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

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

2008 ◽  
Vol 2;11 (3;2) ◽  
pp. 161-186
Author(s):  
Laxmaiah Manchikanti

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.


2009 ◽  
Vol 1;12 (1;1) ◽  
pp. 35-42
Author(s):  
Laxmaiah Manchikanti

In recent years, progress and innovations in healthcare are measured by evidencebased medicine (EBM), systematic reviews, and meta-analyses. A systematic review is defined as, “the application of scientific strategies that limit bias by the systematic assembly, critical appraisal, and synthesis of all relevant studies on a specific topic.” In contrast, meta-analysis is the statistical pooling of data across studies to generate pooled estimates of effects. Meta-analysis usually is the final step in a systematic review. Systematic reviews and meta-analyses are labor intensive, requiring expertise in both the subject matter and review methodology, and also must follow the rules of EBM which suggest that a formal set of rules must complement medical training and common sense for clinicians to interpret the results of clinical research effectively. While expertise in the subject matter is crucial, expertise in review methods is also particularly important. Despite an explosion of systematic reviews and meta-analyses, the empiric research on the quality of systematic reviews has shown that not all systematic reviews are truly systematic, having highly variable quality, deficiencies in methodologic assessment of the quality of the included manuscripts, and bias. Even then, systematic review of the literature is currently the best, least biased, and most rational way to organize, cull, evaluate, and integrate the research evidence from among the expanding medical and healthcare literature. However, a dangerous discrepancy between the experts and the evidence continues to persist in part because multiple instruments are available to assess the quality of systematic reviews or meta-analyses. Steps in conducting systematic reviews include planning, conducting, reporting, and disseminating the results. The Quality of Reporting of Meta-analysis (QUOROM) statement provides a checklist and a flow diagram. The checklist describes the preferred way to present the abstract, introduction, methods, results, and discussion sections of the report of an analysis. This review describes various aspects of systematic reviews and meta-analyses of randomized trials with a special focus on interventional pain management. Key words: Randomized trials, pragmatic trials, evidence-based medicine, systematic reviews, meta-analyses, guidelines, bias, interventional pain management, Quality of Reporting of Meta-analysis (QUOROM), Cochrane reviews


2009 ◽  
Vol 4;12 (4;7) ◽  
pp. E1-E33
Author(s):  
Laxmaiah Manchikanti

Practice guidelines are systematically developed statements to assist practitioners and patients in making decisions about appropriate health care for specific clinical circumstances. Clinical practice guidelines present statements of best practice based on a thorough evaluation of the evidence from published studies on the outcomes of treatment. In November 1989, Congress mandated the creation of the Agency for Healthcare Policy and Research (AHCPR). AHCPR was given broad responsibility for supporting research, data development, and related activities. Associated with this mandate, the National Academy of Sciences published a document indicating that guidelines are expected to enhance the quality, appropriateness, and effectiveness of health care services. Guidelines as a whole have been characterized by multiple conflicts in terminology and technique. These conflicts are notable for the confusion they create and for what they reflect about differences in values, experiences, and interest among different parties. Despite this confusion, public and private development of guidelines is growing exponentially. There are only limited means to coordinate these guidelines in order to resolve inconsistencies, fill in gaps, track applications and results, and assess the soundness of individual guidelines. Significant diversity exists in clinical practice guidelines. The inconsistency amongst guidelines arises from variations in values, tolerance for risks, preferences, expertise, and conflicts of interest. In 2000, the American Society of Interventional Pain Physicians (ASIPP) first created treatment guidelines to help practitioners. There have been 4 subsequent updates. These guidelines address the issues of systematic evaluation and ongoing care of chronic or persistent pain, and provide information about the scientific basis of recommended procedures. These guidelines are expected to increase patient compliance, dispel misconceptions among providers and patients, manage patient expectations reasonably, and form the basis of a therapeutic partnership between the patient, the provider, and payors. The ASIPP guidelines are based on evidence-based medicine (EBM). EBM is in turn based on 4 basic contingencies: the recognition of the patient’s problem and the construction of a structured clinical question; the ability to efficiently and effectively search the medical literature to retrieve the best available evidence to answer the clinical question; clinical appraisal of the evidence; and integration of the evidence with all aspects of the individual patient’s decision-making to determine the best clinical care of the patient. Evidence synthesis for guidelines includes the review of all relevant systematic reviews and individual articles, grading them for relevance, methodologic quality, consistency, and recommendations. Key words: Evidence-based medicine, clinical practice guidelines, critical appraisal, guideline development, interventional pain management, interventional techniques, evidence synthesis, clinical relevance, grading recommendations, systematic reviews


2009 ◽  
Vol 3;12 (3;5) ◽  
pp. 517-540
Author(s):  
Laxmaiah Manchikanti

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)


2012 ◽  
Vol 1;15 (1;1) ◽  
pp. E1-E26 ◽  
Author(s):  
Laxmaiah Manchikanti

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


Neurosurgery ◽  
2020 ◽  
Vol 87 (3) ◽  
pp. 435-441 ◽  
Author(s):  
Victor M Lu ◽  
Christopher S Graffeo ◽  
Avital Perry ◽  
Michael J Link ◽  
Fredric B Meyer ◽  
...  

Abstract Systematic reviews and meta-analyses in the neurosurgical literature have surged in popularity over the last decade. It is our concern that, without a renewed effort to critically interpret and appraise these studies as high or low quality, we run the risk of the quality and value of evidence-based medicine in neurosurgery being misinterpreted. Correspondingly, we have outlined 4 major domains to target in interpreting neurosurgical systematic reviews and meta-analyses based on the lessons learned by a collaboration of clinicians and academics summarized as 4 pearls. The domains of (1) heterogeneity, (2) modeling, (3) certainty, and (4) bias in neurosurgical systematic reviews and meta-analyses were identified as aspects in which the authors’ approaches have changed over time to improve robustness and transparency. Examples of how and why these pearls were adapted were provided in areas of cranial neuralgia, spine, pediatric, and neuro-oncology to demonstrate how neurosurgical readers and writers may improve their interpretation of these domains. The incorporation of these pearls into practice will empower neurosurgical academics to effectively interpret systematic reviews and meta-analyses, enhancing the quality of our evidence-based medicine literature while maintaining a critical focus on the needs of the individual patients in neurosurgery.


2012 ◽  
Vol 19 (4) ◽  
pp. 633-637 ◽  
Author(s):  
Paulo José Fortes Villas Boas ◽  
Regina Stella Spagnuolo ◽  
Amélia Kamegasawa ◽  
Leandro Gobbo Braz ◽  
Adriana Polachini do Valle ◽  
...  

2008 ◽  
Vol 5;12 (5;9) ◽  
pp. 819-850
Author(s):  
Laxmaiah Manchikanti

Observational studies provide an important source of information when randomized controlled trials (RCTs) cannot or should not be undertaken, provided that the data are analyzed and interpreted with special attention to bias. Evidence-based medicine (EBM) stresses the examination of evidence from clinical research and describes it as a shift in medical paradigm, in contrast to intuition, unsystematic clinical experience, and pathophysiologic rationale. While the importance of randomized trials has been created by the concept of the hierarchy of evidence in guiding therapy, much of the medical research is observational. The reporting of observational research is often not detailed and clear enough with insufficient quality and poor reporting, which hampers the assessment of strengths and weaknesses of the study and the generalizability of the mixed results. Thus, in recent years, progress and innovations in health care are measured by systematic reviews and meta-analyses. A systematic review is defined as, “the application of scientific strategies that limit bias by the systematic assembly, clinical appraisal, and synthesis of all relevant studies on a specific topic.” Meta-analysis usually is the final step in a systematic review. Systematic reviews and meta-analyses are labor intensive, requiring expertise in both the subject matter and review methodology, and also must follow the rules of EBM which suggests that a formal set of rules must complement medical training and common sense for clinicians to integrate the results of clinical research effectively. While expertise in the review methods is important, the expertise in the subject matter and technical components is also crucial. Even though, systematic reviews and meta-analyses, specifically of RCTs, have exploded, the quality of the systematic reviews is highly variable and consequently, the opinions reached of the same studies are quite divergent. Numerous deficiencies have been described in methodologic assessment of the quality of the individual articles. Consequently, observational studies can provide an important complementary source of information, provided that the data are analyzed and interpreted in the context of confounding bias to which they are prone. Appropriate systematic reviews of observational studies, in conjunction with RCTs, may provide the basis for elimination of a dangerous discrepancy between the experts and the evidence. Steps in conducting systematic reviews of observational studies include planning, conducting, reporting, and disseminating the results. MOOSE, or Meta-analysis of Observational Studies in Epidemiology, a proposal for reporting contains specifications including background, search strategy, methods, results, discussion, and conclusion. Use of the MOOSE checklist should improve the usefulness of meta-analysis for authors, reviewers, editors, readers, and decision-makers. This manuscript describes systematic reviews and meta-analyses of observational studies. Authors frequently utilize RCTs and observational studies in one systematic review; thus, they should also follow the reporting standards of the Quality of Reporting of Meta-analysis (QUOROM) statement, which also provides a checklist. A combined approach of QUOROM and MOOSE will improve reporting of systematic reviews and lead to progress and innovations in health care. Key words: Observational studies, evidence-based medicine, systematic reviews, metaanalysis, randomized trials, case-control studies, cross-sectional studies, cohort studies, confounding bias, QUOROM, MOOSE


2010 ◽  
Vol 2;13 (1;2) ◽  
pp. 109-116
Author(s):  
Ramsin M. Benyamin

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


Author(s):  
Miltos K. Lazarides ◽  
Irene-Zacharo Lazaridou ◽  
Nikolaos Papanas

Global literature is ever-growing and physicians rely on it for evidence-based decision making. Review articles summarize available literature and provide the current state of knowledge on a given topic. Various review types exist, the main ones being narrative and systematic reviews. The former are based on studies selected in an undefined manner. They express the authors’ opinions of a given topic, lack a systematic search, and are prone to bias. By contrast, the latter represent an unbiased synthesis of knowledge on a particular topic and attempt to offer all relevant evidence. A systematic review may include a meta-analysis, which combines the results of quantitative studies using statistical techniques to provide a more precise summary of the evidence. With a dramatic increase in literature complexity, new “next-generation” types of reviews emerged to improve the quality of evidence synthesis: network meta-analysis, umbrella review, and meta-analysis of individual patient data, among others. Finally, scoping reviews are a special type, conducted as precursors to systematic reviews aiming to reveal specific knowledge gaps in a given subject.


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