TITLE: Whole blood viscosity test implementation: Community based participatory approach study protocol
AUTHORS: Ezekiel U Nwose, Phillip Bwititi, Lexin Wang, Rasheda Khanam, Hayder Al-Aubaidy, San Low, Simon Tawasu, Chukwudiebube Ajaero

[DESCRIPTION]
This study would employ a Community-Based Participatory Research (CBPR) approach, and mapped with implementation strategies, to engage healthcare providers in initiating change. Participants would include cardiologists, general practitioners, and psychiatrists as well as medical laboratory scientists. Expected primary outcome measures include attendance (knowledge impartation) and change in perception regarding the clinical laboratory test tool. Secondary outcome measures will include quantitative analysis of eWBV from workshop.

[BEFORE_START]
 Knowledge of the eWBV method as well as how to use the electronic and hardcopy chart tools are basic imperatives.

[GUIDELINES]
This proposal meant to advance existing guidelines 
1. for monitoring 'at risk hyperviscosity'
2. to predict bleeding risk

[STEPS]
SECTION: Introduction in brief
1. Monitoring of whole blood viscosity (WBV) is critical in patients at risk of hyperviscosity (The
Royal College of Pathologies of Australia, 2019). Prothrombin Time Test (PT/INR), which is currently used is insufficient to predict bleeding risk (Cao et al., 2024). There is a test for blood viscosity, which is cheaper than currently recommended plethora of tests, but clinicians are unaware that haematocrit and serum protein, can be used in an algorithm to obtain eWBV that is specific for the cardiovascular phenomenon (Nwose & Bwititi, 2022).
SECTION: The  protocol
2. Study design: This study employs a Community-Based Participatory Research (CBPR) approach (Holkup et al., 2004; Sanders & Baisch, 2008; Wynn et al., 2011). This is also designed to be observational cohort and pilot studies, hence the methods’ section of STROBE checklist (Kang & Foster, 2022), is adopted in this protocol layout. The cohort component would involve eWBV analysis of deidentified patients’ data, while pilot component is on participant healthcare personnel.
SECTION: The  protocol
3. Participants:  The participants would comprise Australian-based general practitioners (GPs) and clinicians
specialising in diabetes and cardiovascular management. This includes GPs, registrars, cardiology and mental health registrars, nurses. Participants will provide informed consent and receive detailed written information about the study. Inability to provide de-identified necessary clinical and laboratory data and/or be available at seminar, workshop and survey constitute exclusion criteria.
SECTION: The  protocol
4. Variables: This will include the numbers of seminars and workshops organised, attendance at the events, number of clinicians and health facilities reached. There would be results of ‘perception and uptake’ survey, and publications. Summary of metrics matching study objectives is presented in table 1. Further, data variables for the workshop would include:
Clinical data of patients’ diagnosis and treatment in-between serial laboratory tests.
Laboratory data including series of routine haematology and liver function test – at least two sets per patients, with known clinical intervention between tests’ dates. Also, serial INR results done on the same blood collection with routine haematology and liver function test.
Survey dataset: Likert scale data on perception and uptake
 
Table 1: The objectives of the current study and the measurable metrics.
 
 
 

SECTION: The  protocol
5. The process

  
Fig 1: Dynamic flow chart
Seminars and workshops would be
convened in at least one facility in the 6 states/territory. Primary
outcome measures include attendance, survey analysis. Secondary outcome
measures include quantitative analysis of eWBV from workshop (Fig 2).
 

 


SECTION: Conclusion statement
6. Based on the participants’ capacities, survey of ability and willingness to adopt/integrate the laboratory method into practice would be conducted. Analysis of the perception survey will inform next direction in the implementation research.
SECTION: References
7. Cao, C., Xu, Y., Jiang, W., Wu, S., Shen, Y., Xia, X., Wang, L., Zhang, H., Jiang, H., Li, X., Li, X., & Ye, Y. (2024). Nomogram for predicting bleeding events in nonvalvular atrial fibrillation patients receiving rivaroxaban: A retrospective study. Health Sci Rep, 7(1), e1792. https://doi.org/10.1002/hsr2.1792
Holkup, P. A., Tripp-Reimer, T., Salois, E. M., & Weinert, C. (2004). Community-based participatory research: an approach to intervention research with a Native American community. ANS Adv Nurs Sci, 27(3), 162-175. https://doi.org/10.1097/00012272-200407000-00002
Kang, E., & Foster, E. R. (2022). Use of implementation mapping with community-based participatory research: Development of implementation strategies of a new goal setting and goal management intervention system. Front Public Health, 10, 834473. https://doi.org/10.3389/fpubh.2022.834473
Nwose, E. U., & Bwititi, P. T. (2022). Whole blood viscosity: Affordances and re-evaluation of sensitivity and specificity for clinical use. Int J Bio Lab Sci, 11(2), 96 - 103. https://www.ijbls.org/index.php/current-issue/101-articles-2022/187-research-article-whole-blood-viscosity-affordances-and-re-evaluation-of-sensitivity-and-specificity-for-clinical-use
Sanders, J., & Baisch, M. J. (2008). Community-based participatory action: impact on a neighborhood level community health improvement process. Prog Community Health Partnersh, 2(1), 5, 7-15. https://doi.org/10.1353/cpr.2008.0000
The Royal College of Pathologies of Australia. (2019). Viscosity. Retrieved 22nd Aug 2022 from https://www.rcpa.edu.au/Manuals/RCPA-Manual/Pathology-Tests/V/Viscosity
Wynn, T. A., Taylor-Jones, M. M., Johnson, R. E., Bostick, P. B., & Fouad, M. (2011). Using community-based participatory approaches to mobilize communities for policy change. Fam Community Health, 34 Suppl 1, S102-114. https://doi.org/10.1097/FCH.0b013e318202ee72