Transparency Guidelines Research Articles

All your data (effectively) belong to us: data practices among direct-to-consumer genetic testing firms.

Direct-to-consumer genetic testing (DTC-GT) has become a convenient method to help people to understand their genetic makeup. Owing in part to concerns regarding confidentiality, privacy, and secondary use of data, professional and government bodies created guidelines to promote transparency among these companies. Using a comprehensive and systematic approach, this study assessed DTC-GT company compliance with international transparency guidelines. A framework analysis was performed on 30 DTC-GT health and/or ancestry websites identified using a US-based online search strategy during the summer of 2015. A codebook was developed from a synthesis of relevant guidelines from seven DTC-GT guideline documents and applied to each website. Although most companies met guidelines related to transparency regarding security protocols, storage procedures, and third-party disclosures, few met guidelines regarding sharing risks from data disclosures. Additionally, few companies disclosed how long data would be kept for services or research. Use of data for research was frequently mentioned only in privacy policies and terms of service documents, and only two-thirds of companies required an additional consent to use consumer data for health-related research. Our analysis shows that DTC-GT companies do not consistently meet international transparency guidelines related to confidentiality, privacy, and secondary use of data.Genet Med advance online publication 22 September 2016.

CRITÉRIOS PARA A CONSOLIDAÇÃO DE UM PERIÓDICO DE PESQUISA CIENTÍFICA EM FISIOTERAPIA

Introdução: A fisioterapia apresenta elevada produção científica. Periódicos tradicionais não dão conta de publicar todos os relatos de pesquisas realizadas, o que exige a criação de novos periódicos com escopo voltado à produção científica em fisioterapia. Objetivo: Investigar fatores envolvidos com o desenvolvimento de um novo periódico científico brasileiro na área da fisioterapia - Revista Pesquisa em Fisioterapia (RPF). Metodologia: Estudo exploratório e documental. Coletados dados intrínsecos e extrínsecos. Foi utilizado o software Publish or Perish, o Alexa e o próprio portal de periódicos para a coleta de dados. Foram levantados dados dos programas brasileiros de pós-graduação stricto sensu na área de avaliação da CAPES de Educação Física e as revistas melhor classificadas pelo Webqualis na área de Medicina II para comparações. Resultados: A visibilidade da RPF internacionalmente é revelada por 10665 downloads e taxa de conversão de 125,4%. Publicou 137 artigos (2012 a 2016), média de 11,41 artigos por número publicado, 10,94% em inglês, 57,66% originais, média de 9,69 autores por artigo e uma proporção de doutores titulados entre os autores de 36,29%. Seu índice hé 3. Foram identificadas lacunas a serem preenchidas pela gestão: publicação bilíngue e inclusão do ORCID. Conclusão: A RPF é um periódico científico que apresenta características necessárias para um desenvolvimento orgânico compatível com a instituição tradicional a qual se vincula, segue todas as recomendações internacionais para a transparência e qualidade da pesquisa científica no campo da fisioterapia e, por este motivo, deve atingir indicadores necessários para indexação em bases internacionais em futuro não muito longínquo.

When Lying Feels the Right Thing to Do.

Fraud is a pervasive and challenging problem that costs society large amounts of money. By no means all fraud is committed by ‘professional criminals’: much is done by ordinary people who indulge in small-scale opportunistic deception. In this paper, we set out to investigate when people behave dishonestly, for example by committing fraud, in an online context. We conducted three studies to investigate how the rejection of one’s efforts, operationalized in different ways, affected the amount of cheating and information falsification. Study 1 demonstrated that people behave more dishonestly when rejected. Studies 2 and 3 were conducted in order to disentangle the confounding factors of the nature of the rejection and the financial rewards that are usually associated with dishonest behavior. It was demonstrated that rejection in general, rather than the nature of a rejection, caused people to behave more dishonestly. When a rejection was based on subjective grounds, dishonest behavior increased with approximately 10%, but this difference was not statistically significant. We subsequently measured whether dishonesty was driven by the financial loss associated with rejection, or emotional factors such as a desire for revenge. We found that rejected participants were just as dishonest when their cheating did not led to financial gain. However, they felt stronger emotions when there was no money involved. This seems to suggest that upon rejection, emotional involvement, especially a reduction in happiness, drives dishonest behavior more strongly than a rational cost-benefit analysis. These results indicate that rejection causes people to behave more dishonestly, specifically in online settings. Firms wishing to deter customers and employees from committing fraud may therefore benefit from transparency and clear policy guidelines, discouraging people to submit claims that are likely to be rejected.

Public engagement in electricity network development: the case of the Beauly–Denny project in Scotland

Ambitious renewable energy targets and an aging infrastructure necessitate a substantial upgrading and expansion of the electricity networks around Europe and beyond. Although vital for the functioning of the economy and a green energy future, grid development projects are often met by public opposition, which increase costs and lead to lengthy planning processes. Therefore, understanding the social aspects of a green energy economy is becoming increasingly important. The current planning frameworks have proven ineffective at resolving conflicts among stakeholders, indicating the need for a new approach. We analyse these issues from an economic perspective, outlining the economic characteristics of transmission developments and public engagement. We identify previously overlooked features of the planning process that contribute to the rise in conflicts, public opposition and prolonged project realisation. The Scottish Beauly–Denny high voltage transmission development is discussed in detail and our findings indicate a need for better engagement with local communities at an earlier stage of planning. Trust between communities, developers and government is important for the negotiations and can be achieved through transparency, specific education and set guidelines for stakeholder engagement in the planning process.

The Challenge and Promise of Retail Medicine

THE ARTICLES BY Scott A. Mason, DPA, FACHE, and Denise B. Prince and Thomas Graf raise important issues involving the challenges and promise of extending healthcare through retail medicine. They point to the benefits, such as providing care in places convenient for the consumer, greater scalability, a pleasant environment with less environmental harm, increased transparency, and standardization. They also point to a number of challenges, such as pressure to generate commercial-level revenues, an expectation that nearby businesses will benefit economically by drawing in more customers, pressure to increase the number of prescriptions filled at the local pharmacy, and competition for the vaccination business. Prince and Graf report that some large national retail chains now seek to own the healthcare systems rather than contract with them because they lack interoperability among their health information technology systems (Riskin, Koppel, and Riskin 2014).Retail medicine presses healthcare in the direction of commodity economics, with competition, discounting, more consumer choice, and a far greater need to satisfy the customer (what Mason refers to as guests). In addition, the discussions by Mason and Prince and Graf regarding retail medicine point to important challenges that healthcare systems and clinicians need to address as they seek to implement a successful Triple Aim initiative (Institute for Healthcare Improvement 2014):* Improving the patient experience of care (including quality and satisfaction)* Improving the health of populations* Reducing the per capita cost of healthcareThe Triple Aim has been incorporated into the strategy for Lourdes Health System and its parent organization, Trinity Health. Lourdes, located in southern New Jersey, has a network of two hospitals, three outpatient surgery locations, four ambulatory care centers, more than 90 physician practices, and an accountable care organization. It has been working over the past several years to develop its own retail strategy. During this time, its original parent organization, Catholic Health East, formed a productive merger with Midwest-based Trinity Health and has formally taken the Trinity Health name. Trinity Health has provided Lourdes and its fellow regional health ministries (RHMs) with a national platform from which to develop retail partners.HEALTHCARE AS A COMMODITYMedicine is one of the classic professions (Goode i960). Like their brethren in law, religion, and education, clinicians are not viewed as striving primarily to earn money. Faith-based organizations, such as Lourdes and Trinity Health, were established with a mission to serve all, but with a special commitment to the poor. A business provides goods or services to make money, whereas healthcare's primary role is to avoid morbidity and mortality and to promote wellness.Healthcare systems, especially integrated systems such as Trinity Health, provide strategic planning resources to identify populations most likely to need, but also with the ability to pay for, its services. But clinical decisions are expected to be made with reference to patient health and not revenue maximization. Healthcare systems do advertise but focus on quality, not price.Recently, price transparency has been a hot topic. It is easier to identify hospital parking rates than the cost of an electrocardiogram at the same facilities (Bernstein and Bernstein 2014). However, the Affordable Care Act requires hospitals to establish and make public standard charges by diagnosis. National healthcare associations recently launched efforts to provide guidelines for greater pricing transparency (American Hospital Association 2014; HFMA Price Transparency Task Force 2014). Trinity Health has mandated this for its RHMs (information for Lourdes is available at www.lourdesnet.org/ bill-pay-insurance-and-payment-options/).Retail medicine, however, places healthcare providers in settings and with businesses for which maximizing customers and revenues is the primary goal. …

Transparency in the Extractive Industries: Time to Ask for More

The quest for transparency spans countries, policymakers, NGOs, and industries.Transparency can be defined as disclosing to the public, in a timely and reliable manner, information that governments and/or corporations previously con-sidered confidential. Recent examples include the Carbon Disclosure Project,the Aarhus convention on access to environmental information, the Cartagena Protocol on Biosafety and its provisions on global genetically modified organism flows, and a wide array of financial information (e.g., in the G8 declaration of Lough Erne in 2013). Stemming from the “right to know,”advocates from NGOs and development organizations view transparency as a cure for corruption and a benefit for democratic accountability; transparency should lead to stakeholder empowerment and improve legitimacy, learning, investment certainty, and better governance. In this article I look at the efforts to establish financial transparency as a norm for the extractive sector. This sector is important because its activities are accompanied by a high level of corruption, especially in resource-rich developing countries. I show that those efforts are not enough and there is good evidence to demand more. I argue that such transparency norms should be extended to environmental pressures in order to facilitate progress on the circular economy and resource efficiency. My conclusions point at synergies between knowledge generation across financial and environmental information.

Making DA-RT a Reality

Calls for greater data access and research transparency have emerged on many fronts within professional social science. For example, the American Political Science Association (APSA) recently adopted new guidelines for data access and research transparency. APSA has also appointed the Data Access and Research Transparency (DA-RT) ad hoc committee to continue exploring these issues. DA-RT sponsored this symposium. In addition, funding agencies like the National Institutes for Health (NIH) and the National Science Foundation (NSF) have expanded requirements for data management and data distribution. These pressures present challenges to researchers, but they also present opportunities.

Evaluating the characteristics of a non-standardised Model Requirements Analysis (MRA) for the development of policy impact assessment tools

The aim of this paper is to provide a critical analysis of the strengths and weaknesses of a non-standardised Model Requirements Analysis (MRA) used for the purpose of developing the Sustainability Impact Assessment Tool (SIAT). By ‘non-standardised’ we mean not strictly following a published MRA method. The underlying question we are interested in addressing is how non-standardised methods, often employed in research driven projects, compare to defined methods with more standardised structure, with regards their ability to capture model requirements effectively, and with regards their overall usability. Through describing and critically assessing the specific features of the non-standardised MRA employed, the ambition of this paper is to provide insights useful for impact assessment tool (IAT) development. Specifically, the paper will (i) characterise kinds of user requirements relevant to the functionality and design of IATs; (ii) highlight the strengths and weaknesses of non-standardised MRA for user requirements capture, analysis and reflection in the context of IAT; (iii) critically reflect on the process and outcomes of having used a non-standardised MRA in comparison with other more standardised approaches. To accomplish these aims, we first review methods available for IAT development before describing the SIAT development process, including the MRA employed. Major strengths and weaknesses of the MRA method are then discussed in terms of user identification and characterisation, organisational characterisation and embedding, and ability to capture design options for ensuring usability and usefulness. A detailed assessment on the structural differences of MRA with two advanced approaches (Integrated DSS design and goal directed design) and their role in performance of the MRA tool is used to critique the approach employed. The results show that MRA is able to bring thematic integration, establish system performance and technical thresholds as well as detailing quality and transparency guidelines. Nevertheless the discussion points out to a number of deficiencies in application - (i) a need to more effectively characterise potential users, and; (ii) a need to better foster communication among the distinguished roles in the development process. If addressed these deficiencies, SIAT non-standardised MRA could have brought out better outcomes in terms of tool usability and usefulness, and improved embedding of the tool into conditions of targeted end-users.

Interim decisions in oncology trials.

e12530 Background: Interim analyses are commonly performed in oncology clinical trials. For a phase III trial, interim monitoring rules are in general pre-specified for an independent data monitoring committee (DMC) to allow for the possibility of early stopping. Challenges and controversies exist when interim monitoring and subsequent decisions alter the course of the trial. Methods: Abstracts and primary publications of ASCO plenary session presentations for the last 10 years (2003-2012) were reviewed. Interim analyses related to the study design, conduct, endpoints, DMC decision, and reporting were reviewed. Mid-trial adaptations not limited to interim results were also summarized. Results: Fifty-two presentations were identified. Forty-one were randomized controlled trials; almost all were phase III trials. Interim monitoring and analyses were discussed in the primary manuscripts of 31 trials. The objectives of these interim analyses were safety monitoring, inference for superior efficacy, or futility. Fourteen trials crossed interim boundaries and were declared by the DMCs to have met the study objectives on efficacy endpoints such as progression-free survival and overall survival (OS). Mid-trial adaptations included dropping an arm or selecting a dose based on interim safety results. Other trial adaptations, motivated by issues such as slower accrual rate, change in treatment paradigm, or unexpected longer trial duration, included modifications of trial objectives, primary endpoints, sample sizes, and unplanned analyses. Conclusions: Interim monitoring is an important component of clinical trials but is not consistently reported. Decisions made after the primary endpoint has crossed the interim boundary have an impact on subsequent inferences of other endpoints (e.g. OS). Greater transparency and practical guidelines are needed to ensure continued trial integrity and valid inferences post interim.

How transparent is behavioral intervention research on pathological gambling and other gambling‐related disorders? A systematic literature review

To review the transparency of reports of behavioral interventions for pathological gambling and other gambling-related disorders. We used the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) Statement to develop the 59-question adapted TREND questionnaire (ATQ). Each ATQ question corresponds to a transparency guideline and asks how clearly a study reports its objectives, research design, analytical methods and conclusions. A subset of 23 ATQ questions is considered particularly important. We searched PubMed, PsychINFO and Web of Science to identify experimental evaluations published between 2000 and 2011 aiming to reduce problem gambling behaviors or decrease problems caused by gambling. Twenty-six English-language reports met the inclusion criteria and were reviewed by three abstractors using the ATQ. The average report adhered to 38.4 (65.1%) of the 59 ATQ transparency guidelines. Each of the 59 ATQ questions received positive responses from an average of 16.9 (63.8%) of the reports. The subset of 23 particularly relevant questions received an average of 15.3 (66.5%) positive responses. Thirty-two of 59 (54%) ATQ questions were answered positively by 75% or more of the study reports, while 12 (20.3%) received positive responses by 25% or fewer. Publication year did not affect these findings. Gambling intervention reports need to improve their transparency by adhering to currently neglected and particularly relevant guidelines. Among them are recommendations for comparing study participants who are lost to follow-up and those who are retained, comparing study participants with the target population, describing methods used to minimize potential bias due to group assignment, and reporting adverse events or unintended effects.

Reflections on Monetary Policy: Flexibility, Transparency and Inflation Guidelines*

Reflections on Monetary Policy: Flexibility, Transparency and Inflation Guidelines^*

Ethical Considerations in the Early Composite Tissue Allograft Experience: A Review of the Louisville Ethics Program

This paper reviews the formulation and evolution of the ethical component in one of the earliest clinical composite tissue allograft (CTA) programs, the hand transplantation program in Louisville, Kentucky, USA. The purpose was to derive lessons and define principles to give guidance for future programs and introduction of new CTA. We reviewed the initial ethical considerations, including input from respected ethical scholars, guidelines for innovative procedures transparency in public and professional scrutiny, and compliance with human studies regulations (IRB approval). We found the initial focus on ethics, scholarly input, guidelines for innovative procedures, and human studies protection regulations to be valid. Moreover, we noted the effect of autonomy in subjective, quality-of-life benefits on equipoise and effective risk–benefit analysis in effective informed consent. We found that psychiatric screening and support to be exceptionally valuable in protecting autonomy, suitability for participation, assessing personality organization, and determining compliance ability. We conclude that the program ethical principles were validated. For future CTA programs and procedures, we recommend an ethical emphasis with adherence to high standards and transpire to independence to scrutiny and oversight. We recommend protection of autonomy judgments in equipoise judgment and informed consent. We recommend skilled psychiatric screening and support. We endorse scholarship, scientific accuracy, and data sharing.

Dietary sodium and blood pressure.

The importance of dietary sodium chloride in the regulation of blood pressure has received much attention over the past few years. This area of research and knowledge has been controversial for several reasons. The major reason for controversy is that the science of the relationship is difficult to ascertain. Population science is limited by the narrow range of dietary sodium intake by most populations and individuals and the multiple confounders in those populations at the extremes of intake. Results from clinical trials have been difficult to interpret because of the difficulty in maintaining a given level of sodium intake over a period of time sufficient for study. Furthermore, basic science studies have been challenged by identifying appropriate models that mimic salt-sensitive hypertension in humans. Moreover, a lack of a well-funded proponent in industry complicates the research challenges. Guyton’s concept that the role of the kidney in handling sodium is key to the long-term regulation of blood pressure is now generally accepted.1 However, the exact role that dietary sodium plays in this relationship remains controversial. The relationship between renal handling of sodium and blood pressure is apparently influenced by a complex combination of factors including nutritional, other environmental, genetic, neurohormonal, and metabolic factors. The skepticism of many regarding the role of dietary sodium in blood pressure regulation and control has been tempered by the results of the DASH sodium study.2 Most acknowledge that this study reliably confirmed the benefit of dietary sodium restriction in blood pressure management. The study showed a dose-dependent impact of dietary sodium restriction on blood pressure in older hypertensive and nonhypertensive subjects. For many interested in this area of research, the questions have shifted as a result of the DASH sodium study. Rather than questioning whether dietary sodium is important, many investigators have turned their …

Building a consensus for fiscal reform

The financial crisis that started in Asia in 1997 brought up a renewed concern over public finances in emerging economies. As most observers failed to detect creeping fiscal disequilibria, large public contingent liabilities, vulnerable asset-liability structures and time inconsistencies of fiscal policy, international financial institutions committed themselves to promote higher transparency and efficiency in the management of public finances. This has resulted in a stream of transparency codes, guidelines and best practice reports over the last couple of years that intend to prevent such failures in the future...