The Quality of Reporting of Orthopaedic Randomized Trials with Use of a Checklist for Nonpharmacological Therapies

Chan, Simon; Bhandari, Mohit
September 2007
Journal of Bone & Joint Surgery, American Volume;Sep2007, Vol. 89-A Issue 9, p1970
Academic Journal
Background: The Consolidated Standards of Reporting Trials statement for the reporting of randomized controlled trials has been limited by its applicability to surgical trials. In response, a Checklist to Evaluate a Report of a Non-pharmacological Trial was recently developed by the Consolidated Standards of Reporting Trials group to address re- porting issues in surgical trials. We aimed (1) to apply the checklist for nonpharmacological therapies to orthopaedic randomized controlled trials across multiple journals from 2004 through 2005, and (2) to survey authors when methodological safeguards itemized in the checklist were not reported to determine whether they actually had been performed. We hypothesized that lack of reporting of a methodological safeguard did not necessarily mean it had not been conducted. Methods: We searched for relevant orthopaedic randomized controlled trials across eight journals in the period from January 2004 through December 2005. We applied the Checklist to Evaluate a Report of a Nonpharmacological Trial to all eligible studies. We contacted authors to determine what methodological safeguards were actually used, especially when details remained unclear from the publication. Results: We included eighty-seven randomized controlled trials from eighty-five scientific reports. In assessing the randomized controlled trials with the checklist for nonpharmacological therapies, seventy-three studies (84%) had unclear reporting of treatment allocation concealment. Only seventeen studies (20%) mentioned surgeon skill or experience. The blinding of patients, ward staff, rehabilitation staff, clinical outcome assessors, and nonclinical outcome assessors was unclear in forty-eight (55%), sixty-three (72%), sixty-four (74%), forty (46%), and thirty-three studies (38%), respectively. Authors from forty-three randomized controlled trials responded to our survey. The results of the survey showed that 41% (95% confidence interval, 25% to 58%) of the trials had adequate allocation concealment when this had been unclear from the report. Although the surgical experience of the investigators was rarely reported, most authors (70%) acknowledged that they had defined "surgical expertise criteria" such as minimum case criteria, specialized training, and clinical performance. The survey also showed that 28% to 40% of the trials had blinding of relevant groups despite the fact that the reporting of such blinding had been unclear in the publications. Conclusions: The quality of reporting in the orthopaedic literature was highly variable. Readers should not assume that bias-reducing safeguards that were not reported in a randomized controlled trial did not occur. Our study reinforces the need for the consistent use of a tool like the Checklist to Evaluate a Report of a Nonpharmacological Trial to assess the methodology of surgical trials.


Related Articles

  • Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial.  // Advances in Orthopaedics;Sep2010, Vol. 2 Issue 3, p132 

    In this article, promising data from the second Phase III trial of the new oral Factor Xa inhibitor apixaban in patients undergoing knee arthroplasty are presented.

  • Improving Clinical Trials in Dentistry. Giannobile, W.V. // Journal of Dental Research;2015 Supplement, Vol. 94, p6S 

    An introduction is presented in which the editor discusses an assessment of randomized controlled clinical trials in leading dental journals by V. Smaïl-Faugeron and colleagues and mentions the journal will require all submitted studies have a priori clinical trial registration.

  • Emerging Designs in Orthopaedics: Expertise-Based Randomized Controlled Trials. Scholtes, Vanessa A.; Nijman, Thomas H.; van Beers, Loes; Devereaux, P. J.; Poolman, Rudolf W. // Journal of Bone & Joint Surgery, American Volume;7/18/2012 Supp1, Vol. 94-A, p24 

    In this article, we discuss the limitations of conventional randomized controlled trials (RCTs) in the surgical field. Surgeons are often believers in certain surgical techniques and therefore can be reluctant to learn new interventions. In expertise-based trials, the patients are randomized to...

  • Use of Registries to Complement Clinical Trials in Renal Artery Stenting. Rajmony, Pannu; Sanjay, Misra // Angiology;Jun2012, Vol. 63 Issue 3, p161 

    The authors discuss several studies to support their opinion that the use of registry data should complement clinical trials in renal artery atherosclerotic disease management. They offer a brief history of the treatment of atherosclerotic blockages with angioplasty, coronary bypass surgery...

  • The Future of Vertebroplasty: Are Randomized Controlled Trials, or Clinical Experience, the More Appropriate Guide? Andrews, Neil A. // IBMS BoneKEy;Oct2009, p351 

    The article focuses on vertebroplasty (VP) in randomized controlled trials (RCTs). It states that percutaneous VP is a procedure in which cements are inserted into fractured vertebra by needle to relieve pain and disability. It adds that RCTs were not effectively managed by more conservative...

  • To whom do the results of the multicenter, randomized, controlled INSECT trial (ISRCTN 24023541) apply? - assessment of external validity.  // BMC Surgery;2012, Vol. 12 Issue 1, p2 

    The article presents information on a study which analyzes the issues related to the external validity of the INSECT trial, designed as a multicenter randomized controlled trial (mRCT) to define optimal strategies for closure of sutures. It is said that aspects of external validity affect the...

  • CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials. Schulz, Kenneth F.; Altman, Douglas G.; Moher, David // PLoS Clinical Trials;Mar2010, Vol. 7 Issue 3, Special section p1 

    The article discusses the consolidated standards of reporting trials (CONSORT) that is aimed at improving the reporting quality of randomised controlled trials. It presents the updated CONSORT 2010 statement that serves as a guideline for reporting randomised controlled trials, particularly the...

  • Developing a reporting guideline for social and psychological intervention trials. Mayo-Wilson, Evan; Montgomery, Paul; Hopewell, Sally; Macdonald, Geraldine; Moher, David; Grant, Sean // British Journal of Psychiatry;Oct2013, Vol. 203 Issue 4, p250 

    Social and psychological interventions are often complex. Understanding randomised controlled trials (RCTs) of these complex interventions requires a detailed description of the interventions tested and the methods used to evaluate them. However, RCT reports often omit, or inadequately report,...

  • Message from the Editor-in-Chief. Ortmann, O. // Archives of Gynecology & Obstetrics;Sep2014, Vol. 290 Issue 3, p397 

    No abstract available.


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics