Rainbow phlebotomy collection and urine aliquots for emergency department add-on testing in the era of pandemic-driven supply shortages.

BACKGROUND: Rainbow blood draws for add-on testing in the emergency department (ED) are a common practice at our institution. We sought to determine the prevalence of this practice among reference laboratory clients and characterize the impact of pandemic-driven supply shortages. METHODS: This cross-sectional study surveyed 354 client laboratories to understand specimen collection practices in specific clinical environments and how these practices may have been affected by supply chain shortages. Data analysis by descriptive statistics was performed in Qualtrics. RESULTS: A total of 138 laboratories took the survey (39% response rate) with 57% indicating that their ED performed rainbow draws. Of these, 16% have a formal policy regarding rainbow draws, and 76% of respondents indicated that their institution was required to modify practices due to pandemic-driven supply shortages. A total of 19% indicated they routinely collect multiple urine aliquots for add-on testing. CONCLUSION: Rainbow draws and collection of urine aliquots in the ED for add-on testing are relatively common practices, with few institutions maintaining formal policies regarding the practice. Pandemic-driven supply chain shortages affected a majority of respondent laboratories and local cost-benefit analysis regarding extra specimen collection is recommended to limit waste of laboratory resources.

A Cluster Randomized Trial of Primary Care Practice Redesign to Integrate Behavioral Health for Those Who Need It Most: Patients With Multiple Chronic Conditions.

PURPOSE: Patient outcomes can improve when primary care and behavioral health providers use a collaborative system of care, but integrating these services is difficult. We tested the effectiveness of a practice intervention for improving patient outcomes by enhancing integrated behavioral health (IBH) activities. METHODS: We conducted a pragmatic, cluster randomized controlled trial. The intervention combined practice redesign, quality improvement coaching, provider and staff education, and collaborative learning. At baseline and 2 years, staff at 42 primary care practices completed the Practice Integration Profile (PIP) as a measure of IBH. Adult patients with multiple chronic medical and behavioral conditions completed the Patient-Reported Outcomes Measurement Information System (PROMIS-29) survey. Primary outcomes were the change in 8 PROMIS-29 domain scores. Secondary outcomes included change in level of integration. RESULTS: Intervention assignment had no effect on change in outcomes reported by 2,426 patients who completed both baseline and 2-year surveys. Practices assigned to the intervention improved PIP workflow scores but not PIP total scores. Baseline PIP total score was significantly associated with patient-reported function, independent of intervention. Active practices that completed intervention workbooks (n = 13) improved patient-reported outcomes and practice integration (P ≤ .05) compared with other active practices (n = 7). CONCLUSION: Intervention assignment had no effect on change in patient outcomes; however, we did observe improved patient outcomes among practices that entered the study with greater IBH. We also observed more improvement of integration and patient outcomes among active practices that completed the intervention compared to active practices that did not. Additional research is needed to understand how implementation efforts to enhance IBH can best reach patients.

Spirited away: Can ethanol testing in add-on orders provide meaningful results?

Ethanol is a volatile substance, and specimens need to be tightly capped prior to analysis to prevent evaporative loss. However, add-on requests in previously decapped tubes are commonly received, yet ethanol stability in this setting is unclear. We compared the stability of ethanol in capped vs decapped tubes in the context of routine laboratory automation, storage time, and specimen volumes. Serum specimens were pooled and spiked with ethanol followed by simulating an add-on scenario. Additionally, to evaluate ethanol stability at room temperature for extended times, ethanol concentrations were measured in capped or decapped tubes containing 0.5 mL or 0.1 mL samples over a 4 h time course. Finally, the risk of misclassification of ethanol results in decapped tubes was evaluated near the critical value threshold (∼54 mmol/L). The add-on tubes had a mean recovery of 101.5 % (95 % CI: 97.7-105.4 %) relative to the direct tubes. The time-course experiment showed an average recovery of 87.4 % (95 % CI: 81.8-94.0 %) at the 4 h time point in decapped 0.5 mL specimens. An average recovery of 85.4 % (95 % CI: 84.2-86.1 %) was observed for specimens spiked near the critical value threshold. Importantly, all measurements with 0.5 mL specimen volume were within 25 %, which is the total allowable error (TAE) of the assay.However, with a 0.1 mL volume, specimens cross the TAE threshold just after 1 h, and the percent recovery at 4 h dropped to 52.9 % (95 % CI: 50.2-55.7 %). In conclusion, ethanol testing in decapped tubes remains within the TAE for up to 4 h in specimens with a 0.5 mL volume. Therefore, add-on ethanol testing using routine laboratory automation and storage conditions can be successfully performed.

Reported Awareness and Adoption of 2021 Estimated Glomerular Filtration Rate Equations Among US Clinical Laboratories, March 2022.

This study includes clinical laboratories that participated in the first general chemistry proficiency testing survey in 2022 to assess awareness and adoption of new equations from the Chronic Kidney Disease Epidemiology Collaboration for estimated glomerular filtration rate (eGFR) that eliminated race-adjustment factors, including one based on creatinine and one based on creatinine and cystatin C.

Measurement of Urinary Ammonium Using a Commercially Available Plasma Ammonium Assay.

Background: Determination of urinary ammonium excretion is helpful in evaluating patients with acid-base disorders, chronic kidney disease, and nephrolithiasis. However, urinary ammonium levels are only measured by specialized laboratories in the United States, limiting widespread implementation. We evaluated the performance of a plasma ammonium assay to quantify urinary ammonium excretion and also determined ammonium stability under a variety of conditions. Methods: An enzymatic plasma ammonium assay (Randox) was modified to measure urinary ammonium concentration. Urine samples were diluted 40-fold and then assayed on an Abbott Architect ci8200 analyzer. Assay precision, limit of quantitation, and linearity were determined. The method was compared against the formalin titration method, and stability studies were conducted at different temperatures and pH. Results: After dilution, the assay had total precision of 18% at 2.54 mmol/L, 5% at 15.58 mmol/L, and 2% at 29.49 mmol/L, with a limit of quantitation of 2.92 mmol/L. Assay performance was linear in the range of 0.7-45 mmol/L. Method comparison against the formalin method showed a slope of 0.98 and intercept of -0.37 mmol/L. Urinary ammonium was determined to be stable for 48 hours at room temperature and for 9 days at 4°C and -20°C at pH 5.6-6.3. Ammonium was less stable at pH 3.8 and 8.5. When stored at -80°C, urinary ammonium was stable for at least 24 months. Conclusions: The modified enzymatic plasma ammonium assay reliably quantifies urine ammonium at physiologic concentrations. It compares well with the formalin titration method and is suitable for routine clinical use on an automated chemistry analyzer.

Impaired health-related quality of life, psychological distress, and productivity loss in younger people with persistent shoulder pain: a cross-sectional analysis.

PURPOSE: To investigate wellbeing and work impacts in younger people with persistent shoulder pain. MATERIALS AND METHODS: People aged 20-55 years with shoulder pain of >6 weeks' duration (excluding those with recent fracture or dislocation) were recruited from orthopaedic clinics at three major public hospitals. Health-related quality of life (HRQoL) and psychological distress were evaluated using the Assessment of Quality of Life (AQoL) and K10 instruments and compared to population norms. Shoulder-related absenteeism and presenteeism were quantified using the Work Productivity and Activity Impairment (WPAI) Questionnaire. RESULTS: Of the 81 participants (54% male), 69% had shoulder pain for over 12 months. Substantial HRQoL impairment was evident (mean reduction from population norms 0.33 AQoL units, 95% CI -0.38 to -0.27; minimal important difference 0.06 AQoL units). High or very high psychological distress was three times more prevalent among participants than the general population (relative risk 3.67, 95% CI 2.94 to 4.59). One-quarter of participants had ceased paid employment due to shoulder pain and 77% reported shoulder-related impairment at work. CONCLUSIONS: The broader impacts of painful shoulder conditions on younger people extend well beyond pain and upper limb functional limitations. In particular, the work-related impacts should form a routine part of patient assessment and rehabilitation.Implications for rehabilitationPersistent shoulder pain in younger people (aged 20-55 years) is associated with substantially reduced health-related quality of life and greater psychological distress, compared to population norms, as well as work participation and productivity impacts.As rotator cuff conditions, shoulder capsule pathology, and glenohumeral instability are relatively common, our data suggest that persistent shoulder pain is likely to have a high community impact among people of working age.Information resources that people with painful shoulder conditions can share with their families, employers, and colleagues may assist others to better understand the broader impacts of these conditions.Work-related challenges associated with shoulder pain should be considered within routine clinical care, and may require referral to an occupational health clinician or vocational rehabilitation service.

Chronic Primary or Secondary Noninflammatory Musculoskeletal Pain and Disrupted Sexual Function and Relationships: A Systematic Review.

OBJECTIVE: Evidence points to the impact of chronic musculoskeletal pain conditions on sexual function, yet there is little systematic appraisal and synthesis of evidence examining these associations across noninflammatory conditions. We aimed to systematically review evidence surrounding the association between chronic primary and chronic secondary musculoskeletal pain with intimate relationships and sexual function. METHODS: Four electronic databases were searched from January 1, 1990 to September 5, 2019 for cross-sectional or prospective epidemiologic and qualitative studies among cohorts with chronic primary or secondary noninflammatory musculoskeletal pain, defined by International Classification of Diseases, Eleventh Revision classification criteria. RESULTS: Fifty-one eligible studies were included (46 quantitative, 3 qualitative, 2 mixed-methods designs). Sample sizes ranged from 13 to 12,377 and mean age from 32.6 to 69.2 years. Cross-sectional controlled cohort studies consistently reported poorer sexual function outcomes among cohorts with pain relative to comparison groups. Of 15 studies reporting outcomes for the Female Sexual Function Index, 14 demonstrated mean scores of ≤26.55 for the pain group, indicating sexual dysfunction. In 4 studies reporting the International Index of Erectile Function, the pain cohorts demonstrated consistently lower mean subscale scores and the erectile function subscale scores were ≤25.0, indicating erectile dysfunction. Three key themes emerged from a meta-synthesis of qualitative studies: impaired sexual function; compromised intimate relationships; and impacts of pain on sexual identity, body image, and self-worth. CONCLUSION: Sexual dysfunction and negative impacts on intimate relationships are highly prevalent among people with chronic noninflammatory musculoskeletal pain. Consideration of these associations is relevant to the delivery of holistic, person-centered musculoskeletal pain care.

Integrating behavioral health & primary care for multiple chronic diseases: Clinical trial of a practice redesign toolkit.

Context: Most patients in need of behavioral health (BH) care are seen in primary care, which often has difficulty responding. Some practices integrate behavioral health care (IBH), with medical and BH providers at the same location, working as a team. However, it is difficult to achieve high levels of integration. Objective: Test the effectiveness of a practice intervention designed to increase BH integration. Study Design: Pragmatic, cluster-randomized controlled trial. Setting: 43 primary care practices with on-site BH services in 13 states. Population: 2,460 adults with multiple chronic medical and behavioral conditions. Intervention: 24-month practice change process including an online curriculum, a practice redesign and implementation workbook, remote quality improvement coaching services, and an online learning community. Outcomes: Primary outcomes were changes in the 8 Patient-Reported Outcomes Measurement Information System (PROMIS-29) domain scores. Secondary outcomes were changes in medication adherence, self-reported healthcare utilization, time lost due to disability, cardiovascular capacity, patient centeredness, provider empathy, and several condition-specific measures. A sample of practice staff completed the Practice Integration Profile at each time point to estimate the degree of BH integration in that site. Practice-level case studies estimated the typical costs of implementing the intervention. Results: The intervention had no significant effect on any of the primary or secondary outcomes. Subgroup analyses showed no convincing patterns of effect in any populations. COVID-19 was apparently not a moderating influence of the effect of the intervention on outcomes. The intervention had a modest effect on the degree of practice integration, reaching statistical significance in the Workflow domain. The median cost of the intervention was $18,204 per practice. In post-hoc analysis, level of BH integration was associated with improved patient outcomes independent of the intervention, both at baseline and longitudinally. Conclusions: The specific intervention tested in this study was inexpensive, but had only a small impact on the degree of BH integration, and none on patient outcomes. However, practices that had more integration at baseline had better patient outcomes, independent of the intervention. Although this particular intervention was ineffective, IBH remains an attractive strategy for improving patient outcomes.

The effect of the Covid-19 shutdown on glycemic testing and control.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic caused a halt to in-person ambulatory care. We evaluated how the reduction in access to care affected HbA1c testing and patient HbA1c levels. METHODS: HbA1c data from 11 institutions were extracted to compare testing volume and the percentage of abnormal results between a pre-pandemic period (January-June 2019, period 1) and a portion of the COVID-19 pandemic period (Jan-June 2020, period 2). HbA1c results greater than 6.4% were categorized as abnormal. RESULTS: HbA1C testing volumes decreased in March, April and May by 23, 61 and 40% relative to the corresponding months in 2019. The percentage of abnormal results increased in April, May and June (25, 23, 9%). On average, we found that the frequency of abnormal results increased by 0.31% for every 1% decrease in testing volume (p < 0.0005). CONCLUSION: HbA1c testing volume for outpatients decreased by up to 70% during the early months of the pandemic. The decrease in testing was associated with an increase in abnormal HbA1c results.

Australian men's fertility information seeking attitudes and behaviour: A qualitative investigation.

OBJECTIVE: Most women and men want and expect to have children but increasing maternal and paternal ages reduce their ability to achieve this. Most research relating to childbearing has focused on women. The aim of this study was to explore reproductive-aged men's fertility information-seeking attitudes and behaviours. METHODS: Focus group discussions were conducted with younger (18-30 years, 3 groups) and older (31-45 years, 3 groups) men, residing in urban, peri-urban or rural settings in Victoria, Australia. The topics covered included men's fatherhood aspirations and intentions, and their attitudes and behaviours relating to seeking information about fertility. Focus group discussions were audio-recorded and transcribed, and transcripts analyzed thematically. RESULTS: Six focus group discussions were conducted with a total of 39 participants. Four key themes were identified: 1. 'No need for fertility-related information'; 2. 'Knowledge and awareness of fertility'; 3. 'Fertility is women's business'; and 4. 'Fertility and manhood'. Fertility and fertility information seeking was perceived by many participants as women's domain. While men did not seek information about fertility unless they experienced fertility difficulties, they reported learning about fertility through the lived experiences of others, predominantly family and friends who experienced infertility. CONCLUSION: Fertility-related health promotion initiatives and reproductive health information targeting men are needed to encourage men to be active participants in reproductive decision making to optimize the chance of both women and men achieving their parenthood goals. Narrative health messages may be a successful way to convey fertility information to men.

Side-Effects of COVID-19 on Patient Care: An INR Story.

BACKGROUND: Numerous studies have documented reduced access to patient care due to the COVID-19 pandemic, including access to diagnostic or screening tests, prescription medications, and treatment for an ongoing condition. In the context of clinical management for venous thromboembolism, this could result in suboptimal therapy with warfarin. We aimed to determine the impact of the pandemic on utilization of International Normalized Ratio (INR) testing and the percentage of high and low results. METHODS: INR data from 11 institutions were extracted to compare testing volume and the percentage of INR results ≥3.5 and ≤1.5 between a pre-pandemic period (January-June 2019, period 1) and a portion of the COVID-19 pandemic period (January-June 2020, period 2). The analysis was performed for inpatient and outpatient cohorts. RESULTS: Testing volumes showed relatively little change in January and February, followed by a significant decrease in March, April, and May, and then returned to baseline in June. Outpatient testing showed a larger percentage decrease in testing volume compared to inpatient testing. At 10 of the 11 study sites, we observed an increase in the percentage of abnormal high INR results as test volumes decreased, primarily among outpatients. CONCLUSION: The COVID-19 pandemic impacted INR testing among outpatients which may be attributable to several factors. Increased supratherapeutic INR results during the pandemic period when there was reduced laboratory utilization and access to care is concerning because of the risk of adverse bleeding events in this group of patients. This could be mitigated in the future by offering drive-through testing and/or widespread implementation of home INR monitoring.

Performance Characteristics of BinaxNOW COVID-19 Antigen Card for Screening Asymptomatic Individuals in a University Setting.

We compared the performance of the Abbott BinaxNOW COVID-19 antigen card to that of a standard reverse transcription-PCR (RT-PCR) assay (Thermo Fisher TaqPath COVID-19 Combo kit) for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 2,645 asymptomatic students presenting for screening at the University of Utah. SARS-CoV-2 RNA was detected in 1.7% of the study participants by RT-PCR. BinaxNOW identified 24 infections but missed 21 infections that were detected by RT-PCR. The analytical sensitivity (positive agreement) and analytical specificity (negative agreement) for the BinaxNOW were 53.3% and 100%, respectively, compared to the RT-PCR assay. The median cycle threshold (CT ) value in the specimens that had concordant positive BinaxNOW antigen results was significantly lower than that of specimens that were discordant (CT of 17.6 versus 29.6; P < 0.001). In individuals with presumably high viral loads (CT of <23.0), a 95.8% positive agreement was observed between the RT-PCR assay and BinaxNOW. Due to the possibility of false-negative results, caution must be taken when utilizing rapid antigen testing for screening asymptomatic individuals.

Reliability of Total Nucleated Cell Counts in the Setting of Hip Arthroplasty.

BACKGROUND: Total nucleated cell (TNC) count and differential are used to classify joint effusions as inflammatory or noninflammatory. Further diagnostic evaluation and management is contingent on this classification. TNC count can be measured by automated analyzers or by manual assessment using a hemocytometer. Studies have raised concerns regarding the accuracy of TNC counts measured by automated instruments, particularly in the setting of joint arthroplasty. The objective of this study was to determine whether metallosis, a complication of total hip arthroplasty in which metal debris accumulates in periprosthetic tissues and synovial fluid, is associated with inaccurate TNC counts in synovial fluid. METHODS: We compared the accuracy of cell counts measured by the Sysmex XN-1000 and Beckman Coulter Iris iQ200 with the gold standard of manual assessment using a hemocytometer in synovial fluid from patients with suspected metallosis and in fluid obtained from controls from patients with native joints and a history of arthroplasty for other indications. RESULTS: TNC counts produced by automated analyzers were associated with increased levels of discordance (relative to manual counts) in patients with metallosis. Metallosis was not associated with increased levels of discordance for RBC counts or WBC differentials. The Sysmex XN flagged all but 1 metallosis sample for manual verification of the results. CONCLUSIONS: Automated methods are generally reliable for analysis of synovial fluid. TNC counts can be inaccurate in the context of metallosis following total hip arthroplasty. Laboratories should correlate automated cell counts with a microscopic assessment of the specimen, as recommended by instrument manufacturers.

D-Dimer Varies Widely Across Instrument Platforms and is Not a Reliable Indicator of Periprosthetic Joint Infections.

The D-dimer test is a component of the modified scoring criteria for periprosthetic joint infection (PJI). The performance of the D-dimer test varies greatly among laboratories because of the lack of standardization. Laboratories may use different assays and will produce widely varying results for the same sample. This study used published proficiency testing data from 3903 laboratories to demonstrate the variability in D-dimer results and estimate the misclassification rate of patients using the proposed cutoff for the test as a component of PJI criteria. Given the variability in D-dimer results, a clinically significant percentage of patients are likely to be misclassified. The data illustrate that a universal cutoff for this marker in the context of assessment for PJI is not appropriate. Each site must conduct a study to determine an appropriate cutoff for their unique testing platform.

The costs and benefits of cross-level quality control rules.

BACKGROUND: Quality is often monitored by multi-rule schemes that are applied at each level of QC material. Cross Level (CL) quality control rules have been proposed but have not been investigated. METHODS: We used computer simulation to study the impact of CL rules on time to detection and the false positive rate in a system using multirules (3-1s, 2-2s, 4-1s, and 10x) with 2 levels of QC material We also studied the effect of correlation between shifts at each level. The performance of QC policies was compared using simulation analysis. We also compared the detection rates of QC policies (with and without QC rules) using laboratory QC data. RESULTS: Implementing the CL rule increased the false positive rate and increased the detection rate for small shifts (around 1 standard deviation). CL rules had a greater impact when the correlation of shifts between levels was high. CONCLUSIONS: CL rules have the potential to increase detection rates, but also increase false positive rates. It is difficult to identify the circumstances where the benefits of increased detection outweigh the costs of false positives. Alternative approaches to QC should be explored.

Can fecal calprotectin serve as a screen for necrotizing enterocolitis in infants?

BACKGROUND: Researchers are debating if fecal calprotectin results are useful for infant patients, especially in screening for necrotizing enterocolitis (NEC). Currently, none of the FDA-approved calprotectin assays provide a cut-off for infant patients. We retrospectively analyzed data from a reference laboratory and university hospital to investigate if a cut-off could be established for infant patients. METHODS: Data from a national reference laboratory of 5144 test results for fecal calprotectin were analyzed for infant patients, and a cut-off was estimated based on the distribution of results. Additionally, a literature proposed cut-off of 226 µg/g was also considered. Validation of either cut-off was attempted by review of the electronic medical record of our university hospital for 110 infant patients with results for fecal calprotectin. RESULTS: Infants had a high percentage of elevated fecal calprotectin results when using the adult cut-offs set by the manufacturer. A cut-off of 247 µg/g was estimated based on the reference laboratory results for infants 0-2 months old, which is similar to a literature proposed cut-off of 226 µg/g. However, the positive predictive value (PPV) for both cut-offs was <0.6 when retrospectively analyzing data from a university hospital. CONCLUSION: Due to the low PPVs, the two infant-specific cut-offs for fecal calprotectin would not be useful to screen for NEC in infants at our university hospital.