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Clinical Research in Cardiology :... Sep 2018The efficacy and safety of bivalirudin in patients undergoing percutaneous coronary intervention (PCI) for treatment of acute coronary syndromes (ACS) remains... (Meta-Analysis)
Meta-Analysis Review
AIMS
The efficacy and safety of bivalirudin in patients undergoing percutaneous coronary intervention (PCI) for treatment of acute coronary syndromes (ACS) remains controversial despite recent evidence from large randomized-controlled trials (RCTs). Thus, this systematic review and meta-analysis sought to investigate the efficacy and safety of bivalirudin as compared to heparin in patients with ACS undergoing PCI.
METHODS AND RESULTS
Medline/PubMed, Cochrane Central Register of Controlled Trials, and Clinical Trials.gov databases were searched for RCTs. Primary endpoint was MACE consisting of all-cause death, myocardial infarction, and stroke within 30 days. Secondary endpoints were components of the primary endpoint and stent thrombosis. The primary safety endpoint was major bleeding. We identified 12 RCTs comprising 33,844 patients. Between bivalirudin and heparin, there were no significant differences for MACE (OR 1.06; 95% CI 0.96-1.17; p = 0.24), death, myocardial infarction, and stent thrombosis. Similar results were seen following stratification by use of glycoprotein inhibitors (GPI). Major bleeding trended to be less frequent in patients treated with bivalirudin. However, no safety benefit for bivalirudin was seen when use of GPI was balanced between groups (OR 0.88; 95% CI 0.67-1.16; p = 0.35; p for heterogeneity < 0.01).
CONCLUSIONS
Compared with heparin, bivalirudin was associated with a similar incidence of ischemic events following PCI for ACS. An association of bivalirudin with decreased bleeding was not seen with balanced use of GPI.
Topics: Acute Coronary Syndrome; Antithrombins; Global Health; Hirudins; Humans; Incidence; Peptide Fragments; Percutaneous Coronary Intervention; Recombinant Proteins; Thrombosis; Treatment Outcome
PubMed: 29654437
DOI: 10.1007/s00392-018-1251-1 -
European Journal of Anaesthesiology Sep 2023Liposomal bupivacaine is claimed by the manufacturer to provide analgesia for up to 72 h postoperatively. (Meta-Analysis)
Meta-Analysis
The postoperative analgesic efficacy of liposomal bupivacaine versus long-acting local anaesthetics for peripheral nerve and field blocks: A systematic review and meta-analysis, with trial sequential analysis.
BACKGROUND
Liposomal bupivacaine is claimed by the manufacturer to provide analgesia for up to 72 h postoperatively.
OBJECTIVES
To compare the postoperative analgesic efficacy of liposomal bupivacaine versus long-acting local anaesthetics for peripheral nerve or field blocks.
DESIGN
A systematic review and meta-analysis with trial sequential analysis.
DATA SOURCES
MEDLINE, Embase and Web of Science, among others, up to June 2022.
ELIGIBILITY CRITERIA
We retrieved randomised controlled trials comparing liposomal bupivacaine versus bupivacaine, levobupivacaine or ropivacaine for peripheral nerve and field blocks after all types of surgery. Our primary endpoint was rest pain score (analogue scale 0 to 10) at 24 h. Secondary endpoints included rest pain score at 48 and 72 h, and morphine consumption at 24, 48 and 72 h.
RESULTS
Twenty-seven trials including 2122 patients were identified. Rest pain scores at 24 h were significantly reduced by liposomal bupivacaine with a mean difference (95% CI) of -0.9 (-1.4 to -0.4), I2 = 87%, P < 0.001. This reduction in pain scores persisted at 48 h and 72 h with mean differences (95% CI) of -0.7 (-1.1 to -0.3), I2 = 82%, P = 0.001 and -0.7 (-1.1 to -0.3), I2 = 80%, P < 0.001, respectively. There were no differences in interval morphine consumption at 24 h ( P = 0.15), 48 h ( P = 0.15) and 72 h ( P = 0.07). The quality of evidence was moderate.
CONCLUSIONS
There is moderate level evidence that liposomal bupivacaine reduces rest pain scores by 0.9 out of 10 units, when compared with long-acting local anaesthetics at 24 hours after surgery, and by 0.7 up to 72 hours after surgery.
Topics: Humans; Anesthetics, Local; Pain, Postoperative; Bupivacaine; Analgesics; Morphine; Peripheral Nerves; Analgesics, Opioid
PubMed: 37038770
DOI: 10.1097/EJA.0000000000001833 -
BJA Open Dec 2022The use of high-flow nasal oxygen (HFNO) has the potential to improve patient safety by limiting hypoxaemia during gastrointestinal endoscopy. The degree of benefit is... (Review)
Review
BACKGROUND
The use of high-flow nasal oxygen (HFNO) has the potential to improve patient safety by limiting hypoxaemia during gastrointestinal endoscopy. The degree of benefit is not adequately established.
METHODS
English language literature searches of PubMed, Scopus, Web of Science, and Cochrane Library electronic databases were performed to identify randomised controlled trials comparing HFNO and conventional oxygen therapy (COT) for patients undergoing gastrointestinal endoscopy under deep sedation. The primary endpoint was the incidence of hypoxic events observed during endoscopic procedures. The secondary endpoints were the incidence of recourse to rescue manoeuvres, procedure interruption, and adverse events. A meta-analysis and a trial sequence analysis were performed.
RESULTS
A total of 2867 patients from six randomised controlled trials were considered. Desaturation was observed in 5.2% and 27.2% of patients receiving HFNO and COT, respectively. Desaturation <90% was observed in 1.8% and 12.6% of the patients receiving HFNO and COT, respectively. In the subgroup analysis, desaturation occurrence was lower during HFNO than during COT in non-obese patients (2.2% 25.2%) and obese patients (22.9% 43.3%). Desaturation occurrence was lower during maximum (3.6% 26.9%) and minimum (15.9% 29.8%) HFNO therapy than during COT. HFNO showed a lower recurrence to rescue manoeuvres rate (4.7% 34.3%), a lower procedure interruption rate (0.4% 6.7%), and a lower adverse events rate (18.7% 21%) than COT. A high level of heterogeneity between the studies precluded confidence in drawing inference from the meta-analysis.
CONCLUSIONS
The evidence reviewed suggests that compared with COT, HFNO has fewer hypoxaemic events during gastrointestinal endoscopy, but this may not apply to all patients and clinical scenarios.
PubMed: 37588780
DOI: 10.1016/j.bjao.2022.100098 -
Frontiers in Pharmacology 2022Systematic comparison of the efficacy and safety of nebulized corticosteroids and systemic corticosteroids for treating acute exacerbation of chronic obstructive... (Review)
Review
Nebulized corticosteroids systemic corticosteroids for patients with acute exacerbation of chronic obstructive pulmonary disease: A systematic review and meta-analysis comparing the benefits and harms reported by observational studies and randomized controlled trials.
Systematic comparison of the efficacy and safety of nebulized corticosteroids and systemic corticosteroids for treating acute exacerbation of chronic obstructive pulmonary disease reported by high-quality, real-world observational studies and randomized controlled trials. MEDLINE, EMBASE, and Cochrane Library databases were searched from the database creation date to 1 April 2022. Eligible observational studies and randomized controlled trials with changes in lung function and blood gas analysis results as the primary endpoints of interest, and the numbers of deteriorations and adverse events as the secondary endpoints were sought. Of the 2,837 identified studies, 22 were eligible and included in our analysis (N = 5,764 patients). Compared with systemic corticosteroids, nebulized corticosteroids resulted in comparable improvements in predicted FEV%, FEV, PaO, PaCO, and SaO at the treatment endpoint; however, observational studies reported more significant treatment outcomes with nebulized corticosteroids for FEV [mean difference, 0.26; 95% confidence interval (CI), 0.17-0.35; < 0.005]. In terms of adverse reactions, the risks of gastrointestinal symptoms were 11% [Log risk ratio (LogRR) = 0.10; 95% confidence interval, 0.05-0.15; < 0.005] higher for systemic corticosteroids than for nebulized corticosteroids in randomized controlled trials, while the risks of hyperglycemia were 6% (LogRR = 0.06; 95% CI, 0.01-0.11; = 0.01) and 13% (LogRR = 0.12; 95% CI, 0.09-0.16; < 0.005) higher in observational studies and randomized controlled trials, respectively. According to our meta-analysis, either study type supported that nebulized corticosteroids can be used as an alternative to systemic corticosteroids for treating acute exacerbation of the chronic obstructive pulmonary disease. However, more well-designed prospective studies are needed to determine the optimal dose of nebulized corticosteroids and the advantages of sequential therapy.
PubMed: 36278148
DOI: 10.3389/fphar.2022.966637 -
Acta Gastro-enterologica Belgica 2020The coronavirus disease 2019 (COVID-19) is a pandemic infection spreading worldwide at an unprecedented rate. Our aim was to assess the frequency of gastrointestinal... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND AND STUDY AIMS
The coronavirus disease 2019 (COVID-19) is a pandemic infection spreading worldwide at an unprecedented rate. Our aim was to assess the frequency of gastrointestinal (GI) involvement in COVID-19.
PATIENTS AND METHODS
We performed a systematic review and meta-analysis of all studies reporting clinical data about COVID-19 patients, published until 25th March 2020. The primary endpoint was the pooled prevalence of COVID-19 patients complaining of GI symptoms. Secondary endpoints were the pooled prevalence of cases with COVID-19 positive stool samples, and of asymptomatic COVID-19 patients. We used random-effects model for meta-analysis.
RESULTS
Thirty-three studies were included in the meta-analysis. Out of 4434 COVID-19 patients, the pooled prevalence of GI manifestations was 11.51% (95% CI : 8.16 to 15.35). The most frequent GI symptom was diarrhea (7.78% of cases ; 95% CI : 5.05 to 11.04), followed by nausea/vomiting (3.57% ; 95% CI : 1.87 to 5.80), poor appetite (2.39% ; 95%CI : 0.55 ; 5.46) and abdominal pain (0.78% ; 95% CI : 0.26 to 1.57). Positivity for COVID-19 in stool samples was observed in 41.50% (95% CI : 17.70 to 67.65) of cases. 11.85% (95% CI : 3.53 to 24.17) of COVID-19 patients remained asymptomatic.
CONCLUSIONS
The present meta-analysis shows that a significant proportion of COVID-19 patients suffer from GI manifestations, as well as COVID-19 positivity in stool samples. Asymptomatic patients need to be considered a further potential route of viral transmission.
Topics: Betacoronavirus; COVID-19; Coronavirus Infections; Gastrointestinal Diseases; Humans; Pandemics; Pneumonia, Viral; Prevalence; SARS-CoV-2
PubMed: 33321018
DOI: No ID Found -
The Cochrane Database of Systematic... Aug 2016Friedreich ataxia is a rare inherited autosomal recessive neurological disorder, characterised initially by unsteadiness in standing and walking, slowly progressing to... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Friedreich ataxia is a rare inherited autosomal recessive neurological disorder, characterised initially by unsteadiness in standing and walking, slowly progressing to wheelchair dependency usually in the late teens or early twenties. It is associated with slurred speech, scoliosis, and pes cavus. Heart abnormalities cause premature death in 60% of people with the disorder. There is no easily defined clinical or biochemical marker and no known treatment. This is the second update of a review first published in 2009 and previously updated in 2012.
OBJECTIVES
To assess the effects of pharmacological treatments for Friedreich ataxia.
SEARCH METHODS
On 29 February 2016 we searched The Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, EMBASE and CINAHL Plus. On 7 March 2016 we searched ORPHANET and TRIP. We also checked clinical trials registers for ongoing studies.
SELECTION CRITERIA
We considered randomised controlled trials (RCTs) or quasi-RCTs of pharmacological treatments (including vitamins) in people with genetically-confirmed Friedreich ataxia. The primary outcome was change in a validated Friedreich ataxia neurological score after 12 months. Secondary outcomes were changes in cardiac status as measured by magnetic resonance imaging or echocardiography, quality of life, mild and serious adverse events, and survival. We excluded trials of duration shorter than 12 months.
DATA COLLECTION AND ANALYSIS
Three review authors selected trials and two review authors extracted data. We obtained missing data from the two RCTs that met our inclusion criteria. We collected adverse event data from included studies. We used standard methodological procedures expected by Cochrane.
MAIN RESULTS
We identified more than 12 studies that used antioxidants in the treatment of Friedreich ataxia, but only two small RCTs, with a combined total of 72 participants, both fulfilled the selection criteria for this review and published results. One of these trials compared idebenone with placebo, the other compared high-dose versus low-dose coenzyme Q10 and vitamin E (the trialists considered the low-dose medication to be the placebo). We identified two other completed RCTs, which remain unpublished; the interventions in these trials were pioglitazone (40 participants) and idebenone (232 participants). Other RCTs were of insufficient duration for inclusion.In the included studies, the primary outcome specified for the review, change in a validated Friedreich ataxia rating score, was measured using the International Co-operative Ataxia Rating Scale (ICARS). The results did not reveal any significant difference between the antioxidant-treated and the placebo groups (mean difference 0.79 points, 95% confidence interval -1.97 to 3.55 points; low-quality evidence).The published included studies did not assess the first secondary outcome, change in cardiac status as measured by magnetic resonance imaging. Both studies reported changes in cardiac measurements assessed by echocardiogram. The ejection fraction was not measured in the larger of the included studies (44 participants). In the smaller study (28 participants), it was normal at baseline and did not change with treatment. End-diastolic interventricular septal thickness showed a small decrease in the smaller of the two included studies. In the larger included study, there was no decrease, showing significant heterogeneity in the study results; our overall assessment of the quality of evidence for this outcome was very low. Left ventricular mass (LVM) was only available for the smaller RCT, which showed a significant decrease. The relevance of this change is unclear and the quality of evidence low.There were no deaths related to the treatment with antioxidants. We considered the published included studies at low risk of bias in six of seven domains assessed. One unpublished included RCT, a year-long study using idebenone (232 participants), published an interim report in May 2010 stating that the study reached neither its primary endpoint, which was change in the ICARS score, nor a key cardiological secondary endpoint, but data were not available for verification and analysis.
AUTHORS' CONCLUSIONS
Low-quality evidence from two small, published, randomised controlled trials neither support nor refute an effect from antioxidants (idebenone, or a combination of coenzyme Q10 and vitamin E) on the neurological status of people with Friedreich ataxia, measured with a validated neurological rating scale. A large unpublished study of idebenone that reportedly failed to meet neurological or key cardiological endpoints, and a trial of pioglitazone remain unpublished, but on publication will very likely influence quality assessments and conclusions. A single study of idebenone provided low-quality evidence for a decrease in LVM, which is of uncertain clinical significance but of potential importance that needs to be clarified. According to low-quality evidence, serious and non-serious adverse events were rare in both antioxidant and placebo groups. No non-antioxidant agents have been investigated in RCTs of 12 months' duration.
Topics: Antioxidants; Friedreich Ataxia; Heart; Humans; Hypertrophy, Left Ventricular; Randomized Controlled Trials as Topic; Rare Diseases; Ubiquinone; Ultrasonography; Vitamin E
PubMed: 27572719
DOI: 10.1002/14651858.CD007791.pub4 -
International Journal of Surgery... Aug 2022In the modern era, minimally invasive surgery is rapidly evolving and even replacing conventional open techniques in many surgical fields. Thyroidectomy was not an... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
In the modern era, minimally invasive surgery is rapidly evolving and even replacing conventional open techniques in many surgical fields. Thyroidectomy was not an exception, with the introduction of multiple endoscopic thyroidectomy techniques. Trans-oral endoscopic trans-vestibular thyroidectomy (TOT) is a novel technique with promising outcomes. We conducted this meta-analysis to compare surgical outcomes and learning curves for TOT and other endoscopic thyroidectomy techniques.
METHODS
A systematic review in PubMed, MEDLINE, and EMBASE databases was conducted searching for publications on TOT versus trans-axillary thyroidectomy (TAT). The primary endpoint was operative (OR) time. Secondary endpoints were number of harvested lymph nodes (LNs), estimated blood loss (EBL), recurrent laryngeal nerve (RLN) injury, hoarseness, seroma, infection, chyle leak, hypocalcemia, hospital length of stay (LOS), and Cost. We also investigated the learning curve for each technique. Leave-out-out analysis, meta-regression, and subgroup analysis were used. Random effect inverse variance method was utilized.
RESULTS
Among 3820 retrieved studies, 15 studies (10 unmatched and 5 matched), with 2173 (TOT: 1024(47.12%) and TAT:1149(52.87%)) patients, met the inclusion criteria. The operative time and harvested L. Ns number were higher in TOT versus TAT (standard mean difference (SMD) = 0.72 [95%CI 0.07; 1.37], P = 0.029 and SMD = 0.32 [95%CI 0.02; 0.62], P = 0.036 respectively) while less EBL in TOT versus TAT (SMD = -0.26 [-0.43; -0.09], P = 0.0018). All other outcomes showed no significant difference between both groups. Weighted mean values for TOT and TAT were 158.03 vs 144.97 min for OR time, 6.33 vs 5.16 for harvested LNs, and $5,919.05 vs $6,253.79 for the cost. Statistical significance in learning curve development was noticed ranging between 6 and 15 annual cases.
CONCLUSION
Trans-oral thyroidectomy is a safe and reliable technique with outcomes comparable to other endoscopic techniques. It provides better access to the central compartment with a more feasible LN dissection. Improvement in surgical outcomes is expected with growing learning curve and technique mastery.
Topics: Axilla; Endoscopy; Humans; Learning Curve; Operative Time; Thyroid Neoplasms; Thyroidectomy
PubMed: 35764254
DOI: 10.1016/j.ijsu.2022.106739 -
Journal of Robotic Surgery Oct 2023The number of robotic hiatal hernia repairs (RHHR) is increasing. However, the superiority of this minimally invasive approach remains controversial. The aim of this... (Meta-Analysis)
Meta-Analysis Review
The number of robotic hiatal hernia repairs (RHHR) is increasing. However, the superiority of this minimally invasive approach remains controversial. The aim of this study was to evaluate the available literature reporting on outcomes of RHHR compared with laparoscopic hiatal hernia repair (LHHR) in adult patients. The design of this systematic review was developed using the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Web of Science, PubMed, the Cochrane Library, and ClinicalTrials.gov databases were searched. Identified publications were reviewed independently by two authors. High heterogeneity was further explored through sensitivity analysis. The primary endpoint was the development of postoperative complications. Secondary endpoints included operation time, intraoperative complications, 30 day readmission rates and length of stay. The analysis was performed using Stata 17.0 software. A total of 7 studies totaling 10078 patients met the inclusion criteria. Five studies included postoperative complications. The postoperative complications rate was 4.25% (302/7111) in the LHHR group, and 3.49% (38/1088) in the RHHR group. Postoperative complications significantly decreased after RHHR compared with LHHR (OR 0.52; 95% CI 0.36 to 0.75, P = 0.000). Three studies involving 2176 patients reported length of hospital stay. In the three studies, the mean Length of hospital stay was 3.2 days in the RHHR group, and 4.2 days in the LHHR group. Length of hospital stay was decreased by a mean of 0.68 days for RHHR compared with LHHR (WMD, - 0.68 days; 95% CI - 1.32 to - 0.03, P = 0.02). There was no significant difference between the RHHR group and the LHHR group regarding operative time, intraoperative complications, and 30 day readmission (P > 0.05). Our research shows that RHHR may be the better option, as the approach decreases postoperative complications and length of hospital stay.
Topics: Adult; Humans; Herniorrhaphy; Robotic Surgical Procedures; Laparoscopy; Intraoperative Complications; Postoperative Complications; Length of Stay; Hernia, Hiatal
PubMed: 37247119
DOI: 10.1007/s11701-023-01636-5 -
Journal of Clinical Anesthesia May 2024In labor, programmed intermittent epidural bolus (PIEB) can be defined as the bolus administration of epidural solution at scheduled time intervals. Compared to... (Meta-Analysis)
Meta-Analysis Review
Influence of different volumes and frequency of programmed intermittent epidural bolus in labor on maternal and neonatal outcomes: A systematic review and network meta-analysis.
STUDY OBJECTIVE
In labor, programmed intermittent epidural bolus (PIEB) can be defined as the bolus administration of epidural solution at scheduled time intervals. Compared to continuous epidural infusion (CEI) with or without patient controlled epidural analgesia (PCEA), PIEB has been associated with decreased pain scores and need for rescue analgesia and increased maternal satisfaction. The optimal volume and dosing interval of PIEB, however, has still not been determined.
DESIGN
Systematic review and network meta-analysis registered with PROSPERO (CRD42022362708).
SETTINGS
Labor.
PATIENTS
Pregnant patients.
INTERVENTIONS
Central, CINAHL, Global Health, Ovid Embase, Ovid Medline and Web of Science were searched for randomized controlled trials that examined pregnant patients in labor who received CEI or PIEB with or without a PCEA component. Network meta-analysis was performed with a frequentist method, facilitating the indirect comparison of PIEB with different volumes and dosing intervals through the common comparator of CEI and substituting or supplementing direct comparisons with these indirect ones. Continuous and dichotomous outcomes were presented as mean differences and odds ratios, respectively, with 95% confidence intervals. The risk of bias was evaluated using the Cochrane risk of bias 2 tool.
MAIN RESULTS
Overall, 30 trials were included. For the first primary endpoint, need for rescue analgesia, PIEB delivered at a volume of 4 ml and frequency of 45 min (4/45) was inferior to PIEB 8/45 (OR 3.55; 95% CI 1.12-11.33), PIEB 10/60 was superior to PIEB 2.5/15 (OR 0.36; 95% CI 0.16-0.82), PIEB 4/45 (OR 0.14; 95% CI 0.03-0.71) and PIEB 5/60 (OR 0.23; 95% CI 0.08-0.70), and PIEB 5/30 was not inferior to PIEB 10/60 (OR 0.61; 95% CI 0.31-1.19). For the second primary endpoint, maternal satisfaction, no differences were present between the various PIEB regimens. The quality of evidence for these multiple primary endpoints was low owing to the presence of serious limitations and imprecision. Importantly, PIEB 5/30 decreased the pain score at 4 h compared to PIEB 2.5/15 (MD 2.45; 95% CI 0.13-4.76), PIEB 5/60 (MD -2.28; 95% CI -4.18--0.38) and PIEB 10/60 (MD 1.73; 95% CI 0.31-3.16). Mean ranking of interventions demonstrated PIEB 10/60 followed by PIEB 5/30 to be best placed to reduce the cumulative dose of local anesthetic, and this resulted in an improved incidence of lower limb motor blockade for PIEB 10/60 in comparison to CEI (OR 0.30; 95% CI 0.14-0.67). No differences in neonatal outcomes were found. Some concerns were present for the risk of bias in two thirds of trials and the risk of bias was shown to be high in the remaining one third of trials.
CONCLUSIONS
Future research should focus on PIEB 5/30 and PIEB 10/60 and how the method of analgesia initiation, nature and concentration of local anesthetic, design of epidural catheter and rate of administration might influence outcomes related to the mother and neonate.
Topics: Pregnancy; Female; Infant, Newborn; Humans; Anesthetics, Local; Network Meta-Analysis; Labor, Obstetric; Analgesia, Epidural; Analgesia, Patient-Controlled; Pain; Analgesia, Obstetrical
PubMed: 38176084
DOI: 10.1016/j.jclinane.2023.111364 -
Advances in Radiation Oncology 2023Although the frequency of noninferiority trials is increasing, the consistency of the reporting of these trials can vary. The aim of this systematic review was to assess... (Review)
Review
PURPOSE
Although the frequency of noninferiority trials is increasing, the consistency of the reporting of these trials can vary. The aim of this systematic review was to assess the reporting quality of radiation therapy noninferiority trials.
METHODS AND MATERIALS
The PubMed, Embase, and Cochrane databases were queried for randomized controlled radiation therapy trials with noninferiority hypotheses published in English between January 2000 and July 2022, and this was performed by an information scientist. Descriptive statistics were used to summarize data.
RESULTS
Of 423 records screened, 59 (14%) were included after full-text review. All were published after 2003 and open label. The most common primary cancer type was breast (n = 15, 25%). Altered radiation fractionation (n = 26, 45%) and radiation de-escalation (n = 11, 19%) were the most common types of interventions. The most common primary endpoints were locoregional control (n = 17, 29%) and progression-free survival (n = 14, 24%). Fifty-three (90%) reported the noninferiority margin, and only 9 (17%) provided statistical justification for the margin. The median absolute noninferiority margin was 9% (interquartile range, 5%-10%), and the median relative margin was 1.51 (interquartile range, 1.33-2.04). Sample size calculations and confidence intervals were reported in 54 studies (92%). Both intention-to-treat and per-protocol analyses were reported in 27 studies (46%). In 31 trials (53%), noninferiority of the primary endpoint was reached.
CONCLUSIONS
There was variability in the reporting of key components of noninferiority trials. We encourage consideration of additional statistical reasoning such as guidelines or previous trials in the selection of the noninferiority margin, reporting both absolute and relative margins, and the avoidance of statistically vague or misleading language in the reporting of future noninferiority trials.
PubMed: 36852015
DOI: 10.1016/j.adro.2023.101178