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Observational Study
. 2014 Dec 9:349:g6870.
doi: 10.1136/bmj.g6870.

Discontinuation and non-publication of surgical randomised controlled trials: observational study

Stephen J Chapman  1 , Bryony Shelton  2 , Humza Mahmood  3 , J Edward Fitzgerald  4 , Ewen M Harrison  5 , Aneel Bhangu  6
Affiliations
Observational Study

Discontinuation and non-publication of surgical randomised controlled trials: observational study

Stephen J Chapman et al. BMJ. .

Abstract

Objective: To determine the rate of early discontinuation and non-publication of randomised controlled trials involving patients undergoing surgery.

Design: Cross sectional observational study of registered and published trials.

Setting: Randomised controlled trials of interventions in patients undergoing a surgical procedure.

Data sources: The ClinicalTrials.gov database was searched for interventional trials registered between January 2008 and December 2009 using the keyword "surgery". Recruitment status was extracted from the ClinicalTrials.gov database. A systematic search for studies published in peer reviewed journals was performed; if they were not found, results posted on the ClinicalTrials.gov results database were sought. Email queries were sent to trial investigators of discontinued and unpublished completed trials if no reason for the respective status was disclosed.

Main outcome measures: Trial discontinuation before completion and non-publication after completion. Logistic regression was used to determine the effect of funding source on publication status, with adjustment for intervention type and trial size.

Results: Of 818 registered trials found using the keyword "surgery", 395 met the inclusion criteria. Of these, 21% (81/395) were discontinued early, most commonly owing to poor recruitment (44%, 36/81). The remaining 314 (79%) trials proceeded to completion, with a publication rate of 66% (208/314) at a median time of 4.9 (interquartile range 4.0-6.0) years from study completion to publication search. A further 6% (20/314) of studies presented results on ClinicalTrials.gov without a corresponding peer reviewed publication. Industry funding did not affect the rate of discontinuation (adjusted odds ratio 0.91, 95% confidence interval 0.54 to 1.55) but was associated with a lower odds of publication for completed trials (0.43, 0.26 to 0.72). Investigators' email addresses for trials with an uncertain fate were identified for 71.4% (10/14) of discontinued trials and 83% (101/122) of unpublished studies. Only 43% (6/14) and 20% (25/122) replies were received. Email responses for completed trials indicated 11 trials in press, five published studies (four in non-indexed peer reviewed journals), and nine trials remaining unpublished.

Conclusions: One in five surgical randomised controlled trials are discontinued early, one in three completed trials remain unpublished, and investigators of unpublished studies are frequently not contactable. This represents a waste of research resources and raises ethical concerns regarding hidden clinical data and futile participation by patients with its attendant risks. To promote future efficiency and transparency, changes are proposed to research governance frameworks to overcome these concerns.

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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

Figures

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Fig 1 Inclusion and exclusion criteria of clinical trials
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Fig 2 Discontinued trials: authors’ email response
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Fig 3 Completed trials: identified publications and authors’ email response
See this image and copyright information in PMC

Comment in

References

    1. Chan AW, Song F, Vickers A, Jefferson T, Dickersin K, Gøtzsche PC, et al. Increasing value and reducing waste: addressing inaccessible research. Lancet 2014;383:257-66. - PMC - PubMed
    1. Jones CW, Handler L, Crowell KE, Keil LG, Weaver MA, Platts-Mills TF. Non-publication of large randomized clinical trials: cross sectional analysis. BMJ 2013;347:f6104. - PMC - PubMed
    1. Kasenda B, von Elm E, You J, Blümle A, Tomoanga Y, Saccilotto R, et al. Prevalence, characteristics, and publication of discontinued randomized trials. JAMA 2014;311:1045-51. - PubMed
    1. Manzoli L, Flacco ME, D’Addario M, Capasso L, De Vito C, Marzuillo C, et al. Non-publication and delayed publication of randomized trials on vaccines: survey. BMJ 2014;348:g3058. - PubMed
    1. Garas G, Ibrahim A, Ashrafian H, Ahmed K, Patel V, Okabayashi K, et al. Evidence-based surgery: barriers, solutions, and the role of evidence synthesis. World J Surg 2012;36:1723-31. - PubMed

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