Impact of Spin in the Abstracts of Articles Reporting Results of Randomized Controlled Trials in the Field of Cancer: The SPIIN Randomized Controlled Trial

2014 ◽  
Vol 32 (36) ◽  
pp. 4120-4126 ◽  
Author(s):  
Isabelle Boutron ◽  
Douglas G. Altman ◽  
Sally Hopewell ◽  
Francisco Vera-Badillo ◽  
Ian Tannock ◽  
...  
Keyword(s):  
Beneficial Effect ◽  
Randomized Controlled Trials ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Experimental Treatment ◽  
Mean Difference ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Significant Difference ◽  
The Impact

Purpose We aimed to assess the impact of spin (ie, reporting to convince readers that the beneficial effect of the experimental treatment is greater than shown by the results) on the interpretation of results of abstracts of randomized controlled trials (RCTs) in the field of cancer. Methods We performed a two-arm, parallel-group RCT. We selected a sample of published RCTs with statistically nonsignificant primary outcome and with spin in the abstract conclusion. Two versions of these abstracts were used—the original with spin and a rewritten version without spin. Participants were clinician corresponding authors of articles reporting RCTs, investigators of trials, and reviewers of French national grants. The primary outcome was clinicians' interpretation of the beneficial effect of the experimental treatment (0 to 10 scale). Participants were blinded to study hypothesis. Results Three hundred clinicians were randomly assigned using a Web-based system; 150 clinicians assessed an abstract with spin and 150 assessed an abstract without spin. For abstracts with spin, the experimental treatment was rated as being more beneficial (mean difference, 0.71; 95% CI, 0.07 to 1.35; P = .030), the trial was rated as being less rigorous (mean difference, −0.59; 95% CI, −1.13 to 0.05; P = .034), and clinicians were more interested in reading the full-text article (mean difference, 0.77; 95% CI, 0.08 to 1.47; P = .029). There was no statistically significant difference in the clinicians' rating of the importance of the study or the need to run another trial. Conclusion Spin in abstracts can have an impact on clinicians' interpretation of the trial results.

scholarly journals The Timing of Initiating Complementary Feeding in Preterm Infants and Its Effect on Overweight: A Systematic Review

2018 ◽  
Vol 72 (4) ◽  
pp. 307-315 ◽  
Author(s):  
Karin M. Vissers ◽  
Edith J.M. Feskens ◽  
Johannes B. van Goudoever ◽  
Arieke J. Janse
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Preterm Infants ◽  
Complementary Feeding ◽  
Controlled Trial ◽  
Controlled Trials ◽  
Z Score ◽  
Term Infants ◽  
Randomized Controlled ◽  
Significant Difference

Background: What is the appropriate time to start complementary feeding for preterm infants? The answer to this question is yet under debate. The timing of initiating complementary feeding may be associated with overweight in term infants. This systematic review aimed to study the effect of the timing of initiating complementary feeding on overweight in preterm infants. Predefined search items included preterm infants, complementary feeding, overweight, and their synonyms. Summary: The search identified 15,749 articles, of which 5 articles were included. Three studies presented data of randomized controlled trials and 2 studies were cohort studies. Two randomized controlled trials found no significant difference in body mass index (BMI) Z-score between the intervention groups at 12 months of age. One randomized controlled trial presented a significant greater mean rate of growth in length per week until 12 months in the preterm weaning strategy-group compared with the current best practices. One observational study concluded that each month the infants received complementary food later, the Z-score for length and weight was reduced by 0.1. Key Messages: No clear conclusion could be drawn from the included studies. This review illustrates the need for further research to access the effect of the timing of initiating complementary feeding on overweight in preterm infants.

scholarly journals Assessing the impact of retraction on the citation of randomized controlled trial reports: an interrupted time-series analysis

2018 ◽  
Vol 24 (1) ◽  
pp. 44-51 ◽  
Author(s):  
Andrew Mott ◽  
Caroline Fairhurst ◽  
David Torgerson
Keyword(s):  
Time Series ◽  
Randomized Controlled Trial ◽  
Randomized Controlled Trials ◽  
Controlled Trial ◽  
Interrupted Time Series ◽  
Controlled Trials ◽  
Interrupted Time Series Analysis ◽  
Randomized Controlled ◽  
Before And After ◽  
The Impact

Objectives To assess the impact of retraction on the citation of randomized controlled trials. Methods We used an interrupted time-series with matched controls. PubMed, CINHAL, Google and the Retraction Watch Database were searched. We identified retracted publications reporting the results of randomized controlled trials involving human participants with two years of available data before and after retraction. We obtained monthly citation counts across all articles for the 24 months before and after retraction, from Web of Science. We used a Poisson segmented regression to detect changes in the level and trend of citation following retraction. We also undertook a matched control analysis of unretracted randomized controlled trials and a sensitivity analysis to account for cases of large-scale, well-advertised fraud. Results We identified 387 retracted randomized controlled trial reports, of which 218 (56.3%) were included in the interrupted time-series analysis. A reduction of 22.9% (95% CI 4.0% to 38.2%, p = 0.02) was observed in the number of citations in the month after retraction, and a further reduction of 1.9% (95% CI 0.4% to 3.5%, p = 0.02) per month in the following 24 months, relative to the expected trend. There was no evidence of a statistically significant reduction among the matched controls. Authors with a large number of retractions saw a 48.2% reduction at the time of retraction (95% CI 17.7% to 67.3%, p = 0.01). Other cases had a more gradual reduction with no change at the time of retraction and a 1.8% reduction per month in the following 24 months (95% CI 0.2% to 3.4%, p = 0.03). Conclusions Retractions of randomized controlled trial reports can be effective in reducing citations. Other factors, such as the scale of the retractions and media attention, may play a role in the effectiveness of the reduction.

scholarly journals Three-Hourly versus Two-Hourly Feeding Interval in Stable Preterm Infants: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2021 ◽  
Author(s):  
Jogender Kumar ◽  
Jitendra Meena ◽  
Pradeep Debata ◽  
Jeeva Mary Sankar ◽  
Praveen Kumar ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Preterm Infants ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Stage Ii ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Registration Number ◽  
Group 1

Abstract Evidence from randomized controlled trials (RCTs) suggests that three-hourly feeding is safe and might help achieve full feeds earlier in preterm infants. We systematically compared the benefits and harms of three-hourly and two-hourly feeding schedules in preterm infants. We searched electronic databases (MEDLINE, CINAHL, Embase, Web of Science, and Scopus) and trial registries until 30 July 2021 for RCTs comparing the two feeding schedules. We did random-effects meta-analysis using RevMan 5.4 software. The primary outcome was the incidence of stage II or III necrotizing enterocolitis (NEC). Other outcomes were the incidence of any stage NEC, sepsis, mortality, time to full enteral feeds, and hospital stay. Six trials (872 participants) are included. There was no significant difference in the incidence of stage II/III NEC (3 trials; 530 participants; RR 1.39; 95% CI: 0.53,3.65; I2 -0%, low certainty), and any stage NEC (5 studies; 767 participants; RR 0.98; 95% CI: 0.53,1.82; I2 0%, very-low certainty) between three and two-hourly feeding groups. There was no difference in the time to achieve full feeds (5 trials; 755 participants; MD: -0.0 days; 95% CI: -0.32, 0.31, low certainty) or other outcomes. On subgroup analysis, neonates with birthweight <1000 grams and in the three-hourly feeding regime achieved full enteral feeds slower than those in the two-hourly feeding group (1 trial; 84 participants; MD: 2.9 days, 95% CI: 1.16, 4.64, low certainty).ConclusionIn stable preterm infants (1000-1500 grams), three-hourly feeding can be followed safely. In infants <1000 grams, two-hourly feeding should be continued till further evidence.Prospero Registration Number: CRD42021246568

scholarly journals A double-masked placebo-controlled trial of azithromycin to prevent child mortality in Burkina Faso, West Africa: Community Health with Azithromycin Trial (CHAT) study protocol

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Ali Sié ◽  
◽  
Mamadou Ouattara ◽  
Mamadou Bountogo ◽  
Cheik Bagagnan ◽  
...  
Keyword(s):  
West Africa ◽  
Randomized Controlled Trials ◽  
Burkina Faso ◽  
Child Mortality ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Sub Saharan Africa ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
All Cause Mortality

Abstract Background Biannual, mass azithromycin distribution has previously been shown to reduce all-cause child mortality in sub-Saharan Africa. Subgroup analysis suggested that the strongest effects were in the youngest children, leading to the hypothesis that targeting younger age groups might be an effective strategy to prevent mortality. We present the methods of two randomized controlled trials designed to evaluate mass and targeted azithromycin distribution for the prevention of child mortality in Burkina Faso, West Africa. Methods/design The Child Health with Azithromycin Treatment (CHAT) study consists of two nested, randomized controlled trials. In the first, communities are randomized in a 1:1 fashion to biannual, mass azithromycin distribution or placebo. The primary outcome is under-5 all-cause mortality measured at the community level. In the second, children attending primary healthcare facilities during the first 5–12 weeks of life for a healthy child visit (e.g., for vaccination) are randomized in a 1:1 fashion to a single orally administered dose of azithromycin or placebo. The primary outcome is all-cause mortality measured at 6 months of age. The trial commenced enrollment in August 2019. Discussion This study is expected to provide evidence on two health systems delivery approaches (mass and targeted treatment) for azithromycin to prevent all-cause child mortality. The results will inform global and national policies related to azithromycin for the prevention of child mortality. Trial registration ClinicalTrials.gov, ID: NCT03676764. Registered on 19 September 2018; prospectively registered pre results.

Effects of Volatile Anesthetics on Mortality and Postoperative Pulmonary and Other Complications in Patients Undergoing Surgery

2016 ◽  
Vol 124 (6) ◽  
pp. 1230-1245 ◽  
Author(s):  
Christopher Uhlig ◽  
Thomas Bluth ◽  
Kristin Schwarz ◽  
Stefanie Deckert ◽  
Luise Heinrich ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
General Anesthesia ◽  
Odds Ratio ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Volatile Anesthetics ◽  
Noncardiac Surgery ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
The Impact

Abstract Background It is not known whether modern volatile anesthetics are associated with less mortality and postoperative pulmonary or other complications in patients undergoing general anesthesia for surgery. Methods A systematic literature review was conducted for randomized controlled trials fulfilling following criteria: (1) population: adult patients undergoing general anesthesia for surgery; (2) intervention: patients receiving sevoflurane, desflurane, or isoflurane; (3) comparison: volatile anesthetics versus total IV anesthesia or volatile anesthetics; (4) reporting on: (a) mortality (primary outcome) and (b) postoperative pulmonary or other complications; (5) study design: randomized controlled trials. The authors pooled treatment effects following Peto odds ratio (OR) meta-analysis and network meta-analysis methods. Results Sixty-eight randomized controlled trials with 7,104 patients were retained for analysis. In cardiac surgery, volatile anesthetics were associated with reduced mortality (OR = 0.55; 95% CI, 0.35 to 0.85; P = 0.007), less pulmonary (OR = 0.71; 95% CI, 0.52 to 0.98; P = 0.038), and other complications (OR = 0.74; 95% CI, 0.58 to 0.95; P = 0.020). In noncardiac surgery, volatile anesthetics were not associated with reduced mortality (OR = 1.31; 95% CI, 0.83 to 2.05, P = 0.242) or lower incidences of pulmonary (OR = 0.67; 95% CI, 0.42 to 1.05; P = 0.081) and other complications (OR = 0.70; 95% CI, 0.46 to 1.05; P = 0.092). Conclusions In cardiac, but not in noncardiac, surgery, when compared to total IV anesthesia, general anesthesia with volatile anesthetics was associated with major benefits in outcome, including reduced mortality, as well as lower incidence of pulmonary and other complications. Further studies are warranted to address the impact of volatile anesthetics on outcome in noncardiac surgery.

Beyond Randomized Controlled Trials

2012 ◽  
Vol 17 (1) ◽  
pp. 72-75 ◽  
Author(s):  
Isaac Golden
Keyword(s):  
Alternative Medicine ◽  
Randomized Controlled Trials ◽  
Complementary And Alternative Medicine ◽  
Controlled Trial ◽  
Pharmaceutical Research ◽  
Controlled Trials ◽  
Medicine Research ◽  
Randomized Controlled ◽  
The Impact ◽  
Complementary And Alternative

Complementary and alternative medicine is criticized by some as lacking evidence to support the effectiveness of its methods and medicines. Such critics typically point to mixed results from using randomized controlled trials to test complementary and alternative medicine. Randomized controlled trials have been held to be the “gold standard” in pharmaceutical research, but a growing body of evidence in orthodox journals has identified their limitations. Here, 5 fundamental flaws in the randomized controlled trial–based model are discussed as well as the impact on its relevance for testing complementary and alternative medicine therapies. A better way to evaluate complementary and alternative medicine therapies is also proposed. A 7-item checklist is suggested to quantify the strength of an area of complementary and alternative medicine research.

scholarly journals Applying A/B Testing to Clinical Decision Support: Rapid Randomized Controlled Trials

10.2196/16651 ◽  
2021 ◽  
Vol 23 (4) ◽  
pp. e16651
Author(s):  
Jonathan Austrian ◽  
Felicia Mendoza ◽  
Adam Szerencsy ◽  
Lucille Fenelon ◽  
Leora I Horwitz ◽  
...  
Keyword(s):  
Decision Support ◽  
Randomized Controlled Trials ◽  
Clinical Decision Support ◽  
Clinical Decision ◽  
Controlled Trials ◽  
Alert Fatigue ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Acceptance Rates ◽  
The Impact

Background Clinical decision support (CDS) is a valuable feature of electronic health records (EHRs) designed to improve quality and safety. However, due to the complexities of system design and inconsistent results, CDS tools may inadvertently increase alert fatigue and contribute to physician burnout. A/B testing, or rapid-cycle randomized tests, is a useful method that can be applied to the EHR in order to rapidly understand and iteratively improve design choices embedded within CDS tools. Objective This paper describes how rapid randomized controlled trials (RCTs) embedded within EHRs can be used to quickly ascertain the superiority of potential CDS design changes to improve their usability, reduce alert fatigue, and promote quality of care. Methods A multistep process combining tools from user-centered design, A/B testing, and implementation science was used to understand, ideate, prototype, test, analyze, and improve each candidate CDS. CDS engagement metrics (alert views, acceptance rates) were used to evaluate which CDS version is superior. Results To demonstrate the impact of the process, 2 experiments are highlighted. First, after multiple rounds of usability testing, a revised CDS influenza alert was tested against usual care CDS in a rapid (~6 weeks) RCT. The new alert text resulted in minimal impact on reducing firings per patients per day, but this failure triggered another round of review that identified key technical improvements (ie, removal of dismissal button and firings in procedural areas) that led to a dramatic decrease in firings per patient per day (23.1 to 7.3). In the second experiment, the process was used to test 3 versions (financial, quality, regulatory) of text supporting tobacco cessation alerts as well as 3 supporting images. Based on 3 rounds of RCTs, there was no significant difference in acceptance rates based on the framing of the messages or addition of images. Conclusions These experiments support the potential for this new process to rapidly develop, deploy, and rigorously evaluate CDS within an EHR. We also identified important considerations in applying these methods. This approach may be an important tool for improving the impact of and experience with CDS. Trial Registration Flu alert trial: ClinicalTrials.gov NCT03415425; https://clinicaltrials.gov/ct2/show/NCT03415425. Tobacco alert trial: ClinicalTrials.gov NCT03714191; https://clinicaltrials.gov/ct2/show/NCT03714191

scholarly journals The Effects of Qigong for Hypertension: A Meta-Analysis of Randomized Controlled Trials

2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Xiaosheng Dong ◽  
Zhenguo Shi ◽  
Meng Ding ◽  
Xiangren Yi
Keyword(s):  
Blood Pressure ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Reduce Blood Pressure ◽  
Mean Difference ◽  
Controlled Trials ◽  
Electronic Resource ◽  
Complementary And Alternative Therapy ◽  
Randomized Controlled ◽  
Significant Difference

Background. Hypertension has been a global public health problem. Qigong as a complementary and alternative therapy is often used to reduce blood pressure. The aim of this meta-analysis was to investigate the effects of Qigong on blood pressure in hypertensive patients. Methods. Six electronic resource databases were searched from inception to January 2019, and randomized controlled trials of Qigong on hypertension were retrieved. Meta-analysis was conducted according to the guidelines of the Cochrane Collaboration, and Review Manager 5.3 was applied. Two researchers independently identified articles to include based on inclusion/exclusion criteria, data extraction, and quality evaluation. Results. Fourteen studies, with 829 individuals, were included. The meta-analysis demonstrates that, compared with no exercise, Qigong has significant positive effects on systolic blood pressure (mean difference = −8.90, 95% CI (−12.13, −5.67), P < 0.00001 ) and diastolic blood pressure (mean difference = −5.02, 95% CI (−7.88, −2.17), P < 0.00001 ). There is, however, no significant difference between Qigong and other aerobic exercises in reducing blood pressure. Conclusion. Qigong can effectively reduce blood pressure levels. Longer-term engagement in the practice has an even better effect in hypertension patients. However, the conclusion of this study still needs to be verified by more high-quality studies.

scholarly journals Efficacy and Safety of Adalimumab in Noninfectious Uveitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2021 ◽  
Vol 12 ◽  
Author(s):  
Biao Li ◽  
Haoran Li ◽  
Li Zhang ◽  
Yanlin Zheng
Keyword(s):  
Systematic Review ◽  
Treatment Failure ◽  
Randomized Controlled Trials ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Mean Difference ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Risk Of Treatment

Background: Patients with noninfectious uveitis (NIU) are at risk of systemic side effects of long-term glucocorticoid therapy and uncontrolled inflammatory complications. In urgent need to identify more aggressive therapies, adalimumab (ADA) may be the right choice.Objectives: To summarize the current evidence from randomized controlled trials (RCTs) regarding the efficacy and safety of ADA in the treatment of NIU.Methods: We searched Pubmed, Embase, Web of Science, Cochrane Library databases, and Clinical Trials Registry for qualifying articles from their inception to November 19, 2020, with no language restriction. Randomized controlled trials comparing ADA with conventional routine treatment in noninfectious uveitis patients of any age, gender, or ethnicity were included. The primary outcome was the time to treatment failure (TF). The secondary outcomes were the change in best-corrected visual acuity (BCVA), change in the anterior chamber (AC) cell grade, change in vitreous haze (VH) grade, and adverse events (AEs).Main results: The six studies comprised 605 participants in all, and the sample size of each study ranged from 16 to 225. The overall pooled results of the primary outcome (HR = 0.51; 95% CI, 0.41 to –0.63) showed that ADA nearly halved the risk of treatment failure compared to placebo for NIU patients. The pooled mean difference of change in BCVA was -0.05 (95% CI, −0.07 to −0.02). The pooled mean difference of change in AC cell grade and VH grade was −0.29 (95% CI, −0.62 to −0.05) and −0.21 (95% CI, −0.32 to −0.11), respectively. The incidence of AEs in the ADA group was numerically higher than that of AEs in the placebo group (2,237 events and 9.40 events per patient-year, equivalent to 1,257 events and 7.79 events per patient-year).Conclusion: This meta-analysis of six RCTs further confirmed that ADA considerably lowered the risk of treatment failure or visual loss, and moderately reduced AC cell grades and VH grades with slightly more AEs, as compared to placebo. ADA is both effective and safe in treating NIU.Systematic Review Registration: [https://clinicaltrials.gov], identifier [CRD42020217909].

Chinese manipulation for mechanical neck pain: a systematic review

2012 ◽  
Vol 26 (11) ◽  
pp. 963-973 ◽  
Author(s):  
Jian Hua Lin ◽  
Thomas Tai Wing Chiu ◽  
Jia Hu
Keyword(s):  
Pain Relief ◽  
Neck Pain ◽  
Randomized Controlled Trials ◽  
Controlled Trial ◽  
Cervical Vertebrae ◽  
Mean Difference ◽  
Controlled Trials ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Quality Evidence

Objective: To assess whether Chinese manipulation improves pain, function/disability and global perceived effect in adults with acute/subacute/chronic neck pain. Data sources: CAJ Full-text Database (Chinese), Wanfang Database (Chinese), Cochrane Database (English) and Medline (English). Review methods: Literature searching was performed with the following keywords and their combination: ‘manual therapy/bone setting/Chinese manipulation’, ‘neck/cervical pain’, ‘cervical vertebrae’, ‘cervical spondylosis/radiculopathy’ and ‘randomized controlled trial/review.’ Two independent reviewers selected studies, extracted data and assessed risk of bias for each included study. Randomized controlled trials or quasi-randomized controlled trials on the effect of Chinese manipulation in treating adult patients with neck pain were selected. Mean differences with 95% confidence intervals (CI) were calculated. Quality of the evidence was assessed by the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. Results: Four studies (610 participants) were included in this review. There was very low-quality evidence suggesting that, compared to cervical traction in sitting, Chinese manipulation produced more immediate post-intervention pain relief (mean difference: –1.06; 95% CI: –1.37~ –0.75; P < 0.001) and improvement of global signs and symptoms (mean difference: –3.81; 95% CI: −4.71 ~ −2.91; P < 0.001). Very low-quality evidence showed that Chinese manipulation alone was superior to Chinese traditional massage in immediate post-intervention pain relief (mean difference: −2.02; 95% CI: −2.78~ −1.26; P < 0.001). Conclusions: There was limited evidence showing Chinese manipulation could produce short-term improvement for neck pain.

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