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The objective of this study is to characterize nephrology nurses’ and nephrologists’ design expectations and preferences for a wearable dialysis device that allows a dialysis patient greater mobility and improved independence. We gathered ideal design characteristics, acceptable size and weight parameters, and the most preferred design type of a wearable dialysis device. Using qualitative analysis of open-ended questions and quantitative analysis of rank-order questions, our results indicate seven categories of ideal design features and give an estimate of parameters for the largest acceptable size and heaviest acceptable weight of the device. Furthermore, our results show that the clinicians significantly prefer a belt design over a shoulder bag, a vest, or a distributed design type. The findings from this study offer a vision for design preferences and usability objectives to help ensure users’ safe and efficient use of a wearable dialysis device.

Background Home spirometry with regular symptom assessment is one strategy to track lung health to intervene early in episodes of pulmonary exacerbations (PE). In a multi-center randomized controlled trial home spirometry and symptom tracking demonstrated no significant differences regarding the primary clinical endpoint, FEV1, compared to usual care, but did identify differences in healthcare utilization. We used data from the Early Intervention in Cystic Fibrosis Exacerbation (eICE) study to evaluate whether home monitoring of PE is a cost-minimizing intervention in the context of this randomized trial. Methods We reviewed healthcare resource utilization of all 267 eICE participants, including outpatient visits, antibiotics and hospitalizations. Prices were identified in the IBM/Watson MarketScanⓇ Commercial Claims and Encounters Databases and averaged over the 2014-2017 period. Using total healthcare utilization costs, we generated summary statistics by intervention and protocol arm (total cost, mean cost, standard deviation). We performed Welch Two Sample t-tests to determine if total costs and cost by type of utilization differed significantly between groups. Results Outpatient visit costs were significantly higher by 13% in the Early Intervention (EI) than in the usual care (UC) arm ($3,345 vs. $2,966). We found no significant differences in outpatient antibiotic, hospitalization, or total health care costs between the arms. Conclusions Within the context of the eICE trial, outpatient visits were significantly higher in those with experimental home spirometry care, but that did not translate into statistically significant differences of overall health care costs between the two arms.

Background. Cystic fibrosis (CF)-specialized nutrition care strives to meet normal infant growth, but the relationship of dietitian assessments to weight outcomes is unknown. We characterize nutrition management for inadequate weight gain and assess association of dietitian assessments and center-level weight-for-age Z-scores (WAZ). Methods. We used encounter data from 226 infants across 28 US CF Centers from the Baby Observational Nutritional study between January 2012 through December 2017. We identified dietitian assessments and consensus guideline-recommended responses to inadequate weight gain: calorie increases, pancreatic enzyme replacement therapy (PERT) increases, or shortened time to next visit. We compared center assessments by funnel plot and summarize median WAZ by center. Results. Of 2,527 visits, 808 (32%) visits had identified inadequate weight gain, distributed in 216 infants. Assessments occurred in 1953 visits (77%), but varied widely between centers (range 17% - 98%). For inadequate weight gain, most and least common responses were calorie increase (64%) and PERT increase (21%). Funnel plot analysis identified 4 high-performers for frequent dietitian assessments (range 92% - 98%) and 4 under-performers (range 17% - 56%). High-performers treated inadequate weight gain more often with adequate calories (24/30, 80% v. 12/23, 52%) and closer follow up (104/164, 63% v. 60/120, 49%) compared to under-performers. Three of 4 high-performing sites met center nutrition goals for positive median WAZ at 2 years old unlike 3 under-performers (WAZHigh 0.33 v. WAZLow -0.15), despite similar patient characteristics. Conclusion: We characterized multicenter variation in dietitian assessments, identifying opportunities to improve care delivery to target early nutrition outcomes.

Background Modifying physician behavior to more closely align with guideline-based care can be challenging. Few effective strategies resulting in appropriate spine-related health care have been reported. The Lumbar Imaging With Reporting of Epidemiology (LIRE) intervention did not result in reductions in spine care but did in opioid prescriptions written. Objectives To estimate organizational resource needs and costs associated with implementing a pragmatic, decision support-type intervention that inserted age- and modality-matched prevalence information for common lumbar spine imaging findings, using site-based resource use data from the LIRE trial. Research design Time and cost estimation associated with implementing the LIRE intervention in a health organization. Subjects Providers and patients assessed in the LIRE trial. Measures Expected personnel costs required to implement the LIRE intervention. Results Annual salaries were converted to daily average per person costs, ranging from $400 to $2,200 per day (base case) for personnel (range: $300-$2,600). Estimated total average cost for implementing LIRE was $5,009 (range: $2,651-$12,020), including conducting pilot testing with providers. Costs associated with a small amount of time for a radiologist (6-12 hours) and imaging-ordering providers (1-8 hours each) account for approximately 75% of the estimated total cost. Conclusions The process of implementing an intervention for lumbar spine imaging reports containing age- and modality-appropriate epidemiological benchmarks for common imaging findings required radiologists, imaging-ordering providers, information technology specialists, and limited testing and monitoring. The LIRE intervention seems to be a relatively low-cost, evidence-based, complementary tool that can be easily integrated into the reporting of spine imaging.

The objective of this study is to guide the designs of a portable dialysis device that allows patients with End-Stage Renal Disease (ESRD) greater mobility and flexibility to travel. We gathered patients’ and care partners’ motivations behind their travels along with the barriers they experience when planning an overnight trip. Using a quantitative analysis approach for the open-ended questions along with rank-order of response frequencies, our findings indicate that the majority of the motivations behind participants travel is to visit their family and friends but the participants find themselves either completely hindered or experience significant challenges when planning overnight trips where the designs of current dialysis devices and or the logistics of planning or scheduling treatments in an unfamiliar dialysis center outweigh the enjoyment of traveling. Our results give an estimate of parameters for the largest acceptable size and weight of a portable dialysis device that meets users’ needs. The results of this study help provide the designers of a portable dialysis device with better-targeted solutions to design a device that comfortably supports patients’ mobility and freedom of travel.

With increased attention to the financing and structure of healthcare, dramatic increases in the cost of diagnosing and treating cancer, and corresponding disparities in access, the study of healthcare economics and delivery has become increasingly important. The Healthcare Delivery Research Program (HDRP) in the Division of Cancer Control and Population Sciences at the National Cancer Institute (NCI) was formed in 2015 to provide a hub for cancer-related healthcare delivery and economics research. However, the roots of this program trace back much farther, at least to the formation of the NCI Division of Cancer Prevention and Control in 1983. The creation of a division focused on understanding and explaining trends in cancer morbidity and mortality was instrumental in setting the direction of cancer-related healthcare delivery and health economics research over the subsequent decades. In this commentary, we provide a brief history of health economics and healthcare delivery research at NCI, describing the organizational structure and highlighting key initiatives developed by the division, and also briefly discuss future directions. HDRP and its predecessors have supported the growth and evolution of these fields through the funding of grants and contracts; the development of data, tools, and other research resources; and thought leadership including stimulation of research on previously understudied topics. As the availability of new data, methods, and computing capacity to evaluate cancer-related healthcare delivery and economics expand, HDRP aims to continue to support this growth and evolution.

There is limited research on the long-term effectiveness of epidural steroid injections (ESI) in older adults despite the high prevalence of back and leg pain in this age group. We tested the hypotheses that older adults undergoing ESI, compared to patients not receiving ESI: (1) have worse pain, disability and quality of life ('outcomes') pre-ESI, (2) have improved outcomes after ESI and (3) have improved outcomes due to a specific ESI effect.We prospectively studied patients ≥65 years old presenting to primary care with new episodes of back pain in three US healthcare systems (BOLD registry). Outcomes were leg and back pain intensity, disability and quality of life, assessed at baseline and 3-, 6-, 12- and 24-month follow-ups. We categorized participants as: (1) ESI within 6 months from the index visit (n = 295); (2) no ESI within 6 months (n = 4809); (3) no ESI within 6 months, propensity-score matched to group 1 (n = 483). We analysed the data using linear regression and Generalized Estimating Equations.Pain intensity, disability and quality of life at baseline were significantly worse at baseline in ESI patients (group 1) than in group 2. The improvement from baseline to 24 months in all outcomes was statistically significant for group 1. However, no statistically significant differences were observed between outcome trajectories for the propensity-score matched groups 1 and 3.Older adults treated with ESI have long-term improvement. However, the improvement is unlikely the result of a specific ESI effect.In this large, two-year, prospective study in older adults with a new episode of low back pain, back pain, leg pain, disability and quality of life improved after epidural steroid injections; however, propensity-score matching revealed that the improvement was unlikely the result of a specific effect of the injections, indicating that epidural steroids are unlikely to provide long-term benefits in older adults with new episodes of back and leg pain.

The goal of this study is to identify ways to increase the usability of a mobile dialysis device through semi-structured interviews during the early stage of product development. We analyzed interview data using a mixed method of rank order and open-ended questions. The results from the open-ended questions showed that patients and care partners prefer the device being carried on patients’ backs, followed by the waist and the shoulder. We also identified 13 key categories of ideal features that the mobile dialysis device must hold. The results from the rank order question showed that the participants significantly preferred the Vest over the Backpack, Shoulder bag, and Distributed model. Accuracy of the device is more important compared to Safety, Ease of attachment, Comfort, Size, Operational simplicity, and Invisibility. The prioritized needs from patients and care partners provide designers and clinicians with better target solutions for designing a mobile dialysis device.

BACKGROUND: The purpose of these analyses was to determine whether overall costs were reduced in cystic fibrosis (CF) patients experiencing pulmonary exacerbation (PEx) who received shorter versus longer durations of treatment. METHODS: Among people with CF experiencing PEx, we calculated 30-day inpatient, outpatient, emergency room, and medication costs and summed these to derive total costs in 2020 USD. Using the Kaplan-Meier sample average (KMSA) method, we calculated adjusted costs and differences in costs within two pairs of randomized groups: early robust responders (ERR) randomized to receive treatment for 10 days (ERR-10 days) or 14 days (ERR-14 days), and non-early robust responders (NERR) randomized to receive treatment for 14 days (NERR-14 days) or 21 days (NERR-21 days). RESULTS: Patients in the shorter treatment duration groups had shorter lengths of stay per hospitalization (mean ± standard deviation (SD) for ERR-10 days: 7.9 ± 3.0 days per hospitalization compared to 10.1 ± 4.2 days in ERR-14 days; for NERR-14 days: 8.7 ± 4.9 days per hospitalization compared to 9.6 ± 6.5 days in NERR-21 days). We found statistically significantly lower adjusted mean costs (95% confidence interval) among those who were randomized to receive shorter treatment durations (ERR-10 days: $60,800 ($59,150 – $62,430) vs $74,420 ($72,610 – $76,450) in ERR-14 days; NERR-14 days: $66,690 ($65,960–$67,400) versus $74,830 ($73,980–$75,650) in NERR-21 days). CONCLUSIONS: Tied with earlier evidence that shorter treatment duration was not associated with worse clinical outcomes, our analyses indicate that treating with shorter antimicrobial durations can reduce costs without diminishing clinical outcomes.

ImportanceEarly pregnancy loss (EPL), or miscarriage, is the most common complication of early pregnancy, and many patients experiencing EPL present to the emergency department (ED). Little is known about how patients who present to the ED with EPL differ from those who present to outpatient clinics and how their management and outcomes differ.ObjectiveTo compare the management and outcomes of patients with EPL who present to the ED vs outpatient clinics.Design, Setting, and ParticipantsThis retrospective cohort study used the IBM MarketScan Research Database, a national insurance claims database. Participants were pregnant people aged 15 to 49 years in the US who presented to either an ED or outpatient clinic for initial diagnosis of EPL from October 2015 through December 2019. Data analysis was performed from May 2021 to March 2022.ExposuresThe primary exposure was location of service (ED vs outpatient clinic). Other exposures of interest included demographic characteristics, current pregnancy history, and comorbidities.Main Outcomes and MeasuresThe primary outcome was EPL management type (surgical, medication, or expectant management). Complications, including blood transfusion and hospitalization, and characteristics associated with location of service were also evaluated. Bivariable analyses and multivariable logistic regression were used for data analysis.ResultsA total of 117 749 patients with EPL diagnoses were identified, with a mean (SD) age of 31.8 (6.1) years. Of these patients, 20 826 (17.7%) initially presented to the ED, and 96 923 (82.3%) presented to outpatient clinics. Compared with the outpatient setting, patients in the ED were less likely to receive surgical (2925 patients [14.0%] vs 23 588 patients [24.3%]) or medication (1116 patients [5.4%] vs 10 878 patients [11.2%]) management. In the adjusted analysis, characteristics associated with decreased odds of active (surgical or medication) vs expectant management included ED (vs outpatient) presentation (adjusted odds ratio [aOR], 0.46; 95% CI, 0.44-0.47), urban location (aOR, 0.87; 95% CI, 0.82-0.91), and being a dependent on an insurance policy (vs primary policy holder) (aOR, 0.71; 95% CI, 0.67-0.74); whereas older age (aOR per 1-year increase 1.01; 95% CI, 1.01-1.01), established prenatal care (aOR, 2.35; 95% CI, 2.29-2.42), and medical comorbidities (aOR, 1.05; 95% CI, 1.02-1.09) were associated with increased odds of receiving active management. Patients in the ED were more likely than those in outpatient clinics to need a blood transfusion (287 patients [1.4%] vs 202 patients [0.2%]) or hospitalization (463 patients [2.2%] vs 472 patients [0.5%]), but complications were low regardless of location of service.Conclusions and RelevanceIn this cohort study of privately insured patients with EPL, differences in management between the ED vs outpatient setting may reflect barriers to accessing comprehensive EPL management options. More research is needed to understand these significant differences in management approaches by practice setting, and to what extent EPL management reflects patient preferences in both outpatient and ED settings.

Objectives Women experiencing early pregnancy loss (EPL) frequently present to the emergency department (ED), but little is known about who receives EPL care in these settings. We aimed to estimate the proportion of ED visits for EPL‐related care and determine characteristics associated with seeking care for EPL in the ED in a national sample. Methods We conducted a secondary analysis of the 2006–2016 National Hospital Ambulatory Medical Care Survey (NHAMCS), a nationally representative survey of US ED visits. We identified women ages 15–44 years who presented to the ED for threatened or confirmed EPL based on diagnosis code or chief complaint. We estimated the proportion of ED visits attributable to EPL‐related care among all ED visits and among women 15–44 years old. Using multivariable logistic regression, we evaluated patient and visit characteristics associated with receiving EPL‐related care versus all other care. Results The 2006–2016 NHAMCS dataset included 325,037 visits (weighted n = 1,447,144,423), including 82,871 visits among women ages 15–44 years (weighted n = 371,016,125). Of all ED visits for women ages 15–44 years, 2.7% (95% confidence interval, 2.5–2.9) were for EPL‐related care. This equates to ≈900,000 visits annually. Compared with women ages 15–44 years presenting to the ED for other reasons, those presenting for EPL‐related care were younger and more likely to be Black or Hispanic. Conclusions EPL‐related care accounts for over 900,000 ED visits in the United States each year. These findings highlight the current burden of EPL visits upon EDs nationally.

Dialysis is performed mostly in-center for patients with End Stage Renal Disease (ESRD) who lose normal functionality of their kidneys. The Center for Dialysis Innovation (CDI) at the University of Washington is developing a mobile dialysis device called the Ambulatory Kidney to Improve Vitality (AKTIV). Existing mobile dialysis devices focus on functionality, paying limited attention to human factors. The goal of the current study is to identify human factors-related recommendations for the wearable, constantly dialyzing device currently being developed. To reach this goal, we interviewed both patients and caregivers to understand their needs and preferred attributes for such a device while performing daily activities. We found that travel, recreation, and physical exercise were key task types for a wearable dialysis device to accommodate. In addition, safety and accuracy were found to be the attributes most important to participants Incorporating human factors considerations into the design of the mobile dialysis device has the potential to improve the quality of life for patients and caregivers.

BACKGROUND: Pulmonary exacerbations (PEx) in cystic fibrosis (CF) patients reduce quality of life. Lung function, measured by the percent predicted forced expiratory volume in one second (ppFEV1), is widely used to evaluate PEx treatments. We analyzed the correspondence of ppFEV1 with 8 patient-reported symptom-based questions from the Cystic Fibrosis Respiratory Symptom Diary–Chronic Respiratory Infection Symptom Score (CFRSD-CRISS). METHODS: Data were derived from the observational Standardized Treatment of Pulmonary Exacerbations (STOP) study. CF patients who had CFRSD-CRISS and ppFEV1 measurements on ≥2 timepoints were included: 1) day of initial PEx, 2) 7 days later, and/or 3) end of PEx. We calculated age-stratified Spearman correlation coefficients and 95% confidence intervals (95% CIs) between the change in ppFEV1 and change in CFRSD-CRISS items from index to day 7 and from index to the end of PEx treatment. RESULTS: Lung function and symptom scores improved by the end of treatment; however, correlations between ppFEV1 and the specific CFRSD-CRISS measures were mostly weak to moderate. An exception was that among patients

This analysis of death certificate data in Washington State revealed that age-standardized abdominal aortic aneurysm (AAA) related mortality has declined from 1996 to 2016 with a notable significant drop in ruptured AAA-related mortality. The death rate trends vary by sex, race, and county. OBJECTIVE: Management of abdominal aortic aneurysms (AAA) has undergone considerable advances over the last two decades. Our aim was to evaluate AAA-related mortality trends in Washington State (WA) over a 21 year period and to assess variation in AAA-related mortality by sex, race, and county over the same time period. We hypothesized that a significant decline in AAA-related mortality in WA would be noted. METHODS: Death certificate records were obtained from the WA Department of Health for the period of 1996 to 2016. Records in which AAA was listed as an underlying or an associated cause of death were selected for analysis. Age-standardized mortality rates for each year were calculated using the 2016 WA population as the standard. Mortality trends were compared by sex and race using linear regression. County-specific age-standardized ruptured AAA (rAAA) mortality rates were compared using a Kruskal-Wallis test. RESULTS: Of the 1,014,039 deaths occurring in WA during the study period, 4,438 (0.4%) had AAA listed as an underlying or associated cause of death (66.1% Male, 94.8% White, mean age of death 79.4 ± 9.3 years). In 64.1% of the cases, AAA was listed as the underlying cause of death. AAA-related mortality rates declined by 62.1% over the 21 years from 5.8 2.2 deaths per 100,000. Notably, there was a statistically significant drop in ruptured AAA (rAAA) related mortality rates (3.2 to 0.95 per 100,000, decline of 0.12 death/100,000/year, 95% CI: 0.11–0.14, r(2) = 0.95). Men had a significantly steeper decline in age standardized AAA-related mortality rates with 55% decline (6.5 to 3.0 per 100,000) vs. a 41% decline (2.4 to 1.4 per 100,000) among women. , and were younger at the time of death compared to women (78.1 ± 9.4 vs. 81.9 ± 8.6 years respectively, P

BACKGROUND: Pulmonary exacerbations (PEx) in cystic fibrosis (CF) patients decrease lung function, increase symptoms and reduce health-related quality of life (HRQoL). We evaluated associations between 8 symptom-based questions from the Cystic Fibrosis Respiratory Symptom Diary - Chronic Respiratory Infection Symptom Score (CFRSD-CRISS) and the 5-level EuroQOL-5 Dimensions (EQ-5D-5L) summary score and hypothesized the CFRSD-CRISS would be a meaningful way to asses quality-of-life in future cost effectiveness studies among CF patients with PEx. METHODS: CF patients who had CFRSD-CRISS and EQ-5D-5L measurements on the day of the initial PEx, 7 days later, and at the end of intravenous antibiotic treatment were included. We examined age-stratified (

Background Patient-centered approaches to research design are particularly important for diseases with complex treatment decision-making, such as recurrent, high-grade non-muscle-invasive bladder cancer (NMIBC). The objective of this article is to describe patient and public involvement (PPI) in designing a large, pragmatic observational trial and to articulate barriers, challenges, and lessons learned for future design. Methods Through multistakeholder involvement, a large, pragmatic observational trial was designed to investigate the outcomes of high-risk, recurrent NMIBC, and it was titled Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer (CISTO). CISTO's design used the Guidance for Reporting Involvement of Patients and the Public 2 reporting checklist for PPI and built on prior engagement infrastructure in partnership with the Bladder Cancer Advocacy Network. Results CISTO's PPI began with research prioritization to identify the highest priority questions facing patients with NMIBC. A pragmatic observational study design was selected and refined through stakeholder input. PPI included patients and caregivers organized into an advocate advisory board and clinicians, researchers, payers, and industry representatives organized into an external advisory board. An engagement plan was created to define the stages of PPI and the level and nature of the involvement of each group. PPI was measured quantitatively and qualitatively through evaluation surveys and iterative feedback from board members, with changes made for continuous improvement. Conclusions Through intentional PPI, CISTO aims to produce pragmatic and generalizable results that will allow patients to make informed decisions for recurrent, high-risk NMIBC based on their personal experiences. Lay summary Involving patients and other stakeholders in research ensures that it reflects the outcomes that matter most to them. This is especially important when research focuses on conditions in which patients face difficult decisions about treatment options. This article describes the key role that stakeholders played in shaping the Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer (CISTO) study. It compares treatments for recurrent noninvasive bladder cancer and describes how stakeholders were engaged to design and develop the study and the practices that supported their involvement.

Increasing regionalization of pediatric care has led to interfacility transfer of children with general pediatric conditions at rates similar to those of high-risk adults, which may delay appropriate treatment. We sought to identify common medical diagnoses that did not require significant advanced intervention and that had high rates of discharge within 1 day of interfacility transfer. Using the Pediatric Health Information System (PHIS) database, we identified all transfers into PHIS-participating children’s hospitals in 2019. We excluded encounters for mental health, labor/maternity, primary newborn diagnoses, and direct admissions to an intensive care unit. Eligible encounters were categorized by duration of hospitalization and basic vs advanced intervention after transfer. Of 286,905 transfers, 197,386 (68.6%) met inclusion criteria. Cough, febrile seizures, croup, and allergic reactions required advanced interventions

Background Antibiotic therapy has been proposed as an alternative to surgery for the treatment of appendicitis. Methods We conducted a pragmatic, nonblinded, noninferiority, randomized trial comparing antibiotic therapy (10-day course) with appendectomy in patients with appendicitis at 25 U.S. centers. The primary outcome was 30-day health status, as assessed with the European Quality of Life-5 Dimensions (EQ-5D) questionnaire (scores range from 0 to 1, with higher scores indicating better health status; noninferiority margin, 0.05 points). Secondary outcomes included appendectomy in the antibiotics group and complications through 90 days; analyses were prespecified in subgroups defined according to the presence or absence of an appendicolith. Results In total, 1552 adults (414 with an appendicolith) underwent randomization; 776 were assigned to receive antibiotics (47% of whom were not hospitalized for the index treatment) and 776 to undergo appendectomy (96% of whom underwent a laparoscopic procedure). Antibiotics were noninferior to appendectomy on the basis of 30-day EQ-5D scores (mean difference, 0.01 points; 95% confidence interval [CI], -0.001 to 0.03). In the antibiotics group, 29% had undergone appendectomy by 90 days, including 41% of those with an appendicolith and 25% of those without an appendicolith. Complications were more common in the antibiotics group than in the appendectomy group (8.1 vs. 3.5 per 100 participants; rate ratio, 2.28; 95% CI, 1.30 to 3.98); the higher rate in the antibiotics group could be attributed to those with an appendicolith (20.2 vs. 3.6 per 100 participants; rate ratio, 5.69; 95% CI, 2.11 to 15.38) and not to those without an appendicolith (3.7 vs. 3.5 per 100 participants; rate ratio, 1.05; 95% CI, 0.45 to 2.43). The rate of serious adverse events was 4.0 per 100 participants in the antibiotics group and 3.0 per 100 participants in the appendectomy group (rate ratio, 1.29; 95% CI, 0.67 to 2.50). Conclusions For the treatment of appendicitis, antibiotics were noninferior to appendectomy on the basis of results of a standard health-status measure. In the antibiotics group, nearly 3 in 10 participants had undergone appendectomy by 90 days. Participants with an appendicolith were at a higher risk for appendectomy and for complications than those without an appendicolith. (Funded by the Patient-Centered Outcomes Research Institute; CODA ClinicalTrials.gov number, NCT02800785.).

Rapid development and deployment of diagnostic testing for COVID-19 have been a key component of the public health response to the pandemic. Out of necessity, academic and other clinical laboratories developed laboratory testing innovations for COVID-19 to meet clinical testing demands. In addition to constraints on local testing supplies and equipment, a rapidly changing regulatory framework created challenges for translational scientists. Illustrative examples of approaches used to develop laboratory tests during the early stages of the COVID-19 pandemic demonstrate effective team science approaches to this challenging clinical care and public health emergency. These experiences and the associated lessons learned are relevant to the development of public health response plans for future pandemics.

Background: Understanding the impact of precision medicine on medical practice, patient care, and clinical outcomes is a priority for advancing cancer care. With the recent dramatic increase in the use of tumor genomic testing (TGT), records within EHRs are a rich data source for evaluating the impact of TGT results in real-world clinical practice of care and on patient outcomes. However, extracting TGT results from electronic health records (EHR) is challenging due to a lack of standards to communicate genomic information and an inability to store such information in commonly available EHR systems. Moreover, TGT results are delivered to clinicians in unstructured formats and image-based files (PDFs). We initiated a pilot study to assess the ability of natural language processing (NLP) algorithms to convert EHR unstructured clinical text and PDF-formatted TGT results into research-quality data. Methods: One author (RY) drew a sample of approximately 800 clinical text records from 21 breast cancer patients treated at University of Washington. Sources used for data extraction included medical record notes and PDF reports for two breast cancer gene expression tests: 21-gene Recurrence Score (RS, OncotypeDx) and/or the 70-gene signature (MMP, Mammaprint). A team redacted all PHI and provided records to a commercial collaborator (Pangaeadata.AI, UK), along with definitions of variables to be extracted, but without annotated target answers. Existing NLP algorithms that leverage pre-training, fine-tuning and rules were adapted to extract 26 variables specified by the research team (e.g., age at diagnosis, histology, and RS or MMP dates and scores). The output placed variables into relevant, standardized formats and produced a research quality data set. The extraction strategy depended on the feature and variable characteristics. For example, cancer stage, an ordinal numerical variable, was determined with a rule-based extraction method from outpatient clinic notes and pathology reports, whereas the RS score, a continuous variable, came from OncotypeDx PDF and OCR semi-structured retrieval produced the output. Results/Conclusions: The Pangaea tool obtained an average accuracy of 97.3% with a standard deviation of 3.5% across all 26 variables. The approach is developed based on rules designed and validated by clinical experts, using a model that does not require training, making overfitting likely minimal. Qualitative analysis showed that: 1] algorithms used to electronically extract TGT results provided the same data as manual abstraction by physicians, and 2] context matters, namely, the capability of preliminary semantic understanding in the Pangaea model using contextual words and phrases contributed to high accuracy and can be generalized further with larger datasets. Expansion to other health care data systems is needed to assess scalability of these technologies to create research-quality data fit for use. Citation Format: Rachel Yung, Kari A. Stephens, Meliha Yetisgen, Andrea Burnett-Hartman, Ashwani Tanwar, Guilherme Freire, Atri Sharma, Jingqing Zhang, Vibhor Gupta, Yike Guo, VK Gadi, Larry Kessler. Creating research quality cancer genomic data from electronic health records [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 4090.

Key Points Question What is the impact of including benchmark prevalence data of common findings in reports of spinal imaging ordered by primary care clinicians? Findings In this randomized clinical trial that included 250 401 adults, no overall decrease in subsequent spine-related health care utilization after the intervention was observed. However, there was a significant decrease in opioid prescriptions at 1 year in the intervention group compared with the control group. Meaning The findings of this study suggest that including epidemiological benchmarks on spinal imaging reports has little impact on subsequent spine-related utilization overall but may reduce subsequent opioid prescriptions., This randomized clinical trial evaluates the impact of including benchmark prevalence data in routine spinal imaging reports on subsequent spine-related health care utilization and opioid prescriptions., Importance Lumbar spine imaging frequently reveals findings that may seem alarming but are likely unrelated to pain. Prior work has suggested that inserting data on the prevalence of imaging findings among asymptomatic individuals into spine imaging reports may reduce unnecessary subsequent interventions. Objective To evaluate the impact of including benchmark prevalence data in routine spinal imaging reports on subsequent spine-related health care utilization and opioid prescriptions. Design, Setting, and Participants This stepped-wedge, pragmatic randomized clinical trial included 250 401 adult participants receiving care from 98 primary care clinics at 4 large health systems in the United States. Participants had imaging of their backs between October 2013 and September 2016 without having had spine imaging in the prior year. Data analysis was conducted from November 2018 to October 2019. Interventions Either standard lumbar spine imaging reports (control group) or reports containing age-appropriate prevalence data for common imaging findings in individuals without back pain (intervention group). Main Outcomes and Measures Health care utilization was measured in spine-related relative value units (RVUs) within 365 days of index imaging. The number of subsequent opioid prescriptions written by a primary care clinician was a secondary outcome, and prespecified subgroup analyses examined results by imaging modality. Results We enrolled 250 401 participants (of whom 238 886 [95.4%] met eligibility for this analysis, with 137 373 [57.5%] women and 105 497 [44.2%] aged >60 years) from 3278 primary care clinicians. A total of 117 455 patients (49.2%) were randomized to the control group, and 121 431 patients (50.8%) were randomized to the intervention group. There was no significant difference in cumulative spine-related RVUs comparing intervention and control conditions through 365 days. The adjusted median (interquartile range) RVU for the control group was 3.56 (2.71-5.12) compared with 3.53 (2.68-5.08) for the intervention group (difference, −0.7%; 95% CI, −2.9% to 1.5%; P = .54). Rates of subsequent RVUs did not differ between groups by specific clinical findings in the report but did differ by type of index imaging (eg, computed tomography: difference, −29.3%; 95% CI, −42.1% to −13.5%; magnetic resonance imaging: difference, −3.4%; 95% CI, −8.3% to 1.8%). We observed a small but significant decrease in the likelihood of opioid prescribing from a study clinician within 1 year of the intervention (odds ratio, 0.95; 95% CI, 0.91 to 1.00; P = .04). Conclusions and Relevance In this study, inserting benchmark prevalence information in lumbar spine imaging reports did not decrease subsequent spine-related RVUs but did reduce subsequent opioid prescriptions. The intervention text is simple, inexpensive, and easily implemented. Trial Registration ClinicalTrials.gov Identifier: NCT02015455

Background Context Although back pain is common among older adults, there is relatively little research on the course of back pain in this age group. Purpose Our primary goals were to report 2-year outcomes of older adults initiating primary care for back pain and to examine the relative importance of patient factors versus medical interventions in predicting 2-year disability and pain. Study Design/Setting This study used a predictive model using data from a prospective, observational cohort from a primary care setting. Patient Sample The study included patients aged ≥65 years at the time of new primary care visits for back pain. Outcome Measures Self-reported 2-year disability (Roland-Morris Disability Questionnaire [RDQ]) and back pain (0–10 numerical rating scale [NRS]). Methods We developed our models using a machine learning least absolute shrinkage and selection operator approach. We evaluated the predictive value of baseline characteristics and the incremental value of interventions that occurred between 0 and 90 days, and the change in patient disability and pain from 0 to 90 days. Limitations included confounding by indication and unmeasured confounding. Results Of 4,665 patients (89%) with follow-up, both RDQ (from mean 9.6 [95% confidence interval {CI} 9.4–9.7] to mean 8.3 [95% CI 8.0–8.5]) and back pain NRS (from mean 5.0 [95% CI 4.9–5.1] to mean 3.5 [95% CI 3.4–3.6]) scores improved slightly. Only 16% (15%-18%) reported no back pain-related disability or back pain at 2 years after initial visits. Regression model parameters explained 40% of the variation (R2) in 2-year RDQ scores, and the addition of 0- to 3-month change in RDQ score and pain improved prediction (R2=51%). The most consistent predictors of 2-year RDQ scores and back pain NRS scores were 0- to 90-day change in each respective outcome and patient confidence in improvement. Patients experienced 50% and 43% improvement in back pain and disability, respectively, 2 years after their initial visit. However, fewer than 20% of patients had complete resolution of their back pain and disability at that time. Conclusions Baseline patient factors were more important than early interventions in explaining disability and pain after 2 years.

Rationale and Objectives Diagnostic imaging has many effects and there is no common definition of value in diagnostic radiology. As benefit-risk trade-offs are rarely made explicit, it is not clear which framework is used in clinical guideline development. We describe initial steps toward the creation of a benefit-risk framework for diagnostic radiology. Materials and Methods We performed a literature search and an online survey of physicians to identify and collect benefit-risk criteria (BRC) relevant to diagnostic imaging tests. We operationalized a process for selection of BRC with the use of four clinical use case scenarios that vary by diagnostic alternatives and clinical indication. Respondent BRC selections were compared across clinical scenarios and between radiologists and nonradiologists. Results Thirty-six BRC were identified and organized into three domains: (1) those that account for differences attributable only to the test or device ( n = 17); (2) those that account for clinical management and provider experiences ( n = 12); and (3) those that capture patient experience ( n = 7). Forty-eight survey participants selected 22 criteria from the initial list in the survey (9–11 per case). Engaging ordering physicians increased the number of criteria selected in each of the four clinical scenarios presented. We developed a process for standardizing selection of BRC in guideline development. Conclusion These results suggest that a process relying on elements of comparative effectiveness and the use of standardized BRC may ensure consistent examination of differences among alternatives by way of making explicit implicit trade-offs that otherwise enter the decision-making space and detract from consistency and transparency. These findings also highlight the need for multidisciplinary teams that include input from ordering physicians.

The American College of Radiology develops evidence-based practice guidelines to aid appropriate utilization of radiological procedures. Panel members use expert opinion to weight trade-offs and consensus methods to rate appropriateness of imaging tests. These ratings include an equivocal range, assigned when there is disagreement about a technology's appropriateness and the evidence base is weak or for special circumstances. It is not clear how expert consensus merges with the evidence base to arrive at an equivocal rating. Quantitative benefit-risk assessment (QBRA) methods may assist decision makers in this capacity. However, many methods exist and it is not clear which methods are best suited for this application. We perform a critical appraisal of QBRA methods and propose several steps that may aid in making transparent areas of weak evidence and barriers to consensus in guideline development. We identify QBRA methods with potential to facilitate decision making in guideline development and build a decision aid for selecting among these methods. This study identified 2 families of QBRA methods suited to guideline development when expert opinion is expected to contribute substantially to decision making. Key steps to deciding among QBRA methods involve identifying specific benefit-risk criteria and developing a state-of-evidence matrix. For equivocal ratings assigned for reasons other than disagreement or weak evidence base, QBRA may not be needed. In the presence of disagreement but the absence of a weak evidence base, multicriteria decision analysis approaches are recommended; and in the presence of weak evidence base and the absence of disagreement, incremental net health benefit alone or combined with multicriteria decision analysis is recommended. Our critical appraisal further extends investigation of the strengths and limitations of select QBRA methods in facilitating diagnostic radiology clinical guideline development. The process of using the decision aid exposes and makes transparent areas of weak evidence and barriers to consensus.

Recent technical advances have enabled the creation of mobile dialysis device prototypes. These prototypes have been tested for their ability to allow an individual to be dialyzed continuously rather than sporadically. The most recent prototype of a mobile dialysis device aims at increased functionality, which suggests that human factors issues (e.g., efficiency, bulkiness, and weight) are now considered carefully. This study describes advances in the design of an Ambulatory Kidney to Improve Vitality (AKTIV), using an interview protocol during the early stages of product development to capture patients' and caregivers' reactions. The AKTIV has the potential to improve patients' quality of life and decrease mortality rates. The goal of our study is to examine patients' and caregivers’ design preferences and feature considerations for an AKTIV. We interviewed 22 participants (age M = 57.50, SD = 13.30), of whom 12 were female and 16 were patients. A pre-interview survey was distributed to the participants, and semi-structured interviews were subsequently held. The pre-interview results show that the belt and backpack designs were preferred over the shoulder bag and distributed designs. The participants also indicated on their pre-interview forms that safety and accuracy were more important to them than attachment ease, comfort, compactness, or operational simplicity. Invisibility and mobility were frequently mentioned when determining the strengths of each of the five design types during the interviews. Finally, individual differences in preferences for the various design types and attributes were identified. The results from our study have important implications for improving efficiency, effectiveness, and user satisfaction in relation to AKTIV prototypes and products. The findings from this interview study will help to ensure engineers and clinicians have target parameters for redesigning the AKTIV.

To evaluate whether an association exists between the intensity of surveillance following surgical resection for non-small cell lung cancer (NSCLC) and survival.Surveillance guidelines following surgical resection of NSCLC vary widely and are based on expert opinion and limited evidence.A Special Study of the National Cancer Database randomly selected stage I to III NSCLC patients for data reabstraction. For patients diagnosed between 2006 and 2007 and followed for 5 years through 2012, registrars documented all postsurgical imaging with indication (routine surveillance, new symptoms), recurrence, new primary cancers, and survival, with 5-year follow-up. Patients were placed into surveillance groups according to existing guidelines (3-month, 6-month, annual). Overall survival and survival after recurrence were analyzed using Cox Proportional Hazards Models.A total of 4463 patients were surveilled with computed tomography scans; these patients were grouped based on time from surgery to first surveillance. Groups were similar with respect to age, sex, comorbidities, surgical procedure, and histology. Higher-stage patients received more surveillance. More frequent surveillance was not associated with longer risk-adjusted overall survival [hazard ratio for 6-month: 1.16 (0.99, 1.36) and annual: 1.06 (0.86-1.31) vs 3-month; P value 0.14]. More frequent imaging was also not associated with postrecurrence survival [hazard ratio: 1.02/month since imaging (0.99-1.04); P value 0.43].These nationally representative data provide evidence that more frequent postsurgical surveillance is not associated with improved survival. As the number of lung cancer survivors increases over the next decade, surveillance is an increasingly important major health care concern and expenditure.

A number of publications have discussed approaches to training the scientific workforce in comparative effectiveness research (CER) and patient-centered outcomes research (PCOR). To meet this need, funders have offered resources for developing educational materials and establishing training programs. To extend these efforts into specific researcher communities, the Agency for Healthcare Research and Quality developed an R25 Funding Opportunity Announcement that called for basic, advanced, and experiential training for a specific researcher community in collaboration with associated program partners. This paper describes the strategies developed by the 5 subsequently funded programs, their specific researcher communities and program partners, and the challenges associated with developing in-person and online programs. We focus on lessons learned that can be translated into developing training programs nationwide and on training for the special populations of interest. We also discuss the creation of a sustainable network for training and the conduct of comparative effectiveness research/patient-centered outcomes research in targeted communities.

Background One in 5 patients with completely resected early-stage non-small cell lung cancer will recur within 2 years. Risk stratification may facilitate a personalized approach to the use of adjuvant therapy and surveillance imaging. We developed a prediction model for recurrence based on five clinical variables (tumor size and grade, visceral pleural and lymphovascular invasion, and sublobar resection), and tested the hypothesis that the addition of several new molecular markers of poor long-term outcome (vascular endothelial growth factor C; microRNA precursors 486 and 30d) would enhance prediction. Methods We performed a retrospective cohort study of patients with completely resected, node-negative non-small cell lung cancer from 2011 to 2014 (follow-up through 2016) using the Lung Cancer Biospecimen Resource Network. Cox regression was used to estimate the 2-year risk of recurrence. Our primary measure of model performance was the optimism-corrected C statistic. Results Among 173 patients (mean tumor size, 3.6 cm; 12% sublobar resection, 32% poorly differentiated, 16% lymphovascular invasion, 26% visceral pleural invasion), the 2-year recurrence rate was 23% (95% confidence interval, 17% to 31%). A prediction model using five known risk factors for recurrence performed only slightly better than chance in predicting recurrence (optimism-corrected C statistic, 0.54; 95% confidence interval, 0.51 to 0.68). The addition of biomarkers did not improve the model's ability to predict recurrence (corrected C statistic, 0.55; 95% confidence interval, 0.52 to 0.71). Conclusions We were unable to predict lung cancer recurrence using a risk-prediction model based on five well-known clinical risk factors and several biomarkers. Further research should consider novel predictors of recurrence to stratify patients with completely resected early-stage non-small cell lung cancer according to their risk of recurrence.

Although investigators in the imaging community have been active in developing and evaluating quantitative imaging biomarkers (QIBs), the development and implementation of QIBs have been hampered by the inconsistent or incorrect use of terminology or methods for technical performance and statistical concepts. Technical performance is an assessment of how a test performs in reference objects or subjects under controlled conditions. In this article, some of the relevant statistical concepts are reviewed, methods that can be used for evaluating and comparing QIBs are described, and some of the technical performance issues related to imaging biomarkers are discussed. More consistent and correct use of terminology and study design principles will improve clinical research, advance regulatory science, and foster better care for patients who undergo imaging studies.

Diagnostic imaging is often the first step in evaluating patients with back pain and likely functions as a "gateway" to a subsequent cascade of interventions. However, lumbar spine imaging frequently reveals incidental findings among normal, pain-free individuals suggesting that treatment of these "abnormalities" may not be warranted. Our prior work suggested that inserting the prevalence of imaging findings in patients without back pain into spine imaging reports may reduce subsequent interventions. We are now conducting a pragmatic cluster randomized clinical trial to test the hypothesis that inserting this prevalence data into lumbar spine imaging reports for studies ordered by primary care providers will reduce subsequent spine-related interventions.We are using a stepped wedge design that sequentially randomizes 100 primary care clinics at four health systems to receive either standard lumbar spine imaging reports, or reports containing prevalence data for common imaging findings in patients without back pain. We capture all outcomes passively through the electronic medical record. Our primary outcome is spine-related intervention intensity based on Relative Value Units (RVUs) during the following year. Secondary outcomes include subsequent prescriptions for opioid analgesics and cross-sectional lumbar spine re-imaging.If our study shows that adding prevalence data to spine imaging reports decreases subsequent back-related RVUs, this intervention could be easily generalized and applied to other kinds of testing, as well as other conditions where incidental findings may be common. Our study also serves as a model for cluster randomized trials that are minimal risk and highly pragmatic.

BACKGROUND A number of practice guidelines incorporate the use of gene expression profiling (GEP) tests for early-stage, hormone receptor-positive, HER2-negative breast tumors. Few studies describe factors associated with GEP testing in US oncology practice. We assessed the relationship between clinical, demographic, and group-level socioeconomic variables and test use in women younger than 65 years. PATIENTS AND METHODS Data from 5 state cancer registries were linked with insurance claims data and GEP test results. We assessed rates of testing and variables associated with test use in an incident cohort of 9,444 commercially insured women younger than 65 years, newly diagnosed with stage I or II hormone receptor-positive breast cancer from 2006 through 2012. RESULTS Rates of testing for women with N0 disease increased from 20.4% in 2006 to 35.2% in 2011. Variables associated with higher rates of testing, beyond clinical factors such as nodal status (P

BACKGROUND Gene expression profiling (GEP) testing can help to predict the risk of cancer recurrence and guide decisions about adjuvant chemotherapy for breast cancer (BC). However, no prior US studies have evaluated the relation between GEP testing and the use of adjuvant chemotherapy by women treated in a general oncology practice. METHODS Eligible patients were women under the age 65 of years who were newly diagnosed with their first stage I or II, hormone receptor–positive BC between 2006 and 2011 (n = 9405). This retrospective study was conducted with a data set consisting of registry data, health claims data, and GEP testing results. The distribution of GEP test results was reported in terms of the risk of recurrence predicted, and logistic regression was used to assess the association of test results with chemotherapy use, with adjustments made for multiple patient characteristics. RESULTS The proportions of tested women with low, intermediate, and high recurrence score results were 51%, 39%, and 10%, respectively. Among these women, 11%, 47%, and 88%, respectively, received adjuvant chemotherapy. There was a significant, positive linear relation of assay scores with chemotherapy use within the low and intermediate subgroups after adjustments for all other factors (adjusted odds ratios, 1.17 and 1.20, respectively). CONCLUSIONS Adjuvant chemotherapy use after GEP testing is generally consistent with the recommended test interpretation for women with a high or low predicted risk of recurrence. Chemotherapy use in the intermediate-risk group increased with Recurrence Score values, and evidence from ongoing randomized trials may help to clarify whether this finding reflects optimal interpretation of GEP test results. These results demonstrate the principle that genomic testing, on the basis of research establishing its utility, can be applied appropriately in general practice in accordance with guideline recommendations. Cancer 2015;121:4062–4070. © 2015 American Cancer Society.

Aim: Investigate how the results of predictive models of preoperative MRI for breast cancer change based on available data. Materials & methods: A total of 1919 insured women aged ≥18 with stage 0–III breast cancer diagnosed 2002–2009. Four models were compared using nested multivariable logistic, backwards stepwise regression; model fit was assessed via area under the curve (AUC), R 2 . Results: MRI recipients (n = 245) were more recently diagnosed, younger, less comorbid, with higher stage disease. Significant variables included: Model 1/Claims (AUC = 0.76, R 2 = 0.10): year, age, location, income; Model 2/Cancer Registry (AUC = 0.78, R 2 = 0.12): stage, breast density, imaging indication; Model 3/Medical Record (AUC = 0.80, R 2 = 0.13): radiologic recommendations; Model 4/Risk Factor Survey (AUC = 0.81, R 2 = 0.14): procedure count. Conclusion: Clinical variables accounted for little of the observed variability compared with claims data.

Current guidelines recommend routine imaging surveillance for patients with non-small cell lung cancer (NSCLC) after treatment. Little is known about surveillance patterns for patients with surgically resected early-stage lung cancer in the community at large. We sought to characterize surveillance patterns in a national cohort.We conducted a retrospective study using the Surveillance, Epidemiology, and End-Results (SEER)-Medicare database (1995-2010). Patients with stage I/II NSCLC treated with surgical resection were included. Our primary outcome was receipt of imaging between 4 and 8 months after the surgical procedure. Covariates included demographics and comorbidities.Chest radiography (CXR) was the most frequent initial modality (60%), followed by chest computed tomography (CT) (25%). Positron emission tomography (PET) was least frequent as an initial imaging modality (3%). A total of 13% of patients received no imaging within the initial surveillance period. Adherence to National Comprehensive Cancer Network (NCCN) guidelines for imaging by overall prevalence was 47% for receipt of CT; however, rates of CT increased over time from 28% to 61% (p0.01). Reduced rates of CT were associated with stage I disease and surgical resection as the sole treatment modality.Imaging after definitive surgical treatment for NSCLC predominantly used CXR rather than CT. Most of this imaging is likely for surveillance, and in that context CXR has inferior detection rates for recurrence and new cancers. Adherence to guideline-recommended CT surveillance after surgical treatment is poor, but the reasons are multifactorial. Efforts to improve adherence to imaging surveillance must be coupled with greater evidence demonstrating improved long-term outcomes.

Purpose Optimizing evidence-based care to improve quality is a critical priority in the United States. We sought to examine adherence to imaging guideline recommendations for staging in patients with locally advanced lung cancer in a national cohort. Methods We identified 3,808 patients with stage IIB, IIIA, or IIIB lung cancer by using the national Department of Veterans Affairs (VA) Central Cancer Registry (2004-2007) and linked these patients to VA and Medicare databases to examine receipt of guideline-recommended imaging based on National Comprehensive Cancer Network and American College of Radiology Appropriateness Criteria. Our primary outcomes were receipt of guideline-recommended brain imaging and positron emission tomography (PET) imaging. We also examined rates of overuse defined as combined use of bone scintigraphy (BS) and PET, which current guidelines recommend against. All imaging was assessed during the period 180 days before and 180 days after diagnosis. Results Nearly 75% of patients received recommended brain imaging, and 60% received recommended PET imaging. Overuse of BS and PET occurred in 25% of patients. More advanced clinical stage and later year of diagnosis were the only clinical or demographic factors associated with higher rates of guideline-recommended imaging after adjusting for covariates. We observed considerable regional variation in recommended PET imaging and overuse of combined BS and PET. Conclusion Receipt of guideline-recommended imaging is not universal. PET appears to be underused overall, whereas BS demonstrates continued overuse. Wide regional variation suggests that these findings could be the result of local practice patterns, which may be amenable to provider education efforts such as Choosing Wisely.