scholarly journals Guidelines Warfare Over Interventional Techniques: Is There a Lack of Discourse or Straw Man?

2012 ◽  
Vol 1;15 (1;1) ◽  
pp. E1-E26 ◽  
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Pain Management ◽  
Evidence Based Medicine ◽  
Conflicts Of Interest ◽  
Guideline Development ◽  
Evidence Synthesis ◽  
Medical Science ◽  
Medical Knowledge ◽  
Evidence Based ◽  
Interventional Pain Management ◽  
Based Medicine

Guideline development seems to have lost some of its grounding as a medical science. At their best, guidelines should be a constructive response to assist practicing physicians in applying the exponentially expanding body of medical knowledge. In fact, guideline development seems to be evolving into a cottage industry with multiple, frequently discordant guidance on the same subject. Evidence Based Medicine does not always provide for conclusive opinions. With competing interests of payers, practitioners, health policy makers, and third parties benefiting from development of the guidelines as cost saving measures, guideline preparation has been described as based on pre-possession, vagary, rationalization, or congeniality of conclusion. Beyond legitimate differences in opinions regarding the evidence that could yield different guidelines there are potentials for conflicts of interest and various other issues play a major role in guideline development. As is always the case, conflicts of interest in guideline preparation must be evaluated and considered. Following the development of American Pain Society (APS) guidelines there has been an uproar in interventional pain management communities on various issues related to not only the evidence synthesis, but conflicts of interest. A recent manuscript published by Chou et al, in addition to previous publications appear to have limited clinician involvement in the development of APS guidelines, demonstrates some of these challenges clearly. This manuscript illustrates the deficiencies of Chou et al’s criticisms, and demonstrates their significant conflicts of interest, and use a lack of appropriate evaluations in interventional pain management as a straw man to support their argument. Further, this review will attempt to demonstrate that excessive focus on this straw man has inhibited critique of what we believe to be flaws in the approach. Key words: Guidelines, interventional pain management, professionalism, discourse, disclosure, conflicts of interest, evidence-based medicine, comparative effectiveness research, Patient-Centered Outcomes Research Institute

scholarly journals Evidence-Based Interventional Pain Management: Principles, Problems, Potential and Applications

2007 ◽  
Vol 2;10 (3;2) ◽  
pp. 329-356
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Clinical Practice ◽  
Pain Management ◽  
Systematic Reviews ◽  
Evidence Based Medicine ◽  
Randomized Trials ◽  
Evidence Synthesis ◽  
Evidence Based ◽  
Interventional Pain Management ◽  
Based Medicine

Background: The past decade has been marked by unprecedented interest in evidencebased medicine (EBM) and a focus upon the use of innovative methods and protocols to provide valid and reliable information for and about healthcare. Thus (it is at least purported that), healthcare decisions are increasingly being based upon research-derived evidence, rather than on expert opinion or clinical experience alone. But this quest for evidence to support clinical practice also compels the question of whether the methods employed to acquire information, the ranking of information that is acquired, and the prudent use of this information are sound enough to actually sustain the validity of an evidence-based paradigm in practice. Moreover, it is becoming apparent that the scope, depth, and applicability of available evidence to effectively and ethically guide the myriad of situational decisions in clinical practice is not uniform across all medical fields or disciplines. In particular, comprehensive evidence synthesis or complete guidelines for clinical decision-making in interventional pain management remain relatively scarce. EBM is defined as the conscientious, explicit, and judicious use of the current best evidence in making decisions about the care of individual patients. Thus, the practice of EBM requires the integration of individual clinical expertise with the best available external evidence from systematic research. To arrive at evidence-based medical decisions all valid and relevant evidence should be considered alongside randomized controlled trials, patient preferences, and resources. Objective: To describe principles of EBM, and the methods and relative utility of evidence synthesis in interventional pain management. Description: This review provides 1) an understanding of evidence-based medicine, 2) an overview of issues related to evaluating the quality of individual studies, analyses, narrative, and systematic reviews, 3) discussion of factors affecting the strength and value(s) of evidence, 4) analysis of specific reviews of interventional techniques, and finally, 5) the utility and purpose of guidelines in interventional pain management. Conclusion: Interpreting and understanding evidence synthesis, systematic reviews and other analytic literature is a difficult task. It is crucial for pain physicians to understand the goals, principles, and process(es) of EBM so as to meaningfully improve its application(s). This knowledge affords better insight into not only the analytic reviews in interventional pain management provided herein, but ultimately allows future information to be selected, evaluated, and used with prudence in technically competent, ethically sound medical practice. Key words: Interventional pain management, interventional techniques, evidence-based medicine, evidence synthesis, pragmatic or practical clinical trials, randomized trials, observational studies, non-randomized trials, systematic reviews, quality of evidence

scholarly journals Evidence-Based Medicine, Systematic Reviews, and Guidelines in Interventional Pain Management, Part I: Introduction and General Considerations

2008 ◽  
Vol 2;11 (3;2) ◽  
pp. 161-186
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Health Care ◽  
Pain Management ◽  
Systematic Reviews ◽  
Evidence Based Medicine ◽  
Critical Appraisal ◽  
Evidence Based Practice ◽  
The United States ◽  
Evidence Based ◽  
Interventional Pain Management ◽  
Based Medicine

Evidence-based medicine, systematic reviews, and guidelines are part of modern interventional pain management. As in other specialties in the United States, evidence-based medicine appears to motivate the search for answers to numerous questions related to costs and quality of health care as well as access to care. Scientific, relevant evidence is essential in clinical care, policy-making, dispute resolution, and law. Consequently, evidence based practice brings together pertinent, trustworthy information by systematically acquiring, analyzing, and transferring research findings into clinical, management, and policy arenas. In the United States, researchers, clinicians, professional organizations, and government are looking for a sensible approach to health care with practical evidence-based medicine. All modes of evidence-based practice, either in the form of evidence-based medicine, systematic reviews, meta-analysis, or guidelines, evolve through a methodological, rational accumulation, analysis, and understanding of the evidentiary knowledge that can be applied in clinical settings. Historically, evidence-based medicine is traceable to the 1700s, even though it was not explicitly defined and advanced until the late 1970s and early 1980s. Evidence-based medicine was initially called “critical appraisal” to describe the application of basic rules of evidence as they evolve into application in daily practices. Evidence-based medicine is defined as a conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. Evidence-based practice is defined based on 4 basic and important contingencies, which include recognition of the patient’s problem and construction of a structured clinical question, thorough search of medical literature to retrieve the best available evidence to answer the question, critical appraisal of all available evidence, and integration of the evidence with all aspects and contexts of the clinical circumstances. Systematic reviews provide the application of scientific strategies that limit bias by the systematic assembly, critical appraisal, and synthesis of all relevant studies on a specific topic. While systematic reviews are close to meta-analysis, they are vastly different from narrative reviews and health technology assessments. Clinical practice guidelines are systematically developed statements that aim to help physicians and patients reach the best health care decisions. Appropriately developed guidelines incorporate validity, reliability, reproducibility, clinical applicability and flexibility, clarity, development through a multidisciplinary process, scheduled reviews, and documentation. Thus, evidence-based clinical practice guidelines represent statements developed to improve the quality of care, patient access, treatment outcomes, appropriateness of care, efficiency and effectiveness and achieve cost containment by improving the cost benefit ratio. Part 1 of this series in evidence-based medicine, systematic reviews, and guidelines in interventional pain management provides an introduction and general considerations of these 3 aspects in interventional pain management. Key words: Evidence-based medicine, systematic reviews, clinical guidelines, narrative reviews, health technology assessments, grading of evidence, recommendations, grading systems, strength of evidence.

scholarly journals A Perfect Storm in Interventional Pain Management: Regulated, but Unbalanced

2010 ◽  
Vol 2;13 (1;2) ◽  
pp. 109-116
Author(s):  
Ramsin M. Benyamin
Keyword(s):  
Health Care ◽  
Pain Management ◽  
Evidence Based Medicine ◽  
Evidence Based ◽  
Interventional Techniques ◽  
Research Bias ◽  
Interventional Pain Management ◽  
Based Medicine ◽  
The Impact ◽  
Perfect Storm

Interventional pain management now stands at the crossroads at what is described as “the perfect storm.” The confluence of several factors has led to devastating results for interventional pain management. This article seeks to provide a perspective to various issues producing conditions conducive to creating a “perfect storm” such as use and abuse of interventional pain management techniques, and in the same context, use and abuse of various non-interventional techniques. The rapid increase in opioid drug prescribing, costs to health care, large increases in death rates, and random and rampant drug testing, can also lead to increases in health care utilization. Other important aspects that are seldom discussed include medico-legal and ethical perspectives of individual and professional societal opinions and the interpretation of diagnostic accuracy of controlled diagnostic blocks. The aim of this article is to discuss the impact of several factors on interventional pain management and overuse, abuse, waste, and fraud; inappropriate application without evidence-based literature support (sometimes leading to selective use or non-use of randomized or observational studies for proving biased viewpoints — post priori rather than a priori), and issues related to multiple professional societies having their own agendas to push rather than promulgating the science of interventional pain management. This perspective is based on a review of articles published in this issue of Pain Physician, information in the public domain, and other relevant articles. Based on the results of this review, various issues of relevance to modern interventional pain management are discussed and the viewpoints of several experts debated. In conclusion, supporters of interventional pain management disagree on multiple aspects for various reasons while detractors claim that interventional pain management should not exist as a speciality. Issues to be addressed include appropriate use of evidence-based medicine (EBM), overuse, overutilization, and abuse. Key words: Interventional pain management, interventional techniques, physician payment reform, fraud, abuse, evidence-based medicine, health care costs, comparative effectiveness research, bias

scholarly journals Evidence-Based Medicine, Systematic Reviews, and Guidelines in Interventional Pain Management: Part 5. Diagnostic Accuracy Studies

2009 ◽  
Vol 3;12 (3;5) ◽  
pp. 517-540
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Pain Management ◽  
Diagnostic Accuracy ◽  
Diagnostic Test ◽  
Systematic Reviews ◽  
Evidence Based Medicine ◽  
Diagnostic Tests ◽  
Evidence Based ◽  
Interventional Techniques ◽  
Interventional Pain Management ◽  
Based Medicine

Diagnosis is a critical component of health care. The world of diagnostic tests is highly dynamic. New tests are developed at a fast pace and technology of existing tests is continuously being improved. However, clinicians, policy makers, and patients routinely face a range of questions regarding diagnostic tests. Well designed diagnostic test accuracy studies can help in making these decisions, provided that they transparently and fully report their participants, tests, methods, and results (as facilitated). For example, by the standards for the reporting of diagnostic accuracy studies (STARD) statement. Exaggerated and biased results from poorly designed and reported diagnostic test studies can trigger their premature dissemination and lead physicians into making incorrect treatment decisions. Thus, a diagnostic test is useful only to the extent that it distinguishes between conditions or disorders that might otherwise be confused. While almost any test can differentiate healthy persons from severely affected ones, appropriate diagnostic tests should differentiate mild and moderate forms of disease. Shortcomings in a study design and interpretation can affect estimates of diagnostic accuracy. Thus, quality diagnostic studies are essential in medicine in general and interventional pain management in particular. The STARD initiative was developed to improve the accuracy and completeness in the reporting of studies of diagnostic accuracy and provide guidance to assist in reducing the potential for bias in the study and to evaluate a study’s generalizability. In the practice of interventional pain management, in addition to diagnostic tests which include laboratory tests, imaging tests, and physical examination, diagnostic interventional techniques are crucial. Interventional techniques as a diagnostic tool in painful conditions is important due to multiple challenging clinical situations, which include the purely subjective nature of pain and underdetermined and uncertain pathophysiology in most painful spinal conditions. Precision diagnostic blocks are used to clarify these challenging clinical situations in order to determine the pathophysiology of clinical pain, the site of nociception, and the pathway of afferent neural signals. Part 5 of evidence-based medicine (EBM) in interventional pain management describes the various aspects of diagnostic accuracy studies. Key words: Evidence-based medicine, diagnostic studies, systematic reviews, randomized trials, interventional pain management, standards for the reporting of diagnostic accuracy studies (STARD)

scholarly journals Evidence summaries and recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome: assessment and treatment of infertility

2019 ◽  
Vol 2019 (1) ◽  
Author(s):  
M F Costello ◽  
M L Misso ◽  
A Balen ◽  
J Boyle ◽  
L Devoto ◽  
...  
Keyword(s):  
Conflicts Of Interest ◽  
Guideline Development ◽  
Polycystic Ovary ◽  
Evidence Synthesis ◽  
Evidence Based ◽  
Agree Ii ◽  
Infertile Women ◽  
International Evidence ◽  
Consumer Organizations ◽  
Evidence Based Guideline

Abstract STUDY QUESTION What is the recommended assessment and management of infertile women with polycystic ovary syndrome (PCOS), based on the best available evidence, clinical expertize and consumer preference? SUMMARY ANSWER International evidence-based guidelines, including 44 recommendations and practice points, addressed prioritized questions to promote consistent, evidence-based care and improve the experience and health outcomes of infertile women with PCOS. WHAT IS KNOWN ALREADY Previous guidelines on PCOS lacked rigorous evidence-based processes, failed to engage consumer and multidisciplinary perspectives or were outdated. The assessment and management of infertile women with PCOS are inconsistent. The needs of women with PCOS are not being adequately met and evidence practice gaps persist. PARTICIPANTS/MATERIALS, SETTING, METHODS Governance included a six continent international advisory and a project board, a multidisciplinary international guideline development group (GDG), consumer and translation committees. Extensive health professional and consumer engagement informed the guideline scope and priorities. The engaged international society-nominated panel included endocrinology, gynaecology, reproductive endocrinology, obstetrics, public health and other experts, alongside consumers, project management, evidence synthesis and translation experts. Thirty-seven societies and organizations covering 71 countries engaged in the process. Extensive online communication and two face-to-face meetings over 15 months addressed 19 prioritized clinical questions involving nine evidence-based reviews and 10 narrative reviews. Evidence-based recommendations (EBRs) were formulated prior to consensus voting within the guideline panel. STUDY DESIGN, SIZE, DURATION International evidence-based guideline development engaged professional societies and consumer organizations with multidisciplinary experts and women with PCOS directly involved at all stages. A (AGREE) II-compliant processes were followed, with extensive evidence synthesis. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework was applied across evidence quality, desirable and undesirable consequences, feasibility, acceptability, cost, implementation and ultimately recommendation strength. The guideline was peer-reviewed by special interest groups across our partner and collaborating societies and consumer organizations, was independently assessed against AGREE II criteria and underwent methodological review. This guideline was approved by all members of the GDG and has been approved by the NHMRC. MAIN RESULTS AND THE ROLE OF CHANCE The quality of evidence (QOE) for the EBRs in the assessment and management of infertility in PCOS included very low (n = 1), low (n = 9) and moderate (n = 4) quality with no EBRs based on high-quality evidence. The guideline provides 14 EBRs, 10 clinical consensus recommendations (CCRs) and 20 clinical practice points on the assessment and management of infertility in PCOS. Key changes in this guideline include emphasizing evidence-based fertility therapy, including cheaper and safer fertility management. LIMITATIONS, REASONS FOR CAUTION Overall evidence is generally of low to moderate quality, requiring significantly greater research in this neglected, yet common condition. Regional health systems vary and a process for adaptation of this guideline is provided. WIDER IMPLICATIONS OF THE FINDINGS The international guideline for the assessment and management of infertility in PCOS provides clinicians with clear advice on best practice based on the best available evidence, expert multidisciplinary input and consumer preferences. Research recommendations have been generated and a comprehensive multifaceted dissemination and translation program supports the guideline with an integrated evaluation program. STUDY FUNDING/COMPETING INTEREST(S) The guideline was primarily funded by the Australian National Health and Medical Research Council of Australia (NHMRC) supported by a partnership with ESHRE and the American Society for Reproductive Medicine (ASRM). GDG members did not receive payment. Travel expenses were covered by the sponsoring organizations. Disclosures of conflicts of interest were declared at the outset and updated throughout the guideline process, aligned with NHMRC guideline processes. Dr Costello has declared shares in Virtus Health and past sponsorship from Merck Serono for conference presentations. Prof. Norman has declared a minor shareholder interest in the IVF unit Fertility SA, travel support from Merck and grants from Ferring. Prof. Norman also has scientific advisory board duties for Ferring. The remaining authors have no conflicts of interest to declare. This article was not externally peer-reviewed by Human Reproduction Open.

scholarly journals Absurdity in Medicine. Stanisław Trzebiński’s Philosophy of Medicine

2021 ◽  
pp. 9-23
Author(s):  
Jarosław Barański ◽  
Wojciech Mackiewicz
Keyword(s):  
Evidence Based Medicine ◽  
Philosophy Of Medicine ◽  
Medical Knowledge ◽  
Second World War ◽  
Evidence Based ◽  
World War ◽  
Medicine And Literature ◽  
Knowledge And Practice ◽  
Based Medicine ◽  
Second World

Stanisław Trzebiński (1861–1930), professor at Stefan Batory University in Vilnius, was one of the most distinguished representatives of the Polish School of Philosophy of Medicine before the Second World War. He undertook studies in neurology, philosophy of medicine, and literature. The article explores Trzebiński’s philosophical ideas, especially his call for rationality in medicine and the concept of absurdity in medicine as a precondition for the development of medical knowledge and practice. Today this method is an essential background in Evidence-Based Medicine and confirms cultural and scientific forms of cognition.

Evidence-Based Paediatric Oncology

2020 ◽  
pp. 46-51
Author(s):  
Leontien C.M. Kremer ◽  
Erik A.H. Loeffen ◽  
Robert S. Phillips
Keyword(s):  
Patient Care ◽  
Evidence Based Medicine ◽  
Evidence Based Practice ◽  
Guideline Development ◽  
Daily Practice ◽  
Paediatric Oncology ◽  
Evidence Based ◽  
The World ◽  
Optimal Patient Care ◽  
Based Medicine

The practice of evidence-based medicine (EBM) is very important in delivering optimal patient care and the terms evidence-based medicine, or evidence-based practice, are used all around the world. This chapter discusses evidence-based paediatric oncology, including its history, an outline of what EBM is, EBM in paediatric oncology, steps in evidence-based paediatric oncology for a user of EBM, steps in guideline development as an implementer of EBM, common criticisms of EBM, and the future of EBM. The chapter gives an overview how EBM can be used in a non-exhaustive but still comprehensive way in daily practice of care for children with cancer, and which tools are available for paediatric oncologists. The majority of the chapter focuses on how to learn to become a skilled user of EBM.

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