Literature DB >> 29531032

Enhancing primary reports of randomized controlled trials: Three most common challenges and suggested solutions.

Guowei Li1,2,3, Meha Bhatt1, Mei Wang1,3, Lawrence Mbuagbaw1,3, Zainab Samaan4, Lehana Thabane5,2,3.   

Abstract

Evidence from a well-designed randomized controlled trial (RCT) is generally considered to be the gold standard that can inform clinical practice and guide decision-making. However, several deficiencies in the reporting of RCTs have frequently been identified, including incomplete, selective, and biased or inconsistent reporting. Such suboptimal reporting may lead to irreproducible results, substantial waste of resources, impaired study validity, erosion of public trust in science, and a high risk of research misconduct. In this article, we present an overview of the reporting of RCTs in the biomedical literature with a focus on the three most common reporting problems: (i) lack of adherence to reporting guidelines, (ii) inconsistencies between trial protocols or registrations and full reports, and (iii) inconsistencies between abstracts and their corresponding full reports. Unsatisfactory levels of adherence to guidelines and frequent inconsistencies between protocols or registrations and full reports, and between abstracts and full reports, were consistently found in various biomedical research fields. A variety of factors were found to be associated with these reporting challenges. Improved reporting can build public trust and credibility of science, save resources, and enhance the ethical integrity of research. Therefore, joint efforts from the various sectors of the biomedical community (researchers, journal editors and reviewers, educators, healthcare providers, and other research consumers) are needed to reduce and reverse the current suboptimal state of RCT reporting in the literature.

Keywords:  guideline adherence; inconsistent reporting; randomized controlled trial; reporting quality; transparency

Mesh:

Year:  2018        PMID: 29531032      PMCID: PMC5856506          DOI: 10.1073/pnas.1708286114

Source DB:  PubMed          Journal:  Proc Natl Acad Sci U S A        ISSN: 0027-8424            Impact factor:   11.205


  67 in total

1.  Registration rates, adequacy of registration, and a comparison of registered and published primary outcomes in randomized controlled trials published in surgery journals.

Authors:  Shane Killeen; Panos Sourallous; Iain A Hunter; John E Hartley; Helen L O Grady
Journal:  Ann Surg       Date:  2014-01       Impact factor: 12.969

Review 2.  Quality of reporting of randomized controlled trials in general endocrinology literature.

Authors:  Lorena P Rios; Adefowope Odueyungbo; Misha O Moitri; Mohammed O Rahman; Lehana Thabane
Journal:  J Clin Endocrinol Metab       Date:  2008-06-26       Impact factor: 5.958

3.  What is missing from descriptions of treatment in trials and reviews?

Authors:  Paul Glasziou; Emma Meats; Carl Heneghan; Sasha Shepperd
Journal:  BMJ       Date:  2008-06-28

4.  SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials.

Authors:  An-Wen Chan; Jennifer M Tetzlaff; Peter C Gøtzsche; Douglas G Altman; Howard Mann; Jesse A Berlin; Kay Dickersin; Asbjørn Hróbjartsson; Kenneth F Schulz; Wendy R Parulekar; Karmela Krleza-Jeric; Andreas Laupacis; David Moher
Journal:  BMJ       Date:  2013-01-08

Review 5.  Inconsistencies between abstracts and manuscripts in published studies about lumbar spine surgery.

Authors:  Jeff A Lehmen; Rachel M Deering; Andrew K Simpson; Charles S Carrier; Christopher M Bono
Journal:  Spine (Phila Pa 1976)       Date:  2014-05-01       Impact factor: 3.468

6.  Comparison of protocols and registry entries to published reports for randomised controlled trials.

Authors:  Kerry Dwan; Douglas G Altman; Lynne Cresswell; Michaela Blundell; Carrol L Gamble; Paula R Williamson
Journal:  Cochrane Database Syst Rev       Date:  2011-01-19

7.  Reducing waste from incomplete or unusable reports of biomedical research.

Authors:  Paul Glasziou; Douglas G Altman; Patrick Bossuyt; Isabelle Boutron; Mike Clarke; Steven Julious; Susan Michie; David Moher; Elizabeth Wager
Journal:  Lancet       Date:  2014-01-08       Impact factor: 79.321

8.  Effect of using reporting guidelines during peer review on quality of final manuscripts submitted to a biomedical journal: masked randomised trial.

Authors:  E Cobo; J Cortés; J M Ribera; F Cardellach; A Selva-O'Callaghan; B Kostov; L García; L Cirugeda; D G Altman; J A González; J A Sànchez; F Miras; A Urrutia; V Fonollosa; C Rey-Joly; M Vilardell
Journal:  BMJ       Date:  2011-11-22

9.  Effect of editors' implementation of CONSORT guidelines on the reporting of abstracts in high impact medical journals: interrupted time series analysis.

Authors:  Sally Hopewell; Philippe Ravaud; Gabriel Baron; Isabelle Boutron
Journal:  BMJ       Date:  2012-06-22

10.  Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications.

Authors:  Benjamin Kasenda; Stefan Schandelmaier; Xin Sun; Erik von Elm; John You; Anette Blümle; Yuki Tomonaga; Ramon Saccilotto; Alain Amstutz; Theresa Bengough; Joerg J Meerpohl; Mihaela Stegert; Kelechi K Olu; Kari A O Tikkinen; Ignacio Neumann; Alonso Carrasco-Labra; Markus Faulhaber; Sohail M Mulla; Dominik Mertz; Elie A Akl; Dirk Bassler; Jason W Busse; Ignacio Ferreira-González; Francois Lamontagne; Alain Nordmann; Viktoria Gloy; Heike Raatz; Lorenzo Moja; Rachel Rosenthal; Shanil Ebrahim; Per O Vandvik; Bradley C Johnston; Martin A Walter; Bernard Burnand; Matthias Schwenkglenks; Lars G Hemkens; Heiner C Bucher; Gordon H Guyatt; Matthias Briel
Journal:  BMJ       Date:  2014-07-16
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  4 in total

1.  Reproducibility of research: Issues and proposed remedies.

Authors:  David B Allison; Richard M Shiffrin; Victoria Stodden
Journal:  Proc Natl Acad Sci U S A       Date:  2018-03-12       Impact factor: 11.205

Review 2.  Legal regulations, ethical guidelines and recent policies to increase transparency of clinical trials.

Authors:  Jan Borysowski; Agata Wnukiewicz-Kozłowska; Andrzej Górski
Journal:  Br J Clin Pharmacol       Date:  2020-02-19       Impact factor: 4.335

3.  High impact nutrition and dietetics journals' use of publication procedures to increase research transparency.

Authors:  Dennis M Gorman; Alva O Ferdinand
Journal:  Res Integr Peer Rev       Date:  2020-08-31

4.  P-hacking in clinical trials and how incentives shape the distribution of results across phases.

Authors:  Jérôme Adda; Christian Decker; Marco Ottaviani
Journal:  Proc Natl Acad Sci U S A       Date:  2020-06-02       Impact factor: 11.205

  4 in total

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