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Table 1 Clinical trial registry (CTR)-randomised controlled trial (RCT) discrepancies in 20 RCTs scored by assessing and cross-checking inconsistencies in the six reporting domains identified, assessed and scored according to their importance in a well-conducted triala

From: Major discrepancies between what clinical trial registries record and paediatric randomised controlled trials publish

  Sponsors, funding and conflict of interests incompletely declared Discrepant or unclear sample size Inclusion/exclusion criteria not respected or selective crossover Primary outcome or primary outcome measure modified or downgraded or secondary outcomes upgraded Early RCT completion unjustified Main outcome selectively reported or unreported  
1 2 3 Combined discrepancy scores: low ≤4, medium 5–9, high 10–14b
CTR acronyms, registration numbers, and web link for the 20 RCTs published in the journal Pediatrics from July to November 2013 (first author and publication reference) Cited references        
NCT 01351064, URL https://clinicaltrials.gov (Carroll et al. 132(3):e623-e 629 Sept 2013) [25] The RCT incompletely declared funding - - - - The CTR automatically indexed the RCT reference but the authors failed to report the results
Incongruities in the published RCT (abstract and results)
4
NCT 01822626, URL https://clinicaltrials.gov (Davoli et al. 132(5):e1236-e1245 Oct 2013 [26] - Number of eligible participants not provided in the CTR - - - The CTR automatically indexed the RCT reference but the authors failed to report the results 5
ISRCTN 59061709, URL http://www.isrctn.com/ (McCarthy et al. 132(2):e389-e395 Aug 2013) [27] - - The RCT failed to respect the exclusion criteria for three infants. During study conduction one infant crossed over - - The CTR automatically indexed the RCT URL address but the authors failed to report the results 5
NTR 1613, URL www.trialregister.nl (van der Veek et al. 132(5):e1163-e1172 Nov 2013) [28] - - Discrepant children’s age in the inclusion criteria - - The CTR failed to automatically index the RCT URL address or reference and the authors neglected to report the results. The published RCT reported that the intervention yielded insignificant results for all endpoints 5
ISRCTN 72635512, URL http://www.isrctn.com/ (Field et al. 132(5):e1247-e1256 Nov 2013) [29] - - - - Early study completion (March 2010 instead of May 2012) The CTR automatically indexed the RCT URL address but the authors failed to report the results. The published RCT analysed selected data for randomised newborns in the intervention and control group (80 % vs 87 %) and reported an insignificant statistical difference for the primary outcome (cognitive improvement) but the authors inadequately reported more harm than benefit in the intervention group for secondary patient-centred outcomes (death, cerebral palsy) 6
NCT 00548379, URL https://clinicaltrials.gov (Aluisio et al. 132(4):e832-e840 Oct 2013) [30] - - Discrepant RCT inclusion criteria Secondary outcome upgraded in the RCT - The CTR automatically indexed the RCT reference including the CTR primary outcome but neglected to report the RCT including the secondary outcome upgraded and showing an insignificant statistical difference between intervention and control group 8
ISRCTN 31707342, URL http://www.isrctn.com/ (McCarthy et al. 132(1): e135-e141 July 2013) [31] - Discrepancy in the number of children enrolled and analysed (the CTR failed to report that an external Data Safety Monitor Committee stopped the RCT early hence the trial failed to reach the target number of participants) - - The updated CTR failed to report early stopping after a planned interim analysis The CTR automatically indexed the RCT URL address but failed to report early stopping. The RCT unclearly reported the reason for stopping the trial (more harm than good for the primary outcome in the intervention group) 8
NCT 01307293, URL https://clinicaltrials.gov (Shaw et al. 132(4):e886-e894 Oct 2013) [32] - Discrepancy in the age of premature children enrolled - - Early study completion (Dec 2012 instead of Jan 2013) The CTR automatically indexed the RCT reference but the authors failed to report the results. The RCT reported benefits in the intervention group before study completion date 8
ACTRN 12608000056392, URL www.anzctr.org.au (Daniels 132(1):e109- e118 July 2013) [33] Funding incompletely declared in the RCT Discrepancy in the number of participants eligible and enrolled - Primary outcome downgraded in the RCT - The CTR failed to automatically index RCT URL address or reference and the authors neglected to provide results The RCT failed to report that the intervention yielded insignificant results 9
NCT 00409448, URL https://clinicaltrials.gov (Kurowski et al. 132(1):e158-e166 Jul 2013) [34] Discrepancy in declared funding - Discrepant RCT exclusion criteria   Early study completion (Jan 2011 instead of August 2012) The CTR failed to automatically index the RCT URL address or reference and the authors neglected to provide results 9
NCT 00551642, URL https://clinicaltrials.gov (Durrmeyer et al. 132(3):e695-e703 Sept 2013) [35] Funding incompletely declared in the CTR - - Primary outcome completely changed in the RCT Published ongoing study results and follow-up not respected The CTR automatically indexed the RCT reference but the authors failed to report the results. The RCT neglected to report results for the primary outcome (more harm than good in the intervention group) 10
NCT 01403623, URL https://clinicaltrials.gov (Leadford et al. 132(1):e128-e134 Jul 2103) [36] Funding incompletely declared in the CTR - - Primary outcome measure modified in the RCT Early study completion (Oct 2011 instead of Dec 2012) The CTR automatically indexed the RCT reference but the authors failed to report the results. Main outcome measure partially reported in the RCT 10
NCT 00334737, URL https://clinicaltrials.gov (Ohls et al. 132(1):e119-e127 Jul 2013) [37] Discrepancy in declared funding - - Primary outcome partially modified in the RCT Follow-up not respected (presumably an ongoing study or randomisation done for another study) The CTR reported previous published authors’ papers (2004–2006) but failed to automatically index the RCT URL address or reference. The authors failed to report results in the last CTR updated in November 2013. The RCT only partially reported results on the primary outcome 10
NCT 01065272, URL https://clinicaltrials.gov (Alansari et al. 132(4):e810-e816 Sept 2013) [38] - - The RCT incompletely respected inclusion criteria Primary outcome modified in the RCT Early study completion (March 2012 instead of August 2012) The CTR failed to automatically index RCT URL address or reference and the authors neglected to provide results. The RCT reported results for the modified primary outcome 11
NCT 01810978, URL https://clinicaltrials.gov (Dilli et al. 132(4):e932-e938 Oct 2013) [39] - - Discrepancy in the inclusion criteria Primary outcome modified and secondary outcome upgraded in the RCT Early study completion (Apr 2013 instead of May 2013) The CTR automatically indexed the RCT reference but the authors failed to report the results. The RCT reported results for the modified primary outcome and upgraded secondary outcome 11
NTR 2061 and ACTRN 12610000230055, URLs www.trialregister.nl and www.anzctr.org.au (Kamlin et al. 132(2):e381-e388 Aug 2013) [40] Funding incompletely declared in the RCT Discrepancy in the number of participants eligible and enrolled Inclusion criteria modified in the Dutch register (NTR) only. The Australian registry (ANZCTR), retrospectively indexed failed to report inclusion criteria changes - Australian registry retrospectively indexed the trial and failed to report that the trial stopped early on an external data safety committee decision (difficulties in recruiting infants and futility) The NTR, updated on 5 Apr 2012, failed to report completed results but stated that the trial was stopped for slow recruitment and futility. The ANZCTR was retrospectively registered and not updated (‘still recruiting’). The RCT abstract incompletely reported that the external data safety committee stopped the trial early owing to difficulties in recruiting infants. Data for 4 children excluded from the analysis in the RCT 11
CTRI 2010/091/001417, URL http://ctri.nic.in/Clinicaltrials/login.php (Malik et al. 132(1):e46-e52 July 2013) [41] The RCT failed to report that the trial was used for a medical thesis Discrepancy in the number of participants eligible and enrolled The RCT reported that to achieve the final sample size patients were enrolled from an area adjacent to the setting declared Primary outcome downgraded in the RCT - The CTR, updated by the authors on 14 Jun 2012, reported a brief summary of positive results for the downgraded primary outcome but failed to report side effects. The RCT neglected to report increased side effects in the intervention group 11
ACTRN 12612000976886, URL www.anzctr.org.au (McIntosh et al. 132(2):326-331 Aug 2013) [42] - The CTR neglected to report sample size - Primary outcome measure modified in the RCT The CTR was retrospectively registered and the RCT failed to provide completion date The retrospectively registered CTR failed to automatically index the RCT URL address or reference and the authors neglected to provide results. The RCT only partially reported results on the primary outcome 11
ISRCTN 03981121, URL http://www.isrctn.com/ (Wake et al. 132(4):e895-e904 Oct 2013) [43] - Discrepancy in the number of participants eligible and enrolled - Primary outcome measure modified in the RCT No study conduction period specified in the RCT. Results reported for only half of the declared follow-up The CTR automatically indexed the URL address of the published RCT. The RCT neglected to report results for the primary outcome (no statistical difference) but reported a significant difference for a secondary outcome 11
NCT 01604460, URL https://clinicaltrials.gov (Belsches et al. 132(3):e656-e661 Sept 2013) [44] Discrepancy in declared funding - The RCT reported a modified intervention procedure for the included infants Discrepancy in primary outcome measures Early study completion (June 2012 instead of November 2012) The CTR automatically indexed the URL address of the published RCT, but the authors failed to report results. The RCT only partially reported results on the primary outcome 12
  1. aReporting domains chosen from our clinical experience in critically appraising RCTs and the Cochrane Collaboration tool for assessing risk of bias (main outcome selectively reported or unreported) [23, 24]. Upgrading secondary outcomes means reporting secondary outcomes as primary outcomes in the publication. Discrepancies in the domain ‘main outcome selectively reported or unreported’ had similar scores because inconsistencies in this domain could have made the RCT results untrustworthy or less trustworthy. CTR abbreviations: the United States National Institute of Health (NCT), the International Standard Randomised Controlled Trial Number (currently BioMed Central Open Access publishers) (ISRCTN), the Nederlands Trials Register (NTR), the Australian and New Zealand Clinical Trial Registry (ACTRN), and the Clinical Trial Registry-India (CTRI). Trials are listed and grouped according to the combined discrepancy scores. When scores are identical, trials are listed alphabetically by first author surnames. bHigher discrepancy scores suggest risk of bias
  2. CTR clinical trial registry, RCT randomised controlled trial, URL Uniform Resource Locator