Systematic Reviews and Meta-analyses in Regional Anesthesia and Pain Medicine (Part I): Guidelines for Preparing the Review Protocol.

Comprehensive resources exist on how to plan a systematic review and meta-analysis. The objective of this article is to provide guidance to authors preparing their systematic review protocol in the fields of regional anesthesia and pain medicine. The focus is on systematic reviews of health care interventions, with or without an aggregate data meta-analysis. We describe and discuss elements of the systematic review methodology that review authors should prespecify, plan, and document in their protocol before commencing the review. Importantly, authors should explain their rationale for planning their systematic review and describe the PICO framework-participants (P), interventions (I), comparators (C), outcomes (O)-and related elements central to constructing their clinical question, framing an informative review title, determining the scope of the review, designing the search strategy, specifying the eligibility criteria, and identifying potential sources of heterogeneity. We highlight the importance of authors defining and prioritizing the primary outcome, defining eligibility criteria for selecting studies, and documenting sources of information and search strategies. The review protocol should also document methods used to evaluate risk of bias, quality (certainty) of the evidence, and heterogeneity of results. Furthermore, the authors should describe their plans for managing key data elements, the statistical construct used to estimate the intervention effect, methods of evidence synthesis and meta-analysis, and conditions when meta-analysis may not be possible, including the provision of practical solutions. Authors should provide enough detail in their protocol so that the readers could conduct the study themselves.

Systematic reviews and meta-analyses in regional anesthesia and pain medicine (Part I): guidelines for preparing the review protocol.

Comprehensive resources exist on how to plan a systematic review and meta-analysis. The objective of this article is to provide guidance to authors preparing their systematic review protocol in the fields of regional anesthesia and pain medicine. The focus is on systematic reviews of healthcare interventions, with or without an aggregate data meta-analysis. We describe and discuss elements of the systematic review methodology that review authors should prespecify, plan, and document in their protocol before commencing the review. Importantly, authors should explain their rationale for planning their systematic review and describe the PICO framework-participants (P), interventions (I),comparators (C), outcomes (O)-and related elements central to constructing their clinical question, framing an informative review title, determining the scope of the review, designing the search strategy, specifying the eligibility criteria, and identifying potential sources of heterogeneity. We highlight the importance of authors defining and prioritizing the primary outcome, defining eligibility criteria for selecting studies, and documenting sources of information and search strategies. The review protocol should also document methods used to evaluate risk of bias, quality (certainty) of the evidence, and heterogeneity of results. Furthermore, the authors should describe their plans for managing key data elements, the statistical construct used to estimate the intervention effect, methods of evidence synthesis and meta-analysis, and conditions when meta-analysis may not be possible, including the provision of practical solutions. Authors should provide enough detail in their protocol so that the readers could conduct the study themselves.

Consensus Practice Guidelines on Postdural Puncture Headache From a Multisociety, International Working Group: A Summary Report.

Importance: Postdural puncture headache (PDPH) can follow unintentional dural puncture during epidural techniques or intentional dural puncture during neuraxial procedures, such as a lumbar puncture or spinal anesthesia. Evidence-based guidance on the prevention, diagnosis, and management of this condition is, however, currently lacking. Objective: To fill the practice guidelines void and provide comprehensive information and patient-centric recommendations for preventing, diagnosing, and managing PDPH. Evidence Review: With input from committee members and stakeholders of 6 participating professional societies, 10 review questions that were deemed important for the prevention, diagnosis, and management of PDPH were developed. A literature search for each question was performed in MEDLINE on March 2, 2022. Additional relevant clinical trials, systematic reviews, and research studies published through March 2022 were also considered for practice guideline development and shared with collaborator groups. Each group submitted a structured narrative review along with recommendations that were rated according to the US Preventive Services Task Force grading of evidence. Collaborators were asked to vote anonymously on each recommendation using 2 rounds of a modified Delphi approach. Findings: After 2 rounds of electronic voting by a 21-member multidisciplinary collaborator team, 47 recommendations were generated to provide guidance on the risk factors for and the prevention, diagnosis, and management of PDPH, along with ratings for the strength and certainty of evidence. A 90% to 100% consensus was obtained for almost all recommendations. Several recommendations were rated as having moderate to low certainty. Opportunities for future research were identified. Conclusions and Relevance: Results of this consensus statement suggest that current approaches to the treatment and management of PDPH are not uniform due to the paucity of evidence. The practice guidelines, however, provide a framework for individual clinicians to assess PDPH risk, confirm the diagnosis, and adopt a systematic approach to its management.

Evidence-based clinical practice guidelines on postdural puncture headache: a consensus report from a multisociety international working group.

INTRODUCTION: Postdural puncture headache (PDPH) can follow unintentional dural puncture during epidural techniques or intentional dural puncture during neuraxial procedures such as a lumbar puncture or spinal anesthesia. Evidence-based guidance on the prevention, diagnosis or management of this condition is, however, currently lacking. This multisociety guidance aims to fill this void and provide practitioners with comprehensive information and patient-centric recommendations to prevent, diagnose and manage patients with PDPH. METHODS: Based on input from committee members and stakeholders, the committee cochairs developed 10 review questions deemed important for the prevention, diagnosis and management of PDPH. A literature search for each question was performed in MEDLINE (Ovid) on 2 March 2022. The results from each search were imported into separate Covidence projects for deduplication and screening, followed by data extraction. Additional relevant clinical trials, systematic reviews and research studies published through March 2022 were also considered for the development of guidelines and shared with contributors. Each group submitted a structured narrative review along with recommendations graded according to the US Preventative Services Task Force grading of evidence. The interim draft was shared electronically, with each collaborator requested to vote anonymously on each recommendation using two rounds of a modified Delphi approach. RESULTS: Based on contemporary evidence and consensus, the multidisciplinary panel generated 50 recommendations to provide guidance regarding risk factors, prevention, diagnosis and management of PDPH, along with their strength and certainty of evidence. After two rounds of voting, we achieved a high level of consensus for all statements and recommendations. Several recommendations had moderate-to-low certainty of evidence. CONCLUSIONS: These clinical practice guidelines for PDPH provide a framework to improve identification, evaluation and delivery of evidence-based care by physicians performing neuraxial procedures to improve the quality of care and align with patients' interests. Uncertainty remains regarding best practice for the majority of management approaches for PDPH due to the paucity of evidence. Additionally, opportunities for future research are identified.

Congress of Neurological Surgeons Systematic Review and Evidence-Based Guidelines for Occipital Nerve Stimulation for the Treatment of Patients With Medically Refractory Occipital Neuralgia: Update.

BACKGROUND: The Guidelines Task Force conducted a systematic review of the relevant literature on occipital nerve stimulation (ONS) for occipital neuralgia (ON) to update the original 2015 guidelines to ensure timeliness and accuracy for clinical practice. OBJECTIVE: To conduct a systematic review of the literature and update the evidence-based guidelines on ONS for ON. METHODS: The Guidelines Task Force conducted another systematic review of the relevant literature, using the same search terms and strategies used to search PubMed and Embase for relevant literature. The updated search included studies published between 1966 and January 2023. The same inclusion/exclusion criteria as the original guideline were also applied. Abstracts were reviewed, and relevant full text articles were retrieved and graded. Of 307 articles, 18 were retrieved for full-text review and analysis. Recommendations were updated according to new evidence yielded by this update . RESULTS: Nine studies were included in the original guideline, reporting the use of ONS as an effective treatment option for patients with medically refractory ON. An additional 6 studies were included in this update. All studies in the original guideline and this current update provide Class III evidence. CONCLUSION: Based on the availability of new literature, the current article is a minor update only that does not result in modification of the prior recommendations: Clinicians may use ONS as a treatment option for patients with medically refractory ON.

Daring discourse: artificial intelligence in pain medicine, opportunities and challenges.

Artificial intelligence (AI) tools are currently expanding their influence within healthcare. For pain clinics, unfettered introduction of AI may cause concern in both patients and healthcare teams. Much of the concern stems from the lack of community standards and understanding of how the tools and algorithms function. Data literacy and understanding can be challenging even for experienced healthcare providers as these topics are not incorporated into standard clinical education pathways. Another reasonable concern involves the potential for encoding bias in healthcare screening and treatment using faulty algorithms. And yet, the massive volume of data generated by healthcare encounters is increasingly challenging for healthcare teams to navigate and will require an intervention to make the medical record manageable in the future. AI approaches that lighten the workload and support clinical decision-making may provide a solution to the ever-increasing menial tasks involved in clinical care. The potential for pain providers to have higher-quality connections with their patients and manage multiple complex data sources might balance the understandable concerns around data quality and decision-making that accompany introduction of AI. As a specialty, pain medicine will need to establish thoughtful and intentionally integrated AI tools to help clinicians navigate the changing landscape of patient care.

Trial protocol for a multicenter randomized controlled trial to assess the efficacy and safety of intravenous ketamine for chronic daily headaches: the "KetHead" trial.

BACKGROUND: Chronic daily headaches (CDH) are common and associated with significant morbidity, poor quality of life, and substantial burden on the healthcare system. CDH tends to be refractory to conventional medical management and/or patients cannot afford expensive treatments. It is stipulated that CDH share a mechanism of central sensitization in the trigeminocervical complex, mediated by activation of the N-methyl-D-aspartate (NMDA) receptors. Ketamine, a non-competitive NMDA antagonist, has been used in the treatment of chronic pain, but its role in CDH has not been completely established. This trial aims to evaluate the effect of high-dose IV ketamine infusions (compared to placebo) on the number of headache days at 28 days post-infusion. METHODS: A multicenter, placebo-controlled, randomized controlled trial will be conducted with two parallel groups and blinding of participants and outcome assessors. The study will include 56 adults with a CDH diagnosis as per ICHD-3 criteria. Participants will be randomized (1:1) to either ketamine (1 mg. kg-1 bolus followed by infusion of 1 mg. kg-1. h-1 for 6 h) or placebo (0.9% saline in the same volume and infusion rate as the trial medication) bolus and infusion for 6 h. The impact on the number of monthly headache days, headache intensity, physical activity, mood, sleep, quality of life, analgesic consumption, and adverse effects will be recorded at baseline, immediately post-infusion, and from 1 to 28 days, 29 to 56 days, and 57 to 84 days after the infusion DISCUSSION: Despite advancements in treatment, many patients continue to suffer from CDH. This trial investigates whether high-dose IV ketamine infusions can effectively and safely improve the CDH burden as compared to a placebo infusion. This treatment could become a safe, affordable, and widely available option for patients living with refractory headache. TRIAL REGISTRATION: ClinicalTrials.gov NCT05306899. Registered on April 1, 2022.

Role of patient selection and trial stimulation for spinal cord stimulation therapy for chronic non-cancer pain: a comprehensive narrative review.

BACKGROUND/IMPORTANCE: Patient selection for spinal cord stimulation (SCS) therapy is crucial and is traditionally performed with clinical selection followed by a screening trial. The factors influencing patient selection and the importance of trialing have not been systematically evaluated. OBJECTIVE: We report a narrative review conducted to synthesize evidence regarding patient selection and the role of SCS trials. EVIDENCE REVIEW: Medline, EMBASE and Cochrane databases were searched for reports (any design) of SCS in adult patients, from their inception until March 30, 2022. Study selection and data extraction were carried out using DistillerSR. Data were organized into tables and narrative summaries, categorized by study design. Importance of patient variables and trialing was considered by looking at their influence on the long-term therapy success. FINDINGS: Among 7321 citations, 201 reports consisting of 60 systematic reviews, 36 randomized controlled trials (RCTs), 41 observational studies (OSs), 51 registry-based reports, and 13 case reports on complications during trialing were included. Based on RCTs and OSs, the median trial success rate was 72% and 82%, and therapy success was 65% and 61% at 12 months, respectively. Although several psychological and non-psychological determinants have been investigated, studies do not report a consistent approach to patient selection. Among psychological factors, untreated depression was associated with poor long-term outcomes, but the effect of others was inconsistent. Most RCTs except for chronic angina involved trialing and only one RCT compared patient selection with or without trial. The median (range) trial duration was 10 (0-30) and 7 (0-56) days among RCTs and OSs, respectively. CONCLUSIONS: Due to lack of a consistent approach to identify responders for SCS therapy, trialing complements patient selection to exclude patients who do not find the therapy helpful and/or intolerant of the SCS system. However, more rigorous and large studies are necessary to better evaluate its role.

Evidence-based consensus guidelines on patient selection and trial stimulation for spinal cord stimulation therapy for chronic non-cancer pain.

Spinal cord stimulation (SCS) has demonstrated effectiveness for neuropathic pain. Unfortunately, some patients report inadequate long-term pain relief. Patient selection is emphasized for this therapy; however, the prognostic capabilities and deployment strategies of existing selection techniques, including an SCS trial, have been questioned. After approval by the Board of Directors of the American Society of Regional Anesthesia and Pain Medicine, a steering committee was formed to develop evidence-based guidelines for patient selection and the role of an SCS trial. Representatives of professional organizations with clinical expertize were invited to participate as committee members. A comprehensive literature review was carried out by the steering committee, and the results organized into narrative reports, which were circulated to all the committee members. Individual statements and recommendations within each of seven sections were formulated by the steering committee and circulated to members for voting. We used a modified Delphi method wherein drafts were circulated to each member in a blinded fashion for voting. Comments were incorporated in the subsequent revisions, which were recirculated for voting to achieve consensus. Seven sections with a total of 39 recommendations were approved with 100% consensus from all the members. Sections included definitions and terminology of SCS trial; benefits of SCS trial; screening for psychosocial characteristics; patient perceptions on SCS therapy and the use of trial; other patient predictors of SCS therapy; conduct of SCS trials; and evaluation of SCS trials including minimum criteria for success. Recommendations included that SCS trial should be performed before a definitive SCS implant except in anginal pain (grade B). All patients must be screened with an objective validated instrument for psychosocial factors, and this must include depression (grade B). Despite some limitations, a trial helps patient selection and provides patients with an opportunity to experience the therapy. These recommendations are expected to guide practicing physicians and other stakeholders and should not be mistaken as practice standards. Physicians should continue to make their best judgment based on individual patient considerations and preferences.

Violence in the pain clinic: the hidden pandemic.

Workplace violence is any physical assault, threatening behavior or other verbal abuse directed toward persons at work or in the workplace. The incidence of workplace violence in healthcare settings in general and more specifically the pain clinic is thought to be underestimated due to hesitancy to report, lack of support from management and healthcare systems, and lack of institutional policies as it relates to violence from patients against healthcare workers. In the following article, we explore risk factors that place clinicians at risk of workplace violence, the cost and impact of workplace violence, how to build a violence prevention program and lastly how to recover from violence in the practice setting.

ASRA Pain Medicine consensus guidelines on the management of the perioperative patient on cannabis and cannabinoids.

BACKGROUND: The past two decades have seen an increase in cannabis use due to both regulatory changes and an interest in potential therapeutic effects of the substance, yet many aspects of the substance and their health implications remain controversial or unclear. METHODS: In November 2020, the American Society of Regional Anesthesia and Pain Medicine charged the Cannabis Working Group to develop guidelines for the perioperative use of cannabis. The Perioperative Use of Cannabis and Cannabinoids Guidelines Committee was charged with drafting responses to the nine key questions using a modified Delphi method with the overall goal of producing a document focused on the safe management of surgical patients using cannabinoids. A consensus recommendation required ≥75% agreement. RESULTS: Nine questions were selected, with 100% consensus achieved on third-round voting. Topics addressed included perioperative screening, postponement of elective surgery, concomitant use of opioid and cannabis perioperatively, implications for parturients, adjustment in anesthetic and analgesics intraoperatively, postoperative monitoring, cannabis use disorder, and postoperative concerns. Surgical patients using cannabinoids are at potential increased risk for negative perioperative outcomes. CONCLUSIONS: Specific clinical recommendations for perioperative management of cannabis and cannabinoids were successfully created.

American Society of Regional Anesthesia and Pain Medicine contrast shortage position statement.

The medical field has been experiencing numerous drug shortages in recent years. The most recent shortage to impact the field of interventional pain medicine is that of iodinated contrast medium. Pain physicians must adapt to these changes while maintaining quality of care. This position statement offers guidance on adapting to the shortage.

Cannabis, cannabinoids, and cannabis-based medicines: future research directions for analgesia.

The use of cannabis spans thousands of years and encompasses almost all dimensions of the human experience, including consumption for recreational, religious, social, and medicinal purposes. Its use in the management of pain has been anecdotally described for millennia. However, an evidence base has only developed over the last 100 years, with an explosion in research occurring in the last 20-30 years, as more states in the USA as well as countries worldwide have legalized and encouraged its use in pain management. Pain remains one of the most common reasons for individuals deciding to use cannabis medicinally. However, cannabis remains illegal at the federal level in the USA and in most countries of the world, making it difficult to advance quality research on its efficacy for pain treatment. Nonetheless, new products derived both from the cannabis plant and the chemistry laboratory are being developed for use as analgesics. This review examines the current landscape of cannabinoids research and future research directions in the management of pain.

Recommended Musculoskeletal and Sports Ultrasound Terminology: A Delphi-Based Consensus Statement.

OBJECTIVES: The current lack of agreement regarding standardized terminology in musculoskeletal and sports ultrasound presents challenges in education, clinical practice, and research. This consensus was developed to provide a reference to improve clarity and consistency in communication. METHODS: A multidisciplinary expert panel was convened consisting of 18 members representing multiple specialty societies identified as key stakeholders in musculoskeletal and sports ultrasound. A Delphi process was used to reach consensus which was defined as group level agreement >80%. RESULTS: Content was organized into seven general topics including: 1) General Definitions, 2) Equipment and Transducer Manipulation, 3) Anatomic and Descriptive Terminology, 4) Pathology, 5) Procedural Terminology, 6) Image Labeling, and 7) Documentation. Terms and definitions which reached consensus agreement are presented herein. CONCLUSIONS: The historic use of multiple similar terms in the absence of precise definitions has led to confusion when conveying information between colleagues, patients, and third-party payers. This multidisciplinary expert consensus addresses multiple areas of variability in diagnostic ultrasound imaging and ultrasound-guided procedures related to musculoskeletal and sports medicine.