Tag: statistics

J Appl Lab Med. 2025 Jan 3;10(1):13-25. doi: 10.1093/jalm/jfae136.

ABSTRACT

BACKGROUND: Efforts to appropriately utilize laboratory tests have been underway for several decades. However, limited information is available regarding the status of laboratory stewardship at academic medical centers. Prior to initiating a laboratory stewardship committee, a study was initiated to gain insights from peer institutions.

METHODS: An online REDCap survey was created and emailed to US pathology department leaders at 94 academic medical centers.

RESULTS: Response rate was 40%. Sixty-eight percent (n = 26) of respondents indicated that they have a laboratory stewardship committee. There was variability among academic medical institutions regarding governance, committee structure and responsibilities, and assessment of laboratory stewardship committee performance. There was consensus for inclusion of: hospital administration and clinical leadership; informatics (IT) support, and a multidisciplinary clinical team combined with laboratory medicine expertise. Of the 32% (n = 12) without a committee, 4 started one but found it unsustainable, and 6 were unsuccessful at starting a program. Respondents without a current laboratory stewardship program cited lack of leadership support, insufficient management and IT resources, and unclear vision and goals as major factors. Fifty-eight percent of those without a laboratory stewardship committee predicted their hospital would establish one within the next 5 years.

CONCLUSIONS: Survey results provide insights into the status of laboratory stewardship efforts at peer institutions. Awareness of the structural and leadership components critical to successful and sustained initiatives will improve the quality and value of clinical laboratory services.

PMID:39749454 | DOI:10.1093/jalm/jfae136

J Appl Lab Med. 2025 Jan 3;10(1):4-12. doi: 10.1093/jalm/jfae121.

ABSTRACT

BACKGROUND: Referral (send-out) laboratories support clinical needs but may cause issues for hospitals or health systems related to regulations and governance, specimen logistics, test result availability, and cost and reimbursement. The use of a “miscellaneous” referral test order can increase risks of specimen collection or processing errors, result delays, and repeat testing.

METHODS: We established an approved referral laboratory test list and a digital form for providers to request new referral tests. We collated laboratory stewardship committee decisions over a 20-month period. Separately, we retrospectively reviewed referral tests ordered as miscellaneous across our health system over 1 year. Subject matter experts identified appropriate tests to build as discretely orderable in the electronic health record. Following targeted provider notification of the new tests, we assessed their uptake and impact on result turnaround times for the first 5 built tests over 6 months.

RESULTS: Our laboratory stewardship committee approved 16 of 27 provider requests to build new referral tests over the first 20 months following implementation of the new request process. In addition, 37 of the 100 most frequently ordered miscellaneous tests were recommended to be built as discrete orders. Uptake of the first 5 built tests (relative to providers continuing to use miscellaneous orders) averaged 64% over the first 6 months. Result turnaround times improved by an average of 1.1 days when the discrete orders were used.

CONCLUSIONS: We successfully established oversight of referral laboratory testing across our health system, pivoted orders away from miscellaneous, and observed improvements in turnaround times.

PMID:39749453 | DOI:10.1093/jalm/jfae121

J Appl Lab Med. 2025 Jan 3;10(1):79-91. doi: 10.1093/jalm/jfae129.

ABSTRACT

BACKGROUND: The US healthcare system is complex and includes a number of entities and systems that provide services to patients and to pay for them. While improving health and well-being are accepted goals of healthcare, the 3 stakeholder groups relevant to healthcare-patients, providers, and payers-often have different perspectives on how care should be utilized, performed, and paid for. These differing perspectives are discussed as they relate to clinical laboratory testing.

CONTENT: Patients expect that the laboratory tests performed on them are necessary and covered by their insurance. Providers expect that they will be able to carry out what they believe to be the standard of care for their patients, and they furthermore expect that the systems in place from laboratories and payers will support their efforts without exposing their patients or their practice to financial toxicity. Payers, finally, desire to meet the needs of their customers, who are both patients as well as employers, by providing access to necessary healthcare services at a fair cost. Aligning these desires and perspectives is challenging in a fragmented healthcare system, and in the face of substantial opportunities for secondary gain from disreputable practices such as fraud, waste, and abuse.

SUMMARY: Within the constraints of a US healthcare system based on competition and susceptible to misalignment, opportunities nonetheless exist for all relevant stakeholders in the laboratory testing space (patients, providers, and payers) to align and agree on practices that provide reasonably priced, fairly distributed, and medically necessary healthcare.

PMID:39749451 | DOI:10.1093/jalm/jfae129

J Appl Lab Med. 2025 Jan 3;10(1):48-58. doi: 10.1093/jalm/jfae123.

ABSTRACT

BACKGROUND: In prolactinoma diagnosis, current guidelines recommend prolactin (PRL) assessment, considering values exceeding 200 ng/mL highly suggestive of prolactinoma. However, subtler hyperprolactinemia is more common, and to rule out potential prolactinomas, pituitary resonance magnetic imaging (MRI) studies are necessary. These present limitations in terms of availability, costs, and delays in diagnosis. We aimed to evaluate the screening utility of the metoclopramide (MCP) test in identifying patients with moderate hyperprolactinemia for whom MRI studies might be unnecessary.

METHODS: We retrospectively selected patients with moderate hyperprolactinemia, with an MCP test and a pituitary MRI within the same assistance, and with no interfering pharmacological treatment. Increases in PRL (ΔPRLMax) and thyrotropin (ΔTSHMax) after MCP infusion were compared according to MRI findings: patients with microadenoma (<10 mm; n = 23), with macroadenoma (≥10 mm; n = 5), or without adenoma (n = 39).

RESULTS: ΔPRLMax exceeds baseline PRL capability to identify patients with an adenoma (area under the curve = 0.872 vs 0.776). ΔPRLMax below 220% identifies 100% of these patients with 71% of specificity. This screening would have avoided 42% of MRI, resulting in a cost savings of 34%. Analysis of ΔTSHMax only slightly increased specificity when considered as a secondary criterion. Test duration can be shortened to 30 min without compromising its screening capability.

CONCLUSIONS: A short MCP test is a useful and cost-effective screening tool to avoid unnecessary MRI. Its simplicity allows its performance in almost any clinical facility to easily rule out prolactinoma in an important percentage of patients, something of upmost importance especially in regions where MRI facilities or their access are limited.

PMID:39749449 | DOI:10.1093/jalm/jfae123

J Appl Lab Med. 2025 Jan 3;10(1):148-161. doi: 10.1093/jalm/jfae135.

ABSTRACT

BACKGROUND: As clinical laboratories struggle to maintain their financial footing and as patients face mounting out-of-pocket expenses for diagnostic testing, being able to perform financial analysis of laboratory stewardship efforts has become an increasingly important skill.

CONTENT: Understanding the revenue cycle as it relates to diagnostic testing is fundamental to selecting, designing, implementing, and evaluating laboratory stewardship interventions for maximum financial return. Leveraging the data and processes driving the revenue cycle can inform informatics-based interventions (such as clinical decision support) and allow deliberate financial analyses of stewardship-focused projects. For labs striving not only to ensure their own financial health but also to help their patients avoid financial toxicity, the most effective strategies often depend on developing productive partnerships with key players along the revenue cycle.

SUMMARY: Financial laboratory analytics is an emerging skill set that can power laboratory stewardship efforts and whose benefits accrue to patients, clinicians, laboratories, and health systems.

PMID:39749448 | DOI:10.1093/jalm/jfae135

J Appl Lab Med. 2025 Jan 3;10(1):184-191. doi: 10.1093/jalm/jfae126.

ABSTRACT

BACKGROUND: Laboratory stewardship programs are increasingly adopted to enhance test utilization and improve patient care. Despite their potential, implementation within complex healthcare systems remains challenging. Benchmarking metrics helps institutions compare their performance against peers or best practices. However, the application in laboratory stewardship is underrepresented in the literature.

METHODS: The PLUGS (Patient-centered Laboratory Utiliazation Guidance Services) Informatics Working Group developed guidelines to address common test utilization issues. Metrics were based on data that are easily retrievable and calculable. Three key benchmarks were chosen for a pilot study: the ratio of 25-hydroxyvitamin D to 1,25-dihydroxyvitamin D test orders, the ratio of thyroid-stimulating hormone (TSH) to free thyroxine (FT4) test orders, and the percentage of iron workup orders after an initial low mean corpuscular volume (MCV). Institutions analyzed their own data and we established optimal benchmarks through inter-laboratory comparisons.

RESULTS: Nine laboratories evaluated vitamin D testing, with 2 implementing stewardship interventions beforehand. A benchmark of 50:1 was established, where a higher ratio indicates intentional ordering of 1,25-dihydroxyvitamin D. Nine laboratories evaluated thyroid testing, with 3 implementing interventions. The benchmark of 3.5:1 was established, with a higher ratio suggesting judicious TSH ordering. Seven laboratories evaluated iron workups, proposing a benchmark of 50% as a starting metric. Intervention guidelines were provided for laboratories below the benchmarks to promote improvement.

CONCLUSIONS: Benchmarking metrics provide a standardized framework for assessing and enhancing test utilization practices across multiple laboratories. Continued collaboration and refinement of benchmarking methodologies is essential in maximizing the impact of laboratory stewardship programs on patient safety and resource utilization.

PMID:39749447 | DOI:10.1093/jalm/jfae126

J Appl Lab Med. 2025 Jan 3;10(1):73-78. doi: 10.1093/jalm/jfae097.

ABSTRACT

BACKGROUND: Diagnostic stewardship is the science of improving diagnostic test use. Whether electronic health record (EHR) design influences clinician diagnostic testing behavior and electronic medical record interventions can improve diagnostic stewardship outcomes are key questions. We leveraged the natural experiment of a recent change in EHR platforms to investigate if changing how 2 commonly misused tests, blood cultures for acid-fast bacilli (AFB) and fungi, are displayed affected their use.

METHODS: We performed a retrospective chart review of all AFB and fungal blood cultures at 4 hospitals with a shared EHR. The preintervention and postintervention periods were 52 and 26 weeks, respectively. The culture rate was standardized per 1000 patient-days and segmented into 2-week periods. Pre- and postintervention median rates were compared with the Wilcoxon rank sum test and further analyzed with an interrupted time series (ITS) analysis using a quasi-Poisson regression model.

RESULTS: The biweekly median AFB blood culture rate decreased by 41.6% in the postintervention period (0.46/1000 patient-days vs 0.79/1000 patient-days, P < 0.001). The median rate of fungal blood cultures decreased by 54.3% in the postintervention period (0.42/1000 patient-days vs 0.92/1000 patient-days, P < 0.001). In ITS analysis, the EHR change was associated with a level change in AFB (-31.8%, 95% CI: -54.6% to +2.6%) and fungal (-44.6%, 95% CI: -59.3% to -24.7%) blood culture use.

CONCLUSIONS: An electronic medical record design change resulted in decreased use of 2 commonly misused diagnostic tests. This highlights the impact of EHR design on clinician behavior and diagnostic stewardship programs’ potential to reduce waste.

PMID:39749440 | DOI:10.1093/jalm/jfae097

Child Care Health Dev. 2025 Jan;51(1):e70029. doi: 10.1111/cch.70029.

ABSTRACT

BACKGROUND: Malaria remains a major cause of preventable deaths among children worldwide, despite the availability of several interventions for controlling and eliminating the disease. The WHO recommended the first malaria vaccine, RTS, S/AS01 in October 2021 to immunize children in sub-Saharan Africa. In this study, we set out to evaluate the knowledge, awareness and acceptability of the malaria vaccine among mothers of under 5 in south-west Nigeria before the vaccine’s rollout in Nigeria.

METHODS: We employed a hospital-based cross-sectional study for this study. A pretested semistructured, interviewer-administered questionnaire was used to elicit information from the study participants. Data obtained were analysed using the Statistical Package for Social Sciences (SPSS version 20.0).

RESULTS: A total of 797 respondents participated in the study. Only 26.0% of the respondents were aware of the new vaccine. However, the majority (90.0%) were willing to accept the malaria vaccination and to pay for it (82.1%). The crude odds ratio reveals that the odds of awareness of the malaria vaccine were more than 5 times higher among those who have tertiary education (OR = 5.470, CI = 1.224-24.444) compared with those with primary education.

CONCLUSION: The level of awareness of the malarial vaccine is low among the caregivers of under 5 children living in south-western Nigeria. However, the willingness to accept the vaccine is high. Recruiting, training and retraining of healthcare providers and other stakeholders with the designated role of providing health education on malaria prevention and vaccines are key in ensuring the success of malaria vaccination.

PMID:39749414 | DOI:10.1111/cch.70029

Nat Genet. 2025 Jan 2. doi: 10.1038/s41588-024-01994-2. Online ahead of print.

ABSTRACT

Complex diseases often have distinct mechanisms spanning multiple tissues. We propose tissue-gene fine-mapping (TGFM), which infers the posterior inclusion probability (PIP) for each gene-tissue pair to mediate a disease locus by analyzing summary statistics and expression quantitative trait loci (eQTL) data; TGFM also assigns PIPs to non-mediated variants. TGFM accounts for co-regulation across genes and tissues and models uncertainty in cis-predicted expression models, enabling correct calibration. We applied TGFM to 45 UK Biobank diseases or traits using eQTL data from 38 Genotype-Tissue Expression (GTEx) tissues. TGFM identified an average of 147 PIP > 0.5 causal genetic elements per disease or trait, of which 11% were gene-tissue pairs. Causal gene-tissue pairs identified by TGFM reflected both known biology (for example, TPO-thyroid for hypothyroidism) and biologically plausible findings (for example, SLC20A2-artery aorta for diastolic blood pressure). Application of TGFM to single-cell eQTL data from nine cell types in peripheral blood mononuclear cells (PBMCs), analyzed jointly with GTEx tissues, identified 30 additional causal gene-PBMC cell type pairs.

PMID:39747598 | DOI:10.1038/s41588-024-01994-2

Nat Genet. 2025 Jan 2. doi: 10.1038/s41588-024-01997-z. Online ahead of print.

ABSTRACT

Profiling tumors with single-cell RNA sequencing has the potential to identify recurrent patterns of transcription variation related to cancer progression, and to produce therapeutically relevant insights. However, strong intertumor heterogeneity can obscure more subtle patterns that are shared across tumors. Here we introduce a statistical method, generalized binary covariance decomposition (GBCD), to address this problem. We show that GBCD can decompose transcriptional heterogeneity into interpretable components-including patient-specific, dataset-specific and shared components relevant to disease subtypes-and that, in the presence of strong intertumor heterogeneity, it can produce more interpretable results than existing methods. Applied to data on pancreatic ductal adenocarcinoma, GBCD produced a refined characterization of existing tumor subtypes, and identified a gene expression program prognostic of poor survival independent of tumor stage and subtype. The gene expression program is enriched for genes involved in stress responses, and suggests a role for the integrated stress response in pancreatic ductal adenocarcinoma.

PMID:39747597 | DOI:10.1038/s41588-024-01997-z