Quality of Reporting of Harms in the NCI Sponsored Phase III Hematological Malignancies Trials.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 292-292
Author(s):  
Heloisa P. Soares ◽  
Ambuj Kumar ◽  
Benjamin Djulbegovic
Keyword(s):  
Clinical Trials ◽  
Survival Data ◽  
Hematological Malignancy ◽  
Meta Analysis ◽  
Drop Out ◽  
Phase Iii ◽  
Accurate Information ◽  
Power Calculation ◽  
Quality Of Reporting

Abstract Background: To make informed decisions, patients and physicians need accurate information both on treatment benefits and harms. However, reports of clinical trials typically focus on description of benefits only. Research supported by the NCI account almost for 100% of all publicly sponsored phase III trials in the US, and is widely considered as the most important for advancement of treatment against cancer. Therefore, it is important to assess the quality of reporting of treatment-related mortality (TRM) and morbidity (TRMorb) in this setting. Methods: We evaluated all randomized controlled trials (RCTs) that have been conducted by six NCI sponsored cooperative oncology groups (COGs). We included all trials that were completed by 2002. Here we focus on hematological malignancy trials. Data related to TRM and TRMorb were extracted from publications that reported benefits (i.e. survival or event-free survival). Data were pooled using meta-analytic techniques to assess if the harms were worse in experimental vs. standard treatments. Results: We evaluated,114 hematological-malignancy trials. Seventy-nine trials studied leukemias, 32 lymphomas and 3 either multiple myeloma or myelodysplastic syndrome. Quality of reporting for the most important methodological domains (such as randomization methodology, power calculation, drop-out rates, use of intention-to-treat analysis) was high. Data related to TRM were extractable from 41 trials (36%) only. Overall, TRM accounted for less than 5% of all deaths and was shown to be significantly higher in patients allocated to innovative treatments [Odds ratio 1.93: 99%CI (1.11–1.76)]. TRM was similar according to the type of hematological malignancy or COG. Treatment-related morbidity data were reported in different non-standardized formats; therefore, it was not possible to perform a meta-analysis to give an accurate assessment of TRMorb in experimental and conventional treatment arms. Conclusion: Treatment-related harms have been inadequately reported even in the currently best available research. Given the fact, that the users of research evidence can only rely on the available published reports, the NCI should urgently improve the requirment for the standards of reporting of clinical trials it funds.

Quality of reports related to survival events in randomized clinical trials: A review of recent cancer trials published in eight major journals

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6611-6611
Author(s):  
S. Mathoulin-Pelissier ◽  
S. Gourgou-Bourgade ◽  
F. Bonnetain ◽  
A. Kramar
Keyword(s):  
At Risk ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Relevant Information ◽  
Consort Statement ◽  
Phase Iii ◽  
Accurate Information ◽  
Survival Endpoints ◽  
Adequate Definition

6611 Background: About ten years ago, Altman pointed the low quality of survival analyses published in cancer journals. Despite the development of Consort statement, the lack of quality standards remained in the reports of randomized clinical trials (RCT).The aim of this study was to evaluate quality of definitions and reports of survival endpoints in recent cancer RCTs. Methods: A computerized search in Medline databases identified 274 cancer RCTs published from January 2004 to December 2004 in 4 general medical journals (BMJ, JAMA, Lancet, NEJM) and 4 clinical oncology journals (BJC, Cancer, JCO, JNCI). Eligible papers were these that reported primary analyses of RCT with survival endpoints. Three methodologists have reviewed and scored 1/3 of papers according to 7 key points: prevalence of adequate definition of survival end-points (time to origin, survival events, censures) and relevant information about their analyses (Kaplan-meier method, confidence interval, number of events, patients at risk). Reliability of scoring was checked among a random subsample of 30 papers with an independent biostatistician (kappa coefficient). Results: Following eligibility screening, 149 papers were not included. Among the 125 selected papers, 104 trials were of phase III (83%) and 98 publications (78%) were obtained from the 4 oncology journals. Among these RCTs, a total of 268 survivals endpoints were recorded and overall survival (OS) was the most frequent outcome (118 terms, 44%). Survival terms were adequately defined in 116 endpoints (43%) and OS was most frequent adequately defined (49%). Accurate information about analysis was found in 51 endpoints (19%). The less adequate information was patient's number at risk (55%). Finally, according to the 7 key methodological points, optimal quality of report was found in 19 of the endpoints (7 %) i.e.6 articles (kappa value: 0.65). Conclusions: Majority of published papers failed to provide an adequate definition and analysis reports of survival endpoints. Finally survival definitions add another source of variability actually not controlled. Readers should critically pay attention to the reported definitions since the lack of these elements may lead to misinterpretation of the RCT results. No significant financial relationships to disclose.

scholarly journals Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Ismail Zul Khairul Azwadi ◽  
Mohd Noor Norhayati ◽  
Mohd Shafie Abdullah
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Obstructive Uropathy ◽  
Meta Analysis ◽  
Percutaneous Nephrostomy ◽  
Procedural Pain ◽  
Controlled Trials ◽  
Failure Rates ◽  
Ureteral Stenting

AbstractAcute obstructive uropathy is associated with significant morbidity among patients with any condition that leads to urinary tract obstruction. Immediate urinary diversion is necessary to prevent further damage to the kidneys. In many centres, the two main treatment options include percutaneous nephrostomy (PCN) and retrograde ureteral stenting (RUS). The purpose of this study if to compare the efficacy and safety of PCN and RUS for the treatment of acute obstructive uropathy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, CINAHL, EMBASE, the World Health Organisation International Clinical Trials Registry Platform and ClinicalTrials.gov. We also searched the reference lists of included studies to identify any additional trials. We included randomised controlled trials and controlled clinical trials comparing the outcomes of clinical improvement (septic parameters), hospitalisation duration, quality of life, urinary-related symptoms, failure rates, post-procedural pain [measured using a visual analogue scale (VAS)] and analgesics use. We conducted statistical analyses using random effects models and expressed the results as risk ratio (RR) and risk difference (RD) for dichotomous outcomes and mean difference (MD) for continuous outcomes, with 95% confidence intervals (CIs). Seven trials were identified that included 667 patients. Meta-analysis of the data revealed no difference in the two methods in improvement of septic parameters, quality of life, failure rates, post-procedural pain (VAS), or analgesics use. Patients receiving PCN had lower rates of haematuria and dysuria post-operatively and longer hospitalisation duration than those receiving RUS. PCN and RUS are effective for the decompression of an obstructed urinary system, with no significant difference in most outcomes. However, PCN is preferable to RUS because of its reduced impact on the patient’s post-operative quality of life due to haematuria and dysuria, although it is associated with slightly longer hospitalisation duration.

Effects of electromyographic biofeedback interventions for shoulder pain and function: Systematic review and meta-analysis

2021 ◽  
pp. 026921552199095
Author(s):  
Danilo Harudy Kamonseki ◽  
Letícia Bojikian Calixtre ◽  
Rodrigo Py Gonçalves Barreto ◽  
Paula Rezende Camargo
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Confidence Interval ◽  
Shoulder Pain ◽  
Meta Analysis ◽  
Quality Of Evidence ◽  
Electromyographic Biofeedback ◽  
Mean Differences ◽  
And Function

Objective: To systematically review the effectiveness of electromyographic biofeedback interventions to improve pain and function of patients with shoulder pain. Design: Systematic review of controlled clinical trials. Literature search: Databases (Medline, EMBASE, CINAHL, PEDro, CENTRAL, Web of Science, and SCOPUS) were searched in December 2020. Study selection criteria: Randomized clinical trials that investigated the effects of electromyographic biofeedback for individuals with shoulder pain. Patient-reported pain and functional outcomes were collected and synthesized. Data synthesis: The level of evidence was synthesized using GRADE and Standardized Mean Differences and 95% confidence interval were calculated using a random-effects inverse variance model for meta-analysis. Results: Five studies were included with a total sample of 272 individuals with shoulder pain. Very-low quality of evidence indicated that electromyographic biofeedback was not superior to control for reducing shoulder pain (standardized mean differences = −0.21, 95% confidence interval: −0.67 to 0.24, P = 0.36). Very-low quality of evidence indicated that electromyographic biofeedback interventions were not superior to control for improving shoulder function (standardized mean differences = −0.11, 95% confidence interval: −0.41 to 0.19, P = 0.48). Conclusion: Electromyographic biofeedback may be not effective for improving shoulder pain and function. However, the limited number of included studies and very low quality of evidence does not support a definitive recommendation about the effectiveness of electromyographic biofeedback to treat individuals with shoulder pain.

scholarly journals Blockade of the angiotensin system improves mental health domain of quality of life: A meta-analysis of randomized clinical trials

2017 ◽  
Vol 52 (1) ◽  
pp. 24-38 ◽  
Author(s):  
Daniel J Brownstein ◽  
Estela Salagre ◽  
Cristiano Köhler ◽  
Brendon Stubbs ◽  
João Vian ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Angiotensin System ◽  
Health Domain

Surgical treatment of rectovaginal fistulas (systematic literature review)

2021 ◽  
pp. 30-48
Author(s):  
Andrei Anatolevich Mudrov ◽  
Aleksandr Yur’evich Titov ◽  
Mariyam Magomedovna Omarova ◽  
Sergei Alekseevich Frolov ◽  
Ivan Vasilevich Kostarev ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Meta Analysis ◽  
High Recurrence Rate ◽  
Surgical Interventions ◽  
Rectovaginal Fistulas ◽  
Surgical Treatments

Despite the large number of available surgical interventions aimed at the treatment of rectovaginal fistulas, the results of their use remain extremely disappointing, associated with the high recurrence rate of the disease reaching 80 %, as well as the lack of a single tactic to minimize the risk of anal incontinence and the need for colostomy. Objective: to conduct a systematic literature review in order to summarize information related to the rectovaginal fistulas surgery. The systematic review includes the results of an analysis of 97 clinical trials selected from 756 publications found in databases. Inclusion criteria: a full-text article, the presence of at least 5 patients in the study, as well as data on the outcome of surgery. Clinical trials with different surgical treatments were identified and classified into the following categories: elimination of the rectovaginal septal defect with a displaced flap (rectal and vaginal); Martius surgery; gracilis muscle transposition; transperineal procedure; abdominal procedure including endoscopic and laparoscopic methods; use of biological or biocompatible materials. Treatment outcomes vary significantly from 0 % to > 80 %. None of the studies were randomized. Due to the low quality of the identified studies, comparison of results and meta-analysis conduction were not possible. Conclusion: as a result of the systematic review, data for the analysis and development of any strategic and tactical algorithms for the treatment of RVF were not obtained. The most important questions still remain open: what and when surgical method to choose, is it necessary to form a disconnecting stoma?

scholarly journals The Use of Green Coffee Extract as a Weight Loss Supplement: A Systematic Review and Meta-Analysis of Randomised Clinical Trials

2011 ◽  
Vol 2011 ◽  
pp. 1-6 ◽  
Author(s):  
Igho Onakpoya ◽  
Rohini Terry ◽  
Edzard Ernst
Keyword(s):  
Weight Loss ◽  
Clinical Trials ◽  
Methodological Quality ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Significant Heterogeneity ◽  
Green Coffee ◽  
Significant Difference ◽  
Using Data

The purpose of this paper is to assess the efficacy of green coffee extract (GCE) as a weight loss supplement, using data from human clinical trials. Electronic and nonelectronic searches were conducted to identify relevant articles, with no restrictions in time or language. Two independent reviewers extracted the data and assessed the methodological quality of included studies. Five eligible trials were identified, and three of these were included. All studies were associated with a high risk of bias. The meta-analytic result reveals a significant difference in body weight in GCE compared with placebo (mean difference: kg; 95%CI: , ). The magnitude of the effect is moderate, and there is significant heterogeneity amongst the studies. It is concluded that the results from these trials are promising, but the studies are all of poor methodological quality. More rigorous trials are needed to assess the usefulness of GCE as a weight loss tool.

scholarly journals Comparative efficacy of antimicrobial treatments in dairy cows at dry-off to prevent new intramammary infections during the dry period or clinical mastitis during early lactation: a systematic review and network meta-analysis

2019 ◽  
Vol 20 (2) ◽  
pp. 199-216 ◽  
Author(s):  
C. B. Winder ◽  
J. M. Sargeant ◽  
D. Hu ◽  
C. Wang ◽  
D. F. Kelton ◽  
...  
Keyword(s):  
Systematic Review ◽  
Dairy Cows ◽  
Meta Analysis ◽  
Clinical Mastitis ◽  
Comparative Efficacy ◽  
Dry Period ◽  
Quality Of Reporting ◽  
Intramammary Infections ◽  
Antimicrobial Treatments

AbstractA systematic review and network meta-analysis were conducted to assess the relative efficacy of antimicrobial therapy given to dairy cows at dry-off. Eligible studies were controlled trials assessing the use of antimicrobials compared to no treatment or an alternative treatment, and assessed one or more of the following outcomes: incidence of intramammary infection (IMI) at calving, incidence of IMI during the first 30 days in milk (DIM), or incidence of clinical mastitis during the first 30 DIM. Databases and conference proceedings were searched for relevant articles. The potential for bias was assessed using the Cochrane Risk of Bias 2.0 algorithm. From 3480 initially identified records, 45 trials had data extracted for one or more outcomes. Network meta-analysis was conducted for IMI at calving. The use of cephalosporins, cloxacillin, or penicillin with aminoglycoside significantly reduced the risk of new IMI at calving compared to non-treated controls (cephalosporins, RR = 0.37, 95% CI 0.23–0.65; cloxacillin, RR = 0.55, 95% CI 0.38–0.79; penicillin with aminoglycoside, RR = 0.42, 95% CI 0.26–0.72). Synthesis revealed challenges with a comparability of outcomes, replication of interventions, definitions of outcomes, and quality of reporting. The use of reporting guidelines, replication among interventions, and standardization of outcome definitions would increase the utility of primary research in this area.

Sign in / Sign up

Export Citation Format

Share Document