The James Lind Initiative: books, websites and databases to promote critical thinking about treatment claims, 2003 to 2018.

BACKGROUND: The James Lind Initiative (JLI) was a work programme inaugurated by Iain Chalmers and Patricia Atkinson to press for better research for better health care. It ran between 2003 and 2018, when Iain Chalmers retired. During the 15 years of its existence, the JLI developed three strands of work in collaboration with the authors of this paper, and with others. WORK THEMES: The first work strand involved developing a process for use by patients, carers and clinicians to identify shared priorities for research - the James Lind Alliance. The second strand was a series of articles, meetings, prizes and other developments to raise awareness of the massive amounts of avoidable waste in research, and of ways of reducing it. The third strand involved using a variety of approaches to promote better public and professional understanding of the importance of research in clinical practice and public health. JLI work on the first two themes has been addressed in previously published reports. This paper summarises JLI involvement during the 15 years of its existence in giving talks, convening workshops, writing books, and creating websites and databases to promote critical thinking about treatment claims. CONCLUSION: During its 15-year life, the James Lind Initiative worked collaboratively with others to create free teaching and learning resources to help children and adults learn how to recognise untrustworthy claims about the effects of treatments. These resources have been translated in more than twenty languages, but much more could be done to support their uptake and wider use.

Key Concepts for Informed Health Choices: a framework for helping people learn how to assess treatment claims and make informed choices.

Many claims about the effects of treatments, though well intentioned, are wrong. Indeed, they are sometimes deliberately misleading to serve interests other than the well-being of patients and the public. People need to know how to spot unreliable treatment claims so that they can protect themselves and others from harm. The ability to assess the trustworthiness of treatment claims is often lacking. Acquiring this ability depends on being familiar with, and correctly applying, some key concepts, for example, that' association is not the same as causation.' The Informed Health Choices (IHC) Project has identified 36 such concepts and shown that people can be taught to use them in decision making. A randomised trial in Uganda, for example, showed that primary school children with poor reading skills could be taught to apply 12 of the IHC Key Concepts. The list of IHC Key Concepts has proven to be effective in providing a framework for developing and evaluating IHC resources to help children to think critically about treatment claims. The list also provides a framework for retrieving, coding and organising other teaching and learning materials for learners of any age. It should help teachers, researchers, clinicians, and patients to structure critical thinking about the trustworthiness of claims about treatment effects.

Establishing a library of resources to help people understand key concepts in assessing treatment claims-The "Critical thinking and Appraisal Resource Library" (CARL).

BACKGROUND: People are frequently confronted with untrustworthy claims about the effects of treatments. Uncritical acceptance of these claims can lead to poor, and sometimes dangerous, treatment decisions, and wasted time and money. Resources to help people learn to think critically about treatment claims are scarce, and they are widely scattered. Furthermore, very few learning-resources have been assessed to see if they improve knowledge and behavior. OBJECTIVES: Our objectives were to develop the Critical thinking and Appraisal Resource Library (CARL). This library was to be in the form of a database containing learning resources for those who are responsible for encouraging critical thinking about treatment claims, and was to be made available online. We wished to include resources for groups we identified as 'intermediaries' of knowledge, i.e. teachers of schoolchildren, undergraduates and graduates, for example those teaching evidence-based medicine, or those communicating treatment claims to the public. In selecting resources, we wished to draw particular attention to those resources that had been formally evaluated, for example, by the creators of the resource or independent research groups. METHODS: CARL was populated with learning-resources identified from a variety of sources-two previously developed but unmaintained inventories; systematic reviews of learning-interventions; online and database searches; and recommendations by members of the project group and its advisors. The learning-resources in CARL were organised by 'Key Concepts' needed to judge the trustworthiness of treatment claims, and were made available online by the James Lind Initiative in Testing Treatments interactive (TTi) English (www.testingtreatments.org/category/learning-resources).TTi English also incorporated the database of Key Concepts and the Claim Evaluation Tools developed through the Informed Healthcare Choices (IHC) project (informedhealthchoices.org). RESULTS: We have created a database of resources called CARL, which currently contains over 500 open-access learning-resources in a variety of formats: text, audio, video, webpages, cartoons, and lesson materials. These are aimed primarily at 'Intermediaries', that is, 'teachers', 'communicators', 'advisors', 'researchers', as well as for independent 'learners'. The resources included in CARL are currently accessible at www.testingtreatments.org/category/learning-resources. CONCLUSIONS: We hope that ready access to CARL will help to promote the critical thinking about treatment claims, needed to help improve healthcare choices.

The PRIME project: developing a patient evidence-base.

BACKGROUND: The concept of evidence has become firmly rooted in health care, with most importance placed on the outcome of research in clinical and economic spheres. Much less emphasis is placed on the patient's contribution to evidence which remains relatively vague, of low status and often difficult to integrate with other forms of knowledge. AIM: This article proposes a concept of patient-based evidence, to complement clinical and economic forms of evidence, and demonstrates one way in which it has been operationalized. The PRIME project developed a patient evidence-base to capture the lived experience of individuals with myalgic encephalitis (ME) or chronic fatigue syndrome (CFS). DESIGN: Interviews were performed with 40 individuals with ME/CFS who varied in a range of demographic characteristics, including age, gender, and how severely affected individuals were. RESULTS: PRIME has developed a patient evidence-base which has an extensive array of experiences data to provide researchers, clinicians and others with an in-depth insight into the lived experience of ME/CFS that can be used and analysed. Data are grouped into a wide range of themes, which can be downloaded and used in a variety of ways as a source of evidence to enable understanding of the lived experience of ME/CFS and so contribute to the development of a more patient-focused research agenda in ME/CFS. CONCLUSIONS: While patient-based evidence used in the PRIME Project provides a useful start, further work is required to develop this area conceptually and methodologically, particularly in relation to how patient-based evidence can be considered alongside clinical and economic evidence.

Finding and appraising evidence.

Surgeons have tended to regard evidence-based medicine with a degree of skepticism. A variety of reasons for this have been proposed,ranging from the surgical personality to the nature of the research questions that occur when studying surgical treatment. The relative paucity of randomized trials of surgical treatment has been noted by many investigators, and there has been considerable debate about whether this reflects poorly on the scientific education of the surgical community or points to special problems in applying this methodology in this discipline. This debate has matured over the last 10 years, and there is now greater understanding of the factors that make surgical operations difficult subjects for randomized trials; on the other hand, such trials are being done now more than ever before.