Evidence and its uses in health care and research: the role of critical thinking.

Obtaining and critically appraising evidence is clearly not enough to make better decisions in clinical care. The evidence should be linked to the clinician's expertise, the patient's individual circumstances (including values and preferences), and clinical context and settings. We propose critical thinking and decision-making as the tools for making that link. Critical thinking is also called for in medical research and medical writing, especially where pre-canned methodologies are not enough. It is also involved in our exchanges of ideas at floor rounds, grand rounds and case discussions; our communications with patients and lay stakeholders in health care; and our writing of research papers, grant applications and grant reviews. Critical thinking is a learned process which benefits from teaching and guided practice like any discipline in health sciences. Training in critical thinking should be a part or a pre-requisite of the medical curriculum.

Evaluation and stages of surgical innovations.

Surgical innovation is an important part of surgical practice. Its assessment is complex because of idiosyncrasies related to surgical practice, but necessary so that introduction and adoption of surgical innovations can derive from evidence-based principles rather than trial and error. A regulatory framework is also desirable to protect patients against the potential harms of any novel procedure. In this first of three Series papers on surgical innovation and evaluation, we propose a five-stage paradigm to describe the development of innovative surgical procedures.

No surgical innovation without evaluation: the IDEAL recommendations.

Surgery and other invasive therapies are complex interventions, the assessment of which is challenged by factors that depend on operator, team, and setting, such as learning curves, quality variations, and perception of equipoise. We propose recommendations for the assessment of surgery based on a five-stage description of the surgical development process. We also encourage the widespread use of prospective databases and registries. Reports of new techniques should be registered as a professional duty, anonymously if necessary when outcomes are adverse. Case series studies should be replaced by prospective development studies for early technical modifications and by prospective research databases for later pre-trial evaluation. Protocols for these studies should be registered publicly. Statistical process control techniques can be useful in both early and late assessment. Randomised trials should be used whenever possible to investigate efficacy, but adequate pre-trial data are essential to allow power calculations, clarify the definition and indications of the intervention, and develop quality measures. Difficulties in doing randomised clinical trials should be addressed by measures to evaluate learning curves and alleviate equipoise problems. Alternative prospective designs, such as interrupted time series studies, should be used when randomised trials are not feasible. Established procedures should be monitored with prospective databases to analyse outcome variations and to identify late and rare events. Achievement of improved design, conduct, and reporting of surgical research will need concerted action by editors, funders of health care and research, regulatory bodies, and professional societies.

Challenges in evaluating surgical innovation.

Research on surgical interventions is associated with several methodological and practical challenges of which few, if any, apply only to surgery. However, surgical evaluation is especially demanding because many of these challenges coincide. In this report, the second of three on surgical innovation and evaluation, we discuss obstacles related to the study design of randomised controlled trials and non-randomised studies assessing surgical interventions. We also describe the issues related to the nature of surgical procedures-for example, their complexity, surgeon-related factors, and the range of outcomes. Although difficult, surgical evaluation is achievable and necessary. Solutions tailored to surgical research and a framework for generating evidence on which to base surgical practice are essential.

Clinical case reports and case series research in evaluating surgery. Part I. The context: general aspects of evaluation applied to surgery.

The relevance, structure, focus, form, and content of modern clinical case reporting and case series research may be seen and understood only in the context of evaluation in medicine and surgery today. The benefits and effectiveness of surgery remain at the core of evaluation in surgery. Surgical errors evaluation is an increasingly important topic give their impact on patients and human and material resources in medicine and surgery and social and community implications. Evaluation in surgery covers three domains such as research, teaching and practice. Within each domain, soundness, structure, process, impact, constancy and consistency of surgical activities must be known and understood. The proper subject of evaluation in a form of a tridimensional matrix includes aspects of evaluation, phases of surgical activity and types of surgery as domains of application (the "what" matrix). The ways of evaluation include methods of information retrieval, types of analyses of findings, and the context understanding and methods of analysis and interpretation (the "how" matrix). The "teaching and learning" matrix covers desirable assets to be reached by teaching and learning, teaching and learning tools and environments as well as methods of communication used both by learners and their teachers. Single clinical case reports and case series reports contribute to many subcategories of the content and form evaluation in surgery and in numerous domains in which evaluation is used and must be made.

Clinical case reports and case series research in evaluating surgery. Part II. The content and form: uses of single clinical case reports and case series research in surgical specialties.

Single clinical case and case series reports have long been an integral part of medicine and surgery. Despite this, due to their vague objectives and questions to answer, unstructured presentations and absent, exaggerated and/or unsubstantiated conclusions and recommendations, they are sometimes perceived as a lighter piece of evidence in modern surgical understanding and decision-making. Their value may, in fact, be in their contribution to theory, inference, or both. Today, modern case reporting is a balanced mixture of traditional patient-centered reporting methodology, a quantitative approach to ("scientific") inference and growing experience from qualitative research and evaluation methodology in general policies, programs, politics, arts, humanities, business, economics, and the military. Integration of such experiences is possible and even desirable in modern clinical case(s) reporting. Both strengths and weaknesses of case(s) reporting are based on the structure and content of case(s) reports in terms of the clarity of their leading questions and objectives, structured presentation in form and valid argument building blocks founded on the best evidence available leading to their realistic conclusions and claims. Readers must assess their real value in general and in the context of their own decisions in research and practice with patients under their care and in decision-making. Most discussion about single clinical case reports and case series research revolves around their relevance to some degree of proof of cause-effect relationships. The relevance of case reports and case series research goes well beyond this point. Recommendations for both surgical and other case presenters and their interlocutors and readers are offered for consideration.

The hard art of soft science: Evidence-Based Medicine, Reasoned Medicine or both?

In the past 14 years, Evidence-Based Medicine (EBM) has enjoyed unprecedented developments and gained widespread acceptance among health professionals. However, should we be content with producing, critically appraising and using the best evidence available for our understanding of health problems and decision making about them? Are our convictions about EBM's relevance, our conviction and intellectual satisfaction with its mastery and adoption enough? Should we continue pushing forward along this promising path, or should we further diversify the content and scope of EBM? Is EBM the only way to view medicine in the near future? This paper presents some options to choose from in terms of direction and content as well as questions to answer given the current EBM crossroads. More intensive and extensive EBM combined with 'other features'-based medicines may be the preferred strategy to follow in the future to determine the development, use and evaluation of EBM. Argument-based medicine or Reasoned Medicine is one of the options that can be integrated into the mainstream of medical reasoning and decision making.

Evidence-based medicine: fifteen years later. Golem the good, the bad, and the ugly in need of a review?

Despite its well-deserved strengths, Evidence-Based Medicine (EBM)'s shell still remains half-full. Its strong points are clouded in persisting philosophical gaps and mostly ideological advancements of its concepts and rules. Further clarification of its logic and critical use of evidence is required. In this non-systematic essay and review, several present and future necessary achievements are outlined: Solid methodological tools were developed under the umbrella of surprisingly less-operational definition(s) of EBM and 'evidence' itself, incomplete classifications of various evidences and limited scope of original critical appraisal of evidence. The integration of the best evidence with clinical expertise, setting and circumstances, as well as patient expectations, values, and preferences and the application of evidence to a specific patient have only been conceptually traced so far and usable rules remain in waiting. The question of whether the practice of EBM produces better results than its alternatives also remains unanswered. Uses of the best evidence as a basis for the fundamental elements of modern argumentation and critical thinking applied to medicine may be one of the promising paths, but this approach still must be more widely applied and evaluated on its own merit. In other words, we do have a point, but it needs to be improved.

Towards evidence-based critical thinking medicine? Uses of best evidence in flawless argumentations.

Uses of informal logic and critical thinking methodology are increasingly taught, learnt and advantageously applied in such diverse domains as law, the military, business, and education. Health sciences are also following this trend. However, production and critical appraisal of evidence as already practiced in Evidence-Based Medicine must be coupled with equally rigorous uses in order to ensure appropriate health problem understanding and decision-making. Making most proposals and decisions in medicine is the conclusion of an argumentation process that lies behind any communication between health professionals working with patients, performing research or sharing ideas about health problems, their interpretations and solutions with numerous stakeholders in public life. Modern critical thinking and decision making in medicine is not instantly mastered, but is instead a learnt experience as anything else in professional and social interactions. The modern argument as outlined, illustrated and applied to health problems in this essay is an extension of a previously established way of thinking in Evidence-Based Medicine. Ideally, health professionals, their patients and all other stakeholders should speak the same language and it is up to us to make this possible. Evidence and critical thinking - based medicine might be a solution. As modern critical thinkers, we are at the forefront and we must see to it that patients and professional and general communities benefit from this more so even than from other remarkable historical and current contributions to the well-being of those under our care.

How to read, understand, and write 'Discussion' sections in medical articles. An exercise in critical thinking.

Writing and reading 'Discussion' sections in medical articles require a procedure as exact and structured as that involved in raising questions, choosing materials and methods and producing results for a health research study. The medical article as a whole can be considered an exercise in modern argumentation and its 'Discussion' section, a systematic critical appraisal of a path from theses to conclusions. The methodology of modern critical thinking applies perfectly to article writing, reading, and understanding. Structuring the 'Discussion' section as a review of argumentation benefits more than the study and its authors. It allows the reader to grasp the real relevance and validity of the study and its usability for his or her decision-making in clinical and community care, research and health policies and program proposal, implementation, and evaluation.

Evidence-based public health, community medicine, preventive care.

The use of evidence-based reasoning and decision-making theory and practice is becoming increasingly commonplace in most of the health sciences. Public health, which encompasses health protection, disease prevention and health promotion, has traditionally been more evidence-based than clinical medicine. However, more must be done to grade evidence in the absence of classical clinical trials or other experimental proof. Decisions in public health also rely on economical, social and political considerations, but how can evidence in these fields be graded for the best possible decision-making in public health? Moreover, evidence is often unequally distributed in relation to different focus groups. For example, evidence in the area of women's health should be as extensive as it is in the area of men's health. Medicine has traditionally been more ethically inclined than many other fields of human endeavour. In light of this, should we require all decision makers involved in health policies (i.e. politicians, economists, and other stakeholders) to be equally ethically minded? Decisions made without using the best evidence in setting the priorities of health programs and health policies may be ethically questionable. However, the burden and responsibility no longer lie exclusively on the shoulders of physicians and nurses. Evidence-based problem solving and decision-making in health sciences are only approximately a decade old. As a result, the already impressive, but still incomplete accomplishments of the evidence-based medical world require further advancements.