Evidence-based medicine

From Wikipedia, the free encyclopedia

Evidence-based medicine (EBM) is an approach to medical practice intended to optimize decision-making by emphasizing the use of evidence from well-designed and well-conducted research. Although all medicine based on science has some degree of empirical support, EBM goes further, classifying evidence by its epistemologic strength and requiring that only the strongest types (coming from meta-analyses, systematic reviews, and randomized controlled trials) can yield strong recommendations; weaker types (such as from case-control studies) can yield only weak recommendations. The term was originally used to describe an approach to teaching the practice of medicine and improving decisions by individual physicians about individual patients.^[1] Use of the term rapidly expanded to include a previously described approach that emphasized the use of evidence in the design of guidelines and policies that apply to groups of patients and populations ("evidence-based practice policies").^[2] It has subsequently spread to describe an approach to decision-making that is used at virtually every level of health care as well as other fields (evidence-based practice).

Whether applied to medical education, decisions about individuals, guidelines and policies applied to populations, or administration of health services in general, evidence-based medicine advocates that to the greatest extent possible, decisions and policies should be based on evidence, not just the beliefs of practitioners, experts, or administrators. It thus tries to assure that a clinician's opinion, which may be limited by knowledge gaps or biases, is supplemented with all available knowledge from the scientific literature so that best practice can be determined and applied. It promotes the use of formal, explicit methods to analyze evidence and makes it available to decision makers. It promotes programs to teach the methods to medical students, practitioners, and policy makers.

Background, history and definition

In its broadest form, evidence-based medicine is the application of the scientific method into healthcare decision-making. Medicine has a long tradition of both basic and clinical research that dates back at least to Avicenna^[3][4] and more recently to protestant reformation exegesis of the 17th and 18th centuries.^[5] An early critique of statistical methods in medicine was published in 1835.^[6]

However, until recently, the process by which research results were incorporated in medical decisions was highly subjective.^{[citation needed]} Called "clinical judgment" and "the art of medicine", the traditional approach to making decisions about individual patients depended on having each individual physician determine what research evidence, if any, to consider, and how to merge that evidence with personal beliefs and other factors.^{[citation needed]} In the case of decisions which applied to groups of patients or populations, the guidelines and policies would usually be developed by committees of experts, but there was no formal process for determining the extent to which research evidence should be considered or how it should be merged with the beliefs of the committee members.^{[citation needed]} There was an implicit assumption that decision makers and policy makers would incorporate evidence in their thinking appropriately, based on their education, experience, and ongoing study of the applicable literature.^{[citation needed]}

Clinical decision making

Beginning in the late 1960s, several flaws became apparent in the traditional approach to medical decision-making. Alvan Feinstein's publication of Clinical Judgment in 1967 focused attention on the role of clinical reasoning and identified biases that can affect it.^[7] In 1972, Archie Cochrane published Effectiveness and Efficiency, which described the lack of controlled trials supporting many practices that had previously been assumed to be effective.^[8] In 1973, John Wennberg began to document wide variations in how physicians practiced.^[9] Through the 1980s, David M. Eddy described errors in clinical reasoning and gaps in evidence.^{[10][11][12][13]} In the mid 1980s, Alvin Feinstein, David Sackett and others published textbooks on clinical epidemiology, which translated epidemiological methods to physician decision making.^[14][15] Toward the end of the 1980s, a group at RAND showed that large proportions of procedures performed by physicians were considered inappropriate even by the standards of their own experts.^[16] These areas of research increased awareness of the weaknesses in medical decision making at the level of both individual patients and populations, and paved the way for the introduction of evidence-based methods.

Evidence-based

The term "evidence-based medicine", as it is currently used, has two main tributaries. Chronologically, the first is the insistence on explicit evaluation of evidence of effectiveness when issuing clinical practice guidelines and other population-level policies. The second is the introduction of epidemiological methods into medical education and individual patient-level decision-making.^{[citation needed]}

Evidence-based guidelines and policies

The term "evidence-based" was first used by David M. Eddy in the course of his work on population-level policies such as clinical practice guidelines and insurance coverage of new technologies. He first began to use the term "evidence-based" in 1987 in workshops and a manual commissioned by the Council of Medical Specialty Societies to teach formal methods for designing clinical practice guidelines. The manual was widely available in unpublished form in the late 1980s and eventually published by the American College of Medicine.^[17][18] Eddy first published the term "evidence-based" in March, 1990 in an article in the Journal of the American Medical Association that laid out the principles of evidence-based guidelines and population-level policies, which Eddy described as "explicitly describing the available evidence that pertains to a policy and tying the policy to evidence. Consciously anchoring a policy, not to current practices or the beliefs of experts, but to experimental evidence. The policy must be consistent with and supported by evidence. The pertinent evidence must be identified, described, and analyzed. The policymakers must determine whether the policy is justified by the evidence. A rationale must be written."^[19] He discussed "evidence-based" policies in several other papers published in JAMA in the spring of 1990.^[19][20] Those papers were part of a series of 28 published in JAMA between 1990 and 1997 on formal methods for designing population-level guidelines and policies.^[21]

Medical education

The term "evidence-based medicine" was introduced slightly later, in the context of medical education. This branch of evidence-based medicine has its roots in clinical epidemiology. In the autumn of 1990, Gordon Guyatt used it in an unpublished description of a program at McMaster University for prospective or new medical students.^[22] Guyatt and others first published the term two years later (1992) to describe a new approach to teaching the practice of medicine.^[1]

In 1996, David Sackett and colleagues clarified the definition of this tributary of evidence-based medicine as "the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. ... [It] means integrating individual clinical expertise with the best available external clinical evidence from systematic research."^[23] This branch of evidence-based medicine aims to make individual decision making more structured and objective by better reflecting the evidence from research.^[24][25] Population-based data are applied to the care of an individual patient,^[26] while respecting the fact that practitioners have clinical expertise reflected in effective and efficient diagnosis and thoughtful identification and compassionate use of individual patients' predicaments, rights, and preferences.^[23]

This tributary of evidence-based medicine had its foundations in clinical epidemiology, a discipline that teaches health care workers how to apply clinical and epidemiological research studies to their practices. Between 1993 and 2000, the Evidence-based Medicine Working Group at McMaster University published the methods to a broad physician audience in a series of 25 "Users’ Guides to the Medical Literature" in JAMA. In 1995 Rosenberg and Donald defined individual level evidence-based medicine as "the process of finding, appraising, and using contemporaneous research findings as the basis for medical decisions."^[27] In 2010, Greenhalgh used a definition that emphasized quantitative methods: "the use of mathematical estimates of the risk of benefit and harm, derived from high-quality research on population samples, to inform clinical decision-making in the diagnosis, investigation or management of individual patients."^[28] Many other definitions have been offered for individual level evidence-based medicine, but the one by Sackett and colleagues is the most commonly cited.^[23]

The two original definitions^[which?] highlight important differences in how evidence-based medicine is applied to populations versus individuals. When designing guidelines applied to large groups of people in settings where there is relatively little opportunity for modification by individual physicians, evidence-based policymaking stresses that there should be good evidence to document a test´s or treatment´s effectiveness.^[29] In the setting of individual decision-making, practitioners can be given greater latitude in how they interpret research and combine it with their clinical judgment.^[23][30] in 2005 Eddy offered an umbrella definition for the two branches of EBM: "Evidence-based medicine is a set of principles and methods intended to ensure that to the greatest extent possible, medical decisions, guidelines, and other types of policies are based on and consistent with good evidence of effectiveness and benefit."^[31]

Progress

Both branches of evidence-based medicine spread rapidly. On the evidence-based guidelines and policies side, explicit insistence on evidence of effectiveness was introduced by the American Cancer Society in 1980.^[32] The U.S. Preventive Services Task Force (USPSTF) began issuing guidelines for preventive interventions based on evidence-based principles in 1984.^[33] In 1985, the Blue Cross Blue Shield Association applied strict evidence-based criteria for covering new technologies.^[34] Beginning in 1987, specialty societies such as the American College of Physicians, and voluntary health organizations such as the American Heart Association, wrote many evidence-based guidelines. In 1991, Kaiser Permanente, a managed care organization in the US, began an evidence-based guidelines program.^[35] In 1991, Richard Smith wrote an editorial in the British Medical Journal and introduced the ideas of evidence-based policies in the UK.^[36] In 1993, the Cochrane Collaboration created a network of 13 countries to produce of systematic reviews and guidelines.^[37] In 1997, the US Agency for Healthcare Research and Quality (then known as the Agency for Health Care Policy and Research, or AHCPR) established Evidence-based Practice Centers (EPCs) to produce evidence reports and technology assessments to support the development of guidelines.^[38] In the same year, a National Guideline Clearinghouse that followed the principles of evidence-based policies was created by AHRQ, the AMA, and the American Association of Health Plans (now America's Health Insurance Plans).^[39] In 1999, the National Institute for Clinical Excellence (NICE) was created in the UK.^[40] A central idea of this branch of evidence-based medicine is that evidence should be classified according to the rigor of its experimental design, and the strength of a recommendation should depend on the strength of the evidence.

On the medical education side, programs to teach evidence-based medicine have been created in medical schools in Canada, the US, the UK, Australia, and other countries.^[41][42] A 2009 study of UK programs found the more than half of UK medical schools offered some training in evidence-based medicine, although there was considerable variation in the methods and content, and EBM teaching was restricted by lack of curriculum time, trained tutors and teaching materials.^[43] Many programs have been developed to help individual physicians gain better access to evidence. For example, UpToDate was created in the early 1990s.^[44] The Cochrane Collaboration began publishing evidence reviews in 1993.^[35] BMJ Publishing Group launched a 6-monthly periodical in 1995 called Clinical Evidence that provided brief summaries of the current state of evidence about important clinical questions for clinicians.^[45] Since then many other programs have been developed to make evidence more accessible to practitioners.

Current practice

The term evidence-based medicine is now applied to both the programs that are designing evidence-based guidelines and the programs that teach evidence-based medicine to practitioners. By 2000, "evidence-based medicine" had become an umbrella term for the emphasis on evidence in both population-level and individual-level decisions. In subsequent years, use of the term "evidence-based" had extended to other levels of the health care system. An example is "evidence-based health services", which seek to increase the competence of health service decision makers and the practice of evidence-based medicine at the organizational or institutional level.^[46] The concept has also spread outside of healthcare; for example, in his 1996 inaugural speech as President of the Royal Statistical Society, Adrian Smith proposed that "evidence-based policy" should be established for education, prisons and policing policy and all areas of government work.

The multiple tributaries of evidence-based medicine share an emphasis on the importance of incorporating evidence from formal research in medical policies and decisions. However they differ on the extent to which they require good evidence of effectiveness before promulgating a guideline or payment policy, and they differ on the extent to which it is feasible to incorporate individual-level information in decisions. Thus, evidence-based guidelines and policies may not readily 'hybridise' with experience-based practices orientated towards ethical clinical judgement, and can lead to contradictions, contest, and unintended crises.^[13] The most effective 'knowledge leaders' (managers and clinical leaders) use a broad range of management knowledge in their decision making, rather than just formal evidence.^[14] Evidence-based guidelines may provide the basis for governmentality in health care and consequently play a central role in the distant governance of contemporary health care systems.^[15]

Methods

Steps

The steps for designing explicit, evidence-based guidelines were described in the late 1980s: Formulate the question (population, intervention, comparison intervention, outcomes, time horizon, setting); search the literature to identify studies that inform the question; interpret each study to determine precisely what it says about the question; if several studies address the question, synthesize their results (meta-analysis); summarize the evidence in "evidence tables"; compare the benefits, harms and costs in a "balance sheet"; draw a conclusion about the preferred practice; write the guideline; write the rationale for the guideline; have others review each of the previous steps; implement the guideline.^[12]

For the purposes of medical education and individual-level decision making, five steps of EBM in practice were described in 1992^[47] and the experience of delegates attending the 2003 Conference of Evidence-Based Health Care Teachers and Developers was summarized into five steps and published in 2005.^[48] This five step process can broadly be categorized as:

1. Translation of uncertainty to an answerable question and includes critical questioning, study design and levels of evidence^[49]
2. Systematic retrieval of the best evidence available^[50]
3. Critical appraisal of evidence for internal validity that can be broken down into aspects regarding:^[51]
   • Systematic errors as a result of selection bias, information bias and confounding
   • Quantitative aspects of diagnosis and treatment
   • The effect size and aspects regarding its precision
   • Clinical importance of results
   • External validity or generalizability
4. Application of results in practice^[52]
5. Evaluation of performance^[53]

Evidence reviews

Systematic reviews of published research studies is a major part of the evaluation of particular treatments. The Cochrane Collaboration is one of the best-known programs that conducts systematic reviews. Like other collections of systematic reviews, it requires authors to provide a detailed and repeatable plan of their literature search and evaluations of the evidence.^[54] Once all the best evidence is assessed, treatment is categorized as (1) likely to be beneficial, (2) likely to be harmful, or (3) evidence did not support either benefit or harm.

A 2007 analysis of 1,016 systematic reviews from all 50 Cochrane Collaboration Review Groups found that 44% of the reviews concluded that the intervention was likely to be beneficial, 7% concluded that the intervention was likely to be harmful, and 49% concluded that evidence did not support either benefit or harm. 96% recommended further research.^[55] A 2001 review of 160 Cochrane systematic reviews (excluding complementary treatments) in the 1998 database revealed that, according to two readers, 41% concluded positive or possibly positive effect, 20% concluded evidence of no effect, 8% concluded net harmful effects, and 21% of the reviews concluded insufficient evidence.^[56] A review of 145 alternative medicine Cochrane reviews using the 2004 database revealed that 38.4% concluded positive effect or possibly positive (12.4%) effect, 4.8% concluded no effect, 0.7% concluded harmful effect, and 56.6% concluded insufficient evidence.^[57] In 2017, a study assessed the role of systematic reviews produced by Cochrane Collaboration to inform US private payers' policies making; it showed that though medical policy documents of major US private were informed by Cochrane systematic review; there was still scope to encourage the further usage.^[58]

Assessing the quality of evidence

Evidence quality can be assessed based on the source type (from meta-analyses and systematic reviews of triple-blind randomized clinical trials with concealment of allocation and no attrition at the top end, down to conventional wisdom at the bottom), as well as other factors including statistical validity, clinical relevance, currency, and peer-review acceptance. Evidence-based medicine categorizes different types of clinical evidence and rates or grades them^[59] according to the strength of their freedom from the various biases that beset medical research. For example, the strongest evidence for therapeutic interventions is provided by systematic review of randomized, triple-blind, placebo-controlled trials with allocation concealment and complete follow-up involving a homogeneous patient population and medical condition. In contrast, patient testimonials, case reports, and even expert opinion (however, some critics have argued that expert opinion "does not belong in the rankings of the quality of empirical evidence because it does not represent a form of empirical evidence" and continue that "expert opinion would seem to be a separate, complex type of knowledge that would not fit into hierarchies otherwise limited to empirical evidence alone").^[60] have little value as proof because of the placebo effect, the biases inherent in observation and reporting of cases, difficulties in ascertaining who is an expert and more.
Several organizations have developed grading systems for assessing the quality of evidence. For example, in 1989 the U.S. Preventive Services Task Force (USPSTF) put forth the following:^[61]

• Level I: Evidence obtained from at least one properly designed randomized controlled trial.
• Level II-1: Evidence obtained from well-designed controlled trials without randomization.
• Level II-2: Evidence obtained from well-designed cohort studies or case-control studies, preferably from more than one center or research group.
• Level II-3: Evidence obtained from multiple time series designs with or without the intervention. Dramatic results in uncontrolled trials might also be regarded as this type of evidence.
• Level III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.

Another example is the Oxford (UK) CEBM Levels of Evidence. First released in September 2000, the Oxford CEBM Levels of Evidence provides 'levels' of evidence for claims about prognosis, diagnosis, treatment benefits, treatment harms, and screening, which most grading schemes do not address. The original CEBM Levels was Evidence-Based On Call to make the process of finding evidence feasible and its results explicit. In 2011, an international team redesigned the Oxford CEBM Levels to make it more understandable and to take into account recent developments in evidence ranking schemes. The Oxford CEBM Levels of Evidence have been used by patients, clinicians and also to develop clinical guidelines including recommendations for the optimal use of phototherapy and topical therapy in psoriasis^[62] and guidelines for the use of the BCLC staging system for diagnosing and monitoring hepatocellular carcinoma in Canada.^[63]

In 2000, a system was developed by the GRADE (short for Grading of Recommendations Assessment, Development and Evaluation) working group and takes into account more dimensions than just the quality of medical research.^[64] It requires users of GRADE who are performing an assessment of the quality of evidence, usually as part of a systematic review, to consider the impact of different factors on their confidence in the results. Authors of GRADE tables grade the quality of evidence into four levels, on the basis of their confidence in the observed effect (a numerical value) being close to what the true effect is. The confidence value is based on judgements assigned in five different domains in a structured manner.^[65] The GRADE working group defines 'quality of evidence' and 'strength of recommendations' based on the quality as two different concepts which are commonly confused with each other.^[65]

Systematic reviews may include randomized controlled trials that have low risk of bias, or, observational studies that have high risk of bias. In the case of randomized controlled trials, the quality of evidence is high, but can be downgraded in five different domains.^[66]

• Risk of bias: Is a judgement made on the basis of the chance that bias in included studies has influenced the estimate of effect.
• Imprecision: Is a judgement made on the basis of the chance that the observed estimate of effect could change completely.
• Indirectness: Is a judgement made on the basis of the differences in characteristics of how the study was conducted and how the results are actually going to be applied.
• Inconsistency: Is a judgement made on the basis of the variability of results across the included studies.
• Publication bias: Is a judgement made on the basis of the question whether all the research evidence has been taken to account.

In the case of observational studies per GRADE, the quality of evidence starts of lower and may be upgraded in three domains in addition to being subject to downgrading.^[66]

• Large effect: This is when methodologically strong studies show that the observed effect is so large that the probability of it changing completely is less likely.
• Plausible confounding would change the effect: This is when despite the presence of a possible confounding factor which is expected to reduce the observed effect, the effect estimate still shows significant effect.
• Dose response gradient: This is when the intervention used becomes more effective with increasing dose. This suggests that a further increase will likely bring about more effect.

Meaning of the levels of quality of evidence as per GRADE:^[65]

• High Quality Evidence: The authors are very confident that the estimate that is presented lies very close to the true value. One could interpret it as "there is very low probability of further research completely changing the presented conclusions."
• Moderate Quality Evidence: The authors are confident that the presented estimate lies close to the true value, but it is also possible that it may be substantially different. One could also interpret it as: further research may completely change the conclusions.
• Low Quality Evidence: The authors are not confident in the effect estimate and the true value may be substantially different. One could interpret it as "further research is likely to change the presented conclusions completely."
• Very low quality Evidence: The authors do not have any confidence in the estimate and it is likely that the true value is substantially different from it. One could interpret it as "new research will most probably change the presented conclusions completely."

Categories of recommendations

In guidelines and other publications, recommendation for a clinical service is classified by the balance of risk versus benefit and the level of evidence on which this information is based. The U.S. Preventive Services Task Force uses:^[67]

• Level A: Good scientific evidence suggests that the benefits of the clinical service substantially outweigh the potential risks. Clinicians should discuss the service with eligible patients.
• Level B: At least fair scientific evidence suggests that the benefits of the clinical service outweighs the potential risks. Clinicians should discuss the service with eligible patients.
• Level C: At least fair scientific evidence suggests that there are benefits provided by the clinical service, but the balance between benefits and risks are too close for making general recommendations. Clinicians need not offer it unless there are individual considerations.
• Level D: At least fair scientific evidence suggests that the risks of the clinical service outweighs potential benefits. Clinicians should not routinely offer the service to asymptomatic patients.
• Level I: Scientific evidence is lacking, of poor quality, or conflicting, such that the risk versus benefit balance cannot be assessed. Clinicians should help patients understand the uncertainty surrounding the clinical service.

GRADE guideline panelists may make strong or weak recommendations on the basis of further criteria. Some of the important criteria are the balance between desirable and undesirable effects (not considering cost), the quality of the evidence, values and preferences and costs (resource utilization).^[66]

Despite the differences between systems, the purposes are the same: to guide users of clinical research information on which studies are likely to be most valid. However, the individual studies still require careful critical appraisal.

Statistical measures

Evidence-based medicine attempts to express clinical benefits of tests and treatments using mathematical methods. Tools used by practitioners of evidence-based medicine include:

• Likelihood ratio The pre-test odds of a particular diagnosis, multiplied by the likelihood ratio, determines the post-test odds. (Odds can be calculated from, and then converted to, the [more familiar] probability.) This reflects Bayes' theorem. The differences in likelihood ratio between clinical tests can be used to prioritize clinical tests according to their usefulness in a given clinical situation.
• AUC-ROC The area under the receiver operating characteristic curve (AUC-ROC) reflects the relationship between sensitivity and specificity for a given test. High-quality tests will have an AUC-ROC approaching 1, and high-quality publications about clinical tests will provide information about the AUC-ROC. Cutoff values for positive and negative tests can influence specificity and sensitivity, but they do not affect AUC-ROC.
• Number needed to treat (NNT)/Number needed to harm (NNH). Number needed to treat or number needed to harm are ways of expressing the effectiveness and safety, respectively, of interventions in a way that is clinically meaningful. NNT is the number of people who need to be treated in order to achieve the desired outcome (e.g. survival from cancer) in one patient. For example, if a treatment increases the chance of survival by 5%, then 20 people need to be treated in order to have 1 additional patient survive due to the treatment. The concept can also be applied to diagnostic tests. For example, if 1339 women age 50–59 have to be invited for breast cancer screening over a ten-year period in order to prevent one woman from dying of breast cancer,^[68] then the NNT for being invited to breast cancer screening is 1339.

Quality of clinical trials

Evidence-based medicine attempts to objectively evaluate the quality of clinical research by critically assessing techniques reported by researchers in their publications.

• Trial design considerations. High-quality studies have clearly defined eligibility criteria and have minimal missing data.
• Generalizability considerations. Studies may only be applicable to narrowly defined patient populations and may not be generalizable to other clinical contexts.
• Follow-up. Sufficient time for defined outcomes to occur can influence the prospective study outcomes and the statistical power of a study to detect differences between a treatment and control arm.
• Power. A mathematical calculation can determine if the number of patients is sufficient to detect a difference between treatment arms. A negative study may reflect a lack of benefit, or simply a lack of sufficient quantities of patients to detect a difference.

Limitations and criticism

Although evidence-based medicine is regarded as the gold standard of clinical practice, there are a number of limitations and criticisms of its use.^[69] Two widely cited categorization schemes for the various published critiques of EBM include the three-fold division of Straus and McAlister ("limitations universal to the practice of medicine, limitations unique to evidence-based medicine and misperceptions of evidence-based-medicine")^[70] and the five-point categorization of Cohen, Stavri and Hersh (EBM is a poor philosophic basis for medicine, defines evidence too narrowly, is not evidence-based, is limited in usefulness when applied to individual patients, or reduces the autonomy of the doctor/patient relationship).^[71]

In no particular order, some published objections include:

• The theoretical ideal of EBM (that every narrow clinical question, of which hundreds of thousands can exist, would be answered by meta-analysis and systematic reviews of multiple RCTs) faces the limitation that research (especially the RCTs themselves) is expensive; thus, in reality, for the foreseeable future, there will always be much more demand for EBM than supply, and the best humanity can do is to triage the application of scarce resources.
• Research produced by EBM, such as from randomized controlled trials (RCTs), may not be relevant for all treatment situations.^[72] Research tends to focus on specific populations, but individual persons can vary substantially from population norms. Since certain population segments have been historically under-researched (racial minorities and people with co-morbid diseases), evidence from RCTs may not be generalizable to those populations.^[73] Thus EBM applies to groups of people, but this should not preclude clinicians from using their personal experience in deciding how to treat each patient. One author advises that "the knowledge gained from clinical research does not directly answer the primary clinical question of what is best for the patient at hand" and suggests that evidence-based medicine should not discount the value of clinical experience.^[60] Another author stated that "the practice of evidence-based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research."^[74]
• Research can be influenced by biases such as publication bias and conflict of interest. For example, studies with conflicts due to industry funding are more likely to favor their product.^[75][76]
• There is a lag between when the RCT is conducted and when its results are published.^[77]
• There is a lag between when results are published and when these are properly applied.^[78]
• Hypocognition (the absence of a simple, consolidated mental framework that new information can be placed into) can hinder the application of EBM.^[79]
• Values: while patient values are considered in the original definition of EBM, the importance of values is not commonly emphasized in EBM training, a potential problem under current study.^[80][81][82]

Application of evidence in clinical settings

One of the ongoing challenges with evidence-based medicine is that some healthcare providers do not follow the evidence. This happens partly because the current balance of evidence for and against treatments shifts constantly, and it is impossible to learn about every change.^[83] Even when the evidence is unequivocally against a treatment, it usually takes ten years for other treatments to be adopted.^[83] In other cases, significant change can require a generation of physicians to retire or die, and be replaced by physicians who were trained with more recent evidence.^[83]

Another major cause of physicians and other healthcare providers treating patients in ways unsupported by the evidence is that these healthcare providers are subject to the same cognitive biases as all other humans. They may reject the evidence because they have a vivid memory of a rare but shocking outcome (the availability heuristic), such as a patient dying after refusing treatment.^[83] They may overtreat to "do something" or to address a patient's emotional needs.^[83] They may worry about malpractice charges based on a discrepancy between what the patient expects and what the evidence recommends.^[83] They may also overtreat or provide ineffective treatments because the treatment feels biologically plausible.^[83]

Education

The Berlin questionnaire and the Fresno Test^[84][85] are validated instruments for assessing the effectiveness of education in evidence-based medicine.^[86][87] These questionnaires have been used in diverse settings.^[88][89]

A Campbell systematic review that included 24 trials examined the effectiveness of e-learning in improving evidence-based health care knowledge and practice. It was found that e-learning, compared to no learning, improves evidence-based health care knowledge and skills but not attitudes and behaviour. There is no difference in outcomes when comparing e-learning to face-to-face learning. Combining e-learning with face-to-face learning (blended learning) has a positive impact on evidence-based knowledge, skills, attitude and behaviour.^[90] Related to e-learning, medical school students have engaged with editing Wikipedia to increase their EBM skills.^[91]

Natural and legal rights

From Wikipedia, the free encyclopedia

Natural and legal rights are two types of rights. Natural rights are those that are not dependent on the laws or customs of any particular culture or government, and so are universal and inalienable (they cannot be repealed or restrained by human laws). Legal rights are those bestowed onto a person by a given legal system (they can be modified, repealed, and restrained by human laws).

The concept of natural law is related to the concept of natural rights. Natural law first appeared in ancient Greek philosophy,^[1] and was referred to by Roman philosopher Cicero. It was subsequently alluded to in the Bible,^[2] and then developed in the Middle Ages by Catholic philosophers such as Albert the Great and his pupil Thomas Aquinas. During the Age of Enlightenment, the concept of natural laws was used to challenge the divine right of kings, and became an alternative justification for the establishment of a social contract, positive law, and government – and thus legal rights – in the form of classical republicanism. Conversely, the concept of natural rights is used by others to challenge the legitimacy of all such establishments.

The idea of human rights is also closely related to that of natural rights: some acknowledge no difference between the two, regarding them as synonymous, while others choose to keep the terms separate to eliminate association with some features traditionally associated with natural rights.^[3] Natural rights, in particular, are considered beyond the authority of any government or international body to dismiss. The 1948 United Nations Universal Declaration of Human Rights is an important legal instrument enshrining one conception of natural rights into international soft law. Natural rights were traditionally viewed as exclusively negative rights,^[4] whereas human rights also comprise positive rights.^[5] Even on a natural rights conception of human rights, the two terms may not be synonymous.

The proposition that animals have natural rights is one that gained the interest of philosophers and legal scholars in the 20th century and into the 21st.^[6]

History

The idea that certain rights are natural or inalienable also has a history dating back at least to the Stoics of late Antiquity and Catholic law of the early Middle Ages, and descending through the Protestant Reformation and the Age of Enlightenment to today.^{[citation needed]}

The existence of natural rights has been asserted by different individuals on different premises, such as a priori philosophical reasoning or religious principles. For example, Immanuel Kant claimed to derive natural rights through reason alone. The United States Declaration of Independence, meanwhile, is based upon the "self-evident" truth that "all men are … endowed by their Creator with certain unalienable Rights".^[7]

Likewise, different philosophers and statesmen have designed different lists of what they believe to be natural rights; almost all include the right to life and liberty as the two highest priorities. H. L. A. Hart argued that if there are any rights at all, there must be the right to liberty, for all the others would depend upon this. T. H. Green argued that “if there are such things as rights at all, then, there must be a right to life and liberty, or, to put it more properly to free life.”^[8] John Locke emphasized "life, liberty and property" as primary. However, despite Locke's influential defense of the right of revolution, Thomas Jefferson substituted "pursuit of happiness" in place of "property" in the United States Declaration of Independence.

Ancient

Stephen Kinzer, a veteran journalist for The New York Times and the author of the book All The Shah's Men, writes in the latter that:

The Zoroastrian religion taught Iranians that citizens have an inalienable right to enlightened leadership and that the duty of subjects is not simply to obey wise kings but also to rise up against those who are wicked. Leaders are seen as representative of God on earth, but they deserve allegiance only as long as they have farr, a kind of divine blessing that they must earn by moral behavior.

The Stoics held that no one was a slave by nature; slavery was an external condition juxtaposed to the internal freedom of the soul (sui juris). Seneca the Younger wrote:

It is a mistake to imagine that slavery pervades a man's whole being; the better part of him is exempt from it: the body indeed is subjected and in the power of a master, but the mind is independent, and indeed is so free and wild, that it cannot be restrained even by this prison of the body, wherein it is confined.^[9]

Of fundamental importance to the development of the idea of natural rights was the emergence of the idea of natural human equality. As the historian A.J. Carlyle notes: "There is no change in political theory so startling in its completeness as the change from the theory of Aristotle to the later philosophical view represented by Cicero and Seneca.... We think that this cannot be better exemplified than with regard to the theory of the equality of human nature."^[10] Charles H. McIlwain likewise observes that "the idea of the equality of men is the profoundest contribution of the Stoics to political thought" and that "its greatest influence is in the changed conception of law that in part resulted from it."^[11] Cicero argues in De Legibus that "we are born for Justice, and that right is based, not upon opinions, but upon Nature."^[12]

Modern

One of the first Western thinkers to develop the contemporary idea of natural rights was French theologian Jean Gerson, whose 1402 treatise De Vita Spirituali Animae is considered one of the first attempts to develop what would come to be called modern natural rights theory.^[13]

Centuries later, the Stoic doctrine that the "inner part cannot be delivered into bondage"^[14] re-emerged in the Reformation doctrine of liberty of conscience. Martin Luther wrote:

Furthermore, every man is responsible for his own faith, and he must see it for himself that he believes rightly. As little as another can go to hell or heaven for me, so little can he believe or disbelieve for me; and as little as he can open or shut heaven or hell for me, so little can he drive me to faith or unbelief. Since, then, belief or unbelief is a matter of every one's conscience, and since this is no lessening of the secular power, the latter should be content and attend to its own affairs and permit men to believe one thing or another, as they are able and willing, and constrain no one by force.^[15]

17th-century English philosopher John Locke discussed natural rights in his work, identifying them as being "life, liberty, and estate (property)", and argued that such fundamental rights could not be surrendered in the social contract. Preservation of the natural rights to life, liberty, and property was claimed as justification for the rebellion of the American colonies. As George Mason stated in his draft for the Virginia Declaration of Rights, "all men are born equally free," and hold "certain inherent natural rights, of which they cannot, by any compact, deprive or divest their posterity."^[16] Another 17th-century Englishman, John Lilburne (known as Freeborn John), who came into conflict with both the monarchy of King Charles I and the military dictatorship of Oliver Cromwell governed republic, argued for level human basic rights he called "freeborn rights" which he defined as being rights that every human being is born with, as opposed to rights bestowed by government or by human law.

The distinction between alienable and unalienable rights was introduced by Francis Hutcheson. In his Inquiry into the Original of Our Ideas of Beauty and Virtue (1725), Hutcheson foreshadowed the Declaration of Independence, stating: “For wherever any Invasion is made upon unalienable Rights, there must arise either a perfect, or external Right to Resistance. . . . Unalienable Rights are essential Limitations in all Governments.” Hutcheson, however, placed clear limits on his notion of unalienable rights, declaring that “there can be no Right, or Limitation of Right, inconsistent with, or opposite to the greatest publick Good."^[17] Hutcheson elaborated on this idea of unalienable rights in his A System of Moral Philosophy (1755), based on the Reformation principle of the liberty of conscience. One could not in fact give up the capacity for private judgment (e.g., about religious questions) regardless of any external contracts or oaths to religious or secular authorities so that right is "unalienable." Hutcheson wrote: "Thus no man can really change his sentiments, judgments, and inward affections, at the pleasure of another; nor can it tend to any good to make him profess what is contrary to his heart. The right of private judgment is therefore unalienable."^[18]

In the German Enlightenment, Hegel gave a highly developed treatment of this inalienability argument. Like Hutcheson, Hegel based the theory of inalienable rights on the de facto inalienability of those aspects of personhood that distinguish persons from things. A thing, like a piece of property, can in fact be transferred from one person to another. According to Hegel, the same would not apply to those aspects that make one a person:

The right to what is in essence inalienable is imprescriptible, since the act whereby I take possession of my personality, of my substantive essence, and make myself a responsible being, capable of possessing rights and with a moral and religious life, takes away from these characteristics of mine just that externality which alone made them capable of passing into the possession of someone else. When I have thus annulled their externality, I cannot lose them through lapse of time or from any other reason drawn from my prior consent or willingness to alienate them.^[19]

In discussion of social contract theory, "inalienable rights" were said to be those rights that could not be surrendered by citizens to the sovereign. Such rights were thought to be natural rights, independent of positive law. Some social contract theorists reasoned, however, that in the natural state only the strongest could benefit from their rights. Thus, people form an implicit social contract, ceding their natural rights to the authority to protect the people from abuse, and living henceforth under the legal rights of that authority.

Many historical apologies for slavery and illiberal government were based on explicit or implicit voluntary contracts to alienate any "natural rights" to freedom and self-determination.^[20] The de facto inalienability arguments of Hutcheson and his predecessors provided the basis for the anti-slavery movement to argue not simply against involuntary slavery but against any explicit or implied contractual forms of slavery. Any contract that tried to legally alienate such a right would be inherently invalid. Similarly, the argument was used by the democratic movement to argue against any explicit or implied social contracts of subjection (pactum subjectionis) by which a people would supposedly alienate their right of self-government to a sovereign as, for example, in Leviathan by Thomas Hobbes. According to Ernst Cassirer,

There is, at least, one right that cannot be ceded or abandoned: the right to personality...They charged the great logician [Hobbes] with a contradiction in terms. If a man could give up his personality he would cease being a moral being. … There is no pactum subjectionis, no act of submission by which man can give up the state of free agent and enslave himself. For by such an act of renunciation he would give up that very character which constitutes his nature and essence: he would lose his humanity.^[21]

These themes converged in the debate about American Independence. While Jefferson was writing the Declaration of Independence, Richard Price in England sided with the Americans' claim "that Great Britain is attempting to rob them of that liberty to which every member of society and all civil communities have a natural and unalienable title."^[22]:67 Price again based the argument on the de facto inalienability of "that principle of spontaneity or self-determination which constitutes us agents or which gives us a command over our actions, rendering them properly ours, and not effects of the operation of any foreign cause."^[22]:67–68 Any social contract or compact allegedly alienating these rights would be non-binding and void, wrote Price:

Neither can any state acquire such an authority over other states in virtue of any compacts or cessions. This is a case in which compacts are not binding. Civil liberty is, in this respect, on the same footing with religious liberty. As no people can lawfully surrender their religious liberty by giving up their right of judging for themselves in religion, or by allowing any human beings to prescribe to them what faith they shall embrace, or what mode of worship they shall practise, so neither can any civil societies lawfully surrender their civil liberty by giving up to any extraneous jurisdiction their power of legislating for themselves and disposing their property.^[22]:78–79

Price raised a furor of opposition so in 1777 he wrote another tract that clarified his position and again restated the de facto basis for the argument that the "liberty of men as agents is that power of self-determination which all agents, as such, possess."^[23] In Intellectual Origins of American Radicalism, Staughton Lynd pulled together these themes and related them to the slavery debate:

Then it turned out to make considerable difference whether one said slavery was wrong because every man has a natural right to the possession of his own body, or because every man has a natural right freely to determine his own destiny. The first kind of right was alienable: thus Locke neatly derived slavery from capture in war, whereby a man forfeited his labor to the conqueror who might lawfully have killed him; and thus Dred Scott was judged permanently to have given up his freedom. But the second kind of right, what Price called "that power of self-determination which all agents, as such, possess," was inalienable as long man remained man. Like the mind's quest for religious truth from which it was derived, self-determination was not a claim to ownership which might be both acquired and surrendered, but an inextricable aspect of the activity of being human.^[24]

Meanwhile, in America, Thomas Jefferson "took his division of rights into alienable and unalienable from Hutcheson, who made the distinction popular and important",^[25] and in the 1776 United States Declaration of Independence, famously condensed this to:

We hold these truths to be self-evident, that all men are created equal, that they are endowed by their Creator with certain unalienable Rights...

In the 19th century, the movement to abolish slavery seized this passage as a statement of constitutional principle, although the U.S. constitution recognized and protected slavery. As a lawyer, future Chief Justice Salmon P. Chase argued before the Supreme Court in the case of John Van Zandt, who had been charged with violating the Fugitive Slave Act, that:

The law of the Creator, which invests every human being with an inalienable title to freedom, cannot be repealed by any interior law which asserts that man is property.

The concept of inalienable rights was criticized by Jeremy Bentham and Edmund Burke as groundless. Bentham and Burke, writing in 18th century Britain, claimed that rights arise from the actions of government, or evolve from tradition, and that neither of these can provide anything inalienable. (See Bentham's "Critique of the Doctrine of Inalienable, Natural Rights", and Burke's Reflections on the Revolution in France). Presaging the shift in thinking in the 19th century, Bentham famously dismissed the idea of natural rights as "nonsense on stilts". By way of contrast to the views of British nationals Burke and Bentham, the leading American revolutionary scholar James Wilson condemned Burke's view as "tyranny."^[26]

The signers of the Declaration of Independence deemed it a "self-evident truth" that all men are endowed by their Creator with certain unalienable Rights". In The Social Contract, Jean-Jacques Rousseau claims that the existence of inalienable rights is unnecessary for the existence of a constitution or a set of laws and rights. This idea of a social contract – that rights and responsibilities are derived from a consensual contract between the government and the people – is the most widely recognized alternative.

One criticism of natural rights theory is that one cannot draw norms from facts.^[27] This objection is variously expressed as the is-ought problem, the naturalistic fallacy, or the appeal to nature. G.E. Moore, for example, said that ethical naturalism falls prey to the naturalistic fallacy.^{[citation needed]} Some defenders of natural rights theory, however, counter that the term "natural" in "natural rights" is contrasted with "artificial" rather than referring to nature. John Finnis, for example, contends that natural law and natural rights are derived from self-evident principles, not from speculative principles or from facts.^[27]

There is also debate as to whether all rights are either natural or legal. Fourth president of the United States James Madison, while representing Virginia in the House of Representatives, believed that there are rights, such as trial by jury, that are social rights, arising neither from natural law nor from positive law (which are the basis of natural and legal rights respectively) but from the social contract from which a government derives its authority.^[28]

Thomas Hobbes

Thomas Hobbes

Thomas Hobbes (1588–1679) included a discussion of natural rights in his moral and political philosophy. Hobbes' conception of natural rights extended from his conception of man in a "state of nature". Thus he argued that the essential natural (human) right was "to use his own power, as he will himself, for the preservation of his own Nature; that is to say, of his own Life; and consequently, of doing any thing, which in his own judgement, and Reason, he shall conceive to be the aptest means thereunto." (Leviathan. 1, XIV)

Hobbes sharply distinguished this natural "liberty", from natural "laws", described generally as "a precept, or general rule, found out by reason, by which a man is forbidden to do, that, which is destructive of his life, or taketh away the means of preserving his life; and to omit, that, by which he thinketh it may best be preserved." (Leviathan. 1, XIV)

In his natural state, according to Hobbes, man's life consisted entirely of liberties and not at all of laws – "It followeth, that in such a condition, every man has the right to every thing; even to one another's body. And therefore, as long as this natural Right of every man to every thing endureth, there can be no security to any man... of living out the time, which Nature ordinarily allow men to live." (Leviathan. 1, XIV)

This would lead inevitably to a situation known as the "war of all against all", in which human beings kill, steal and enslave others in order to stay alive, and due to their natural lust for "Gain", "Safety" and "Reputation". Hobbes reasoned that this world of chaos created by unlimited rights was highly undesirable, since it would cause human life to be "solitary, poor, nasty, brutish, and short". As such, if humans wish to live peacefully they must give up most of their natural rights and create moral obligations in order to establish political and civil society. This is one of the earliest formulations of the theory of government known as the social contract.

Hobbes objected to the attempt to derive rights from "natural law," arguing that law ("lex") and right ("jus") though often confused, signify opposites, with law referring to obligations, while rights refer to the absence of obligations. Since by our (human) nature, we seek to maximize our well being, rights are prior to law, natural or institutional, and people will not follow the laws of nature without first being subjected to a sovereign power, without which all ideas of right and wrong are meaningless – "Therefore before the names of Just and Unjust can have place, there must be some coercive Power, to compel men equally to the performance of their Covenants..., to make good that Propriety, which by mutual contract men acquire, in recompense of the universal Right they abandon: and such power there is none before the erection of the Commonwealth." (Leviathan. 1, XV)

This marked an important departure from medieval natural law theories which gave precedence to obligations over rights.

John Locke

John Locke, "Life, Liberty, Estate (property)"

John Locke (1632 – 1704) was another prominent Western philosopher who conceptualized rights as natural and inalienable. Like Hobbes, Locke believed in a natural right to life, liberty, and property. It was once conventional wisdom that Locke greatly influenced the American Revolutionary War with his writings of natural rights, but this claim has been the subject of protracted dispute in recent decades. For example, the historian Ray Forrest Harvey declared that Jefferson and Locke were at "two opposite poles" in their political philosophy, as evidenced by Jefferson’s use in the Declaration of Independence of the phrase "pursuit of happiness" instead of "property."^[29] More recently, the eminent^[30] legal historian John Phillip Reid has deplored contemporary scholars’ "misplaced emphasis on John Locke," arguing that American revolutionary leaders saw Locke as a commentator on established constitutional principles.^[31][32] Thomas Pangle has defended Locke's influence on the Founding, claiming that historians who argue to the contrary either misrepresent the classical republican alternative to which they say the revolutionary leaders adhered, do not understand Locke, or point to someone else who was decisively influenced by Locke.^[33] This position has also been sustained by Michael Zuckert.^[34][35][36]

According to Locke there are three natural rights:

• Life: everyone is entitled to live.^[37]
• Liberty: everyone is entitled to do anything they want to so long as it doesn't conflict with the first right.
• Estate: everyone is entitled to own all they create or gain through gift or trade so long as it doesn't conflict with the first two rights.

In developing his concept of natural rights, Locke was influenced by reports of society among Native Americans, whom he regarded as "natural peoples" who lived in a state of liberty and "near prefect freedom", but not license.^[38] It also informed his conception of social contract.

The social contract is an agreement between members of a country to live within a shared system of laws. Specific forms of government are the result of the decisions made by these persons acting in their collective capacity. Government is instituted to make laws that protect these three natural rights. If a government does not properly protect these rights, it can be overthrown.

Thomas Paine

Thomas Paine

Thomas Paine (1731–1809) further elaborated on natural rights in his influential work Rights of Man (1791), emphasizing that rights cannot be granted by any charter because this would legally imply they can also be revoked and under such circumstances they would be reduced to privileges:

It is a perversion of terms to say that a charter gives rights. It operates by a contrary effect – that of taking rights away. Rights are inherently in all the inhabitants; but charters, by annulling those rights, in the majority, leave the right, by exclusion, in the hands of a few. … They...consequently are instruments of injustice.

The fact therefore must be that the individuals themselves, each in his own personal and sovereign right, entered into a compact with each other to produce a government: and this is the only mode in which governments have a right to arise, and the only principle on which they have a right to exist.

American individualist anarchists

Benjamin Tucker

While at first American individualist anarchists adhered to natural rights positions, later in this era led by Benjamin Tucker, some abandoned natural rights positions and converted to Max Stirner's Egoist anarchism. Rejecting the idea of moral rights, Tucker said there were only two rights: "the right of might" and "the right of contract".^{[citation needed]} He also said, after converting to Egoist individualism, "In times past... it was my habit to talk glibly of the right of man to land. It was a bad habit, and I long ago sloughed it off.... Man's only right to land is his might over it."^[39]

According to Wendy McElroy:

In adopting Stirnerite egoism (1886), Tucker rejected natural rights which had long been considered the foundation of libertarianism. This rejection galvanized the movement into fierce debates, with the natural rights proponents accusing the egoists of destroying libertarianism itself. So bitter was the conflict that a number of natural rights proponents withdrew from the pages of Liberty in protest even though they had hitherto been among its frequent contributors. Thereafter, Liberty championed egoism although its general content did not change significantly.^[40]

Several periodicals were "undoubtedly influenced by Liberty's presentation of egoism, including I published by C.L. Swartz, edited by W.E. Gordak and J.W. Lloyd (all associates of Liberty); The Ego and The Egoist, both of which were edited by Edward H. Fulton. Among the egoist papers that Tucker followed were the German Der Eigene, edited by Adolf Brand, and The Eagle and The Serpent, issued from London. The latter, the most prominent English-language egoist journal, was published from 1898 to 1900 with the subtitle 'A Journal of Egoistic Philosophy and Sociology'".^[40]
Among those American anarchists who adhered to egoism include Benjamin Tucker, John Beverley Robinson, Steven T. Byington, Hutchins Hapgood, James L. Walker, Victor Yarros and E.H. Fulton.^[40]

Contemporary

Many documents now echo the phrase used in the United States Declaration of Independence. The preamble to the 1948 United Nations Universal Declaration of Human Rights asserts that rights are inalienable: "recognition of the inherent dignity and of the equal and inalienable rights of all members of the human family is the foundation of freedom, justice and peace in the world." Article 1, § 1 of the California Constitution recognizes inalienable rights, and articulated some (not all) of those rights as "defending life and liberty, acquiring, possessing, and protecting property, and pursuing and obtaining safety, happiness, and privacy." However, there is still much dispute over which "rights" are truly natural rights and which are not, and the concept of natural or inalienable rights is still controversial to some.

Erich Fromm argued that some powers over human beings could be wielded only by God, and that if there were no God, no human beings could wield these powers.^[41]

Contemporary political philosophies continuing the classical liberal tradition of natural rights include libertarianism, anarcho-capitalism and Objectivism, and include amongst their canon the works of authors such as Robert Nozick, Ludwig von Mises, Ayn Rand,^[42] and Murray Rothbard.^[43] A libertarian view of inalienable rights is laid out in Morris and Linda Tannehill's The Market for Liberty, which claims that a man has a right to ownership over his life and therefore also his property, because he has invested time (i.e. part of his life) in it and thereby made it an extension of his life. However, if he initiates force against and to the detriment of another man, he alienates himself from the right to that part of his life which is required to pay his debt: "Rights are not inalienable, but only the possessor of a right can alienate himself from that right – no one else can take a man's rights from him."^[44]

Various definitions of inalienability include non-relinquishability, non-salability, and non-transferability.^[45] This concept has been recognized by libertarians as being central to the question of voluntary slavery, which Murray Rothbard dismissed as illegitimate and even self-contradictory.^[46] Stephan Kinsella argues that "viewing rights as alienable is perfectly consistent with – indeed, implied by – the libertarian non-aggression principle. Under this principle, only the initiation of force is prohibited; defensive, restitutive, or retaliatory force is not."^[47]

Various philosophers have created different lists of rights they consider to be natural. Proponents of natural rights, in particular Hesselberg and Rothbard, have responded that reason can be applied to separate truly axiomatic rights from supposed rights, stating that any principle that requires itself to be disproved is an axiom. Critics have pointed to the lack of agreement between the proponents as evidence for the claim that the idea of natural rights is merely a political tool.

Hugh Gibbons has proposed a descriptive argument based on human biology. His contention is that Human Beings were other-regarding as a matter of necessity, in order to avoid the costs of conflict. Over time they developed expectations that individuals would act in certain ways which were then prescribed by society (duties of care etc.) and that eventually crystallized into actionable rights.^[48]