Abstract
Perioperative blood transfusion is associated with poorer postoperative outcomes following hip and knee replacement surgery. Evidence for the effectiveness of some measures aimed at reducing blood transfusions in this setting are limited and often rely on weak pre-post study designs. Quasi-experimental study designs such as interrupted time series (ITS) and regression discontinuity design (RDD) address many of the weaknesses of the pre-post study design. In addition, a priori publication of statistical analysis plans for such studies increases their transparency and likely validity, as readers are able to distinguish between pre-planned and exploratory analyses. As such, this article, written prospective of any analysis, provides the statistical analysis plan for an ITS and RDD study based on a data set of 20,772 primary elective hip and knee replacement patients in a single English NHS Trust. The primary aim is to evaluate the impact of a preoperative anaemia optimisation service on perioperative blood transfusion (within 7 days of surgery) using both ITS and RDD methods. A secondary aim is to evaluate the impact of a policy of increased tranexamic acid dose given at the time of surgery, using ITS methods.
Highlights
Peri-operative red blood cell (RBC) transfusion is associated with poorer post-operative outcomes across surgical disciplines, including elective total hip (THR) and knee replacement (TKR) surgery[1,2,3]
Debate exists around optimal tranexamic acid (TXA) dose and there is a lack of high quality randomised controlled trials (RCT) into preoperative anaemia optimisation, with much of the evidence coming from pre-post design observational studies
The primary aim of this study is to evaluate the clinical effectiveness of introducing a preoperative anaemia optimisation programme, using iron, for patients undergoing primary elective THR or TKR surgery
Summary
Effectiveness of pre-operative anaemia screening and increased Tranexamic acid dose on outcomes following unilateral primary, elective total hip or knee replacement: a statistical analysis plan for an interrupted time series and regression discontinuity study [version 1; peer review: 2 approved]. Scrimshire 1,2, Caroline Fairhurst 1, Catriona McDaid 1, David J.
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