scholarly journals Research Methods in Healthcare Epidemiology and Antimicrobial Stewardship: Randomized Controlled Trials

2016 ◽  
Vol 37 (6) ◽  
pp. 629-634 ◽  
Author(s):  
Deverick J. Anderson ◽  
Manisha Juthani-Mehta ◽  
Daniel J. Morgan

Randomized controlled trials (RCT) produce the strongest level of clinical evidence when comparing interventions. RCTs are technically difficult, costly, and require specific considerations including the use of patient- and cluster-level randomization and outcome selection. In this methods paper, we focus on key considerations for RCT methods in healthcare epidemiology and antimicrobial stewardship (HE&AS) research, including the need for cluster randomization, conduct at multiple sites, behavior modification interventions, and difficulty with identifying appropriate outcomes. We review key RCTs in HE&AS with a focus on advantages and disadvantages of methods used. A checklist is provided to aid in the development of RCTs in HE&AS.Infect Control Hosp Epidemiol 2016;37:629–634

2019 ◽  
Vol 30 (05) ◽  
pp. 420-428 ◽  
Author(s):  
Joachim F. Kuebler ◽  
Jens Dingemann ◽  
Benno M. Ure ◽  
Nagoud Schukfeh

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.


2020 ◽  
Author(s):  
Mei-Lan Sun ◽  
Yong Zhang(Former Corresponding Author) ◽  
Bo Wang ◽  
Tean Ma ◽  
Hong Jiang ◽  
...  

Abstract Aim: The application of laparoscopic catheterization technology in peritoneal dialysis (PD) patients has recently increased. However, the advantages and disadvantages of laparoscopic versus conventional open PD catheter placement are still controversial. The aim of this meta-analysis is to assess the complications of catheterization in PD patients and to provide a reference for choosing a PD-catheter placement technique in the clinic.Methods: We searched numerous databases, including Embase, PubMed, CNKI and the Cochrane Library, for published randomized controlled trials (RCTs).Results: Eight relevant studies (n=646) were included in the meta-analysis. The pooled results showed a lower incidence of catheter migration (OR: 0.42, 95% CI: 0.19 to 0.90, P: 0.03) and catheter removal (OR: 0.41, 95% CI: 0.21 to 0.79, P: 0.008) but a higher incidence of bleeding (OR: 3.25, 95% CI: 1.18 to 8.97, P: 0.02) with a laparoscopic approach than with a conventional approach. There was no significant difference in the incidence of omentum adhesion (OR: 0.32, 95% CI: 0.05 to 2.10, P: 0.24), hernia (OR: 0.38, 95% CI: 0.09 to 1.68, P: 0.20), leakage (OR: 0.69, 95% CI: 0.38 to 1.26, P: 0.23), intestinal obstruction (OR: 0.96, 95% CI: 0.48 to 1.91, P: 0.90) or perforation (OR: 0.95, 95% CI: 0.06 to 15.42, P: 0.97). The statistical analysis showed no significant difference in early (OR: 0.44, 95% CI: 0.15 to 1.33, P: 0.15) , late (OR: 0.89, 95% CI: 0.41 to 1.90, P: 0.76) or total (OR: 0.68, 95% CI: 0.42 to 1.12, P: 0.13) peritonitis infections between the 2 groups, and there are no no significant difference in early ( OR: 0.39, 95% CI: 0.06 to 2.36, P: 0.30), late ( OR: 1.35, 95% CI: 0.78 to 2.33, P: 0.16) or total ( OR: 1.20, 95% CI: 0.71 to 2.02, P: 0.17) tunnel or exit-site infections between the 2 groups.Conclusion: Laparoscopic catheterization and conventional open catheter placement in PD patients have unique advantages, but laparoscopic PD catheterization may be superior to conventional open catheter placement. However, this conclusion needs to be confirmed with further large-sample-size, multi-centre, high-quality RCTs.


2017 ◽  
Vol 11 (1) ◽  
pp. 27-38
Author(s):  
Nichole Giardina ◽  
Barbara Marriage

Background:The incidence of food allergy is a growing health concern in the United States. Research suggests that there is a link between the gut microbiota and the development of allergy. As a result, researchers propose that gut microbial populations could affect the development and management of immunological disease.Objectives:The purpose of this review is to present current evidence of the advantages and disadvantages of probiotic and/or prebiotic addition to extensively hydrolyzed protein (EHF) and amino acid-based infant formulas (AAF) for the management of food allergy.Method:Only randomized controlled trials were included for review. The randomized controlled trials were limited to human subjects less than 12 years of age with a confirmed case of food allergy who were consuming EHF or AAF supplemented with probiotics and/or prebiotics.Results:Eleven studies were included for review. Probiotic and synbiotic addition was associated with an improvement in SCORAD index in EHF and AAF, and EHF significantly moderated immunologic and/or inflammatory responses. Probiotic addition to EHF benefited patients exhibiting hematochezia, and synbiotic addition resulted in softer stool, higher stool frequency, and decreased incidence of infection in some studies.Conclusion:Although few studies report statistically significant effects upon feeding prebiotics or probiotics with EHF and AAF on food allergy, this review sheds light on evidence that such inclusion may have positive impacts on SCORAD index, stool quality, immunologic and inflammatory factors, and incidence of infection.


2019 ◽  
Author(s):  
Mei-lan Sun ◽  
Bo Wang ◽  
Piao Zhang ◽  
yong zhang

Abstract Aim The application of laparoscopic catheterization technology in peritoneal dialysis (PD) patients has recently increased. However, the advantages and disadvantages of laparoscopic versus conventional open catheterization are still controversial. The aim of this meta-analysis is to assess complications of catheterization in PD patients and to provide a reference for the clinical choice of PD catheter placement technique. Methods We searched numerous databases, including Embase, PubMed, CNKI and the Cochrane Library, for published randomized controlled trials (RCTs). Results Eight relevant studies (n=646) were included in the meta-analysis. The pooled results showed a lower incidence of catheter migration (P: 0.03, OR: 0.42, 95% CI: 0.19 to 0.90) and malfunction (P: 0.008, OR: 0.41, 95% CI: 0.21 to 0.79) but a higher incidence of bleeding (P: 0.02, OR: 3.25, 95% CI: 1.18 to 8.97) with a laparoscopic approach than with a conventional approach. There was no significant difference in the incidence of obstruction (P: 0.24, OR: 0.32, 95% CI: 0.05 to 2.10), hernia (P: 0.20, OR: 0.38, 95% CI: 0.09 to 1.68), leakage (P: 0.23, OR: 0.69, 95% CI: 0.38 to 1.26), mechanical dysfunction (P: 0.90, OR: 0.96, 95% CI: 0.48 to 1.91), malfunction (P: 0.008, OR: 0.41, 95% CI: 0.21 to 0.79), perforation (P: 0.97, OR: 0.95, 95% CI: 0.06 to 15.42), peritonitis (P: 0.13, OR: 0.95, 95% CI: 0.42 to 1.12) or tunnel or exit-site infections (P: 0.49, OR: 0.95, 95% CI: 0.71 to 2.02). Conclusion Laparoscopic catheterization and conventional open catheter placement in PD patients have unique advantages, but laparoscopic catheterization may be superior to conventional open catheter placement. However, this conclusion needs to be confirmed with further large-sample-size, multi-centre, high-quality RCTs.


Mastology ◽  
2021 ◽  
Author(s):  
Aline Tenório Dourado ◽  
Amanda Vasconcelos de Albuquerque ◽  
Dayse Figueiredo Ribeiro de Sena ◽  
José Lamartine de Andrade Aguiar

Introduction: Surgery is the most effective treatment for breast cancer; however, several factors can impair the immune system during the perioperative period, including the anesthetic technique. Since metastasis is the leading cause of death, one of the treatment pillars is to prevent cancer progression. This systematic review will focus on the prospective clinical evidence available on anesthesia's role in favoring breast cancer recurrence. Methods: The Cochrane Library, Medline, Embase, LILACs, and Web of Science were electronically searched from inception through December 2020 for randomized controlled trials assessing the association of postoperative recurrence and survival with the use of regional anesthesia, opioids, anesthetic adjuncts, and general anesthesia during surgical resection of breast cancer. In total, 711 articles were retrieved. After title and abstract screening and full-text reviews, five randomized controlled trials were selected. Results: Two studies compared inhalation anesthesia with total intravenous anesthesia, while three compared general anesthesia with regional anesthesia and analgesia. There was no significant association between the anesthetic technique and local recurrence, metastasis, or survival. Conclusion: This systematic review did not find an association between the type of anesthesia performed and a higher breast cancer recurrence rate. Up to this time, there is no clinical evidence to support a specific anesthetic technique for malignant breast tumor resection surgeries.


2019 ◽  
Author(s):  
Mei-lan Sun ◽  
Bo Wang ◽  
Piao Zhang ◽  
yong zhang

Abstract Aim The application of laparoscopic catheterization technology in peritoneal dialysis (PD) patients has recently increased. However, the advantages and disadvantages of laparoscopic versus conventional open catheterization are still controversial. The aim of this meta-analysis is to assess complications of catheterization in PD patients and to provide a reference for the clinical choice of PD catheter placement technique. Methods We searched numerous databases, including Embase, PubMed, CNKI and the Cochrane Library, for published randomized controlled trials (RCTs). Results Eight relevant studies (n=646) were included in the meta-analysis. The pooled results showed a lower incidence of catheter migration (P: 0.03, OR: 0.42, 95% CI: 0.19 to 0.90) and malfunction (P: 0.008, OR: 0.41, 95% CI: 0.21 to 0.79) but a higher incidence of bleeding (P: 0.02, OR: 3.25, 95% CI: 1.18 to 8.97) with a laparoscopic approach than with a conventional approach. There was no significant difference in the incidence of obstruction (P: 0.24, OR: 0.32, 95% CI: 0.05 to 2.10), hernia (P: 0.20, OR: 0.38, 95% CI: 0.09 to 1.68), leakage (P: 0.23, OR: 0.69, 95% CI: 0.38 to 1.26), mechanical dysfunction (P: 0.90, OR: 0.96, 95% CI: 0.48 to 1.91), malfunction (P: 0.008, OR: 0.41, 95% CI: 0.21 to 0.79), perforation (P: 0.97, OR: 0.95, 95% CI: 0.06 to 15.42), peritonitis (P: 0.13, OR: 0.95, 95% CI: 0.42 to 1.12) or tunnel or exit-site infections (P: 0.49, OR: 0.95, 95% CI: 0.71 to 2.02). Conclusion Laparoscopic catheterization and conventional open catheter placement in PD patients have unique advantages, but laparoscopic catheterization may be superior to conventional open catheter placement. However, this conclusion needs to be confirmed with further large-sample-size, multi-centre, high-quality RCTs.


2018 ◽  
Vol 2018 ◽  
pp. 1-11
Author(s):  
Dabin Lee ◽  
Hojung Lee ◽  
Jiwon Kim ◽  
Taehun Kim ◽  
Siyun Sung ◽  
...  

Introduction. Infantile colic is a common condition causing considerable deterioration in the quality of life of both infants and their parents. Minimal acupuncture, a gentle needling technique without strong muscle stimulation, has primarily been used to treat this condition, but the clinical evidence of its efficacy and safety is yet to be established. The objective of this review was to assess clinical evidence of the safety and efficacy of acupuncture for infantile colic. Methods. To identify studies for inclusion, PubMed, Cochrane Library, Google Scholar, China Knowledge Resource Integrated Database, Wanfang, and Oriental Medicine Advanced Searching Integrated System were searched until January 2017. Only randomised controlled trials of infantile colic in patients aged 0 to 25 weeks, who were treated with acupuncture, were included. To assess the quality, the risk of bias was determined for each study by two authors. The intention was to perform a meta-analysis, but this was not possible in this study due to considerable clinical heterogeneity among the included studies. Results. Of the 601 studies identified, only four randomized controlled trials were included in this review. All included studies were conducted in northern European countries. Most studies showed a low risk of bias in most domains. Minimal acupuncture on LI4 or ST36 without strong stimulation was used in all studies. From the narrative analysis, acupuncture appears to be effective in alleviating the symptoms of colic, including crying and feeding and stooling problems, and may have only minor adverse effects. However, clinical evidence could not be confirmed owing to considerable clinical heterogeneity and the small sample sizes of the included studies. Conclusion. There is currently no conclusive evidence on the safety and efficacy of acupuncture for infantile colic. Rigorous full-scale randomized controlled trials will be necessary in future.


Sign in / Sign up

Export Citation Format

Share Document