Limitations Of Evidence-based Medicine Research Articles

How misunderstanding the principles and limitations of evidence-based medicine may discredit the concept

The discussion on the methodological limitations of the quasi- measurement of human feelings and sensations, started by the author in the journal Neurology bulletin, continues. There are a number of reasons for accepting/rejecting and understanding the principles and limitations of clinical epidemiology/evidence-based medicine (EBM) to the point of deliberate distortion. It is shown that the ideas of freedom and creativity in medicine, are ways of avoiding control and the realization of biopower. A concrete example, the study of the efficacy of antidepressants, shows how it is possible, either unintentionally or intentionally, to obtain a false result without following the principles and tenets of EBM.

The complex issue of medication management in older persons: a challenge for nurses

With increasing life expectancy, the share of older persons with coexisting multiple chronic degenerative diseases (comorbidity / multimorbidity) is expanding. These conditions require the use of multiple drugs, leading to polypharmacy, which plays a central role in making the therapeutic approach to the elderly particularly complex, together with age-related changes in pharmacokinetics and pharmacodynamics.
 Physicians and nurses both are challenged by polypharmacy and by the other drug-related issues involving older patients, in all care settings. In particular, nurses should be aware of the main issues of pharmacotherapy in older persons, because they are often the frontline for older patients care, especially in nursing homes.
 This review addresses the main issues related to pharmacotherapy in late life, such as pharmacokinetics and pharmacodynamics changes, limitations of evidence-based medicine, polypharmacy, drug interactions, adverse drug reactions, and lack of adherence. Focus will be on how these problems may impact on nursing, and on what nurses should know and do to improve drug treatment of older patients.
 In the last decade, the role and responsibilities of nurses in the management of drug therapy have significantly changed in most countries. There is consensus in educational programs and legislation that the preparation and administration of medications are essential aspects of nursing practice. These are considered as collaborative tasks with physicians and not purely mechanistic tasks. The nurse must intervene in the event of a perceived error, and he/she must report doubts about congruity or relevance of the therapy.
 Although nursing students gain knowledge and develop skills on drug therapy during their education, these are often perceived as insufficient. The need for post-graduation continuing education should be also emphasized. Thus, graduate and post-graduate educational programs should be developed, in order to offer adequate answers to the increasing and challenging share of older patients seen in clinical practice.

Prevenção quaternária como diretriz para a equipe editorial de uma revista de medicina baseada em evidência

O presente artigo tem como objetivo analisar as atividades de redação da revista Minerva, periódico belga de medicina baseada em evidência (MBE), de acordo com as diretrizes da prevenção quaternária. A partir da produção editorial da revista Minerva foi realizada uma análise narrativa de suas atividades de redação em relação ao questionamento clínico, à pesquisa, à crítica e à interpretação de informações clínicas relevantes à prática profissional. São detalhados os limites da MBE e as ferramentas e linhas de reflexão emitidas pela equipe de redação da revista a fim de favorecer a implementação da MBE na prática clínica. Dessa forma, se pretende prevenir o intervencionismo médico desnecessário, ao se fortalecer a prevenção quaternária como uma competência fundamental dos trabalhadores da saúde ao longo de sua vida profissional a serviço dos pacientes, o que pode ser reforçado pelo trabalho da equipe editorial de uma revista de MBE.

Response to Miles and Mezzich

Miles and Mezzich offer a substantial and focussed account of a “crisis” of knowledge, care, compassion and costs in modern medicine. Their claim is that an over-emphasis on scientific, even scientistic medicine, has resulted in the depersonalisation of care. In response, they propose an emergent model of clinical practice grounded in person-centred medicine (PCM). We are honoured to have been offered an opportunity to respond to this paper. We will not attempt to de-construct the paper or rehearse arguments concerning the limitations of evidence-based medicine (EBM). Rather, we would like to support the general thesis of the paper and offer some form of thought related to how PCM might best develop. In doing this, we will be very careful not to dismiss the valuable role that science and systematic research play in healthcare. Thus, we have little interest in using EBM as some form of ‘strawman’ by which to pronounce ‘the new way’. Parts of Miles and Mezzich’s paper appear at times to do this. Ultimately, however, we do not see this as the primary intent of their otherwise excellent discussion paper.

Facing Levels of Evidence

Facing Levels of Evidence

The Limits of Evidence-Based Medicine and Its Application to Mental Health Evidence-Based Practice (Part Two): Assertive Community Treatment Assertively Reviewed

This article is the second of two published in Ethical Psychology and Psychiatry; the first appeared in Volume 15, Number 1. The first article argued the very serious limitations of evidence-based medicine (EBM) and its very popular mental health offshoot evidence-based practice (EBP; Gomory, 2013). This article is meant to be a consolidation and update of a 1999 analysis of Assertive Community Treatment (ACT), the best “validated” mental health EBP according the National Institute of Mental Health (NIMH) and academic researchers. This analysis reconfirms the failure of ACT as a treatment modality and a platform for successfully reducing hospitalization; its touted consistent effect except when ACT can apply administrative coercion to keep its clients out of the hospital or quickly discharge them. When ACT fails to have such administrative coercive control, it does no better than other community mental health delivery systems. The use of ACT coercion begun over 40 years ago, the article further argues, set the table for conventionalizing psychiatric coercion as evidence-based best practice.

The Limits of Evidence-Based Medicine and Its Application to Mental Health Evidence-Based Practice: Part One

The present article outlines the major limitations of evidence-based medicine (EBM) and through a close review demonstrates that the three component EBM process model is a pseudoscientific tool. Its “objective” component is the collection, systematic analysis, and listing of “effective” treatments applying a research hierarchy from most rigorous (systematic reviews of randomized controlled trials [RCTs]) to least rigorous (expert opinion). Its two subjective components are the clinical judgment of helping professionals about which “evidence-based” treatment to select and the specific and unique relevant personal preferences of the potential recipients regarding treatment. This procedural mishmash provides no more rigor in choosing “best practice” than has been provided by good clinical practitioners in the past because both turn out to be subjective and authority based. The article also discusses EBM’s further methodological dilution in the National Institute of Mental Health (NIMH) endorsed Evidence-Based Mental Health Practice (EBP) movement. In EBP, the allegedly rigorous EBM protocol is altered. Instead of systematic expert protocol-driven EBM reviews of RCTs, NIMH sanctioned expert consensus panels decide “evidence-based practices.” This further problematizes the development of best practices in mental health by converting it to a political process. The article concludes with some observations on these issues. In a second article (part two) forthcoming, assertive community treatment (ACT) is examined as an example of an EBP that fails as a scientifically effective treatment despite its EBP certification and general popularity among practitioners.

Limitations of Evidence-based Medicine

Advances in statistical science and the development of computers (a result of the digital revolution) have allowed many disciplines, including medicine, to develop a more objective analysis of data as applied to decision making. The concept of evidence-based medicine (EBM) includes that scientific study of disease and treatment efficacy will allow high-quality, cost-effective treatment. The concept of EBM is well established in medical specialties, particularly for cardiovascular disease and cancer, but less developed in the surgical specialties. Multiple factors make evidence-based surgical (EBS) studies more problematic. Entering children into prospective surgical treatment trials remains difficult for the parents and patients who are asked to allow a choice of procedures for a surgical intervention that will take just an hour or two but whose results could change the child's entire life. Comparative effectiveness research, a subset of EBM, is of special interest to surgeons, who often need to decide on an expensive new implant versus a reliable, less expensive, established one. Factors that make the scientific analysis of surgical treatment efficacy more difficult include issues as practical as surgical skill. Prescribing an antihypertensive medication or a lipid-lowering drug has little variability in its delivery. Performance of a complex surgical procedure can vary immensely, allowing a procedure to be very effective in one surgeon's hands but far less applicable by another surgeon (eg, arthroscopic vs. open shoulder surgery). Thus, large patient series with careful follow-up are required to clarify outcome differences. Scientific study of surgical treatment outcomes in childhood orthopaedic conditions remains in its infancy. Because of minimal funding available for such research, most available studies are poorly designed with an inadequate study sample size. As for the near future, neither the government nor industry sources seem to have a strong incentive to study outcomes in childhood surgical diseases that have a low prevalence. Because current research provides little evidence to guide parents and their surgeon (when a choice exists), consumers generally seek what they believe to be the best available "expert opinion." Properly funded, the digital revolution will allow radical advances in establishing EBS decision making. However, the same digital revolution has produced an educated populace, greatly increasing their capacity for critical analysis of available data. Currently, both sophisticated parents and their surgeons remain hesitant to accept results from poorly designed studies when deciding on surgery for their child. As a result, expert opinion remains central to surgical decision making in children's orthopaedics. Knowledgeable surgeons look forward to future quantum improvements in research quality that will allow secure EBS-based decisions for their surgical patients.

Cochrane reviews and the behavioural turn in evidence-based medicine

Evidence-based medicine (EBM) has been one of the most important movements in clinical medicine and public health in recent years. At the heart of the EBM movement lies the Cochrane Collaboration, an influential organisation that produces systematic assessments of healthcare interventions known as Cochrane reviews. Although Cochrane methods were initially designed to test the efficacy of medical therapies, the desire for ‘evidence-based’ practice has pushed the movement far beyond its initial scope into the assessment of complex social phenomena. Through an examination of one particular Cochrane review – Physician advice for smoking cessation – this paper highlights the limitations of EBM ‘creep’, and some of the more problematic conceptions of human nature underwriting Cochrane principles and methodologies.

No Need to Fear Evidence-Based Medicine

Evidence-based medicine (EBM) aims to apply the best available evidence gained from the scientific method to clinical decision making. The notion seems noble in its purpose, yet there are some apprehensions and misconceptions among physicians, especially those in a predominantly surgical field such as facial plastic surgery. Developing a sophisticated understanding of the inherent biases and limitations of EBM will become increasingly important for the researcher and practicing surgeon as we strive to improve the rigor of our studies and produce noteworthy scientific evidence that improves the health outcomes for our patients.

The Limitations of Evidence-Based Medicine: Applying Population-Based Recommendations to Individual Patients

While practicing evidence-based medicine may maximize the likelihood of positive outcomes in a large population, it does not necessarily yield the best decision in a particular situation. To date, EBM proponents have not figured out how to account for patients’ differences from trial subjects, intangible factors detectable by experienced doctors, and patients’ values. Virtual Mentor is a monthly bioethics journal published by the American Medical Association.

Invited Article: Threats to physician autonomy in a performance-based reimbursement system

Physician autonomy is currently threatened by the external application of pay for performance standards and required conformity to practice guidelines. This phenomenon is being driven by concerns over the economic viability of increasing per capita health care expenditures without a concomitant rise in favorable health outcomes and by the unjustified marked variations among physicians' practice patterns. Proponents contend that altering the reimbursement system to encourage physicians to make choices based upon the best available evidence would be one way to ensure better outcomes per health care dollar spent. Although physician autonomy is most easily justified when decisions are made by appealing to the best available evidence, incentivizing decision-making risks sacrificing physician autonomy to political and social forces if the limitations of evidence-based medicine are not respected. Any reimbursement system designed to encourage physicians to utilize the best available evidence by providing financial incentives must recognize physicians who try to play to the numbers as well as physicians who refuse to follow the best available evidence if doing so would conflict with good medicine or patient preferences. By designing, promulgating, and updating evidence-based clinical practice guidelines, medical specialty societies can limit threats to physician autonomy while improving medical practice.

The European consensus on ulcerative colitis: new horizons?

A European consensus on anything is not easy to achieve, and inflammatory bowel disease (IBD) is no exception. The European Crohn’s and Colitis Organisation (ECCO), has now published the Consensus...

The weight of evidence

The weight of evidence

Limits of Evidence-Based Medicine in Older Adults

Drug therapy mistreatment, undertreatment and overtreatment of older persons are prevalent. Given the pharmacokinetic and pharmacodynamic changes in seniors, the risk versus benefit of treatment should be weighed before implementing pharmacotherapy. Clinicians cannot rely exclusively on high-quality scientific evidence to make treatment decisions, given the paucity of evidence-based approaches to care in this population. A growing emphasis is needed, by pharmaceutical companies and independent researchers, to understand the value of treatment in older persons. An examination of the evidence for treatment of depression Alzheimer’s disease, behavioral symptoms of dementia and depression in older persons is presented. Further research in this growing and highly vulnerable population is needed to guide informed treatment decisions.

Medicine in Black and White: BiDil®: Race and the Limits of Evidence-Based Medicine

Abstract When the US Food and Drug Administration licensed the drug BiDil® in June 2005 it was hailed as a significant step towards “personalised prescribing”. This is because BiDil® had been patented, tested and approved for use by just one group of patients: those “of African descent”. George Ellison examines the statistical evidence that underpinned the development of BiDil® as a “racial drug” and finds it less than satisfactory.

Evidence‐based medicine: Arguments for and against

In this article I will discuss the various definitions of evidence-based medicine (EBM), and summarize the application, criticisms and limitations of EBM. The spectrum of evidence, from pathophysiological inference to randomized controlled trials, will be presented as a mechanism for filtering bias with more rigorous evidence being required when bias is more likely. Although randomized controlled trials and meta-analyses are at the top of the evidence hierarchy, they are not always necessary, might not be the most appropriate forms of evidence for some clinical questions, and have their own limitation that need to be understood. Best available evidence, applied to individual patients, is the corner stone of EBM. Although there are valid criticisms and limitations of EBM, if these are understood then the practice of EBM can provide guidance to the clinician and enhance patient care.

Evidence-based medicine in general practice: Helping the whole patient

This article is based on a keynote presentation at the 13th Nordic Congress in General Practice in Helsinki, Finland in September 2003. The aim was to demonstrate the strengths and limitations of evidence-based medicine (EBM) in a primary healthcare setting, and to show how and why it also can represent a hindrance to optimal medical care. The presentation comprised two separate lectures. Initially, Marjukka Mäkelä pointed to strengths to underline the need for EBM in general practice. Subsequently, Irene Hetlevik argued that the concept of EBM, on the contrary, could be a hindrance for good general practice.

A critical appraisal of 'evidence-based medicine' in allergy and asthma.

Clinical guidelines are 'systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances'. They may offer concise instructions on which diagnostic or screening tests to order, stipulate how medical services should be provided, how long patients should stay in hospital, or many other details relevant to clinical practice. This paper argues that guidelines should be simple, adapted to the clinical setting they inform and to treatment availability in their respective geographic context and that they should not be viewed as a yardstick but as support for physicians. The benefits of evidence-based-medicine (EBM), which defines the value of medical interventions in terms of empiric evidence from clinical trials, are growing in many contexts and are well described. Not sufficiently acknowledged, however, are the limits of EBM. A gap still exists between clinical research and clinical practice which should be better recognized and assessed.

A categorization and analysis of the criticisms of Evidence-Based Medicine

The major criticisms and limitations of Evidence-Based Medicine (EBM) appearing in the literature over the past decade can be summarized and categorized into five recurring themes. The themes include: reliance on empiricism, narrow definition of evidence, lack of evidence of efficacy, limited usefulness for individual patients, and threats to the autonomy of the doctor/patient relationship. Analysis of EBM according to these themes leads to the conclusion that EBM can be a useful tool, but has severe drawbacks when used in isolation in the practice of individual patient care. Modern medicine must strive to balance an extremely complex set of priorities. To be an effective aid in achieving this balance, the theory and practice of EBM must expand to include new methods of study design and integration, and must adapt to the needs of both patients and the health care system in order to provide patients with the best care at the lowest cost.