scholarly journals Trial registration and selective outcome reporting in 585 clinical trials investigating drugs for prevention of postoperative nausea and vomiting

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Manuel Riemer ◽  
Peter Kranke ◽  
Antonia Helf ◽  
Debora Mayer ◽  
Maria Popp ◽  
...  
Keyword(s):  
Clinical Trials ◽  
High Risk ◽  
Postoperative Nausea ◽  
Cochrane Review ◽  
Postoperative Nausea And Vomiting ◽  
Risk Of Bias ◽  
The Body ◽  
Trial Registration ◽  
Selective Outcome Reporting ◽  
Outcome Reporting

Abstract Background Selective outcome reporting in clinical trials introduces bias in the body of evidence distorting clinical decision making. Trial registration aims to prevent this bias and is suggested by the International Committee of Medical Journal Editors (ICMJE) since 2004. Methods The 585 randomized controlled trials (RCTs) published between 1965 and 2017 that were included in a recently published Cochrane review on antiemetic drugs for prevention of postoperative nausea and vomiting were selected. In a retrospective study, we assessed trial registration and selective outcome reporting by comparing study publications with their registered protocols according to the ‘Cochrane Risk of bias’ assessment tool 1.0. Results In the Cochrane review, the first study which referred to a registered trial protocol was published in 2004. Of all 585 trials included in the Cochrane review, 334 RCTs were published in 2004 or later, of which only 22% (75/334) were registered. Among the registered trials, 36% (27/75) were pro- and 64% (48/75) were retrospectively registered. 41% (11/27) of the prospectively registered trials were free of selective outcome reporting bias, 22% (6/27) were incompletely registered and assessed as unclear risk, and 37% (10/27) were assessed as high risk. Major outcome discrepancies between registered and published high risk trials were a change from the registered primary to a published secondary outcome (32%), a new primary outcome (26%), and different outcome assessment times (26%). Among trials with high risk of selective outcome reporting 80% favoured at least one statistically significant result. Registered trials were assessed more often as ‘overall low risk of bias’ compared to non-registered trials (64% vs 28%). Conclusions In 2017, 13 years after the ICMJE declared prospective protocol registration a necessity for reliable clinical studies, the frequency and quality of trial registration in the field of PONV is very poor. Selective outcome reporting reduces trustworthiness in findings of clinical trials. Investigators and clinicians should be aware that only following a properly registered protocol and transparently reporting of predefined outcomes, regardless of the direction and significance of the result, will ultimately strengthen the body of evidence in the field of PONV research in the future.

scholarly journals Quality assessment of studies included in Cochrane oral health systematic reviews

2020 ◽  
Author(s):  
Ahmad Sofi-Mahmudi ◽  
Pouria Iranparvar ◽  
Maryam Shakiba ◽  
Erfan Shamsoddin ◽  
Hossein Mohammad-Rahimi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Oral Health ◽  
High Risk ◽  
Systematic Reviews ◽  
Randomized Clinical Trials ◽  
Cochrane Review ◽  
Risk Of Bias ◽  
Double Blind ◽  
Cochrane Reviews ◽  
Performance Bias

AbstractObjectivesThe Risk of Bias (RoB) and other characteristics of randomized clinical trials included in Cochrane oral health systematic reviews were assessed.Study Design and SettingsAll the trials included in Cochrane oral health systematic reviews were examined. The RoB was evaluated for all the included clinical trials according to the Cochrane review standards. The Overall Risk of Bias (ORoB) was defined in this study based on the criteria for determining the overall bias in Cochrane’s RoB tool-v2. Descriptive analyses were carried out to determine the frequency of each intended variable.ResultsA total of 2565 studies were included in our analysis. The majority of the studies (n=1600) had sample sizes of 50 or higher. As for blinding, 907 studies were labelled as double-blind. Performance bias showed the highest rate of high risk (31.4%). Almost half of the studies had a high ORoB compared to 11.1% with low ORoB. The studies that used placebos had higher low ORoB (14.8% vs. 10.7%). The double-blind studies had the highest low ORoB (23.6%). The studies with a cross-over design had the highest low ORoB (28.8%).ConclusionOverall, the RoB for the studies on dentistry and oral health in Cochrane reviews was deemed high.

scholarly journals Quality Assessment of Clinical Trials Included in Cochrane Oral Health Systematic Reviews

2021 ◽  
Author(s):  
Ahmad Sofi-Mahmudi ◽  
Pouria Iranparvar ◽  
Maryam Shakiba ◽  
Erfan Shamsoddin ◽  
Hossein Mohammad-Rahimi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Oral Health ◽  
High Risk ◽  
Systematic Reviews ◽  
Cochrane Review ◽  
Risk Of Bias ◽  
Double Blind ◽  
Cochrane Reviews ◽  
Health Studies ◽  
Performance Bias

Abstract Background: Risk of Bias (RoB) and other characteristics of randomised clinical trials included in Cochrane oral health systematic reviews were assessed.Methods: All the trials included in Cochrane oral health systematic reviews were identified and examined. The RoB was evaluated for all the included clinical trials according to the Cochrane review standards. The Overall Risk of Bias (ORoB) was defined in this study based on the criteria in Cochrane’s RoB tool-v2. Descriptive analyses were carried out to determine the frequency of each intended variable.Results: In a total of 2565 included studies, the majority (n=1600) had 50 or higher sample sizes. As for blinding, 907 studies were labelled as double-blind. Performance bias showed the highest rate of high risk (31.4%). Almost half of the studies had a high ORoB compared to 11.1% with low ORoB. The studies that used placebos had higher low ORoB (14.8% vs 10.7%). The double-blind studies had the highest low ORoB (23.6%). The studies with a cross-over design had the highest low ORoB (28.8%).Conclusion: The RoB of oral health studies in Cochrane reviews was deemed high. Special efforts may be required to improve conducting and reporting of trials in this area.

Evaluation of selective outcome reporting and trial registration practices among addiction clinical trials

Addiction ◽  
2020 ◽  
Vol 115 (6) ◽  
pp. 1172-1179 ◽  
Author(s):  
Matt Vassar ◽  
William Roberts ◽  
Craig M. Cooper ◽  
Cole Wayant ◽  
Michael Bibens
Keyword(s):  
Clinical Trials ◽  
Trial Registration ◽  
Selective Outcome Reporting ◽  
Outcome Reporting

Selective outcome reporting in root coverage randomized clinical trials

2021 ◽  
Author(s):  
Daniel Isaac Sendyk ◽  
Nathalia Vilela Souza ◽  
João Batista César Neto ◽  
Dimitris N. Tatakis ◽  
Cláudio Mendes Pannuti
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Root Coverage ◽  
Selective Outcome Reporting ◽  
Outcome Reporting

Dexamethasone in Patients with Spontaneous Intracerebral Hemorrhage: An Updated Meta-Analysis

2020 ◽  
Vol 49 (5) ◽  
pp. 495-502
Author(s):  
Stephanie Wintzer ◽  
Josef Georg Heckmann ◽  
Hagen B. Huttner ◽  
Stefan Schwab
Keyword(s):  
Clinical Trials ◽  
High Risk ◽  
Intracerebral Hemorrhage ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Spontaneous Intracerebral Hemorrhage ◽  
Control Groups ◽  
Language Data ◽  
Negative Effect

<b><i>Background:</i></b> Spontaneous intracerebral hemorrhage (ICH) is a frequent cerebrovascular disorder and still associated with high mortality and poor clinical outcomes. The purpose of this review was to update a 15-year-old former meta-analysis on randomized clinical trials (RCTs) addressing the question of whether ICH patients treated with dexamethasone have better outcomes than controls. <b><i>Methods:</i></b> The electronic databases PubMed, SCOPUS, and Cochrane as well as web platforms on current clinical trials were searched for the years 1970–2020 without constriction on language. Data were extracted and outcomes were pooled for conventional and cumulative meta-analysis using a commercial software program (www.Meta-Analysis.com). <b><i>Results:</i></b> Finally, 7 RCTs were identified and analyzed including 248 participants in the dexamethasone groups and 242 in the control groups. Five studies showed a high risk of bias. The overall relative risk (RR) for death was 1.32 (95% confidence interval [CI] 0.99–1.76; <i>p</i> = 0.06) and did not differ significantly between the 2 groups. After exclusion of studies with high risk of bias, the RR for death was 1.37 (95% CI 0.54–3.42; <i>p</i> = 0.51). The RR for poor outcome did not differ significantly between the 2 groups analyzed for all included studies (RR = 0.69; 95% CI 0.47–1; <i>p</i> = 0.05) and after exclusion of studies with high risk of bias (RR = 0.7; 95% CI 0.45–1.08; <i>p</i> = 0.11). The RR for complications did not differ significantly including all studies (RR = 1.29; 95% CI 0.77–2.17; <i>p</i> = 0.34) and after exclusion of studies with high risk of bias (RR = 1.27; 95% CI 0.18–8.89; <i>p</i> = 0.81). The cumulative statistics delivered no other results; however, it pointed out fewer complications over time in the dexamethasone group. <b><i>Conclusion:</i></b> Clear evidence of a beneficial or negative effect of dexamethasone is still lacking. Modern RCTs or observational studies with propensity design are necessary to evaluate the efficacy and safety of treatment with dexamethasone in patients with ICH.

scholarly journals The Effect of a Multifaceted Postoperative Nausea and Vomiting Reduction Strategy on Prophylaxis Administration Amongst Higher-Risk Adult Surgical Patients

2018 ◽  
Vol 46 (2) ◽  
pp. 185-189 ◽  
Author(s):  
A. Pym ◽  
E. Ben-Menachem
Keyword(s):  
High Risk ◽  
Postoperative Nausea ◽  
Postoperative Nausea And Vomiting ◽  
Outcome Data ◽  
Nausea And Vomiting ◽  
Surgical Patients ◽  
Evidence Based ◽  
Post Intervention ◽  
Reduction Strategy ◽  
Risk Patients

Postoperative nausea and vomiting (PONV) is a common and distressing problem for patients and increases the burden of care in post-anaesthesia care units (PACU). As such it has been a recent focus for quality improvement. Evidence-based guidelines have demonstrated the benefit of PONV risk stratification and prophylaxis, but may be underutilised in clinical practice. This prospective pre-/post-intervention study was conducted at an adult tertiary hospital in non-cardiac adult surgical patients at higher risk of PONV. The intervention included promotion of an evidence-based PONV guideline, and provision of individualised prescribing and patient outcome data to anaesthetists. Six hundred and twenty-eight patients with ≥2 risk factors for PONV following general anaesthesia for non-cardiac surgery were included (333 pre-intervention and 295 post-intervention). Prior to the intervention, 9.0% (30/333) of moderate- and high-risk patients received antiemetic prophylaxis consistent with our guideline. Post-intervention, the rate of guideline adherence was 19.3% (57/295). In the high-risk PONV group, the time in PACU was significantly reduced post-intervention, 66 minutes versus 83 minutes (P=0.032). This institution-specific PONV reduction strategy had a modest but significant effect on improving prophylaxis administration. However, our findings indicate that further efforts would be required to ensure fuller compliance with the current extensive evidence base for PONV management in higher-risk patients.

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