Analysis of articles directly related to randomized trials finds poor protocol availability and inconsistent linking of articles

Journal of Clinical Epidemiology

Volumn 124, Issue , 2020, Pages 69-74

  Sender, David ^a   Clark, Justin ^a   Hoffmann, Tammy C ^a  

^a BOND UNIVERSITY   (Australia)

Author keywords

Protocol; Randomized controlled trial; Records; Registries; Trial registration

Indexed keywords

ARTICLE; CONTROLLED STUDY; HUMAN; QUALITATIVE RESEARCH; RANDOMIZED CONTROLLED TRIAL; SECONDARY ANALYSIS; INFORMATION DISSEMINATION; METHODOLOGY; PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC); REGISTER;

HUMANS; INFORMATION DISSEMINATION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REGISTRIES; RESEARCH DESIGN;

EID: 85084823821     PISSN: 08954356     EISSN: 18785921     Source Type: Journal    
DOI: 10.1016/j.jclinepi.2020.04.017     Document Type: Article

References (19)

1. Goldacre, B., Gray, J., OpenTrials: towards a collaborative open database of all available information on all clinical trials. Trials, 17, 2016, 164.
2. Chalmers, I., Altman, D.G., How can medical journals help prevent poor medical research? Some opportunities presented by electronic publishing. Lancet 353 (1999), 490–493.
3. Altman, D.G., Furberg, C.D., Grimshaw, J.M., Shanahan, D.R., Linked publications from a single trial: a thread of evidence. Trials, 15, 2014, 369.
4. Bashir, R., Bourgeois, F.T., Dunn, A.G., A systematic review of the processes used to link clinical trial registrations to their published results. Syst Rev, 6(1), 2017, 123.
5. Mayo-Wilson, E., Li, T., Fusco, N., Dickersin, K., Practical guidance for using multiple data sources in systematic reviews and meta-analyses (with examples from the MUDS study). Res Synth Methods 9:1 (2018), 2–12.
6. Hoffmann, T.C., Erueti, C., Glasziou, P.P., Poor description of non-pharmacological interventions: analysis of consecutive sample of randomised trials. BMJ, 347, 2013, f3755.
7. Chan, A.W., Tetzlaff, J.M., Gotzsche, P.C., Altman, D.G., Mann, H., Berlin, J.A., et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ, 346, 2013, e7586.
8. Glasziou, P., Altman, D.G., Bossuyt, P., Boutron, I., Clarke, M., Julious, S., et al. Reducing waste from incomplete or unusable reports of biomedical research. Lancet 383 (2014), 267–276.
9. ICMJE recommendations for the conduct, reporting, editing and publication of scholarly work in medical journals. Available at http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/. (Accessed 10 January 2020)
10. Macleod, M.R., Michie, S., Roberts, I., Dirnagl, U., Chalmers, I., Ioannidis, J.P., et al. Biomedical research: increasing value, reducing waste. Lancet 383:9912 (2014), 101–104.
11. Hoffmann, T., Glasziou, P., Beller, E., Goldacre, B., Chalmers, I., Focus on sharing individual patient data distracts from other ways of improving trial transparency. BMJ, 357, 2017, j2782.
12. Ebrahim, S., Montoya, L., Kamal El Din, M., Sohani, Z.N., Agarwal, A., Bance, S., et al. Randomized trials are frequently fragmented in multiple secondary publications. J Clin Epidemiol 79 (2016), 130–139.
13. Shokraneh, F., Adams, C.E., Study-based registers of randomized controlled trials: starting a systematic review with data extraction or meta-analysis. Bioimpacts 7:4 (2017), 209–217.
14. Shokraneh, F., Adams, C.E., Increasing value and reducing waste in data extraction for systematic reviews: tracking data in data extraction forms. Syst Rev, 6(1), 2017, 153.
15. Saquib, N., Saquib, J., Ioannidis, J.P.A., Practices and impact of primary outcome adjustment in randomized controlled trials: meta-epidemiologic study. BMJ, 347, 2013, f4313.
16. Lucey, M., Clark, J., Glasziou, P., Public availability of trial protocols. Lancet 390 (2017), e54–e55.
17. Chan, A.-W., Pello, A., Kitchen, J., Axentiev, A., Virtanen, J.I., Liu, A., et al. Association of trial registration with reporting of primary outcomes in protocols and publications. JAMA 318 (2017), 1709–1711.
18. Chan, A.W., Hrobjartsson, A., Haahr, M.T., Gotzsche, P.C., Altman, D.G., Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA 291 (2004), 2457–2465.
19. Huser, V., Cimino, J.J., Linking ClinicalTrials.gov and PubMed to track results of interventional human clinical trials. PLoS one, 8, 2013, e68409.