Trish Groves

SPIRIT 2013 Statement: defining standard protocol items for clinical trials.

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

Taking healthcare interventions from trial to practice

The results of thousands of trials are never acted on because their published reports do not describe the interventions in enough detail. How can we improve the reporting?

Care for chronic diseases

See pp 954, 914, 925, 961 This is the third in the BMJ s series of theme issues on managing chronic diseases. This focus reflects the increasing demands on practitioners and health systems around the globe posed by mounting numbers of chronically ill patients.1 The term “chronic disease” usually connotes the prevalent chronic degenerative diseases such as diabetes, coronary artery disease, hypertension, and chronic obstructive pulmonary disease. But papers in the three theme issues argue that a much broader array of health problems generate similar needs for patients and similar challenges for health services—these include diseases such as chronic uveitis, gastro-oesophageal reflux disease, multiple sclerosis, depression, and osteoporosis. Despite the clinical differences across these chronic conditions, each illness confronts patients and their families with the same spectrum of needs: to alter their behaviour; to deal with the social and emotional impacts of symptoms, disabilities, and approaching death; to take medicines; and to interact with medical care over time. In return, healthcare must …

Sharing Clinical Trial Data — A Proposal from the International Committee of Medical Journal Editors

The International Committee of Medical Journal Editors (ICMJE) believes that there is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk. In a growing consensus, many funders around the world — foundations, government agencies, and industry — now mandate data sharing. Here we outline the ICMJE’s proposed requirements to help meet this obligation. We encourage feedback on the proposed requirements. Anyone can provide feedback at www.icmje.org by 18 April 2016. The ICMJE defines a clinical trial as any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome. Further details may be found in the Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals at www.icmje.org. As a condition of consideration for publication of a clinical trial report in our member journals, the ICMJE proposes to require authors to share with others the deidentified individualpatient data (IPD) underlying the results presented in the article (including tables, figures, and appendices or supplementary material) no later than 6 months after publication. The data underlying the results are defined as the IPD required to reproduce the article’s findings, including necessary metadata. This requirement will go into effect for clinical trials that begin to enroll participants beginning 1 year after the ICMJE adopts its data-sharing requirements. (The ICMJE plans to adopt data-sharing requirements after considering feedback received to the proposals made here.) Enabling responsible data sharing is a major endeavor that will affect the fabric of how clinical trials are planned and conducted and how their data are used. By changing the requirements of the manuscripts we will consider for publication in our journals, editors can help foster this endeavor. As editors, our direct influence is logically, and practically, limited to those data underpinning the results and analyses we publish in our journals. The ICMJE also proposes to require that authors include a plan for data sharing as a component of clinical trial registration. This plan must include where the researchers will house the data and, if not in a public repository, the mechanism by which they will provide others access to the data, as well as other data-sharing plan elements outlined in the 2015 Institute of Medicine Report (e.g., whether data will be freely available to anyone upon request or only after application to and approval by a learned intermediary, whether a data use agreement will be required).1 ClinicalTrials.gov has added an element to its registration platform to collect datasharing plans. We encourage other trial registries to similarly incorporate mechanisms for the registration of data-sharing plans. Trialists who want to publish in ICMJE member journals (or nonmember journals that choose to follow these recommendations) should choose a registry that includes a data-sharing plan element as a specified registry item or allows for its entry as a free-text statement in a miscellaneous registry field. As a condition of consideration for publication in our member journals, authors will be

Enhancing the quality and transparency of health research

EQUATOR is an essential web resource for researchers, reviewers, editors, and readers

Advances in managing chronic disease. Research, performance measurement, and quality improvement are key.

Chronic diseases have been around as long as humans. But now, in most industrialised nations and in many developing countries, they predominate among the leading causes of death.1 For many years public health practitioners have recognised the increasing burden of chronic illness.2 Just as chronic disease control has developed into a distinct discipline in public health, so chronic disease management is beginning to develop its own identity as an important component of health care. No longer is each chronic illness—asthma, diabetes, arthritis, etc—being considered in isolation. Awareness is increasing that similar strategies can be equally effective in treating many different conditions. In recognition of the maturing field, this issue of the BMJ— and the February issue of its sister journal, the Western Journal of Medicine —is devoted to chronic disease management. Three essential ingredients are required for continued progress in chronic disease management: research, performance measurement, and quality improvement. Research on innovative methods to treat people with chronic illness should be high on the agenda of organisations that fund health research. The Robert Wood Johnson Foundation, a leading American philanthropic institution, has already designated chronic disease care as one of its major priorities (www.rwjf.org), and its programme emphasises the commonalities of effective …

Managing chronic disease.

Rapid improvements in health and longevity are dramatically changing the burden of illness throughout the world. In developed countries changes in lifestyle and improvements in the treatment of major causes of mortality have aged the population and increased the prevalence of chronic diseases. Poor countries that have achieved gains in life expectancy are also experiencing an increase in chronic disease as they proceed through the “epidemiological transition”—the changing pattern of health in which they inherit the problems of the rich.1 The epidemiological transition (now called the “health transition”) has progressed substantially in several developing regions. This is shown clearly in the ratio of disability adjusted life years (DALYs; the number of years lost from premature death plus the years lived with a disability) caused by non-communicable diseases to DALYs caused by communicable, maternal, perinatal, and nutritional conditions (see figure).2 The established market economies and the formerly socialist economies of Europe have essentially completed the transition. Non-communicable diseases already predominate as a cause of DALYs in China and in Latin America and the Caribbean, while “other Asia and islands” and the Middle East are close to that transition point. Ratio of disability adjusted life years (DALYs) caused by non-communicable diseases to DALYs caused by communicable, …

The new BMJ policy on sharing data from drug and device trials

Is a necessary first step towards the full sharing of all anonymised trial data

Registration of observational studies

The next step towards research transparency

Sharing Clinical Trial Data: A Proposal from the International Committee of Medical Journal Editors

In a joint publication across 14 member journals, the International Committee of Medical Journal Editors (ICMJE) proposes to require sharing of deidentified individual patient data underlying published clinical trials.