Table 1 Characteristics of included studies
From: Comparison of registered and published outcomes in randomized controlled trials: a systematic review
Authors | Journal and publication year | Publication dates of included trials | Trials registries used | Description of included trials | Trials included in outcome consistency assessment | Date of initial registry search | Method of identifying included studies | Used prospectively registered outcomes in discrepancy analysis | Method of characterizing outcome discrepancies | Subgroup analyses | Additional comparisons between registry and manuscript |
|---|---|---|---|---|---|---|---|---|---|---|---|
Anand et al. [16] | Intensive Care Med. 2014 | 2005–2011 | ClinicalTrials.gov, ISRCTN, anzctr.org.au | Critical care trials | 55 | Unknown | Publication search | Yes | Not applicable | Journals following ICMJE recommendations | Sample size |
Bourgeois et al. [17] | Ann Intern Med. 2010 | Not available | ClinicalTrials.gov | Trials of anticholestermics, antidepressants, antipsychotics, proton pump inhibitors, vasodilators | 85 | 31 August 2009 | Registry search | No | Not applicable | Funding source | None |
Chahal et al. [18] | Am J Sports Med. 2012 | Not available | ClinicalTrials.gov | Orthopedic sports medicine trials | 20 | Unknown | Registry search | No | Modified version of Chan’s classification | None | Sample size, inclusion criteria |
Ewart et al. [15] | Ann Fam Med. 2009 | 2006–2007 | ClinicalTrials.gov, ISRCTN, anzctr.org.au, national register for included trials | Trials in high-impact journals | 110 | Unknown | Publication search | No | Chan | None | None |
Gandhi et al. [19] | BMC Musculoskelet Disord. 2011 | 1999–2010 | ClinicalTrials.gov | Trials related to orthopedic trauma | 20 | July 2010 | Registry search | No | Chan | Funding source | Sample size |
Hannink et al. [20] | Ann Surg. 2013 | 2007–2012 | ClinicalTrials.gov, ISRCTN, anzctr.org.au, “Other” | Trials assessing surgical interventions | 152 | Unknown | Publication search | Yes | Chan | General medical vs surgical journals | None |
Hartung et al. [21] | Ann Intern Med. 2014 | Not available | ClinicalTrials.gov | Random sample of phase 3 or 4 trials completed before January 2009 with results available in ClinicalTrials.gov | 110 | 15 February 2011 | Registry search | No | Not applicable | None | Results, adverse events |
Huić et al. [22] | PLoS One. 2011 | 2005–2005 | ClinicalTrials.gov | Trials in ICMJE member journals | 152 | Unknown | Publication search | Yes | Chan | None | Title, start date, trial methods, sample size |
Hutfless et al. [23] | Abstract from American Gastroenterological Association 2013 meeting | Not available | ClinicalTrials.gov | Trials of Crohn’s disease medications | 25 | July 2010 | Unknown | No | Not applicable | None | None |
Jones et al. [24] | Ann Emerg Med. 2012 | 2008–2011 | ClinicalTrials.gov, ISRCTN, WHO portal, national register for included trials | Trials published in emergency medicine journals | 57 | Unknown | Publication search | Yes | Chan | None | None |
Khan et al. [25] | Arthritis Rheum. 2012 | 2002–2007 | ClinicalTrials.gov | Trials of drug therapy for rheumatoid arthritis | 6 | Unknown | Publication search | No | Not applicable | None | None |
Killeen et al. [26] | Ann Surg. 2014 | 2009–2010 | ClinicalTrials.gov, ISRCTN, WHO portal, national register for included trials | Trials from surgical journals | 108 | Unknown | Publication search | No | Chan | None | None |
Li et al. [27] | Scand J Gastroenterol. 2013 | 2009–2012 | “Registries accepted by the ICMJE” | Gastroenterology trials | 155 | Unknown | Publication search | No | Chan | General medical vs gastroenterology & hepatology journals | None |
Liu et al. [28] | BMJ Open. 2013 | Not available | WHO registry portal plus Korean Clinical Research Information Service | Trials of traditional Chinese medicine | 65 | July 2012 | Registry search | No | Not applicable | None | Sample size, study methods |
Mathieu et al. [7] | JAMA. 2009 | 2008 | ClinicalTrials.gov, ISRCTN, WHO portal, national register for included trials | Cardiology, rheumatology, and gastroenterology trials in high-impact general medical and specialty journals | 147 | Unknown | Publication search | Yes | Chan | General medical vs specialty journals | None |
Mathieu et al. [29] | Joint Bone Spine. 2012 | 2006–2008 | ClinicalTrials.gov, ISRCTN | Trials on rheumatoid arthritis, osteoarthritis, and spondyloarthropathies | 40 | Unknown | Publication search | No | Not applicable | None | None |
Milette et al. [30] | J Psychosom Res. 2011 | 2008–2009 | ClinicalTrials.gov, ISRCTN, WHO portal, national register for included trials | Trials in psychosomatic and behavioral health journals | 1 | Unknown | Publication search | Yes | Not described | None | None |
Nankervis et al. [31] | J Invest Dermatol. 2012 | 2007–2011 | WHO portal | Eczema trials from the Global Resource for Eczema Trials (GREAT) database | 8 | Unknown | Publication search | Yes | Differences in primary and published outcomes or outcome timing | None | None |
Pinto et al. [32] | Phys Ther. 2013 | 2009 | ClinicalTrials.gov, ISRCTN, WHO portal, anzctr.org.au, national register for included trials | Physical therapy trials indexed in the Physiotherapy Evidence Database (PEDro) | 62 | Unknown | Publication search | No | Chan | None | None |
Rosenthal et al. [33] | Ann Surg. 2013 | 2010 | ClinicalTrials.gov, ISRCTN, WHO portal | Trials from high impact general surgical journals | 51 | Unknown | Publication search | No | Chan | Funding source, registration timing | Trial methods, sample size, analytical plan |
Ross et al. [8] | PLoS Med. 2009 | Not available | ClinicalTrials.gov | Random sample of phase 2–4 trials registered in ClinicalTrials.gov and completed by June 2007 | 198 | Unknown | Registry search | No | Not applicable | None | None |
Smith et al. [34] | J Arthroplasty. 2012 | 2006–2011 | ClinicalTrials.gov | Arthroplasty trials | 25 | July 2010 | Registry search | No | Chan | Funding source | Sample size |
Smith et al. [9] | Pain. 2013 | 2002–2011 | ClinicalTrials.gov | Trials from the Repository of Registered Analgesic Clinical Trials | 79 | 1 December 2011 | Registry search | No | Chan | Funding source, trial phase | Analytical plan, missing data plan |
Vera-Badillo et al. [35] | Ann Oncol. 2013 | 1995–2011 | ClinicalTrials.gov | Breast cancer trials | 30 | Unknown | Publication search | No | Not applicable | Funding source | None |
Walker et al. [36] | JRSM Open. 2014 | 2011–2012 | ClinicalTrials.gov, ISRCTN, national register based on first author nationality | Trials from the Journal of the American Medical Association and BMJ | 75 | Unknown | Publication search | Yes | Chan | None | Sample size, analytical plan |
Wildt et al. [37] | BMJ Open. 2011 | 1980–2011 | ClinicalTrials.gov | Trials on diseases of the digestive system | 66 | 1 January 2009 | Registry search | No | Not described | None | Sample size |
You et al. [38] | J Clin Oncol. 2012 | 2005–2009 | ClinicalTrials.gov, ISRCTN | Adult solid tumor oncology trials | 134 | August 2009 | Publication search | No | Not applicable | Funding source, journal impact factor, publication year, location of author | None |