Design, Conduct, and Analysis of Surgical Randomized Controlled Trials

Yu, Jiajie; Chen, Wenwen; Chen, Shidong; Jia, Pengli; Su, Guanyue; Li, Youping; Sun, Xin

doi:10.1097/sla.0000000000002860

Cited by 23 publications

(10 citation statements)

References 33 publications

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“…The study design did not include patient randomization, which is the standard robust methodological approach [27]. However, given the fact that study participants stemmed from the same reference population and that no differences in baseline patient demographics or tumor data could be demonstrated, implementing randomization would have been highly challenging for logistics in the multicenter setting without necessarily adding much more to the study results [28].…”

Section: Discussionmentioning

confidence: 99%

Optimizing Dose and Timing in Magnetic Tracer Techniques for Sentinel Lymph Node Detection in Early Breast Cancers: The Prospective Multicenter SentiDose Trial

Hersi

Pistioli

Luberth

et al. 2021

Cancers

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Superparamagnetic iron oxide nanoparticles (SPIO) are non-inferior to radioisotope and blue dye (RI + BD) for sentinel lymph node (SLN) detection. Previously, 2 mL SPIO (Sienna+®) in 3 mL NaCl was used. In this dose-optimizing study, lower doses of a new refined SPIO solution (Magtrace®) (1.5 vs. 1.0 mL) were tested in different timeframes (0–24 h perioperative vs. 1–7 days preoperative) and injections sites (subareolar vs. peritumoral). Two consecutive breast cancer cohorts (n = 328) scheduled for SLN-biopsy were included from 2017 to 2019. All patients received isotope ± blue dye as back-up. SLNs were identified primarily with the SentiMag® probe and thereafter a gamma-probe. The primary endpoint was SLN detection rate with SPIO. Analyses were performed as a one-step individual patient-level meta-analysis using patient-level data from the previously published Nordic Trial (n = 206) as a third, reference cohort. In 534 patients, the SPIO SLN detection rates were similar (97.5% vs. 100% vs. 97.6%, p = 0.11) and non-inferior to the dual technique. Significantly more SLNs were retrieved in the preoperative 1.0 mL cohort compared with 1.5 and the 2.0 mL cohorts (2.18 vs. 1.85 vs. 1.83, p = 0.003). Lower SPIO volumes injected up to 7 days before the operation have comparable efficacy to standard SPIO dose and RI + BD for SLN detection.

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Section: Discussionmentioning

confidence: 99%

Optimizing Dose and Timing in Magnetic Tracer Techniques for Sentinel Lymph Node Detection in Early Breast Cancers: The Prospective Multicenter SentiDose Trial

Hersi

Pistioli

Luberth

et al. 2021

Cancers

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“…Given obvious ethical and applicative challenges in randomising between BCS and mastectomy, further advancement of the knowledge base on optimal surgical treatment will require some degree of reliance on observational studies. Although these studies do not replicate the purity of RCTs, nevertheless, they offer crucial information for real-life clinical practice [25,26,57].…”

Section: Discussionmentioning

confidence: 98%

Does Mastectomy Reduce Overall Survival in Early Stage Breast Cancer?

Murphy

Gandhi

2021

Clinical Oncology

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“…Limitations of our meta-analysis include the retrospective and observational nature of included studies and the significant heterogeneity among the studies. There were no randomized controlled trials in this study, although conducting one could account for potential biases and confounders, the non-randomized evidence to the risk of meningiomas is so extensive that this would unlikely take place, from practical and ethical standpoints 66 . A further limitation of the available data is that there is little known about the impact of past exposure or whether there is a cumulative dose effect, and hence we were unable to weigh the effect of historical doses versus current doses differently.…”

Section: Discussionmentioning

confidence: 99%

A systematic review and meta-analysis of the association between cyproterone acetate and intracranial meningiomas

Lee

Zhang

Kirollos

et al. 2022

Sci Rep

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The influence of exposure to hormonal treatments, particularly cyproterone acetate (CPA), has been posited to contribute to the growth of meningiomas. Given the widespread use of CPA, this systematic review and meta-analysis attempted to assess real-world evidence of the association between CPA and the occurrence of intracranial meningiomas. Systematic searches of Ovid MEDLINE, Embase and Cochrane Controlled Register of Controlled Trials, were performed from database inception to 18th December 2021. Four retrospective observational studies reporting 8,132,348 patients were included in the meta-analysis. There was a total of 165,988 subjects with usage of CPA. The age of patients at meningioma diagnosis was generally above 45 years in all studies. The dosage of CPA taken by the exposed group (n = 165,988) was specified in three of the four included studies. All studies that analyzed high versus low dose CPA found a significant association between high dose CPA usage and increased risk of meningioma. When high and low dose patients were grouped together, there was no statistically significant increase in risk of meningioma associated with use of CPA (RR = 3.78 [95% CI 0.31–46.39], p = 0.190). Usage of CPA is associated with increased risk of meningioma at high doses but not when low doses are also included. Routine screening and meningioma surveillance by brain MRI offered to patients prescribed with CPA is likely a reasonable clinical consideration if given at high doses for long periods of time. Our findings highlight the need for further research on this topic.

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Design, Conduct, and Analysis of Surgical Randomized Controlled Trials

Cited by 23 publications

References 33 publications

Optimizing Dose and Timing in Magnetic Tracer Techniques for Sentinel Lymph Node Detection in Early Breast Cancers: The Prospective Multicenter SentiDose Trial

Optimizing Dose and Timing in Magnetic Tracer Techniques for Sentinel Lymph Node Detection in Early Breast Cancers: The Prospective Multicenter SentiDose Trial

Does Mastectomy Reduce Overall Survival in Early Stage Breast Cancer?

A systematic review and meta-analysis of the association between cyproterone acetate and intracranial meningiomas

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