Study design and setting
This prospective point-of-care interventional study spanned from January 1st to November 30th, 2023, with the primary aim of investigating the prevalence of chronic kidney disease (CKD) in high-risk patients and evaluating the effectiveness of a point-of-care screening program administered by community pharmacists. The study was conducted at six carefully selected community pharmacies in the United Arab Emirates, encompassing both chain and independent establishments, and participation was voluntary and random.
The choice of these pharmacies was deliberate, based on specific criteria. They were chosen for their substantial patient volume and the comprehensive range of services, including medication reviews, management of chronic diseases, prescription medication dispensing, recommendations for over-the-counter (OTC) medications, as well as nutrition and dietary counseling. Additionally, these pharmacies had the requisite personnel capable of conducting the study with precision and competence.
Study population (inclusion and exclusion criteria)
During the process of medication evaluation, individuals, both UAE nationals and non-UAE nationals, were considered eligible for participation if they exhibited at least one of the following recognized risk factors for chronic kidney disease (CKD): diabetes, hypertension, a history of cardiovascular illness, a family history of renal disease, or an age above 55 years.
To be eligible for participation in the study, individuals had to meet the following criteria: Aged 18 or over and meet at least one of the following conditions under the KDIGO International Guidelines, rendering them at risk for CKD:
Sample size calculation
Given a reported CKD prevalence of 4.6% among males and 2.8% among females in the UAE3 and considering the recent study’s findings revealing an 11.4% incidence of CKD stages 3–530, we initially anticipated that the percentage of individuals with CKD stages 3–5 in our study would approximate 12%.. Our chosen significance level (alpha) was 5% to produce 95% confidence intervals. Moreover, we aimed for a precision (D) of 5% within these 95% confidence intervals to ensure a broad 95% range of ± 10%.
Based on these underlying assumptions, we determined that a minimum sample size of n = 312 participants would be necessary, factoring in an estimated nonresponse rate of approximately 50%. Consequently, our final sample size was established at 400 participants.
Data collection
Patients visiting the pharmacy for prescription drop-off or pick-up were identified as potential participants. Those who met the eligibility criteria were then approached and invited to join the study, receiving comprehensive information about its purpose and procedures. Subsequently, they were requested to provide written informed consent indicating their willingness to participate.
The pharmacy’s staff pharmacists oversaw the consent process and facilitated utilizing the on-site PICCOLO Comprehensive Metabolic Panel and blood chemistry analyzer for data collection. Once the necessary data had been gathered, additional consent was sought from patients to allocate a unique participant ID, ensuring both confidentiality and anonymity in the use of their data for research purposes. Patients were allowed to share their demographic and result information anonymously voluntarily.
Intervention and measurement tool
A disposable lancet was employed to extract a venous blood sample through a self-administered fingerstick, following the prior cleaning of the finger with an alcohol swab.
To prevent significant hemolysis, the initial blood drop was carefully wiped away. Subsequently, a minimum sample volume of 100 μL was acquired through capillary action and gentle finger pressure at the puncture site, allowing for the collection of successive drops into a designated collection tube. Following this, the pharmacist pipetted the collected material into a metabolic panel disc to prepare it for analysis using the PICCOLO instrument. Once the blood was placed within the panel disc, it underwent heparinization and was spun into cuvette wells that contained dry sample blank reagent beads. These beads were equipped with the necessary reagents, buffers, surfactants, and excipients for absorption chemistry analysis32.
The PICCOLO blood chemistry analyzer utilized the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) research equation and the creatinine levels assessed by the panel to estimate the Glomerular Filtration Rate (eGFR) for each patient, incorporating the provided age, gender, and race data31,32. Typically, results were available within a span of 10 to 15 min.
PICCOLO instrument
The PICCOLO device, when deployed at the point of care, serves as a portable diagnostic analyzer offering a comprehensive array of CLIA-waived blood chemistry tests. CLIA-waived blood tests are those exempt from the Clinical Laboratory Improvement Amendments (CLIA) requirements in the United States. Irrespective of the testing location, the CLIA federal regulatory framework establishes quality standards for all laboratory testing, ensuring precision, reliability, and the swift delivery of patient test results. Tests deemed straightforward with a low risk of inaccurate results and those considered user-friendly fall under the waived category.
The PICCOLO instrument represents an innovative, fully automated tool employed at the point of care across diverse healthcare settings, including pediatric offices, oncology clinics, urgent care centers, and physician’s offices. In blood testing, CLIA-waived tests are typically uncomplicated point-of-care procedures that can be conducted outside traditional laboratory settings.
Meeting a wide range of clinical chemistry needs, the PICCOLO Xpress delivers real-time blood chemistry diagnostic information within minutes. Despite its compact size, this PICCOLO instrument excels in accuracy, reliability, and repeatability.
These tests are designed for individuals without laboratory backgrounds, such as healthcare professionals working in clinics, pharmacies, or other point-of-care settings. They often require minimal technical expertise. Depending on their waiver status, certain more stringent regulatory requirements applicable to more complex laboratory processes are waived for these tests.
Study variables
An estimated Glomerular Filtration Rate (eGFR) of 90 or higher indicated normal renal function. An eGFR falling within the range of 60 to 89 (CKD Stage 2) signified a mild impairment in renal function, while an eGFR in the 30 to 59 range (CKD Stage 3) indicated a significant reduction in renal function.
Each participant completed a paper-based questionnaire during this phase, providing additional insights into the specific risk factor for which they were selected to participate. This questionnaire collected data on demographics (age, gender), lifestyle factors, and health characteristics (such as tobacco use, body mass index [BMI], history of diabetes, hypertension, kidney disease, vascular disease, and family history of renal disease). Additionally, the pharmacist conducted a comprehensive medication review with each patient and made tailored recommendations, which might include dietary adjustments or referrals to their primary care physician when necessary. These recommendations were grounded in the patient’s medication history and risk factors, relying on the pharmacist’s professional judgment.
Ethical approval
The study received approval from the Institutional Ethical Review Committee of Ajman University (Approval Number: P-H-S-2022-2-9). All methods were carried out under relevant guidelines and regulations. Before collecting data, all participants were duly informed about the study’s objectives and explicitly consented to completing the questionnaire. Written informed consent was obtained from all respondents. To safeguard participant anonymity, no information was gathered that could potentially disclose their identities, and rigorous measures were implemented to uphold the confidentiality of participant data.
Statistical analyses
For data analysis, we utilized SPSS Version 26. Continuous variables with a normal distribution were assessed using means and standard deviations (SD), while categorical variables were analyzed through frequencies and percentages. We employed one-way ANOVAs, nonparametric alternatives, and unpaired Student t-tests to identify disparities among quantitative variables. In order to determine the variables that exerted an influence on CKD, we applied univariate and multivariate logistic regression models. Statistical significance was defined when p < 0.05.
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- Source: https://www.nature.com/articles/s41598-024-56765-0