Systematic reviews of randomized controlled trials (RCTs) are the highest level of evidence used to inform patient care. However, it has been suggested that the quality of randomization in RCTs in orthopaedic surgery may be low. This study aims to describe the quality of randomization in trials included in systematic reviews in orthopaedic surgery. Systematic reviews of RCTs testing orthopaedic procedures published in 2022 were extracted from PubMed, Embase, and the Cochrane Library. A random sample of 100 systematic reviews was selected, and all included RCTs were retrieved. To be eligible for inclusion, systematic reviews must have tested an orthopaedic procedure as the primary intervention, included at least one study identified as a RCT, been published in 2022 in English, and included human clinical trials. The Cochrane Risk of Bias-2 Tool was used to assess random sequence generation as ‘adequate’, ‘inadequate’, or ‘no information’; we then calculated the proportion of trials in each category. We also collected data to test the association between these categories and characteristics of the RCTs and systematic reviews.Aims
Methods
Orthopaedic surgeries are complex, frequently performed procedures associated with significant haemorrhage and perioperative blood transfusion. Given refinements in surgical techniques and changes to transfusion practices, we aim to describe contemporary transfusion practices in orthopaedic surgery in order to inform perioperative planning and blood banking requirements. We performed a retrospective cohort study of adult patients who underwent orthopaedic surgery at four Canadian hospitals between 2014 and 2016. We studied all patients admitted to hospital for nonarthroscopic joint surgeries, amputations, and fracture surgeries. For each surgery and surgical subgroup, we characterized the proportion of patients who received red blood cell (RBC) transfusion, the mean/median number of RBC units transfused, and exposure to platelets and plasma.Aims
Methods
We evaluated the quality of guidelines on thromboprophylaxis
in orthopaedic surgery by examining how they adhere to validated
methodological standards in their development. A structured review
was performed for guidelines that were published between January
2005 and April 2013 in medical journals or on the Internet. A pre-defined
computerised search was used in MEDLINE, Scopus and Google to identify
the guidelines. The AGREE II assessment tool was used to evaluate
the quality of the guidelines in the study. Seven international and national guidelines were identified.
The overall methodological quality of the individual guidelines
was good. ‘Scope and Purpose’ (median score 98% interquartile range
(IQR)) 86% to 98%) and ‘Clarity of Presentation’ (median score 90%,
IQR 90% to 95%) were the two domains that received the highest scores. ‘Applicability’
(median score 68%, IQR 45% to 75%) and ‘Editorial Independence’
(median score 71%, IQR 68% to 75%) had the lowest scores. These findings reveal that although the overall methodological
quality of guidelines on thromboprophylaxis in orthopaedic surgery
is good, domains within their development, such as ‘Applicability’
and ‘Editorial Independence’, need to be improved. Application of
the AGREE II instrument by the authors of guidelines may improve
the quality of future guidelines and provide increased focus on
aspects of methodology used in their development that are not robust. Cite this article: Bone Joint J 2014;96-B:19–23.
High-quality randomised controlled trials (RCTs)
evaluating surgical therapies are fundamental to the delivery of
evidence-based orthopaedics. Orthopaedic clinical trials have unique
challenges; however, when these challenges are overcome, evidence
from trials can be definitive in its impact on surgical practice.
In this review, we highlight several issues that pose potential
challenges to orthopaedic investigators aiming to perform surgical randomised
controlled trials. We begin with a discussion on trial design issues,
including the ethics of sham surgery, the importance of sample size,
the need for patient-important outcomes, and overcoming expertise
bias. We then explore features surrounding the execution of surgical
randomised trials, including ethics review boards, the importance
of organisational frameworks, and obtaining adequate funding. Cite this article:
