scholarly journals The Honeypot Randomized Controlled Trial Statistical Analysis Plan

2013 ◽  
Vol 33 (4) ◽  
pp. 426-435 ◽  
Author(s):  
Elaine Mary Pascoe ◽  
Serigne Lo ◽  
Anish Scaria ◽  
Sunil V. Badve ◽  
Elaine Mary Beller ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Statistical Analysis ◽  
Data Extraction ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Open Label ◽  
Randomized Controlled ◽  
Technical Requirements ◽  
Sufficient Detail ◽  
Study Results

BackgroundThe HONEYPOT study is a multicenter, open-label, blinded-outcome, randomized controlled trial designed to determine whether, compared with standard topical application of mupirocin for nasal staphylococcal carriage, exit-site application of antibacterial honey reduces the rate of catheter-associated infections in peritoneal dialysis patients.ObjectiveTo make public the pre-specified statistical analysis principles to be adhered to and the procedures to be performed by statisticians who will analyze the data for the HONEYPOT trial.MethodsStatisticians and clinical investigators who were blinded to treatment allocation and treatment-related study results and who will remain blinded until the central database is locked for final data extraction and analysis determined the statistical methods and procedures to be used for analysis and wrote the statistical analysis plan. The plan describes basic analysis principles, methods for dealing with a range of commonly encountered data analysis issues, and the specific statistical procedures for analyzing the primary, secondary, and safety outcomes.ResultsA statistical analysis plan containing the pre-specified principles, methods, and procedures to be adhered to in the analysis of the data from the HONEYPOT trial was developed in accordance with international guidelines. The structure and content of the plan provide sufficient detail to meet the guidelines on statistical principles for clinical trials produced by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.ConclusionsMaking public the pre-specified statistical analysis plan for the HONEYPOT trial minimizes the potential for bias in the analysis of trial data and the interpretation and reporting of trial results.

scholarly journals Statistical analysis plan for the Surgery for Cancer with Option of Palliative Care Expert (SCOPE) trial: a randomized controlled trial of a specialist palliative care intervention for patients undergoing surgery for cancer

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Onur M. Orun ◽  
Myrick C. Shinall ◽  
Aimee Hoskins ◽  
Ellis Morgan ◽  
Mohana Karlekar ◽  
...  
Keyword(s):  
Palliative Care ◽  
Randomized Controlled Trial ◽  
Statistical Analysis ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Specialist Palliative Care ◽  
Randomized Controlled ◽  
Care Intervention ◽  
Scope Trial

Abstract Background The impact of specialist palliative care intervention in patients undergoing surgery for cancer has not been studied extensively. The SCOPE randomized controlled trial will investigate the effect of specialist palliative care intervention in cancer patients undergoing surgery for selected abdominal malignancies. The study protocol of the SCOPE Trial was published in December 2019. Methods and design The SCOPE Trial is a single-center, single-blind, prospective, randomized controlled trial that will investigate specialist palliative care intervention for cancer patients undergoing surgery for selected abdominal malignancies. The study plans to enroll 236 patients that will be randomized to specialist palliative care (intervention arm) and usual care (control arm) in a 1:1 ratio. Results The primary outcome of the study is the Functional Assessment of Cancer Therapy-General (FACT-G) Trial Outcome Index (TOI) at 90 days postoperatively. Secondary outcomes of the study include the total FACT-G score at 90 days postoperatively, days alive at home without an emergency room visit within 90 days of operation, and all-cause mortality at 1 year after operation. Time frames for all outcomes will start on the day of surgery. Conclusion This manuscript serves as the formal statistical analysis plan (version 1.0) for the SCOPE randomized controlled trial. The statistical analysis plan was completed on 6 April 2021. Trial registration ClinicalTrials.gov NCT03436290. Registered on 16 February 2018

scholarly journals Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: statistical analysis plan for a randomized controlled trial

2019 ◽  
Author(s):  
Jian-Feng Tu ◽  
Jing-Wen Yang ◽  
Li-Qiong Wang ◽  
Yang Wang ◽  
Jin-ling Li ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Statistical Analysis ◽  
Knee Osteoarthritis ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Sham Acupuncture ◽  
Manual Acupuncture ◽  
Randomized Controlled ◽  
Secondary Outcomes

Abstract Background: Acupuncture therapies are widely used for knee osteoarthritis (KOA), despite contradictory evidences. Current study is designed to determine the efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for KOA. Methods/design: Current study is a multi-center, three-arm, randomized controlled trial which will enroll 480 participants with KOA in China. Participants will be randomly assigned (1:1:1) to receive 24 sessions of electro-acupuncture, manual acupuncture, or sham acupuncture over 8 weeks. The primary outcome is the response rate - the proportion of patients who simultaneously achieve minimal clinically important improvement in pain and function domains at 8 weeks. The primary outcome will be analyzed using Z-test with intention-to-treat set. Secondary outcomes contain pain, function, global patient assessment and quality of life. Full details of the statistical analysis plan for the primary and secondary outcomes will be described in this article. The statistical analysis plan was written and submitted without knowledge of the study data. Discussion: The data will be analyzed according to this pre-specified statistical analysis plan to avoid data-driven analysis and enhance the transparency of current trial. The trial will provide high-quality evidence on the efficacy of acupuncture for KOA.

scholarly journals Efficacy and Safety of Inhaled Ciclesonide in Treating Patients With Asymptomatic or Mild COVID-19 in the RACCO Trial: Protocol for a Multicenter, Open-label, Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Junko Terada-Hirashima ◽  
Manabu Suzuki ◽  
Yukari Uemura ◽  
Masayuki Hojo ◽  
Ayako Mikami ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Controlled Trial ◽  
Symptomatic Treatment ◽  
Open Label ◽  
Exacerbation Rate ◽  
Treatment Groups ◽  
Randomized Controlled ◽  
Computed Tomography Images ◽  
Study Results

BACKGROUND Currently, there are no specific effective treatments for SARS-CoV-2 infection; however, various COVID-19 treatment options are under investigation. It is vital to continue investigating the landscape of SARS-CoV-2–induced pneumonia and therapeutic interventions. OBJECTIVE This paper presents the protocol for a randomized controlled trial that aims to compare the pneumonia exacerbation rate between ciclesonide (ALVESCO; Teijin Pharma Limited) administration and symptomatic treatment in patients with COVID-19 and to determine the efficacy of ciclesonide. The secondary objectives are to investigate the safety of ciclesonide administration, changes in clinical and laboratory findings, and the number of viral genome copies of SARS-CoV-2 over time between the 2 groups. METHODS In this investigator-initiated, exploratory, prospective, multicenter, parallel-group, open-label, randomized controlled trial, a total of 90 patients diagnosed with COVID-19 will be recruited from 21 hospitals in Japan based on specific inclusion and exclusion criteria. Participants will be randomized either to the ciclesonide group, which will receive a 400-µg dose of ciclesonide 3 times per day over a 7-day period, or to the symptomatic treatment group. Both groups will receive antitussives and antipyretics as required. Data collection for various parameters will be conducted on days 1, 2, 4, 8, 22, and 29 to record baseline assessments and the findings over an extended period. Computed tomography images taken prior to drug administration and 1 week following treatment will be compared, and efficacy will be confirmed by checking for pneumonia exacerbation. Primary endpoint analysis will be performed using the Fisher exact test to determine statistically significant differences in the pneumonia exacerbation rate between the ciclesonide and symptomatic treatment groups. RESULTS The first trial participant was enrolled on April 3, 2020. Recruitment is expected to be completed on September 30, 2020, while follow-up assessments of all participants are expected to be completed by October 31, 2020. The study results will be published in a peer-reviewed scientific journal. CONCLUSIONS The RACCO (Randomized Ciclesonid COVID-19) study will provide definitive comparative effectiveness data and important clinical outcomes data between the ciclesonide and symptomatic treatment groups. If the hypotheses that pneumonia exacerbation rate reduction is more significant in the ciclesonide treatment group than in the symptomatic treatment group and that ciclesonide is safe for use are valid, ciclesonide will serve as an important therapeutic option for patients with COVID-19. CLINICALTRIAL Japan Registry of Clinical Trials jRCTs031190269; https://jrct.niph.go.jp/en-latest-detail/jRCTs031190269 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/23830

scholarly journals TOPS – a randomized controlled trial of exercise and education to prevent recurrence of low back pain: statistical analysis plan

2020 ◽  
Vol 24 (4) ◽  
pp. 373-380
Author(s):  
Giovanni E. Ferreira ◽  
Chung-Wei Christine Lin ◽  
Matthew Leigh Stevens ◽  
Mark J. Hancock ◽  
Jane Latimer ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Back Pain ◽  
Statistical Analysis ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Low Back ◽  
Randomized Controlled
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