The impact of a fourteen-gene molecular assay on physician treatment decisions in non-small-cell lung cancer.

BACKGROUND: Five-year survival in early-stage, non-squamous, non-small-cell lung cancer (NSCLC) remains poor compared with other solid tumors, even after complete resection. Post-operative management depends on prognostic staging to identify individuals at highest risk for death, and therefore with the greatest need for further intervention. A 14-gene quantitative RT-PCR test successfully differentiates stage I-III NSCLC patients who are at high-, intermediate-, or low-risk for 5-year mortality. This study assesses the impact of the assay's prognostic information on physician decisions regarding adjuvant chemotherapy. METHODS: We invited 115 physicians who ordered the test to participate in an on-line survey. The primary outcome measure was the proportion of patients with different pre- and post-test chemotherapy recommendations. RESULTS: Fifty-eight physicians (50 %) completed the survey on 120 stage I or II NSCLC patients. Ninety-one patients (76 %) had stage I lung cancer; 27 (23 %), 39 (33 %), and 54 (45 %) patients had low-, intermediate-, and high-risk scores, respectively. Physicians' chemotherapy recommendations were changed post-testing in 37 patients (30.8 %, 95 % CI 22.7-39.9 %). High-risk patients were more likely to have a change in treatment recommendation (44.4 %, 95 % CI 30.9-58.6 %) than low risk patients (3.7 %, 95 % CI 0.1-19.0 %); a substantial number of changes were observed in both stage I (33.0 %, 95 % CI 23.5-43.6 %) and stage II (24.1 %, 95 % CI 10.3-43.5 %). CONCLUSIONS: Our data show that the assay resulted in a significant impact on physician treatment decisions in early-stage NSCLC, and that the nature of treatment changes generally correlated with the test's assessment of risk.

The quality of ambulatory care delivered to children in the United States.

BACKGROUND: Little is known about the magnitude of deficits in the quality of care delivered to children, since comprehensive studies have been lacking. METHODS: We assessed the extent to which care processes recommended for pediatric outpatients are delivered. Quality indicators were developed with the use of the RAND-UCLA modified Delphi method. Parents of 1536 children who were randomly selected from 12 metropolitan areas provided written informed consent to obtain medical records from all providers who had seen the children during the 2-year period before the date of study recruitment. Trained nurses abstracted these medical records. Composite quality scores were calculated by dividing the number of times indicated care was documented as having been ordered or delivered by the number of times a care process was indicated. RESULTS: On average, according to data in the medical records, children in the study received 46.5% (95% confidence interval [CI], 44.5 to 48.4) of the indicated care. They received 67.6% (95% CI, 63.9 to 71.3) of the indicated care for acute medical problems, 53.4% (95% CI, 50.0 to 56.8) of the indicated care for chronic medical conditions, and 40.7% (95% CI, 38.1 to 43.4) of the indicated preventive care. Quality varied according to the clinical area, with the rate of adherence to indicated care ranging from 92.0% (95% CI, 89.9 to 94.1) for upper respiratory tract infections to 34.5% (95% CI, 31.0 to 37.9) for preventive services for adolescents. CONCLUSIONS: Deficits in the quality of care provided to children appear to be similar in magnitude to those previously reported for adults. Strategies to reduce these apparent deficits are needed.

Require Individuals to Obtain Coverage.

This article explores how requiring individuals to obtain health insurance (an individual mandate) would affect health system performance along nine dimensions. An individual mandate would increase the number of people with coverage by 9 to 34 million, depending on the policy's design. Newly insured individuals would have improved patient experience and increased life expectancy. There is little evidence about how an individual mandate would affect waste; it would have no effect on spending, consumer financial risk, the reliability of receiving recommended care, or system capacity. Implementing an individual mandate would be challenging because it is difficult to determine compliance and enforce penalties for noncompliance.

Require Employers to Offer Coverage.

This article explores how requiring employers to offer health insurance (an employer mandate) would affect health system performance along nine dimensions. An employer mandate would increase the number of people with coverage by 1.8 to 3.4 million; the newly insured would have better health, as measured by life expectancy. No studies directly analyze how an employer mandate would affect patient experience; it would have no effect on spending, consumer financial risk, waste, the reliability of receiving recommended care, or system capacity. An employer mandate would be moderately challenging to implement primarily because of the need to monitor and enforce compliance.