Changes In Testing Rates Research Articles

Sociodemographic differences in the response to changes in COVID-19 testing guidelines.

During the coronavirus disease 2019 (COVID-19) pandemic, Sweden emphasized voluntary guidelines over mandates. We exploited a rapid change and reversal of the Public Health Agency of Sweden's COVID-19 testing guidelines for vaccinated and recently infected individuals as a quasi-experiment to examine sociodemographic differences in the response to changes in pandemic guidelines. We analyzed daily polymerase chain reaction tests from 1 October 2021 to 15 December 2021, for vaccinated or recently infected adults (≥20 years; n = 1596321) from three Swedish regions (Stockholm, Örebro, and Dalarna). Using interrupted time series analysis, we estimated abrupt changes in testing rates at the two dates when the guidelines were changed (1 November and 22 November). Stratified analysis and meta-regression were employed to explore sociodemographic differences in the strength of the response to the guideline changes. Testing rates declined substantially when guideline against testing of vaccinated and recently infected individuals came into effect on 1 November [testing rate ratio: 0.50 (95% confidence interval, CI 0.41, 0.61)], and increased again from these lowered levels by a similar amount upon its reversal on 22 November [testing rate ratio: 2.19 (95% CI: 1.69, 2.85)]. Being Sweden-born, having higher household income, or higher education, were all associated with a stronger adherent response to the guideline changes. Adjusting for stratum-specific baseline testing rates and test-positivity did not influence the results. Our findings suggest that the population was responsive to the rapid changes in testing guidelines, but with clear sociodemographic differences in the strength of the response.

Temporal trends in lipoprotein(a) testing among United States veterans from 2014 to 2023

ObjectiveLipoprotein (a) [Lp(a)] is a causal, genetically-inherited risk amplifier for atherosclerotic cardiovascular disease (ASCVD). Practice guidelines increasingly recommend broad Lp(a) screening among various populations to optimize preventive care. Corresponding changes in testing rates and population-level detection of elevated Lp(a) in recent years has not been well described. MethodsUsing Veterans Affairs electronic health record data, we performed a retrospective cohort study evaluating temporal trends in Lp(a) testing and detection of elevated Lp(a) levels (defined as greater than 50 mg/dL) from January 1, 2014 to December 31, 2023 among United States Veterans without prior Lp(a) testing. Testing rates were stratified based on demographic and clinical factors to investigate possible drivers for and disparities in testing: age, sex, race and ethnicity, history of ASCVD, and neighborhood social vulnerability. ResultsLp(a) testing increased nationally from 1 test per 10,000 eligible Veterans (558 tests) in 2014 to 9 tests per 10,000 (4,440 tests) in 2023, while the proportion of elevated Lp(a) levels remained stable. Factors associated with higher likelihood of Lp(a) testing over time were a history of ASCVD, Asian race, and residing in neighborhoods with less social vulnerability. ConclusionDespite a 9-fold increase in Lp(a) testing among US Veterans over the last decade, the overall testing rate remains extremely low. The steady proportion of Veterans with elevated Lp(a) over time supports the clinical utility of testing expansion. Efforts to increase testing, especially among Veterans living in neighborhoods with high social vulnerability, will be important to reduce emerging disparities as novel therapeutics to target Lp(a) become available.

Real-World Biomarker Testing Patterns in Patients With Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) in a US Community-Based Oncology Practice Setting

Introduction/BackgroundThis study was designed to describe real-world changes in biomarker testing among patients with non-squamous, metastatic non-small cell lung cancer (mNSCLC) in a community oncology setting from 2015 to 2020. Patients and MethodsThis retrospective study randomly selected 500 adult patients diagnosed with nonsquamous mNSCLC to undergo chart review and data extraction. Data were extracted and validated by 2 independent abstractors. Biomarker testing rates were described before and after national guideline updates and FDA approval of targeted agents. ResultsAt least 1 biomarker test was received by 89.4% of patients with mNSCLC. Of all patients, 46.6%, 34.6%, and 8.2% received both single-gene and next generation sequencing (NGS)-based testing, single-gene testing only, and NGS-based testing only, respectively. However, there were changes in testing rates at the time of drug approvals for targeted agents. Biomarker testing increased for ALK (45.0% before to 78.3% after ALK-targeted drug approval), BRAF (from 20.0% to 67.8%), EGFR (from 20.0% to 78.2%), NTRK (from 34.6% to 55.7%), and ROS1 (increased from 29.6% before approval to 74.2% after). Biomarker testing increased after changes were made to national guidelines for BRAF (from 18.8% before to 68.1% after inclusion in guidelines), NTRK (from 37.2% to 56.5%), and ROS1 (increased from 40.8% to 74.5% after guideline updates). Targeted therapy was received by 62.4% of patients with a positive biomarker. ConclusionIncreases in biomarker testing rates were observed relative to targeted agent approvals and national guideline updates. However, many patients with non-squamous mNSCLC did not receive full genotyping in accordance with national guidelines and represent an opportunity to identify reasons and solutions for barriers to care.

Modeling waning and boosting of COVID-19 in Canada with vaccination

SARS-CoV-2, the causative agent of COVID-19, has caused devastating health and economic impacts around the globe since its appearance in late 2019. The advent of effective vaccines leads to open questions on how best to vaccinate the population. To address such questions, we developed a model of COVID-19 infection by age that includes the waning and boosting of immunity against SARS-CoV-2 in the context of infection and vaccination. The model also accounts for changes to infectivity of the virus, such as public health mitigation protocols over time, increases in the transmissibility of variants of concern, changes in compliance to mask wearing and social distancing, and changes in testing rates. The model is employed to study public health mitigation and vaccination of the COVID-19 epidemic in Canada, including different vaccination programs (rollout by age), and delays between doses in a two-dose vaccine. We find that the decision to delay the second dose of vaccine is appropriate in the Canadian context. We also find that the benefits of a COVID-19 vaccination program in terms of reductions in infections is increased if vaccination of 15–19 year olds are included in the vaccine rollout.

Biomarker testing and tissue journey among patients with metastatic non-small cell lung cancer receiving first-line therapy in The US Oncology Network

ObjectivesThe MYLUNG (Molecularly Informed Lung Cancer Treatment in a Community Cancer Network) consortium pragmatic study assessed real-world biomarker testing rates and turnaround times within a large community-based oncology network. Materials and MethodsThis retrospective observational chart review study investigated patients with mNSCLC initiating first-line (1L) systemic therapy between 01-April-2018 and 31-March-2020. Biomarker testing rates and timing relative to 1L therapy for EGFR, ALK, ROS1, BRAF, and PD-L1 were assessed, including use of next-generation sequencing (NGS). ResultsAmong 3474 adults: 74% had adenocarcinoma and 76% had a documented ECOG performance status of 0 or 1. Ninety percent had testing for at least one biomarker, and 46% received all 5 biomarker tests. Changes in testing rates from 2018 to 2020 were 71% to 71% for EGFR, 71% to 70% for ALK, 69% to 67% for ROS1, 51% to 59% for BRAF, 82% to 84% for PD-L1, and 42% to 49% for all 5 biomarkers. NGS testing increased from 33% to 45% (p < 0.0001). Median time from mNSCLC diagnosis to 1L therapy was 35 days. Median turnaround times from biomarker testing orders to results ranged from 10 to 15 days for the individual biomarkers and 18 days for NGS. ConclusionIn this real-world study, while most patients received at least one biomarker test prior to 1L, <50% received all 5 tests. NGS testing also occurred in < 50% of patients but appeared to increase over time. The next phase of MYLUNG will evaluate contemporary ordering practices and turnaround times prospectively.

Pathology molecular reflex testing improves turn-around-time and overall molecular testing rates in NSCLC.

e13507 Background: Dozens of genetic aberrations have become druggable targets or act as biomarkers of diseases for which pts may qualify for precision medicine treatment options. Biomarker informed treatments can lead to vast improvements in patient outcomes over traditional approaches like chemo. However, comprehensive molecular profiling (CMP) to identify eligible pts is not always accomplished, particularly in the community setting where molecular testing is often outsourced to third party laboratories. Here we report our experience with reflex testing protocols, where a pathology department has responsibility for initiating biomarker testing without the need for direct oncologist involvement. In this study we investigate and report how pathologist initiated reflex protocols influences access to molecular biomarker testing and assessed changes in testing rates, result tracking, and timeliness of results. Methods: We reviewed a reflex testing protocol at Hoag Hospital (Newport Beach, California), for NSCLC pts. A process map was generated to identify pts who qualified for reflex testing. After developing the process map, we used VIPER software that gathers data from electronic medical records and pathology systems to perform our analysis. We evaluated protocol adherence, failures, QNS rates, and TAT from test ordering to sample receipt and processing and ultimately all the way to results being received and compared patients that followed the reflex protocol as compared to those that did not to determine any differences. Data analysis was performed to understand how effective the reflex system was in ensuring the appropriate patients received CMP and any benefits in efficiency that resulted. Results: We evaluated 300 NSCLC pts over a 12-month timeframe for their reflex testing statuses. 78.5% of those pts tested received Next Generation Sequencing (NGS) tests, vs. 21.5% receiving non-NGS based tests. We also found over 75% of the pts that were qualified for reflex testing had complete tests, while 25% were not able to be completed. Of those who did not meet reflex criteria, only 28% went on to receive CMP. The primary reason for a patient who qualified for reflex testing but did not have testing initiated was due to insurance or reimbursement concerns (42%). The average time from a reflex test being ordered to results available was 25.9 days. Without reflex the TAT averaged 40.5 days (15.4 days difference). For reflexed cases, 78% of CMP results were available prior to treatment initiation. Conclusions: We demonstrate that implementation of a CMP reflex testing program is feasible and can ensure that a higher percentage of NSCLC pts receive molecular testing and that these results can be provided nearly two times sooner than without such programs. Our next steps are to automate this process to allow practices that do not have the personnel to manage such programs can still benefit via technology assistance.

Biomarker tissue journey among patients (pts) with untreated metastatic non-small cell lung cancer (mNSCLC) in the U.S. Oncology Network community practices.

9004 Background: Given the importance of molecular testing and targeted therapy for mNSCLC, the MYLUNG (Molecularly Informed Lung Cancer Treatment in a Community Cancer Network) consortium pragmatic study assessed real-world biomarker testing rates and turnaround times (TAT) within The US Oncology Network of over 1,000 providers across the United States. Methods: This was a retrospective observational chart review study of pts with mNSCLC initiating first-line (1L) systemic therapy between 04/01/2018 and 03/31/2020. iKnowMed electronic health records were used to examine timing of biomarker testing: before 1L therapy (cohort 1), after 1L therapy (cohort 2) or no testing (cohort 3). We assessed testing rates for ALK, BRAF, EGFR, ROS1, and PD-L1; use of full next-generation sequencing panel (NGS); time from mNSCLC diagnosis (dx) to 1L therapy; TAT from biomarker orders to results; and time from mNSCLC dx to test results. Results: We identified 3474 adults. Median age was 69 years (range 23-90), 51% female, 74% with adenocarcinoma and 76% with a documented ECOG performance status of 0 or 1. Testing rates are shown in table: 90% of pts had at least one biomarker test and 46% received all 5 biomarker tests. Changes in testing rates from 2018 to 2020 were 51% to 59% for BRAF, 71% to 71% for EGFR, 71% to 70% for ALK, 69% to 67% for ROS1, 82% to 84% for PD-L1, and 42% to 49% for pts tested for all 5 biomarkers. NGS testing increased from 33% to 44% (p&lt;0.0001). The median (interquartile range [IQR]) time from mNSCLC dx to 1L therapy for all pts was 35 (22, 55) days. Median (IQR) TAT from biomarker testing orders to results ranged from 10 (6, 17) to 15 (10, 22) days for the individual biomarkers; and time from mNSCLC dx to biomarker results ranged from 14 (7, 26) to 21 (12, 36) days by biomarker. Conclusions: This real-world study showed that most pts received at least one biomarker test prior to 1L, but &lt;50% received all 5 tests. NGS testing occurred in &lt;50% of pts but increased over the periods examined. Median time from dx to 1L therapy was about 5 weeks and TAT from orders to results about 2 weeks. Analyses by histology and other trends will be reported. These data will be compared to the next phase of the MYLUNG study, which will evaluate contemporary ordering practices and TATs prospectively[Table: see text]

Changes in testing rates could mask the novel coronavirus disease (COVID-19) growth rate

Since the novel coronavirus disease (COVID-19) emerged in December 2019 in China, it has rapidly spread around the world, leading to one of the most significant pandemic events of recent history. Deriving reliable estimates of the COVID-19 epidemic growth rate is quite important to guide the timing and intensity of intervention strategies. Indeed, many studies have quantified the epidemic growth rate using time-series of reported cases during the early phase of the outbreak to estimate the basic reproduction number, R0. Using daily time series of COVID-19 incidence, we illustrate how epidemic curves of reported cases may not always reflect the true epidemic growth rate due to changes in testing rates, which could be influenced by limited diagnostic testing capacity during the early epidemic phase.

Increase in Gonorrhea Incidence Associated With Enhanced Partner Notification Strategy.

Partner notification services for reportable sexually transmitted infections vary based on jurisdiction, resources, type of infection, and whether an outbreak has been reported. The objective of this study was to determine whether case finding increased after implementation of enhanced notification and follow-up activities for contacts of cases of Neisseria gonorrhoeae in Central Zone, the largest health authority in Nova Scotia, Canada. Enhanced contact tracing by public health professionals was implemented in May 2015. N. gonorrhoeae multiantigen sequence typing (NG-MAST) was conducted on all positive specimens. Epidemiologic and NG-MAST information for reported gonorrhea cases were captured and analyzed. Case numbers, rates, and NG-MAST results in the preintervention and postintervention periods were compared. Laboratory testing data were extracted and analyzed for association with reported incidence. There was a significant increase in the number of reported gonorrhea cases per month when comparing the preintervention and postintervention periods. The reported gonorrhea rate in 2016 was 2.9 times that in 2014. This increase was not associated with changes in testing rates and was more pronounced among women than men. Larger groups of cases sharing the same NG-MAST profiles were detected postintervention. The implementation of an enhanced contact tracing program for N. gonorrhoeae resulted in increased case finding and a notable increase in the reported rate of cases per 100,000 population. Owing to these findings, the practice of enhanced partner notification was continued as standard public health practice in Central Zone. An understanding of case finding efforts is required when interpreting observed trends in rates of N. gonorrhoeae, as early infection is highly asymptomatic in women and can be asymptomatic in men.

Disparities in Zika Virus Testing and Incidence Among Women of Reproductive Age-New York City, 2016.

The New York City Department of Health and Mental Hygiene (NYC DOHMH) performs surveillance for reportable diseases, including Zika virus (ZIKV) infection and disease, to inform public health responses. Incidence rates of other mosquito-borne diseases related to international travel are associated with census tract poverty level in NYC, suggesting that high poverty areas might be at higher risk for ZIKV infections. We assessed ZIKV testing rates and incidence of travel-associated infection among reproductive age women in NYC to identify areas with high incidence and low testing rates and assess the effectiveness of public health interventions. We analyzed geocoded ZIKV surveillance data collected by NYC DOHMH. Women aged 15 to 44 years tested during January-July 2016 (n = 4733) were assigned to census tracts, which we grouped by poverty level and quartile of the number of persons born in countries or territories with mosquito-borne ZIKV transmission as a proxy for risk of travel to these areas. We calculated crude ZIKV testing rates, incidence rates, and incidence rate ratios (IRRs). New York City. Eight percent of patients (n = 376) tested had evidence of ZIKV infection. Cumulative incidence was higher both in areas with higher versus lower poverty levels (IRR = 2.4; 95% confidence interval [CI], 2.0-3.0) and in areas with the largest versus smallest populations of persons born in countries or territories with mosquito-borne ZIKV transmission (IRR = 11.3; 95% CI, 6.2-20.7). Initially, ZIKV testing rates were lowest in higher poverty areas with the largest populations of persons born in countries or territories with mosquito-borne ZIKV transmission (15/100 000), but following targeted interventions, testing rates were highest in these areas (80/100 000). Geocoded data enabled us to identify communities with low testing but high ZIKV incidence rates, intervene to promote testing and reduce barriers to testing, and measure changes in testing rates.

Positive spillover effects of prescribing requirements: increased cardiac testing in patients treated with trastuzumab for HER2+ metastatic breast cancer

Cardiotoxicity is a concern in patients on trastuzumab therapy, and cardiac function assessment is a recommended practice. In 2006, trastuzumab was publically subsidised for human epidermal growth factor receptor-2 early stage breast cancer with a requirement for cardiac testing prior to and during treatment. To investigate the spillover effects of this requirement on testing rates in metastatic patients treated with trastuzumab where no monitoring requirements are applied. We examined cardiac testing (echocardiography or multiple-gated acquisition scan) in 3779 women with metastatic breast cancer receiving trastuzumab between December 2001 and February 2010 and used interrupted time-series analyses to estimate changes in testing rates. The main outcome measures were the proportion of eligible patients, by quarter, receiving a cardiac function test pretreatment and during trastuzumab therapy. Only 21% of women had a cardiac function test pretreatment, and 47% were tested at some point during the first year of trastuzumab therapy. The introduction of mandatory cardiac testing for early breast cancer was associated with an immediate 8% increase (95% confidence interval, 2-14%) in pretreatment cardiac testing and an immediate 7% increase (95% confidence interval, 4-10%) in testing during therapy in metastatic patients. Testing rates during therapy increased steadily from early 2005, coinciding with the release of interim results from several trastuzumab trials reporting cardiac-safety outcomes. The introduction of mandatory cardiac testing for early stage disease spilled over to the metastatic setting. While deviation from guidelines may be warranted in some cases, this study suggests underutilisation of cardiac testing among patients treated with trastuzumab in the metastatic setting.

Replacement of conventional HIV testing with rapid testing: mathematical modelling to predict the impact on further HIV transmission between men

BackgroundRapid HIV testing is not permitted in Australia at the point of care. The authors evaluate the expected net effect of rapid HIV testing compared with standard serology diagnostic tests...

Surveillance Testing Among Survivors of Early-Stage Breast Cancer

Guidelines recommend against routine surveillance testing for women who have had breast cancer. We described follow-up care for breast cancer survivors, examined how surveillance testing varies by the types of physicians seen, and assessed changes in testing rates over time. Using Surveillance, Epidemiology, and End Results-Medicare data, we studied a population-based cohort of 44,511 women age > or = 65 years diagnosed with stage I/II breast cancer during 1992 to 1999 and observed through 2001. We measured bone scans, tumor antigen tests, chest x-rays, and other chest/abdominal imaging during 3 consecutive surveillance years. We described physicians seen in follow-up and used repeated-measures logistic regression to assess the relationship with testing and to assess testing trends over time. Nearly half of breast cancer survivors saw a medical oncologist in surveillance year 1, but only 27% saw a medical oncologist annually for 3 years. In adjusted analyses, women seeing medical oncologists had more bone scans, tumor antigen testing, chest x-rays, and chest/abdominal imaging than other women (all P < .001). Nevertheless, rates of testing decreased over time (all P < .001). Rates of tumor antigen testing and chest x-rays decreased faster and chest/abdominal imaging increased slower among women seeing medical oncologists than among other women (all P < .05). Non-recommended testing for early-stage breast cancer patients has decreased over time. Although most breast cancer survivors did not see oncologists annually, those who did had substantially higher rates of testing than others; whether such testing in this low-risk population was due to more symptoms or excessive surveillance is an important question for additional study.

Diabetes Disease Management in Medicaid Managed Care: A Program Evaluation

The objective of this study was to evaluate the outcomes of a diabetes disease management initiative among TennCare's Medicaid Population. A quasi-experimental group design was conducted using a control group and a diabetes disease management intervention group. Primary outcomes measures were rates for three key recommended tests (ie, microalbuminuria, lipids, and hemoglobin A1c). Secondary performance measures --patient satisfaction and program evaluation issues -- also were assessed. The study was performed among TennCare beneficiaries with diabetes mellitus. It utilized a quasi-experimental nonequivalent control group design, with 993 intervention participants in Knoxville and 1167 control group members in Chattanooga. Variables analyzed included testing rates for hemoglobin A1c, lipids, microalbuminuria, and demographics. A logistic regression model using baseline covariates was constructed to analyze the differences between the intervention and the control groups. Intracluster correlations were accounted for by generalized estimating equations. Statistical process control detected process changes in testing rates over time. There were meaningful changes in the rate of ordering recommended tests. The odds of an individual in the intervention group having at least one microalbuminuria test were 196% more (confidence interval [CI] = 1.50, 5.82; p = 0.002); the odds of having at least one lipid profile were 43% more (CI = 1.01, 2.02; p = 0.042); and the odds of having two or more hemoglobin A1c tests were 39% more (CI = 0.87, 2.23; p = 0.165) than the odds of an individual in the control group. The analysis also showed a high rate of satisfaction among patients in the intervention group. The program was successful in meeting its stated goals of providing effective disease management for TennCare patients with diabetes.

The association between HIV media campaigns and number of patients coming forward for HIV antibody testing.

To assess the relationship between national and local media campaigns with respect to the number of patients requesting HIV antibody tests as a surrogate marker of the effectiveness of different campaign strategies. Analysis by month of the numbers of HIV tests performed in the regional genitourinary (GUM) clinic for Lothian over a 5 year period and in the whole of Lothian Region, Scotland over a 3 year period. Changes in testing rates were monitored with respect to media campaigns over the same time period. Television based media campaigns produced the greatest increase in testing rates (average 46% increase over 2 months) compared with newspapers and poster campaigns (average 6% increase over 2 months). Regional HIV testing rates correlated significantly with GUM clinic testing rates. No increase in positive HIV tests was seen following media campaigns. Using HIV testing rates as a surrogate marker, television based media campaigns appear to be the most effective way of increasing awareness of HIV. The effect of media campaigns is short-lived indicating a need for constant reminder of the dangers of HIV infection. The increase in HIV testing occurs largely in the "worried well" with few additional HIV positive patients being identified.