Cargando…

Maintaining the blind in sham controlled interventional trials: lessons from the EPISOD study

Objective and study aims This study was designed to demonstrate the techniques used and the effectiveness of blinding in the EPISOD study (Evaluating Predictors and Interventions in Sphincter of Oddi Dysfunction). This was a large sham-controlled trial evaluating the efficacy of endoscopic sphincte...

Descripción completa

Detalles Bibliográficos
Autores principales:	Cotton, Peter, Pauls, Qi, Wood, April, Durkalski-Mauldin, Valerie
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	© Georg Thieme Verlag KG 2019
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6805196/ https://www.ncbi.nlm.nih.gov/pubmed/31673601 http://dx.doi.org/10.1055/a-0900-3789

Ejemplares similares

Sphincter of Oddi Manometry: Reproducibility of Measurements and Effect of Sphincterotomy in the EPISOD Study
por: Suarez, Alejandro L, et al.
Publicado: (2016)

The discussion on the validity of sham controls and patient blinding in a sham-controlled acupuncture trial
por: Ge, Yuansen
Publicado: (2022)

Non-invasive vagus nerve stimulation (nVNS) for the preventive treatment of episodic migraine: The multicentre, double-blind, randomised, sham-controlled PREMIUM trial
por: Diener, Hans-Christoph, et al.
Publicado: (2019)

Development of a Sham Protocol to Investigate Transcutaneous Tibial Nerve Stimulation in Randomised, Sham-Controlled, Double-Blind Clinical Trials
por: Stalder, Stephanie A., et al.
Publicado: (2023)

Reply to “The discussion on the validity of sham controls and patient blinding in a sham-controlled acupuncture trial” [Integr Med Res 2022; 11: 100795]
por: Kim, Mikyung, et al.
Publicado: (2022)

Rationale and design: telephone-delivered behavioral skills interventions for Blacks with type 2 diabetes
por: Egede, Leonard E, et al.
Publicado: (2010)

Transcranial stimulation in frontotemporal dementia: A randomized, double‐blind, sham‐controlled trial
por: Benussi, Alberto, et al.
Publicado: (2020)

Efficacy and safety of daily home-based transcranial direct current stimulation as adjunct treatment for bipolar depressive episodes: Double-blind sham-controlled randomized clinical trial
por: Lee, Jangwon, et al.
Publicado: (2022)

Non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: A randomized, double-blind, sham-controlled ACT2 study
por: Goadsby, Peter J, et al.
Publicado: (2017)

Cryoneurolysis for the management of chronic pain in patients with knee osteoarthritis; a double-blinded randomized controlled sham trial
por: Nygaard, Niels-Peter Brøchner, et al.
Publicado: (2021)

Acupuncture for tension-type headache: a multicentre, sham-controlled, patient-and observer-blinded, randomised trial
por: Endres, Heinz G., et al.
Publicado: (2007)

Safety and efficacy of venoplasty in MS: A randomized, double-blind, sham-controlled phase II trial
por: Traboulsee, Anthony L., et al.
Publicado: (2018)

Electro-acupuncture for central obesity: randomized, patient-assessor blinded, sham-controlled clinical trial protocol
por: Zhong, Linda L. D., et al.
Publicado: (2021)

Acupuncture for hypertension with insomnia: Study protocol for a randomized, sham-controlled, subject-and-assessor-blinded trial
por: Wang, Xiaoqiu, et al.
Publicado: (2022)

Electroacupuncture treatment of primary dysmenorrhea: A randomized, participant-blinded, sham-controlled clinical trial protocol
por: Xue, Xiao, et al.
Publicado: (2023)

Effectiveness and tolerability of repetitive transcranial magnetic stimulation for preventive treatment of episodic migraine: a single-centre, randomised, double-blind, sham-controlled phase 2 trial (Magnet-EM)
por: Mohamad Safiai, Nabil Izzaatie, et al.
Publicado: (2020)

Sham Electroacupuncture Methods in Randomized Controlled Trials
por: Chen, Zi-xian, et al.
Publicado: (2017)

Blinding and sham control methods in trials of physical, psychological, and self-management interventions for pain (article I): a systematic review and description of methods
por: Hohenschurz-Schmidt, David, et al.
Publicado: (2023)

Blinding and sham control methods in trials of physical, psychological, and self-management interventions for pain (article II): a meta-analysis relating methods to trial results
por: Hohenschurz-Schmidt, David, et al.
Publicado: (2023)

DTMS Combined with a Pain-directed Psychotherapeutic Intervention in Fibromyalgia - A Randomized Double-blind Sham-controlled Study
por: Tilbor, E., et al.
Publicado: (2023)

The effectiveness of moxibustion for the treatment of functional constipation: a randomized, sham-controlled, patient blinded, pilot clinical trial
por: Park, Ji-Eun, et al.
Publicado: (2011)

Resistive Exercise for Arthritic Cartilage Health (REACH): A randomized double-blind, sham-exercise controlled trial
por: Lange, Angela K, et al.
Publicado: (2009)

Semi-Individualized Acupuncture for Insomnia Disorder and Oxidative Stress: A Randomized, Double-Blind, Sham-Controlled Trial
por: Yeung, Wing-Fai, et al.
Publicado: (2021)

Dry needling has lasting analgesic effect in shoulder pain: a double-blind, sham-controlled trial
por: Pai, Marcus Yu Bin, et al.
Publicado: (2021)

Phase 3 randomized, double-blind, sham-controlled Trial of e-TNS for the Acute treatment of Migraine (TEAM)
por: Kuruvilla, Deena E., et al.
Publicado: (2022)

Acupuncture for chemotherapy-associated insomnia in breast cancer patients: an assessor-participant blinded, randomized, sham-controlled trial
por: Zhang, Jialing, et al.
Publicado: (2023)

Effects of transcranial pulse stimulation on autism spectrum disorder: a double-blind, randomized, sham-controlled trial
por: Cheung, Teris, et al.
Publicado: (2023)

A randomized, double-blind sham-controlled trial on the efficacy of arthroscopic tennis elbow release for the management of chronic lateral epicondylitis
por: Matache, Bogdan A., et al.
Publicado: (2016)

Comparison of Bayesian vs Frequentist Adaptive Trial Design in the Stroke Hyperglycemia Insulin Network Effort Trial
por: Broglio, Kristine, et al.
Publicado: (2022)

Is Sham Laser a Valid Control for Acupuncture Trials?
por: Irnich, Dominik, et al.
Publicado: (2011)

Sham block in a randomised controlled trial: Is it ethical?
por: Nair, Abhijit, et al.
Publicado: (2020)

A Randomized, Double-Blind, Sham-Controlled Trial of Transcranial Direct Current Stimulation in Attention-Deficit/Hyperactivity Disorder
por: Cosmo, Camila, et al.
Publicado: (2015)

Efficacy of Bee Venom Acupuncture for Chronic Low Back Pain: A Randomized, Double-Blinded, Sham-Controlled Trial
por: Seo, Byung-Kwan, et al.
Publicado: (2017)

Clinical Evaluation of Acupuncture as Treatment for Complications of Cerebrovascular Accidents: A Randomized, Sham-Controlled, Subject- and Assessor-Blind Trial
por: Liao, Hsien-Yin, et al.
Publicado: (2017)

Effectiveness of acupuncture for breast cancer related lymphedema: protocol for a single-blind, sham-controlled, randomized, multicenter trial
por: Zhu, Huiru, et al.
Publicado: (2017)

Transcutaneous vagus nerve stimulation in erosive hand osteoarthritis: protocol for the randomised, double-blind, sham-controlled ESTIVAL trial
por: Courties, Alice, et al.
Publicado: (2022)

Electrical stimulation of the trigeminal nerve improves olfaction in healthy individuals: A randomized, double-blind, sham-controlled trial
por: Badran, Bashar W., et al.
Publicado: (2022)

Acupuncture for comorbid depression and insomnia in perimenopause: A feasibility patient-assessor-blinded, randomized, and sham-controlled clinical trial
por: Zhao, Fei-Yi, et al.
Publicado: (2023)

A randomized, sham-controlled, quintuple-blinded trial to evaluate the NET device as an alternative to medication for promoting opioid abstinence
por: Greenwald, Mark K., et al.
Publicado: (2022)

Intensive Versus Standard Treatment of Hyperglycemia in Acute Ischemic Stroke Patient: A Randomized Clinical Trial Subgroups Analysis
por: Torbey, Michel T., et al.
Publicado: (2022)

Cannot write session to /tmp/vufind_sessions/sess_i5n27f3ib8r47u28ljpje771jn