Barbara McNeil

Diagnostic tests are usually evaluated for their informational content and effect on health outcomes. Yet patient attitudes toward taking risks and the morbid sequelae associated with either the diagnostic test or its consequences are seldom considered. The authors present a prototypical model which incorporates patient attitudes into the evaluative process. Based on traditional indices of test efficacy, preoperative searches for occult metastases in patients with presumably operable bronchogenic carcinoma should never be performed. However, if patient attitudes toward perioperative death are considered, many should have preoperative staging tests. The exact percentage of patients benefiting from testing varies with test sensitivity and specificity. This integrative approach is appropriate for oncologic patients who frequently undergo treatment.

Findings from computed tomography (CT) and ultrasound (US) examinations of 74 patients who were clinically thought to have pelvic masses and of 110 patients who had possible recurrence of pelvic tumors were analyzed. There was no significant difference in the ability of the two modalities to identify masses or to predict disease extent. Although both CT and US failed to detect some examples of spread outside of the pelvis, overstaging (apart from two cases of unconfirmed parametrial spread) did not occur with CT and occurred only once with US. The sensitivity was 0.96 for CT and 0.91 for US in the detection of pelvic masses. Both modalities had an accuracy of 0.81 in the detection of recurrent disease.

We have attempted to evaluate the role of preoperative and postoperative bone scans in patients with localized carcinoma of the breast. The yield of positive preoperative scans in patients with Stages I and II disease is low and confounded by a relatively high percentage of false-positive results. Conversely, 16 per cent of patients with Stage III disease had evidence of bony metastasis at the time of operation. Positive bone scans were found three times as frequently in patients with axillary node involvement than in those without. Thirty per cent of those observed for varying times up to 41 months had evidence of bony metastases. Again, there was a correlation with initial clinical staging with 3.6 to 8.0 times more conversions in patients with Stage II or III disease than in those with Stage I disease. It appears that the majority of metastases to the bone become apparent within the first years. This observation deserves further study to elaborate the natural history of metastati...

Ascertaining comorbid conditions in cancer patients is important for research and clinical quality measurement, and is particularly important for understanding care and outcomes for older patients and those with multi-morbidity. We compared the medical records-based ACE-27 index and the claims-based Charlson index in predicting receipt of therapy and survival for lung and colon cancer patients. We calculated the Charlson index using administrative data and the ACE-27 score using medical records for Veterans Affairs patients diagnosed with stage I/II non-small cell lung or stage III colon cancer from January 2003 to December 2004. We compared the proportion of patients identified by each index as having any comorbidity. We used multivariable logistic regression to ascertain the predictive power of each index regarding delivery of guideline-recommended therapies and two-year survival, comparing the c-statistic and the Akaike information criterion (AIC). Overall, 97.2% of lung and 90.9% of colon cancer patients had any comorbidity according to the ACE-27 index, versus 59.5% and 49.7%, respectively, according to the Charlson. Multivariable models including the ACE-27 index outperformed Charlson-based models when assessing receipt of guideline-recommended therapies, with higher c-statistics and lower AICs. Neither index was clearly superior in prediction of two-year survival. The ACE-27 index measured using medical records captured more comorbidity and outperformed the Charlson index measured using administrative data for predicting receipt of guideline-recommended therapies, demonstrating the potential value of more detailed comorbidity data. However, the two indices had relatively similar performance when predicting survival.

The introduction of the Medicare Prospective Payment System (PPS) is markedly influencing the environment in which hospitals care for patients, teach medical students and residents, and perform clinical research. Hospitals, particularly teaching institutions, are responding to this challenge by developing new management reports, by analyzing physicians' practice patterns, and by estimating more precisely the fixed and variable costs of various ancillary services. The common objective of these activities is to improve our knowledge of clinical practices, and thereby improve decisions relating to the cost-effectiveness and quality of care delivered to patients in the hospital.

Results. The overall thrombolysis rate for patients with acute myocardial infarction increased from 11% in fiscal year 1988 to 18% in fiscal year 1990 and has remained approximately at that level since then. In mid-1989, tissue plasminogen activator was used in 90% of the ...

Basically there are 62 sections on some of the most common dilemmas dealt with. These are followed by four interesting appendixes. The clinical sections are grouped under eight headings: abdominal disease (12 sections), genito-urinary disease (seven), chest ...

In both the United States and Europe, efforts to reduce soaring health care costs have led to intense scrutiny of both standard and innovative uses of imaging. Given that the United States spends a larger share of its gross domestic product on health care than any other nation and also has the most varied health care financing and delivery systems in the world, it has become an especially fertile environment for developing and testing approaches to controlling health care costs and value. This report focuses on recent reforms that have had a dampening effect on imaging use in the United States and provides a glimpse of obstacles that imaging practices may soon face or are already facing in other countries. On the basis of material presented at the 2015 meeting of the International Society for Strategic Studies in Radiology, this report outlines the effects of reforms aimed at (a) controlling imaging use, (b) controlling payer expense through changes in benefit design, and (c) contro...

The data for medical decision analyses are often unreliable. Traditional sensitivity analysis--varying one or more probability or utility estimates from baseline values to see if the optimal strategy changes--is cumbersome if more than two values are allowed to vary concurrently. This paper describes a practical method for probabilistic sensitivity analysis, in which uncertainties in all values are considered simultaneously. The uncertainty in each probability and utility is assumed to possess a probability distribution. For ease of application we have used a parametric model that permits each distribution to be specified by two values: the baseline estimate and a bound (upper or lower) of the 95 percent confidence interval. Following multiple simulations of the decision tree in which each probability and utility is randomly assigned a value within its distribution, the following results are recorded: (a) the mean and standard deviation of the expected utility of each strategy; (b) the frequency with which each strategy is optimal; (c) the frequency with which each strategy "buys" or "costs" a specified amount of utility relative to the remaining strategies. As illustrated by an application to a previously published decision analysis, this technique is easy to use and can be a valuable addition to the armamentarium of the decision analyst.

The public has just begun to recognize that despite the enormous achievements of American medicine and the American health care system, the quality of care in this country needs to be and can be improved. Two recent reports from the Institute of Medicine ...

Theoretic modeling suggests that common office tests as a group are profitable. To determine whether practicing internists perceive this profitability and whether their perceptions differ for different tests or for patients with different types of insurance coverage, the authors surveyed 111 physicians in private office practice. Respondents' estimates of receipts for tests done on patients with Medicare or Blue Cross/Blue Shield coverage were higher than their estimated costs for the testing. Estimates of receipts from Medicaid patients were lower than estimated costs of testing. After standardizing the estimated receipts from patients with different insurance coverages, the authors found that the average estimated profits for different tests on an "average insured patient" varied sixfold, from $5.99 for an electrocardiogram to $1.01 for a urinalysis. The authors suggest that perceived financial incentives are extremely variable by test. Different insurance coverages are perceived as providing varying financial incentives for testing; Medicaid provides a disincentive. Appropriate reform of the existing fee schedules should be selective by test and coverage.

Nonrandomized comparative effectiveness studies contribute to clinical and biologic understanding of treatments by themselves, via subsequent confirmation in a more targeted randomized clinical trial, or through advances in basic science. Although methodological challenges and a lack of accepted principles to assess the quality of nonrandomized studies of comparative effectiveness have limited the practical use of these investigations, even imperfect studies can contribute useful information if they are thoughtfully designed, well conducted, carefully analyzed, and reported in a manner that addresses concerns from skeptical readers and reviewers. The GRACE (Good Research for Comparative Effectiveness) principles have been developed to help healthcare providers, researchers, journal readers, and editors evaluate the quality inherent in observational research studies of comparative effectiveness. The GRACE principles were developed by experienced academic and private sector researchers and were vetted over several years through presentation, critique, and consensus building among outcomes researchers, pharmacoepidemiologists, and other medical scientists and via formal review by the International Society of Pharmacoepidemiology. In contrast to other documents that guide systematic review and reporting, the GRACE principles are high-level concepts about good practice for nonrandomized comparative effectiveness research. The GRACE principles comprise a series of questions to guide evaluation. No scoring system is provided or encouraged, as interpretation of these observational studies requires weighing of all available evidence, tempered by judgment regarding the applicability of the studies to routine care.

Multicenter, collaborative studies offer an effective way to meet the growing need for timely and generalizable clinical evaluations of imaging technologies. This article discusses issues of study design, statistical analysis, organization, and day-to-day group operation for collaborative prospective clinical evaluations. It draws significantly on the authors' experience with the Radiology Diagnostic Oncology Group, a cooperative group funded by the National Cancer Institute, which conducts comparative studies of the ability of diagnostic imaging modalities to enable the staging of various types of cancer including that of the prostate gland, lung, pancreas, colon, and rectum. The results from 2 1/2 years of the experience of this group hold promise for the importance of this approach to the future growth of radiologic research.

Profiling provider performance for the assessment of quality involves a number of issues related to selection of appropriate quality measures, subsequent data collection and analysis, and selection of standards of comparison. This article emphasizes the limitations of current data systems for this purpose and discusses hierarchical modeling as the optimal analytic approach for analyzing resulting data. Mention is made of the difficulties of achieving large enough sample sizes for statistical significance at the individual provider level. Finally, the article discusses feasible options for profiling quality.

From 2009-2010, 12 accountable care organizations (ACOs) entered into the Alternative Quality Contract (AQC), BlueCross BlueShield of Massachusetts's global payment arrangement. The AQC included six outpatient pediatric quality measures among 64 total measures tied to pay-for-performance (P4P) bonuses and incorporated pediatric populations in their global budgets. We characterized the pediatric infrastructure of these adult-oriented ACOs and obtained leaders' perspectives on their ACOs' response to pediatric incentives. We use Massachusetts Health Quality Partners and American Hospital Association Survey data to characterize ACOs' pediatric infrastructure as "extremely limited," "basic," and "substantial" based on the extent of pediatric primary care, outpatient specialist, and inpatient services. After ACOs had 16-43 months of experience with the AQC, we interviewed 22 leaders to gain insight into how organizations: (a) made changes to improve pediatric care quality, (b) tried to reduce pediatric spending, and (c) addressed care for children with special health care needs (CSHCN). ACOs' pediatric infrastructure ranged from extremely limited (e.g., no general pediatricians in their primary care workforce) to substantial (e.g., 42% of workforce were general pediatricians). Most leaders reported intensifying their pediatric quality improvement efforts and witnessing changes in quality metrics; most also investigated pediatric spending patterns but struggled to change patients' utilization patterns. All reported that the AQC did little to incentivize care for CSHCN and that future incentive programs should include this population. Although ACOs involved in the AQC were adult-oriented, most augmented their pediatric quality improvement and spending reduction efforts when faced with pediatric incentives.

To compare the abilities of magnetic resonance (MR) imaging and computed tomography (CT) in detection of lymph node metastasis from head and neck squamous cell carcinoma. MR imaging and CT were performed with standard protocols in patients with known carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. Histopathologic examination was performed to validate imaging findings. Between 1991 and 1994, 213 patients undergoing 311 neck dissections were accrued at three institutions. For the upper jugular and spinal accessory regions, the areas under the receiver operating characteristic curves for combined information on size and internal abnormality were 0.80 for CT and 0.75 for MR imaging. Sensitivities, specificities, negative predictive values (NPVs), and positive predictive values (PPVs) were calculated for various size criteria with and without internal abnormality information. With use of a 1-cm size or an internal abnormality to indicate a positive node, CT had an NPV of 84% and a PPV of 50%, and MR imaging had an NPV of 79% and a PPV of 52%. CT achieved an NPV of 90%, correlating with a PPV of 44%, with use of 5-mm size as an indicator of a positive node. CT performed slightly better than MR imaging for all interpretative criteria. However, a high NPV was achieved only when a low size criterion was used and was therefore associated with a relatively low PPV.

To determine the effects on the accuracy of staging prostate gland cancer of diagnostic prediction rules based on demographic, clinical, histologic, and magnetic resonance (MR) image variables. A total of 200 cases from four medical centers were evaluated by nine radiologists experienced in MR imaging. The accuracies of the four diagnostic variables (age, prostate specific antigen level, Gleason tumor grade, and MR imaging findings) were measured, both singly and combined in a particular sequence, by calculating the area index of the receiver operating characteristic curve. The accuracy of staging with single variables (age, 0.58; prostate specific antigen level, 0.74; Gleason grade 0.73, MR image findings, 0.74) increased as the variables were optimally merged. The first two variables combined to yield an accuracy of 0.74; the first three combined to yield an accuracy of 0.81; and all four variables resulted in an accuracy of 0.86. In a clinically important subset of 69 cases for w...

... BUDINGER, MCNEIL. ... By using clearance observations with aerosols of diethylene-triaminepenta-acetic acid (DTPA) and conventional instrumentation (12), or other molecules and positron emission tomography, it is pos sible to evaluate some features of membrane trans port. ...

The assessment of new radiologic tests can be seriously hampered by the presence of systematic bias. Biases can arise from incomplete verification of the sample population; omission of uninterpretable tests; absence of a definitive reference test; extraneous factors affecting interpretation; and extrapolation factors including variations in test efficacy among patients, hospitals, and the radiologists who interpret the tests. The authors review these biases that affect the results of efficacy studies and provide guidelines to avoid these problems.

The usefulness of performing diagnostic staging tests on patients thought to have operable bronchial carcinoma was explored by modeling the diagnostic and therapeutic processes for patients with this disease. The availability of appropriate autopsy and survival data allowed this investigation. We analyzed the results of two diagnostic and therapeeutic strategies: a test strategy in which extensive staging tests are performed preoperatively on patients with Stage I or II disease and a no test strategy in which such examinations are not performed. Average survival times are little affected by the choice of the test or no test diagnostic strategy. The chance of an immediate postoperative death, of an unnecessary operation and of a long term cure are affected more. Within the error of measurement, financial costs for the two strategies are probably the same. This investigation is a prototype for estimating the value of diagnostic staging tests and the effects of consequent alternative m...

A group of 1,041 patients was studied in an attempt to identify symptoms, signs, or laboratory findings (disease indicators) associated with either a high or low yield of abnormal barium enemas. A specific search was undertaken for subgroups with one or more statistically significant indicators of large bowel disease. If enemas were performed only for statistically significant indicators (fever, positive stool benzidine, rectal or abdominal mass, low hematocrit) or indicators of clinical importance (weight loss, constipation, diarrhea, etc.) only 13% of examinations would be eliminated. At the same time, however, 10% of patients with gastrointestinal disease would be missed.

This exploratory study examined the extent to which factors beyond characteristics of the patient, such as discharging hospital attributes and State factors, contributed to variations in post-acute services use (PASU) in a cohort of elderly Medicare patients following acute myocardial infarction (AMI). Thirty-seven percent of this cohort received PAS within 30 days of discharge and home health care was the most common type of service used. Patient severity of illness at hospital discharge, for-profit ownership of the discharging hospital, and discharging hospital provision of home health services were shown to be important predictors of PASU. After adjusting for many patient and hospital characteristics, however, variation in PASU remained across States.