scholarly journals Absence of a positive outcome bias in randomized controlled trials of minimally invasive surgical techniques

2020 ◽  
Author(s):  
Rashid K. Sayyid ◽  
Soum D. Lokeshwar ◽  
David Tella ◽  
Caitlin E. Jones ◽  
Zachary Klaassen ◽  
...  
Keyword(s):  
Minimally Invasive ◽  
Randomized Controlled Trials ◽  
Surgical Techniques ◽  
Positive Outcome ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Minimally Invasive Surgical ◽  
Outcome Bias

Thirty Years of Minimally Invasive Surgery in Children: Analysis of Meta-Analyses

2019 ◽  
Vol 30 (05) ◽  
pp. 420-428 ◽  
Author(s):  
Joachim F. Kuebler ◽  
Jens Dingemann ◽  
Benno M. Ure ◽  
Nagoud Schukfeh
Keyword(s):  
Minimally Invasive Surgery ◽  
Minimally Invasive ◽  
Randomized Controlled Trials ◽  
Invasive Surgery ◽  
Pediatric Surgery ◽  
Controlled Trials ◽  
Advantages And Disadvantages ◽  
Randomized Controlled ◽  
Lower Complication ◽  
Meta Analyses

Abstract Introduction In the last three decades, minimally invasive surgery (MIS) has been widely used in pediatric surgery. Meta-analyses (MAs) showed that studies comparing minimally invasive with the corresponding open operations are available only for selected procedures. We evaluated all available MAs comparing MIS with the corresponding open procedure in pediatric surgery. Materials and Methods A literature search was performed on all MAs listed on PubMed. All analyses published in English, comparing pediatric minimally invasive with the corresponding open procedures, were included. End points were advantages and disadvantages of MIS. Results of 43 manuscripts were included. MAs evaluating the minimally invasive with the corresponding open procedures were available for 11 visceral, 4 urologic, and 3 thoracoscopic types of procedures. Studies included 34 randomized controlled trials. In 77% of MAs, at least one advantage of MIS was identified. The most common advantages of MIS were a shorter hospital stay in 20, a shorter time to feeding in 11, and a lower complication rate in 7 MAs. In 53% of MAs, at least one disadvantage of MIS was found. The most common disadvantages were longer operation duration in 16, a higher recurrence rate of diaphragmatic hernia in 4, and gastroesophageal reflux in 2 MAs. A lower native liver survival rate after laparoscopic Kasai-portoenterostomy was reported in one MA. Conclusion In the available MAs, the advantages of MIS seem to outnumber the disadvantages. However, for some types of procedures, MIS may have considerable disadvantages. More randomized controlled trials are required to confirm the advantage of MIS for most procedures.

Association of author’s financial conflict of interest with characteristics and outcome of rheumatoid arthritis randomized controlled trials

Rheumatology ◽  
2018 ◽  
Vol 58 (5) ◽  
pp. 776-785 ◽  
Author(s):  
Nasim Ahmed Khan ◽  
Chau L Nguyen ◽  
Talha Khawar ◽  
Horace Spencer ◽  
Karina D Torralba
Keyword(s):  
Drug Therapy ◽  
Randomized Controlled Trials ◽  
Conflicts Of Interest ◽  
Phase 1 ◽  
Temporal Trends ◽  
Positive Outcome ◽  
Stock Ownership ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Research Grant

Abstract Objective To examine the prevalence, types and temporal trends of reported financial conflicts of interest (FCOIs) among authors of drug therapy randomized controlled trials (RCTs) for RA and their association with study outcomes. Methods We identified original, non–phase 1, parallel-group, drug therapy RA RCTs published in the years 2002–03, 2006–07, and 2010–11. Two investigators independently obtained trial characteristics data. Authors’ FCOIs were classified as honoraria/consultation fees receipt, employee status, research grant, and stock ownership. Multivariable logistic regression was performed to identify whether FCOIs were independently associated with study outcome. Results A total of 146 eligible RCTs were identified. Of these, 83 (58.4%) RCTs had at least one author with an FCOI [employee status: 63 (43.2%), honoraria/consultation fees receipt: 49 (33.6%), research grant: 30 (20.5%), and stock ownership: 28 (19.2%)]. A remarkable temporal increase in reporting of honoraria/consultation fees receipt, research grant, and stock ownership was seen. The reporting of any FCOI itself was not associated with positive outcome [50/73 (68.5%) with author FCOI vs 36/52 (69.2%) without author FCOI, P = 0.93]. However, honoraria/consulting fees receipt was independently associated with increased likelihood of a positive outcome [adjusted odds ratio (95% CI) of 3.24 (1.06–9.88)]. In general, trials with FCOIs were significantly more likely to be multicentre, have larger enrolment, use biologic or a small molecule as the experimental intervention, and have better reporting of some methodological quality measures. Conclusion FCOI reporting in RA drug RCT authors is common and temporally increasing. Receipt of honoraria/consulting fees was independently associated with a positive study outcome.

scholarly journals Can musical intervention improve memory in Alzheimer’s patients? Evidence from a systematic review

2018 ◽  
Vol 12 (2) ◽  
pp. 133-142 ◽  
Author(s):  
Shirlene Vianna Moreira ◽  
Francis Ricardo dos Reis Justi ◽  
Marcos Moreira
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Randomized Trials ◽  
Positive Outcome ◽  
Memory Deficit ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Exclusion Criteria ◽  
Randomized Controlled

ABSTRACT Treatment with music has shown effectiveness in the treatment of general behavioural and cognitive symptoms of patients with various types of dementia. Objective: To assess the effectiveness of treatment with music on the memory of patients with Alzheimer’s disease (AD). Methods: A systematic search was performed on PubMed (Medline), Cochrane Library, PsycINFO and Lilacs databases up to June 2017 and included all randomized controlled trials that assessed memory using musical interventions in patients with AD. Results: Forty-two studies were identified, and 24 studies were selected. After applying the exclusion criteria, four studies involving 179 patients were included. These studies showed the benefits of using music to treat memory deficit in patients with AD. Conclusion: To the best of our knowledge, this is the first systematic review focusing on randomized trials found in the literature that analysed the role of musical interventions specifically in the memory of patients with AD. Despite the positive outcome of this review, the available evidence remains inconsistent due to the small number of randomized controlled trials.

scholarly journals Precisely Equal Group Size and Allocation Bias in Nursing Randomized Controlled Trials: A Scientiometric Study

2021 ◽  
Author(s):  
Richard Gray ◽  
Daniel Bressington ◽  
Martin Jones ◽  
David R. Thompson
Keyword(s):  
Randomized Controlled Trials ◽  
Sample Size ◽  
Group Size ◽  
Sample Size Calculation ◽  
Positive Outcome ◽  
Outcome Data ◽  
Controlled Trials ◽  
Nursing Science ◽  
Equal Group ◽  
Randomized Controlled

The manipulation of participant allocation in randomized controlled trials to achieve equal groups sizes may introduce allocation bias potentially leading to larger treatment effect estimates. This study aimed to estimate the proportion of nursing trials that have precisely equal group sizes and examine if there was an association with trial outcome. Data were extracted from a sample of 148 randomized controlled trials published in nursing science journals in 2017. One hundred trials (68%) had precisely equal group sizes. Respectively, a positive outcome was reported in 70% and 58% of trials with equal/unequal groups. Trials from Asia were more likely to have equal group sizes than those from the rest of the world. Most trials reported a sample size calculation (n=105, 71%). In a third of trials (n=36, 34%), the number of participants recruited precisely matched the requirement of the sample size calculation; this was significantly more common in studies with equal group sizes. The high number of nursing trials with equal groups may suggest nurses con-ducting clinical trials are manipulating participant allocation to ensure equal group size increasing the risk of bias.

scholarly journals SURGICAL TECHNIQUES FOR THE TREATMENT OF RECTAL ENDOMETRIOSIS: A SYSTEMATIC REVIEW OF RANDOMIZED CONTROLLED TRIALS AND OBSERVATIONAL STUDIES

2021 ◽  
Vol 58 (4) ◽  
pp. 548-559
Author(s):  
Pedro POPOUTCHI ◽  
Oswaldo Wiliam MARQUES JUNIOR ◽  
Pedro AVERBACH ◽  
Celso Augusto Milani CARDOSO FILHO ◽  
Marcelo AVERBACH
Keyword(s):  
Systematic Review ◽  
Surgical Treatment ◽  
Randomized Controlled Trials ◽  
Observational Studies ◽  
Surgical Techniques ◽  
Segmental Resection ◽  
Common Disease ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Rectal Endometriosis

ABSTRACT BACKGROUND Endometriosis is a common disease in reproductive-age women and it is estimated to occur in up to 50% of those with infertility. Intestinal involvement is reported in up to a third of the cases. This condition is related to chronic pain and loss of quality of life, resulting in emotional, social and economic costs. Treatment consists of hormonal block and surgical resection, with variable side effects and efficacy. The best choice for surgical treatment for rectal endometriosis is a matter of discussion regarding the indication and the best technique to be employed. OBJECTIVE To summarize data on indications, results and complications of surgical techniques for the treatment of rectal endometriosis. METHODS: This comprehensive systematic review is a compilation of the available literature and discussion, carried out by a team with experience in the surgical treatment of intestinal endometriosis. Data regarding indications, results and complications of conservative and radical techniques for the surgical treatment of rectal endometriosis was carefully reviewed. Searches of PubMed, EMBASE, and CENTRAL up to May 2021 were performed to identify randomized controlled trials (RCTs) and observational studies that compared at least two of the three surgical techniques of interest (i.e., shaving, discoid resection, segmental resection). RESULTS: One RCT and nine case series studies with a total of 3,327 patients met the eligibility criteria. Participants ages ranged from a mean of 30.0 to 37.9 years old. Mean follow-up ranged from 1.2 to 42.76 months. With regards the methodological quality, overall the included studies presented a low risk of bias in the majority of the domains. Surgical treatment of rectal endometriosis is indicated for patients with obstructive symptoms and those with pain scores above 7/10. Patients with disease involving beyond muscularis propria of the rectum, documented in magnetic resonance imaging or transvaginal pelvic ultrasound with intestinal preparation, are candidates for discoid or segmental resection. The presence of multifocal disease, extension greater than 3 cm and infiltration greater than 50% of the loop circumference favor the radical technique. The distance from the lesion to the anal verge, age, symptoms and reproductive desire are other factors that influence the choice of the technique to be employed. The risk of complications and unfavorable functional results seems to be directly related to the complexity of the procedure. CONCLUSION: The choice of surgical technique performed for the treatment of rectal endometriosis is a matter of discussion and depends not only on the preoperative staging, but also on the patient’s expectations, risks and potential complications, recurrence rates and the expertise of the multidisciplinary team.

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