PMO-9 Reducing intravenous monoclonal antibody observation times without compromising patient safety; a single-centre observational study.

Abstract Background Monoclonal antibodies (MAbs) are integral to manage Inflammatory Bowel Disease (IBD). At Brighton & Sussex University Hospitals, intravenous MAbs, infliximab and vedolizumab, are administered in an outpatient setting. Licensing specifies post-infusion observation times of 1 to 2 hours. This affects waiting lists and capacity, particularly pertinent during the COVID-19 pandemic. Methods A single-centre observation study was conducted. Part 1 Retrospective data was collected for all infliximab and vedolizumab infusions from April to July 2019. Patients seen twice, were included once. For established infusion patients, historical reactions were recorded. Reaction incidence was established by observations, patient questioning and patient record review. To standardise the reactions, we used the cancer Common Terminology Criteria for Adverse Events; grade 3 is ‘severe’. Part 2 Observation time was removed from infusion 4 in April 2020. Prospective data was collected for all infliximab and vedolizumab infusions from April to December 2020. Multiple attendances were included. Results Part 1 130 infliximab patients (2607 infusions) and 69 vedolizumab patients (557 infusions) were reviewed. No severe reactions were recorded. All reactions occurred during induction dosing period. Analysis showed high levels of ‘no reactions observed’ after the first 4 infliximab infusions 97.7% (+1.6%, -4.7%), and the first 3 vedolizumab infusions 96.9% (+2.3%, -8.8%). 121 hours could be saved for infliximab and 64 hours for vedolizumab. Extrapolated this equates to 740 hours per year. Part 2 679 infliximab infusions were administered (including 12 new starters). 418 vedolizumab infusions were administered (16 new starters). No reactions were reported. Table key: Pt – patients, Inf – infusions, MAb – monoclonal antibody, Induct – Induction, Maint – maintenance, IV – intravenous, PO – oral, NC – not collected Conclusion All MAb infusion reactions occurred within 3 infusions, were non-severe and managed in clinic. By removing observation periods from infusion 4, capacity increased in concordance with COVID-19 social distancing, without affecting waiting times or patient safety. Patient experience was anecdotally improved. Further data from other centres are required to prove significance.

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P604 Can we reduce intravenous monoclonal antibody observation times without compromising patient safety? A single centre retrospective observational study

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.732 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S504-S505

Author(s):

F REES ◽

A Packham ◽

C Blake ◽

E Hills ◽

G Scutt ◽

...

Keyword(s):

Patient Safety ◽

Observational Study ◽

Small Sample Size ◽

Waiting Times ◽

Small Sample ◽

University Hospital ◽

Single Centre ◽

Maintenance Infusion ◽

Survival Plot ◽

Observation Times

Abstract Background Monoclonal antibodies (MAbs) are integral to inflammatory bowel disease (IBD) management. The administration of intravenous (IV) MAbs, infliximab and vedolizumab, for Brighton and Sussex University Hospital patients is via an outpatient clinic. Licensing specifies lengthy observation times; infliximab for induction (infusion 1 to 3) and maintenance (infusion 4 onwards) requires 1 to 2 h observation. Vedolizumab for induction (infusion 1 to 2) requires 2 h observation and maintenance (infusion 3 onwards) 1-h observation. This can affect waiting times; 33% UK patients waited longer than two weeks for infliximab. A reduction in observation times could improve capacity but needs to be done without compromising patient safety. Methods A single centre observational study was conducted. Retrospective data were collected on all current patients receiving infliximab or vedolizumab at BSUH. Data were collected over 12 weeks (April to July 2019); patients seen twice in this period were included once. The presence of reaction from current and previous infusions was determined by patient questioning and patient records review. Reaction occurrence, nature and management were recorded. There is not a grading system for IBD infusion-related reactions. To standardise we used the cancer Common Terminology Criteria for Adverse Events; grade 3 and above is designated severe (grade 5 being death). Results For infliximab 130 patients were reviewed with 2607 infusions administered in total. For vedolizumab 69 patients were reviewed with 557 infusions administered in total. Due to the small sample size significance could not be reached. The survival plot indicates high levels of ‘no reactions’ observed in the first 4 infusions of infliximab 97.7% (+1.6%, -4.7%), and first 3 infusions of vedolizumab 96.9% (+2.3%, −8.8%). Considering capacity over 12 weeks, for infliximab a minimum of 121 could be recouped and 64 h for vedolizumab. Extrapolated this could equate to 740 h per year. Conclusion All reactions occurred within three infusions, were non-severe and managed within the infusion clinic. By removing the observation period from infusion 4 onwards, infusion clinic capacity could be increased but further data from multiple centres are required to prove significance.

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Perioperative echocardiography in Ozaki’s procedure: An observational study - Single centre experience

MedPulse International Journal of Anesthesology ◽

10.26611/101511314 ◽

2019 ◽

Vol 11 (3) ◽

pp. 268-273

Author(s):

Pushpa J ◽

◽

Ananda Bhat ◽

Parimala Prasanna Simha ◽

Prasanna Simha M ◽

...

Keyword(s):

Observational Study ◽

Single Centre ◽

Single Centre Experience

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Safety of vitamin E-infused highwall liners for routine use in primary total hip arthroplasty: single centre, short-term follow-up of 1221 cases

Hip International ◽

10.1177/1120700020969644 ◽

2020 ◽

pp. 112070002096964

Author(s):

Kirill Gromov ◽

Nanna H Sillesen ◽

Thomas Kallemose ◽

Henrik Husted ◽

Henrik Malchau ◽

...

Keyword(s):

Patient Safety ◽

Vitamin E ◽

Total Hip Arthroplasty ◽

Hip Arthroplasty ◽

Single Centre ◽

Short Term ◽

Total Hip ◽

Arthroplasty Registry ◽

Primary Total Hip Arthroplasty

Background: Introduction of new implants should be monitored closely to capture any signs of compromising patient safety. Vitamin E infused highly-crosslinked polyethylene liners (VEPE) offer the potential for reduced wear. Highwall liners have been hypothesised to result in increased wear and potential liner fractures. The aim of this study was to determine the 3–7-year follow-up of highwall VEPE for primary total hip arthroplasty (THA), focusing on liner-related complications. Methods: We included 1221 consecutive THA operations from July 2010 to May 2014 with minimum follow-up of 3 (3.1–6.8) years Data collected included demographics, implant data, complications, reoperations, and deaths. Data were cross-referenced with the Danish Hip Arthroplasty Registry in order to ensure validity and completeness. Acetabular shell position was measured using Martell Hip Analysis Suite in a subgroup of 931 THAs. Results: Cumulative stem revision and shell revision at 3-year follow-up was 3.4% and 0.4% respectively. There were no revisions due to liner failure. Reason for revision included 11 dislocations, 15 soft-tissue revisions for infection, 44 stem revisions of which 34 were periprosthetic fractures and 13 shell revisions of which 6 were combined shell and stem revisions. Conclusion: Early follow-up of VEPE liners for primary THA have not shown any revisions associated with liner failure. Continued monitoring of new materials are necessary to capture any signs of compromised patient safety.

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