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Table 3 Detailed information of what had been reported in the included studies regarding the inconsistency between protocols or registrations and full reportsa

From: A systematic review of comparisons between protocols or registrations and full reports in primary biomedical research

First author, year Levels of inconsistent reporting between protocols or registrations and full reports
Participant eligibility criteria Sample size Randomization Interventions and their delivery Blinding Outcome measure Study duration Statistical analysis choice (e.g., model selection, model adjustment, missing data handling, intention-to-treat, et al) Subgroup analysis Funding source Othersb
Al-Marzouki, 2008 [17] 30% 36%
Chan, 2004 (from CMAJ) [19] 40%
Chan, 2004 (from JAMA) [7] 62%
Boonacker, 2011 [18] 75%
Chan, 2008 [3] 53% 60% Handling missing data: 80% Interim analyses: 62% Model adjustments: 82% 100%  
Dekkers, 2015 [11] Noninferiority margin definitions reported: 9% Noninferiority margins and confidence intervals reported: 28%
Hahn, 2002 [20] 33% Analysis plans reported: 88%
Hannink, 2013 [21] 49%
Hartung, 2014 [22] 15%  
Hernandez, 2005 [23] 100%
Kasenda, 2014 [9] 38%
Killlen, 2014 29%
Korevaar, 2014 [25] 12% 21%   Result presentations: 6%
Li, 2013 [26] 14%
Mathieu, 2009 [27] 31%
Maund, 2014 [28] Primary efficacy analyses reported: 14% Adverse events reported: 100%
Melander, 2003 [29] Intention-to-treat or per-protocol analyses reported: 93%
Mhaskar, 2012 [30] 59% 77% 72% 53% Intention-to-treat analyses reported: 70%  
Milette, 2011 [31] 100%
Nankervis, 2012 [32] 72%  
Norris, 2014 [33] 83% 20% Adverse events reported; 43%
Redmond, 2013 [34] 29% (primary outcomes: 17%; secondary outcomes: 33%)
Riehm, 2015 [35] 33%
Rising, 2008 [36] 31% Conclusions reported: 9%
Riveros, 2013 [37] 87% Adverse events reported: 37%
Rongen, 2016 [38] 54%  
Rosati, 2016 [39] 45% 40% 100% Studies discontinued early without justifications:65% Intention-to-treat analysis: 10% 45%  
Rosenthal, 2013 [40] 27% 2% 23% Primary outcomes: 45% Secondary outcomes: 67% Start of patient enrolment reported: 43% End of enrollment reported: 71% 45% Ethical committee approval: 2%
Saquib, 2013 [41] Analysis plans reported: 47%
Smith, 2013 [42] 79%
Soares, 2004 [48] 60% 59% Intention-to-treat analysis: 14% Dropouts reported: 9%
Su, 2015 [43] 45%
Turner, 2012 [44] 25%- Effect sizes reported: 8%
Vedula, 2009 [45] 67%
Vedula, 2013 [10] Intention-to-treat analysis definitions: 67% Safety analysis definitions: 50%
Vera-Badillo 2013 [46] 23%
You, 2012 [47] 14%
  1. aCells with a ‘-’ indicated the information was not reported in the included studies
  2. bOther inconsistency measures including comparisons of effect size, sample size, control, ethics, key finding reporting, and/or conclusion reporting