Results from a type two hybrid-effectiveness study to implement a preoperative anemia and iron deficiency screening, evaluation, and management pathway.

BACKGROUND: Implementation of pathways to screen surgical patients for preoperative anemia and iron deficiency remains limited. This study sought to measure the impact of a theoretically informed, bespoke change package on improving the uptake of a Preoperative Anemia and Iron Deficiency Screening, Evaluation, and Management Pathway. STUDY DESIGN AND METHODS: Pre-post interventional study using a type two hybrid-effectiveness design evaluated implementation. Four hundred (400) patient medical record reviews provided the dataset (200 pre- and 200-post implementation). The primary outcome measure was compliance with the pathway. Secondary outcome measures (clinical outcomes) were anemia on day of surgery, exposure to a red blood cell (RBC) transfusion, and hospital length of stay. Validated surveys facilitated data collection of implementation measures. Propensity score-adjusted analyses determined the effect of the intervention on clinical outcomes, and a cost analysis determined the economic impact. RESULTS: For the primary outcome, compliance improved significantly post-implementation (Odds Ratio 10.6 [95% CI 4.4-25.5] p < .000). In secondary outcomes, adjusted analyses point estimates showed clinical outcomes were slightly improved for anemia on day of surgery (Odds Ratio 0.792 [95% CI 0.5-1.3] p = .32), RBC transfusion (Odds Ratio 0.86 [95% CI 0.41-1.78] p = .69) and hospital length of stay (Hazard Ratio 0.96 [95% CI 0.77-1.18] p = .67), although these were not statistically significant. Cost savings of $13,340 per patient were realized. Implementation outcomes were favorable for acceptability, appropriateness, and feasibility. CONCLUSION: The change package significantly improved compliance. The absence of a statistically significant change in clinical outcomes may be because the study was powered to detect an improvement in compliance only. Further prospective studies with larger samples are needed. Cost savings of $13,340 per patient were achieved and the change package was viewed favorably.

Transfusion-related acute lung injury (TRALI): a retrospective review of reported cases in Queensland, Australia over 20 years.

BACKGROUND: Transfusion-related acute lung injury (TRALI) is a rare but potentially fatal transfusion reaction. An effective haemovigilance programme is important in implementing successful and targeted risk reduction strategies. We aim to provide a summary of TRALI cases referred for investigation in Queensland (QLD) Australia from 1999 to 2019, describing the epidemiological and laboratory features of local TRALI cases. MATERIALS AND METHODS: A retrospective audit evaluated all cases reported to the QLD Australian Red Cross Lifeblood over the 20-year study period. Cases were categorised according to the 2004 Canadian consensus criteria. RESULTS: Of the 91 cases referred for investigation, expert review confirmed 30 of TRALI and 18 of possible TRALI. A total of 238 donors and 110 blood products were assessed in confirmed cases. TRALI affected patients of all ages. Most patients had underlying haematological malignancies (25%), surgery (15%) or liver disease (13%). TRALI incidence was measured at 1 in 130,000 per issued product in QLD. Red cells were transfused in 32 cases, platelets in 18 and plasma products in 21, with 16 cases involving multiple products. Following laboratory assessment, 23% of cases had findings supportive of antibody mediated TRALI and 21% as likely non-antibody mediated. Possible TRALI was identified in 37.5% of cases of which 25% were antibody mediated and 12.5% non-antibody mediated. Nine (18.5%) cases were uncategorised due to insufficient immunologic investigations. DISCUSSION: Rates of TRALI incidence measured are lower than those seen in many international studies. A reduction in confirmed cases has been noted over recent years, supporting the implementation of risk-reduction strategies. We report a relatively higher proportion of non-antibody mediated TRALI and possible TRALI cases in more recent years, suggesting the need to further understand the role of product age and biological risk modifiers.

A Theoretically Informed Approach to Support the Implementation of Pre-Operative Anemia and Iron Deficiency Screening, Evaluation, and Management Pathways: Protocol for a Type Two Hybrid-Effectiveness Study.

INTRODUCTION: Blood transfusions are a risk factor for increased morbidity, mortality, and length of hospital stay. Patient blood management guidelines provide guidance to reduce risk and improve patient outcomes. They outline steps to help prevent transfusions and considerations for when deciding to transfuse. One recommendation to prevent unnecessary transfusion is to optimize patients using Pre-operative Anemia and Iron Deficiency Screening, Evaluation and Management Pathways (PAIDSEM-P). The uptake of these recommendations is highly variable, and an effective approach to implementing them in a tailored and context-specific manner remains elusive. METHOD AND DESIGN: A mixed-methods, interventional study, using a type two-hybrid effectiveness-implementation design, will evaluate the impact of a change package to improve the uptake of PAIDSEM-P. The change package consists of the intervention (PAIDSEM-P) supported by theoretically informed implementation strategies. Pre- and post-implementation, retrospective health record reviews will determine the effect of the change package on provider outcomes, including compliance with guideline recommendations as measured by the proportion of patients who have the appropriate tests performed, and, if required, appropriate treatment and/or referrals. Patient outcomes will be measured by checking for any difference in the proportion of patients with anemia on the day of surgery and the proportion of patients who receive a blood transfusion during the peri-operative period. An economic evaluation will be conducted to compare health outcomes and costs. The feasibility, acceptability and appropriateness of the PAIDSEM-P will be assessed using a quantitative, validated survey to measure implementation outcomes. DISCUSSION: Testing of implementation theory is required to advance understanding of what works, in what context, and the impact on implementation success. This study aims to evaluate the impact of a theoretically informed change package on improving the uptake of PAIDSEM-P. If successful, it will also provide a framework for health care facilities to follow when addressing other evidence-practice gaps.

Pralatrexate in relapsed/refractory T-cell lymphoma: a retrospective multicenter study.

We present a retrospective multicenter study of pralatrexate treatment outcomes in an Australian practice setting for patients with relapsed/refractory T-cell lymphoma who had failed 1+ systemic therapies, treated via a compassionate access program. Endpoints assessed included response rates, toxicities, and subsequent therapies. Progression-free survival (PFS), time to next treatment (TTNT), event-free survival (EFS), overall survival (OS), and time to best response, were assessed by Kaplan-Meier analysis. The study included 31 patients, with median age 69 years. We demonstrated ORR of 35.5% (n = 11), including 4 complete responses (13%) and 7 partial responses (23%). The predicted median OS was 10 months, with EFS of 9 months, and PFS of 9 months. Median TTNT was 8 months. Mucositis was the most commonly observed toxicity. This study - the second largest real-world cohort reported to date - underscores the importance of pralatrexate in relapsed/refractory T-cell lymphoma, as well as its acceptable toxicity profile.

Brentuximab vedotin in combination with sequential procarbazine, cyclophosphamide and prednisolone for the management of Hodgkin's lymphoma-associated vanishing bile duct syndrome (VBDS) with severe obstructive liver failure.

We present a novel treatment protocol that was successful in the management of Hodgkin's-associated vanishing bile duct syndrome, a rare but serious complication of Hodgkin's lymphoma. We believe that publication of this treatment protocol and the rationale for its development will be of interest to anyone faced with treating this challenging condition.