{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,1,15]],"date-time":"2024-01-15T10:42:23Z","timestamp":1705315343747},"reference-count":20,"publisher":"Georg Thieme Verlag KG","issue":"05","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Neurol Surg A Cent Eur Neurosurg"],"published-print":{"date-parts":[[2020,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>\n          Background\u2003The use of sham interventions in randomized controlled trials (RCTs) is essential to minimize bias. However, their use in surgical RCTs is rare and subject to ethical concerns. To date, no studies have looked at the use of sham interventions in RCTs in neurosurgery.<\/jats:p><jats:p>\n          Methods\u2003This study evaluated the frequency, type, and indication of sham interventions in RCTs in neurosurgery. RCTs using sham interventions were also characterized in terms of design and risk of bias.<\/jats:p><jats:p>\n          Results\u2003From a total of 1,102 identified RCTs in neurosurgery, 82 (7.4%) used sham interventions. The most common indication for the RCT was the treatment of pain (67.1%), followed by the treatment of movement disorders and other clinical problems (18.3%) and brain injuries (12.2%). The most used sham interventions were saline injections into spinal structures (31.7%) and peripheral nerves (10.9%), followed by sham interventions in cranial surgery (26.8%), and spine surgery (15.8%). Insertion of probes or catheters for a sham lesions was performed in 14.6%.<\/jats:p><jats:p>In terms of methodology, most RCTs using sham interventions were double blinded (76.5%), 9.9% were single blinded, and 13.6% did not report the type of blinding.<\/jats:p><jats:p>\n          Conclusion\u2003Sham-controlled RCTs in neurosurgery are feasible. Most aim to minimize bias and to evaluate the efficacy of pain management methods, especially in spinal disorders. The greatest proportion of sham-controlled RCTs involves different types of substance administration routes, with sham surgery the less commonly performed.<\/jats:p>","DOI":"10.1055\/s-0040-1709161","type":"journal-article","created":{"date-parts":[[2020,5,21]],"date-time":"2020-05-21T22:52:30Z","timestamp":1590101550000},"page":"456-462","source":"Crossref","is-referenced-by-count":1,"title":["Use of Sham Interventions in Randomized Controlled Trials in Neurosurgery"],"prefix":"10.1055","volume":"81","author":[{"given":"Rodrigo Panico","family":"Gorayeb","sequence":"additional","affiliation":[{"name":"Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Portugal"}]},{"given":"Maria Jo\u00e3o","family":"Forjaz","sequence":"additional","affiliation":[{"name":"National School of Public Health, Institute of Health Carlos III and REDISSEC, Madrid, Spain"}]},{"given":"Ant\u00f3nio Gon\u00e7alves","family":"Ferreira","sequence":"additional","affiliation":[{"name":"Institute of Anatomy, Faculdade de Medicina, Universidade de Lisboa, Portugal"}]},{"given":"Joaquim Jos\u00e9","family":"Ferreira","sequence":"additional","affiliation":[{"name":"Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Portugal"},{"name":"Instituto de Medicina Molecular, Lisbon, Portugal"}]}],"member":"194","published-online":{"date-parts":[[2020,5,21]]},"reference":[{"key":"ref1","doi-asserted-by":"crossref","first-page":"21","DOI":"10.1016\/j.amsu.2016.10.007","article-title":"Critical review of sham surgery clinical trials: confounding factors analysis","volume":"12","author":"M Ciccozzi","year":"2016","journal-title":"Ann Med Surg (Lond)"},{"issue":"17","key":"ref2","doi-asserted-by":"crossref","first-page":"e3516","DOI":"10.1097\/MD.0000000000003516","article-title":"Placebo-controlled trials in surgery: a systematic review and 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