A Systematic Review of Pediatric and Adult In-Flight Medical Emergencies

In-flight medical emergencies (IMEs) are acute onboard events of illnesses or injuries with potential immediate risk to a passenger’s short- or long-term health, or life. IMEs are significant events that are related to public safety concerns. With the increasing amount of annual air travel every year, it is expected that the number of encountered IMEs will continue to grow. Thus, it will be critical to develop and implement appropriate measures to manage IMEs with the best possible outcome. Despite the fact that most IMEs are self-limited with no serious adverse events, serious IME can lead to death, disability, or other unfavorable health outcomes, particularly as a result of suboptimal medical care. In this article, we systematically reviewed the published up-to-date evidence on the subject of in-flight emergencies with a specific focus on pediatric population.

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Long-term and serious harms of medical cannabis and cannabinoids for chronic pain: A systematic review of non-randomized studies

10.1101/2021.05.27.21257921 ◽

2021 ◽

Author(s):

Dena Zeraatkar ◽

Matthew Cooper ◽

Arnav Agarwal ◽

Robin Vernooij ◽

Gareth Leung ◽

...

Keyword(s):

Systematic Review ◽

Chronic Pain ◽

Adverse Events ◽

Cochrane Central Register ◽

Medical Cannabis ◽

Management Options ◽

Serious Adverse Events ◽

Randomized Studies

Objective: To establish the risk and prevalence of long-term and serious harms of medical cannabis and cannabinoids for chronic pain. Design: Systematic review and meta-analysis. Data sources: MEDLINE, EMBASE, PsycInfo, and the Cochrane Central Register of Controlled Trials (CENTRAL) from inception to April 1, 2020. Study selection: Non-randomized studies reporting on harms of medical cannabis or cannabinoids in people living with chronic pain with ≥4 weeks of follow-up. Data extraction and synthesis: A parallel guideline panel provided input on the design and interpretation of the systematic review, including selection of adverse events for consideration. Two reviewers, working independently and in duplicate, screened the search results, extracted data, and assessed risk of bias. We used random-effects models for all meta-analyses and the GRADE approach to evaluate the certainty of evidence. Results: We identified 39 eligible studies that enrolled 12,143 patients with chronic pain. Very low certainty evidence suggests that adverse events are common (prevalence: 26.0%; 95% CI 13.2 to 41.2) among users of medical cannabis or cannabinoids for chronic pain, particularly any psychiatric adverse events (prevalence: 13.5%; 95% CI 2.6 to 30.6). However, very low certainty evidence indicates serious adverse events, adverse events leading to discontinuation, cognitive adverse events, accidents and injuries, and dependence and withdrawal syndrome are uncommon and typically occur in fewer than one in 20 patients. We compared studies with <24 weeks and ≥ 24 weeks cannabis use and found more adverse events reported among studies with longer follow-up (test of interaction p < 0.01). Palmitoylethanolamide was usually associated with few to no adverse events. We found insufficient evidence addressing the harms of medical cannabis compared to other pain management options, such as opioids. Conclusions: There is very low certainty evidence that adverse events are common among people living with chronic pain who use medical cannabis or cannabinoids, but that few patients experience serious adverse events. Future research should compare long-term and serious harms of medical cannabis with other management options for chronic pain, including opioids.

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Letter to the editor re: ‘serious adverse events and deaths in PCSK9 inhibitor trials reported on ClinicalTrials.gov: a systematic review’

Expert Review of Clinical Pharmacology ◽

10.1080/17512433.2021.1874346 ◽

2021 ◽

pp. 1-2 ◽

Cited By ~ 1

Author(s):

Marc S. Sabatine ◽

Robert P. Giugliano ◽

Gregory G. Schwartz,

Keyword(s):

Systematic Review ◽

Adverse Events ◽

Serious Adverse Events ◽

Pcsk9 Inhibitor ◽

Letter To The Editor

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Beneficial and harmful effects of antidepressants versus placebo, ‘active placebo’, or no intervention for adults with major depressive disorder: a protocol for a systematic review of published and unpublished data with meta-analyses and trial sequential analyses

Systematic Reviews ◽

10.1186/s13643-021-01705-6 ◽

2021 ◽

Vol 10 (1) ◽

Author(s):

Sophie Juul ◽

Faiza Siddiqui ◽

Marija Barbateskovic ◽

Caroline Kamp Jørgensen ◽

Michael Pascal Hengartner ◽

...

Keyword(s):

Systematic Review ◽

Major Depressive Disorder ◽

Depressive Symptoms ◽

Adverse Events ◽

Depressive Disorder ◽

Meta Analysis ◽

Risk Of Bias ◽

Major Depressive ◽

Serious Adverse Events ◽

Harmful Effects

Abstract Background Major depressive disorder is one of the most common, burdensome, and costly psychiatric disorders worldwide. Antidepressants are frequently used to treat major depressive disorder. It has been shown repeatedly that antidepressants seem to reduce depressive symptoms with a statistically significant effect, but the clinical importance of the effect sizes seems questionable. Both beneficial and harmful effects of antidepressants have not previously been sufficiently assessed. The main objective of this review will be to evaluate the beneficial and harmful effects of antidepressants versus placebo, ‘active placebo’, or no intervention for adults with major depressive disorder. Methods/design A systematic review with meta-analysis will be reported as recommended by Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA), bias will be assessed with the Cochrane Risk of Bias tool-version 2 (ROB2), our eight-step procedure will be used to assess if the thresholds for clinical significance are crossed, Trial Sequential Analysis will be conducted to control for random errors, and the certainty of the evidence will be assessed with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. To identify relevant trials, we will search both for published and unpublished trials in major medical databases from their inception to the present. Clinical study reports will be obtained from regulatory authorities and pharmaceutical companies. Two review authors will independently screen the results of the literature searches, extract data, and perform risk of bias assessment. We will include any published or unpublished randomised clinical trial comparing one or more antidepressants with placebo, ‘active placebo’, or no intervention for adults with major depressive disorder. The following active agents will be included: agomelatine, amineptine, amitriptyline, bupropion, butriptyline, cianopramine, citalopram, clomipramine, dapoxetine, demexiptiline, desipramine, desvenlafaxine, dibenzepin, dosulepin, dothiepin, doxepin, duloxetine, escitalopram, fluoxetine, fluvoxamine, imipramine, iprindole, levomilnacipran, lofepramine, maprotiline, melitracen, metapramine, milnacipran, mirtazapine, nefazodone, nortriptyline, noxiptiline, opipramol, paroxetine, protriptyline, quinupramine, reboxetine, sertraline, trazodone, tianeptine, trimipramine, venlafaxine, vilazodone, and vortioxetine. Primary outcomes will be depressive symptoms, serious adverse events, and quality of life. Secondary outcomes will be suicide or suicide attempt, suicidal ideation, and non-serious adverse events. Discussion As antidepressants are commonly used to treat major depressive disorder in adults, a systematic review evaluating their beneficial and harmful effects is urgently needed. This review will inform best practice in treatment and clinical research of this highly prevalent and burdensome disorder. Systematic review registration PROSPERO CRD42020220279

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The Effect of Intimate Partner Violence on the Physical Health and Health-Related Behaviors of Women: A Systematic Review of the Literature

Trauma Violence & Abuse ◽

10.1177/1524838020985541 ◽

2021 ◽

pp. 152483802098554

Author(s):

Anita Stubbs ◽

Cassandra Szoeke

Keyword(s):

Systematic Review ◽

Intimate Partner Violence ◽

Health Outcomes ◽

Physical Health ◽

Partner Violence ◽

Intimate Partner ◽

Physical Health Outcomes ◽

Health Related Behaviors ◽

Health Related

Aim: The long-term effects of intimate partner violence (IPV) on physical health outcomes and health-related behaviors are underresearched in comparison to the effects on mental health and pregnancy. This systematic review examines the recent research in this area from 2012 through 2019. Methods: SCOPUS, PubMed, EBSCOhost, and gray literature were searched using the key words “intimate partner violence” and “health.” To meet inclusion criteria, studies needed to be original research and focus on IPV during adulthood and its effects on the physical health or health-related behaviors of women. Fifty-two studies were qualitatively analyzed, with results grouped into broad categories of effects, including cardiovascular, endocrine, infectious diseases, and health screening. Results: IPV was shown to have negative effects on physical health outcomes for women, including worsening the symptoms of menopause and increasing the risk of developing diabetes, contracting sexually transmitted infections, engaging in risk-taking behaviors including the abuse of drugs and alcohol, and developing chronic diseases and pain. It also has significant effects on human immunodeficiency virus outcomes, worsening CD4+ cell depletion. Results varied regarding the effects of IPV on cardiovascular health outcomes. Conclusion: The result of this review demonstrates that women who have experienced violence and abuse are at significantly increased risk of poor health outcomes in a variety of areas and so require specialized and tailored primary care. This review highlights significant gaps in this field of research, particularly in relation to cardiovascular disease, endocrine dysfunction, and neurological symptoms and conditions. It demonstrates a need for additional long-term studies in this field to better inform the health care of women who have experienced IPV and to establish the physiological mediators of these outcomes.

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EP.WE.14Prognostic significance of metabolic syndrome in patients undergoing carotid artery revascularisation: A systematic review and meta-analysis

British Journal of Surgery ◽

10.1093/bjs/znab308.001 ◽

2021 ◽

Vol 108 (Supplement_7) ◽

Author(s):

Shahab Hajibandeh ◽

Shahin Hajibandeh

Keyword(s):

Myocardial Infarction ◽

Systematic Review ◽

Adverse Events ◽

Meta Analysis ◽

Prognostic Significance ◽

Long Term Outcomes ◽

Short Term ◽

All Cause Mortality ◽

Major Adverse Events

Abstract Aims to evaluate prognostic significance of metabolic syndrome (MetS) in patients undergoing carotid artery revascularisation. Methods A systematic review and meta-analysis was performed in compliance with PRISMA standards to evaluate prognostic significance of MetS in patients undergoing carotid endarterectomy or carotid stenting. Short-term (<30 days) postoperative outcomes (all-cause mortality, stroke or transient ischaemic attack (TIA), myocardial infarction, major adverse events) and long-term outcomes (restenosis, all-cause mortality, stroke or TIA, myocardial infarction, major adverse events) were considered as outcomes of interest. Random effects modelling was applied for the analyses. Results Analysis of 3721 patients from five cohort studies showed no difference between the MetS and no MetS groups in terms of the following short-term outcomes: all-cause mortality (OR: 1.67,P=0.32), stroke or TIA (OR: 2.44,P=0.06), myocardial infarction (OR: 1.01,P=0.96), major adverse events (OR: 1.23, P = 0.66). In terms of long-term outcomes, MetS was associated with higher risk of restenosis (OR: 1.75,P=0.02), myocardial infarction (OR: 2.12,P=0.04), and major adverse events (OR: 1.30, P = 0.009) but there was no difference between the two groups in terms of all-cause mortality (OR: 1.11, P = 0.25), and stroke or TIA (OR: 1.24, P = 0.33). The quality and certainty of the available evidence were judged to be moderate. Conclusions The best available evidence suggest that although MetS may not affect the short-term postoperative morbidity and mortality outcomes in patients undergoing carotid revascularisation, it may result in higher risks of restenosis, myocardial infarction and major adverse events in the long-term. Evidence from large prospective cohort studies are required for more robust conclusions.

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Reducing the Toxicity of Long-Term Glucocorticoid Treatment in Large Vessel Vasculitis

Current Rheumatology Reports ◽

10.1007/s11926-020-00961-0 ◽

2020 ◽

Vol 22 (12) ◽

Author(s):

Andriko Palmowski ◽

Frank Buttgereit

Keyword(s):

Adverse Events ◽

Takayasu Arteritis ◽

Term Treatment ◽

Large Vessel Vasculitis ◽

Large Vessel ◽

Serious Adverse Events ◽

Glucocorticoid Treatment ◽

Long Term Treatment ◽

Higher Doses

Abstract Purpose While glucocorticoids (GCs) are effective in large vessel vasculitis (LVV), they may cause serious adverse events (AEs), especially if taken for longer durations and at higher doses. Unfortunately, patients suffering from LVV often need long-term treatment with GCs; therefore, toxicity needs to be expected and countered. Recent Findings GCs remain the mainstay of therapy for both giant cell arteritis and Takayasu arteritis. In order to minimize their toxicity, the following strategies should be considered: GC tapering, administration of conventional synthetic (e.g., methotrexate) or biologic (e.g., tocilizumab) GC-sparing agents, as well as monitoring, prophylaxis, and treatment of GC-related AEs. Several drugs are currently under investigation to expand the armamentarium for the treatment of LVV. Summary GC treatment in LVV is effective but associated with toxicity. Strategies to minimize this toxicity should be applied when treating patients suffering from LVV.

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A156 LOW COMPLICATION RATE IN THE OUTPATIENT INTRAJEJUNAL LEVODOPA/CARBIDOPA INTESTINAL GEL CLINICAL PROGRAM

Journal of the Canadian Association of Gastroenterology ◽

10.1093/jcag/gwz047.155 ◽

2020 ◽

Vol 3 (Supplement_1) ◽

pp. 20-21

Author(s):

N Al Yatama ◽

C H Parker ◽

Y Tse ◽

T Naranian ◽

A Fasano ◽

...

Keyword(s):

Data Collection ◽

Adverse Events ◽

Hospital Admissions ◽

Retrospective Chart Review ◽

Current Method ◽

Final Analysis ◽

Outpatient Setting ◽

Fistula Formation ◽

Serious Adverse Events

Abstract Background Levodopa/carbidopa intestinal gel (LCIG) is a formulation that is delivered continuously through a percutaneous endoscopy gastro-jejunal tube (PEG-J) for the treatment of patients with advanced Parkinson’s disease (PD). LCIG significantly reduces periods of increased motor symptoms without troublesome dyskinesia. Adverse events related to this treatment have been attributed to PEG-J insertion and the device used for LCIG delivery, rather than to the LCIG preparation itself. To date, the data evaluating long-term efficacy and safety of PEG-J insertion for LCIG administration in the outpatient setting is limited. Aims The aim of this study is to describe short and long-term adverse events (AEs) associated with outpatient PEG-J tube insertion for LCIG administration at our centre. Methods A retrospective chart review was performed of all PD patients who underwent PEG-J insertion for LCIG therapy at Toronto Western Hospital from March 2011 to October 2019. All AEs associated with PEG-J insertion were collected including procedure and tube related complications, hospital admissions, emergency room (ER) visits and deaths. Data was analyzed using descriptive statistics. Results A total of 58 patients were identified and included in the final analysis. 37 (64%) male, with a mean age of 74 years +/-6.17. The mean duration of PD diagnosis prior to PEG-J insertion was 16.5 years +/-2.0. Mean time from PEG-J insertion to data collection was 37.5 months +/- 19.3. 30 (51%) patients had post-procedural abdominal pain or site pain. This pain improved with over the counter analgesics. 9 (16%) had possible site infection; 6 received oral antibiotics and 3 had the tube replaced. 19 (33%) developed granulation tissue, with only 2 patients requiring tube exchange. 32 (55%) had their tube removed or exchanged secondary to PEG-J malfunction. No ER visits related to the PEG-J were recorded. During the data collection period, 12 (21%) patients died for reasons unrelated to PEG-J insertion. There were no reported serious adverse events (SAEs), including post-procedure perforation, bleeding, fistula formation, development of intra-abdominal collections or buried bumper syndrome. Conclusions This study demonstrates the absence of serious AEs associated with outpatient PEG-J insertion for LCIG administration in patients with advanced PD. The most common short-term AE was post-procedural pain. The most common long-term AE was related to PEG-J malfunction requiring replacement. This study supports that the current method of outpatient PEG-J insertion for the administration of LCIG is safe in patients with advanced PD. Funding Agencies None

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Cessation of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation

Heart ◽

10.1136/heartjnl-2020-317418 ◽

2020 ◽

pp. heartjnl-2020-317418

Author(s):

Melissa E Middeldorp ◽

Aashray Gupta ◽

Adrian Elliott ◽

Kadhim Kadhim ◽

Anand Thiyagarajah ◽

...

Keyword(s):

Atrial Fibrillation ◽

Adverse Events ◽

Vitamin K ◽

Oral Anticoagulants ◽

Female Gender ◽

Vitamin K Antagonist ◽

Serious Adverse Events ◽

Care Clinic ◽

Multivariable Analyses

ObjectiveTo characterise the rate, causes and predictors of cessation of non-vitamin K antagonist oral anticoagulants (NOACs) in patients with atrial fibrillation (AF).Patients and methodsConsecutive patients with AF with a long-term anticoagulation indication treated with NOACs (dabigatran, apixaban and rivaroxaban) in our centre from September 2010 through December 2016 were included. Prospectively collected data with baseline characteristics, causes of cessation, mean duration-to-cessation and predictors of cessation were analysed.ResultsThe study comprised 1415 consecutive patients with AF, of whom 439 had a CHA2DS2-VASc≥1 and were on a NOAC. Mean age was 71.9±8.7 years and 37% were females. Over a median follow-up of 3.6 years (IQR=2.7–5.3), 147 (33.5%) patients ceased their index-NOAC (113 switched to a different form of OAC), at a rate of 8.8 per 100 patient-years. Serious adverse events warranting NOAC cessation occurred in 28 patients (6.4%) at a rate of 1.6 events per 100 patient-years. The mean duration-to-cessation was 4.9 years (95% CI 4.6 to 5.1) and apixaban had the longest duration-to-cessation with (5.1, 95% CI 4.8 to 5.4) years, compared with dabigatran (4.6, 95% CI 4.2 to 4.9) and rivaroxaban (4.5, 95% CI 3.9 to 5.1), pairwise log-rank p=0.002 and 0.025, respectively. In multivariable analyses, age was an independent predictor of index-NOAC cessation (HR 1.03, 95% CI 1.01 to 1.05; p=0.006). Female gender (HR 2.2, 95% CI 1.04 to 4.64; p=0.04) independently predicted serious adverse events.ConclusionIn this ‘real world’ cohort, NOAC use is safe and well-tolerated when prescribed in an integrated care clinic. Whether apixaban is better tolerated compared with other NOACs warrants further study.

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Adverse events of exercise therapy in randomised controlled trials: a systematic review and meta-analysis

British Journal of Sports Medicine ◽

10.1136/bjsports-2018-100461 ◽

2019 ◽

Vol 54 (18) ◽

pp. 1073-1080 ◽

Cited By ~ 4

Author(s):

Andre Niemeijer ◽

Hans Lund ◽

Signe Nilssen Stafne ◽

Thomas Ipsen ◽

Cathrine Luhaäär Goldschmidt ◽

...

Keyword(s):

Systematic Review ◽

Relative Risk ◽

Adverse Events ◽

Exercise Therapy ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Control Group ◽

Controlled Trials ◽

Serious Adverse Events ◽

Randomised Controlled

ObjectiveTo evaluate the relative risk (RR) of serious and non-serious adverse events in patients treated with exercise therapy compared with those in a non-exercising control group.DesignSystematic review and meta-analysis.Data sourcesPrimary studies were identified based on The Cochrane Database of Systematic Reviews investigating the effect of exercise therapy.Eligibility criteriaAt least two of the authors independently evaluated all identified reviews and primary studies. Randomised controlled trials were included if they compared any exercise therapy intervention with a non-exercising control. Two authors independently extracted data. The RR of serious and non-serious adverse events was estimated separately.Results180 Cochrane reviews were included and from these, 773 primary studies were identified. Of these, 378 studies (n=38 368 participants) reported serious adverse events and 375 studies (n=38 517 participants) reported non-serious adverse events. We found no increase in risk of serious adverse events (RR=0.96 (95%CI 0.90 to 1.02, I2: 0.0%) due to exercise therapy. There was, however, an increase in non-serious adverse events (RR=1.19 (95%CI 1.09 to 1.30, I2: 0.0%). The number needed to treat for an additional harmful outcome for non-serious adverse events was 6 [95%CI 4 to 11).ConclusionParticipating in an exercise intervention increased the relative risk of non-serious adverse events, but not of serious adverse events. Exercise therapy may therefore be recommended as a relatively safe intervention.PROSPERO registration numberCRD42014014819.

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