Transparency in surgical randomized clinical trials: cross-sectional observational study.

BACKGROUND: RCTs provide the scientific basis upon which treatment decisions are made. To facilitate critical review, it is important that methods and results are reported transparently. The aim of this study was to explore transparency in surgical RCTs with respect to trial registration, disclosure of funding sources, declarations of investigator conflicts and data-sharing. METHODS: This was a cross-sectional review of published surgical RCTs. Ten high-impact journals were searched systematically for RCTs published in years 2009, 2012, 2015 and 2018. Four domains of transparency were explored: trial registration, disclosure of funding, disclosure of investigator conflicts, and a statement relating to data-sharing. RESULTS: Of 611 RCTs, 475 were eligible for analysis. Some 397 RCTs (83.6 per cent) were registered on a trial database, of which 190 (47·9 per cent) had been registered prospectively. Prospective registration increased over time (26 per cent in 2009, 33·0 per cent in 2012, 54 per cent in 2015, and 72·7 per cent in 2018). Funding disclosure was present in 55·0, 65·0, 69·4 and 75·4 per cent of manuscripts respectively. Conflict of interest disclosure was present in 49·5, 89·1, 94·6 and 98·3 per cent of manuscripts across the same time periods. Data-sharing statements were present in only 15 RCTs (3·2 per cent), 11 of which were published in 2018. CONCLUSION: Trial registration, disclosure of funding and disclosure of investigator conflicts in surgical RCTs have improved markedly over the past 10 years. Disclosure of data-sharing plans is exceptionally low. This may contribute to research waste and represents a target for improvement.

ANTECEDENTES: Los ensayos clínicos aleatorizados y controlados (randomized controlled trials, RCT) proporcionan la base científica para la toma de decisiones terapéuticas. Es importante que los métodos y los resultados se presenten de forma transparente para facilitar la revisión crítica. El objetivo de este estudio fue investigar la transparencia en los RCTs del ámbito quirúrgico según su registro, declaraciones de las fuentes de financiación del estudio y conflicto de interés de los investigadores, así como información referente a compartir los datos. MÉTODOS: Revisión transversal de RCTs quirúrgicos publicados. Se realizó una búsqueda sistemática de los RCTs publicados en 10 revistas de alto impacto en los años 2009, 2012, 2015 y 2018. Se exploraron cuatro dominios de transparencia: el registro de los ensayos, la declaración de los fondos utilizados, la declaración de los conflictos de los investigadores y la información referente a la forma de compartir los datos. RESULTADOS: De 611 RCTs, se incluyeron en el análisis 475. Un total de 397 (83,6%) estudios se registraron en una base de datos de ensayos clínicos, de forma prospectiva en 190 (47,9%). El registro prospectivo aumentó a lo largo del tiempo (26,0% en 2009, 33,0% en 2012, 53,5% en 2015 y 72,7% en 2018). Se mencionaban las fuentes de financiación en el 55%, 65%, 69,4% y 75,4% de los manuscritos, respectivamente. La declaración de conflictos de interés estuvo presente en el 49,5%, 89,1%, 94,6% y 98,3% de los manuscritos en esos mismos períodos de tiempo. Las declaraciones relativas a compartir los datos de la investigación constaban en solo 15 (3,2%) RCTs, 11 de los cuales fueron publicados en el 2018. CONCLUSIÓN: En los últimos 10 años ha mejorado de forma notable el registro de los ensayos y las declaraciones de las fuentes de financiación y conflicto de interés en los RCTs quirúrgicos. La declaración referente a compartir los datos es excepcionalmente baja, lo que puede contribuir al desperdicio de la investigación y constituye un objetivo de mejora.

Shortage of paediatric radiologists acting as an expert witness: position statement from the British Society of Paediatric Radiology (BSPR) National Working Group on Imaging in Suspected Physical Abuse (SPA).

One of the most challenging areas of radiological imaging in children is the diagnosis of physical abuse. There is a dearth of paediatric radiologists willing to act as expert witnesses, particularly in the family courts. There are a number of reasons why radiologists may not be interested or willing to put themselves forward to work as expert witnesses in this field. A group of imaging experts recently formed the "British Society of Paediatric Radiology (BSPR) Working Group on Imaging in Suspected Physical Abuse (SPA)". The group comprises radiologists and neuroradiologists with current or previous experience of providing expert witness reports to the court in cases of SPA. The group met in January 2019 to explore pragmatic solutions to the chronic inefficiencies in both medical and legal practices and the challenges that arise from working in a legal arena with different structures, goals, and assessment criteria. Key issues concerned organisational inefficiencies, variable support from National Health Service Trusts and the Royal College of Radiologists to conduct this work, and the risk/benefit of involvement. This work is important for the patient, parents, and society in general, and highly rewarding for clinical practitioners who are involved, but there are several issues with current practices that discourage active participation. With several members of the group either retired or close to retirement, the shortage of experts is becoming a pressing issue within the UK, which requires an engaged multidisciplinary group to come up with creative solutions. Here, the group provide a consensus opinion highlighting the current barriers and potential facilitators to increasing the number of radiologists willing to provide opinions to the court.

Who uses foodbanks and why? Exploring the impact of financial strain and adverse life events on food insecurity.

Background: Rising use of foodbanks highlights food insecurity in the UK. Adverse life events (e.g. unemployment, benefit delays or sanctions) and financial strains are thought to be the drivers of foodbank use. This research aimed to explore who uses foodbanks, and factors associated with increased food insecurity. Methods: We surveyed those seeking help from front line crisis providers from foodbanks (N = 270) and a comparison group from Advice Centres (ACs) (N = 245) in relation to demographics, adverse life events, financial strain and household food security. Results: About 55.9% of foodbank users were women and the majority were in receipt of benefits (64.8%). Benefit delays (31.9%), changes (11.1%) and low income (19.6%) were the most common reasons given for referral. Compared to AC users, there were more foodbank users who were single men without children, unemployed, currently homeless, experiencing more financial strain and adverse life events (P = 0.001). Food insecurity was high in both populations, and more severe if they also reported financial strain and adverse life events. Conclusions: Benefit-related problems appear to be a key reason for foodbank referral. By comparison with other disadvantaged groups, foodbank users experienced more financial strain, adverse life events, both increased the severity of food insecurity.

Vertebral fractures assessment in children: Evaluation of DXA imaging versus conventional spine radiography.

Vertebral fracture assessment (VFA) by DXA is an accepted tool in adults. However, its use in children has not been assessed. The aim of this study was to evaluate DXA VFA and morphometric analysis (MXA) using a GE Lunar iDXA bone densitometer against spinal radiographic assessment (RA) for the identification of vertebral fractures in children. Spine RA and VFA (T3-L5) were acquired on the same day in 80 children. Forty children considered high risk for fracture by their metabolic bone specialist were referred for spinal RA. Another 40 children were recruited as part of a prospective fracture study and were considered low risk for vertebral fracture. Agreement between RA and VFA was assessed by an expert paediatric radiologist and two paediatricians with expertise in bone pathology. Agreement between RA and MXA was assessed by an expert paediatric radiologist, two clinical scientists and an experienced paediatric radiographer. Vertebrae were ranked as normal, mild, moderate or severe if they had <10%, 11-25%, 26-50% and >50% deformity, respectively. Levels of agreement were calculated using the Cohen kappa score. Evaluating the data from all readable vertebrae, 121 mild, 44 moderate and 16 severe vertebral fractures were identified; with 26, 8, and 5 subjects having at least one mild, moderate or severe fracture, respectively. Depending on rater, 92.8-94.8% of the vertebrae were evaluable by RA. In contrast, 98.4% were evaluable by VFA and only 83.6% were evaluable by MXA. Moderate agreement was found between raters for RA [kappa 0.526-0.592], and VFA [kappa 0.601-0.658] and between RA and VFA [kappa 0.630-0.687]. In contrast, only slight agreement was noted between raters for MXA [kappa 0.361-0.406] and between VFA and MXA [kappa 0.137-0.325]. Agreement substantially improved if the deformities were dichotomised as normal or mild versus moderate or severe [kappa 0.826-0.834]. For the detection of moderate and/or severe fractures the sensitivities & specificities were 81.3% & 99.3%, and 62.5% & 99.2% for VFA and MXA, respectively. This study demonstrates that VFA is as good as RA for detecting moderate and severe vertebral fractures. Given the significant radiation dose saving of VFA compared with RA, VFA is recommended as a diagnostic tool for the assessment of moderate or severe vertebral fracture in children.

Open source marketing: Camel cigarette brand marketing in the "Web 2.0" world.

BACKGROUND: The international trend towards comprehensive bans on tobacco advertising has seen the tobacco industry become increasingly innovative in its approach to marketing. Further fuelling this innovation is the rapid evolution and accessibility of web-based technology. The internet, as a relatively unregulated marketing environment, provides many opportunities for tobacco companies to pursue their promotional ambitions. METHODS: In this paper, "open source marketing" is considered as a vehicle that has been appropriated by the tobacco industry, through a case study of efforts to design the packaging for the Camel Signature Blends range of cigarettes. Four sources are used to explore this case study including a marketing literature search, a web-based content search via the Google search engine, interviews with advertising trade informants and an analysis of the Camel brand website. RESULTS: RJ Reynolds (RJR) has proven to be particularly innovative in designing cigarette packaging. RJR engaged with thousands of consumers through their Camel brand website to design four new cigarette flavours and packages. While the Camel Signature Blends packaging designs were subsequently modified for the retail market due to problems arising with their cartoon-like imagery, important lessons arise on how the internet blurs the line between marketing and market research. CONCLUSIONS: Open source marketing has the potential to exploit advertising ban loopholes and stretch legal definitions in order to generate positive word of mouth about tobacco products. There are also lessons in the open source marketing movement for more effective tobacco control measures including interactive social marketing campaigns and requiring plain packaging of tobacco products.

Gone viral? Heard the buzz? A guide for public health practitioners and researchers on how Web 2.0 can subvert advertising restrictions and spread health information.

Many nations have banned or curtailed advertising of potentially harmful products to protect public health, particularly in the area of chronic disease control. The growth in Internet-based marketing techniques is subverting these advertising regulations. Explosive rises in use of social networking and user-generated content websites is further fuelling product promotion through electronic media. In contrast, there is a very limited body of public health research on these "new media" advertising methods. This paper provides an overview of these advertising methods and details examples relevant to chronic disease control. There is a vast untapped potential for health practitioners and researchers to exploit these same media for health promotion.

Global perspective on tobacco control. Part II. The future of tobacco control: making smoking history?

Serious efforts to reduce the harm caused by tobacco use throughout populations require implementation policies and interventions capable of reaching all smokers and potential smokers. While the Framework Convention on Tobacco Control promises to accelerate the adoption of comprehensive tobacco control policies throughout the world, its extensive 'optional' language provides considerable latitude for governments unwilling to implement rigorous controls. This paper examines four broad areas in which important debates and policy advances will be necessary to ensure population-wide impact of tobacco control: harm reduction; demand reduction strategies involving particularly the use of news generation in increasing the coverage of tobacco and health issues; denormalisation of tobacco use, especially among health workers in nations where use remains high; and further efforts to regulate the tobacco industry, particularly in regard to plain packaging, under-the-counter retail sales and the regulation of tobacco products.

"Banned from the streets I have paid to use": an analysis of Australian print media coverage of proposals for passenger and night driving restrictions for young drivers.

OBJECTIVE: To catalogue arguments that can be anticipated in public debate when passenger and night driving restrictions are being advocated. DESIGN AND SETTING: Frame analysis of all relevant coverage of these topics in Australian print media during the three month period between June and September 2004 when intensive debate on the topic occurred. MAIN OUTCOME MEASURES: Debating frames used in reports and commentary on passenger and night driving restrictions. RESULTS: There were 52 relevant articles published containing seven distinct frames supporting the restrictions and six opposing them. Overall, more instances of frames supporting the restrictions were published; these mostly focused on the potential for saving lives. Opposition to the restrictions focused largely on their inappropriateness as a road safety measure as well as on the importance of young people's autonomy and freedom. CONCLUSIONS: Advocates of passenger and night driving restrictions have a number of arguments available to advance their case; however, it is important to anticipate and address possible counter arguments. Future research should address the saliency of different arguments to the public and key decision makers in government.

Ensuring smokers are adequately informed: reflections on consumer rights, manufacturer responsibilities, and policy implications.

The right to information is a fundamental consumer value. Following the advent of health warnings, the tobacco industry has repeatedly asserted that smokers are fully informed of the risks they take, while evidence demonstrates widespread superficial levels of awareness and understanding. There remains much that tobacco companies could do to fulfil their responsibilities to inform smokers. We explore issues involved in the meaning of "adequately informed" smoking and discuss some of the key policy and regulatory implications. We use the idea of a smoker licensing scheme-under which it would be illegal to sell to smokers who had not demonstrated an adequate level of awareness-as a device to explore some of these issues. We also explore some of the difficulties that addiction poses for the notion that smokers might ever voluntarily assume the risks of smoking.

"A phony way to show sincerity, as we all well know": tobacco industry lobbying against tobacco control in Hong Kong.

OBJECTIVE: To examine the tobacco industry's efforts to influence public policy and block the legislative process on tobacco control in Hong Kong, 1973 to 1997. METHOD: Systematic review of relevant tobacco industry documents made public via the Master Settlement Agreement. RESULTS: The tobacco industry in Hong Kong has sought to manipulate the policymaking process and delay the introduction of tobacco control legislation in Hong Kong from at least 1973. The industry ensured that each of the government's initial meagre steps toward tobacco control were delayed and thwarted by drawn out "cooperation" followed by voluntary concessions on issues the industry regarded as minor. By the 1980s the government had became increasingly active in tobacco control and introduced a number of initiatives, resulting in some of the tightest legislative restrictions on smoking in Asia. The tobacco industry was successful in thwarting only one of these initiatives. CONCLUSIONS: Throughout the 1980s and 1990s two factors played a significant role in hindering the tobacco industry from successfully blocking policy initiatives: a growing political imperative, and an active and sophisticated tobacco control movement. Political will to promote public health and a strong tobacco control advocacy presence can enable governments to resist the enormous pressure exerted upon them by multinational tobacco companies.

Industry sponsored youth smoking prevention programme in Malaysia: a case study in duplicity.

OBJECTIVE: To review tobacco company strategies of using youth smoking prevention programmes to counteract the Malaysian government's tobacco control legislation and efforts in conducting research on youth to market to them. METHODS: Systematic keyword and opportunistic website searches of formerly private internal industry documents. Search terms included Malay, cmtm, jaycees, YAS, and direct marketing; 195 relevant documents were identified for this paper. RESULTS: Industry internal documents reveal that youth anti-smoking programmes were launched to offset the government's tobacco control legislation. The programme was seen as a strategy to lobby key politicians and bureaucrats for support in preventing the passage of legislation. However, the industry continued to conduct research on youth, targeted them in marketing, and considered the teenage market vital for its survival. Promotional activities targeting youth were also carried out such as sports, notably football and motor racing, and entertainment events and cash prizes. Small, affordable packs of cigarettes were crucial to reach new smokers. CONCLUSION: The tobacco industry in Malaysia engaged in duplicitous conduct in regard to youth. By buying into the youth smoking issue it sought to move higher on the moral playing field and strengthen its relationship with government, while at the same time continuing to market to youth. There is no evidence that industry youth smoking prevention programmes were effective in reducing smoking; however, they were effective in diluting the government's tobacco control legislation.

A mire of highly subjective and ineffective voluntary guidelines: tobacco industry efforts to thwart tobacco control in Malaysia.

OBJECTIVE: To describe tobacco industry efforts in Malaysia to thwart government efforts to regulate tobacco promotion and health warnings. METHODS: Systematic keyword and opportunistic website searches of formerly private tobacco industry internal documents made available through the Master Settlement Agreement and secondary websites; relevant information from news articles and financial reports. RESULTS: Commencing in the 1970s, the industry began to systematically thwart government tobacco control. Guidelines were successfully promoted in the place of legislation for over two decades. Even when the government succeeded in implementing regulations such as health warnings and advertising bans they were compromised and acted effectively to retard further progress for years to come. CONCLUSION: Counter-measures to delay or thwart government efforts to regulate tobacco were initiated by the industry. Though not unique to Malaysia, the main difference lies in the degree to which strategies were used to successfully counter stringent tobacco control measures between 1970 and 1995.

"The world's most hostile environment": how the tobacco industry circumvented Singapore's advertising ban.

OBJECTIVE: To review how tobacco transnational companies conducted their business in the hostile environment of Singapore, attempting to counter some of the government's tobacco control measures; to compare the Malaysian and the Singaporean governments' stance on tobacco control and the direct bearing of this on the way the tobacco companies conduct their business. METHODS: Systematic keyword and opportunistic website searches of formerly private internal industry documents. RESULTS: The comprehensive prohibition on advertising did not prevent the companies from advertising cigarettes to Singaporeans. Both British American Tobacco and Philip Morris used Malaysian television to advertise into Singapore. To launch a new brand of cigarettes, Alpine, Philip Morris used a non-tobacco product, the Alpine wine cooler. Other creative strategies such as innovative packaging and display units at retailers were explored to overcome the restrictions. Philip Morris experimented with developing a prototype cigarette using aroma and sweetened tipping paper to target the young and health conscious. The industry sought to weaken the strong pack warnings. The industry distributed anti-smoking posters for youth to retailers but privately salivated over their market potential.

"It is possible he is a kind of nut": how the tobacco industry quietly promoted Dr William Whitby.

Dr William Whitby was a general practitioner in Sydney who, from 1978 until about 1987, self published two books extolling the virtues of smoking and ridiculing anti-smoking claims. Privately the tobacco industry regarded him as "nutty", while nonetheless believing that his views should be promoted. They quietly supported him by distributing his book, offering legal advice, and persuading him to take media training. Many Australians would have been exposed to his views.

"A deep fragrance of academia": the Australian Tobacco Research Foundation.

OBJECTIVES: (1) To review the history of the tobacco industry supported Australian Tobacco Research Foundation (ATRF)(1970-1994) for evidence of the industry's use of the Foundation to further its objectives that "more research was needed" on smoking and health and to promulgate the view that nicotine was not addictive. (2) To review efforts by public health advocates to discredit the ATRF as a public relations tool used by the Australian industry. METHODS: Systematic search of previously internal industry documents released through the US Master Settlement Agreement. RESULTS: The ATRF was headed by prestigious Australian medical scientists, with at least one considered by the industry to be "industry positive". An international ATRF symposium on nicotine was vetted by the industry and heavily attended by industry approved scientists. Following sustained criticism from the health and medical community about the industry's creation of the ATRF to further its objectives, the ATRF's scientific committee was provoked to publicly declare in 1988 that smoking was a causative agent in disease. This criticism led to growing ATRF boycotts by scientists and substandard applications, causing the industry to see the ATRF as being poor value-for-money and eventually abandoning it. CONCLUSIONS: The raison d'etre for the ATRF's establishment was to allow the Australian industry to point to its continuing commitment to independent medical research, with the implied corollary that tobacco control measures were premature in the face of insufficient evidence about tobacco's harms. Sustained criticism of tobacco industry funded research schemes can undermine their credibility among the scientific community.

The Australian tar derby: the origins and fate of a low tar harm reduction programme.

OBJECTIVE: To document the development of the low tar harm reduction programme in Australia, including tobacco industry responses. DATA SOURCES: Tobacco industry documents, retail tobacco journals, newspapers, medical journals, and Anti-Cancer Council of Victoria (ACCV) newsletters and archival records. STUDY SELECTION: Documents on the strategies and knowledge bases of the ACCV, other Australian health authorities, and the tobacco industry. RESULTS: The ACCV built a durable system for measuring and publicising the tar and nicotine yields of Australian cigarettes and influencing their development. The tobacco industry initially sought to block the development of this system but later appeared to cooperate with it, as is evidenced by the current market dominance of low tar brands. However, behind the scenes, the industry used its substantial knowledge advantage regarding compensatory smoking and its ability to re-engineer cigarettes to gain effective control of the system and subvert the ACCV's objectives. CONCLUSIONS: Replacement of the low tar programme with new means of minimising the harms from cigarette smoking should be a policy priority for the Australian government. This will require regulation, rather than further voluntary agreements, and stringent monitoring of successor programmes will be necessary.

"Conclusions about exposure to ETS and health that will be unhelpful to us": how the tobacco industry attempted to delay and discredit the 1997 Australian National Health and Medical Research Council report on passive smoking.

BACKGROUND: Major reviews of the health effects of passive smoking have been subjected to tobacco industry campaigns to refute the scientific evidence. Following the 1992 US Environmental Protection Agency review, the Australian National Health and Medical Research Council (NHMRC) initiated a review of the health effects of passive smoking. At the time of this review, evidence that environmental tobacco smoke causes disease was being increasingly accepted in courts of law and voluntary adoption of smoking restrictions was rapidly growing. OBJECTIVE: To demonstrate how the tobacco industry attempted to delay and discredit the publication of a report on passive smoking that the tobacco industry anticipated to contain recommendations that would be unfavourable to their business. METHODS: A search of tobacco industry documents on the Master Settlement Agreement websites was conducted using the terms and acronyms representative of the NHMRC review. RESULTS: The tobacco industry sought to impede the progress of the NHMRC Working Party by launching an intensive campaign to delay and discredit the report. The main strategies used were attempts to criticise the science, extensive use of Freedom of Information provisions to monitor all activity of the group, legal challenges, ad hominem attacks on the credibility of the Working Party members, rallying support from industry allies, and influencing public opinion through the media. CONCLUSIONS: The Australian tobacco industry deliberately impeded the NHMRC Working Party's progress and successfully prevented the publication of the report's recommendations. The tobacco industry's motivation and capacity to disrupt the advancement of scientific knowledge and policy in tobacco control should be recognised and anticipated.

"Can't stop the boy": Philip Morris' use of Healthy Buildings International to prevent workplace smoking bans in Australia.

OBJECTIVE: To document the relationship of the indoor air consultancy company Healthy Buildings International (HBI) with the Australian tobacco industry. DESIGN: Systematic keyword and opportunistic website searches of tobacco industry internal documents made available through the Master Settlement Agreement. RESULTS: Since 1987 HBI has played a high profile role in advancing the Australian tobacco industry's concerns to prevent building owners introducing smoke-free workplaces by advocating for ventilation solutions. HBI invoiced Philip Morris' US lawyers Covington and Burling for work undertaken in Australia and sought to publicly deny its association with the industry. HBI breached Standards Australia protocols in providing PM with confidential public submissions made to a review of the Australian standard on ventilation and acted as an undeclared cipher into the review for Philip Morris's concerns, leading to the eventual dismissal of the HBI representative from the standards subcommittee. CONCLUSIONS: HBI in Australia exemplifies the tobacco industry's use of third party strategy in publicly advancing a case against smoke-free indoor air.