings show that risk factors for severe H1N1 infection are similar to those for seasonal influenza, with some notable differences: a substantial proportion of people with severe and fatal cases of H1N1 had pre-existing chronic illness, which indicates that the presence of chronic illness increases the likelihood of death. Cardiac disease, chronic respiratory disease, and diabetes are important risk factors for severe disease that will be especially relevant for countries with high rates of these illnesses. Approximately 2/3 of hospitalized people and 40% of people who died from H1N1 infection did not have any identified pre-existing chronic illness, but this study was not able to comprehensively assess how many of these cases had other risk factors, such as pregnancy, obesity, smoking, and alcohol misuse. Because of large differences between countries, the role of risk factors such as obesity and pregnancy need further study—although there is sufficient evidence to support vaccination and early intervention for pregnant women. Overall, the findings of this study reinforce the need to identify and target high-risk groups for interventions such as immunization, early medical advice, and use of antiviral medications.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001053.
WHO provides a Global Alert and Response (GAR) with updates on a number of influenza-related topics
The US Centers for Disease Control and Prevention provides information on risk factors and H1N1
doi:10.1371/journal.pmed.1001053
PMCID: PMC3130021  PMID: 21750667
11.  “Working the System”—British American Tobacco's Influence on the European Union Treaty and Its Implications for Policy: An Analysis of Internal Tobacco Industry Documents 
PLoS Medicine  2010;7(1):e1000202.
Katherine Smith and colleagues investigate the ways in which British American Tobacco influenced the European Union Treaty so that new EU policies advance the interests of major corporations, including those that produce products damaging to health.
Background
Impact assessment (IA) of all major European Union (EU) policies is now mandatory. The form of IA used has been criticised for favouring corporate interests by overemphasising economic impacts and failing to adequately assess health impacts. Our study sought to assess how, why, and in what ways corporations, and particularly the tobacco industry, influenced the EU's approach to IA.
Methods and Findings
In order to identify whether industry played a role in promoting this system of IA within the EU, we analysed internal documents from British American Tobacco (BAT) that were disclosed following a series of litigation cases in the United States. We combined this analysis with one of related literature and interviews with key informants. Our analysis demonstrates that from 1995 onwards BAT actively worked with other corporate actors to successfully promote a business-oriented form of IA that favoured large corporations. It appears that BAT favoured this form of IA because it could advance the company's European interests by establishing ground rules for policymaking that would: (i) provide an economic framework for evaluating all policy decisions, implicitly prioritising costs to businesses; (ii) secure early corporate involvement in policy discussions; (iii) bestow the corporate sector with a long-term advantage over other actors by increasing policymakers' dependence on information they supplied; and (iv) provide businesses with a persuasive means of challenging potential and existing legislation. The data reveal that an ensuing lobbying campaign, largely driven by BAT, helped secure binding changes to the EU Treaty via the Treaty of Amsterdam that required EU policymakers to minimise legislative burdens on businesses. Efforts subsequently focused on ensuring that these Treaty changes were translated into the application of a business orientated form of IA (cost–benefit analysis [CBA]) within EU policymaking procedures. Both the tobacco and chemical industries have since employed IA in apparent attempts to undermine key aspects of European policies designed to protect public health.
Conclusions
Our findings suggest that BAT and its corporate allies have fundamentally altered the way in which all EU policy is made by making a business-oriented form of IA mandatory. This increases the likelihood that the EU will produce policies that advance the interests of major corporations, including those that produce products damaging to health, rather than in the interests of its citizens. Given that the public health community, focusing on health IA, has largely welcomed the increasing policy interest in IA, this suggests that urgent consideration is required of the ways in which IA can be employed to undermine, as well as support, effective public health policies.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
The primary goal of public health, the branch of medicine concerned with the health of communities, is to improve lives by preventing disease. Public-health groups do this by assessing and monitoring the health of communities, by ensuring that populations have access to appropriate and cost-effective health care, and by helping to formulate public policies that safeguard human health. Until recently, most of the world's major public-health concerns related to infectious diseases. Nowadays, however, many major public-health concerns are linked to the goods made and marketed by large corporations such as fast food, alcohol, tobacco, and chemicals. In Europe, these corporations are regulated by policies drawn up both by member states and by the European Commission, the executive organ of the European Union (EU; an economic and political partnership among 27 democratic European countries). Thus, for example, the tobacco industry, which is widely recognized as a driver of the smoking epidemic, is regulated by Europe-wide tobacco control policies and member state level policies.
Why Was This Study Done?
Since 1997, the European Commission has been required by law to assess the economic, social (including health), and environmental consequences of new policy initiatives using a process called an “impact assessment” (IA). Because different types of IA examine the likely effects of policies on different aspects of daily life—a health impact assessment, for example, focuses on a policy's effect on health—the choice of IA can lead to different decisions being taken about new policies. Although the IA tool adopted by the European Commission aims to assess economic, environmental and social impacts, independent experts suggest this tool does not adequately assess health impacts. Instead, economic impacts receive the most attention, a situation that may favour the interests of large businesses. In this study, the researchers seek to identify how and why the EU's approach to IA developed. More specifically, the researchers analyze internal documents from British American Tobacco (BAT), which have been disclosed because of US litigation cases, to find out whether industry has played a role in promoting the EU's system of IA.
What Did the Researchers Do and Find?
The researchers analyzed 714 BAT internal documents (identified by searching the Legacy Tobacco Documents Library, which contains more than 10 million internal tobacco company documents) that concerned attempts made by BAT to influence regulatory reforms in Europe. They also analyzed related literature from other sources (for example, academic publications) and interviewed 16 relevant people (including people who had worked at the European Commission). This analysis shows that from 1995, BAT worked with other businesses to promote European regulatory reforms (in particular, the establishment of a business-orientated form of IA) that favor large corporations. A lobbying campaign, initiated by BAT but involving a “policy network” of other companies, first helped to secure binding changes to the EU Treaty that require policymakers to minimize legislative burdens on businesses. The analysis shows that after achieving this goal, which BAT described as an “important victory,” further lobbying ensured that these treaty changes were translated into the implementation of a business-orientated form of IA within the EU. Both the tobacco industry and the chemical industry, the researchers argue, have since used the IA to delay and/or weaken EU legislation intended to protect public health.
What Do These Findings Mean?
These findings suggest that BAT and its corporate allies have fundamentally altered the way in which EU policy is made by ensuring that all significant EU policy decisions have to be assessed using a business-orientated IA. As the authors note, this situation increases the likelihood that the EU will produce policies that favor big business rather than the health of its citizens. Furthermore, these findings suggest that by establishing a network of other industries to help in lobbying for EU Treaty changes, BAT was able to distance itself from the push to establish a business-orientated IA to the extent that Commission officials were unaware of the involvement of the tobacco industry in campaigns for IA. Thus, in future, to safeguard public health, policymakers and public-health groups must pay more attention to corporate efforts to shape decision-making processes. In addition, public-health groups must take account of the ways in which IA can be used to undermine as well as support effective public-health policies and they must collaborate more closely in their efforts to ensure effective national and international policy.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/0.1371/journal.pmed.1000202.
Wikipedia has a page on public health (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
More information on the European Union (in several languages), on public health in the European Union, and on impact assessment by the European Commission is available
The Legacy Tobacco Documents Library is a public, searchable database of tobacco company internal documents detailing their advertising, manufacturing, marketing, sales, and scientific activities
The World Health Organization provides information about the dangers of tobacco (in several languages)
The Smoke Free Partnership contains more information about smoking prevalence in Europe and about European policies to tackle the public health issues associated with tobacco use
For more information about tobacco industry influence on policy see the 2009 World Health Organization report on tobacco industry interference with tobacco control
doi:10.1371/journal.pmed.1000202
PMCID: PMC2797088  PMID: 20084098
12.  Welcome to Journal of Foot and Ankle Research: a new open access journal for foot health professionals 
Journal of Foot and Ankle Research (JFAR) is a new, open access, peer-reviewed online journal that encompasses all aspects of policy, organisation, delivery and clinical practice related to the assessment, diagnosis, prevention and management of foot and ankle disorders. JFAR will cover a wide range of clinical subject areas, including diabetology, paediatrics, sports medicine, gerontology and geriatrics, foot surgery, physical therapy, dermatology, wound management, radiology, biomechanics and bioengineering, orthotics and prosthetics, as well the broad areas of epidemiology, policy, organisation and delivery of services related to foot and ankle care. The journal encourages submission from all health professionals who manage lower limb conditions, including podiatrists, nurses, physical therapists and physiotherapists, orthopaedists, manual therapists, medical specialists and general medical practitioners, as well as health service researchers concerned with foot and ankle care. All manuscripts will undergo open peer review, and all accepted manuscripts will be freely available on-line using the open access platform of BioMed Central.
doi:10.1186/1757-1146-1-1
PMCID: PMC2547890  PMID: 18822156
13.  Child Mortality Estimation: Estimating Sex Differences in Childhood Mortality since the 1970s 
PLoS Medicine  2012;9(8):e1001287.
Cheryl Sawyer uses new methods to generate estimates of sex differences in child mortality which can be used to pinpoint areas where these differences in mortality merit closer examination.
Introduction
Producing estimates of infant (under age 1 y), child (age 1–4 y), and under-five (under age 5 y) mortality rates disaggregated by sex is complicated by problems with data quality and availability. Interpretation of sex differences requires nuanced analysis: girls have a biological advantage against many causes of death that may be eroded if they are disadvantaged in access to resources. Earlier studies found that girls in some regions were not experiencing the survival advantage expected at given levels of mortality. In this paper I generate new estimates of sex differences for the 1970s to the 2000s.
Methods and Findings
Simple fitting methods were applied to male-to-female ratios of infant and under-five mortality rates from vital registration, surveys, and censuses. The sex ratio estimates were used to disaggregate published series of both-sexes mortality rates that were based on a larger number of sources. In many developing countries, I found that sex ratios of mortality have changed in the same direction as historically occurred in developed countries, but typically had a lower degree of female advantage for a given level of mortality. Regional average sex ratios weighted by numbers of births were found to be highly influenced by China and India, the only countries where both infant mortality and overall under-five mortality were estimated to be higher for girls than for boys in the 2000s. For the less developed regions (comprising Africa, Asia excluding Japan, Latin America/Caribbean, and Oceania excluding Australia and New Zealand), on average, boys' under-five mortality in the 2000s was about 2% higher than girls'. A number of countries were found to still experience higher mortality for girls than boys in the 1–4-y age group, with concentrations in southern Asia, northern Africa/western Asia, and western Africa. In the more developed regions (comprising Europe, northern America, Japan, Australia, and New Zealand), I found that the sex ratio of infant mortality peaked in the 1970s or 1980s and declined thereafter.
Conclusions
The methods developed here pinpoint regions and countries where sex differences in mortality merit closer examination to ensure that both sexes are sharing equally in access to health resources. Further study of the distribution of causes of death in different settings will aid the interpretation of differences in survival for boys and girls.
Please see later in the article for the Editors' Summary.
Editors' Summary
Background
In 2000, world leaders agreed to eradicate extreme poverty by 2015. To help track progress towards this global commitment, eight Millennium Development Goals (MDGs) were set. MDG 4, which aims to reduce child mortality, calls for a reduction in under-five mortality (the number of children who die before their fifth birthday) to a third of its 1990 level of 12 million by 2015. The under-five mortality rate is also denoted in the literature as U5MR and 5q0. Progress towards MDG 4 has been substantial, but with only three years left to reach it, efforts to strengthen child survival programs are intensifying. Reliable estimates of trends in childhood mortality are pivotal to these efforts. So, since 2004, the United Nations Inter-agency Group for Child Mortality Estimation (UN IGME) has used statistical regression models to produce estimates of trends in under-five mortality and infant mortality (death before age one year) from data about childbearing and child survival collected by vital registration systems (records of all births and deaths), household surveys, and censuses.
Why Was This Study Done?
In addition to estimates of overall childhood mortality trends, information about sex-specific childhood mortality trends is desirable to monitor progress towards MDG 4, although the interpretation of trends in the relative mortality of girls and boys is not straightforward. Newborn girls survive better than newborn boys because they are less vulnerable to birth complications and infections and have fewer inherited abnormalities. Thus, the ratio of infant mortality among boys to infant mortality among girls is greater than one, provided both sexes have equal access to food and medical care. Beyond early infancy, girls and boys are similarly vulnerable to infections, so the sex ratio of deaths in the 1–4-year age group is generally lower than that of infant mortality. Notably, as living conditions improve in developing countries, infectious diseases become less important as causes of death. Thus, in the absence of sex-specific differences in the treatment of children, the sex ratio of childhood mortality is expected be greater than one and to increase as overall under-five mortality rates in developing countries decrease. In this study, the researcher evaluated national and regional changes in the sex ratios of childhood mortality since the 1970s to investigate whether girls and boys have equal access to medical care and other resources.
What Did the Researcher Do and Find?
The researcher developed new statistical fitting methods to estimate trends in the sex ratio of mortality for infants and young children for individual countries and world regions. When considering individual countries, the researcher found that for 92 countries in less developed regions, the median sex ratio of under-five mortality increased between the 1970s and the 2000s, in line with the expected changes just described. However, the average sex ratio of under-five mortality for less developed regions, weighted according to the number of births in each country, did not increase between the 1970s and 2000s, at which time the average under-five mortality rate of boys was about 2% higher than that of girls. This discrepancy resulted from India and China—the two most populous developing countries—having sex ratios for both infant and under-five mortality that remained constant or declined over the study period and were below one in the 2000s, a result that indicates excess female mortality. In China, for example, infant mortality was found to be 12% higher for boys than for girls in the 1970s, but 24% lower for boys than for girls in the 2000s. Finally, although in the less developed regions (excluding India and China) girls went from having a slight survival disadvantage at ages 1–4 years in the 1970s, on average, to having a slight advantage in the 2000s, girls remained more likely to die than boys in this age group in several Asian and African countries.
What Do These Findings Mean?
Although the quality of the available data is likely to affect the accuracy of these findings, in most developing countries the ratio of male to female under-five mortality has increased since the 1970s, in parallel with the decrease in overall childhood mortality. Notably, however, in a number of developing countries—including several each in sub-Saharan Africa, northern Africa/western Asia, and southern Asia—girls have higher mortality than boys at ages 1–4 years, and in India and China girls have higher mortality in infancy. Thus, girls are benefitting less than boys from the overall decline in childhood mortality in India, China, and some other developing countries. Further studies are needed to determine the underlying reasons for this observation. Nevertheless, the methods developed here to estimate trends in sex-specific childhood mortality pinpoint countries and regions where greater efforts should be made to ensure that both sexes have equal access to health care and other important resources during early life.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001287.
This paper is part of a collection of papers on Child Mortality Estimation Methods published in PLOS Medicine
The United Nations Childrens Fund works for children's rights, survival, development, and protection around the world; it provides information on Millennium Development Goal 4, and its Childinfo website provides detailed statistics about child survival and health, including a description of the United Nations Inter-agency Group for Child Mortality Estimation; the 2011 UN IGME report Levels & Trends in Child Mortality is available
The World Health Organization also has information about Millennium Development Goal 4 and provides estimates of child mortality rates (some information in several languages)
Further information about the Millennium Development Goals is available
A 2011 report by the United Nations Department of Economic and Social Affairs entitled Sex Differentials in Childhood Mortality is available
doi:10.1371/journal.pmed.1001287
PMCID: PMC3429399  PMID: 22952433
14.  Steps toward improving diet and exercise for cancer survivors (STRIDE): a quasi-randomised controlled trial protocol 
BMC Cancer  2014;14:428.
Background
Cancer survivorship rates have increased in developed countries largely due to population ageing and improvements in cancer care. Survivorship is a neglected phase of cancer treatment and is often associated with adverse physical and psychological effects. There is a need for broadly accessible, non-pharmacological measures that may prolong disease-free survival, reduce or alleviate co-morbidities and enhance quality of life. The aim of the Steps TowaRd Improving Diet and Exercise (STRIDE) study is to evaluate the effectiveness of an online-delivered physical activity intervention for increasing walking in cancer survivors living in metropolitan and rural areas of South Australia.
Methods/Design
This is a quasi-randomised controlled trial. The intervention period is 12-weeks with 3-month follow-up. The trial will be conducted at a university setting and community health services in South Australia. Participants will be insufficiently active and aged 18 years or older. Participants will be randomly assigned to either the intervention or control group. All participants will receive a pedometer but only the intervention group will have access to the STRIDE website where they will report steps, affect and ratings of perceived exertion (RPE) during exercise daily. Researchers will use these variables to individualise weekly step goals to increase walking.
The primary outcome measure is steps per day. The secondary outcomes are a) health measures (anthropometric and physiological), b) dietary habits (consumption of core foods and non-core foods) and c) quality of life (QOL) including physical, psychological and social wellbeing. Measures will be collected at baseline, post-intervention and 3-month follow-up.
Discussion
This protocol describes the implementation of a trial using an online resource to assist cancer survivors to become more physically active. It is an innovative tool that uses ratings of perceived exertion and daily affect to create individualised step goals for cancer survivors. The research findings may be of relevance to public health policy makers as an efficacious and inexpensive online-delivered intervention can have widespread application and may improve physical and psychological outcomes among this vulnerable population. Findings may indicate directions for the implementation of future physical activity interventions with this population.
Trial registration
Australian New Zealand Clinical Trials Registry: ACTRN12613000473763.
doi:10.1186/1471-2407-14-428
PMCID: PMC4067363  PMID: 24923623
Physical activity; Walking; Pedometer; Cancer survivorship; Online intervention; Lifestyle intervention
15.  Cost-Effectiveness of Interventions to Promote Physical Activity: A Modelling Study 
PLoS Medicine  2009;6(7):e1000110.
Linda Cobiac and colleagues model the costs and health outcomes associated with interventions to improve physical activity in the population, and identify specific interventions that are likely to be cost-saving.
Background
Physical inactivity is a key risk factor for chronic disease, but a growing number of people are not achieving the recommended levels of physical activity necessary for good health. Australians are no exception; despite Australia's image as a sporting nation, with success at the elite level, the majority of Australians do not get enough physical activity. There are many options for intervention, from individually tailored advice, such as counselling from a general practitioner, to population-wide approaches, such as mass media campaigns, but the most cost-effective mix of interventions is unknown. In this study we evaluate the cost-effectiveness of interventions to promote physical activity.
Methods and Findings
From evidence of intervention efficacy in the physical activity literature and evaluation of the health sector costs of intervention and disease treatment, we model the cost impacts and health outcomes of six physical activity interventions, over the lifetime of the Australian population. We then determine cost-effectiveness of each intervention against current practice for physical activity intervention in Australia and derive the optimal pathway for implementation. Based on current evidence of intervention effectiveness, the intervention programs that encourage use of pedometers (Dominant) and mass media-based community campaigns (Dominant) are the most cost-effective strategies to implement and are very likely to be cost-saving. The internet-based intervention program (AUS$3,000/DALY), the GP physical activity prescription program (AUS$12,000/DALY), and the program to encourage more active transport (AUS$20,000/DALY), although less likely to be cost-saving, have a high probability of being under a AUS$50,000 per DALY threshold. GP referral to an exercise physiologist (AUS$79,000/DALY) is the least cost-effective option if high time and travel costs for patients in screening and consulting an exercise physiologist are considered.
Conclusions
Intervention to promote physical activity is recommended as a public health measure. Despite substantial variability in the quantity and quality of evidence on intervention effectiveness, and uncertainty about the long-term sustainability of behavioural changes, it is highly likely that as a package, all six interventions could lead to substantial improvement in population health at a cost saving to the health sector.
Please see later in the article for Editors' Summary
Editors' Summary
Background
The human body needs regular physical activity throughout life to stay healthy. Physical activity—any bodily movement produced by skeletal muscles that uses energy—helps to maintain a healthy body weight and to prevent or delay heart disease, stroke, type 2 diabetes, colon cancer, and breast cancer. In addition, physically active people feel better and live longer than physically inactive people. For an adult, 30 minutes of moderate physical activity—walking briskly, gardening, swimming, or cycling—at least five times a week is sufficient to promote and maintain health. But at least 60% of the world's population does not do even this modest amount of physical activity. The daily lives of people in both developed and developing countries are becoming increasingly sedentary. People are sitting at desks all day instead of doing manual labor; they are driving to work in cars instead of walking or cycling; and they are participating less in physical activities during their leisure time.
Why Was This Study Done?
In many countries, the chronic diseases that are associated with physical inactivity are now a major public-health problem; globally, physical inactivity causes 1.9 million deaths per year. Clearly, something has to be done about this situation. Luckily, there is no shortage of interventions designed to promote physical activity, ranging from individual counseling from general practitioners to mass-media campaigns. But which intervention or package of interventions will produce the optimal population health benefits relative to cost? Although some studies have examined the cost-effectiveness of individual interventions, different settings for analysis and use of different methods and assumptions make it difficult to compare results and identify which intervention approaches should be give priority by policy makers. Furthermore, little is known about the cost-effectiveness of packages of interventions. In this study, the researchers investigate the cost-effectiveness in Australia (where physical inactivity contributes to 10% of deaths) of a package of interventions designed to promote physical activity in adults using a standardized approach (ACE-Prevention) to the assessment of the cost-effectiveness of health-care interventions.
What Did the Researchers Do and Find?
The researchers selected six interventions for their study: general practitioner “prescription” of physical activity; general practitioner referral to an exercise physiologist; a mass-media campaign to promote physical activity; the TravelSmart car use reduction program; a campaign to encourage the use of pedometers to increase physical activity; and an internet-based program. Using published data on the effects of physical activity on the amount of illness and death caused by breast and colon cancer, heart disease, stroke, and type 2 diabetes and on the effectiveness of each intervention, the researchers calculated the health outcomes of each intervention in disability-adjusted life years (DALY; a year of healthy life lost because of premature death or disability) averted over the lifetime of the Australian population. They also calculated the costs associated with each intervention offset by the costs associated with the five conditions listed above. These analyses showed that the pedometer program and the mass-media campaign were likely to be the most cost-effective interventions. These interventions were also most likely to be cost-saving. Referral to an exercise physiologist was the least cost-effective intervention. The other three interventions, though unlikely to be cost-saving, were likely to be cost-effective. Finally, a package of all six interventions would be cost-effective and would avert 61,000 DALYs, a third of what could be achieved if every Australian did 30 minutes of physical activity five times a week.
What Do These Findings Mean?
As in all modeling studies, these findings depend on the quality of the data and on the assumptions included by the researchers in their calculations. Unfortunately, there was substantial variability in the quantity and quality of evidence on the effectiveness of each intervention and uncertainty about the long-term effects of each intervention. Nevertheless, the findings presented in this study suggest that the assessment of the cost-effectiveness of a combination of interventions designed to promote physical activity might provide policy makers with some guidance about the best way to reduce the burden of disease caused by physical inactivity. More specifically, for Australia, these findings suggest that the package of the six interventions considered here is likely to provide a cost-effective way to substantially improve the health of the nation.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000110.
The World Health Organization provides information about physical activity and health (in several languages); it also provides an explanation of DALYs
The US Centers for Disease Control and Prevention provides information on physical activity for different age groups and for health professionals
The UK National Health Service information source Choices also explains the benefits of regular physical activity
MedlinePlus has links to other resources about exercise and physical fitness (in English and Spanish)
The University of Queensland Web site has more information on ACE-Prevention (Assessing Cost-Effectiveness Prevention)
doi:10.1371/journal.pmed.1000110
PMCID: PMC2700960  PMID: 19597537
16.  Integrating evidence into policy and sustainable disability services delivery in western New South Wales, Australia: the 'wobbly hub and double spokes' project 
Background
Policy that supports rural allied health service delivery is important given the shortage of services outside of Australian metropolitan centres. The shortage of allied health professionals means that rural clinicians work long hours and have little peer or service support. Service delivery to rural and remote communities is further complicated because relatively small numbers of clients are dispersed over large geographic areas. The aim of this five-year multi-stage project is to generate evidence to confirm and develop evidence-based policies and to evaluate their implementation in procedures that allow a regional allied health workforce to more expeditiously respond to disability service need in regional New South Wales, Australia.
Methods/Design
The project consists of four inter-related stages that together constitute a full policy cycle. It uses mixed quantitative and qualitative methods, guided by key policy concerns such as: access, complexity, cost, distribution of benefits, timeliness, effectiveness, equity, policy consistency, and community and political acceptability.
Stage 1 adopts a policy analysis approach in which existing relevant policies and related documentation will be collected and reviewed. Policy-makers and senior managers within the region and in central offices will be interviewed about issues that influence policy development and implementation.
Stage 2 uses a mixed methods approach to collecting information from allied health professionals, clients, and carers. Focus groups and interviews will explore issues related to providing and receiving allied health services. Discrete Choice Experiments will elicit staff and client/carer preferences.
Stage 3 synthesises Stage 1 and 2 findings with reference to the key policy issues to develop and implement policies and procedures to establish several innovative regional workforce and service provision projects.
Stage 4 uses mixed methods to monitor and evaluate the implementation and impact of new or adapted policies that arise from the preceding stages.
Discussion
The project will provide policy makers with research evidence to support consideration of the complex balance between: (i) the equitable allocation of scarce resources; (ii) the intent of current eligibility and prioritisation policies; (iii) workforce constraints (and strengths); and (iv) the most effective, evidence-based clinical practice.
doi:10.1186/1472-6963-12-70
PMCID: PMC3368922  PMID: 22436650
Rural; Remote; Regional; Allied health; Disability; Workforce; Retention; Policy; Service provision; Access
17.  Journal of Orthopaedic Surgery and Research Editorial 
Journal of Orthopaedic Surgery and Research is an open access, online journal that aims to expeditiously publish clinical and basic research studies related to musculoskeletal issues in different cultural communities. It provides a platform for exchanges of new clinical and scientific information in the most precise and expeditious way to achieve dissemination of information and cross-fertilization of ideas. The open access nature of this journal allows articles to be universally and freely accessible via the Internet. This ensures a rapid and efficient communication of research findings. The journal welcomes all types of articles related to musculoskeletal issues. Its timely publication and high visibility are the two most important features that make this journal different from other traditional journals in the orthopaedic field.
doi:10.1186/1749-799X-1-1
PMCID: PMC1634995  PMID: 17150116
18.  Why a new online open access journal in the field of clinical and epidemiological research in mental health? 
Clinical Practice and Epidemiology in Mental Health will encompass all aspects of clinical and epidemiological research in psychiatry and mental health, and will aim to build a bridge between clinical and epidemiological research. There are several outstanding mental heath journals covering all aspects of this dynamic field, but none of these journals is devoted to bridging clinical and epidemiological research. The Open Access online distribution of the journal and its inclusion in the leading data bases (such as PubMed Central) will ensure widespread and ready visibility, which are indispensable given the demand for immediate debate and comparison of scientific findings. This launch Editorial provides an overview of the field, and highlights some of the journal policies.
doi:10.1186/1745-0179-1-1
PMCID: PMC1151593  PMID: 15967051
psychiatry; epidemiology; clinical practice; mental health; publication; scientific journals; online journals; Open Access; psychiatric journals
19.  A randomised controlled trial of an intervention to increase the implementation of a healthy canteen policy in Australian primary schools: study protocol 
Background
The implementation of healthy school canteen policies has been recommended as a strategy to help prevent unhealthy eating and excessive weight gain. Internationally, research suggests that schools often fail to implement practices consistent with healthy school canteen policies. Without a population wide implementation, the potential benefits of these policies will not be realised. The aim of this trial is to assess the effectiveness of an implementation intervention in increasing school canteen practices consistent with a healthy canteen policy of the New South Wales (NSW), Australia, government known as the ‘Fresh Tastes @ School NSW Healthy School Canteen Strategy’.
Methods/design
The parallel randomised trial will be conducted in 70 primary schools located in the Hunter region of New South Wales, Australia. Schools will be eligible to participate if they are not currently meeting key components of the healthy canteen policy. Schools will be randomly allocated after baseline data collection in a 1:1 ratio to either an intervention or control group using a computerised random number function in Microsoft Excel. Thirty-five schools will be selected to receive a multi-component intervention including implementation support from research staff, staff training, resources, recognition and incentives, consensus and leadership strategies, follow-up support and implementation feedback. The 35 schools allocated to the control group will not receive any intervention support as part of the research trial. The primary outcome measures will be i) the proportion of schools with a canteen menu that does not contain foods or beverages restricted from regular sale (‘red’ and ‘banned’ items) and ii) the proportion of schools where healthy canteen items (‘green’ items) represent the majority (>50%) of products listed on the menu. Outcome data will be collected via a comprehensive menu audit, conducted by dietitians blind to group allocation. Intervention effectiveness will be assessed using logistic regression models adjusting for baseline values.
Discussion
The proposed trial will represent a novel contribution to the literature, being the first randomised trial internationally to examine the effectiveness of an intervention to facilitate implementation of a healthy canteen policy.
Trial registration
Australian New Zealand Clinical Trials Registry ACTRN12613000311752
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-014-0147-3) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-014-0147-3
PMCID: PMC4197283  PMID: 25300221
Healthy eating; Canteens; Schools; Policy; Nutrition; Children; Implementation
20.  Timing and Completeness of Trial Results Posted at ClinicalTrials.gov and Published in Journals 
PLoS Medicine  2013;10(12):e1001566.
Agnes Dechartres and colleagues searched ClinicalTrials.gov for completed drug RCTs with results reported and then searched for corresponding studies in PubMed to evaluate timeliness and completeness of reporting.
Please see later in the article for the Editors' Summary
Background
The US Food and Drug Administration Amendments Act requires results from clinical trials of Food and Drug Administration–approved drugs to be posted at ClinicalTrials.gov within 1 y after trial completion. We compared the timing and completeness of results of drug trials posted at ClinicalTrials.gov and published in journals.
Methods and Findings
We searched ClinicalTrials.gov on March 27, 2012, for randomized controlled trials of drugs with posted results. For a random sample of these trials, we searched PubMed for corresponding publications. Data were extracted independently from ClinicalTrials.gov and from the published articles for trials with results both posted and published. We assessed the time to first public posting or publishing of results and compared the completeness of results posted at ClinicalTrials.gov versus published in journal articles. Completeness was defined as the reporting of all key elements, according to three experts, for the flow of participants, efficacy results, adverse events, and serious adverse events (e.g., for adverse events, reporting of the number of adverse events per arm, without restriction to statistically significant differences between arms for all randomized patients or for those who received at least one treatment dose).
From the 600 trials with results posted at ClinicalTrials.gov, we randomly sampled 50% (n = 297) had no corresponding published article. For trials with both posted and published results (n = 202), the median time between primary completion date and first results publicly posted was 19 mo (first quartile = 14, third quartile = 30 mo), and the median time between primary completion date and journal publication was 21 mo (first quartile = 14, third quartile = 28 mo). Reporting was significantly more complete at ClinicalTrials.gov than in the published article for the flow of participants (64% versus 48% of trials, p<0.001), efficacy results (79% versus 69%, p = 0.02), adverse events (73% versus 45%, p<0.001), and serious adverse events (99% versus 63%, p<0.001).
The main study limitation was that we considered only the publication describing the results for the primary outcomes.
Conclusions
Our results highlight the need to search ClinicalTrials.gov for both unpublished and published trials. Trial results, especially serious adverse events, are more completely reported at ClinicalTrials.gov than in the published article.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
When patients consult a doctor, they expect to be recommended what their doctor believes is the most effective treatment with the fewest adverse effects. To determine which treatment to recommend, clinicians rely on sources that include research studies. Among studies, the best evidence is generally agreed to come from systematic reviews and randomized controlled clinical trials (RCTs), studies that test the efficacy and safety of medical interventions by comparing clinical outcomes in groups of patients randomly chosen to receive different interventions. Decision-making based on the best available evidence is called evidence-based medicine. However, evidence-based medicine can only guide clinicians if trial results are published in a timely and complete manner. Unfortunately, underreporting of trials is common. For example, an RCT in which a new drug performs better than existing drugs is more likely to be published than one in which the new drug performs badly or has unwanted adverse effects (publication bias). There can also be a delay in publishing the results of negative trials (time-lag bias) or a failure to publish complete results for all the prespecified outcomes of a trial (reporting bias). All three types of bias threaten informed medical decision-making and the health of patients.
Why Was This Study Done?
One initiative that aims to prevent these biases was included in the 2007 US Food and Drug Administration Amendments Act (FDAAA). The Food and Drug Administration (FDA) is responsible for approving drugs and devices that are marketed in the US. The FDAAA requires that results from clinical trials of FDA-approved drugs and devices conducted in the United States be made publicly available at ClinicalTrials.gov within one year of trial completion. ClinicalTrials.gov—a web-based registry that includes US and international clinical trials—was established in 2000 in response to the 1997 FDA Modernization Act, which required mandatory registration of trial titles and designs and of the conditions and interventions under study. The FDAAA expanded these mandatory requirements by requiring researchers studying FDA-approved drugs and devices to report additional information such as the baseline characteristics of the participants in each arm of the trial and the results of primary and secondary outcome measures (the effects of the intervention on predefined clinical measurements) and their statistical significance (an indication of whether differences in outcomes might have happened by chance). Researchers of other trials registered in ClinicalTrials.gov are welcome to post trial results as well. Here, the researchers compare the timing and completeness (i.e., whether all relevant information was fully reported) of results of drug trials posted at ClinicalTrials.gov with those published in medical journals.
What Did the Researchers Do and Find?
The researchers searched ClinicalTrials.gov for reports of completed phase III and IV (late-stage) RCTs of drugs with posted results. For a random sample of 600 eligible trials, they searched PubMed (a database of biomedical publications) for corresponding publications. Only 50% of trials with results posted at ClinicalTrials.gov had a matching published article. For 202 trials with both posted and published results, the researchers compared the timing and completeness of the results posted at ClinicalTrials.gov and of results reported in the corresponding journal publication. The median time between the study completion date and the first results being publicly posted at ClinicalTrials.gov was 19 months, whereas the time between completion and publication in a journal was 21 months. The flow of participants through trials was completely reported in 64% of the ClinicalTrials.gov postings but in only 48% of the corresponding publications. Results for the primary outcome measure were completely reported in 79% and 69% of the ClinicalTrials.gov postings and corresponding publications, respectively. Finally, adverse events were completely reported in 73% of the ClinicalTrials.gov postings but in only 45% of the corresponding publications, and serious adverse events were reported in 99% and 63% of the ClinicalTrials.gov postings and corresponding publications, respectively.
What Do These Findings Mean?
These findings suggest that the reporting of trial results is significantly more complete at ClinicalTrials.gov than in published journal articles reporting the main trial results. Certain aspects of this study may affect the accuracy of this conclusion. For example, the researchers compared the results posted at ClinicalTrials.gov only with the results in the publication that described the primary outcome of each trial, even though some trials had multiple publications. Importantly, these findings suggest that, to enable patients and physicians to make informed treatment decisions, experts undertaking assessments of drugs should consider seeking efficacy and safety data posted at ClinicalTrials.gov, both for trials whose results are not published yet and for trials whose results are published. Moreover, they suggest that the use of templates to guide standardized reporting of trial results in journals and broader mandatory posting of results may help to improve the reporting and transparency of clinical trials and, consequently, the evidence available to inform treatment of patients.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001566.
Wikipedia has pages on evidence-based medicine and on publication bias (note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The US Food and Drug Administration provides information about drug approval in the US for consumers and health-care professionals, plus detailed information on the 2007 Food and Drug Administration Amendments Act
ClinicalTrials.gov provides information about the US National Institutes of Health clinical trial registry, including background information about clinical trials, and a fact sheet detailing the requirements of the 2007 Food and Drug Administration Amendments Act
PLOS Medicine recently launched a Reporting Guidelines Collection, an open access collection of reporting guidelines, commentary, and related research on guidelines from across PLOS journals that aims to help advance the efficiency, effectiveness, and equitability of the dissemination of biomedical information; a 2008 PLOS Medicine editorial discusses the 2007 Food and Drug Administration Amendments Act
doi:10.1371/journal.pmed.1001566
PMCID: PMC3849189  PMID: 24311990
21.  Assessing the capacity of the health services research community in Australia and New Zealand 
Background
In order to profile the health services research community in Australia and New Zealand and describe its capacity, a web-based survey was administered to members of the Health Services Research Association of Australia and New Zealand (HSRAANZ) and delegates of the HSRAANZ's Third Health Services Research and Policy Conference.
Results
Responses were received from 191 individuals (68%). The responses of the 165 (86%) who conducted or managed health services research indicated that the health services research community in Australia and New Zealand is characterised by highly qualified professionals who have come to health services research via a range of academic and professional routes (including clinical backgrounds), the majority of whom are women aged between 35 and 54 who have mid- to senior- level appointments. They are primarily employed in universities and, to a lesser extent, government departments and health services. Although most are employed in full time positions, many are only able to devote part of their time to health services research, often juggling this with other professional roles. They rely heavily on external funding, as only half have core funding from their employing institution and around one third have employment contracts of one year or less. Many view issues around building the capacity of the health services research community and addressing funding deficits as crucial if health services research is to be translated into policy and practice. Despite the difficulties they face, most are positive about the support and advice available from peers in their work settings, and many are actively contributing to knowledge through academic and other written outputs.
Conclusion
If health services research is to achieve its potential in Australia and New Zealand, policy-makers and funders must take the concerns of the health services research community seriously, foster its development, and contribute to maximising its capacity through a sustainable approach to funding. There is a clear need for a strategic approach, where the health services research community collaborates with competitive granting bodies and government departments to define and fund a research agenda that balances priority-driven and investigator-driven research and which provides support for training and career development.
doi:10.1186/1743-8462-2-4
PMCID: PMC1079789  PMID: 15755322
Health services research; capacity; resources; funding; outputs; Australia; New Zealand
22.  Immunity & Ageing: a new journal looking at ageing from an immunological point of view 
In the elderly, many alterations of both innate and clonotypic immunity have been described. Alterations to the immune system in the elderly are generally viewed as a deterioration of immunity, leading to the use of the term immunosenescence. However, although many immunological parameters are often notably reduced in the elderly, retained function of both innate and clonotypic immunity in the elderly is tightly correlated to health status. Recognising the important role of the immune system in ageing, over the last few years, journals oriented towards gerontology and geriatric sciences have increasingly published articles dealing with the immunology of ageing, but a specialised journal in this area does not exist. Immunity & Ageing is a new Open Access, peer reviewed journal that aims to cover all the topics dealing with innate and clonotypic immunity which are relevant to ageing. The journal will provide an opportunity to focus on this topic, which is emerging as one of the critical mechanisms of ageing. Furthermore, as an online, Open Access journal, Immunity & Ageing will promote immediate accessibility to research, which is generally not possible for articles published in printed journals. We hope this forum, concentrating on the themes of ageing and immunology with a strong focus on human studies, will create a new perspective for viewing a world that is inevitably becoming older.
doi:10.1186/1742-4933-1-1
PMCID: PMC544954  PMID: 15679921
ageing; immunosenescence; inflammation; open access
23.  Global Mortality Estimates for the 2009 Influenza Pandemic from the GLaMOR Project: A Modeling Study 
PLoS Medicine  2013;10(11):e1001558.
Lone Simonsen and colleagues use a two-stage statistical modeling approach to estimate the global mortality burden of the 2009 influenza pandemic from mortality data obtained from multiple countries.
Please see later in the article for the Editors' Summary
Background
Assessing the mortality impact of the 2009 influenza A H1N1 virus (H1N1pdm09) is essential for optimizing public health responses to future pandemics. The World Health Organization reported 18,631 laboratory-confirmed pandemic deaths, but the total pandemic mortality burden was substantially higher. We estimated the 2009 pandemic mortality burden through statistical modeling of mortality data from multiple countries.
Methods and Findings
We obtained weekly virology and underlying cause-of-death mortality time series for 2005–2009 for 20 countries covering ∼35% of the world population. We applied a multivariate linear regression model to estimate pandemic respiratory mortality in each collaborating country. We then used these results plus ten country indicators in a multiple imputation model to project the mortality burden in all world countries. Between 123,000 and 203,000 pandemic respiratory deaths were estimated globally for the last 9 mo of 2009. The majority (62%–85%) were attributed to persons under 65 y of age. We observed a striking regional heterogeneity, with almost 20-fold higher mortality in some countries in the Americas than in Europe. The model attributed 148,000–249,000 respiratory deaths to influenza in an average pre-pandemic season, with only 19% in persons <65 y. Limitations include lack of representation of low-income countries among single-country estimates and an inability to study subsequent pandemic waves (2010–2012).
Conclusions
We estimate that 2009 global pandemic respiratory mortality was ∼10-fold higher than the World Health Organization's laboratory-confirmed mortality count. Although the pandemic mortality estimate was similar in magnitude to that of seasonal influenza, a marked shift toward mortality among persons <65 y of age occurred, so that many more life-years were lost. The burden varied greatly among countries, corroborating early reports of far greater pandemic severity in the Americas than in Australia, New Zealand, and Europe. A collaborative network to collect and analyze mortality and hospitalization surveillance data is needed to rapidly establish the severity of future pandemics.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Every winter, millions of people catch influenza—a viral infection of the airways—and hundreds of thousands of people (mainly elderly individuals) die as a result. These seasonal epidemics occur because small but frequent changes in the influenza virus mean that the immune response produced by infection with one year's virus provides only partial protection against the next year's virus. Influenza viruses also occasionally emerge that are very different. Human populations have virtually no immunity to these new viruses, which can start global epidemics (pandemics) that kill millions of people. The most recent influenza pandemic, which was first recognized in Mexico in March 2009, was caused by the 2009 influenza A H1N1 pandemic (H1N1pdm09) virus. This virus spread rapidly, and on 11 June 2009, the World Health Organization (WHO) declared that an influenza pandemic was underway. H1N1pdm09 caused a mild disease in most people it infected, but by the time WHO announced that the pandemic was over (10 August 2010), there had been 18,632 laboratory-confirmed deaths from H1N1pdm09.
Why Was This Study Done?
The modest number of laboratory-confirmed H1N1pdm09 deaths has caused commentators to wonder whether the public health response to H1N1pdm09 was excessive. However, as is the case with all influenza epidemics, the true mortality (death) burden from H1N1pdm09 is substantially higher than these figures indicate because only a minority of influenza-related deaths are definitively diagnosed by being confirmed in laboratory. Many influenza-related deaths result from secondary bacterial infections or from exacerbation of preexisting chronic conditions, and are not recorded as related to influenza infection. A more complete assessment of the impact of H1N1pdm09 on mortality is essential for the optimization of public health responses to future pandemics. In this modeling study (the Global Pandemic Mortality [GLaMOR] project), researchers use a two-stage statistical modeling approach to estimate the global mortality burden of the 2009 influenza pandemic from mortality data obtained from multiple countries.
What Did the Researchers Do and Find?
The researchers obtained weekly virology data from the World Health Organization FluNet database and national influenza centers to identify influenza active periods, and obtained weekly national underlying cause-of-death time series for 2005–2009 from collaborators in more than 20 countries (35% of the world's population). They used a multivariate linear regression model to measure the numbers and rates of pandemic influenza respiratory deaths in each of these countries. Then, in the second stage of their analysis, they used a multiple imputation model that took into account country-specific geographical, economic, and health indicators to project the single-country estimates to all world countries. The researchers estimated that between 123,000 and 203,000 pandemic influenza respiratory deaths occurred globally from 1 April through 31 December 2009. Most of these deaths (62%–85%) occurred in people younger than 65 years old. There was a striking regional heterogeneity in deaths, with up to 20-fold higher mortality in Central and South American countries than in European countries. Finally, the model attributed 148,000–249,000 respiratory deaths to influenza in an average pre-pandemic season. Notably, only 19% of these deaths occurred in people younger than 65 years old.
What Do These Findings Mean?
These findings suggest that respiratory mortality from the 2009 influenza pandemic was about 10-fold higher than laboratory-confirmed mortality. The true total mortality burden is likely to be even higher because deaths that occurred late in the winter of 2009–2010 and in later pandemic waves were missed in this analysis, and only pandemic influenza deaths that were recorded as respiratory deaths were included. The lack of single-country estimates from low-income countries may also limit the accuracy of these findings. Importantly, although the researchers' estimates of mortality from H1N1pdm09 and from seasonal influenza were of similar magnitude, the shift towards mortality among younger people means that more life-years were lost during the 2009 influenza pandemic than during an average pre-pandemic influenza season. Although the methods developed by the GLaMOR project can be used to make robust and comparable mortality estimates in future influenza pandemics, the lack of timeliness of such estimates needs to be remedied. One potential remedy, suggest the researchers, would be to establish a collaborative network that analyzes timely hospitalization and/or mortality data provided by sentinel countries. Such a network should be able to provide the rapid and reliable data about the severity of pandemic threats that is needed to guide public health policy decisions.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001558.
The US Centers for Disease Control and Prevention provides information about influenza for patients and professionals, including archived information on H1N1pdm09
Flu.gov, a US government website, provides access to information on seasonal and pandemic influenza H1N1pdm09
The World Health Organization provides information on influenza and on the global response to H1N1pdm09, including a publication on the evolution of H1N1pdm09 (some information in several languages). Information on FluNet, a global tool for influenza surveillance, is also available
Public Health England provides information on pandemic influenza and archived information on H1N1pdm09
More information for patients about H1N1pdm09 is available through Choices, an information resource provided by the UK National Health Service
More information about the GLaMOR project is available
doi:10.1371/journal.pmed.1001558
PMCID: PMC3841239  PMID: 24302890
24.  Lessons for a national pharmaceuticals strategy in Canada from Australia and New Zealand 
BACKGROUND:
The provincial formulary review processes in Canada lead to the slow and inequitable availability of new products. In 2004, the exploration of a national pharmaceuticals strategy (NPS) was announced. The pricing policies of New Zealand and Australia have been suggested as possible models for the NPS.
OBJECTIVE:
To compare health care indexes and health care use information from Canada, Australia and New Zealand.
METHODS:
The 2006 Organisation for Economic Co-operation and Development health data were used to compare health and health care indexes from Canada, Australia and New Zealand between 1994 and 2002 to 2004. The principal focus of the evaluation was cardiovascular and respiratory disorders.
RESULTS:
Although the mortality rate from acute myocardial infarction decreased in each country from 1994, it levelled off in New Zealand in 1997, 1998 and 1999. Between 1994 and 2003, the average length of hospital stay for any cause and for cardiovascular disorders was stable in Australia and Canada, but increased in New Zealand, while the rate of hospital discharges for cardiovascular diseases decreased in Canada and Australia, but strongly increased in New Zealand. Over the same period, sales of cardiovascular drugs decreased in New Zealand, while sharply increasing in Canada and Australia.
CONCLUSIONS:
Although only circumstantial, our results suggest an association between decreasing cardiovascular drug sales and markers of declining cardiovascular health in New Zealand. Careful consideration must be given to the potential consequences of any model for an NPS in Canada, as well as to opportunities provided for discussion and input from health care professionals and patients.
PMCID: PMC2651914  PMID: 17622393
Canadian health care system; Health outcomes; Health policy; Prescription drugs
25.  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

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