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Background: There are no core outcome domain or measurement sets for Total Joint Replacement (TJR) clinical trials. Our objective was to achieve an International consensus by orthopaedic surgeons on the OMERACT core domain/area set for TJR clinical trials. Methods: We conducted surveys of two orthopaedic surgeon cohorts, which included (1) the leadership of international orthopaedic societies and surgeons (IOS; cohort 1), and (2) the members of the American Academy of Orthopaedic Surgeons' Outcome Special Interest Group (AAOS-Outcome SIG), and/or the Outcome Research Interest Group of the Orthopaedic Research Society (ORS; cohort 2). Participants rated OMERACT-endorsed preliminary core area set for TJR clinical trials on a 1 to 9 scale, indicating 1-3 as domain of limited importance, 4-6 being important, but not critical, and 7-9 being critical. Results: Eighteen survey participants from the IOS group and 69 participants from the AAOS-Outcome SIG/ORS groups completed the survey questionnaire. The median (interquartile range [IQR]) scores were seven or higher for all six proposed preliminary core areas/domains across both groups, IOS and AAOS-Outcome SIG/ORS, respectively: pain, 8 [8, 9] and 8 [7, 9]; function, 8 [8, 8] and 8 [7, 9]; patient satisfaction, 8 [7, 9] and 8 [7, 8]; revision surgery, 7 [6, 9] and 8 [6, 8]; adverse events, 7 [5, 8] and 7 [6, 9]; and death, 7 [7, 9] and 8 [5, 9]. Respective median scores were lower for two additional optional domains: patient participation, 6.5 [5, 7] and 6 [5, 8]; and cost, 6 [5, 7] and 6 [5, 7]. Conclusions: This study showed that two independent surveys dervied from three groups of orthopaedic surgeons with international representation endorsed a preliminary/draft OMERACT core domain/area set for Joint Replacement clinical trials.

The purpose of this research study was to improve the nursing care of intravenous catheters by providing evidence on the effects of prolonged duration of intravenous administration set use. Intravenous therapy is a vital part of modern health care. However, its invasive nature can result in infection, with high associated morbidity and mortality. The highest infection rates are displayed in intensive care patients with central venous catheters. The duration of intravenous administration set use may have an impact on infection rates,however the current practice usage and the optimum duration of use is unknown. Previous studies of central venous catheters have reported equal infection rates with 1 to 4 days of administration set use; however few patients have been evaluated with administration sets used beyond this time. Previous research has been limited by the inadequacy of available definitions for Catheter-Related Infection. A prospective, randomised, controlled clinical trial was performed to assess the infection risk of using administration sets for prolonged periods. In the developmental phase prior to the clinical trial; definitions of Catheter-Related Bloodstream Infection (CRBSI) were developed; a nursing practice survey was undertaken to establish the current duration of administration set use; and laboratory experiments were executed to assess the impact of prolonged use on administration set physical integrity and performance. Central venous catheters were randomised to have their administration sets used for 4 days (n = 203) or 7 days (n = 201). Percutaneous central venous catheters were enrolled into the study from two adult intensive care units at a metropolitan, tertiary-referral, teaching hospital. Catheters were multiple-lumen, chlorhexidine-gluconate and silver-sulphadiazine coated lines, both inserted and removed in the intensive care unit. Catheters were cultured for microbial colonisation on removal using the Maki roll-plate technique. Patients were assessed for CRBSI using the developed definitions consisting of categories: definite, probable (type I and II), possible and absent. Prior to the clinical trial, a practice survey questionnaire was administered, and laboratory experimentation was performed. Normality of distribution for continuous variables was assessed using the Kolmogorov- Smirnov statistic. The distribution between groups of variables considered risk factors for Catheter-Related Infection were tested to assess for bias using Chi-square and T-test. Logistic regression modelling was performed to analyse the influence of potentially confounding variables. The incidence of catheter colonisation and CRBSI was tested between groups using Kaplan-Meier survival curve with Log-rank test. Paired T-tests were performed to test for difference in programmed and delivered volumes of administration sets. A general linear model (ANOVA)± a Scheffe post hoc test to isolate difference was fitted to the standardised values of delivered volumes to determine the effects of day of measurement and volume delivery rate on the accuracy of volume delivery. There were 10 colonised tips in the intervention group and 19 in the control group. This difference was not statistically significant (Kaplan Meier survival analysis, Log Rank = 0.87, df = 1, p = 0.35). There were 3 cases of CRBSI per group and the difference in survival from CRBSI was not statistically significant (Kaplan Meier with Log Rank test, p = 0.86). The pre-clinical trial phases of the research programme established that current clinical practice was 3 to 7-day use of administration sets; that administration sets were physically intact and delivered clinically accurate volumes after 7 days of use; and developed useful definitions of CRBSI. Prolonged intravenous administration set use of 7 days was found to have no significant impact on patient infection indicators or physical performance of the sets. This finding is congruent with previous research and trends in current clinical practice. In conclusion, the research findings support the use of intravenous administration sets for 7 days.