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

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

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 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)


2019 ◽  
pp. 089719001988525
Author(s):  
CVN Harish ◽  
Devaraj Belavigi ◽  
Amol N. Patil ◽  
Smita Pattanaik ◽  
Ashish Kakkar ◽  
...  

Background: Drug Information Center (DIC) with on-call evidence-based medicine service can revolutionize health-care practice and also can play a major role in health-care delivery in both developed and developing countries. Objective: To assess the feedback received from hospital clinicians for the newly initiated DIC services in a tertiary care hospital of North India. Methods: This is a retrospective cohort study conducted between January 1, 2016, to December 31, 2018. The clinicians approached DIC for specific pharmacotherapeutic questions for managing an index patient. After providing consultation, DIC followed up with them for the action taken and feedback on the consultation. The results of the data analyzed using Fisher Exact test and descriptive statistics. Results: Of 264 encounters, more than 98% of clinicians found the service satisfactory. There was a statistically significant association between the timely answer provided to treating physicians and their level of satisfaction with the service ( P < .05). There was no significant association between academic experiences and the satisfaction or dissatisfaction among the clinical fraternity colleagues. The interpretation ability of on-call pharmacology postgraduate students was a significantly associated factor with clinician’s satisfaction level ( P < .05). More than 96% of clinicians followed the pharmacotherapy advice recommended by DIC in their patient management. Conclusion: Thorough evaluation of published research needs to be taught to budding pharmacologists, pharmacists in their curriculum for an effective DIC service. DIC service has the potential to minimize the barrier of evidence-based medicine practice in developing as well as developed countries.


2002 ◽  
Vol 21 (3) ◽  
pp. 245-254 ◽  
Author(s):  
Nada Majkic-Singh

Evidence-based laboratory medicine (EBLM) is the use of the current best evidence of the utility of laboratory tests in making decisions about the care of individual patients. This practice means integrating laboratory and clinical experience with the last available external evidence from systematic research. It means that the definition of EBLM focuses on two key elements: experience and evidence from systematic research. Although the term evidence-based medicine (EBM) was created in Canada at Mc Master University by a group lad by Dr Gard Guyatt, there are various claims as to the origin of its practice. Regardless of its origins, many factors have come together over the past 30 years to drive the movement to EBM. One factor is those individual physicians, faced with numerous medical informations; the second factor is the global phenomenon of increasing health care costs and third is that patients who have generally more education, want the best in diagnostics and therapies. It means that evidence-based medicine has been driven by the need to cape with information overload, by costcontrol, and by public impatient for the best in diagnostics and treatment. Clinical guidelines care maps, and outcome measures are quality improvement tools for the appropriateness, efficiency and effectiveness of health services. Laboratory professionals must direct more effort to demonstrating the impact of laboratory tests on a greater variety of clinical outcomes. Evidence-based laboratory medicine aims to advise clinical diagnosis and management of disease through systematic researching and disseminating generalisible new knowledge that meets the standard of critical review on clinically effective practice of laboratory investigations. In laboratory medicine, the use of tests increases; new tests are constantly introduced, but "old" tests are seldom removed from the repertoire. This, together with limited public funds for the health care should underline the challenge for laboratory professionals to provide evidence for the utility of different tests. This practice means integrating laboratory and clinical experience with the best available external evidence from systematic research therefore, it is important that advice given by laboratory medicine professionals are sound and based on evidence in the pre-analytical, analytical, and post-analytical phases of the diagnostic process. This paper provides an insight into the rationale, methodology and the phases of the EBLM.


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


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


2019 ◽  
Vol 18 (1) ◽  
pp. 1
Author(s):  
Antonio Marcos Andrade

Em 2005, o grego John Loannidis, professor da Universidade de Stanford, publicou um artigo na PLOS Medicine intitulado “Why most published research findings are false” [1]. Ele que é dos pioneiros da chamada “meta-ciência”, disciplina que analisa o trabalho de outros cientistas, avaliou se estão respeitando as regras fundamentais que definem a boa ciência. Esse trabalho foi visto com muito espanto e indignação por parte dos pesquisadores na época, pois colocava em xeque a credibilidade da ciência.Para muitos cientistas, isso acontece porque a forma de se produzir conhecimento ficou diferente, ao ponto que seria quase irreconhecível para os grandes gênios dos séculos passados. Antigamente, se analisavam os dados em estado bruto, os autores iam às academias reproduzir suas experiências diante de todos, mas agora isso se perdeu porque os estudos são baseados em seis milhões de folhas de dados. Outra questão importante que garantia a confiabilidade dos achados era que os cientistas, independentemente de suas titulações e da relevância de suas descobertas anteriores, tinham que demonstrar seus novos achados diante de seus pares que, por sua vez, as replicavam em seus laboratórios antes de dar credibilidade à nova descoberta. Contudo, na atualidade, essas garantias veem sendo esquecidas e com isso colocando em xeque a validade de muitos estudos na área de saúde.Preocupados com a baixa qualidade dos trabalhos atuais, um grupo de pesquisadores se reuniram em 2017 e construíram um documento manifesto que acabou de ser publicado no British Medical Journal “Evidence Based Medicine Manifesto for Better Health Care” [2]. O Documento é uma iniciativa para a melhoria da qualidade das evidências em saúde. Nele se discute as possíveis causas da pouca confiabilidade científica e são apresentadas algumas alternativas para a correção do atual cenário. Segundo seus autores, os problemas estão presentes nas diferentes fases da pesquisa:Fases da elaboração dos objetivos - Objetivos inúteis. Muito do que é produzido não tem impacto científico nem clínico. Isso porque os pesquisadores estão mais interessados em produzir um número grande de artigos do que gerar conhecimento. Quase 85% dos trabalhos não geram nenhum benefício direto a humanidade.Fase do delineamento do estudo - Estudos com amostras subdimensionados, que não previnem erros aleatórios. Métodos que não previnem erros sistemáticos (viés na escolha das amostras, falta de randomização correta, viés de confusão, desfechos muito abertos). Em torno de 35% dos pesquisadores assumem terem construídos seus métodos de maneira enviesada.Fase de análise dos dados - Trinta e cinco por cento dos pesquisadores assumem práticas inadequadas no momento de análise dos dados. Muitos assumem que durante esse processo realizam várias análises simultaneamente, e as que apresentam significância estatística são transformadas em objetivos no trabalho. As revistas também têm sua parcela de culpa nesse processo já que os trabalhos com resultados positivos são mais aceitos (2x mais) que trabalhos com resultados negativos.Fase de revisão do trabalho - Muitos revisores de saúde não foram treinados para reconhecer potenciais erros sistemáticos e aleatórios nos trabalhos.Em suma é necessário que pesquisadores e revistas científicas pensem nisso. Só assim, teremos evidências de maior qualidade, estimativas estatísticas adequadas, pensamento crítico e analítico desenvolvido e prevenção dos mais comuns vieses cognitivos do pensamento.


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