scholarly journals Uses of equipoise in discussions of the ethics of randomized controlled trials of COVID-19 therapies

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Hayden P. Nix ◽  
Charles Weijer
Keyword(s):  
Randomized Controlled Trials ◽  
Scoping Review ◽  
Patient Preference ◽  
Primary Outcome ◽  
Ethical Problem ◽  
Therapeutic Benefit ◽  
Early Termination ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Unproven Therapies

Abstract Background Early in the COVID-19 pandemic, the urgent need to discover effective therapies for COVID-19 prompted questions about the ethical problem of randomization along with its widely accepted solution: equipoise. In this scoping review, uses of equipoise in discussions of randomized controlled trials (RCT) of COVID-19 therapies are evaluated to answer three questions. First, how has equipoise been applied to COVID-19 research? Second, has equipoise been employed accurately? And third, do concerns about equipoise pose a barrier to the ethical conduct of COVID-19 RCTs? Methods Google Scholar and Pubmed were searched for articles containing substantial discussion about equipoise and COVID-19 RCTs. 347 article titles were screened, 91 full text articles were assessed, and 48 articles were included. Uses of equipoise were analyzed and abstracted into seven categories. Results and discussion Approximately two-thirds of articles (33/48 articles) used equipoise in a way that is consistent with the concept. They invoked equipoise to support (1) RCTs of specific therapies, (2) RCTs in general, and (3) the early termination of RCTs after achieving the primary outcome. Approximately one-third of articles (15/48 articles) used equipoise in a manner that is inconsistent with the concept. These articles argued that physician preference, widespread use of unproven therapies, patient preference, or expectation of therapeutic benefit may undermine equipoise and render RCTs unethical. In each case, the purported ethical problem can be resolved by correcting the use of equipoise. Conclusions Our findings highlight the continued relevance of equipoise as it supports the conduct of well-conceived RCTs and provides moral guidance to physicians and researchers as they search for effective therapies for COVID-19.

scholarly journals Conservative oxygen therapy for critically ill patients: a meta-analysis of randomized controlled trials

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Xiao-Li Chen ◽  
Bei-Lei Zhang ◽  
Chang Meng ◽  
Hui-Bin Huang ◽  
Bin Du
Keyword(s):  
Sensitivity Analysis ◽  
Randomized Controlled Trials ◽  
Critically Ill Patients ◽  
Oxygen Therapy ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Icu Patients ◽  
Randomized Controlled

Abstract Objective Conservative oxygen strategy is recommended in acute illness while its benefit in ICU patients remains controversial. Therefore, we sought to conduct a systematic review and meta-analysis to examine such oxygen strategies’ effect and safety in ICU patients. Methods We searched PubMed, Embase, and the Cochrane database from inception to Feb 15, 2021. Randomized controlled trials (RCTs) that compared a conservative oxygen strategy to a conventional strategy in critically ill patients were included. Results were expressed as mean difference (MD) and risk ratio (RR) with a 95% confidence interval (CI). The primary outcome was the longest follow-up mortality. Heterogeneity, sensitivity analysis, and publication bias were also investigated to test the robustness of the primary outcome. Results We included seven trials with a total of 5265 patients. In general, the conventional group had significantly higher SpO2 or PaO2 than that in the conservative group. No statistically significant differences were found in the longest follow-up mortality (RR, 1.03; 95% CI, 0.97–1.10; I2=18%; P=0.34) between the two oxygen strategies when pooling studies enrolling subjects with various degrees of hypoxemia. Further sensitivity analysis showed that ICU patients with mild-to-moderate hypoxemia (PaO2/FiO2 >100 mmHg) had significantly lower mortality (RR, 1.24; 95% CI, 1.05–1.46; I2=0%; P=0.01) when receiving conservative oxygen therapy. These findings were also confirmed in other study periods. Additional, secondary outcomes of the duration of mechanical ventilation, the length of stay in the ICU and hospital, change in sequential organ failure assessment score, and adverse events were comparable between the two strategies. Conclusions Our findings indicate that conservative oxygen therapy strategy did not improve the prognosis of the overall ICU patients. The subgroup of ICU patients with mild to moderate hypoxemia might obtain prognosis benefit from such a strategy without affecting other critical clinical results.

Efficacy and tolerability of Lavandula angustifolia in treating patients with the diagnosis of depression: a systematic review of randomized controlled trials

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Ahmad Shamabadi ◽  
Shahin Akhondzadeh
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Large Scale ◽  
Primary Outcome ◽  
Controlled Trials ◽  
Lavandula Angustifolia ◽  
Randomized Controlled ◽  
Depressed Patients ◽  
Antidepressant Effects ◽  
And Control

Abstract Pharmacotherapy is the conventional treatment for depression, with only half of the patients responding to the first trial of monotherapy with first-line medicines. One way to overcome this resistance is to use complementary and alternative medicine. The antidepressant effects of Lavandula angustifolia, which is commonly called lavender, have been investigated in previous studies. This study aims to provide the first systematic review of lavender in treating patients with depression diagnosis. ISI Web of Science, Scopus, PubMed, Embase, PsycINFO, Google Scholar, and three trial registries were searched until May 2020 to find randomized controlled trials on lavender for depressed patients. The primary outcome was difference between the intervention and control groups in changing depression scores from baseline to endpoint. The included studies were assessed for effect size and methodological quality. Seven clinical trials were identified, in which 852 patients were studied. In six trials, the effectiveness of lavender in treating depression was reported, as being more pronounced adjunct to a typical antidepressant in one study. Significant reported side effects include headaches and eructation. Lavender is beneficial, tolerable, and safe in treating depression. Despite obtaining promising results, they are not enough to recommend prescribing lavender to depressed patients. Further high-quality, large-scale studies for rectifying the shortcomings of existing studies are recommended.

scholarly journals Multidisciplinary Chronic Kidney Disease Clinic Practices: A Scoping Review

2019 ◽  
Vol 6 ◽  
pp. 205435811988266 ◽  
Author(s):  
David Collister ◽  
Lonnie Pyne ◽  
Jessie Cunningham ◽  
Maoliosa Donald ◽  
Amber Molnar ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Randomized Controlled Trials ◽  
Glomerular Filtration ◽  
Scoping Review ◽  
Observational Studies ◽  
Controlled Trials ◽  
Team Composition ◽  
Randomized Controlled

Background: Multidisciplinary chronic kidney disease (CKD) clinics improve patient outcomes but their optimal design is unclear. Objective: To perform a scoping review to identify and describe current practices (structure, function) associated with multidisciplinary CKD clinics. Design: Scoping review. Setting: Databases included Medline, EMBASE, Cochrane, and CINAHL. Patients: Patients followed in multidisciplinary CKD clinics globally. Measurements: Multidisciplinary CKD clinic composition, entry criteria, follow-up, and outcomes. Methods: We systematically searched the literature to identify randomized controlled trials, non-randomized interventional studies, or observational studies of multidisciplinary CKD clinics defined by an outpatient setting where two or more allied health members (with or without a nephrologist) provided longitudinal care to 50 or more adult or pediatric patients with CKD. Included studies were from 2002 to present. Searches were completed on August 10, 2018. Title, abstracts, and full texts were screened independently by two reviewers with disagreements resolved by a third. We abstracted data from included studies to summarize multidisciplinary CKD clinic team composition, entry criteria, follow-up, and processes. Results: 40 studies (8 randomized controlled trials and 32 non-randomized interventional studies or observational studies) involving 23 230 individuals receiving multidisciplinary CKD care in 12 countries were included. Thirty-eight focused on adults (27 with CKD, 10 incident dialysis patients, one conservative therapy) while two studies focused on adolescents or children with CKD. The multidisciplinary team included a mean of 4.6 (SD 1.5) members consisting of a nephrologist, nurse, dietician, social worker, and pharmacist in 97.4%, 86.8%, 84.2%, 57.9%, and 42.1% of studies respectively. Entry criteria to multidisciplinary CKD clinics ranged from glomerular filtration rates of 20 to 70 mL/min/1.73m2 or CKD stages 1 to 5 without any proteinuria or risk equation-based criteria. Frequency of follow-up was variable by severity of kidney disease. Team member roles and standardized operating procedures were infrequently reported. Limitations: Unstandardized definition of multidisciplinary CKD care, studies limited to CKD defined by glomerular filtration rate, and lack of representation from countries other than Canada, Taiwan, the United States, and the United Kingdom. Conclusions: There is heterogeneity in multidisciplinary CKD team composition, entry criteria, follow-up, and processes with inadequate reporting of this complex intervention. Additional research is needed to determine the best model for multidisciplinary CKD clinics. Trial registration: Not applicable.

scholarly journals The Effect of Exercise on Cancer-Related Cognitive Impairment and Applications for Physical Therapy: Systematic Review of Randomized Controlled Trials

2020 ◽  
Vol 100 (3) ◽  
pp. 523-542 ◽  
Author(s):  
Kristin L Campbell ◽  
Kendra Zadravec ◽  
Kelcey A Bland ◽  
Elizabeth Chesley ◽  
Florian Wolf ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cognitive Impairment ◽  
Cognitive Function ◽  
Randomized Controlled Trials ◽  
Primary Outcome ◽  
Cognitive Impairments ◽  
Common Side Effect ◽  
Future Research ◽  
Controlled Trials ◽  
Randomized Controlled

Abstract Background Cancer-related cognitive impairment (CRCI), often called “chemo-brain” or “chemo-fog,” is a common side effect among adults with cancer, which can persist well after treatment completion. Accumulating evidence demonstrates exercise can improve cognitive function in healthy older adults and adults with cognitive impairments, suggesting exercise may play a role in managing CRCI. Purpose The purpose was to perform a systematic review of randomized controlled trials (RCTs) to understand the effect of exercise on CRCI. Data Sources Relevant literature was retrieved from CINAHL, Medline (Ovid), and EMBASE. Study Selection Eligible articles were RCTs that prescribed aerobic, resistance, combined aerobic/resistance, or mind-body (eg, yoga or Qigong) exercise during or following cancer treatment and included cognitive function outcome measures. Data Extraction Descriptive information and Cohen d effect sizes were directly extracted or calculated for included trials. Data Synthesis Twenty-nine trials were included in the final analysis. A statistically significant effect of exercise on self-reported cognitive function, both during and postadjuvant treatment, was reported in 12 trials (41%) (Cohen d range: 0.24–1.14), most commonly using the EORTC QLQ-C30. Ten trials (34%) performed neuropsychological testing to evaluate cognitive function; however, only 3 trials in women with breast cancer reported a significant effect of exercise (Cohen d range: 0.41–1.47). Limitations Few RCTs to date have evaluated the effect of exercise on CRCI as a primary outcome. Twenty-six trials (90%) in this review evaluated CRCI as secondary analyses. Conclusions Evidence supporting exercise as a strategy to address CRCI is limited. Future research evaluating CRCI as a primary outcome, including self-reported and objective measures, is needed to confirm the possible role of exercise in preventing and managing cognitive impairments in adults with cancer.

A Scoping Review on the Use of Antibiotic-Impregnated Beads and Applications to Vascular Surgery

2019 ◽  
Vol 54 (2) ◽  
pp. 147-161 ◽  
Author(s):  
Brandon McGuinness ◽  
Khatija Pinky Ali ◽  
Steven Phillips ◽  
Michael Stacey
Keyword(s):  
High Risk ◽  
Vascular Surgery ◽  
Randomized Controlled Trials ◽  
Scoping Review ◽  
Graft Infection ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
High Risk Patients ◽  
Randomized Controlled ◽  
Risk Patients

Introduction: Surgical site infection (SSI) presents a ubiquitous concern to surgical specialties, especially in the presence of prosthetic material. Antibiotic-impregnated beads present a novel and evolving means to combat this condition. This review aims to analyze the quality of evidence and methods of antibiotic bead use, particularly for application within vascular surgery. Methods: A systematic scoping review was conducted within Embase, MEDLINE, and the Cochrane Registry of Randomized Controlled Trials. Articles were evaluated by 2 independent reviewers. Level of evidence was evaluated using the Oxford Center for Evidence-Based Medicine Criteria and the Cochrane Risk of Bias Tool for Randomized Controlled Trials. Results: The search yielded 6951 papers, with 275 included for final analysis. Publications increased in frequency from 1978 to the present. The most common formulation was polymethyl methacrylate; however publications on biodegradable formulations, including calcium sulfate beads, have been published with increasing frequency. Most publications had positive conclusions (94.2%); however, the data was mainly subjective and may be prone to publication bias. Only 11 randomized controlled trials were identified and all but one was evaluated to be at a high risk of bias. The most common indication was for osteomyelitis (52%), orthopedic prosthetic infections (20%), and trauma (9%). Within vascular surgery, beads have been used primarily for the treatment of graft infection, with freedom from recurrence rates being reported from 41% to 87.5%. Conclusions: Antibiotic-impregnated beads provide a means to deliver high doses of antibiotic directly to a surgical site, without the risks of parenteral therapy. There has yet to be significant high-level quality data published on their use. There is a large body of evidence that suggests antibiotic beads may be used in SSIs in high-risk patients, prosthetic infections, and other complex surgical infections. Important potential areas of application in vascular surgery include graft infection, prevention of wound infection in high-risk patients, and diabetic foot infection.

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