Coerced consent in clinical research: study protocol for a randomized controlled trial.

BACKGROUND: Despite the low-risk nature of participation in most clinical anesthesia trials, subject recruitment on the same day as surgery is often restricted due to the concerns of researchers and local research ethics boards that same-day consent may not afford adequate time and opportunity for patients to weigh and make decisions, as well as perceptions of patient vulnerability immediately prior to surgery that could impact the voluntary nature and the rigor of the informed consent process. However, specialties such as anesthesiology, critical care, interventional radiology, and emergency medicine have a varied pattern of practice and patient acquaintance that does not typically afford the luxury of time or, in many cases, advance consent for participation in research. Indeed, the initial encounter between anesthesiologists and patients undergoing elective procedures routinely occurs on the day of surgery. Concerns of coercion related to same-day consent for clinical anesthesia research trials have not been borne out in the literature, and represent a significant obstacle to clinical researchers, as well as to the patients who are denied opportunities for potential benefit through participation in research studies. METHODS: We describe the protocol for a prospective randomized controlled trial examining the voluntariness of patient consent, solicited either in advance of surgery or on the same day, to participate in an anesthesia research study at Women's College Hospital. One hundred fourteen patients scheduled to undergo ambulatory anterior cruciate ligament repair facilitated by general anesthesia with an adductor canal block will be randomized for recruitment either (a) in the pre-operative assessment clinic before the day of surgery or (b) on the day of surgery, to be approached for consent to participate in a fabricated research study of adjunct medications in adductor canal blocks. Regardless of allocation, patients in both groups will receive the same routine standard of care and will complete a post-operative questionnaire to signal perceptions of undue influence in the process of providing informed consent for the fabricated trial. DISCUSSION: This study will inform trial design and practice guidelines surrounding the amount of time patients ought to be afforded in order to make durable decisions to participate (or not) in clinical research studies. This is expected to impact trial recruitment in a variety of clinical settings where researchers have only brief opportunities to interface with patients. TRIAL REGISTRATION: The trial was registered prospectively on the Open Science Framework (OSF), registration #46twc, on 2023-Mar-17.

Prevalence and Management of Chronic Obstructive Pulmonary Disease in the Gulf Countries with a Focus on Inhaled Pharmacotherapy.

Background: Chronic obstructive pulmonary disease (COPD) is a preventable, progressive disease and the third leading cause of death worldwide. The epidemiological data of COPD from Gulf countries are very limited, as it remains underdiagnosed and underestimated. Risk factors for COPD include tobacco cigarette smoking, water pipe smoking (Shisha), exposure to air pollutants, occupational dusts, fumes, and chemicals. Inadequate treatment of COPD leads to worsening of disease. The 2024 GOLD guidelines recommend use of inhaled bronchodilators, corticosteroids, and adjunct therapies for treatment and management of COPD patients based on an individual assessment of the severity of symptoms and risk of exacerbations. This article reviews COPD pharmacotherapy in the Gulf countries and explores the role of nebulization in the management of COPD in this region. Methods: To review the COPD pharmacotherapy in the Gulf Countries, literature search was conducted using PubMed, Medline, Cochrane Systematic Reviews, and Google Scholar databases (before December 2022), using search terms such as COPD, nebulization, inhalers/inhalation, aerosols, and Gulf countries. Relevant articles from the reference list of identified studies were reviewed. Consensus statements, expert opinion, and other published review articles were included. Results: In the Gulf countries, pressurized metered-dose inhalers (pMDIs), dry powder inhalers (DPIs), soft mist inhalers, and nebulizers are used for drug delivery to COPD patients. pMDIs and DPIs are most prone to errors in technique and other common device handling errors. Nebulization is another mode of inhalation drug delivery, which is beneficial in certain patient populations such as the elderly and patients with cognitive impairment, motor or neuromuscular disorders, and other comorbidities. Conclusion: There is no major difference between Gulf countries and rest of the world in the approach to management of COPD. Nebulizers should be considered for patients who have difficulties in accessing or using MDIs and DPIs, irrespective of geographical location.

What Is the Risk of Postoperative Neurologic Symptoms After Regional Anesthesia in Upper Extremity Surgery? A Systematic Review and Meta-analysis of Randomized Trials.

BACKGROUND: The risk of neurologic symptoms after regional anesthesia in orthopaedic surgery is estimated to approach 3%, with long-term deficits affecting 2 to 4 per 10,000 patients. However, current estimates are derived from large retrospective or observational studies that are subject to important systemic biases. Therefore, to harness the highest quality data and overcome the challenge of small numbers of participants in individual randomized trials, we undertook this systematic review and meta-analysis of contemporary randomized trials. QUESTIONS/PURPOSES: In this systematic review and meta-analysis of randomized trials we asked: (1) What is the aggregate pessimistic and optimistic risk of postoperative neurologic symptoms after regional anesthesia in upper extremity surgery? (2) What block locations have the highest and lowest risk of postoperative neurologic symptoms? (3) What is the timing of occurrence of postoperative neurologic symptoms (in days) after surgery? METHODS: We searched Ovid MEDLINE, Embase, Cochrane Central Register of Controlled Trials and Cochrane Database of Systematic Reviews, Web of Science, Scopus, and PubMed for randomized controlled trials (RCTs) published between 2008 and 2019 that prospectively evaluated postoperative neurologic symptoms after peripheral nerve blocks in operative procedures. Based on the Grading of Recommendations, Assessment, Development, and Evaluation guidance for using the Risk of Bias in Non-Randomized Studies of Interventions tool, most trials registered a global rating of a low-to-intermediate risk of bias. A total of 12,532 participants in 143 trials were analyzed. Data were pooled and interpreted using two approaches to calculate the aggregate risk of postoperative neurologic symptoms: first according to the occurrence of each neurologic symptom, such that all reported symptoms were considered mutually exclusive (pessimistic estimate), and second according to the occurrence of any neurologic symptom for each participant, such that all reported symptoms were considered mutually inclusive (optimistic estimate). RESULTS: At any time postoperatively, the aggregate pessimistic and optimistic risks of postoperative neurologic symptoms were 7% (915 of 12,532 [95% CI 7% to 8%]) and 6% (775 of 12,532 [95% CI 6% to 7%]), respectively. Interscalene block was associated with the highest risk (13% [661 of 5101] [95% CI 12% to 14%]) and axillary block the lowest (3% [88 of 3026] [95% CI 2% to 4%]). Of all symptom occurrences, 73% (724 of 998) were reported between 0 and 7 days, 24% (243 of 998) between 7 and 90 days, and 3% (30 of 998) between 90 and 180 days. Among the 31 occurrences reported at 90 days or beyond, all involved sensory deficits and four involved motor deficits, three of which ultimately resolved. CONCLUSION: When assessed prospectively in randomized trials, the aggregate risk of postoperative neurologic symptoms associated with peripheral nerve block in upper extremity surgery was approximately 7%, which is greater than previous estimates described in large retrospective and observational trials. Most occurrences were reported within the first week and were associated with an interscalene block. Few occurrences were reported after 90 days, and they primarily involved sensory deficits. Although these findings cannot inform causation, they can help inform risk discussions and clinical decisions, as well as bolster our understanding of the evolution of postoperative neurologic symptoms after regional anesthesia in upper extremity surgery. Future prospective trials examining the risks of neurologic symptoms should aim to standardize descriptions of symptoms, timing of evaluation, classification of severity, and diagnostic methods. LEVEL OF EVIDENCE: Level I, therapeutic study.

Expert review and recommendations for the management of acute, chronic, and neuropathic pain in Qatar.

BACKGROUND: Pain management is an evolving area of expertise in Qatar. Gaps in knowledge, inadequate training for physicians and nurses, and the absence of policies/guidelines are the main barriers to effective pain management in Qatar. In addition, the use of certain pain medication, especially opioids, is highly regulated, limiting their availability in outpatient pain management. These factors are responsible for the undertreatment of pain in Qatar. This study aimed to standardize evidence-based local recommendations for pharmacological treatment of pain in Qatar. METHODS: An expert panel of physicians from different disciplines, with experience in diagnosis and treatment of the three pain types (i.e., acute, chronic, and neuropathic), was convened for two face-to-face meetings in Doha, Qatar, on November 29, 2019, and on February 22, 2020, with subsequent virtual meetings. A literature search was performed on Medline and Google Scholar databases from inception till December 2019, and all relevant articles were selected. Based on these articles and repeated feedback from the authors, the final pain treatment protocols were developed. RESULTS: Recommendations for the treatment of acute pain, based on pain severity, followed three approaches: acetaminophen/paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs) for mild pain and moderate pain and referral to a pain specialist for severe pain. Acetaminophen/paracetamol or NSAIDs is recommended for chronic pain, and the use of opioids was strongly discouraged because of its long-term side effects. For neuropathic pain, tricyclic antidepressants or gabapentin or pregabalin or serotonin-norepinephrine reuptake inhibitors were recommended first-line agents. Non-responders must be referred to neurologists or a pain specialist. CONCLUSION: The expert panel provides recommendations for the management of acute, chronic, and neuropathic pain based on international guidelines adapted to local practice and treatment availability in Qatar. More importantly, the panel has recommended taking extreme caution in the use of opioids for long-term management of chronic pain and to refer the patient to a pain specialist clinician as required.

Intertruncal approach to the supraclavicular brachial plexus, current controversies and technical update: a daring discourse.

We propose a new approach to local anesthetic injection for the supraclavicular brachial plexus block: an intertruncal approach by which local anesthetic is deposited in the two adipose tissue planes between the upper and middle and the middle and lower trunks. We present sonographic and microscopic images to illustrate the relevant anatomy. This approach offers potential advantages over the 'corner pocket' technique in that it results in consistent local anesthetic spread to the three plexus trunks and the needle endpoint lies farther away from the pleural surface which is important for the prevention of pneumothorax. It also offers an advantage over the 'intracluster' approach as it purposefully avoids intraneural injection respecting the integrity of the epineurium of individual trunks. Comparative studies are required to confirm that these anatomic and technical advantages result in improved outcomes.