Evidence-Based Clinical Practice Guidelines on Regenerative Medicine Treatment for Chronic Pain: A Consensus Report from a Multispecialty Working Group.

Purpose: Injectable biologics have not only been described and developed to treat dermal wounds, cardiovascular disease, and cancer, but have also been reported to treat chronic pain conditions. Despite emerging evidence supporting regenerative medicine therapy for pain, many aspects remain controversial. Methods: The American Society of Pain and Neuroscience (ASPN) identified the educational need for an evidence-based guideline on regenerative medicine therapy for chronic pain. The executive board nominated experts spanning multiple specialties including anesthesiology, physical medicine and rehabilitation, and sports medicine based on expertise, publications, research, and clinical practice. A steering committee selected preliminary questions, which were reviewed and refined. Evidence was appraised using the United States Preventive Services Task Force (USPSTF) criteria for evidence level and degree of recommendation. Using a modified Delphi approach, consensus points were distributed to all collaborators and each collaborator voted on each point. If collaborators provided a decision of "disagree" or "abstain", they were invited to provide a rationale in a non-blinded fashion to the committee chair, who incorporated the respective comments and distributed revised versions to the committee until consensus was achieved. Results: Sixteen questions were selected for guideline development. Questions that were addressed included type of injectable biologics and mechanism, evidence in treating chronic pain indications (eg, tendinopathy, muscular pathology, osteoarthritis, intervertebral disc disease, neuropathic pain), role in surgical augmentation, dosing, comparative efficacy between injectable biologics, peri-procedural practices to optimize therapeutic response and quality of injectate, federal regulations, and complications with mitigating strategies. Conclusion: In well-selected individuals with certain chronic pain indications, use of injectable biologics may provide superior analgesia, functionality, and/or quality of life compared to conventional medical management or placebo. Future high-quality randomized clinical trials are warranted with implementation of minimum reporting standards, standardization of preparation protocols, investigation of dose-response associations, and comparative analysis between different injectable biologics.

Wearable Technologies for Detecting Burnout and Well-Being in Health Care Professionals: Scoping Review.

BACKGROUND: The occupational burnout epidemic is a growing issue, and in the United States, up to 60% of medical students, residents, physicians, and registered nurses experience symptoms. Wearable technologies may provide an opportunity to predict the onset of burnout and other forms of distress using physiological markers. OBJECTIVE: This study aims to identify physiological biomarkers of burnout, and establish what gaps are currently present in the use of wearable technologies for burnout prediction among health care professionals (HCPs). METHODS: A comprehensive search of several databases was performed on June 7, 2022. No date limits were set for the search. The databases were Ovid: MEDLINE(R), Embase, Healthstar, APA PsycInfo, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Web of Science Core Collection via Clarivate Analytics, Scopus via Elsevier, EBSCOhost: Academic Search Premier, CINAHL with Full Text, and Business Source Premier. Studies observing anxiety, burnout, stress, and depression using a wearable device worn by an HCP were included, with HCP defined as medical students, residents, physicians, and nurses. Bias was assessed using the Newcastle Ottawa Quality Assessment Form for Cohort Studies. RESULTS: The initial search yielded 505 papers, from which 10 (1.95%) studies were included in this review. The majority (n=9) used wrist-worn biosensors and described observational cohort studies (n=8), with a low risk of bias. While no physiological measures were reliably associated with burnout or anxiety, step count and time in bed were associated with depressive symptoms, and heart rate and heart rate variability were associated with acute stress. Studies were limited with long-term observations (eg, ≥12 months) and large sample sizes, with limited integration of wearable data with system-level information (eg, acuity) to predict burnout. Reporting standards were also insufficient, particularly in device adherence and sampling frequency used for physiological measurements. CONCLUSIONS: With wearables offering promise for digital health assessments of human functioning, it is possible to see wearables as a frontier for predicting burnout. Future digital health studies exploring the utility of wearable technologies for burnout prediction should address the limitations of data standardization and strategies to improve adherence and inclusivity in study participation.

The World's consumption of free web-based Otolaryngology-Head and Neck Surgery educational resources: A global assessment of video usage trends.

Objectives: Online educational platforms with open access have seen a growing adoption in the field of medical education. However, the extent of their global usage is still unclear. To fill this knowledge gap, our objective is to examine the usage patterns of two renowned open-access resources in Otolaryngology. This includes identifying the most sought-after topics and understanding the demographics of their users. Methods: Retrospective study of web analytics data between 2016 and 2021 extracted from the Headmirror.com and Mayo Clinic Otolaryngology YouTube channel platforms analyzing demographic and education topic trends via descriptive, geospatial, time-series, t-tests, and ANOVA analyses. Results: Viewership spanned 124 countries in 7 different geographic regions, with 72 countries comprising low- to middle-income countries, mostly represented ages of 25-34 years old, came from high-income countries rather than low-income (p < .001), and used mobile phones followed by computers for device access. Video-educational material comprised of subspecialty topics on Rhinology and Sinus Surgery (25%) at the highest end and Facial Trauma (1%) at the lowest. Controlling for the age of the video content, the most-accessed videos comprised of subspecialty topics on Head and Neck Surgery at the highest end and Laryngology at the lowest with significant differentiation across topics of interest (p < .044). Conclusions: This assessment of web-analytics platforms from two widely used otolaryngology free, online-access materials showed increasing global usage trends with significant differentiating factors along viewership demographics, as well as sought-after subspecialty topics of interest. In turn, our results not only lay the groundwork for characterizing the global otolaryngology audience but also for future development of targeted educational materials and accessibility initiatives aimed at ameliorating global educational disparities in the field.

Emotional distress and future healthcare utilization in oncology populations: A systematic review.

OBJECTIVE: Emotional distress has been correlated with greater healthcare utilization and economic costs in cancer; however, the prospective relationship between positive distress screens and future healthcare utilization is less clear. Taken together, there is a critical need to synthesize studies examining the prospective relationship between emotional distress and future healthcare use to inform distress management protocols and motivate institutional resource allocation to distress management. The aim of the systematic review is to explore the relationship between emotional distress, measured via validated emotional distress questionnaires, and subsequent healthcare utilization in patients diagnosed with cancer. METHODS: A systematic search of seven databases was conducted on 29 March 2022 and updated 3 August 2023. Eligibility criteria were: (1) peer-reviewed, (2) quantitative or mixed methods, (3) adults (≥18 years) diagnosed with cancer, (4) cancer distress questionnaire(s) completed prior to healthcare utilization, and (5) written in English. Exclusion criteria included: (1) non-emotional aspects of distress (i.e., spiritual or physical distress), (2) healthcare utilization characterized via economic or monetary variables, and (3) caregiver or non-cancer populations. RESULTS: Nineteen peer-reviewed articles were included in the review. There was significant heterogeneity in emotional distress instruments and type of healthcare utilization used. Most studies examining general distress or anxiety found that increased distress was predictive of greater future healthcare utilization. CONCLUSION: The results suggest that individuals with higher levels of general distress and anxiety are at increased risk for future healthcare utilization.

Efficacy and safety of transcranial magnetic stimulation on cognition in mild cognitive impairment, Alzheimer's disease, Alzheimer's disease-related dementias, and other cognitive disorders: a systematic review and meta-analysis.

OBJECTIVE: We aim to analyze the efficacy and safety of TMS on cognition in mild cognitive impairment (MCI), Alzheimer's disease (AD), AD-related dementias, and nondementia conditions with comorbid cognitive impairment. DESIGN: Systematic review, Meta-Analysis. SETTING: We searched MEDLINE, Embase, Cochrane database, APA PsycINFO, Web of Science, and Scopus from January 1, 2000, to February 9, 2023. PARTICIPANTS AND INTERVENTIONS: RCTs, open-label, and case series studies reporting cognitive outcomes following TMS intervention were included. MEASUREMENT: Cognitive and safety outcomes were measured. Cochrane Risk of Bias for RCTs and MINORS (Methodological Index for Non-Randomized Studies) criteria were used to evaluate study quality. This study was registered with PROSPERO (CRD42022326423). RESULTS: The systematic review included 143 studies (n = 5,800 participants) worldwide, encompassing 94 RCTs, 43 open-label prospective, 3 open-label retrospective, and 3 case series. The meta-analysis included 25 RCTs in MCI and AD. Collectively, these studies provide evidence of improved global and specific cognitive measures with TMS across diagnostic groups. Only 2 studies (among 143) reported 4 adverse events of seizures: 3 were deemed TMS unrelated and another resolved with coil repositioning. Meta-analysis showed large effect sizes on global cognition (Mini-Mental State Examination (SMD = 0.80 [0.26, 1.33], p = 0.003), Montreal Cognitive Assessment (SMD = 0.85 [0.26, 1.44], p = 0.005), Alzheimer's Disease Assessment Scale-Cognitive Subscale (SMD = -0.96 [-1.32, -0.60], p < 0.001)) in MCI and AD, although with significant heterogeneity. CONCLUSION: The reviewed studies provide favorable evidence of improved cognition with TMS across all groups with cognitive impairment. TMS was safe and well tolerated with infrequent serious adverse events.

Clinical Characterization, Course, and Treatment of Othello Syndrome: A Case Series and Systematic Review of the Literature.

BACKGROUND: Othello syndrome (OS) is a condition characterized by a delusion of jealousy that one's spouse is having extramarital affairs. As in the eponymous Shakespearean tragedy, there is an unfortunate risk of violence. For patients with these symptoms, consultation-liaison psychiatrists may be asked to assist with evaluating the differential diagnosis, assessing safety, and developing treatment options. OBJECTIVE: This study's objective was to solidify current knowledge of the clinical presentations and management of OS through a systematic review of the literature and description of 2 new cases. METHODS: We conducted a literature search from the start of relevant databases through August 2023 to identify English language case reports of adults (≥18 years) with OS that described clinical evaluations, biological treatments, and outcomes. We extracted demographics, proposed etiologies, treatment choices and responses, duration of delusions, comorbid psychiatric symptoms, neuro-radiographic findings, and presence of physical violence. We reported clinical findings for 2 new cases. RESULTS: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we screened 705 abstracts and conducted full-text reviews of 118 articles to identify 73 cases published from 1983 to 2023 meeting inclusion criteria. The mean age was 58.2 years with male predominance (M:F = 1.88). Etiologies included primary psychiatric disorders (16, 22%), other medical conditions (38, 52%), and medications or other substances (19, 26%). Delusional disorder, cerebrovascular accident, and dopaminergic agonists were the most common etiologies, respectively, in these groups. Antipsychotics were the most common treatment (57, 78%). Symptom remission was reported in 51 (70%) cases. The average duration of OS was 39.5 months. Of 32 cases reporting brain imaging insults, 12 of 20 (60%) showed right-sided lesions, and 8 of 20 (40%) showed left-sided lesions, with 9 of 32 (28%) located in the frontal lobes. The most commonly co-existing psychiatric symptom was depression (14, 19%). Violence was reported in 25 cases (34%). Our 2 new cases were consistent with these findings. CONCLUSIONS: OS may be a manifestation of several neuropsychiatric conditions, primarily delusional disorder, cerebrovascular accident, Alzheimer's dementia, and the use of dopaminergic agonists. One-third of cases include violent behaviors. It appears to respond to antipsychotic medications, but treatment is delayed more than 3 years on average. Available data have not localized OS to a specific brain region.

Traumatic vertebral artery injury: Denver grade, bilaterality, and stroke risk. A systematic review and meta-analysis.

OBJECTIVE: Vertebral artery injury (VAI), a complication of blunt trauma, may cause posterior circulation stroke. An association of disease severity, classified in Denver grades, with stroke risk has not been shown. Using a literature-based analysis, the authors estimated the incidence of VAI following blunt trauma with the aim to investigate the impact of Denver grade and bilateral VAI on stroke occurrence. METHODS: A systematic review of the literature on VAI following blunt trauma was conducted, and data on its incidence, the severity per Denver grade, and stroke occurrence were collected. The incidence of VAI and stroke occurrence were analyzed cumulatively and between Denver grades. A meta-analysis with random-effects models was performed. RESULTS: Fifty-six studies including 2563 patients were identified. The overall incidence of VAI was 0.49% among blunt trauma cases and 14.5% among patients screened via any type of angiography. The incidence rates of bilateral VAI and concurrent carotid injury among all VAIs were 12.3% and 19.2%, respectively. VAI severity by Denver grade was as follows: grade I, 23.4%; grade II, 28.2%; grade III, 5.8%; grade IV, 42.1%; and grade V, 0.5%. The overall stroke risk was 5.32%, differing significantly among lesions of different Denver grades (p = 0.02). Grade III and IV lesions had the highest stroke prevalence (9.8% and 10.9% respectively), while strokes occurred significantly less frequently in patients with grade I and II lesions (1.9% and 3.0%, respectively). Denver grade V cases were too rare for meaningful analysis. Bilateral VAI was associated with a 33.2% stroke prevalence. The association between Denver grade and stroke occurrence persisted in a sensitivity subanalysis including only unilateral cases (p = 0.03). CONCLUSIONS: VAI complicates a small yet nontrivial fraction of blunt trauma cases, with Denver grade IV lesions being the most common. This is the first study to document a significantly higher stroke prevalence among grade III and IV VAIs compared with grade I and II VAIs independently from bilaterality. Bilateral VAIs carry a significantly higher stroke rate.

Venous thromboembolism following surgical management of proximal humerus fractures: a systematic review.

Background: Currently, there is limited information on the incidence of venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE) after surgical treatment of proximal humerus fractures (PHFs). Therefore, the purpose of this systematic review is to evaluate the incidence of VTE, DVT, and PE following surgery for PHFs. Methods: A comprehensive search of several databases was performed from inception to May 27, 2022. Studies were screened and evaluated by 2 reviewers independently utilizing the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. Only original, English studies that evaluated the incidences of VTE following surgical management of PHFs were included. Surgical procedures consisted of shoulder arthroplasty (SA) including both hemiarthroplasty (Hemi) and reverse shoulder arthroplasty (RSA) in addition to open reduction and internal fixation (ORIF). A pooled incidence for postoperative DVT, PE, and overall VTE was reported. Results: Twelve studies met the inclusion and exclusion criteria, encompassing a total of 18,238 patients. The overall DVT, PE, and VTE rates were 0.14%, 0.59%, and 0.7%, respectively. VTE was more frequently reported after SA than ORIF, (1.27% vs. 0.53%, respectively). Among SA patients, a higher rate of DVT was seen with RSA (1.2%) with the lowest DVT rate was observed for ORIF with 0.03%. Conclusions: Symptomatic VTEs following surgical treatment of PHFs, are rare, yet still relevant as a worrisome postoperative complication. Among the various procedures, VTE was the most frequently reported after SA when compared to ORIF, with RSA having the highest VTE rate.

Treatment of pain in length-dependent peripheral neuropathy with the use of spinal cord stimulation: a systematic review.

BACKGROUND: Chronic intractable pain from peripheral neuropathy is a debilitating condition that might not respond to conventional medical management and pharmacotherapy. The primary objective of this systematic review was to assess change (or reduction) in pain intensity in patients with length-dependent peripheral neuropathy after spinal cord stimulation (SCS) therapy. METHODS: This systematic review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. The primary outcome was change (or reduction) in pain intensity after 12 months of SCS therapy compared with baseline in participants with length-dependent peripheral neuropathy. Secondary outcomes included change in pain intensity after 6 months and change in opioid consumption after 12 months. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) guidelines were used to appraise the quality of evidence. RESULTS: Nineteen studies consisting of 376 participants who underwent SCS implantation met the inclusion criteria. Qualitative synthesis revealed that all eligible studies reported a significant improvement in pain intensity after 12 months of SCS therapy as compared with baseline. Mean differences with 95% confidence intervals were calculated for 4 studies, all of which achieved the minimal clinically important difference for change in pain intensity at 12 months. The GRADE quality of evidence for this outcome was appraised as very low quality. CONCLUSION: This systematic review highlights that SCS could lead to significant improvement in pain intensity for length-dependent peripheral neuropathy, although future well-powered randomized controlled trials are warranted to increase the certainty of evidence in this finding. STUDY REGISTRATION: PROSPERO (https://www.crd.york.ac.uk/PROSPERO/) ID: CRD42022377572.

Effectiveness and Safety Profile of Budesonide Maintenance in Microscopic Colitis: A Systematic Review and Meta-Analysis.

BACKGROUND: Microscopic colitis (MC) is a common cause of chronic diarrhea. Randomized controlled trials (RCTs) have demonstrated the efficacy of budesonide treatment for MC. However, relapse is frequent after discontinuation of budesonide, and data on maintenance therapy are limited. We performed a systematic review and meta-analysis evaluating these outcomes in clinical trials and real-world settings. METHODS: A systematic search was performed on October 31, 2022, of Medline, Embase, Cochrane, and Scopus. Case series, case-control, cohort studies, and RCTs of adults with MC were included. Data were pooled using random effects models to calculate weighted pooled estimates and 95% confidence intervals. Heterogeneity was assessed using the I2 statistic. RESULTS: We included 35 studies (11 RCTs, 24 observational studies) with 1657 MC patients treated with budesonide induction and 146 for maintenance. The overall pooled clinical remission rate with budesonide treatment was similar between RCTs and observational studies. The pooled remission rate with budesonide maintenance therapy was 84% (95% CI, 0.60-1.00; I2 = 91%). After budesonide discontinuation, the pooled relapse rate was 53% (95% CI, 0.42-0.63; I2 = 76%). On maintenance therapy, no differences were noted in adverse events (eg, metabolic bone disease, hypertension, hyperglycemia, cataracts/glaucoma) in those on budesonide vs placebo or other noncorticosteroid medications for MC (P = .9). CONCLUSIONS: Budesonide is an effective maintenance treatment for MC. There is a high risk of recurrence after budesonide discontinuation, but long-term use at the lowest effective dose appears to be relatively safe and have limited adverse effects.

Catheter ablation of atrial fibrillation in patients with and without hypertrophic cardiomyopathy: systematic review and meta-analysis.

BACKGROUND: Atrial fibrillation (AF) is common in hypertrophic cardiomyopathy (HCM). There is limited data regarding the outcomes of AF catheter ablation in HCM patients. In this study, we aimed to synthesize all available evidence on the effectiveness of ablation of AF in patients with HCM compared to those without HCM. METHODS AND RESULTS: We systematically reviewed bibliographic databases to identify studies published through February 2023. We included cohort studies with available quantitative information on rates of recurrent atrial arrhythmias, anti-arrhythmic drug (AAD) therapy, and repeat ablation procedures after initial AF ablation in patients with vs without HCM. Estimates were combined using random-effects meta-analysis models and reported as risk ratios (RR) and 95% confidence intervals (CI). Eight studies were included in quantitative synthesis (262 HCM and 642 non-HCM patients). During median follow-up 13-54 months across studies, AF recurrence rates ranged from 13.3% to 92.9% in HCM and 7.6% to 58.8% in non-HCM patients. The pooled RR for recurrent atrial arrhythmia after the first AF ablation in HCM patients compared to non-HCM controls was 1.498 (95% CI = 1.305-1.720; P < 0.001). During follow-up, HCM patients more often required AAD therapy (RR = 2.844; 95% CI = 1.713-4.856; P < 0.001) and repeat AF ablation (RR = 1.544; 95% CI = 1.070-2.228; P = 0.02). The pooled RR for recurrent atrial arrhythmias after the last AF ablation was higher in patients with HCM than those without HCM (RR = 1.607; 95% CI = 1.235-2.090; P < 0.001). CONCLUSIONS: Compared to non-HCM patients, those with HCM had higher rates of recurrent atrial arrhythmias, AAD use, and need for repeat AF ablation after initial ablation of AF.

The utility of PET for detecting corticotropinomas in Cushing disease: a scoping review.

While magnetic resonance imaging (MRI) is the current standard imaging method for diagnosing and localizing corticotropinomas in Cushing disease, it can fail to detect adenomas in up to 40% of cases. Recently, positron emission tomography (PET) has shown promise as a diagnostic tool to detect pituitary adenomas in Cushing disease. We perform a scoping review to characterize the uses of PET in diagnosing Cushing disease, with a focus on describing the types of PET investigated and defining PET-positive disease. A scoping review was conducted following the PRISMA-ScR guidelines. Thirty-one studies fulfilled our inclusion criteria, consisting of 10 prospective studies, 8 retrospective studies, 11 case reports, and 2 illustrative cases with a total of 262 patients identified. The most commonly utilized PET modalities in prospective/retrospective studies were FDG PET (n = 5), MET PET (n = 5), 68 Ga-DOTATATE PET (n = 2), 13N-ammonia PET (n = 2), and 68 Ga-DOTA-CRH PET (n = 2). MRI positivity ranged from 13 to 100%, while PET positivity ranged from 36 to 100%. In MRI-negative disease, PET positivity ranged from 0 to 100%. Five studies reported the sensitivity and specificity of PET, which ranged from 36 to 100% and 50 to 100%, respectively. PET shows promise in detecting corticotropinomas in Cushing disease, including MRI-negative disease. MET PET has been highly investigated and has demonstrated excellent sensitivity and specificity. However, preliminary studies with FET PET and 68 Ga-DOTA-CRH PET show promise for achieving high sensitivity and specificity and warrant further investigation.

Efficacy and Safety of Clonidine in the Treatment of Acute Mania in Bipolar Disorder: A Systematic Review.

Clonidine, an alpha-2 adrenergic agonist, has been proposed as an antimanic agent that acts by reducing noradrenergic transmission. We conducted a systematic review to examine the efficacy and safety of clonidine for acute mania/hypomania. A comprehensive literature search was performed to identify randomized controlled trials (RCT) and non-randomized studies investigating the efficacy and safety of monotherapy/adjuvant treatment with clonidine for acute mania/hypomania in patients with bipolar disorder (BD). Nine studies (n = 222) met our inclusion criteria, including five RCTs (n = 159) and four non-randomized studies (n = 63). Non-randomized studies showed clonidine to help reduce symptoms of mania. However, data from placebo controlled RCTs were inconsistent. One RCT showed adjuvant clonidine as superior to placebo, whereas another RCT reported that clonidine was not better than placebo. In individual RCTs, lithium and valproate offered better antimanic effects compared to clonidine. Studies reported hypotension, depression, and somnolence as common adverse effects. Significant differences in study design and sample size contributed to high heterogeneity. This systematic review suggests low-grade evidence for clonidine as an adjuvant treatment for acute mania with mood stabilizers and inconclusive efficacy as monotherapy, warranting further well-designed RCTs.

Perioperative Management of Vitamin K Antagonists and Direct Oral Anticoagulants: A Systematic Review and Meta-analysis.

BACKGROUND: The management of patients who are receiving chronic oral anticoagulation therapy and require an elective surgery or an invasive procedure is a common clinical scenario. RESEARCH QUESTION: What is the best available evidence to support the development of American College of Chest Physicians guidelines on the perioperative management of patients who are receiving long-term vitamin K agonist (VKA) or direct oral anticoagulant (DOAC) and require elective surgery or procedures? STUDY DESIGN AND METHODS: A literature search including multiple databases from database inception through July 16, 2020, was performed. Meta-analyses were conducted when appropriate. RESULTS: In patients receiving VKA (warfarin) undergoing elective noncardiac surgery, shorter (< 3 days) VKA interruption is associated with an increased risk of major bleeding. In patients who required VKA interruption, heparin bridging (mostly with low-molecular-weight heparin [LMWH]) was associated with a statistically significant increased risk of major bleed, representing a very low certainty of evidence (COE). Compared with DOAC interruption 1 to 4 days before surgery, continuing DOACs may be associated with higher risk of bleeding demonstrated in some, but not all studies. In patients who needed DOAC interruption, bridging with LMWH may be associated with a statistically significant increased risk of bleeding, representing a low COE. INTERPRETATION: The certainty in the evidence supporting the perioperative management of anticoagulants remains limited. No high-quality evidence exists to support the practice of heparin bridging during the interruption of VKA or DOAC therapy for an elective surgery or procedure, or for the practice of interrupting VKA therapy for minor procedures, including cardiac device implantation, or continuation of a DOAC vs short-term interruption of a DOAC in the perioperative period.

Smoking Cessation Interventions in Indigenous North Americans: A Meta-Narrative Systematic Review.

INTRODUCTION: Indigenous North Americans have the highest cigarette smoking prevalence among all racial and ethnic groups in the United States. We seek to identify effective components of smoking cessation interventions in Indigenous people in the United States associated with favorable cessation outcomes. METHODS: A review of literature studying smoking cessation interventions in Indigenous North Americans (American Indians and Alaska Natives) from January 2010 through August 2021 was completed. The primary objective of this study was to identify components of interventions associated with positive smoking cessation outcomes in Indigenous people. The studies identified were synthesized in a meta-narrative approach. RESULTS: Ten studies out of 608 titles were included (6 randomized trials, 2 single-arm studies, 1 cohort study, and 1 prospective observational study). Five categories of smoking cessation interventions were identified; phone or web-based tools, culturally-tailored interventions, the inclusion of Indigenous study personnel, pharmaceutical cessation aids, and behavioral health interventions. Phone and web tools, cultural tailoring, and inclusion of Indigenous personnel conditions inconsistently influenced smoking cessation. Pharmaceutical aids were viewed favorably among participants. Individualized behavioral counseling sessions were effective at promoting smoking cessation, as was input from local communities in the planning and implementation phases of study. CONCLUSION: A successful smoking cessation intervention in Indigenous North Americans includes Tribal or community input in intervention design and implementation; should provide individualized counseling sessions for participants, and offer access to validated smoking cessation tools including pharmacotherapy. IMPLICATIONS: This study identifies a paucity of smoking interventions utilizing standard of care interventions in Indigenous North Americans. Standard of care interventions including individualized cessation counseling and pharmacotherapy were effective at promoting cessation. The use of novel culturally tailored cessation interventions was not more effective than existing evidence-based care with the exception of including Tribal and local community input in intervention implementation. Future smoking cessation interventions in Indigenous North Americans should prioritize the use of standard of care cessation interventions.

Angiotensin Converting Enzyme Inhibitors and Angiotensin Receptor Blockers and Mortality Among COVID-19 Patients: A Systematic Review and Meta-Analysis.

BACKGROUND: Angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) are known to increase the expression of angiotensin converting enzyme 2 receptor, which has been shown to be the receptor for the acute severe respiratory syndrome coronavirus 2 (SARS-CoV-2). AREAS OF UNCERTAINTY: Based on these observations, speculations raised the concerns that ACEIs/ARBs users would be more susceptible to SARS-CoV-2 infection and would be at higher risk for severe COVID-19 disease and death. Therefore, we systematically reviewed the literature and performed a meta-analysis of the association between prior use of ACEIs and ARBs and mortality due to COVID-19 disease. DATA SOURCES: A comprehensive search of several databases from November 2019 to June 18, 2020 was conducted. The databases included Ovid MEDLINE(R) and Epub Ahead of Print, In-Process and Other Non-Indexed Citations and Daily, Ovid Embase, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, Web of Science, and Scopus. Medrxiv.org was also searched for unpublished data. THERAPEUTIC ADVANCES: Nine studies with a total of 18,833 patients infected with SARS-CoV-2 met our eligibility criteria. Prior use of ACEIs and/or ARBs was associated with reduced mortality among SARS-CoV-2-infected patients, with a pooled adjusted relative risk (aRR) from 6 studies of 0.63, 95% confidence interval (CI) (0.42-0.94) (I 2 = 65%). Three studies reported separately on ACEIs or ARBs and their association with survival among SARS-CoV-2-infected patients, with a pooled adjusted relative risk of 0.78, 95% CI (0.58-1.04) (I 2 = 0%) and 0.97, 95% CI (0.73-1.30) (I 2 = 0%) respectively. The results of sensitivity analyses were consistent with the main analysis. CONCLUSION: Our meta-analysis suggests that use of ACEIs/ARBs is associated with a decreased risk of death among SARS-CoV-2-infected patients. This finding provides a reassurance to the public not to stop prescribed ACEIs/ARBs because of fear of severe COVID-19.

Measurement Properties of Outcome Instruments for Large-Vessel Vasculitis: A Systematic Literature Review.

OBJECTIVE: To systematically review the measurement properties of outcome instruments used in large-vessel vasculitis (LVV). METHODS: MEDLINE, Embase, Cochrane, and Scopus databases were searched for studies published from inception to July 14, 2020, that addressed measurement properties of instruments used in giant cell arteritis (GCA) and Takayasu arteritis (TA). The measurement properties of the instruments identified were collected following the Outcome Measures in Rheumatology (OMERACT) and Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) frameworks. Instruments were grouped according to the following domains measured: disease activity/damage, organ function, and health-related quality of life (HRQOL)/health status. RESULTS: From 3534 articles identified, 13 met the predefined criteria. These studies addressed 12 instruments: 4 specific to TA, 2 designed for all types of systemic vasculitis, and 6 non-disease-specific instruments. No instruments specific to GCA were identified. Regarding TA, the Indian Takayasu Clinical Activity Score (ITAS) showed very good consistency, adequate reliability, but doubtful validity for disease activity. The Disease Extent Index-Takayasu (DEI-Tak) showed adequate construct validity but doubtful discriminating validity for disease activity/damage. Instruments, including the Vasculitis Damage Index and the Birmingham Vasculitis Activity Score, were poorly assessed for disease activity/damage. In total, 6 non-vasculitis-specific patient-reported outcome (PRO) instruments showed inadequate validity in GCA/TA. CONCLUSION: The measurement properties of 12 outcome instruments for LVV covering the OMERACT domains of disease activity/damage, organ function, and HRQOL were assessed. The ITAS and the DEI-Tak were the instruments with the most adequate measurement properties for disease activity/damage in TA. Disease activity/damage instruments specific to GCA, as well as validated PROs for both GCA and TA, are lacking.

Efficacy and safety of lamotrigine in pediatric mood disorders: A systematic review.

AIM: To appraise the current evidence on the efficacy and safety of lamotrigine (LAM) in the treatment of pediatric mood disorders (PMD) (i.e., Major Depressive disorder [MDD], bipolar disorder [BD]). METHODS: Major databases were searched for randomized controlled trials (RCTs), open-label trials, and observational studies reporting on pediatric (age < 18 years) patients treated with LAM for mood disorders. RESULTS: A total of 3061 abstracts were screened and seven articles were selected for inclusion. Seven studies (319 BD and 43 MDD patients), including one RCT (n = 173), three prospective (n = 105), and three retrospective (n = 84) studies, met the study criteria with a study duration range from 8 to 60.9 weeks. The mean age of this pooled data is 14.6 ± 2.0 years. LAM daily dosage varied from 12.5 to 391.3 mg/day among the studies. In an important finding, the RCT reported favorable outcomes with LAM (HR = 0.46; p = 0.02) in 13- to 17-year-old age group as compared with 10- to 12-year-old age group (HR = 0.93; p = 0.88). In addition, time to occurrence of a bipolar event trended toward favoring LAM over placebo. All the studies identified LAM as an effective and safe drug in PMDs especially, BDs. Overall, LAM was well tolerated with no major significant side effects and no cases of Stevens-Johnson syndrome. CONCLUSIONS: Most studies suggested that LAM was safe and effective in pediatric patients with mood disorders. However, the data regarding the therapeutic range for LAM are lacking. Based on the data, there is inconsistent evidence to make conclusive recommendations on therapeutic LAM dosage for mood improvement in the pediatric population. Further studies including larger sample sizes are required to address this relevant clinical question.

Video-based observation research: A systematic review of studies in outpatient health care settings.

OBJECTIVE: To examine the use of video-based observation research in outpatient health care encounter research. METHODS: We conducted a systematic search of MEDLINE, Scopus, Cochrane and other databases from database inception to October 2020 for reports of studies that used video recording to investigate ambulatory patient-clinician interactions. Two authors independently reviewed all studies for eligibility and extracted information related to study setting and purpose, participant recruitment and consent processes, data collection procedures, method of analysis, and participant sample characteristics. RESULTS: 175 articles were included. Most studies (65%) took place in a primary care or family practice setting. Study objectives were overwhelmingly focused on patient-clinician communication (81%). Reporting of key study elements was inconsistent across included studies. CONCLUSION: Video recording has been used as a research method in outpatient health care in a limited number and scope of clinical contexts and research domains. In addition, reporting of study design, methodological characteristics, and ethical considerations needs improvement. PRACTICE IMPLICATIONS: Video recording as a method has been relatively underutilized within many clinical and research contexts. This review will serve as a practical resource for health care researchers as they plan and execute future video-based studies.

Early switch to oral antibiotic therapy for the treatment of patients with bacterial native vertebral osteomyelitis: a quaternary center experience, systematic review, and meta-analysis.

Recent data suggest that oral therapy can be effective for bone infections. We aim to assess the efficacy of an early switch to oral therapy ( < 2  weeks) compared to a non-early switch in bacterial native vertebral osteomyelitis. We conducted a cohort study at Mayo Clinic, Rochester (MN), between 2019-2021 combined with a systematic review, which queried multiple databases. Data were analyzed using a random-effects model. The cohort study included 139 patients: two received an early switch. Of 3708 citations, 13 studies were included in the final analysis. Meta-analysis demonstrated no difference in treatment failure (odds ratio  =  1.073, 95 % confidence interval 0.370-3.116), but many studies presented high risk of bias. Current evidence is insufficient to conclude the proportion of patients with failure or relapse is different in the two groups. High-quality studies are warranted before early switch can be routinely recommended.