scholarly journals Assessment of Methodologic Quality of Randomized Trials of Interventional Techniques: Development of an Interventional Pain Management Specific Instrument

2014 ◽  
Vol 3;17 (3;5) ◽  
pp. E263-E290 ◽  
Author(s):  
Laxmaiah Manchikanti

Background: A major component of a systematic review is an assessment of the methodological quality and bias of randomized trials. The most commonly utilized methodological quality assessment and bias assessment for randomized trials is by the Cochrane Review Group. While this is not a “gold standard,” it is an indication of the current state-of-the-art review methodology. There is, however, no specific instrument to assess the methodological quality of manuscripts published for interventional techniques. Objectives: Our objective was to develop an instrument specifically for interventional pain management, to assess the methodological quality of randomized trials of interventional techniques. Methods: Item generation for the instrument was based on a definition of quality, to the extent to which the design and conduct of the trial were congruent with the objectives of the trial. Applicability was defined as the extent to which the trial produced procedures could be applied with contemporary interventional pain management techniques. Multiple items based on Cochrane review criteria were utilized along with specific requirements for interventional techniques. Results: A total of 22 items were developed which formed IPM-QRB or Interventional Pain Management Techniques – Quality Appraisal of Reliability and Risk of Bias Assessment tool. This included 9 of the 12 items from the Cochrane review criteria with deletion of some items that were repetitive or duplicate, and the addition of 13 new items. The results were compared for inter-rater reliability of Cochrane review criteria and IPM-QRB, and interinstrument reliability. The assessment was performed in multiple stages with an initial learning curve. The final assessment was for 4 randomized controlled trials (RCTs) utilizing both Cochrane review criteria and IPM-QRB criteria. The inter-rater agreement for Cochrane review criteria with overall intra-class correlation coefficient was 0.407 compared to an intra-class correlation coefficient of 0.833 for IPM-QRB criteria. The inter-rater agreement was superior for IPM-QRB criteria compared to Cochrane review criteria despite twice the items of Cochrane review criteria as IPM-QRB criteria with the detailed nature of assessment. Limitations: Limited validity or accuracy assessment of the instrument and the large number of items to be scored. Conclusion: We have developed a new comprehensive instrument to assess the methodological quality of randomized trials of interventional techniques. This instrument is superior to Cochrane review methodology criteria in that it provides more extensive and specific information for interventional techniques that will be useful in assessing the methodologic quality and bias of interventional techniques. Key words: Methodological quality assessment, evidence-based medicine, comparative effectiveness research, Cochrane Reviews, interventional techniques, risk of bias assessment

2014 ◽  
Vol 3;17 (3;5) ◽  
pp. E291-E317 ◽  
Author(s):  
Laxmaiah Manchikanti

Background: The major component of a systematic review is assessment of the methodologic quality and bias of randomized and nonrandomized trials. While there are multiple instruments available to assess the methodologic quality and bias for randomized controlled trials (RCTs), there is a lack of extensively utilized instruments for observational studies, specifically for interventional pain management (IPM) techniques. Even Cochrane review criteria for randomized trials is considered not to be a “gold standard,” but merely an indication of the current state of the art review methodology. Recently a specific instrument to assess the methodologic quality of randomized trials has been developed for interventional techniques. Objectives: Our objective was to develop an IPM specific instrument to assess the methodological quality of nonrandomized trials or observational studies of interventional techniques. Methods: The item generation for the instrument was based on a definition of quality, to the extent to which the design and conduct of the trial were congruent with the objectives of the study. Applicability was defined as the extent to which procedures produced by the study could be applied using contemporary IPM techniques. Multiple items based on Cochrane review criteria and Interventional Pain Management Techniques – Quality Appraisal of Reliability and Risk of Bias Assessment for Nonrandomized Studies (IPM-QRBNR) were utilized. Results: A total of 16 items were developed which formed the IPM-QRBNR tool. The assessment was performed in multiple stages. The final assessment was 4 nonrandomized studies. The inter-rater agreement was moderate to good for IPM-QRBNR criteria. Limitations: Limited validity or accuracy assessment of the instrument and the large number of items to be scored were limitations. Conclusion: We have developed a new comprehensive instrument to assess the methodological quality of nonrandomized studies of interventional techniques. This instrument provides extensive information specific to interventional techniques is useful in assessing the methodological quality and bias of observational studies of interventional techniques. Key words: Methodological quality assessment, evidence-based medicine, comparative effectiveness research, Cochrane Reviews, interventional techniques, risk of bias assessment, nonrandomized trials, observational studies


2008 ◽  
Vol 4;11 (8;4) ◽  
pp. 393-482
Author(s):  
Laxmaiah Manchikanti

Background: Appropriately developed practice guidelines present statements of best practice based on a thorough evaluation of the evidence from published studies on the outcomes of treatments, which include the application of multiple methods for collecting and evaluating evidence for a wide range of clinical interventions and disciplines. However, the guidelines are neither infallible, nor a substitute for clinical judgment. While the guideline development process is a complex phenomenon, conflict of interest in guideline development and inappropriate methodologies must be avoided. It has been alleged that the guidelines by the American College of Occupational and Environmental Medicine (ACOEM) prevent injured workers from receiving the majority of medically necessary and appropriate interventional pain management services. An independent critical appraisal of both chapters of the ACOEM guidelines showed startling findings with a conclusion that these guidelines may not be applied in patient care as they scored below 30% in the majority of evaluations utilizing multiple standardized criteria. Objective: To reassess the evidence synthesis for the ACOEM guidelines for the low back pain and chronic pain chapters utilizing an expanded methodology, which includes the criteria included in the ACOEM guidelines with the addition of omitted literature and application of appropriate criteria. Methods: For reassessment, randomized trials were utilized as it was in the preparation of the guidelines. In this process, quality of evidence was assessed and recommendations were made based on grading recommendations of Guyatt et al. The level of evidence was determined utilizing the quality of evidence criteria developed by the U.S. Preventive Services Task Force (USPSTF), as well as the outdated quality of evidence criteria utilized by ACOEM in the guideline preparation. Methodologic quality of each individual article was assessed utilizing the Agency for Healthcare Research and Quality (AHRQ) methodologic assessment criteria for diagnostic interventions and Cochrane methodologic quality assessment criteria for therapeutic interventions. Results: The results of reassessment are vastly different from the conclusions derived by the ACOEM guidelines. The differences in strength of rating for the diagnosis of discogenic pain by provocation discography and facet joint pain by diagnostic facet joint nerve blocks is established with strong evidence. Therapeutic cervical and lumbar medial branch blocks and radiofrequency neurolysis, therapeutic thoracic medial branch blocks, cervical interlaminar epidural steroid injections, caudal epidural steroid injections, lumbar transforaminal epidural injections, percutaneous and endoscopic adhesiolysis, and spinal cord stimulation qualified for moderate to strong evidence. Additional insight is also provided for evidence rating for intradiscal electrothermal therapy (IDET), automated percutaneous disc decompression, and intrathecal implantables. Conclusion: The reassessment and reevaluation of the low back and chronic pain chapters of the ACOEM guidelines present results that are vastly different from the published and proposed guidelines. Contrary to ACOEM’s conclusions of insufficient evidence for most interventional techniques, the results illustrate moderate to strong evidence for most diagnostic and therapeutic interventional techniques. Key words: Guidelines, evidence-based medicine, systematic reviews, ACOEM, interventional pain management, interventional techniques, guideline development, workers’ compensation, chronic pain guidelines, low back pain guidelines


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


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


2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Jackie Walumbe ◽  
Joletta Belton ◽  
Diarmuid Denneny

AbstractObjectivesDuring the current COVID-19 pandemic, healthcare has been transformed by the rapid switch from in person care to use of remote consulting, including video conferencing technology. Whilst much has been published on one-to-one video consultations, little literature exists on use of this technology to facilitate group interventions. Group pain management programmes are a core treatment provided by many pain services. This rapid review aimed to identify the extent of use of video conferencing technology for delivery of group pain management programmes and provide an overview of its use.MethodsA rapid review of the literature published up to April 2020 (PubMed, PsycINFO and PEDro) was performed. The search string consisted of three domains: pain/CP (MeSH term) AND Peer group[MeSH] AND Videoconferencing[MeSH]/Telemedicine[MeSH]/Remote Consultation[MeSH]. The studies were of poor methodological quality and study design, and interventions and chronic pain conditions were varied.ResultsLiterature searching yielded three eligible papers for this review. All studies had low methodological quality and risk of bias. Heterogeneity and variability in outcome reporting did not allow any pooling of data. The results demonstrated that videoconferencing for delivery of group programmes is possible, yet there is little extant literature on how to develop, deliver and measure outcomes of such programmes.ConclusionsThis review demonstrates that there is little evidence to support or guide the use of synchronous videoconferencing to deliver pain management programmes. We present issues to consider, informed by this review and our experience, when implementing video conferencing. Study quality of existing work is variable, and extensive future research is necessary.


2006 ◽  
Vol 3 (2) ◽  
pp. 201-207 ◽  
Author(s):  
Taras I. Usichenko ◽  
Hardy Edinger ◽  
Vasyl V. Gizhko ◽  
Christian Lehmann ◽  
Michael Wendt ◽  
...  

Millimeter wave therapy (MWT), a non-invasive complementary therapeutic technique is claimed to possess analgesic properties. We reviewed the clinical studies describing the pain-relief effect of MWT. Medline-based search according to review criteria and evaluation of methodological quality of the retrieved studies was performed. Of 13 studies, 9 of them were randomized controlled trials (RCTs), only three studies yielded more than 3 points on the Oxford scale of methodological quality of RCTs. MWT was reported to be effective in the treatment of headache, arthritic, neuropathic and acute postoperative pain. The rapid onset of pain relief during MWT lasting hours to days after, remote to the site of exposure (acupuncture points), was the most characteristic feature in MWT application for pain relief. The most commonly used parameters of MWT were the MW frequencies between 30 and 70 GHz and power density up to 10 mW cm−2. The promising results from pilot case series studies and small-size RCTs for analgesic/hypoalgesic effects of MWT should be verified in large-scale RCTs on the effectiveness of this treatment method.


2008 ◽  
Vol 3;11 (5;3) ◽  
pp. 271-289
Author(s):  
Laxmaiah Manchikanti

In the modern day environment, workers’ compensation costs continue to be a challenge, with a need to balance costs, benefits, and quality of medical care. The cost of workers’ compensation care affects all stakeholders including workers, employers, providers, regulators, legislators, and insurers. Consequently, a continued commitment to quality, accessibility to care, and cost containment will help ensure that workers are afforded accessible, high quality, and cost-effective care. In 2004, workers’ compensation programs in all 50 states, the District of Columbia, and federal programs in the United States combined received an income of $87.4 billion while paying out only $56 billion in medical and cash benefits with $31.4 billion or 37% in administrative expenses and profit. Occupational diseases represented only 8% of the workers’ compensation claims and 29% of the cost. The American College of Occupational and Environmental Medicine (ACOEM) has published several guidelines; though widely adopted by WCPs, these guidelines evaluate the practice of medicine of multiple specialties without adequate expertise and expert input from the concerned specialties, including interventional pain management. An assessment of the ACOEM guidelines utilizing Appraisal of Guidelines for Research and Evaluation (AGREE) criteria, the criteria developed by the American Medical Association (AMA), the Institute of Medicine (IOM), and other significantly accepted criteria, consistently showed very low scores (< 30%) in most aspects of the these guidelines. The ACOEM recommendations do not appear to have been based on a careful review of the literature, overall quality of evidence, standard of care, or expert consensus. Based on the evaluation utilizing appropriate and current evidence-based medicine (EBM) principles, the evidence ratings for diagnostic techniques of lumbar discography; cervical, thoracic, and lumbar facet joint nerve blocks and sacroiliac joint nerve blocks; therapeutic cervical and lumbar medial branch blocks and radiofrequency neurolysis; cervical interlaminar epidural steroid injections, caudal epidural steroid injections, and lumbar transforaminal epidural injections; caudal percutaneous adhesiolysis; abd spinal cord stimulation were found to be moderate with strong recommendation applying for most patients in most circumstances. The evidence ratings for intradiscal electrothermal therapy (IDET), an automated percutaneous disc decompression and also deserve further scrutiny and analysis. In conclusion, these ACOEM guidelines for interventional pain management have no applicability in modern patient care due to lack of expertise by the developing organization (ACOEM), lack of utilization of appropriate and current EBM principles, and lack of significant involvement of experts in these techniques resulting in a lack of clinical relevance. Thus, they may result in reduced medical quality of care; may severely hinder access to appropriate, medically needed and essential medical care; and finally, they may increase costs for injured workers, third party payors, and the government by transferring the injured worker into a non-productive disability system. Key words: Guidelines, ACOEM, ASIPP, interventional pain management, interventional techniques, evidence-based medicine, systematic reviews, guideline development, AHCPR, AHRQ, IOM, AMA, AGREE, workers’ compensation, chronic pain guidelines, low back pain guidelines


2021 ◽  
Author(s):  
John Cardenas ◽  
Juan Felipe Vargas-Silva ◽  
Alejandro Ramirez

Abstract Chronic pain of oncological origin is one of the most frequent complications and is difficult to control, that results in a decrease in the quality of life and disability among patients suffering from this pathology. Primary or metastatic tumors originating from lung, colonic, or breast neoplasms can invade the chest wall, causing progressive respiratory pain and symptoms that require multiple interventions to achieve adequate control. Many of these cases presenting with advanced-stage cancer are often incurable; thus, pain management and palliative care are primary objectives. Multimodal management is the strategy of choice in these cases through the participation of a multidisciplinary team. Analgesic therapy covers the use of potent opioids, opioid rotation, adjuvant analgesics, and interventional pain management strategies. We report two cases of chronic oncological pain of the chest wall refractory to pharmacological analgesic management. The optimization of multimodal management and the performance of neurolysis by phenolization of the erector spinae plane achieved an adequate response.


2003 ◽  
Vol 31 (03) ◽  
pp. 337-354 ◽  
Author(s):  
Jianping Liu ◽  
Minghui Zhu ◽  
Rui Shi ◽  
Min Yang

To evaluate the effects of radix Sophorae flavescentis for chronic hepatitis B, a systematic review of randomized clinical trials was conducted. Randomized trials comparing extract of radix Sophorae flavescentis versus placebo, no intervention, non-specific treatment, other active medicines, or interferon for chronic hepatitis B were identified by electronic and manual searches. Trials of Sophorae herb plus other drugs versus other drugs alone were also included. No blinding and language limitations were applied. The methodological quality of trials was assessed by the Jadad scale plus allocation concealment. Meta-analysis was performed where data was available. Twenty-two randomized trials (n = 2409) were included. Methodological quality of the trials was generally low. The combined results showed that matrine (aqueous extract of Sophorae flavescentis) had antiviral activity, positive liver biochemical effects, and improved symptoms and signs compared with non-specific treatment and other herbal medicines. The combination of matrine and interferon-α (IFN-α), thymosin, or basic treatment showed better effects on viral and liver biochemical responses. The antiviral and biochemical responses were not significantly different between matrine and IFN-α. No serious adverse event was reported. Based on the review, Sophorae flavescentis extract (matrine) may have antiviral activity and positive effects on liver biochemistry in chronic hepatitis B. However, the evidence is not sufficient to recommend matrine for routine clinical use due to the generally low methodological quality of the studies. Further rigorous trials are needed.


2008 ◽  
Vol 1;11 (1;1) ◽  
pp. 43-55
Author(s):  
YiLi Zhou

Background: A recent study has indicated that quality assurance for interventional pain management procedures (IPMPs) can be achieved in university pain clinics. However, the issue of quality assurance for IPMPs in private practice has not yet been addressed. Objective: This study was designed to monitor the quality of IPMPs in a private pain practice in north Florida. Methods: From November 2005 to July 2006, we monitored the quality of IPMPs in a private pain practice in north Florida. Questionnaires regarding degree of pain relief, patient satisfaction, and complications were handed to patients immediately after the completion of each IPMP. Follow-up phone calls were also made to patients 1 day after the IPMPs. Results: A total of 771 (male: 249, female: 522) patients with a mean age of 58.1 years participated in the study. Office-based IPMPs included lumbar and cervical epidural steroid injections, lumbar and cervical facet joint blocks, selective nerve root blocks, lumbar and cervical sympathetic nerve blocks, sacroiliac joint injection, and large joint injections. Seven-hundred patients (90.8%) reported various degrees of pain relief immediately following IPMPs. Average pain score decreased by 4.3 on a 0 to 10 scale (p=<0.001). Number needed to be treated (NNT) to reach 50% or more pain relief immediately after IPMPs was 1.4. Six-hundred ninety-two (89.7%) patients were satisfied or very satisfied with the results of IPMPs. sixty-two patients (8%) developed headaches after IPMPs, which lasted from 30 minutes to 4 days. None of these patients required a blood patch. Five patients developed moderate vasovagal responses during IPMPs, in which their heart rates decreased to <45/min, BP <90/60mmHg. The IPMPs were aborted immediately. All of these patients recovered uneventfully within a few minutes. No other serious adverse events were reported. Conclusions: The results of the current study suggest that high quality private interventional pain programs with high efficacy, high patient satisfaction, and low complication rates can be achieved through appropriate staff training, proper monitoring of patients during IPMPs, and adequate handling of patients after the IPMPs. Key words: Interventional pain management procedures, quality assurance, efficacy, patient satisfaction


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