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• W2897619994 abstract "Selective outcome reporting (SOR) is a type of in-study publication bias that occurs when only some outcomes listed in trial registries are reported in published articles often to increase the appearance of positive findings [[1]Norris S.L. Holmer H.K. Ogden L.A. Fu R. Abou-Setta A.M. Viswanathan M.S. et al.Selective outcome reporting as a source of bias in reviews of comparative effectiveness. Agency for Healthcare Research and Quality (Report No.: 12-EHC110-EF), Rockvile, MD2012Google Scholar]. SOR contributes to distorting the scientific literature [2Abaid L.N. Grimes D.A. Schulz K.F. Reducing publication bias through trial registration.Obstet Gynecol. 2007; 109: 1434-1437Crossref PubMed Scopus (26) Google Scholar, 3Dickersin K. Chalmers I. Recognizing, investigating and dealing with incomplete and biased reporting of clinical research: from Francis Bacon to the WHO.J R Soc Med. 2011; 104: 532-538Crossref PubMed Scopus (69) Google Scholar, 4Dwan K. Gamble C. Williamson P.R. Kirkham J.J. Systematic review of the empirical evidence of study publication bias and outcome reporting bias - an updated review.PLoS One. 2013; 8: e66844Crossref PubMed Scopus (641) Google Scholar]. We investigated the presence of SOR in randomized controlled trials (RCTs) of lung cancer immunotherapies and noted the presence of trial registration, reporting of trial registration numbers, prospective registration, and compliance with CONSORT guidelines. Detailed methods can be found in the Supplementary Materials (Appendix 1) at www.jclinepi.com. Briefly, we searched MEDLINE and the Cochrane Central Register of Controlled Trials for eligible RCTs. We found corresponding trial registration entries by checking to see if authors reported the registration numbers in the text of their articles or by hand-searching ISCRCTN.org. Using Fisher's exact test, we compared whether the presence of SOR was associated with study significance (P ≤ 0.05 vs. P > 0.05), prospective registration (yes/no), and funding source (industry/other). Supplementary Fig. 1 and Table 1 in the Supplementary Materials show the study selection process and study characteristics. Characteristics are also summarized in Supplementary Fig. 2. Of 42 articles that met our criteria, 20 did not report a trial registration number in the text. Overall, we identified 26 trial registrations, 22 on account of reported registration numbers, and four through manual searching of trial registries [5Ramlau R. Quoix E. Rolski J. Pless M. Lena H. Lévy E. et al.A phase II study of Tg4010 (Mva-Muc1-Il2) in association with chemotherapy in patients with stage III/IV non-small cell lung cancer.J Thorac Oncol. 2008; 3: 735-744Abstract Full Text Full Text PDF PubMed Scopus (167) Google Scholar, 6Iclozan C. Antonia S. Chiappori A. Chen D.-T. Gabrilovich D. Therapeutic regulation of myeloid-derived suppressor cells and immune response to cancer vaccine in patients with extensive stage small cell lung cancer.Cancer Immunol Immunother. 2013; 62: 909-918Crossref PubMed Scopus (221) Google Scholar, 7Kimura H. Matsui Y. Ishikawa A. Nakajima T. Yoshino M. Sakairi Y. Randomized controlled phase III trial of adjuvant chemo-immunotherapy with activated killer T cells and dendritic cells in patients with resected primary lung cancer.Cancer Immunol Immunother. 2015; 64: 51-59Crossref PubMed Scopus (56) Google Scholar, 8Giaccone G. Debruyne C. Felip E. Chapman P.B. Grant S.C. Millward M. et al.Phase III study of adjuvant vaccination with Bec2/bacille calmette-guerin in responding patients with limited-disease small-cell lung cancer (European organisation for research and treatment of cancer 08971-08971B; Silva study).J Clin Oncol. 2005; 23: 6854-6864Crossref PubMed Scopus (193) Google Scholar]. Ideally, all studies should provide registration numbers in published reports to comply with International Committee of Medical Journal Editors recommendations and CONSORT guidelines [[9]Moher D. Hopewell S. Schulz K.F. Montori V. Gøtzsche P.C. Devereaux P.J. et al.CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials.BMJ. 2010; 340: c869Crossref PubMed Scopus (3561) Google Scholar]; however, individual journals enforce compliance differently [[10]International Committee of Medical JournalICMJE | recommendations | clinical trials [internet].http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.htmlDate accessed: February 19, 2018Google Scholar]. Of 26 articles, 19 had prospective registration, and seven were registered during the trial or after completion, with six of seven articles published before 2013. Twenty-four articles met criteria for SOR analysis; the most common SOR was the addition or omission of secondary outcomes (Supplementary Table 2; Fig. 1 below). Five articles did not have any SOR present [11Antonia S. Goldberg S.B. Balmanoukian A. Chaft J.E. Sanborn R.E. Gupta A. et al.Safety and antitumour activity of durvalumab plus tremelimumab in non-small cell lung cancer: a multicentre, phase 1b study.Lancet Oncol. 2016; 17: 299-308Abstract Full Text Full Text PDF PubMed Scopus (490) Google Scholar, 12Butts C. Maksymiuk A. Goss G. Soulières D. Marshall E. Cormier Y. et al.Updated survival analysis in patients with stage IIIB or IV non-small-cell lung cancer receiving BLP25 liposome vaccine (L-BLP25): phase IIB randomized, multicenter, open-label trial.J Cancer Res Clin Oncol. 2011; 137: 1337-1342Crossref PubMed Scopus (158) Google Scholar, 13Neal J.W. Dahlberg S.E. Wakelee H.A. Aisner S.C. Bowden M. Huang Y. et al.Erlotinib, cabozantinib, or erlotinib plus cabozantinib as second-line or third-line treatment of patients with EGFR wild-type advanced non-small-cell lung cancer (ECOG-ACRIN 1512): a randomised, controlled, open-label, multicentre, phase 2 trial.Lancet Oncol. 2016; 17: 1661-1671Abstract Full Text Full Text PDF PubMed Scopus (89) Google Scholar, 14Rittmeyer A. Barlesi F. Waterkamp D. Park K. Ciardiello F. von Pawel J. et al.Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial.Lancet. 2017; 389: 255-265Abstract Full Text Full Text PDF PubMed Scopus (3166) Google Scholar, 15Thomas M. Sadjadian P. Kollmeier J. Lowe J. Mattson P. Trout J.R. et al.A randomized, open-label, multicenter, phase II study evaluating the efficacy and safety of BTH1677 (1,3–1,6 beta glucan; Imprime PGG) in combination with cetuximab and chemotherapy in patients with advanced non-small cell lung cancer.Invest New Drugs. 2017; 35: 345-358Crossref PubMed Scopus (30) Google Scholar]. Only two of the 24 articles adhered to CONSORT guidelines [7Kimura H. Matsui Y. Ishikawa A. Nakajima T. Yoshino M. Sakairi Y. Randomized controlled phase III trial of adjuvant chemo-immunotherapy with activated killer T cells and dendritic cells in patients with resected primary lung cancer.Cancer Immunol Immunother. 2015; 64: 51-59Crossref PubMed Scopus (56) Google Scholar, 16Vansteenkiste J. Zielinski M. Linder A. Dahabreh J. Gonzalez E.E. Malinowski W. et al.Adjuvant MAGE-A3 immunotherapy in resected non–small-cell lung cancer: phase II randomized study results.J Clin Oncol. 2013; 31: 2396-2403Crossref PubMed Scopus (254) Google Scholar]. SOR was found to be associated with study significance (P = 0.04), but not prospective registration or funding source (Supplementary Tables 3–5). Researchers may alter secondary outcomes more often than primary outcomes because doing so is unlikely to change the primary study question or design. Thus, researchers might believe that a comprehensive list of secondary outcomes is not necessary for trial registration, and subsequent changes to the list do not require updates to the registry. Our study showed that the use of trial registries in cancer immunotherapy is inconsistent and SOR exists, emphasizing the need for more concern with SOR in this field. The need for initiatives, such as AllTrials and COMPare [17Goldacre B. Drysdale H. Powell-Smith A. Dale A. Milosevic I. Slade E. et al.Tracking switched outcomes in clinical trials [Internet].2016http://compare-trials.org/Date accessed: January 26, 2018Google Scholar, 18Sense about ScienceAllTrials – find out more [internet].http://www.alltrials.net/find-out-more/Date accessed: March 8, 2018Google Scholar], highlights the persistence of SOR in health care research. We advise journal editors to enforce International Committee of Medical Journal Editors and CONSORT guidelines regarding trial registration, reporting of registration numbers in submitted articles, and the need for explanations of outcome switching. The authors wish to thank Susan Mirabi for screening articles. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Download .xml (.0 MB) Help with xml files Data Profile Download .pdf (.74 MB) Help with pdf files Letter Appendix" @default.
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• W2897619994 title "Selective outcome reporting is present in randomized controlled trials in lung cancer immunotherapies" @default.
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