Rationale for randomized controlled trials and for intention-to-treat analysis in transfusion medicine: are they one and the same?

Vox Sanguinis ◽  
2008 ◽  
Vol 95 (3) ◽  
pp. 165-173 ◽  
Author(s):  
E. C. Vamvakas
Keyword(s):  
Randomized Controlled Trials ◽  
Controlled Trials ◽  
Transfusion Medicine ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Treat Analysis

Quality of surgical randomized controlled trials in hand surgery: a systematic review

2018 ◽  
Vol 43 (8) ◽  
pp. 801-807 ◽  
Author(s):  
Chao Long ◽  
Heather E. desJardins-Park ◽  
Rita Popat ◽  
Paige M. Fox
Keyword(s):  
Randomized Controlled Trials ◽  
Hand Surgery ◽  
Controlled Trials ◽  
Jadad Score ◽  
Surgical Interventions ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Treat Analysis ◽  
Over Time

We assessed the quantity, quality and trends of randomized controlled trials comparing hand surgical interventions. Study characteristics were collected for 125 randomized controlled trials comparing hand surgical interventions. The Jadad scale (0–5), which assesses methodological quality of trials, was calculated. Logistic regressions were conducted to determine associations with the Jadad score. The studies were published between 1981 and 2015, with an increase over time, most often in Journal of Hand Surgery (European). Mean study size was 68 patients. Mean Jadad score was 2.1, without improvement over time. Thirty percent conducted a power analysis and 8% an intention-to-treat analysis. Studies conducted in the United Kingdom and with smaller sample sizes, power analysis and intention-to-treat analysis were associated with a higher Jadad score. The quantity of trials has increased over time while methodological quality has remained low, indicating a need to improve quality of trials in hand surgery literature.

scholarly journals Estimates of Inactivated Influenza Vaccine Effectiveness Among Children in Senegal: Results From 2 Consecutive Cluster-Randomized Controlled Trials in 2010 and 2011

2020 ◽  
Author(s):  
Mbayame Nd Niang ◽  
Jonathan D Sugimoto ◽  
Aldiouma Diallo ◽  
Bou Diarra ◽  
Justin R Ortiz ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Randomized Controlled Trials ◽  
Vaccine Effectiveness ◽  
Controlled Trials ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Herd Protection ◽  
Cluster Randomized Controlled Trials ◽  
Influenza Illness ◽  
Cluster Randomized

Abstract Background We report results of years 2 and 3 of consecutive cluster-randomized controlled trials of trivalent inactivated influenza vaccine (IIV3) in Senegal. Methods We cluster-randomized (1:1) 20 villages to annual vaccination with IIV3 or inactivated poliovirus vaccine (IPV) of age-eligible residents (6 months–10 years). The primary outcome was total vaccine effectiveness against laboratory-confirmed influenza illness (LCI) among age-eligible children (modified intention-to-treat population [mITT]). Secondary outcomes were indirect (herd protection) and population (overall community) vaccine effectiveness. Results We vaccinated 74% of 12 408 age-eligible children in year 2 (June 2010–April 11) and 74% of 11 988 age-eligible children in year 3 (April 2011–December 2011) with study vaccines. Annual cumulative incidence of LCI was 4.7 (year 2) and 4.2 (year 3) per 100 mITT child vaccinees of IPV villages. In year 2, IIV3 matched circulating influenza strains. The total effectiveness was 52.8% (95% confidence interval [CI], 32.3–67.0), and the population effectiveness was 36.0% (95% CI, 10.2–54.4) against LCI caused by any influenza strain. The indirect effectiveness against LCI by A/H3N2 was 56.4% (95% CI, 39.0–68.9). In year 3, 74% of influenza detections were vaccine-mismatched to circulating B/Yamagata and 24% were vaccine-matched to circulating A/H3N2. The year 3 total effectiveness against LCI was −14.5% (95% CI, −81.2–27.6). Vaccine effectiveness varied by type/subtype of influenza in both years. Conclusions IIV3 was variably effective against influenza illness in Senegalese children, with total and indirect vaccine effectiveness present during the year when all circulating strains matched the IIV3 formulation. Clinical Trials Registration ClinicalTrials.gov; NCT00893906.

Methodological and Reporting Quality of Noninferiority Randomized Controlled Trials Comparing Antibiotic Therapies: A Systematic Review

2020 ◽  
Author(s):  
Anthony D Bai ◽  
Adam S Komorowski ◽  
Carson K L Lo ◽  
Pranav Tandon ◽  
Xena X Li ◽  
...  
Keyword(s):  
Systematic Review ◽  
Pharmaceutical Industry ◽  
Randomized Controlled Trials ◽  
Reporting Quality ◽  
Controlled Trials ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Noninferiority Trials ◽  
Noninferiority Margin

Abstract Background Antibiotic noninferiority randomized controlled trials (RCTs) are used for approval of new antibiotics and making changes to antibiotic prescribing in clinical practice. We conducted a systematic review to assess the methodological and reporting quality of antibiotic noninferiority RCTs. Methods We searched MEDLINE, Embase, the Cochrane Database of Systematic Reviews, and the Food and Drug Administration drug database from inception until November 22, 2019, for noninferiority RCTs comparing different systemic antibiotic therapies. Comparisons between antibiotic types, doses, administration routes, or durations were included. Methodological and reporting quality indicators were based on the Consolidated Standards of Reporting Trials reporting guidelines. Two independent reviewers extracted the data. Results The systematic review included 227 studies. Of these, 135 (59.5%) studies were supported by pharmaceutical industry. Only 83 (36.6%) studies provided a justification for the noninferiority margin. Reporting of both intention-to-treat (ITT) and per-protocol (PP) analyses were done in 165 (72.7%) studies. The conclusion was misleading in 34 (15.0%) studies. The studies funded by pharmaceutical industry were less likely to be stopped early because of logistical reasons (3.0% vs 19.1%; odds ratio [OR] = 0.13; 95% confidence interval [CI], .04–.37) and to show inconclusive results (11.1% vs 42.9%; OR = 0.17; 95% CI, .08–.33). The quality of studies decreased over time with respect to blinding, early stopping, reporting of ITT with PP analysis, and having misleading conclusions. Conclusions There is room for improvement in the methodology and reporting of antibiotic noninferiority trials. Quality can be improved across the entire spectrum from investigators, funding agencies, as well as during the peer-review process. There is room for improvement in the methodology and reporting of antibiotic noninferiority trials including justification of noninferiority margin, reporting of intention-to-treat analysis with per-protocol analysis, and having conclusions that are concordant with study results. PROSPERO registration number CRD42020165040.

Randomized controlled trials in otolaryngology journals

2007 ◽  
Vol 137 (4) ◽  
pp. 539-544 ◽  
Author(s):  
Francisca Yao ◽  
Michael Singer ◽  
Richard M. Rosenfeld
Keyword(s):  
Randomized Controlled Trials ◽  
Treatment Efficacy ◽  
Included Study ◽  
Controlled Trials ◽  
Industry Funding ◽  
For Profit ◽  
Randomized Controlled ◽  
Frequent Use ◽  
Intent To Treat ◽  
Treat Analysis

Objective To identify trends in randomized controlled trials (RCTs) in leading otolaryngology journals. Study Design and Setting We reviewed all RCTs of treatment efficacy from 2000 through 2005 in 4 major otolaryngology journals. Data included study quality, author's conclusions, adverse events, and study support/funding. Results Of 5467 total articles, 202 (3.7%) were RCTs of treatment efficacy. Slightly more than half of the trials were supported by for-profit organizations (25%), not-for-profit groups (21%), or both (7%). Intent-to-treat analysis was used in 58 percent of trials, P values in 88 percent, and confidence intervals in 11 percent. Conclusions favoring the experimental group were unrelated to presence or absence of industry funding, and conclusions suggesting equivalence were unrelated to sample size. Conclusions RCTs are uncommon in otolaryngology journals, but they demonstrate frequent use of intent-to-treat analysis, no evidence of publication bias for funded studies, and no evidence of low power in studies suggesting equivalence. Significance This study has implications for both the otolaryngology researcher designing studies and the practicing clinician interpreting them.

Cochrane corner: antibiotic prophylaxis for mammalian bites (intervention review)

2012 ◽  
Vol 37 (8) ◽  
pp. 804-806 ◽  
Author(s):  
J. Henton ◽  
A. Jain
Keyword(s):  
Randomized Controlled Trials ◽  
Wound Infection ◽  
School Age Children ◽  
Controlled Trials ◽  
Emergency Rooms ◽  
Bite Wound ◽  
Hospital Emergency ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Data Collection And Analysis

Background: Bites by mammals are a common problem and they account for up to 1% of all visits to hospital emergency rooms. Dog and cat bites are the most common, and people are usually bitten by their own pets or by an animal known to them. School-age children make up almost a half of those bitten. Prevention of tetanus, rabies and wound infection are the priorities for staff in emergency rooms. The use of antibiotics may be useful to reduce the risk of developing a wound infection. Objectives: To determine if the use of prophylactic antibiotics in mammalian bites is effective in preventing bite-wound infection. Search methods: Relevant randomized controlled trials (RCTs) were identified by electronic searches of MEDLINE, EMBASE, LILACS and the Cochrane Controlled Trials Register databases in November 2000. Selection criteria: We included randomized controlled trials that studied patients with bites from all mammals. Comparisons were made between antibiotics and placebo or no intervention. The outcome of interest was the number of infections at the site of the bite. Data collection and analysis: Two reviewers extracted the data independently. All analyses were performed according to the intention-to-treat method.

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