Patient-reported outcomes of serum eye drops manufactured from Australian blood donations and packaged using Meise vials.

Introduction: Serum eye drops (SED) are an effective treatment for dry eye syndrome. However, autologous serum collection can have challenges. Patient-tailored (allogeneic) SED (PT-SED) can be made from healthy blood donors. Australian Red Cross Lifeblood has manufactured both autologous SED (Auto-SED) and PT-SED and, in May 2021, introduced Meise vial packaging. This study aimed to explore SED patient-reported outcomes and vial packaging satisfaction. Methods: A prospective cohort study was conducted with recruitment between 1 November 2021 and 30 June 2022. Participants completed the dry eye questionnaire (DEQ5), health-related quality-of-life (SF-8™), functional assessment of chronic illness therapy-treatment satisfaction-general (FACIT-TS-G), and general wellbeing surveys. Existing patients completed these once, and new patients were surveyed at baseline, 3 months post-treatment, and 6 months post-treatment. Results: Participants who completed all study requirements were 24 existing and 40 new Auto-SED and 10 existing and 8 new PT-SED patients. Auto-SED patients were younger [56.2 (±14.7) years] than PT-SED patients [71.4 (±10.0) years]. Participants used a mean of 1.8 (±1.1) SED, 5.3 (±2.9) times per day. In new patients, DEQ5 scores improved within 6 months from 14.0 (±2.9) to 10.6 (±3.4) for Auto-SED and from 12.9 (±3.7) to 11.4 (±2.8) for PT-SED. General wellbeing measures improved in the new Auto-SED from 7.0 (±1.9) to 7.8 (±1.7) but were reduced for new PT-SED from 6.7 (±2.9) to 6.1 (±2.9). Discussion: SED improved dry eye symptoms in most patients, regardless of the serum source. Patients using PT-SED showed decreases in some quality-of-life measures; however, recruitment was reduced due to operational constraints, and concurrent comorbidities were not assessed. General feedback for SED and vial packaging was positive, with some improvements identified.

The Troublesome Ticks Research Protocol: Developing a Comprehensive, Multidiscipline Research Plan for Investigating Human Tick-Associated Disease in Australia.

In Australia, there is a paucity of data about the extent and impact of zoonotic tick-related illnesses. Even less is understood about a multifaceted illness referred to as Debilitating Symptom Complexes Attributed to Ticks (DSCATT). Here, we describe a research plan for investigating the aetiology, pathophysiology, and clinical outcomes of human tick-associated disease in Australia. Our approach focuses on the transmission of potential pathogens and the immunological responses of the patient after a tick bite. The protocol is strengthened by prospective data collection, the recruitment of two external matched control groups, and sophisticated integrative data analysis which, collectively, will allow the robust demonstration of associations between a tick bite and the development of clinical and pathological abnormalities. Various laboratory analyses are performed including metagenomics to investigate the potential transmission of bacteria, protozoa and/or viruses during tick bite. In addition, multi-omics technology is applied to investigate links between host immune responses and potential infectious and non-infectious disease causations. Psychometric profiling is also used to investigate whether psychological attributes influence symptom development. This research will fill important knowledge gaps about tick-borne diseases. Ultimately, we hope the results will promote improved diagnostic outcomes, and inform the safe management and treatment of patients bitten by ticks in Australia.

Evaluation of a sterile surgical skin marker to indicate the optimal vein for venepuncture in the blood donation setting.

BACKGROUND AND OBJECTIVES: Phlebotomy is a central task for blood donation; however, not all blood donors have veins that are easy to see or feel. This study aimed to determine whether use of a surgical skin marker to highlight the donors' vein location and direction prior to venepuncture increased blood donation success. METHODS: All blood donors who participated in this study were eligible to donate according to Australian guidelines. Ten donor centres with phlebotomy success rates <95% were selected. A randomized cluster trial design assigned five sites to test the skin marking device and five sites as controls. Single-use sterile Gentian violet skin marker pens were used to mark donors' veins. Phlebotomy site skin bacterial load after using the skin marking device was tested on a subset of 100 donors. Phlebotomy success rates and donor adverse events were recorded. RESULTS: Of the control donors, 6993 had successful phlebotomies and 225 failed. Of the skin marker donors, 6998 had successful phlebotomies and 248 failed. No statistically significant differences in phlebotomy success were found between the two groups (OR: 0·91, 96·4% CI [96·0, 96·8], P-value 0·348). CONCLUSION: The use of skin marker pens did not increase overall phlebotomy success rate. There was no increase in phlebotomy site skin bacterial load, and amendments to standard skin disinfection techniques were not required. Blood donors were not concerned about the pen mark on their arms. Generally, staff indicated that the markers may be valuable to assist with phlebotomies for donors with difficult or deep veins.

Evaluation of a tool to score donor vein suitability for blood donation.

BACKGROUND AND OBJECTIVES: Phlebotomy is a central task for whole blood donation, yet there are no published standards regarding systematic donor vein assessment or the impact of vein quality on successful blood donation. Blood donation failures and related adverse events are highly predictive of donors not returning for future blood donation. A specific blood donation vein scoring tool was assessed to measure donor vein suitability for whole blood collection and investigate the correlation of the donor's veins with donation outcomes. MATERIALS AND METHODS: The vein assessment tool consisted of three questions using a 5-point Likert-type scale to measure responses. Two phlebotomists performed blinded assessments of each donor's veins on each arm using the tool. The individual measures were then aggregated to provide a total vein score out of 12. Inter-rater reliability of the vein score tool was assessed by calculating the intraclass correlation coefficient for absolute agreement. RESULTS: Fifty-seven phlebotomists across four fixed blood donation centres performed paired vein assessments on 553 blood donors. The intraclass correlation coefficient indicated moderate inter-rater reliability was achieved. The median scores for viable donations were 10, for non-viable donations were 6·5 and for failed phlebotomies were 4. Donation histories of donors with lower vein scores indicated lower success during blood donation. CONCLUSION: The vein score tool appears to be predictive of a successful donation outcome, however, since there was not a suitably high correlation between the scores of the two assessors, further refinement of the tool will be required prior to wider use.

Does using applied muscle tension at strategic time points during donation reduce phlebotomist- and donor-reported vasovagal reaction rates? A three-armed randomized controlled trial.

BACKGROUND: Vasovagal reactions (VVRs) have a negative impact on donor safety and return. Applied muscle tension (AMT) increases blood pressure temporarily and has been suggested as a way to reduce donors' risk of VVRs. This study evaluated whether using AMT at three different time points during the donation procedure reduces the VVR symptoms reported by donors and the VVR reactions recorded by phlebotomists. STUDY DESIGN AND METHODS: A three-arm, multicenter, open-label randomized controlled trial was used to compare VVR symptoms and reaction rates between those practicing AMT during the entire donation (n = 244) to practicing AMT at VVR high-risk time points (n = 250) to a standard blood donation control group (n = 240). All participants were asked to drink 500 mL of water in the waiting area, and an even distribution of new and repeat donors was sought across conditions. RESULTS: Across all conditions, donors reported few VVR symptoms and the rate of reporting did not differ significantly across conditions. However, donors who practiced AMT at strategic time points had a significantly lower number of phlebotomist-registered VVRs in comparison to the other two study groups, with these rates not varying by sex or donor status. Greater compliance by donors with AMT instructions was observed in those asked to practice AMT at strategic time points compared to those asked to practice AMT during the entire donation. CONCLUSION: Practicing AMT at VVR high-risk time points reduces the number of phlebotomist-registered VVRs.