scholarly journals Side effects of acetazolamide: a systematic review and meta-analysis assessing overall risk and dose dependence

2020 ◽  
Vol 7 (1) ◽  
pp. e000557 ◽  
Author(s):  
Christopher N Schmickl ◽  
Robert L Owens ◽  
Jeremy E Orr ◽  
Bradley A Edwards ◽  
Atul Malhotra
Keyword(s):  
Side Effects ◽  
Clinical Decision Making ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Clinical Decision ◽  
Dose Dependence ◽  
Total Daily Dose ◽  
Effect Estimate ◽  
Moderate Quality ◽  
Meta Analyses

IntroductionAcetazolamide (AZM) is used for various conditions (eg, altitude sickness, sleep apnoea, glaucoma), but therapy is often limited by its side effect profile. Our objective was to estimate the risk of commonly reported side effects based on meta-analyses. We hypothesised that these risks are dose-dependent.MethodsWe queried MEDLINE/EMBASE (Medical Literature Analysis and Retrieval System Online/Excerpta Medica dataBASE) up until 04/10/2019, including any randomised placebo-controlled trial in which adults received oral AZM versus placebo reporting side effects. Eligibility assessment was performed by two independent reviewers. Data were abstracted by one reviewer who verified key entries at a second time point. For side effects reported by >3 studies a pooled effect estimate was calculated, and heterogeneity assessed via I2; for outcomes reported by >5 studies effect modification by total daily dose (EMbyTDD; <400 mg/d, 400–600 mg/d, >600 mg/d) was assessed via meta-regression. For pre-specified, primary outcomes (paraesthesias, taste disturbances, polyuria and fatigue) additional subgroup analyses were performed using demographics, intervention details, laboratory changes and risk of bias.ResultsWe included 42 studies in the meta-analyses (Nsubjects=1274/1211 in AZM/placebo groups). AZM increased the risk of all primary outcomes (p<0.01, I2 ≤16% and low-to-moderate quality of evidence for all)—the numbers needed to harm (95% CI; nStudies) for each were: paraesthesias 2.3 (95% CI 2 to 2.7; n=39), dysgeusia 18 (95% CI 10 to 38, n=22), polyuria 17 (95% CI 9 to 49; n=22), fatigue 11 (95% CI 6 to 24; n=14). The risk for paraesthesias (beta=1.8 (95% CI 1.1 to 2.9); PEMbyTDD=0.01) and dysgeusia (beta=3.1 (95% CI 1.2 to 8.2); PEMbyTDD=0.02) increased with higher AZM doses; the risk of fatigue also increased with higher dose but non-significantly (beta=2.6 (95% CI 0.7 to 9.4); PEMbyTDD=0.14).DiscussionThis comprehensive meta-analysis of low-to-moderate quality evidence defines risk of common AZM side effects and corroborates dose dependence of some side effects. These results may inform clinical decision making and support efforts to establish the lowest effective dose of AZM for various conditions.

Systematic reviews and meta-analysis of prognosis research studies

2019 ◽  
pp. 208-244
Author(s):  
Richard D Riley ◽  
Karel GM Moons ◽  
Thomas PA Debray ◽  
Douglas G Altman ◽  
Gary S Collins
Keyword(s):  
Prognostic Factor ◽  
Systematic Reviews ◽  
Clinical Decision Making ◽  
Meta Analysis ◽  
Clinical Decision ◽  
Relevant Information ◽  
Included Study ◽  
Prognosis Research ◽  
Meta Analyses ◽  
Research Studies

Systematic reviews and meta-analyses identify, evaluate, and summarize prognosis research studies and their findings. The chapter provides a guide to the key components and methods for conducting a systematic review and meta-analysis for each of the four types of prognosis studies. The CHARMS checklist is introduced as a guide to identifying clear review objectives and design, and to extracting the relevant information from each included study. Many existing prognosis studies are at high risk of bias, because (for example) of selective recruitment and reporting. Tools for examining quality of studies are discussed—the QUIPS for prognostic factor research and PROBAST for prognostic model research. The statistical principles of meta-analysis are described, and the key statistics that can be synthesized are outlined. Challenges are identified, such as the potential for publication bias and substantial heterogeneity in published prognostic factor cut points and methods of prognostic factor measurement. Despite these challenges the chapter emphasizes the crucial importance of prognosis reviews for evidence-based guidelines and clinical decision making.

scholarly journals Meta-analyses in paediatric surgery are often fragile: implications and consequences

2021 ◽  
Vol 37 (3) ◽  
pp. 363-367
Author(s):  
Arne Schröder ◽  
Oliver J. Muensterer ◽  
Christina Oetzmann von Sochaczewski
Keyword(s):  
Clinical Decision Making ◽  
Meta Analysis ◽  
Statistical Significance ◽  
Clinical Decision ◽  
Paediatric Surgery ◽  
Fragility Index ◽  
Level Of Evidence ◽  
Randomised Controlled ◽  
Meta Analyses ◽  
Surgical Condition

Abstract Purpose Meta-analyses occupy the highest level of evidence and thereby guide clinical decision-making. Recently, randomised-controlled trials were evaluated for the robustness of their findings by calculating the fragility index. The fragility index is the number of events that needs to be added to one treatment arm until the statistical significance collapses. We, therefore, aimed to evaluate the robustness of paediatric surgical meta-analyses. Methods We searched MEDLINE for paediatric surgical meta-analyses in the last decade. All meta-analyses on a paediatric surgical condition were eligible for analysis if they based their conclusion on a statistically significant meta-analysis. Results We screened 303 records and conducted a full-text evaluation of 60 manuscripts. Of them, 39 were included in our analysis that conducted 79 individual meta-analyses with significant results. Median fragility index was 5 (Q25–Q75% 2–11). Median fragility in relation to included patients was 0.77% (Q25–Q75% 0.29–1.87%). Conclusion Paediatric surgical meta-analyses are often fragile. In almost 60% of results, the statistical significance depends on less than 1% of the included population. However, as the fragility index is just a transformation of the P value, it basically conveys the same information in a different format. It therefore should be avoided.

scholarly journals Critical appraisal and meta-analysis of biological variation estimates for kidney related analytes

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Niels Jonker ◽  
Berna Aslan ◽  
Beatriz Boned ◽  
Fernando Marqués-García ◽  
Carmen Ricós ◽  
...  
Keyword(s):  
Critical Appraisal ◽  
Clinical Decision Making ◽  
Meta Analysis ◽  
Clinical Decision ◽  
Biological Variation ◽  
Plasma Albumin ◽  
Literature Searches ◽  
Global Estimates ◽  
Correct Application ◽  
Meta Analyses

AbstractObjectiveKidney markers are some of the most frequently used laboratory tests in patient care, and correct clinical decision making depends upon knowledge and correct application of biological variation (BV) data. The aim of this study was to review available BV data and to provide updated BV estimates for the following kidney markers in serum and plasma; albumin, creatinine, cystatin C, chloride, potassium, sodium and urea.ContentRelevant studies were identified from a historical BV database as well as by systematic literature searches. Retrieved publications were appraised by the Biological Variation Data Critical Appraisal Checklist (BIVAC). Meta-analyses of BIVAC compliant studies with similar design were performed to deliver global estimates of within-subject (CVI) and between-subject (CVG) BV estimates. Out of the 61 identified papers, three received a BIVAC grade A, four grade B, 48 grade C, five grade D grade and one was not appraised as it did not report numerical BV estimates. Most studies were identified for creatinine (n=48). BV estimates derived from the meta-analysis were in general lower than previously reported estimates for all analytes except urea. For some measurands, BV estimates may be influenced by age or states of health, but further data are required.SummaryThis review provides updated global BV estimates for kidney related measurands. For all measurands except for urea, these estimates were lower than previously reported.OutlookFor the measurands analyzed in this review, there are sufficient well-designed studies available to publish a trustworthy estimate of BV. However, for a number of newly appearing kidney markers no suitable data is available and additional studies are required.

scholarly journals PALM: Patient-centered Treatment Ranking via Large-scale Multivariate Network Meta-analysis

2020 ◽  
Author(s):  
Rui Duan ◽  
Jiayi Tong ◽  
Lifeng Lin ◽  
Lisa D Levine ◽  
Mary D Sammel ◽  
...  
Keyword(s):  
Large Scale ◽  
Clinical Decision Making ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Treatment Options ◽  
Clinical Decision ◽  
Multiple Outcomes ◽  
Patient Centered ◽  
Joint Inference ◽  
Treatment Comparisons

AbstractThe growing number of available treatment options have led to urgent needs for reliable answers when choosing the best course of treatment for a patient. As it is often infeasible to compare a large number of treatments in a single randomized controlled trial, multivariate network meta-analyses (NMAs) are used to synthesize evidence from existing trials of a subset of the available treatments, where outcomes related to both efficacy and safety are considered simultaneously. However, these large-scale multiple-outcome NMAs have created challenges to existing methods due to the increasingly complexity of the unknown correlation structures between different outcomes and treatment comparisons. In this paper, we proposed a new framework for PAtient-centered treatment ranking via Large-scale Multivariate network meta-analysis, termed as PALM, which includes a parsimonious modeling approach, a fast algorithm for parameter estimation and inference, a novel visualization tool for comparing treatments with multivariate outcomes termed as the star plot, as well as personalized treatment ranking procedures taking into account the individual’s considerations on multiple outcomes. In application to an NMA that compares 14 treatment options for labor induction over five modalities, we provided a comprehensive illustration of the proposed framework and demonstrated its computational efficiency and practicality. Our analysis leads to new insights on comparing these 14 treatment options based on joint inference of multiple outcomes that cannot be obtained from univariate NMAs, and novel visualizations of evidence to support patient-centered clinical decision making.

Risks of Cardiovascular Disease and Beyond in Prescription of Nonsteroidal Anti-Inflammatory Drugs

2019 ◽  
Vol 25 (1) ◽  
pp. 3-6 ◽  
Author(s):  
Manas A. Rane ◽  
Alexander Gitin ◽  
Benjamin Fiedler ◽  
Lawrence Fiedler ◽  
Charles H. Hennekens
Keyword(s):  
Cardiovascular Disease ◽  
Side Effects ◽  
Health Care Providers ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Care Providers ◽  
Relieve Pain ◽  
Gastrointestinal Side Effects ◽  
Inflammatory Drugs ◽  
Anti Inflammatory

Introduction: Nonsteroidal anti-inflammatory drugs (NSAIDs) include aspirin, naproxen, diclofenac, and ibuprofen, as well as selective cyclooxygenase 2 inhibitors such as celecoxib. Their use is common, as well as their side effects which cause 100 000 hospitalizations and 17 000 deaths annually. Recently, the US Food and Drug Administration strengthened its warning about the risks of cardiovascular disease (CVD) attributed to nonaspirin NSAIDs. Methods: When the sample size is large, randomization provides control of confounding not possible to achieve with any observational study. Further, observational studies and, especially, claims data have inherent confounding by indication larger than the small to moderate effects being sought. Results: While trials are necessary, they must be of sufficient size and duration and achieve high compliance and follow-up. Until then, clinicians should remain uncertain about benefits and risks of these drugs. Conclusions: Since the totality of evidence remains incomplete, health-care providers should consider all these aforementioned benefits and risks, both CVD and beyond, in deciding whether and, if so, which, NSAID to prescribe. The factors in the decision of whether and, if so, which NSAID to prescribe for relief of pain from inflammatory arthritis should not be limited to risks of CVD or gastrointestinal side effects but should also include potential benefits including improvements in overall quality of life resulting from decreases in pain or impairment from musculoskeletal pain syndromes. The judicious individual clinical decision-making about the prescription of NSAIDs to relieve pain based on all these considerations has the potential to do much more good than harm.

Abstract P111: Comparative Efficacy Of Bisoprolol Compared To Other Selective Beta-1 Blockers In Patients With Hypertension - A Systematic Review And Meta-analysis Of Observational Studies

Hypertension ◽  
2021 ◽  
Vol 78 (Suppl_1) ◽  
Author(s):  
Uday M Jadhav ◽  
Tiny Nair ◽  
SANDEEP BANSAL ◽  
Saumitra Ray
Keyword(s):  
Lipid Profile ◽  
Observational Studies ◽  
Clinical Decision Making ◽  
Meta Analysis ◽  
Hdl Cholesterol ◽  
Clinical Decision ◽  
Cochrane Library ◽  
Favourable Effect ◽  
Pooled Data ◽  
Cholesterol Levels

Introduction: Selective beta-1 blockers (s-BBs) are used in the management of hypertension (HT) in specific subsets. Studies comparing the potency of blood pressure (BP) lowering with different s-BBs are sparse. The objective of this meta-analysis was to evaluate the efficacy of bisoprolol compared to other s-BBs (Atenolol, Betaxolol, Esmolol, Acebutolol, Metoprolol, Nebivolol) in HT patients by examining their effect on BP, heart rate (HR) and metabolic derangements, by examining the evidences reported in observational studies. Methods: Electronic databases like PubMed, EMBASE, Cochrane Library, Clinicaltrials.gov, Surveillance, Epidemiology and End Results Program and 12 PV databases were systematically searched from inception to October 2019. Observational studies that compared bisoprolol with other s-BBs in patients with HT were evaluated in accordance with the PRISMA guidelines. Pooled data were calculated using random-effects model for meta-analysis in terms of mean difference (MD) and 95% confidence interval (95% CI) for each outcome. Outcomes of interest were BP, HR and lipid profile. Results: Four observational studies which compared bisoprolol with other s-BBs (nebivolol and atenolol) were included in this meta-analysis. Significant reduction was observed in office diastolic BP [MD: -1.70; 95% CI: -2.68,-0.72; P <0.01] among arterial HT patients treated with bisoprolol for 26 weeks (w) compared to those treated with other s-BBs. HT patients treated with bisoprolol for 26 w showed significant reduction in HR [MD: -2.20; 95% CI: -3.57,-0.65; P <0.01] and office HR [MD: -2.55; 95% CI: -3.57,-1.53; P <0.01] than other s-BBs. HDL cholesterol levels increased significantly in essential HT patients treated with bisoprolol at 26 w [MD: 7.17; 95% CI: 1.90,12.45; P <0.01], 78 w [MD: 11.70; 95% CI: 4.49,18.91; P <0.01] and 104 w [MD: 10.20, 95% CI: 4.49,18.91; P <0.01] compared to other s-BBs. Conclusion: Our results suggests that bisoprolol is superior to other s-BBs in reducing BP and HR. Bisoprolol also had a favourable effect on lipid profile shown by increase in HDL cholesterol. This meta-analysis emphasizes the efficacy of bisoprolol over other s-BBs, which aids clinical decision making in treatment of patients with HT.

A meta-analysis of confidence and judgment accuracy in clinical decision making.

2015 ◽  
Vol 62 (4) ◽  
pp. 553-567 ◽  
Author(s):  
Deborah J. Miller ◽  
Elliot S. Spengler ◽  
Paul M. Spengler
Keyword(s):  
Decision Making ◽  
Clinical Decision Making ◽  
Meta Analysis ◽  
Clinical Decision ◽  
Judgment Accuracy

scholarly journals Therapeutic Index (TIX) for intranasal corticosteroids in the treatment of allergic rhinitis

2011 ◽  
Vol 49 (3) ◽  
pp. 272-280
Author(s):  
T. Schafer ◽  
M. Schnoor ◽  
M. Wagenmann ◽  
L. Klimek ◽  
C. Bachert
Keyword(s):  
Allergic Rhinitis ◽  
Side Effects ◽  
Clinical Decision Making ◽  
Therapeutic Index ◽  
Clinical Decision ◽  
Efficacy And Safety ◽  
Medline Search ◽  
Intranasal Corticosteroids ◽  
Ocular Symptoms ◽  
Safety Outcomes

Background: Intranasal corticosteroids (INS) are the first line treatment for allergic rhinitis (AR). To guide clinical decision-making, we created a therapeutic index (TIX) for INS reflecting efficacy and safety. Methods: A Medline search (1966 to June 2009) was carried out to identify all placebo-controlled randomized trials, and observational reports for safety issues, with Dexamethasone, Budesonide (BUD), Fluticasone propionate (FP), Fluticasone furoate (FF), Flunisolide, Mometasone furoate (MF), Triamcinolone (TRIAM), and Beclomethasone dipropionate (BDP) as treatment for AR. Data on three efficacy (nasal symptoms, ocular symptoms, global assessment) and three safety outcomes (epistaxis, growth, systemic ocular effects) were extracted. Meta analyses were performed for each INS and outcome and results were categorised into scores by quartiles. Scores of the three efficacy and safety outcomes were summed up to create summation scores for efficacy (ES) and side effects (AES), respectively with a maximum of 9 points. The TIX was then defined as the ratio of ES and AES. Results: Data of 84 studies were extracted. Based on availability of data, a TIX was calculated for 6 substances. BUD showed the highest efficacy score followed by MF and TRIAM. The lowest scores for side effects were achieved by MF and TRIAM followed by FP. These findings resulted in TIX scores of 7 and 5 for MF and TRIAM, respectively, indicating a high efficacy and low potential of adverse events. Medium scores were reached by BUD and FP and lower scores by BDP and FF. Conclusion: Although safety and efficacy is proven for all available INS by multiple studies, the systematic aggregation and analysis of data allows for a differentiated summary on clinically important features.

scholarly journals Opioid Analgesia: Perspectives on Right Use and Utility

2007 ◽  
Vol 3;10 (5;3) ◽  
pp. 479-491 ◽  
Author(s):  
Jane C. Ballantyne
Keyword(s):  
Quality Of Life ◽  
Chronic Pain ◽  
Side Effects ◽  
Clinical Decision Making ◽  
Analgesic Efficacy ◽  
Clinical Decision ◽  
Opioid Analgesia ◽  
Opioid Treatment

The ability of opioids to effectively and safely control acute and cancer pain has been one of several arguments used to support extending opioid treatment to patients with chronic pain, against a backdrop of considerable caution that has been based upon fears of addiction. Of course, opioids may cause addiction, but the “principle of balance” may justify that “…efforts to address abuse should not interfere with legitimate medical practice and patient care.” Yet, situations are increasingly encountered in which opioid-maintained patients are refractory to analgesia during periods of pain, or even during the course of chronic treatment. The real question is whether analgesic efficacy of opioids can be maintained over time. Overall, the evidence supporting long-term analgesic efficacy is weak. The putative mechanisms for failed opioid analgesia may be related to tolerance or opioid-induced hyperalgesia. Advances in basic sciences may help in understanding these phenomena, but the question of whether long-term opioid treatment can improve patients’ function or quality of life remains a broader issue. Opioid side effects are well known, but with chronic use, most (except constipation) subside. Still, side effects can negatively affect the outcomes and continuity of therapy. This paper addresses 1) what evidence supports the long-term utility of opioids for chronic pain; 2) how side effects may alter quality of life; 3) the nature of addiction and why it is different in pain patients, and 4) on what grounds could pain medication be denied? These questions are discussed in light of patients’ rights, and warrant balancing particular responsibilities with risks. These are framed within the Hippocratic tradition of “producing good for the patient and protecting from harm,” so as to enable 1) more informed clinical decision making, and 2) progress towards right use and utility of opioid treatment for chronic pain. Key Words: Opioids, chronic pain, addiction, side effects, utility, ethics

Unintended Side Effects of Electronic Cigarettes in Otolaryngology: A Scoping Review

2022 ◽  
pp. 019459982110695
Author(s):  
Ameen Amanian ◽  
Jobanjit Phulka ◽  
Amanda C. Hu
Keyword(s):  
Side Effects ◽  
Electronic Cigarettes ◽  
Meta Analysis ◽  
Senior Author ◽  
Significant Heterogeneity ◽  
Recent Emergence ◽  
Scoping Reviews ◽  
Long Term Impact ◽  
Meta Analyses

Objective Electronic cigarettes (E-cigs) are nicotine delivery systems with increasing popularity. The US Food and Drug Administration defines side effects as unwanted or unexpected events or reactions. Our objective was to examine the unintended otolaryngology-related side effects associated with E-cigs. Data Sources Medline, EMBASE, CINAHL, Web of Science, and CENTRAL databases. Review Methods Study selection was independently performed by 2 authors in accordance with the PRISMA-ScR statement (Preferred Reporting Items for Systematic Reviews and Meta-analyses Extension for Scoping Reviews); discrepancies were resolved by the senior author. English studies from database inception to May 1, 2020, with a sample size >5 were included. In vitro, animal, and lower respiratory tract studies were excluded. The main outcome was defined as otolaryngology-related side effects following E-cig use. Levels of evidence per the Oxford Centre for Evidence-Based Medicine were used to determine study quality. Results From 1788 articles, 32 studies were included. The most common unintended side effects were throat irritation (n = 16), cough (n = 16), mouth irritation (n = 11), and oral mucosal lesions (n = 8). A large proportion of participants also reported conventional tobacco use in addition to E-cigs. Eight studies investigated the effectiveness of vaping on smoking cessation. The quality of the literature was level 2 to 4. Given the significant heterogeneity in the studies, meta-analysis was not performed. Conclusion The most reported side effects were throat and mouth irritation, followed by cough. The long-term impact of E-cigs is not known given the recent emergence of this technology. Future studies are warranted.

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