Model-Based Eligibility for Lung Cancer Screening: Where Theory Meets Practice

An Independent Evaluation of the Accuracy and Usability of Electronic Adherence Monitoring Devices

Long-Term Outcomes Among Patients Discharged From the Hospital With Moderate Anemia: A Retrospective Cohort Study: Annals of Internal Medicine: Vol 170, No 2

Background: Randomized clinical trial findings support decreased red blood cell (RBC) transfusion and short-term tolerance of in-hospital anemia. However, long-term outcomes related to changes in transfusion practice have not been described. Objective: To describe the prevalence of anemia at and after hospital discharge and associated morbidity and mortality events. Design: Retrospective cohort study. Setting: Integrated health care delivery system with 21 hospitals serving 4 million members. Participants: 445 371 surviving adults who had 801 261 hospitalizations between January 2010 and December 2014. Measurements: Hemoglobin levels and RBC transfusion, rehospitalization, and mortality events within 6 months of hospital discharge. Generalized estimating equations were used to examine trends over time, accounting for correlated observations and patient-level covariates. Results: From 2010 to 2014, the prevalence of moderate anemia (hemoglobin levels between 7 and 10 g/dL) at hospital discharge increased from 20% to 25% (P < 0.001) and RBC transfusion declined by 28% (39.8 to 28.5 RBC units per 1000 patients; P < 0.001). The proportion of patients whose moderate anemia had resolved within 6 months of hospital discharge decreased from 42% to 34% (P < 0.001), and RBC transfusion and rehospitalization within 6 months of hospital discharge decreased from 19% to 17% and 37% to 33%, respectively (P < 0.001 for both). During this period, the adjusted 6-month mortality rate decreased from 16.1% to 15.6% (P = 0.004) in patients with moderate anemia, in parallel with that of all others. Limitation: Possible unmeasured confounding. Conclusion: Anemia after hospitalization increased in parallel with decreased RBC transfusion. This increase was not accompanied by a rise in subsequent RBC use, rehospitalization, or mortality within 6 months of hospital discharge. Longitudinal analyses support the safety of practice recommendations to limit RBC transfusion and tolerate anemia during and after hospitalization. Primary Funding Source: National Heart, Lung, and Blood Institute.

The ACC/AHA 2017 Hypertension Guidelines: Both Too Much and Not Enough of a Good Thing?

U.S. Food and Drug Administration Precertification Pilot Program for Digital Health Software: Weighing the Benefits and Risks

In 2017, the U.S. Food and Drug Administration (FDA) announced a new program for software classified as a medical device. The Digital Health Software Precertification (Pre-Cert) Program is designed to expedite regulatory review for companies that demonstrate quality and organizational excellence in software development. Although Pre-Cert is intended to promote the worthy goals of access and innovation in digital health, many questions have been raised. In particular, Pre-Cert may reduce incentives for developers to study the safety and effectiveness of their software products before patients start to rely on them. Although postmarket surveillance can mitigate risks of these products, the FDA does not have as much authority after a product's widespread use to enforce data collection deadlines. Pre-Cert may also create confusion for patients and physicians, who may believe that marketed products were subject to rigorous study.

Implications of Nine Risk Prediction Models for Selecting Ever-Smokers for Computed Tomography Lung Cancer Screening

Background: Lung cancer screening guidelines recommend using individualized risk models to refer ever-smokers for screening. However, different models select different screening populations. The performance of each model in selecting ever-smokers for screening is unknown. Objective: To compare the U.S. screening populations selected by 9 lung cancer risk models (the Bach model; the Spitz model; the Liverpool Lung Project [LLP] model; the LLP Incidence Risk Model [LLPi]; the Hoggart model; the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial Model 2012 [PLCOM2012]; the Pittsburgh Predictor; the Lung Cancer Risk Assessment Tool [LCRAT]; and the Lung Cancer Death Risk Assessment Tool [LCDRAT]) and to examine their predictive performance in 2 cohorts. Design: Population-based prospective studies. Setting: United States. Participants: Models selected U.S. screening populations by using data from the National Health Interview Survey from 2010 to 2012. Model performance was evaluated using data from 337 388 ever-smokers in the National Institutes of Health–AARP Diet and Health Study and 72 338 ever-smokers in the CPS-II (Cancer Prevention Study II) Nutrition Survey cohort. Measurements: Model calibration (ratio of model-predicted to observed cases [expected–observed ratio]) and discrimination (area under the curve [AUC]). Results: At a 5-year risk threshold of 2.0%, the models chose U.S. screening populations ranging from 7.6 million to 26 million ever-smokers. These disagreements occurred because, in both validation cohorts, 4 models (the Bach model, PLCOM2012, LCRAT, and LCDRAT) were well-calibrated (expected–observed ratio range, 0.92 to 1.12) and had higher AUCs (range, 0.75 to 0.79) than 5 models that generally overestimated risk (expected–observed ratio range, 0.83 to 3.69) and had lower AUCs (range, 0.62 to 0.75). The 4 best-performing models also had the highest sensitivity at a fixed specificity (and vice versa) and similar discrimination at a fixed risk threshold. These models showed better agreement on size of the screening population (7.6 million to 10.9 million) and achieved consensus on 73% of persons chosen. Limitation: No consensus on risk thresholds for screening. Conclusion: The 9 lung cancer risk models chose widely differing U.S. screening populations. However, 4 models (the Bach model, PLCOM2012, LCRAT, and LCDRAT) most accurately predicted risk and performed best in selecting ever-smokers for screening. Primary Funding Source: Intramural Research Program of the National Institutes of Health/National Cancer Institute.

Identifying Patients for Whom Lung Cancer Screening Is Preference-Sensitive: A Microsimulation Study: Annals of Internal Medicine: Vol 169, No 1

Background: Many health systems are exploring how to implement low-dose computed tomography (LDCT) screening programs that are effective and patient-centered. Objective: To examine factors that influence when LDCT screening is preference-sensitive. Design: State-transition microsimulation model. Data Sources: Two large randomized trials, published decision analyses, and the SEER (Surveillance, Epidemiology, and End Results) cancer registry. Target Population: U.S.-representative sample of simulated patients meeting current U.S. Preventive Services Task Force criteria for screening eligibility. Time Horizon: Lifetime. Perspective: Individual. Intervention: LDCT screening annually for 3 years. Outcome Measures: Lifetime quality-adjusted life-year gains and reduction in lung cancer mortality. To examine the effect of preferences on net benefit, disutilities (the “degree of dislike”) quantifying the burden of screening and follow-up were varied across a likely range. The effect of varying the rate of false-positive screening results and overdiagnosis associated with screening was also examined. Results of Base-Case Analysis: Moderate differences in preferences about the downsides of LDCT screening influenced whether screening was appropriate for eligible persons with annual lung cancer risk less than 0.3% or life expectancy less than 10.5 years. For higher-risk eligible persons with longer life expectancy (roughly 50% of the study population), the benefits of LDCT screening overcame even highly negative views about screening and its downsides. Results of Sensitivity Analysis: Rates of false-positive findings and overdiagnosed lung cancer were not highly influential. Limitation: The quantitative thresholds that were identified may vary depending on the structure of the microsimulation model. Conclusion: Identifying circumstances in which LDCT screening is more versus less preference-sensitive may help clinicians personalize their screening discussions, tailoring to both preferences and clinical benefit. Primary Funding Source: None.

Effect of a Digital Health Intervention on Receipt of Colorectal Cancer Screening in Vulnerable Patients: A Randomized Controlled Trial: Annals of Internal Medicine: Vol 168, No 8

Background: Screening for colorectal cancer (CRC) reduces mortality, yet more than one third of age-eligible Americans are unscreened. Objective: To examine the effect of a digital health intervention, Mobile Patient Technology for Health–CRC (mPATH-CRC), on rates of CRC screening. Design: Randomized clinical trial. (ClinicalTrials.gov: NCT02088333) Setting: 6 community-based primary care practices. Participants: 450 patients (223 in the mPATH-CRC group and 227 in usual care) scheduled for a primary care visit and due for routine CRC screening. Intervention: An iPad application that displays a CRC screening decision aid, lets patients order their own screening tests, and sends automated follow-up electronic messages to support patients. Measurements: The primary outcome was chart-verified completion of CRC screening within 24 weeks. Secondary outcomes were ability to state a screening preference, intention to receive screening, screening discussions, and orders for screening tests. All outcome assessors were blinded to randomization. Results: Baseline characteristics were similar between groups; 37% of participants had limited health literacy, and 53% had annual incomes less than $20 000. Screening was completed by 30% of mPATH-CRC participants and 15% of those receiving usual care (logistic regression odds ratio, 2.5 [95% CI, 1.6 to 4.0]). Compared with usual care, more mPATH-CRC participants could state a screening preference, planned to be screened within 6 months, discussed screening with their provider, and had a screening test ordered. Half of mPATH-CRC participants (53%; 118 of 223) “self-ordered” a test via the program. Limitation: Participants were English speakers in a single health care system. Conclusion: A digital health intervention that allows patients to self-order tests can increase CRC screening. Future research should identify methods for implementing similar interventions in clinical care. Primary Funding Source: National Cancer Institute.

Interactions Between Physicians and Skilled Home Health Care Agencies in the Certification of Medicare Beneficiaries' Plans of Care: Results of a Nationally Representative Survey

Background: Physicians are required to certify a plan of care for patients who receive Medicare skilled home health care (SHHC) services. The Centers for Medicare & Medicaid Services form 485 (CMS-485) is typically used for certification of SHHC plans of care and for interactions between SHHC agencies and physicians. Little is known about how physicians use the CMS-485 or their perceptions of its usefulness with respect to coordinating care with SHHC agencies. Objective: To determine how physicians interact with SHHC agencies and use the CMS-485 in care coordination for patients receiving SHHC services. Design: Mailed survey. Setting: Nationally representative random sample. Participants: Physicians from the American Medical Association Physician Masterfile specializing in family or general medicine (excluding adolescent and sports medicine), geriatrics, geriatric psychiatry, internal medicine, or hospice and palliative medicine. Measurements: Time spent reviewing the plan of care and experiences with making changes and communicating with SHHC clinicians. Results: The response rate after 3 mailings was 53% (1044 of 1968). Of 1005 respondents who provided patient care, 72% had certified at least 1 plan of care in the past year. Nearly half (47%) reported spending less than 1 minute reviewing the CMS-485 before certification, whereas 21% reported spending at least 2 minutes. Physicians typically interacted with multiple SHHC agencies by fax or mail. Approximately 80% rarely or never changed an order on the CMS-485, and 78.3% rarely or never contacted SHHC clinicians with questions about information. The mean reported ease of contacting the SHHC agency was 4.7 (SD, 2.3) on a scale of 1 (easy) to 10 (difficult). Limitation: Self-reported data and 53% response rate. Conclusion: The CMS-485 does not meaningfully engage physicians. Physicians spend little time reviewing or acting on the SHHC plan of care. Strategies to enhance meaningful communication between SHHC agencies and physicians are needed. Primary Funding Source: National Institute on Aging and National Institute of Mental Health.

Swan, Ganz, and Their Catheter: Its Evolution Over the Past Half Century

Jeremy Swan and William Ganz developed their eponymous pulmonary artery (PA) catheter in the 1970s and, in the process, revolutionized measurement of cardiac output, pressures within the left side of the heart, and resistance in systemic and pulmonary circulations. Their invention enabled diagnostic measurements at the bedside and contributed to the birth of critical care medicine; technologic advances preceding the PA catheter generally could not be used at the bedside and required patients to be stable enough to be taken to the catheterization laboratory. Swan and Ganz worked in the same department but had quite dissimilar backgrounds and personalities. This article describes their lives and careers, the state of intensive care before and after their catheter was introduced, and the natural life cycle the PA catheter faced as new, less invasive technology arrived to replace it.