{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T18:12:36Z","timestamp":1777659156419,"version":"3.51.4"},"reference-count":67,"publisher":"SAGE Publications","issue":"3","license":[{"start":{"date-parts":[[2019,6,7]],"date-time":"2019-06-07T00:00:00Z","timestamp":1559865600000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Global Spine Journal"],"published-print":{"date-parts":[[2020,5]]},"abstract":"<jats:sec>\n                    <jats:title>Study Design:<\/jats:title>\n                    <jats:p>Systematic review.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>Superiority claims for medical devices are commonly derived from noninferiority trials, but interpretation of such claims can be challenging. This study aimed to ( a) establish the prevalence of noninferiority and superiority designs among spinal device trials, ( b) assess the frequency of post hoc superiority claims from noninferiority studies, and ( c) critically evaluate the risk of bias in claims that could translate to misleading conclusions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Study bias was assessed using the Cochrane Risk of Bias Tool. The risk of bias for the superiority claim was established based on post hoc hypothesis specification, analysis of the intention-to-treat population, post hoc modification of a priori primary outcomes, and sensitivity analyses.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Forty-one studies were identified from 1895 records. Nineteen (46%) were noninferiority trials. Fifteen more (37%) were noninferiority trials with a secondary superiority hypothesis specified a priori. Seven (17%) were superiority trials. Of the 34 noninferiority trials, 14 (41%) made superiority claims. A medium or high risk of bias was related to the superiority claim in 9 of those trials (64%), which was due to the analyzed population, lacking sensitivity analyses, claims not being robust during sensitivity analyses, post hoc hypotheses, or modified endpoints. Only 4 of the 14 (29%) noninferiority studies provided low bias in the superiority claim, compared with 3 of the 5 (60%) superiority trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Health care decision makers should carefully evaluate the risk of bias in each superiority claim and weigh their conclusions appropriately.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/2192568219841046","type":"journal-article","created":{"date-parts":[[2019,6,7]],"date-time":"2019-06-07T21:35:38Z","timestamp":1559943338000},"page":"332-345","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":1,"title":["Superiority Claims for Spinal Devices: A Systematic Review of Randomized Controlled Trials"],"prefix":"10.1177","volume":"10","author":[{"given":"S. Raymond","family":"Golish","sequence":"first","affiliation":[{"name":"Jupiter Medical Center, Palm Beach, FL, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael W.","family":"Groff","sequence":"additional","affiliation":[{"name":"Brigham and Women\u2019s Hospital, Boston, MA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ali","family":"Araghi","sequence":"additional","affiliation":[{"name":"The CORE Institute, Phoenix, AZ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5221-273X","authenticated-orcid":false,"given":"Jason A.","family":"Inzana","sequence":"additional","affiliation":[{"name":"Telos Partners, LLC, Denver, CO, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2019,6,7]]},"reference":[{"key":"bibr1-2192568219841046","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2007.02.015"},{"key":"bibr2-2192568219841046","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-017-2032-2"},{"key":"bibr3-2192568219841046","doi-asserted-by":"publisher","DOI":"10.1016\/j.spinee.2016.09.015"},{"key":"bibr4-2192568219841046","doi-asserted-by":"publisher","DOI":"10.1081\/BIP-120024199"},{"key":"bibr5-2192568219841046","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2125.2001.01397-3.x"},{"key":"bibr6-2192568219841046","unstructured":"International Council for Harmonisation. Guidance for industry. E9: statistical principals for clinical trials. https:\/\/www.fda.gov\/downloads\/drugs\/guidancecomplianceregulatoryinformation\/guidances\/ucm073137.pdf. Published September 1998. Accessed August 6, 2018."},{"key":"bibr7-2192568219841046","unstructured":"International Council for Harmonisation of Technical Requirements for pharmaceuticals for human use. ICH Harmonised Guideline. Estimands and sensitivity analysis in clinical trials. Draft E9(R1). http:\/\/www.ich.org\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Efficacy\/E9\/E9-R1EWG_Step2_Guideline_2017_0616.pdf. 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Accessed September 6, 2018."},{"key":"bibr13-2192568219841046","doi-asserted-by":"publisher","DOI":"10.1016\/0197-2456(82)90024-1"},{"key":"bibr14-2192568219841046","doi-asserted-by":"publisher","DOI":"10.1016\/0197-2456(84)90116-8"},{"key":"bibr15-2192568219841046","doi-asserted-by":"publisher","DOI":"10.3171\/spi.2007.6.3.198"},{"key":"bibr16-2192568219841046","doi-asserted-by":"publisher","DOI":"10.1097\/BRS.0000000000000031"},{"key":"bibr17-2192568219841046","doi-asserted-by":"publisher","DOI":"10.1097\/BRS.0b013e318217668f"},{"key":"bibr18-2192568219841046","doi-asserted-by":"publisher","DOI":"10.1097\/BRS.0000000000001245"},{"key":"bibr19-2192568219841046","doi-asserted-by":"publisher","DOI":"10.1016\/j.spinee.2018.05.003"},{"key":"bibr20-2192568219841046","doi-asserted-by":"publisher","DOI":"10.14444\/2006"},{"key":"bibr21-2192568219841046","unstructured":"US Food and Drug Administration. FDA executive summary: DIAM Spinal Stabilization System (P140007). https:\/\/wayback.archive-it.org\/7993\/20170723181343\/https:\/\/www.fda.gov\/downloads\/AdvisoryCommittees\/CommitteesMeetingMaterials\/MedicalDevices\/MedicalDevicesAdvisoryCommittee\/OrthopaedicandRehabilitationDevicesPanel\/UCM486413.pdf. Accessed September 4, 2018."},{"key":"bibr22-2192568219841046","doi-asserted-by":"publisher","DOI":"10.1002\/rcs.1779"},{"key":"bibr23-2192568219841046","unstructured":"Office of Surveillance and Biometrics. Final statistical review of PMA P040001, St. Francis Medical\u2019s X-STOP\u00d2 Interspinous Process Distraction System. https:\/\/wayback.archive-it.org\/7993\/20170405120856\/https:\/\/www.fda.gov\/ohrms\/dockets\/ac\/04\/briefing\/2004-4064b1_04_statistics%20memo-print%20version.pdf. Accessed September 4, 2018."},{"key":"bibr24-2192568219841046","unstructured":"US Food and Drug Administration. FDA PMA P070023 executive summary. 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Accessed June 14, 2018."},{"key":"bibr32-2192568219841046","unstructured":"US Food and Drug Administration. Premarket approval (P060018). https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpma\/pma.cfm? id=P060018. Accessed August 6, 2018."},{"key":"bibr33-2192568219841046","doi-asserted-by":"publisher","DOI":"10.1097\/BRS.0b013e31818ee263"},{"key":"bibr34-2192568219841046","unstructured":"US Food and Drug Administration. Premarket approval (P060023). https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpma\/pma.cfm? id=P060023. Accessed August 7, 2018."},{"key":"bibr35-2192568219841046","doi-asserted-by":"publisher","DOI":"10.3171\/2013.6.SPINE12527"},{"key":"bibr36-2192568219841046","unstructured":"US Food and Drug Administration. Premarket approval (P110009). https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpma\/pma.cfm? id=P110009. 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Executive summary for P050036 Medtronic\u2019s AMPLIFY\u2122 rhBMP-2 matrix. https:\/\/wayback.archive-it.org\/7993\/20170114052355\/http:\/\/www.fda.gov\/downloads\/AdvisoryCommittees\/CommitteesMeetingMaterials\/MedicalDevices\/MedicalDevicesAdvisoryCommittee\/OrthopaedicandRehabilitationDevicesPanel\/UCM220079.pdf. Published July 27, 2010. Accessed September 4, 2018."},{"key":"bibr62-2192568219841046","doi-asserted-by":"publisher","DOI":"10.1097\/BRS.0b013e3182309af7"},{"key":"bibr63-2192568219841046","doi-asserted-by":"publisher","DOI":"10.1097\/BRS.0b013e31822ba50b"},{"key":"bibr64-2192568219841046","doi-asserted-by":"publisher","DOI":"10.1097\/BRS.0000000000000906"},{"key":"bibr65-2192568219841046","doi-asserted-by":"publisher","DOI":"10.1097\/00007632-200010150-00017"},{"key":"bibr66-2192568219841046","unstructured":"US Food and Drug Administration. Summary of safety and effectiveness (P980048). https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf\/P980048B.pdf. 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