Research design considerations for randomized controlled trials of spinal cord stimulation for pain

Background: In randomized controlled trials, attrition rates often differ by treatment status, jeopardizing causal inference. Inverse probability weighting methods and estimation of treatment effect bounds have been used to adjust for this bias. Objectives: We compare the performance of various methods within two samples, both generated through lottery-based randomization: one with considerable differential attrition and an augmented dataset with less problematic attrition. Research Design: We assess the performance of various correction methods within the dataset with problematic attrition. In addition, we conduct simulation analyses. Results: Within the more problematic dataset, we find the correction methods often performed poorly. Simulation analyses indicate that deviations from the underlying assumptions for bounding approaches damage the performance of estimated bounds. Conclusions: We recommend the verification of the underlying assumptions in attrition correction methods whenever possible and, when verification is not possible, using these methods with caution.

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Implementation research design: integrating participatory action research into randomized controlled trials

Implementation Science ◽

10.1186/1748-5908-4-69 ◽

2009 ◽

Vol 4 (1) ◽

Cited By ~ 63

Author(s):

Luci K Leykum ◽

Jacqueline A Pugh ◽

Holly J Lanham ◽

Joel Harmon ◽

Reuben R McDaniel

Keyword(s):

Action Research ◽

Randomized Controlled Trials ◽

Participatory Action Research ◽

Research Design ◽

Implementation Research ◽

Controlled Trials ◽

Participatory Action ◽

Randomized Controlled

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Acupuncture for Cancer-Induced Bone Pain in Animal Models: A Systemic Review and Meta-Analysis

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2020/5606823 ◽

2020 ◽

Vol 2020 ◽

pp. 1-14

Author(s):

Mei-ling Yu ◽

Jia-jia Qian ◽

Shu-ping Fu ◽

Jia-ying Chen ◽

Yu-wen Zheng ◽

...

Keyword(s):

Spinal Cord ◽

Body Weight ◽

Randomized Controlled Trials ◽

Bone Pain ◽

Meta Analysis ◽

Systemic Review ◽

Control Group ◽

Controlled Trials ◽

Wait List ◽

Randomized Controlled

Background. Cancer-induced bone pain (CIBP) is a highly prevalent symptom, which afflicts vast majority of patients who suffer from cancer. The current treatment options failed to achieve satisfactory effect and the side effects were prominent. Recent randomized controlled trials (RCTs) of animal demonstrate the benefit of acupuncture for CIBP. We sought to determine if the pooled data from available RCTs supports the use of acupuncture for CIBP. Methods. A literature search for randomized controlled trials was conducted in six electronic databases from inception to May 31, 2019. Meta-analysis was performed with Review Manager 5.3 software; the publication bias was assessed by Stata 12.0 software. We used random effects model for pooling data because heterogeneity is absolute among studies to some extent. Results. Twenty-four trials were included in the review, of which 12 trials provided detailed data for meta-analyses. Preliminary evidence indicates that compared to wait list/sham group, acupuncture was effective on increasing paw withdrawal threshold (PWT) and paw withdrawal latency (PWL). Compared to medicine, acupuncture was less effective on PWT, but as effective as medicine on PWL. Acupuncture can reinforce medicine’s effect on PWT and PWL. Compared to the control group, acupuncture was superior to increase body weight (BW), decrease spinal cord glial fibrillary acidic protein (GFAP), and interleukin-1β (IL-1β). Furthermore, some studies showed acupuncture delay or partially reverse morphine tolerance. Three studies found acupuncture has no effect on PWT, but 2 of them found acupuncture could enhance small dose of Celebrex’s effect on CIBP. Conclusions. Acupuncture was superior to wait list/sham acupuncture on increasing PWT and has no less effect on increasing PWL compared to medicine; acupuncture improved the efficacy of drugs, increased the CIBP animals’ body weight, and decreased their spinal cord GFAP and IL-1β. High-quality studies are necessary to confirm the results.

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The efficacy and safety of bisphosphonate analogs for treatment of osteoporosis after spinal cord injury: a systematic review and meta-analysis of randomized controlled trials

Osteoporosis International ◽

10.1007/s00198-020-05807-0 ◽

2021 ◽

Author(s):

Y. Wu ◽

F. Wang ◽

Z. Zhang

Keyword(s):

Systematic Review ◽

Spinal Cord ◽

Spinal Cord Injury ◽

Randomized Controlled Trials ◽

Meta Analysis ◽

Controlled Trials ◽

Efficacy And Safety ◽

Treatment Of Osteoporosis ◽

Randomized Controlled ◽

Cord Injury

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A mapping review of randomized controlled trials in the spinal cord injury research literature

Spinal Cord ◽

10.1038/s41393-018-0155-2 ◽

2018 ◽

Vol 56 (8) ◽

pp. 725-732 ◽

Cited By ~ 2

Author(s):

Amanda McIntyre ◽

◽

Brooke Benton ◽

Shannon Janzen ◽

Jerome Iruthayarajah ◽

...

Keyword(s):

Spinal Cord ◽

Spinal Cord Injury ◽

Randomized Controlled Trials ◽

Research Literature ◽

Controlled Trials ◽

Randomized Controlled ◽

Cord Injury ◽

Mapping Review ◽

Injury Research

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Research design

Oxford Handbook of Medical Statistics ◽

10.1093/med/9780199551286.003.0001 ◽

2010 ◽

pp. 1-73 ◽

Cited By ~ 4

Author(s):

Janet L. Peacock ◽

Philip J. Peacock

Keyword(s):

Randomized Controlled Trials ◽

Research Design ◽

Controlled Trials ◽

Crossover Designs ◽

Randomized Controlled ◽

Equivalence Trials ◽

Patient Consent ◽

Research Questions ◽

Research Studies

Introduction 2 Introduction to research 3 Research questions 4 Interventional studies 6 Randomized controlled trials 8 Randomization in RCTs 10 Patient consent in research studies 12 Blinding in RCTs 14 RCTs: parallel groups and crossover designs 16 Zelen randomized consent design 18 Superiority and equivalence trials ...

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Zoledronic Acid Versus Denosumab for Prevention of Spinal Cord Compression in Advanced Cancers With Spine Metastasis: A Meta-Analysis of Randomized Controlled Trials

Global Spine Journal ◽

10.1177/2192568219884069 ◽

2019 ◽

Vol 10 (6) ◽

pp. 784-789

Author(s):

Humaid Al Farii ◽

Abbey Frazer ◽

Leila Farahdel ◽

Saud Alfayez ◽

Michael Weber

Keyword(s):

Spinal Cord ◽

Zoledronic Acid ◽

Randomized Controlled Trials ◽

Spinal Cord Compression ◽

Meta Analysis ◽

Cord Compression ◽

Controlled Trials ◽

Randomized Controlled ◽

Spine Metastases ◽

Significant Difference

Study Design: Meta-analysis of randomized controlled trials (RCTs). Objectives: The aim was to analyze the efficacy of zoledronic acid (ZA) versus denosumab in the prevention of spinal cord compression in patients with spine metastases from advanced cancers, by evaluating all available RCTs on this subject. Methods: A systematic search of electronic databases (PubMed and MEDLINE) was performed to identify all published RCTs comparing ZA with denosumab in prevention of spinal cord compressions in spine metastases. Risk of bias of the studies was assessed. The primary outcomes evaluated were spinal cord compression. Results: Three RCTs (5274 patients) were included. Denosumab was not significantly superior to ZA in reducing the likelihood of spinal cord compression, when all tumor types were combined (odds ratio [OR] 0.92, 95% confidence interval [CI; 0.66, 1.28], P = .66). Denosumab was not significantly favored over ZA in endodermal origin (breast and prostate; OR 0.72, 95% CI [0.43, 1.19], P = .20) and mesodermal origin tumors (solid tumors and multiple myeloma; OR 1.10, 95% CI [0.72, 1.69], P = .66). Conclusion: Denosumab does not significantly reduce the likelihood of spinal cord compressions in comparison to ZA in patients with spine metastases. When spinal cord compressions were grouped by tumor origin (endodermal or mesodermal), there remained no significant difference between denosumab and ZA. Further long-term studies are needed to determine the effectiveness of these treatment regimens.

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